Manual H-902

Reference Guide
Roche Diagnostics/Hitachi 902 Analyzer Reference Guide V1.2 RG - 1

Copyrights
© 1999 - 2003, Roche Diagnostics GmbH. All rights reserved.
Trademarks
The following trademarks are acknowledged:
Roche and Roche logo are registered trademarks of the Roche group.
Publisher
This manual is published by the
Roche Diagnostics GmbH.
Questions/comments regarding the content of this
manual can be directed to:
Roche Diagnostics GmbH
Lab. Systems Service IM & Documentation
Sandhoferstr. 116
D-68305 Mannheim
Phone: +49 621 759 4445
Manual Version 1.2
Date of Publication: Sept, 2003
Order Number: 11808923 001
Software Version 05-20, Mai 2000
Revised Manual Pages

Revised pages for this manual are provided by Roche Diagnostics when neces-
sary. No part of this publication may be reproduced in any form or by any means
without prior written permission.
Publication Reference No. Date Pages Affected
Version 1.1 June, 2000 All
Version 1.2 Sept, 2003 RG-2 to RG-4, 2-4, 3-1 to 3-10

4-16
RG - 2 Roche Diagnostics/Hitachi 902 Analyzer Reference Guide V1.2

Intended use
The Roche Diagnostics/Hitachi 902 is a fully automated system for photometric
analysis. It is important that the operator read this manual thoroughly before using
the system.
Instrument approvals
Our instruments meet the protection requirements laid down in IVD Directive 98/
79/EC and the European Standard EN 591.
Furthermore, our instruments are manufactured and tested according to the
international standards IEC/EN 61010-1 / IEC 61010-2-101.
Compliance is demonstrated by the following marks:
Complies with the IVD directive 98/79/EC.
Issued by Underwriters Laboratories, Inc. (UL) for Canada and the US.
C ® US
Contact addresses
Manufacturer
Hitachi High-Technologies Corporation

24-14. Nishi-shimbashi 1-chome, Minato-ku
Tokyo. 105-8717, JAPAN
Authorized Representative

Sandhofer Strasse 116
D-68305 Mannheim
Germany
Roche Diagnostics/Hitachi 902 Analyzer Reference Guide V1.2 RG - 3

NOTES
RG - 4 Roche Diagnostics/Hitachi 902 Analyzer Reference Guide V1.2

Table of Contents
Chapter 1 - System Description
1.1 Introduction ____________________________________________ 1-2

Introduction ____________________________________________________ 1-2
The RD/Hitachi 902 System ______________________________________ 1-3
1.2 General Overview _______________________________________ 1-4

Analyzer characteristics __________________________________________ 1-4
Materials Required ______________________________________________ 1-4
Trademarks ____________________________________________________ 1-4
Using the Operator’s Manual _____________________________________ 1-5
Manual Set-up System __________________________________________ 1-6
Manual Revisions _______________________________________________ 1-6
Analyzer Installation _____________________________________________ 1-6
Service ________________________________________________________ 1-6
Customer Training _______________________________________________ 1-6
Test Specific Information _________________________________________ 1-6
Ordering Information _____________________________________________ 1-6
Analyzer Operational Systems ____________________________________ 1-7
Analytical Unit Operating Principle _________________________________ 1-8
Control System _________________________________________________ 1-9
LCD Touchscreen _______________________________________________ 1-9
Printer _________________________________________________________ 1-9
Host Interface __________________________________________________ 1-9
FD Drive (analyzer unit) __________________________________________ 1-9
1.3 Sampling System _______________________________________ 1-10

Introduction ____________________________________________________ 1-10
Sample Disk ___________________________________________________ 1-10
Sample Probe __________________________________________________ 1-11
Sample Probe Arm ______________________________________________ 1-11
Sample Syringe/Pipettor _________________________________________ 1-12
Sample Probe Rinse Station ______________________________________ 1-12
Sampling System Flowpath ______________________________________ 1-13
Roche Diagnostics/Hitachi 902 Analyzer Reference Guide V1.2

i
1.4 Reagent System ________________________________________ 1-14
Introduction ____________________________________________________ 1-14
Reagent Disks __________________________________________________ 1-14
Reagent Probe _________________________________________________ 1-15
Reagent Probe Arm _____________________________________________ 1-15
Reagent Syringes/Pipettor ________________________________________ 1-16
Reagent Probe Rinse Station _____________________________________ 1-16
Reagent Flowpath _______________________________________________ 1-17
Stirring Unit ____________________________________________________ 1-17
1.5 Photometric Measuring System __________________________ 1-18

Introduction ____________________________________________________ 1-18
Reaction Disk __________________________________________________ 1-18
Reaction Bath __________________________________________________ 1-19
Hitergent ______________________________________________________ 1-19
Photometer ____________________________________________________ 1-20
1.6 Cell Rinse System _______________________________________ 1-22

Cell Rinse Unit _________________________________________________ 1-22
Cell Blanking ___________________________________________________ 1-24
Water Supply __________________________________________________ 1-25
Vacuum System ________________________________________________ 1-25
1.7 Operational Modes _____________________________________ 1-26

Introduction ____________________________________________________ 1-26
Initialization (INITIAL) _____________________________________________ 1-26
STAND-BY _____________________________________________________ 1-26
Parameter Check (PARAM. CHK.) _________________________________ 1-26
RESET ________________________________________________________ 1-26
Maintenance ___________________________________________________ 1-27
OPERATION ___________________________________________________ 1-27
Sampling Stop (S. STOP) _________________________________________ 1-27
STOP _________________________________________________________ 1-27
Screen Saver ___________________________________________________ 1-28
Emergency Stop (E. STOP) _______________________________________ 1-28
ii Roche Diagnostics/Hitachi 902 Analyzer Reference Guide V1.2

Chapter 2 - Instrument Specifications
2.1 Instrument Specifications _______________________________ 2-2

Introduction ____________________________________________________ 2-2
Dimensions ____________________________________________________ 2-2
Electrical ______________________________________________________ 2-2
Interface _______________________________________________________ 2-2
Test Modes ____________________________________________________ 2-2
Facility Specifications ___________________________________________ 2-3
Sampling System _______________________________________________ 2-4
Barcode Types _________________________________________________ 2-4
Reagent System ________________________________________________ 2-4
Photometric Measuring System ___________________________________ 2-4
ISE System ____________________________________________________ 2-4
Chapter 3 - Potential Hazards and Safety Precautions
3.1 Safety Classification ____________________________________ 3-2

3.2 Safety Precautions ______________________________________ 3-3
3.3 Safety Labels ___________________________________________ 3-9
Chapter 4 - Mechanical Theory
4.1 Overview _______________________________________________ 4-2

Introduction ____________________________________________________ 4-2
General Characteristics __________________________________________ 4-2
4.2 Begin Operation ________________________________________ 4-4

Introduction ____________________________________________________ 4-4
Mechanical Cycle _______________________________________________ 4-4

iii
4.3 Photometric Sample Processing _________________________ 4-9
Sample Aspiration ______________________________________________ 4-9
Sample Dispense _______________________________________________ 4-10
Sample Probe Rinse ____________________________________________ 4-10
R1 Aspiration ___________________________________________________ 4-10
R1 Dispense ___________________________________________________ 4-11
R1 Reagent Probe Rinse _________________________________________ 4-11
Sample and R1 Stirring __________________________________________ 4-11
Reagent Dispense at R2 Timing ___________________________________ 4-11
Reagent Dispense at R3 Timing ___________________________________ 4-11
Aspirate Reaction Mixture to Waste _______________________________ 4-12
Sampling End __________________________________________________ 4-12
4.4 ISE Sample Processing __________________________________ 4-13

Introduction ____________________________________________________ 4-13
ISE Sample Aspiration ___________________________________________ 4-13
ISE Sample Dispense ___________________________________________ 4-14
Sample Probe Rinse ____________________________________________ 4-14
ISE Diluent Aspiration ____________________________________________ 4-14
ISE Diluent Dispense ____________________________________________ 4-14
Reagent Probe Rinse ____________________________________________ 4-15
Sample and Diluent Stirring _______________________________________ 4-15
Internal Standard Dispense–Start of Rotation #2 _____________________ 4-15
Diluted ISE Sample Aspiration ____________________________________ 4-15
KCI and Reference Cartridge Flowpath _____________________________ 4-16
Measuring Cartridge Flowpath ____________________________________ 4-16
iv Roche Diagnostics/Hitachi 902 Analyzer Reference Guide V1.2

Chapter 5 - Measurement Principles
5.1 Overview _______________________________________________ 5-2

Introduction ____________________________________________________ 5-2
General Photometer Characteristics _______________________________ 5-2
5.2 Assay Techniques ______________________________________ 5-5

Introduction ____________________________________________________ 5-5
Selecting Assay Type and Measure Points _________________________ 5-5
Example of Endpoint Assay Entry _________________________________ 5-6
Cell Blank Report _______________________________________________ 5-8
Reference Information ___________________________________________ 5-9
Calibration Screen ______________________________________________ 5-10
Sample Program—Endpoint Assay without Sample Blanking __________ 5-11
5.3 1-Point Endpoint Assay - One Reagent ___________________ 5-13

Assay Characteristics ___________________________________________ 5-13
1-Point Endpoint Assay Graph–R1 Timing __________________________ 5-14
Sample Calculations ____________________________________________ 5-15
5.4 1-Point Endpoint Assay - Two Reagents __________________ 5-16

1-Point Endpoint Assay Graph–R1 and R3 Timing ___________________ 5-17
Sample Program and Calculations _________________________________ 5-17
5.5 1-Point Endpoint Assay with Prozone Check ______________ 5-19

1-Point Endpoint Assay with Prozone Check Graph __________________ 5-20
Sample Program and Results Calculations __________________________ 5-20
Sample Program and Prozone Check Value Calculations ______________ 5-21
5.6 2-Point Endpoint Assay _________________________________ 5-23

2-Point Endpoint Assay Graph–R1 and R2 Timing ___________________ 5-24
5.7 2-Point Endpoint Assay with Prozone Check ______________ 5-26

2-Point Endpoint Assay with Prozone Check Graph __________________ 5-27
Sample Program and Prozone Check Value Calculations ______________ 5-29

v
5.8 3-Point Endpoint Assay _________________________________ 5-31
3-Point Endpoint Assay Graph ____________________________________ 5-32
5.9 1-Point Endpoint and Rate Assay ________________________ 5-34

1-Point Endpoint and Rate Assay Graph–R1 and R3 Timing ___________ 5-35
5.10 2-Point Rate Assay ____________________________________ 5-37

2-Point Rate Assay Graph–R1 Timing ______________________________ 5-38
2-Point Rate Assay Graph–R1 and R2 Timing _______________________ 5-39
5.11 Rate A Assay __________________________________________ 5-41

Rate A Assay Graph–R1 Timing ___________________________________ 5-41
Rate A Assay Graph–R1 and R2 Timing ____________________________ 5-42
5.12 Rate A Assay with Sample Blank ________________________ 5-43

Assay Characteristics with Sample Blank __________________________ 5-43
Rate A Assay With Sample Blank Graph–R1 and R2 or R3 Timing _____ 5-43
5.13 Rate B Assay - Mode 1 _________________________________ 5-45

Rate B Assay – Mode 1 Graph–R1 and R3 Timing ___________________ 5-46
5.14 Rate B Assay - Mode 2 _________________________________ 5-48

Rate B Assay - Mode 2 Graph–R1 and R3 Timing ___________________ 5-49
5.15 Summary of Assay Techniques __________________________ 5-51
vi Roche Diagnostics/Hitachi 902 Analyzer Reference Guide V1.2

Chapter 6 - Calibration Types
6.1 Calibration Overview ____________________________________ 6-2

Calibration Methods _____________________________________________ 6-2
Using Calibration Values _________________________________________ 6-6
Calculation of Results ___________________________________________ 6-7
Calibration Mode Chart __________________________________________ 6-8
6.2 1-Point Linear Calibration _______________________________ 6-10

Selecting Linear Calibration _______________________________________ 6-10
1-Point Linear Calibration Graph __________________________________ 6-11
1-Point Linear Calculation ________________________________________ 6-12
Assay Types ___________________________________________________ 6-13
6.3 2-Point Linear Calibration _______________________________ 6-14

Selecting 2-Point Linear Calibration ________________________________ 6-14
2-Point Linear Calibration Graph __________________________________ 6-14
2-Point Linear Calculation ________________________________________ 6-16
Assay Types ___________________________________________________ 6-17
6.4 Nonlinear Logit-Log 4P Calibration _______________________ 6-18

Selecting Nonlinear Logit-Log 4P Calibration ________________________ 6-18
Nonlinear Logit-Log 4P Calibration Graph ___________________________ 6-18
Nonlinear Logit-Log 4P Calculation ________________________________ 6-19
Assay Types ___________________________________________________ 6-20
6.5 Use of Weighting in Nonlinear Calibration _________________ 6-21

Introduction ____________________________________________________ 6-21
Calculation without Weighting _____________________________________ 6-21
Calculation with Weighting _______________________________________ 6-21
Weighting Factors _______________________________________________ 6-22
6.6 Nonlinear Logit-Log 5P Calibration _______________________ 6-23

Selecting Nonlinear Logit-log 5P Calibration _________________________ 6-23
Nonlinear Logit-Log 5P Calibration Graph ___________________________ 6-23
Nonlinear Logit-Log 5P Calculation ________________________________ 6-24
Using the Weight Factors ________________________________________ 6-25
Assay types ___________________________________________________ 6-26

vii
6.7 Nonlinear Spline Calibration _____________________________ 6-27
Selecting Nonlinear Spline Calibration ______________________________ 6-27
Nonlinear Spline Calibration Graph ________________________________ 6-27
Nonlinear Spline Calculation ______________________________________ 6-28
Assay types ___________________________________________________ 6-29
6.8 Nonlinear Point to Point Calibration ______________________ 6-30

Selecting Nonlinear Point to Point Calibration ________________________ 6-30
Nonlinear Line-Graph Calibration Graph ____________________________ 6-30
Nonlinear Point to Point Calculation ________________________________ 6-31
Assay types ___________________________________________________ 6-31
6.9 ISE Calibration __________________________________________ 6-32

ISE Calibration __________________________________________________ 6-32
Slope Calculation _______________________________________________ 6-33
Internal Standard Calculation _____________________________________ 6-34
Single Point Adjustment __________________________________________ 6-35
Compensation Overview _________________________________________ 6-36
Compensation Value Calculation __________________________________ 6-36
Reference Cartridge _____________________________________________ 6-37
Nernst Equation ________________________________________________ 6-37
Calculation of Unknown Sample Concentrations _____________________ 6-39
Chapter 7 - Serum Index Function
7.1 Serum Index Function ___________________________________ 7-2

Introduction ____________________________________________________ 7-2
Definition of Serum Indices _______________________________________ 7-2
Serum Index Screen _____________________________________________ 7-3
Using Existing Chemistry Channel _________________________________ 7-3
Using a Saline Channel __________________________________________ 7-4
Saline Parameters _______________________________________________ 7-4
Selecting Serum Indices _________________________________________ 7-7
Calibrate the Serum Indices ______________________________________ 7-7
Save Parameter Changes ________________________________________ 7-7
Graphic Representation of Serum Indices __________________________ 7-8
Calculation of Serum Indices _____________________________________ 7-9
viii Roche Diagnostics/Hitachi 902 Analyzer Reference Guide V1.2

Chapter 8 - Data Alarms
8.1 Data Alarms ____________________________________________ 8-2

Result Integrity Checks __________________________________________ 8-2
Prozone Effect __________________________________________________ 8-2
Linearity Verification (LIN.) ________________________________________ 8-4
Calculation for LIN. Data Alarm ____________________________________ 8-5
Linearity Verification (LIN.8) _______________________________________ 8-6
Calculation of Lin.8 ______________________________________________ 8-7
Sensitivity Limit (SENS) __________________________________________ 8-7
S1 Absorbance Limit (S1ABS?) ____________________________________ 8-8
Duplicate Limit (DUP) ____________________________________________ 8-8
Substrate Depletion (LIMT.0, LIMT.1, LIMT.2) ________________________ 8-8

ix
NOTES
x Roche Diagnostics/Hitachi 902 Analyzer Reference Guide V1.2

Chapter 1
System Description

1-1
1.1 Introduction
Introduction
The Reference Guide is part of the total documentation for the RD/Hitachi 902
analyzer, additionally consisting of the Software Guide, User’s Guide and the
Tutorial Guide.
This Reference Guide gives a comprehensive overview of the RD/Hitachi 902
analyzer and describes the basic operation of the analytical unit and the control
unit.
Furthermore, this guide gives background information on all system-specific
topics that are not necessarily part of the daily routine, but give valuable informa-
tion on the function of the entire system.
This Reference Guide covers all topics relating to the functionality of the instru-
ment, the technical data, and the structure of the software. In addition, it contains
descriptions of the measuring methods the tests are based on with regard to
calibration and quality control.
The Reference Guide also describes in detail the safety precautions that must be
heeded while working with the RD/Hitachi 902 system.
1-2 Roche Diagnostics/Hitachi 902 Analyzer Reference Guide V1.1

1.1 Introduction
The RD/Hitachi 902 System
The Roche Diagnostics/Hitachi 902 analyzer is shown above. The analyzer is used
to report test results on various body fluid samples for a wide range of analytes.
This analyzer:
• is fully automated
• is discrete
• is computerized
• allows the use of serum/plasma, urine, CSF, supernatant, and other sample
types
• performs in vitro quantitative tests on a wide range of analytes
• performs potentiometric and photometric assays.
The RD/Hitachi 902 analyzer includes:
• photometric measuring systems
• analytical processing unit
• LCD touchscreen
• printer.

1-3
1.2 General Overview
Analyzer characteristics include:

• ready to use 24 hours per day
• sample bar code capability
• 200 tests photometric tests/hour throughput
• 300 ISE tests/hour throughput
• refrigerated storage for 40 reagent containers
• 60 positions for routine, STAT, calibrator, QC samples and wash solution
• endpoint, kinetic, and isoenzyme chemistries
• Ion Selective Electrode (ISE) chemistries
Materials Required
Packaged with your analyzer, you will receive:
• Accessory Box
• Ion Selective Electrode (ISE) Accessory Parts Case
• Installation Kit.
After your instrument is installed, the following consumable materials should be

ordered as necessary from Roche Diagnostics:
• Reagents • Printer Paper
• System Cleaning Solution • Reaction Cells
• Hitergent • Diskettes
• Sample Cups • Syringe (Pipettor) Seals
• Photometer Lamps • Sample and Reagent Probes
• Sample Barcode Labels • ISE Cartridges & Reference Cartridge
• Stirrer Paddle.
Other materials required for operation of your analyzer, but not provided by
Roche Diagnostics, include:
• Centrifuge
• Saline (non-buffered).
Trademarks
The following are registered trademarks of Roche Diagnostics:
Precical
Precitrol
The following is a registered trade name of Roche Diagnostics:
Roche Diagnostics/Hitachi 902 Analyzer

Using the Operator’s Manual

This operator’s manual is an instructional aid in the performance of tasks related
to the operation and general maintenance of the Roche Diagnostics/Hitachi 902
analyzer. The complete operator’s manual is comprised of four guides, the Refer-
ence Guide, Software Guide, User’s Guide and the Tutorial Guide. The contents of
each guide is outlined below.
Reference Guide
This guide contains detailed descriptions of instrument features and specifica-
tions. It also contains instrument and chemistry theory, including assay techniques
and calibration types.
Software Guide
This guide contains information on the operation of the RD/Hitachi 902 software,
software basics, screen navigation, etc. It also contains detailed information on
every screen within the software. This guide also explains all reports generated by
the analyzer.
User’s Guide
This guide contains information required for troubleshooting and maintenance of
your analyzer. General troubleshooting, data alarms, instrument alarms, mainte-
nance, and spare parts are all covered within this guide.
Tutorial Guide
This guide contains step-by-step daily operating procedures, daily maintenance
procedures and practical answers to many operational questions.
Each guide is arranged in a progressive sequence for easy study and reference. In
addition, each guide contains an index that cross references all the guides. Do not
operate the instrument until thoroughly familiar with the information in each guide.
The key to good performance is good preparation by thoroughly studying the
information contained in this operator’s manual.

1-5
Manual Set-up System

The general table of contents at the beginning of each guide and the subject index
located in the back of the guide provide points of quick correlation in cross
referencing. Pictorials are repeated as necessary to minimize page flipping and
references are made between sections to point out specific information.
Manual Revisions
The arrangement of the manual facilitates easy updating and revision. Page
revision packages are issued from time to time for user insertion into the manual.
Instructions accompany each revision package.
Analyzer Installation
Installation is performed by a Roche Diagnostics representative. The customer is
responsible for providing the necessary facilities as detailed in Chapter 2,
Instrument Specifications.
Service
Contact your local Roche Diagnostics representative for further information
regarding the RD/Hitachi 902 analyzer service agreement.
Customer Training
Contact your local Roche Diagnostics representative for questions regarding
RD/Hitachi 902 analyzer training.
Test Specific Information

Information specific to a particular chemistry test can be found in the chemistry
package insert and/or application sheet for that method.
Ordering Information
Replacement parts, consumable materials, reagents, calibrators and controls
should be ordered as necessary from Roche Diagnostics. When ordering, please
use the Roche Diagnostics catalog number and reference name for each item.

Analyzer Operational Systems

The analyzer uses several operational systems to perform required functions.
These systems include:
• Control System
• Sampling System
• Reagent System
• Photometric Measuring System
• Cell Rinse System.

1-7
Analytical Unit Operating Principle

The photograph below shows an overview of the instrument. The general se-
quence of events illustrated is:
• The sample disk rotates the appropriate sample to the sample probe 1
• The sample probe aspirates sample for testing
• The sample is delivered into a reaction cell on the reaction disk 4
• After the sample is placed into the reaction cell, the reagent probe adds up
to three different reagents in separate dispense cycles 5
• The stirring paddle mixes the sample after the addition of each reagent 6
• Incubation occurs as cells are immersed in the incubation bath below the
reaction disk. Reaction cells rotate through the photometer lightpath and a
measurement is taken
• The cell rinse unit removes reaction product waste and washes, rinses and
blanks reaction cells for reuse 8
❸
❺
❶ Sample Disk ❺ Stirring Paddle

❷ Sample Probe ❻ Cell Rinse Unit
❸ Reaction Disk/Incubation Bath
❹ Reagent Probe

Control System
The control system is used to control all instrument functions. Components
include the LCD touchscreen monitor and printer. An interface port for a host
computer is also available.
LCD Touchscreen
The touchscreen, where you can make selections by merely touching the screen
with your finger, is used to:
• display instrument status
• initiate instrument functions.
Each screen displays selections relating to specific instrument functions. Refer to
the Software Guide for more information on screen descriptions.
Printer
The instrument uses an 20-column, thermal dot printer. Examples of each printed
report are found in Chapter 7 of the Software Guide.
Host Interface
The instrument can be interfaced bidirectionally or unidirectionally with a host
computer. Details concerning the interfacing of the analyzer are available by
calling your local Roche Diagnostics representative.
FD Drive (analyzer unit)

The 3.5 inch floppy disk drives in the analyzer unit are used to load system
parameters during initialization and store analyzer results during operation.

1-9
1.3 Sampling System
Introduction
The Sampling System consists of a sample disk, sample syringe (pipettor), sample
probe, and a sample probe rinse station. The sample probe is mounted on a
robotic sample probe arm that moves the probe from its home position to its
aspirate and dispense positions. Each of these components is explained in detail
in the following sections.
❶ Sample Disk
❷ Sample Probe Rinse Station
❸ Sample Probe and
❸ Probe Arm
Sample Disk
The sample disk sits on a motor-driven turntable. Two concentric rings of sample
positions are arranged as follows:
Outer ring: 35 positions for routine samples
Inner ring: 3 positions for wash solutions
22 positions for controls and calibrators
The sample disk is removable. Calibrator and control materials are placed in
dedicated positions on the inner disk ring. Routine patient samples are placed in
positions on the outer ring as defined when making test selections. STAT samples
are placed in positions reserved from the System Parameters menu.
The sample disk rotates to bring the desired sample cup into position next to the
sample probe (sampling station) for specimen sampling.

1.3 Sampling System
Sample Probe
The sample probe carries sample from the sample disk to a reaction cell. The
sample probe is mounted on the sample probe arm and also has a liquid-level
sensor wire to sense the level of the liquid. This wire also functions to alert you of
insufficient sample volumes.
Sample Probe Arm

The motor-driven sample probe arm moves the sample probe from its home
position to the aspiration position at the sample disk, and then lowers the probe
into the sample. Once the sample probe detects sample via liquid level detection,
the sample probe arm stops, and sample is aspirated.
After sample has been aspirated, the probe is raised from the sample and is
moved to the reaction disk. The sample probe arm lowers the probe into the
reaction cell at the sample dispense position. Sample is dispensed while the
beveled sample probe tip is in contact with the bottom of the reaction cell. This
ensures that a precise volume of sample is deposited into the bottom of the
reaction cell even when using a low dispense volume. The sample probe is spring-
mounted on the arm to avoid damage to the probe or reaction cell.

1-11
1.3 Sampling System
Sample Syringe/Pipettor
The sample syringe is a positive-displacement pipettor, positioned behind the left
front cover of the instrument. The syringe and the plastic tubing that connects it to
the sample probe are filled with deionized water.
Sample
–––––––––
Syringe
Sample syringe
The syringe motor retracts the plunger within the chamber of the syringe. Sample
is aspirated into the tip of the sample probe. The sample probe arm moves the
sample probe to the reaction disk. The sample probe lowers into the reaction cell
and the sample pipetting syringe motor reverses to dispense the sample. The
sample probe arm lifts the sample probe from the reaction cell and moves it to the
sample probe rinse station.
Sample Probe Rinse Station

The sample probe rinse station is located between the sample disk and the
reaction disk. When sampling is completed for a particular sample, the sample
probe arm moves back into position above the rinse station. Water is flushed
through the probe and onto the outer surface of the probe tip before aspirating the
next sample. This rinse removes excess sample adhering to the inside or outside
of the probe.

1.3 Sampling System
Sampling System Flowpath

The diagram below shows the sampling system flowpath.
Sample system flowpath diagram

1-13
1.4 Reagent System
Introduction
The reagent system consists of a reagent disk, reagent syringe (pipettor) that
aspirates reagent into the reagent probe and the reagent probe rinse station.
❶ Reagent Disk
❷ Reagent Probe Rinse Station
❸ ❸ Reagent Probe and
Probe Arm
Reagent Disks
Reagent bottles are stored on the instrument in the reagent disk. The reagent disk
contains 40 positions for reagent bottles including one position (position 39) for
System Cleaning Solution (Multiclean)/1% Hitergent and one position (position 40)
for Hitergent. The reagent compartment is refrigerated. A cutaway section in the
cover allows reagent probe access to aspirate reagent.
When the instrument is ready to add reagent to a reaction cell, the reagent disk
rotates, bringing the required reagent container into position at the reagent aspira-
tion station.

1.4 Reagent System
Reagent Probe
The reagent probe carries reagent from the reagent disk to the reaction cells. The
reagent probe is mounted on the reagent probe arm. The reagent probe has a
liquid level sensor wire signaling the computer when the reagent probe tip is
immersed in reagent (or if no reagent is present).
Reagent Probe Arm

The reagent probe is mounted on a motor-driven reagent probe arm. After the
reagent container is in position at the reagent aspiration station, the reagent probe
arm moves the reagent probe from its home position to the reagent disk and
lowers the probe into the reagent container. When the reagent liquid level sensor
detects reagent, the instrument stops lowering the probe, and reagent is aspi-
rated.
After reagent has been aspirated, the probe moves from the reagent container to
the reaction disk, where reagent is dispensed into a reaction cell containing the
sample. Unlike the sample probe, the reagent probe is not lowered into the
reaction cell. Reagent is dispensed from the top of the reaction cell.

1-15
1.4 Reagent System
Reagent Syringes/Pipettor
The reagent syringe is a positive-displacement pipettor, positioned behind the
front cover of the instrument. The syringe, and the plastic tubing connecting it to
the reagent probe, is filled with deionized water.
Reagent
Syringe ––––––––––––––
Reagent syringe
When the reagent probe tip is immersed in reagent, the reagent syringe motor
retracts the plunger within the chamber of the syringe, and reagent is aspirated
into the reagent probe.
After the reagent probe is in position above the reaction disk, the syringe motor is
reversed, and reagent is dispensed into the reaction cell. Following reagent
dispense, the reagent probe is moved to the reagent probe rinse station.
Reagent Probe Rinse Station

Reagent probe rinse station is located between the reaction disk and the reagent
disk. After each reagent dispense, water is flushed through the probe and onto its
outside surface prior to aspiration of the next reagent.

1.4 Reagent System
Reagent Flowpath
The diagram below shows the reagent system flowpath.
Reagent system flowpath diagram
Stirring Unit
The stirring unit consists of a slender stirring paddle, the motor that spins the
paddle, the motor that moves the stirring paddle to and from the reaction disk,
and the motor that moves the stirring paddle up and down.
Following the addition of each reagent to a reaction cell, the stirring unit moves
from its home position to the reaction disk, and the stirring paddle is lowered into
the reaction cell. As the paddle is fully lowered into the cells, the stirring motor is
briefly activated to mix the contents of the reaction cell. The stirring unit then is
lifted from the reaction cell, and returned to its original position where it is thor-
oughly rinsed with deionized water.

1-17
1.5 Photometric Measuring System
Introduction
All photometric tests are measured by the photometer. The photometer is located
adjacent to the reaction disk. The photometric measuring system detects color or
turbidity change produced by chemical reactions between reagents and the
analyte of interest in the sample, while in the reaction cells. The photometric
measuring system is capable of monochromatic and bichromatic photometry of
endpoint, kinetic, ultraviolet, and visible light chemistry determinations. These
types of chemistry assays are discussed in detail in Chapter 5 of this guide,
Measurement Principles.
The remainder of this section discusses the functions of the photometric measur-
ing system components.
Reaction Disk
The reaction disk, shown below, is a large rotatable disk holding 48 reusable
plastic reaction cells (cuvettes) around the outside perimeter of the disk. These
cells are immersed in the reaction bath. The bath maintains the cells at
37 ± 0.1 °C, an optimal temperature for the chemical reactions occurring in the
cells. The reaction disk rotates to move the cells to all reaction processing stations
including the photometer lightpath.
Reaction disk and cell rinse unit

Reaction Bath
The circular reaction bath, positioned beneath the reaction disk, maintains the
reaction mixtures in the reaction cells at a temperature of 37 °C. Water in the
reaction bath is circulated by a pump through a refrigeration unit and heater where
it is cooled or heated, as necessary, to maintain the temperature (± 0.1 °C).
Two glass windows (inner and outer) are positioned in opposite walls of the
reaction bath. These windows permit light from the photometer lamp to pass
through the reaction bath water, and through the reaction cells in the bath. The
light beam passes through the inner window of the reaction bath and enters the
instrument photometer.
Photometer window
A liquid level sensor detects the water level of the bath. Deionized water is auto-
matically added to the reaction bath, as determined by the liquid level sensor, to
compensate for evaporation. This occurs even in STAND-BY. In addition, the
entire reaction bath water volume is automatically replaced with fresh deionized
water each time the instrument is powered up.
Hitergent
Hitergent is a non-ionic, bacteriostatic detergent automatically added to the
reaction bath by the reagent probe whenever the water is exchanged. It acts as a
surfactant to minimize the formation of bubbles that could potentially interfere with
the photometer readings. Hitergent is located in position 40 on the reagent disk.

1-19
Photometer
The photometer is positioned so that absorbance readings of each reaction cell
are taken as the reaction disk is turning. This arrangement enables the instrument
to read the absorbance of each reaction cell once every 18 seconds.
The photometer lamp is positioned beneath the center of the reaction disk, within
the ring of the reaction bath.
Photometer lamp
The lamp is encased in a constant-temperature water jacket (shown in the photo-

graph above), which helps to maintain a constant energy output from the lamp,
and also extends the lamp life.
After the reaction mixture is stirred and incubated, the absorbance of the reaction
mixture is measured by the photometer, and the results are calculated from those
readings.
The light from the photometer lamp passes through the following structures in
sequence:
1) inner reaction bath window
2) reaction bath water
3) reaction cell and its contents
4) reaction bath water
5) outer reaction bath window
6) photometer.

When the light beam enters the photometer, it strikes a diffraction grating. This
separates the light into its constituent wavelengths, and reflects them onto a fixed
array of 12 photodetectors. Each photodetector is permanently positioned to
detect light at a different wavelength. There are no moving parts within the pho-
tometer, therefore no maintenance is required. The figure below shows a cutaway
of the photometer light path.
Instrument parameter information for each assay is programmed into the instru-
ment computer. The computer uses the parameter information programmed to
select the wavelengths and the times at which a reaction mixture’s absorbance is
read and results calculated.
The instrument computer keeps track of which test is being performed in each
reaction cell. It also knows when each reaction cell passes through the photom-
eter light path. The computer uses this tracking ability and the programmed read
instructions to obtain test results. A complete discussion of the instrument’s
calculation of results is found in Chapter 5 of this guide, Measurement Principles.

1-21
1.6 Cell Rinse System
Cell Rinse Unit

As shown in the photograph below, the reaction cell rinse unit consists of a series
of nozzles mounted above one side of the reaction disk. The nozzles are con-
nected to vacuum lines and deionized water supply lines. The reaction cell rinse
unit performs the following functions:
• removes reaction mixture waste from reaction cells
• rinses reaction cells with deionized water
• aspirates rinse water from reaction cells
• dispenses deionized water into reaction cells for photometric cell blanking
• aspirates water from reaction cells after photometric cell blanking
• dries inside walls of reaction cells prior to sample dispense.
These functions occur as part of the instrument’s routine operation. Each reaction
cell is thoroughly cleaned after final absorbance measurement of a reaction
mixture. The reaction cell integrity is checked prior to reusing the cell for additional
patient samples.
Cell Rinse Unit

The figure below shows the rinse order for reaction cells and water blank mea-
surements.
Arrangement of Rinse Nozzles
Nozzle #1, at the far right side of the rinse unit, is the home or starting position for
the reaction cells. The reaction disk moves counterclockwise and the reaction
cells are indexed through the rinse unit from right to left.
The function of the reaction cell rinse unit can best be described by following a
reaction cell as it indexes through the rinse unit.
Once every 18 seconds the cell rinse unit lowers into the reaction cells and
vacuum is applied to its vacuum nozzles. These spring-loaded nozzles touch the
bottom of the reaction cells and aspirate the liquid from them.
Thirty-eight disk rotations after sample is added to a reaction cell, that same cell
pauses at cell rinse nozzle #1. The results have been calculated and reported for
the reaction mixture in this cell. Nozzle 1A aspirates the reaction mixture into a
vacuum trap. The high concentration waste drains into the serum waste container.
A solenoid valve opens, permitting deionized water to flow through nozzle 1D into
the reaction cell.
The cell rinse unit raises and the reaction disk begins its next rotation. Deionized
water remains in the cell until it reaches the next cell rinse nozzle (18 seconds
later). This “soak” allows effective cleaning of the reaction cells.
This reaction cell is positioned at cell rinse nozzle 2A, which aspirates the deion-
ized water and transfers the cell contents to the main instrument floor drain.
Nozzle 2D dispenses deionized water into the cell. The rinse unit raises, and the
reaction disk begins its next rotation.
Cell rinse nozzle 3A aspirates the distilled water and transfers the cell contents to
the main instrument floor drain. Nozzle 3D dispenses deionized water into the cell.

1-23
The rinse unit raises, and the reaction disk begins its next rotation.
Cell rinse nozzle 4A has a Teflon block at its tip. This block directs a vacuum to
the corners of the reaction cell as the nozzle removes all water from the cell. The
rinse unit raises and the reaction disk begins its next rotation.
Cell rinse nozzle 5D dispenses deionized water into the cell. This water is left in
the cell for reading cell blank absorbance. The cell rinse unit raises and the
reaction disk begins its next rotation.
The deionized water remains undisturbed in the reaction cell during the next four
reaction disk rotations. During each rotation, cell blank absorbance is determined
and compared to cell blank data stored in the computer memory. See the follow-
ing section for an explanation of this cell blank procedure.
Cell rinse nozzle 6A aspirates cell blank water from the cells. The cell rinse unit is
raised and the reaction disk begins its next rotation.
Cell rinse nozzle 7A aspirates any remaining water from the cells. Nozzle 7A has a
Teflon block at its tip to direct a vacuum to the corners of the reaction cell. Nozzle
7D dispenses water to rinse the Teflon block on nozzle 7A. This occurs only during
the first few rotations preceding the first sample aspiration. The cell rinse unit
raises and the reaction disk begins its next rotation.
Sample is dispensed into the cell two rotations after completing the cell rinse and
corresponding water blanks.
Cell Blanking
Cell blank absorbances are used for two purposes:
• to confirm the optical characteristics of the cell
• to serve as a baseline for the reaction measurement.
Weekly cell blanking is performed from the Maintenance/Cell Blank screen. Refer
to the User’s Guide for instructions on how to perform a weekly cell blank. All
reaction cells are filled with deionized water. The cells pass through the photom-
eter light path, where their absorbances are measured at 12 wavelengths. The
measured absorbance data for all 48 cells is stored on the parameter disk and in
computer memory for subsequent comparison.
When reaction cells are photometrically blanked during operation, the values
obtained are compared with the values stored in memory. The absorbance of
each reaction cell filled with deionized water is measured on four consecutive
rotations. All cell blanks are streak blanks, taken while the reaction disk is in
motion. The streak blank measures only the two reaction wavelengths needed for
the assay to be performed in the cell.

To confirm the cell’s optical characteristics, each measurement of the water-filled

cell is compared to the reading of that same cell obtained during a cell blank
performed from the Maintenance/Cell Blank screen. (This cell blank reading is
automatically updated when each new cell blank procedure is performed.) If
acceptable, the readings serve as the zero offset or baseline for calculating final
results. The first time these pre-sample cell blank readings are outside compari-
son absorbance limits stored in the computer memory for that cell, no alarm is
issued, but the cell is not used for a test. The sample dispense is held until the
next acceptable cell is available. If additional cells are not acceptable, a series of
cell blank alarm messages may occur. Refer to the User’s Guide for more informa-
tion on the different cell blank alarms that are issued.
Cell blanks must also performed after changing the reaction cells or the photometer lamp.
n
Water Supply
The reaction cell rinse unit uses the deionized water supply and the internal
vacuum system. The deionized water supply system consists of the deionized
water reservoir, and a series of pumps and electronic solenoid valves. Water is
supplied to the reaction cell rinse unit directly from the deionized water reservoir.
Water is automatically added to the reservoir when necessary. Water from this
source is also supplied to the probe and stirring unit rinse baths and to the reac-
tion bath.
Vacuum System
The vacuum system consists of a vacuum pump, vacuum reservoir, and high
concentration waste container. The vacuum system is used by the reaction cell
rinse unit to aspirate reaction mixture waste and reaction cell rinse water. Reac-
tion mixture waste drains into the high concentration waste container. Reaction
cell rinse water is removed from the instrument through the main floor drain line.
The vacuum system is located in the rear of the analyzer and should be accessed
only by your Roche Diagnostics service representative.

1-25
1.7 Operational Modes
Introduction
While the instrument is on, it is in one of several operational states, or modes. The
current operational mode reflects instrument activity. For example, while the
instrument is in the Operate mode, maintenance functions cannot be requested.
The operational mode is displayed in the left portion of the analyzer status line at
the top of the Status screens. An overview of the functions occurring in each
mode is provided in the following sections.
Initialization (INITIAL)
The Initialization mode begins when the instrument is powered on. During this
period (approximately 13 minutes), system parameter information is automatically
read and various mechanisms are synchronized and readied to perform functions
as instructed by the operator. During Initialization:
• reaction bath water is exchanged
• Hitergent is added to the bath
• mechanical reset is performed.
LCD touch-screen functions cannot be requested during the Initialization mode.
STAND-BY
STAND-BY is defined as a waiting mode; the instrument is ready to perform
functions, as requested. This is the usual mode of the instrument when not in the
Operate mode.
Parameter Check (PARAM. CHK.)

Parameter Check is a momentary state that occurs when the instrument is placed
into Operation. During this time, the instrument computer checks internal param-
eters to ensure that no abnormal conditions exist.
RESET
Immediately following Parameter Check the instrument enters Reset, during which
it resets all mechanisms to verify proper alignment and synchronization prior to
entering Operate. This state is transitional and lasts less than one minute.

Maintenance
The following modes indicate that a maintenance function is being performed.
WATER EXG. PROBE ADJ. PROBE WASH
WASH MECHA. CHK. ISE MAINT.
PHOTO CHK ISE PRIME CHECK
CELL BLANK ISE CHECK ID CHECK
OPERATION
The Operation mode is the state during which the instrument processes samples.
This includes the time after the instrument has passed through Parameter Check
and Reset, when the instrument is preparing reaction cells for sample dispense.
After the instrument has sampled and dispensed all specimens programmed by
the operator, it automatically leaves the Operation mode and enters the Sampling
Stop mode.
Sampling Stop (S. STOP)

Sampling Stop is the time period, in the Batch mode, after the instrument has
sampled and dispensed all specimens programmed, and before all reaction
processing is completed. You may instruct the instrument to enter this state by
touching the Stop key on the LCD touch-screen. This can be done to stop sam-
pling without terminating reaction processing already in progress.
The Sampling Stop mode is terminated after all results have been printed and all
reaction cells have been cleaned by the cell rinse unit.
STOP
When the instrument completes all sample processing in the Batch mode, it enters
the Stop mode. When in the Easy mode, the analyzer does not automatically enter
the Stop mode. The Stop key must be touched to place the analyzer in the Stop
mode. This mode is transitional, and remains in effect for less than one minute.
Following the Stop mode, the instrument enters STAND-BY.
All test processing functions stop at the end of the current mechanical cycle,
batch transfer of results to the host computer terminates, and operator-controlled
maintenance functions such as probe adjust end.

1-27
Screen Saver
The instrument puts itself in the screen-save mode after being idle for approxi-
mately 10 minutes. In the screen-saver mode, the LCD screen is blank. To reacti-
vate the screen, touch the screen surface.
Emergency Stop (E. STOP)

Emergency Stop is initiated by the analyzer due to a mechanical or system
problem detected by the analyzer. All functions are terminated immediately.

Chapter 2
Instrument Specifications
Roche Diagnostics/Hitachi 902 Analyzer Reference Guide V1.2 2-1

2.1 Instrument Specifications
Introduction
The following specifications apply to the Roche Diagnostics/Hitachi 902 analyzer.
Dimensions
Analytical Unit
Width 28.1" (720 mm)
Depth 28.1" (720 mm)
Height 42.3" (1085 mm)
Weight 418.9 lb (190 kg)
Clearance on all sides should be 22 inches (564 mm) minimum after installation. The
instrument requires a minimum door width of 31 inches (794 mm) and a turning radius
of 64 inches (1640 mm). The weight of each unit is evenly distributed on four leveling
feet. Access to normal laboratory facilities such as sink, refrigerator, and storage
space is essential. No fume hood or external exhaust system is required.
Electrical
A separate, instrument-dedicated circuit supplying such power must be provided.
United States and Canada
115 ± 10%, 20 amp dedicated line
60 Hz ± 0.5 Hz
All other countries
230 ± 10%, 10 amp dedicated line
50 Hz ± 0.5 Hz
≤ 1.5 KVA
Ground terminal is needed, ground resistance is 10 Ω maximum.
Interface
RS-232 Serial Interface, bidirectional
Test Modes
Monochromatic Bichromatic
Endpoint Endpoint with sample blanking
Kinetics Kinetics with sample blanking

Simultaneous endpoint and kinetic Simultaneous double endpoint and kinetic

Ion Selective Electrodes (ISEs)
Facility Specifications
Installation of the instrument is performed by a Roche Diagnostics representative.
The customer is responsible for providing the necessary facilities as specified in
the following paragraphs
For US customers: If, after completion of the site survey, the facility water specifications do
n not meet those stated in the water paragraph of this section, Roche Diagnostics will provide
you with technical assistance in locating the water conditioning equipment necessary to meet
the stated requirements. Contact your local representative for more information.
Water Requirement: 12 liters of bacteria-free water per hour during
operation
1.5 megohm minimum resistance
100 liters per hour flow rate
15 - 25 psi, 0.5 - 3.5 Kgf/cm2
Reaction Bath: Circulating incubation bath; 37 ± 0.1 °C
Reaction Cells: 48 semi-disposable plastic cuvettes
Operating Conditions: 18 to 30 ± 2 °C (59 to 86 °F) room temperature
20 to 80% relative humidity with no dew conden-
sation
Drain: Although the instrument is equipped with a 10-liter
waste water container, it is preferable that a floor
drain be provided. It should be capable of carrying
15 liters of waste water per hour during maximum
operation. The drain cannot be more than 4 inches
(10 cm) above the floor level and 16 feet (4.88 m)
from the analyzer.
Temperature and The instrument generates approximately 5,200
Humidity: BTU/hour.There must be adequate ventilation in
the area of the instrument. Room temperature
variation within any specific day should not
exceed ± 2 °C (± 4 °F). The top of the instrument
must not be in direct sunlight or in the path of
forced air flow. Free air flow must be allowed
around all sides of the instrument.

Sampling System
Sample Volume/Test: 2 - 50 µl
Throughput: 200 photometric tests per hour
300 ISE tests per hour
Barcode Types
Use only barcodes with check digits. Barcode label misreads could potentially go
undetected when a check digit is not used.
• Code 128 • Interleaved 2 of 5
• Codabar (NW 7) • Code 39
Reagent System
Reaction Volume/Test: 250 - 500 µl
Reagent Dispense Volume: 20 - 350 µl
Reagent Storage: Refrigerated (5 - 15 °C) compartment containing
40 refrigerated positions
Reagent Bottles: 20 ml and 50 ml
Reagent Pipettor: Positive displacement stepper motor driven
Photometric Measuring System

Light Source: Tungsten halogen lamp
Photometer: Multiple wavelength spectrophotometer
Optical Mode: Monochromatic and bichromatic
Wavelength: 12 wavelengths available: 340, 376, 415, 450, 480,
505, 546, 570, 600, 660, 700, 800 ± 2 nm
Light Path: 6 ± 0.2 mm
Optical Range: 0.0000 -2.5000 absorbance
ISE System
Sample Volume: 10 µl
Tests: Na, K, Cl
Type: Flow through, liquid membrane
Method: Indirect potentiometry
Measurement Range:Serum/Plasma Urine
Na: 80 - 180 mmol/l 10 - 250 mmol/l
K: 1.5 - 10.0 mmol/l 1 - 100 mmol/l
Cl: 60 - 120 mmol/l 10 - 250 mmol/l

Chapter 3
Potential Hazards and Safety Precautions

3.1 Safety Classification
Safety classifications
Throughout this manual three icons are used to draw attention to certain information.
The icons and their definitions are listed below.
Notes contain important information about a topic in the text.
n
Caution messages contain information which, if not observed, could result in loss of data or in
damage to the analyzer.
Warning messages contain information which, if not followed, could cause serious personal
injury and/or damage to the analyzer.

3.2 Safety Precautions
Safety Precautions
Before working with the analyzer, you should become acquainted with all safety
precautions and regulations concerning handling of materials and the system’s
electrical and mechanical components. This protects you and your colleagues from
potential hazards. .
Particular attention must be taken of the following safety precautions. If these safety
precautions are ignored, the operator may suffer serious or fatal injury. Each precaution is
important
Operator Qualification
Operation should be conducted under the supervison of a technician who has
undergone training at the facility specified by the sales agent.
For clinical tests, the instrument should be used under the direction of a Ph.D.,
clinical chemist or pathologist.
Electrical Safety Precautions
As with any electronic equipment, electrical shock can occur. DO NOT attempt to
gain access to parts of the instrument marked with this label. DO NOT attempt to
work in any electronic compartment. Installation, service and repair can only be
performed by authorized and qualified personnel.
Should one of the instrument circuit breakers or fuses “blow,” DO NOT attempt to
operate the analyzer before contacting Roche Diagnostics.
Chemical Safety Precautions
The operator is responsible for taking all necessary precautions against hazards
associated with the use of clinical laboratory chemicals. Specific recommendations
for each reagent used on the analyzer are found on reagent packaging.
Immediately clean reagent spills from the instrument.
Mechanical Safety Precautions
As with any mechanical system, there are certain precautions to take when operat-
ing the instrument. DO NOT wear loose garments or jewelry that could catch in
moving mechanisms. DO NOT put your hands into the pathway of any moving parts
while the analyzer is in the Operation mode or in any maintenance mode. The
sample probe pathway is indicated by yellow warning labels on the surface of the
instrument. Whenever possible, operate the instrument with covers in place. DO
NOT attempt mechanical repair unless the instrument is in STAND-BY or is turned
off.

Particular attention must be taken of the following safety precautions. If these safety
precautions are ignored, the operator may suffer serious or fatal injury. Each precaution is
important
Flammables
Avoid using dangerous flammables around the instrument. Fire or explosion may
result.
Mechanisms in Action
Do not open the rear or side covers with the power supply turned on. If you touch
the cooling fan, you may be injured.
Avoid touching the sample pipetting mechanism, reagent pipetting mechanism,
stirring mechanism, rinse mechanism, and other moving parts while the instrument
is operating. Otherwise, personal injury may result.
Photometer Lamp
Avoid looking at the light from the lamp with the naked eye, as your eyesight may
be impaired. If you need to look at the lamp, wear tinted safety glasses to shield
your eyes from ultraviolet rays.
To avoid burns, do not touch the hot lamp and lamp housing. Do not touch the new
lamp as oils remain causing a “hot spot” shortening lamp life.
Accuracy/Precision of Measured Results
For proper use of the instrument, measure control samples and monitor the instru-
ment during operation.
An incorrect measuring result may lead to an error in diagnosis, therefore posing
danger to the patient.
Operation and Maintenance
During operation and maintenance of the instrument, proceed according to the
instructions and do not touch any parts of the instrument other than those specified.
Avoid touching the sample pipetting mechansim, reagent pipetting mechansim,
stirring mechanism, rinse mechanism and other moving parts while the instrument is
operating. Otherwise, personal injury may occur, the instrument may be damaged
or operation may be stopped.
Avoid touching the reaction disk, the sample disk and the reagent disk while the
instrument is in operation. Otherwise, personal injury may occur, the instrument
may be damaged or operation may be stopped.
Loading of Samples and Reagents
Load samples and reagents only into the specified positions on the instrument. If
sample or reagent is spilled, this may cause the instrument to malfunction.

Moving Parts
Do not touch moving parts of the sample probe, reagent probe, stirring mechanism,
or rinsing mechanism during instrument operation. Otherwise, the instrument may be
damaged or the operator may be injured.
Instrument Covers
While the instrument is operating, keep all covers closed and in place except to add
samples. This includes the sample tray cover.
Sample Disk
Do not touch the sample disk during instrument operation.
Do not place hands in yellow stickered area during operation.
When inserting/removing the sample disk ensure the instrument is in STAND-BY
and hold the sample disk by the handle.
Reaction Disk
Do not touch the reaction disk during instrument operation.
Heed all instructions when removing, inserting, and replacing the reaction disk or the
reaction cell segments. Otherwise, the instrument may be damaged.
Reagent Disk
Do not touch the reagent disk or the reagent disk cover during instrument operation.
Otherwise, the instrument may be damaged or operation may be stopped.
Do not open the reagent disk covers except for replacing of reagents. Otherwise, this
may cause a drop in the cooling effect or deterioration of the reagents.
Power Interruption
On occurrence of momentary power voltage drop due to power interruption or
lightning, the control section of this instrument may become faulty, or the system
software, application software or data may be damaged.
Cooling Fans
Before cleaning the cooling fans, properly shut down the system and turn off the
power at the Power switch of the instrument and the power supply board.
If cleaning is attempted with the power turned on, electrical shock may occur when
touching the cooling fan.

Caution messages contain information which, if not observed, could result in loss of data or in
damage to the analyzer.
Application
The instrument is designed for photometric and potentiometric analysis using water-
soluble samples and reagents. Other types of analyses are not supported on this
instrument.
Installation Requirements
Installation is performed by a Roche Diagnostics representative. The customer is
responsible for providing the necessary facilities as detailed in Chapter 2 of this
guide.
Restrictions on Samples and Reagent Solutions
The reaction cells, sample cups, and waste solution flow path are not guaranteed to
be chemically resistant against organic solvents. Therefore, do not use organic
solvents on these parts.
Avoid using sample and reagent solutions that are likely to adhere to the sample
probe, reagent probes, and reaction cells.
Reaction Cells
If a reaction cell dries out after use, removal of contaminants becomes difficult. For
this reason, reaction cells must be immersed in deionized water for storage after
use. If the instrument is not used for more than three days, remove the reaction cells
from the reaction disk and immerse them in a 2% Hitergent solution.
Switching On the Instrument
Never turn on the power within one second after turning it off.
Instrument Unused for a Long Time
If the instrument is not used for a long period of time, the Main Power switch must
be set to off. Also, remove the reaction cells and immerse them in a 2% Hitergent
solution.
Stirrer
Do not bend the stirrer.
Insoluble Contaminants in Sample
Insoluble contaminants such as fibrin and dust in samples may cause pipetting
volume shortage and deterioration in measurement accuracy. When loading samples
on the instrument, make sure that samples contain no insoluble contaminants such
as fibrin or dust.

Spillage
Any liquid spilled on the instrument may result in the malfunctioning of the system.
If liquid does spill on the instrument, wipe it up immediately and apply disinfectant.
Particular care must be taken when performing the following procedures:
Preparing and processing samples
Using the SysClean M solution
Emptying the liquid waste container (if installed)
Electromagnetic Devices
Devices that emit electromagnetic waves may affect measured data, or cause the
instrument to malfunction. DO NOT operate the following devices in the same room
where the system is installed:
Mobile phone
Transceiver
Cordless phone
Other electrical devices that generate electromagnetic waves
Approved Parts
Only use parts and devices approved by Roche Diagnostics. Use of non-approved
parts or devices may result in malfunction of the instrument and may render the
warranty null and void.
Biohazardous Materials
As is the case with all in vitro diagnostic equipment, patient samples, serum-based
calibrators and quality control (QC) products assayed on this system, as well as all waste in
the waste solution reservoir, should be treated as potentially biohazardous materials. All
materials and mechanical components associated with the ISE and photometric sampling and
waste systems should be handled according to your facility’s biohazard procedure. Use the
personal protective equipment recommended by your facility when handling any of these
components.
Samples
Contact with samples may results in infection. When handling samples, be sure to
ware protective equipment. If samples directly contact your skin, wash it off
immediately with water and apply a disinfectant. Consult a physician.
If sample is spilt on the instrument, be sure to wear protective equipment, and wipe
it off with a gauze square. Then, apply a disinfectant.
Liquid Waste Solution
Dispose of waste solution according to the appropriate local regulations for handling
biohazardous materials.

Consult the reagent manufacturer’s material safety data sheets (MSDS) for
information on the concentrations of heavy metals and other toxic constituents in
each reagent.
Laboratory Solutions
Specific recommendations for the handling of each reagent or cleaning solution
used on the system are found in the packaging. MSDSs are available for Roche
Diagnostics reagents and cleaning solutions.
Handling of Cleaning Solutions (Detergents)
Roche Diagnostics cleaning solutions have corrosive properties. Handling of
cleaning solutions with bare hands may result in skin or eye damage. Always wear
protective (chemical resistant) gloves and safety glasses when handling cleaning
solutions.

3.3 Safety Labels
Safety Labels of the System

Warning labels have been placed on the modules to draw your attention to areas of
potential hazards. The labels and their definitions are listed below.
Warning
This label indicates there is a danger of hazardous
situations within the vicinity of this label, which may
result in death or serious injury.
Biohazard Warning
This label indicates there are potential biohazards
within the vicinity of this label. The relevant
laboratory procedures on safe use must be observed
Do Not Touch
This label indicates the area within the vicinity of this
label should not be touched or slight or minor injuries,
and/or damage to equipment may occur
Spillage
This label indicates the instrument may be damaged
if a spillage occurs within the vicinity of this label.
DO NOT place liquids in this area.
Do not insert hand
Do not insert the hand within the range of sample-
probe upon setting a sample. Contact causes injury.

3.3 Safety Labels
NOTES

Chapter 4
Mechanical Theory

4.1 Overview
Introduction
This section gives a detailed explanation of the analytical unit’s mechanical sys-
tems. These systems include:
• Sampling system • Photometric measuring system
• Reagent system • Cell rinse system
• Reaction bath system • ISE system
These mechanical systems work together with the chemistry system and the control
unit to produce final results. For a detailed explanation of the control unit systems,
refer to Chapter 1 of this guide. For a detailed explanation of the chemistry system
refer to Chapter 5 of this guide, Measurement Principles.
General Characteristics
The analyzer is a totally self-contained COMPUTERIZED, PROGRAMMABLE,
DISCRETE, SELECTIVE, SEQUENTIAL, FULLY AUTOMATED chemistry analyzer.
Each of these terms is defined below as they relate to the analyzer.
COMPUTERIZED—Calibration, calculations, and quality control analyses are
performed by the computer. Test parameters are entered and stored on the
parameter disk. The mechanical functions of the instrument are also controlled by
the computer.
PROGRAMMABLE—The operator provides input to the instrument computer for test
requests, quality control manipulation, and calculated tests. Maintenance proce-
dures are requested from the LCD screen.
DISCRETE—Each photometric test is performed in its own reaction cell. Most
chemistry procedures require no pretreatment of the sample by the operator or the
instrument.
The Ion-Selective Electrode (ISE) Assembly assays sodium, potassium, and chlo-
ride on a single sample at the same time. The electrolytes can be performed alone,
or at the same time photometric chemistries are performed.
SELECTIVE—The operator programs the instrument to perform one test, several
tests, or a full test profile on each sample. The analyzer performs only the selected
tests on each sample.
SEQUENTIAL—Tests are performed in reaction cells, positioned in the reaction disk.
The reaction disk rotates 360° plus one cell position every 18 seconds. The rotation
allows sequential processing to occur.

4.1 Overview
FULLY AUTOMATED—After pressing the Start button, the analyzer performs all
programmed tests on each sample, as well as calibrations followed by controls,
without operator intervention.

4.2 Begin Operation
Introduction
This section describes the mechanical function of the instrument. The mechanical
cycle is defined as a series of mechanical events occurring at specific times within
an 18-second time period.
Mechanical Cycle
The reaction disk (part of the photometric measuring system) is the central compo-
nent of reaction processing. All other systems associated with reaction processing
are distributed around the reaction disk. The discussion of the mechanical cycle
centers on the activity of the reaction disk and its associated components, as
shown below.
❶
❼
❺
❻
Reaction Processing Components
❶ Reaction Disk ❷ Cell Rinse Unit

❸ Sample Probe ❹ Sample Disk
❺ Reagent Probe ❻ Reagent Disk
❼ Stirrer

4.2 Begin Operation
The figure below illustrates the reaction disk in a close-up view. The reaction cell
positions are numbered and the position where each component interacts with the
reaction disk is labeled. The counter-clockwise rotation is also illustrated.
Reaction Disk Positions
During each 18-second mechanical cycle, the reaction disk rotates counter-clock-
wise 360° plus one reaction cell position. The reaction disk pauses three times
during each 18-second cycle.
The reaction disk rotates as follows:
Moves 12 cells—pauses
Moves 5 cells—pauses
Moves 32 cells—pauses.
This completes one mechanical cycle. This series of movements and pauses allow
the analyzer to:
• pipette sample every 18 seconds (once per cycle)
• advance each reaction cell one position every 18 seconds
• rotate each reaction cell through the photometer lightpath
• pipette up to three reagents per test
• stir the reaction mixture.

4.2 Begin Operation
During each reaction disk rotation, one photometric measurement per reaction cell is
taken. This photometric measurement also is referred to as a measure point or
absorbance reading.
The figure below illustrates the timing of the reaction processing sequence.
Reaction Processing Sequence

4.2 Begin Operation
The first reagent is pipetted during the first rotation. The second reagent is added
during the fifth rotation. The third reagent is added during the 17th rotation.
The figure below illustrates the timing of reaction events in relation to reaction disk
rotation.
Reaction Processing Sequence

4.2 Begin Operation
The absorbance of the reaction mixture is measured every 18 seconds (one time
per reaction disk rotation). Absorbance measurements are determined while the
reaction disk is moving. Absorbance measure points to be used in result calculation
are programmed in the Test Parameters screens. For more detailed explanation of
absorbance measurements, refer to Chapter 5 of this guide, Measurement Prin-
ciples.
The figure below illustrates absorbance measure points over time, throughout
reaction processing.
Absorbance Measure Points Over Time

4.3 Photometric Sample Processing
Sample Aspiration
The first reaction cell receives sample and reagent(s) after it has been rinsed and
blanked. The instrument’s computer searches its memory and determines whether
a calibrator, control, or patient sample is to be aspirated first.
The sample disk can rotate in either direction to bring the sample to the sample
aspiration position.
The sample probe arm pivots and moves the sample probe to rest over the first
sample. The sample syringe motor activates, and a small volume of air is aspirated
into the tip of the probe. This air interface prevents the sample from mixing with
water in the sample pipetting system.
The sample probe arm motor lowers the sample probe into the sample cup. The
sample probe has a liquid level wire sensor at the tip of the probe. If no sample is
detected, a data alarm, SAMPL, is issued on the printout in the remark column. In
addition, a photodetector is located in the sample probe arm to detect any abnor-
mality in the descent of the arm. The probe tip is immersed in the sample and the
sample syringe aspirates the correct sample volume. The correct sample volume is
part of the information programmed in the chemistry parameters for each test.
A small volume of extra sample is aspirated with the first test of each sample. This
sample buffer removes any water that may line the interior wall of the sample
probe. This buffer is discarded to waste after the last test of the sample is dis-
pensed. Also, extra sample is aspirated for spit-back. When the stepper motor
reverses direction from aspiration to dispense, this extra volume is “spit-back” into
the sample cup. This ensures a reliable sample volume. The sample probe moves
to the sample dispense position.

Sample Dispense
Sample is dispensed into a reaction cell. The sample probe is spring-loaded where
it connects to the probe arm. This allows the probe to touch the bottom of the
reaction cell as it is lowered. The sample probe touches the reaction cell bottom to
ensure precise delivery of an accurate volume.
The sample probe dispenses the required sample volume into the bottom of the
reaction cell. The probe is lifted from the cell, and either goes back to the sample
disk (if there are more tests to be performed on the sample) or moves to the sample
probe rinse station.
Sample Probe Rinse

The sample probe is rinsed between samples. When the last test for a sample has
been pipetted, the sample probe moves to the probe rinse station. Deionized water
is flushed through the probe and over the outer surface of the probe.
While the sample probe is being rinsed, the reaction disk continues to rotate. The
reaction disk moves 12 cell positions and pauses. The reaction disk then moves
another 5 cell positions and pauses. The reaction cell containing sample is now in
position to receive any R1 reagent.
R1 Aspiration
The reagent disk also rotates during the sample probe rinse to bring the correct
reagent container to the reagent aspiration position. The reagent disk rotates in
either direction, using the shortest route to position the correct reagent. The reagent
aspiration positions are defined by the arc of the reagent probe movement. Cut-
away sections in the reagent disk evaporation cover gives the reagent probe
access.
When the reagent disk stops, the reagent probe pivots over the disk. The correct
R1 is aspirated. The reagent syringe is activated and aspirates a small volume of
air into the reagent probe. This air interface prevents reagent from mixing with water
in the reagent pipetting system. The probe moves down using a wire liquid level
sensor to detect the reagent or diluent. A photodetector is located in the reagent
probe arm to detect any abnormality in the descent of the arm.

R1 Dispense
The reagent probe moves to the reagent dispense position. The syringe motor
activates, and reagent is dispensed into the reaction cell containing sample. The
reagent probe does not descend into the reaction cell, but dispenses from the top
of the cell.
R1 Reagent Probe Rinse

The reagent probe arm brings the reagent probe to its rinse station after completion
of R1 dispense. Deionized water is flushed through the probe as well as on its
exterior surface to ensure proper cleaning. This rinse mechanism is similar to that
used for the sample probe.
Sample and R1 Stirring

While the reagent probe is rinsing, the stirring paddle moves to the reaction disk
and stirs the sample and R1. After the reaction mixture is stirred, the stirrer moves
to its rinse station and is rinsed with deionized water.
The reaction disk moves 32 cell positions and pauses. The sample and reagent
disks rotate at this time, if necessary, to bring the appropriate sample and reagent
into position for the next dispense.
Reagent Dispense at R2 Timing

At the end of each 18 second rotation, the reaction cell containing the sample + R1
moves one position closer to the R2 reagent dispense position. During the fifth
rotation following dispense, the reaction cell moves into position for dispense of R2
reagent, if needed. R2 reagent is dispensed by the reagent probe. R2 stirring
occurs immediately.
Reagent Dispense at R3 Timing

At the end of each 18 second rotation, the reaction cell containing the sample + R1
+ R2 moves one position closer to the R3 reagent dispense position. During the
17th rotation following dispense, the reaction cell moves into position for dispense
of R3 reagent, if needed. R3 reagent is dispensed by the reagent probe. R3 stirring
occurs immediately.
Additional samples and reagents are aspirated and dispensed throughout this time.
The cell rinse unit is also active, cleaning and blanking reaction cells for more
samples to be processed.

Aspirate Reaction Mixture to Waste

At the end of the 35th rotation, the first reaction mixture is in position at the first
nozzle of the cell rinse unit. By this time, all photometric readings have occurred for
this reaction mixture, and results have been calculated, printed, and/or sent to the
host. The cell rinse unit is lowered, the reaction mixture is aspirated to the waste
container, and the cell is filled with wash solution.
During the next ten rotations, the reaction cell is rinsed and photometrically blanked
and dried. Two rotations later, it will again be in position for sample dispense.
Sampling End
Sampling end occurs in the batch mode at the end of the batch of samples.

4.4 ISE Sample Processing
Introduction
The ISE (Ion Selective Electrode) system determines sample concentrations of
sodium, potassium and chloride. ISE analysis of a sample can occur at the same
time as photometric chemistry assays, or can occur alone. The ISE system can
process up to 100 samples per hour. The ion selective electrodes used by this
instrument are color-coded, modular plug-in cartridges.
The main components of this system include: three ISE measuring cartridges, a
reference cartridge and three syringes/pipettors.
The sipper, reagent and sample syringes are behind the left front panel. The elec-
trodes are positioned in a temperature-controlled compartment. The ISE compart-
ment is found on the top surface of the analyzer to the right of the sample probe.
Because the response of the electrodes is affected by temperature, the ISE
compartment is heated to a constant temperature with 37 °C water.
ISE Sample Aspiration

The first reaction cell receives sample and reagent(s) after it has been rinsed. The
instrument’s computer searches its memory and determines whether a calibrator,
control, or patient sample is to be aspirated first.
The sample disk can rotate in either direction to bring the sample to the sample
aspiration position.
The sample probe arm pivots and moves the sample probe to rest over the first
sample. The sample syringe motor activates, and a small volume of air is aspirated
into the tip of the probe. This air interface prevents the sample from mixing with
water in the sample pipetting system.
The sample probe arm motor lowers the sample probe into the sample cup. The
sample probe has a liquid level wire sensor at the tip of the probe. If no sample is
detected, a data alarm, SAMPL, is issued on the printout in the remark column. In
addition, a photodetector is located in the sample probe arm to detect any abnor-
mality in the descent of the arm. The probe tip is immersed in the sample and the
sample syringe aspirates 10 µl of sample.
A small volume of extra sample is aspirated with the first test of each sample. This
sample buffer removes any water that may line the interior wall of the sample
probe. This buffer is discarded to waste after the last test of the sample is dis-
pensed. Also, extra sample is aspirated for spit-back. When the stepper motor
reverses direction from aspiration to dispense, this extra volume is “spit-back”
into the sample cup. This ensures a reliable sample volume. The sample probe
moves to the sample dispense position.

The sample probe moves from its position at the probe rinse station to the sample
aspiration position. Sample (10 µl) is aspirated into the probe when the sample
syringe piston moves downward. (The sample syringe is located behind the left
front panel.) The sample probe then moves to the reaction disk.
ISE Sample Dispense

The probe lowers into the reaction cell and delivers sample to the bottom of the
cell, as the sample syringe moves upward. Before the sample can be drawn
through the measuring cartridge flowpath, it must be diluted 1:50 with 308 µl of ISE
diluent and 182 µl of system water.
Sample Probe Rinse

The sample probe is rinsed between samples. When the last test for a sample has
been pipetted, the sample probe moves to the probe rinse station. Deionized water
is flushed through the probe and over the outer surface of the probe.
While the sample probe is being rinsed, the reaction disk continues to rotate. The
reaction disk moves 12 cell positions and pauses. The reaction disk then moves
another 5 cell positions and pauses. The reaction cell containing sample is now in
position to receive the diluent.
ISE Diluent Aspiration

The reagent disk also rotates during the sample probe rinse to bring the ISE diluent
container to the reagent aspiration position. The reagent disk rotates in either
direction, using the shortest route to position the diluent. The reagent aspiration
positions are defined by the arc of the reagent probe movement. Cutaway sections
in the reagent disk evaporation cover gives the reagent probe access.
When the reagent disk stops, the reagent probe pivots over the disk. The reagent
syringe is activated and aspirates a small volume of system water into the reagent
probe. The probe moves down using a wire liquid level sensor to detect the reagent
or diluent. A photodetector is located in the reagent probe arm to detect any
abnormality in the descent of the arm.
While the tip of the reagent probe is immersed in diluent, the reagent syringe motor
activates and aspirates diluent into the reagent probe. The reagent probe moves to
the dispense position over the reaction cell.
ISE Diluent Dispense

The syringe motor activates and diluent + system water is dispensed into the
reaction cell containing the sample. The reagent probe does not descend into the
reaction cell, but dispenses from the top of the cell.

Reagent Probe Rinse

The reagent probe arm brings the reagent probe to its rinse station after completion
of diluent dispense. Deionized water is flushed through the probe as well as on its
exterior surface to ensure proper cleaning. This rinse mechanism is similar to that
used for the sample probe.
Sample and Diluent Stirring

While the reagent probe is rinsing, the stirring paddle moves to the reaction disk
and stirs the sample and diluent. After the mixture is stirred, the stirrer moves to its
rinse station and is rinsed with deionized water.
Internal Standard Dispense–Start of Rotation #2

Since the first sample dispense was for an ISE sample, no sample is dispensed in
the next reaction cell.
Instead, the internal standard is dispensed in the next reaction cell by the reagent
probe. This is followed by a reagent probe rinse.
Each time a sample is dispensed for the ISE tests, during the mechanical cycle immediately
n following, the internal standard is dispensed in the next reaction cell.
Diluted ISE Sample Aspiration

At the start of the seventh mechanical cycle the diluted ISE mixture is now in
position for the ISE nozzle to aspirate the diluted sample. The sipper syringe uses
the ISE nozzle to aspirate the diluted sample through the Na+, K+, and Cl- measuring
cartridges. The electrical voltage is measured. The voltage is proportional to the
concentration of the electrolytes in the sample. This measurement occurs alone
when no photometric chemistries are ordered. When photometric chemistry assays
are also requested, ISE measurement occurs simultaneously.
The next reaction disk rotation brings the internal standard in position for the ISE
nozzle to aspirate it. The sipper syringe uses the ISE nozzle to aspirate the internal
standard through the Na+, K+, and Cl- measuring cartridges.

KCI and Reference Cartridge Flowpath

The sipper syringe downstrokes and pulls liquid through one of two flowpaths, the
measuring flowpath or the reference flowpath. Sipper syringe aspiration tubing
divides where the two flowpaths meet, at the reference cartridge block. The refer-
ence flowpath originates at the KCl bottle and past the reference cartridge. The
measuring flowpath originates at the reaction cell, past a pinch valve, and through
the three measuring cartridges.
The reference cartridge is positioned in the KCl flowpath. This flowpath is electri-
cally continuous with the measuring cartridge flowpath. The analyzer measures the
difference in potential between the two flowpaths. This reference potential serves
as the zero baseline in ISE calculations. Before every ISE measurement, the pinch
valve closes and the solenoid valve opens and 65 µl of KCl is drawn into the
reference cartridge by the action of the sipper syringe. The solenoid valve closes
and the pinch valve opens as the syringe’s piston continues downward, drawing
the diluted sample through the measuring cartridges.
Measuring Cartridge Flowpath

There are three electrodes housed in cartridges (green = chloride, yellow = sodium,
and red = potassium). These channeled cartridges are connected together to form a
flowpath for the diluted sample. The action of the sipper syringe piston draws the
diluted sample from the dilution vessel into the measuring cartridges.
Patient sample is pulled through the sipper syringe. Exercise the normal precautions
n required for biohazardous material when handling the sipper syringe.
The pinch valve opens and the KCl line solenoid valve closes. The sipper syringe
downstrokes to aspirate contents of the reaction cell through the nozzle and into the
measuring flowpath.

As the diluted sample sits in the measuring cartridges, equilibration is achieved

and a measurement of the Electromotive Force (EMF) or voltage at the membrane of
the electrode is taken. The figure below shows the relative position of membrane to
sample in each electrode.
Measuring Cartridge
The selectivity of the membrane to a particular ion is dependent on the composition

of the membrane. Result calculation for ion selective electrode measurements is
discussed in Chapter 6 of this guide.
The composition of the membrane in each electrode determines its selectivity for a
certain ion:
• The PVC (polyvinyl chloride) material of the sodium electrode membrane
contains a neutral carrier that provides a cavity for capturing the sodium ion.
• The molecular structure of the antibiotic valinomycin in a PVC membrane in
the potassium electrode makes the electrode selective for the potassium ion.
• The chloride electrode membrane employs ion exchange with a type of salt in
the membrane that pairs with chloride ions.

NOTES

Chapter 5
Measurement Principles

5.1 Overview
Introduction
The principles of measurement provided in this chapter include an overview of the
different calibration methods and assay techniques used on the analyzer. Cross
references to additional information relating to calibration and results calculation are
provided.
General Photometer Characteristics

An illustration showing a cut away view of the photometer is shown below.
Photometer
Reaction Bath
Windows
Outer
Lens
Inner
Light Source
Water Jacket
Cut Away View of Photometer

5.1 Overview
Light from the photometer lamp passes through the following structures in
sequence:
1. Lens 5. Reaction bath water
2. Inner reaction bath window 6. Outer reaction bath window
3. Reaction bath water 7. Photometer
4. Reaction cell and its contents
When the light beam enters the photometer, it strikes a diffraction grating, which
separates the light into its constituent wavelengths and reflects them onto a fixed
array of 12 photodiodes. Each photodiode is permanently positioned to detect
light at a different wavelength. The photometer contains no moving parts.
Absorbance readings are taken each time a reaction cell rotates past the photom-
eter. When the reaction cell passes through the photometer lightpath, absorbance
at the two programmed wavelengths for each individual assay is measured.
Readings from the programmed measure cycle(s) or measure point(s) are for-
warded to the computer for calculation of final results. Readings can also be taken
at only one wavelength (monochromatic).

5.1 Overview
Roche Diagnostics chemistries use two wavelength readings (bichromatic) to

calculate results. The end product of a chemical reaction absorbs the most light at
one primary wavelength. However, using the difference between readings at two
wavelengths (bichromatic system) eliminates the effect of colorimetric interfer-
ences sometimes found when using a single wavelength (monochromatic system).
Bichromatic analysis uses two wavelengths: one that is at or near the peak
absorbance of the chromogen produced by the reaction, and a second wave-
length at which little or no absorbance of the desired chromogen occurs.
Any absorbance (A2) that occurs, due to interference from other substances in the
sample, is measured at the secondary wavelength. This amount is then subtracted
from the total absorbance (A1) occurring at the primary wavelength to yield the net
absorbance (AC), shown graphically in the figure below:
Bichromatic Absorbance
The optimum measure points for each test are part of the chemistry parameters.
All measure points for Roche Diagnostics chemistries are included with the
chemistry parameters.
The assay code and calibration method programmed from the chemistry param-
eters determine how final results are calculated for each test. Assay codes and
calibration methods are discussed in the following sections.

5.2 Assay Techniques
Introduction
There are two fundamental types of photometric assays on this instrument:
• endpoint assays
• rate assays
Measurements are taken by the photometer at specific measure points. If mea-
surements are taken after the reactions have stopped (are completed), the inten-
sity of the colored (or turbid) product is an indicator of the sample component’s
concentration. These are called endpoint assays.
If measurements are taken as the reaction proceeds, the rate of the reaction is
proportional to the sample component’s concentration or activity being analyzed.
These are called rate reactions. There are also modifications of these two tech-
niques possible in this instrument, as well as a combination of the two.
Selecting Assay Type and Measure Points

The Test Parameters screen displays the assay type and measure points that have
been entered for an individual test.
To view the assay type or measure point for a specific test follow these steps:
1. From the Home screen, touch Param. .

2. Touch Test Param . .
3. Enter the channel number of the test you wish to view in the Channel No
field. Touch .
4. Enter the parameter number, <2>, in the Parameter No field. Touch .

The assay type is displayed to the right of the Select key.
There are seven different assay types including:
• 1-Point
• 1-Point & Rate
• 2-Point Rate
• Rate-A
• 2-Point End
• Rate-B
• 3-Point
Assay Code selections 1-Point, 2-Point End and 3-Point are all endpoint assays.
Assay Code selections 2-Point Rate, Rate-A and Rate-B are all rate assays. Assay
Code selection 1-Point & Rate is a combination of endpoint and rate assay types.

Measure point 1 is displayed in the Contents field.


The parameter fields 5-8, Assay Point 1-4, display chosen measure points. Refer
to Chapter 6 of the Software Guide for additional information on assay codes or
assay points.
The remaining sections in this chapter explain the assay types in detail.
Example of Endpoint Assay Entry

Some Roche Diagnostics reagents use the endpoint assay technique. An example
of entries for an endpoint chemistry are shown below:
Parameter Number Entry Example
2. Assay Code (Mthd) 2-Point End
4. Reaction time 3
5. Assay Point 1 5
6. Assay Point 2 11
7. Assay Point 3 0
8. Assay Point 4 0
This assay is sample-blanked; “2-Point End” means that the instrument reads the
absorbance of the reaction mixture at two points. The 1st measure point is
subtracted from the second measure point as the sample blank. Typically the R1
is nonreactive and the R2 contains the reactive substance. The reaction time is
three minutes.
The sample blank absorbance (sample plus the first reagent) is determined by the
measurement taken during reaction disk rotation 5. (Refer to Chapter 4, Mechani-
cal Theory, of this guide for a complete description of reaction disk rotations.) The
absorbance of the sample plus the first and second reagents is determined by the
measurement taken during rotation 11.
The instrument always makes endpoint assay absorbance determinations in
duplicate. The measure points for this example are defined as disk rotations 5 and
11; in each case, a duplicate reading is also made in the previous disk rotation.
The sample blank readings occur during disk rotations 4 and 5. The final absor-
bance readings occur during rotations 10 and 11.

When a sample is diluted with R1 reagent and read as a blank, it cannot be

subtracted from the reading taken after the addition of R2 reagent and/or R3
reagent unless a correction for the dilution (from R2, R3) is taken into account:
sample volume + R1 reagent volume

dilution factor =
sample volume + R1 volume + (R2, R3) volume
The dilution factor (d) is applied as a multiplier to the absorbance values used for
calculations in the previous example.
Such as: d ( A4 + A5
2
)
d = dilution factor
A4 = absorbance at reaction disk rotation 4
A5 = absorbance at reaction disk rotation 5

Cell Blank Report

Reaction absorbance in a cell is measured against the cell’s water blank value.
The water blank value is the average absorbance of four rotations of the cell in
front of the photometer prior to the sample being added to the cell.
Printed cell blank values for cells 2 through 48 are the differences from cell 1, and
if added to the value of cell 1, their actual values can be determined at any wave-
length. Refer to section 7.10 “Cell Blank Measurement” in the Software Guide for
detailed information on the Cell Blank report.
Cell Blank Check

02/13/97 10:56
No NM SUB MAIN
1 340 10099 10099
376 9555 9554
415 9071 9071
450 8708 8708
480 8682 8682
505 8592 8592
546 8437 8438
570 8303 8303
600 8253 8253
660 8199 8198
700 8231 8232
800 7843 7842
2 340 52 53
376 52 54
415 31 31
450 6 7
480 0 0
505 3 3
546 -3 -4
570 3 2
600 -4 -3
660 -3 -2
700 -17 -17
800 0 1

Reference Information
The table below lists the definitions for the symbols utilized in the formulas for
calculating results. Examples of reaction curves are given for each assay type.
More detail on both the formulas for calculating results and the reaction curves are
given in the sections that explain each assay type individually.
Abbreviations, Symbols, and Codes Used in Formulae

A = absorbance (also Abs. or abs.)
Ab = absorbance of blank
Ac = absorbance of standard
Ax = absorbance of unknown
C1-C4 = cell blanks 1, 2, 3, and 4
∆ = change in Abs./minute (∆A)
e = molar absorptivity
TV = total reaction volume in µl
SV = sample volume in µl
K = Factor (K Factor) preset or determined at calibration
d = dilution factor
Cb = concentration or activity of blank
Cc = concentration or activity of standard
Cx = concentration or activity of unknown
mp = programmed abs. measuring point
endpoint: mp1 (first point), mp2 (second point)
rate: mpinitial through mpfinal
R = reagent (R1, reagent one; R2, reagent two)
S = stirring
b = light path in cm. (902 is 0.6 corrected to 1.0)
IFA, IFB = instrument constants for slope (1.0) and intercept (0)

Calibration Screen
The Calibration screen displays current calibration values. Values in the S1Abs.
field relate to the test’s blank. These values are absorbance X 104 and for rate
assays are change of the reaction’s absorbance per minute.
The S1Abs. value is updated with each calibration. It is subtracted from the
reaction absorbance of all other samples including standards 2 - 6, controls, stats
and routine samples.
Some tests are normally calibrated with a S1Abs. only and use K values or K
factors that are preset at the time the analyzer is installed. The K factor for tests
using standards 2 - 6 is calculated during calibration.
The calculated K factors are rounded and displayed as whole numbers on the
Calibration screen. During calculation, decimal placement in a test’s K factor is
determined by the decimal placement in the programmed value of the test’s blank
concentration (Standard 1), programmed via the Test Parameters screen. This also
determines the decimal placement in calculated results, as shown in the table
below:
STD 1 Conc K (Posted) K (Calculations) Result

0 25 25 5
0.0 253 25.3 5.1
0.00 2528 25.28 5.13
The two main types of assays use the following formulas:

• Endpoint reactions Cx = {[K (Ax - Ab) + Cb] • IFA} + IFB
• Rate reactions Cx = K (∆Ax - ∆Ab) + Cb] • IFA} + IFB
Calculation of the concentration or activity of an unknown (Cx) uses:

Ax = the unknown’s reaction absorbance
K = the preset or calculated K Factor
Ab = blank absorbance (Standard 1)
Cb = concentration or activity of blank (Standard 1)
∆Ax = change per minute in unknown's absorbance
∆Ab = change per minute in blank absorbance
IFA, IFB = instrument constants representing slope and intercept

Sample Program—Endpoint Assay without Sample Blanking

The following data from the Test Parameter screen is used for this example:
Parameter Number Example Entry
2. Assay Code (Mthd) 1-Point End
5. Assay Point 1 34
9. Wave Leng. (SUB) 700
10. Wave Leng. (MAIN) 505
23. Calib. Conc. 1 0
The following data from the Calibration screen is used for this example:
S1Abs = 386 or .0386 x 104
K factor = 792
Endpoint assays that do not require sample blanking are programmed for one
measure point (Amp1). The reaction absorbance used for calculation of concentra-
tion or activity is based upon the average of the absorbance at the single pro-
grammed measure point (Amp1) and that taken during the cycle immediately prior
to the programmed measure point (Amp1-1).
(Amp1 + Amp1-1)
2
This example test is a 1-point endpoint assay, programmed to read at cycle 34.
Absorbance during cycle 34 (2440) is averaged with that during cycle 33 (2438).
Therefore:
(Amp34 + Amp34-1) = 2440 + 2438 = 2439
2 2
The absorbance used in calculations (Ax) will be: .2439

Calculating the concentration of the unknown using the endpoint reaction formula
of:
Cx = {[K (Ax - Ab) + Cb ] • IFA } + IFB
and the information from the previous page:
K = 792
Ax = .2439
Ab (Blank Abs.) = 386 (.0386 for calculations)
Cb (Blank Conc.) =0
IFA and IFB = 1 and 0
Cx = {[792 (0.2439 - 0.0386) + 0] • 1} + 0
= 162.6
The result is rounded to 163 on the report because the concentration of the blank
contains no decimal.

5.3 1-Point Endpoint Assay - One Reagent
Assay Characteristics
Entries on the Test Parameters Screen
Parameter Number Parameter Entry
2. Assay Code (Mthd) 1-Point
4. Reaction time reaction time in minutes
5. Assay Point 1 mp1
6. Assay Point 2 0
7. Assay Point 3 0
8. Assay Point 4 0
1 ≤ mp1 ≤ 35
• Called 1-Point because only one measure point (or duplicate reading at
mp1) is taken (and only one measure point is designated in the test param-
eters as explained above).
• No sample blanking required.
• The absorbance reading for this type of assay can be taken during any disk
rotation between 1 and 35 if one reagent is added.
• Total reaction volume must be between 250 and 500 µl.

1-Point Endpoint Assay Graph–R1 Timing

A graphic representation of a 1-Point endpoint assay using a reagent dispensed at
R1 timing is shown on the next page. The figure below shows an increase in
absorbance as the reaction progresses with an eventual endpoint or plateau
occurring. A decrease in absorbance as the reaction occurs is also possible. Color
development is proportional to the concentration of the analyte if the calibration
method is linear.
1-Point Endpoint Assay - Reagent at R1 Timing

Sample Calculations
The calculation of Ax uses the following equation:
Amp1 + Amp1-1
Ax =
2
where:
Ax = mean absorbance of the unknown sample
Amp1 = absorbance at measurement of point 1
Amp1-1 = absorbance at reaction disk revolution prior to measure-
ment of point 1
The calculation of an unknown sample concentration uses the following equation:

Cx = [{K (Ax - Ab) + Cb} • IFA] + IFB
where:
Cx = concentration of the unknown patient sample
K = calibration factor
Ab = absorbance of STD1
Cb = concentration of STD1
IFA, IFB = instrument constants, for slope of 1 and intercept of 0

5.4 1-Point Endpoint Assay - Two Reagents
6. Assay Point 2 0
7. Assay Point 3 0
8. Assay Point 4 0
1 ≤ mp1 ≤ 35
mp1) is taken (and only one measure point is designated on the test param-
eters).
• The absorbance reading for this type of assay can be taken during any
disk rotation, after addition of the final reagent, when more than one reagent
is added.

1-Point Endpoint Assay Graph–R1 and R3 Timing

A graphic representation of a 1-Point endpoint assay using reagents dispensed at
R1 and R3 timing is shown below. The figure shows an increase in absorbance as
the reaction progresses with an eventual endpoint or plateau occurring. A de-
crease in absorbance as the reaction occurs is also possible. Color development
is proportional to the concentration of the analyte.
1-Point Endpoint Assay - Reagent at R1 and R3 Timing
Sample Program and Calculations

Amp1 + Amp1-1
Ax =
2
where:
Amp1-1 = absorbance at reaction disk revolution prior to measure-
ment of point 1


where:
Ab = absorbance of STD1/Blank
Cb = concentration of STD1/Blank
IFA, IFB = instrument constants, representing slope (1) and intercept
(0)

5.5 1-Point Endpoint Assay with Prozone Check
7. Assay Point 3 0
8. Assay Point 4 0
51. Prz. Limit prozone limit value
52. Prz. Limit (U/D) prozone limit - upper or lower
1 ≤ mp1 < mp2 ≤ 35

Parameter 51 displays the prozone limit from -32000 to 32000. Parameter 52
displays the prozone comparison, upper or lower. The prozone photometric
measure point is mp2.
mp1) is taken.
• The absorbance reading for this type of assay can be taken during any
disk rotation, after addition of the final reagent, when more than one reagent
is added.

1-Point Endpoint Assay with Prozone Check Graph

A graphic representation of a 1-Point endpoint assay with prozone check is shown
below. The figure shows an increase in absorbance as the reaction occurs. A
decrease in absorbance as the reaction occurs is also possible. R3 may be
antigen or antibody in an immunological assay.
1-Point Endpoint Assay with Prozone Check
Sample Program and Results Calculations

Amp1 + Amp1-1
Ax = 2
where:
Amp1-1 = absorbance at reaction disk revolution prior to
measurement of point 1


where:
Sample Program and Prozone Check Value Calculations

The calculation of the prozone check value uses the following equation:
PC = (Amp2 + Amp2-1) - d (Amp1 + Amp1-1)

2 2
SV + RV1
d=
SV + RV1 + RV2
where:
PC = prozone check value
d = liquid volume correction factor (dilution factor)
SV = sample volume
RV1 = reagent 1 volume

Prozone Prozone Calculated

Limit Entry Comparison Prozone Value Data Flag Result
X Lower Less than X Prozone check fails and the
Prozone data alarm is issued.
Prozone check value prints on
the patient report along with
data flag.
X Lower Greater than X Prozone check passes and no
check value or alarm prints.
X Upper Greater than X Prozone check fails and the
data flag.
X Upper Less than X Prozone check passes and no

5.6 2-Point Endpoint Assay
7. Assay Point 3 0
8. Assay Point 4 0
1 ≤ mp1 < mp2 ≤ 35
• Called 2-Point because there are readings at two measure points, mp1 and
mp2 (blank and final), which are designated on the test parameters.
• Allows for two or more reagent additions.
• Sample blanking is possible.
• The first absorbance reading (mp1) for this type of assay can be taken
during any disk rotation before the final reagent is added.
• Measure point (mp2) is at the endpoint of reaction after final reagent addi-
tion.
• The second absorbance reading (mp2) for this type of assay can be taken
during any disk rotation after the final reagent is added.

2-Point Endpoint Assay Graph–R1 and R2 Timing

R1 and R2 timing is shown below.
2-Point Endpoint Assay - Reagents at R1 and R2 Timing
Sample Calculations
(Amp 2
+ Amp2-1 ) – d ( Amp1 + Amp1-1 )
Ax = 2 2
SV + RV1
d=
SV + RV1 + RV2
where:
Ax = mean absorbance of the unknown
SV = sample volume


where:
Ax = mean absorbance of the unknown patient sample

51. Prz. Limit prozone limit value
52. Prz. Limit (U/D) prozone limit - upper or lower
53. Prz. (End Point) prozone measure point, mp2'
1 ≤ mp1 < mp3 < mp4 < mp2 ≤ 35, mp4 < mp2' ≤ 35
Parameter 51 displays the prozone limit from -32000 to 32000. Parameter 52

displays the prozone comparison, upper or lower. Parameter 53 displays the
prozone photometric measure point. This may be the same as mp2.
• Called 2-Point because there are readings at two measure points, mp1 and
mp2 (blank and final).
• Allows for two or more reagent additions.
• Sample blanking is possible.
• The first absorbance reading (mp1) for this type of assay can be taken
during any disk rotation before the final reagent is added.
• Measure point (mp2) is at endpoint of reaction after final reagent addition.
• The second absorbance reading (mp2) for this type of assay can be taken
during any disk rotation after the final reagent is added.

2-Point Endpoint Assay with Prozone Check Graph

A graphic representation of a 2-Point endpoint assay with prozone check is shown
below.
2-Point Endpoint Assay with Prozone Check

Sample Calculations
(Amp2 + Amp2-1) - d (Amp1 + Amp1-1)

Ax =
2 2
where:
SV + RV1
d=
SV + RV1 + RV2
where:
SV = sample volume

where:
Ax = mean absorbance of the unknown patient sample

Sample Program and Prozone Check Value Calculations

The calculation of the prozone check value uses the following equation:
∆Amp2’ • mp3
PC = x 100
∆Amp4 • mp3
Amp2' - Amp3
∆Amp2' • mp3 =
mp2' - mp3
Amp4 - Amp3
∆Amp4 • mp3 =
mp4 - mp3
where:
PC = Prozone check value
∆Amp2' • mp3 = change in absorbance per minute between
measure point 2' and measure point 3
∆Amp4 • mp3 = change in absorbance per minute between
measure point 4 and measure point 3
mp2' = Prozone check measure point; if 0 is entered
then mp2 is used in the calculation

Prozone Prozone Calculated

Limit Entry Comparison Prozone Value Data Flag Result
X Lower Less than X Prozone check fails and the
data flag.
X Lower Greater than X Prozone check passes and no
X Upper Greater than X Prozone check fails and the
data flag.
X Upper Less than X Prozone check passes and no

The 3-Point endpoint assay is used to perform two different tests, a 1-Point (test
1) and a 2-Point (test 2) in one reaction cell.
mp1 = the only measure point for test 1 (a one point endpoint)
mp3 - mp2 = 2-Point endpoint for test 2 with sample blanking
(final) - (blank)
Test 1:
2. Assay Code (Mthd) 3-Points
3. Assay Code (Test) input the channel no. of test B
6. Assay Point 2 0
7. Assay Point 3 0
8. Assay Point 4 0
Test 2:
2. Assay Code (Mthd) 3-Points
7. Assay Point 3 0
8. Assay Point 4 0
1 ≤ mp1 ≤ mp2 ≤ mp3 ≤ 35
• The first reagent may or may not participate in the second reaction. (The
first reagent may only act as a sample diluent for the second endpoint
reaction.)

3-Point Endpoint Assay Graph

3-Point Endpoint Assay - Reagents at R1 and R3 Timing
Sample Calculations
The calculation of the mean sample absorbance uses the following equation:
Test 1:
Amp1 + Amp1-1
AXA =
2
where:
AXA = mean absorbance of the unknown sample for test 1
Amp1 = absorbance at mp1
Amp1-1 = absorbance at reaction disk prior to measurement of mp1


Cx = [{K (AXA - Ab) + Cb} • IFA] + IFB
where:
K = calibration factor (test 1)
AXA = mean absorbance of unknown sample
Ab = mean absorbance of STD1/Blank
The calculation for absorbance in the Test 2 example uses the following equation:
( Amp 3
+ Amp3-1 ) – d ( Amp2 + Amp2-1 )
AXB =
2 2
SV + RV1
d=
SV + RV1 + RV2
where:
AXB = mean absorbance of the unknown sample for test 2
SV = sample volume
Cx = [{K (AXB - Ab) + Cb} • IFA] + IFB
where:
AXB = mean absorbance of unknown sample

5.9 1-Point Endpoint and Rate Assay
The 1-Point endpoint and rate assay is used to perform two different tests and two
different types of tests in one reaction cell. The first test is an endpoint assay, the
second test is a rate assay with sample blank.
2. Assay Code (Mthd) 1-Point & rate
3. Assay Code (Test) input the channel no. of test B
6. Assay Point 2 0
7. Assay Point 3 0
8. Assay Point 4 0
Test 2:
2. Assay Code (Mthd) 1-Point & rate
1 - mp1 < mp2 - mp3 < mp4 < mp5 ≤ 35
mp2+2 < mp3, mp4+2 < mp5
• Rate assay blank = ∆ Abs (mp1, mp2 )

• Rate (A) assay final reaction = ∆ Abs (mp4, mp5)
• Linearity and substrate depletion of Rate A test are monitored.
• Endpoint measure point = mp3 = Test 1 result = Amp3 + Amp3-1
• mp3 = the only measure point for test 1 (a 1-Point endpoint)
• ∆ Abs mp5, mp4 - ∆ Abs mp2, mp1 = Rate assay with sample blanking for
(final) (blank) test 2.

1-Point Endpoint and Rate Assay Graph–R1 and R3 Timing

A graphic representation of a 1-Point endpoint and rate assay using reagents
dispensed at R1 and R3 timing is shown below.
1-Point Endpoint and Rate Assay - Reagents at R1 and R3 Timing

Cx = [{K (AXA - Ab) + Cb} • IFA] + IFB
where:
AXA = mean absorbance of unknown sample

The calculation for absorbance in the Test 2 example uses the following equa-
tions:
∆AXB = ∆Amp4 • mp5 - d(∆Amp1 • mp2)
SV + RV1
d=
SV + RV1 + RV2
where:
∆AXB = change in absorbance per minute of the
unknown sample for test 2
SV = sample volume
The calculation of Cx for Test 2 uses the following equation:

Cx = [{K (∆AXB - ∆Ab) + Cb} • IFA] + IFB
where:
∆AXB = change in absorbance per minute of unknown sample at
∆Amp4 • mp5 - d(∆Amp1 • mp2)
∆Ab = change in absorbance per minute of STD1/Blank at
∆Amp1 • mp2

5.10 2-Point Rate Assay
2. Assay Code (Mthd) 2-Point rate
7. Assay Point 3 0
8. Assay Point 4 0
1 ≤ mp1 < mp2 ≤ 35
• Rate assay measures change in absorbance per minute.

• Called 2-Point because there are two measure points (or duplicate readings
at mp1 and mp2) programmed on the Application screen as explained
above.
• The first absorbance reading for this type of assay can be taken during any
disk rotation after the final reagent is added.
• ∆Abs/min. from mp1 to mp2. Monitors for substrate depletion but not for
linearity.

2-Point Rate Assay Graph–R1 Timing

A graphic representation of a 2-Point rate assay using a reagent dispensed at R1
timing is shown below.
2-Point Rate Assay - Reagent at R1 Timing

2-Point Rate Assay Graph–R1 and R2 Timing

A graphic representation of a 2-Point rate assay using reagents dispensed at R1
and R2 timing is shown below.
2-Point Rate Assay - Reagents at R1 and R2 Timing
Sample Calculations
Ax =
( Amp2 + Amp2-1
2
) ( Amp1 + Amp1-1
2 .
)
t
where:
t = time in minutes between mp1 and mp2


Cx = [{K (∆Ax - ∆Ab) + Cb} • IFA] + IFB

∆Ax = mean absorbance of the unknown patient sample, as
change in absorbance per minute
∆Ab = mean absorbance of STD1/Blank, as change in absor-
bance per minute

5.11 Rate A Assay
2. Assay Code (Mthd) Rate A
7. Assay Point 3 0
8. Assay Point 4 0
1 ≤ mp1 < mp2 ≤ 35, mp1 + 2 < mp2
• One or more reagent additions possible.
• Substrate depletion and linearity is monitored (see Chapter 8 of this guide).
Rate A Assay Graph–R1 Timing

A graphic representation of a rate A assay using a reagent dispensed at R1 timing
is shown below.
Rate A Assay - Reagent at R1 Timing

5.11 Rate A Assay
Rate A Assay Graph–R1 and R2 Timing

A graphic representation of a rate A assay using a reagent dispensed at R1 and
R2 timing is shown below.
Rate A Assay - Reagents at R1 and R2 Timing
Sample Calculations
Calculation of the change in absorbance per minute uses the following equation:
∆AX = ∆Amp1 • mp2
where:
∆AX = change in absorbance per minute of unknown
∆Amp1 • mp2 = change in absorbance per minute between mp1 and
mp2
Calculation of an unknown sample concentration uses the following equation:

where:
∆Ax = measured change in absorbance per minute of unknown
patient sample
∆Ab = measured change in absorbance per minute of STD1/
Blank

5.12 Rate A Assay with Sample Blank
Assay Characteristics with Sample Blank

2. Assay Code (Mthd) Rate A
1 ≤ mp3 < mp4 < mp1 < mp2 ≤ 35, mp3 + 4 < mp4
• One or more reagent additions possible.
• Rate of absorbance change per minute is calculated by least squares
method.
• Substrate depletion and linearity are monitored (see Chapter 8 of this
guide).
Rate A Assay With Sample Blank Graph–R1 and R2 or R3 Timing

A graphic representation of a rate A assay using a reagent dispensed at R1 and
R3 timing is shown below.
Rate A Assay with Sample Blank - Reagents at R1 and R3 Timing

5.12 Rate A Assay with Sample Blank
Sample Calculations
Calculation of the change in absorbance per minute uses the following equation:
∆AX = ∆Amp1 • mp2 - d ∆Amp3 • mp4
SV + RV1
d=
SV + RV1 + RV2
where:
∆AX = change in absorbance per minute of the unknown patient
sample
∆Amp3 • mp4 = change in absorbance per minute between mp3 and mp4
SV = sample volume
Calculation of an unknown sample concentration uses the following equation:

where:
∆Ax = measured change in absorbance per minute of unknown
patient sample
∆Ab = measured change in absorbance per minute of STD1/
Blank

5.13 Rate B Assay - Mode 1
• Simultaneous analysis of two tests by rate assay.
• Used to perform two different rate reactions in the same reaction cell.
• Sample blank compensation is available for test 2.
• Test 1 and test 2 have identical wavelengths.
• Sample blank compensation for test 2 in Mode 1 only occurs when the
wavelengths are identical for the two tests.
Test 1:
2. Assay Code (Mthd) Rate B
3. Assay Code (Test) channel no. of test B
7. Assay Point 3 0
8. Assay Point 4 0
3 ≤ mp1 < mp2 < mp3 < mp4 ≤ 35
mp1+2 < mp2, mp3+2 < mp4
Test 2:
7. Assay Point 3 0
8. Assay Point 4 0
3 ≤ mp1 < mp2 < mp3 < mp4 ≤ 35
mp1 + 2 < mp2, mp3 + 2 < mp4
• During the first half of the incubation, test 1 is measured. During the final
half of the incubation, test 2 is measured.
• Linearity and substrate depletion are monitored.
• Rate of absorbance change is calculated by least squares method.
• Total reagent volume must be between 250 and 500 µl.
• ∆Abs mp3, mp4 - d∆Abs mp1, mp2 for sample blanking.

Rate B Assay – Mode 1 Graph–R1 and R3 Timing

A graphic representation of a Rate B–Mode 1 assay using reagents dispensed at
Rate B - Mode 1 Assay - Reagents at R1 and R3 Timing
Sample Calculations
Test 1:
∆AXA = ∆Amp1 • mp2
where:
∆AXA = change in absorbance per minute of the unknown sample
for test 1
The calculation of the change in absorbance per minute when test 1 and test 2 are
measured at different wavelengths uses the following equations:

Test 2:
∆AXB = ∆Amp3 • mp4
where:
∆AXB = change in absorbance per minute of the unknown
sample for test 2
∆Amp3 • mp4 = change in absorbance per minute between mp3 and
mp4
The calculation of an unknown sample concentration uses the following equation,
whether test 1 and test 2 use the same or different wavelengths:
Cx = [{K (∆AXA - ∆Ab) + Cb} • IFA] + IFB
where:
∆AXA = change in absorbance per minute of unknown patient
sample
∆Ab = change in absorbance per minute of STD1/Blank
The calculation for absorbance in the test 2 example when the wavelengths are
identical to the test 1 wavelengths uses the following equations:
Test 2:
∆AXB = ∆Amp3 • mp4 - d (∆Amp1 • mp2)
SV + RV1
d=
SV + RV1 + RV2
where:
∆AXB = change in absorbance per minute of the unknown
patient sample for test 2
∆Amp3 • mp4 = change in absorbance per minute between measure
point 3 and measure point 4
∆Amp1 • mp2 = change in absorbance per minute between measure
point 1 and measure point 2
SV = sample volume

• Simultaneous analysis of two tests by rate assay.
• Used to perform two different rate reactions in one reaction cell.
• In Mode 2, sample blank compensation is always performed regardless of
wavelengths selected.
Test 1:
3. Assay Code (Test) channel no. of test B
7. Assay Point 3 0
8. Assay Point 4 0
3 ≤ mp1 < mp2 < mp3 < mp4 < mp5 < mp6 ≤ 35
mp1 + 2 < mp2
The first entry of the Assay/Time/Point displays assay type [ Rate B ]. The second
entry displays the reaction time in minutes. The third entry displays the first
measure point of the first test, mp1. The fourth entry displays the second measure
point of the first test, mp2. The remaining entries are not applicable
Test 2:
3 ≤ mp1 < mp2 < mp3 < mp4 < mp5 < mp6 ≤ 35
mp1 + 2 < mp2, mp3 + 2 < mp4, mp5 + 2 < mp6
• Used to perform two different rate reactions in one reaction cell.
• Linearity and substrate depletion are monitored.
• Rate of absorbance change is calculated by least squares method.
• Test 1 = ∆Abs mp1, mp2
• Test 2 = ∆Abs mp5, mp6 − d∆Abs mp3, mp4 for sample blanking.

Rate B Assay - Mode 2 Graph–R1 and R3 Timing

A graphic representation of a Rate B–Mode 2 assay using reagents dispensed at
Rate B - Mode 2 Assay - Reagents at R1 and R3 Timing

Sample Calculations
The calculation of the mean sample absorbance for test 1 uses the following
equation:
Test 1:
∆AXA = ∆Amp1 • mp2
where:
∆AXA = change in absorbance per minute of the unknown sample for test 1
Test 1:
Cx = [{K (∆AXA - ∆Ab) + Cb} • IFA] + IFB
where:
∆AXA = change in absorbance per minute of unknown patient sample
∆Ab = change in absorbance per minute of STD1/Blank
The calculation for absorbance in the test 2 example uses the following equation:
Test 2:
∆AXB = ∆Amp5 • mp6 - d (∆A mp3 • mp4)
SV + RV1
d=
SV + RV1 + RV2
where:
∆AXB = change in absorbance per minute of the unknown sample
for test 2
∆Amp3 • mp4 = change in absorbance per minute between measure point
3 and measure point 4
∆Amp5 • mp6 = change in absorbance per minute between measure point
5 and measure point 6
SV = sample volume

5.15 Summary of Assay Techniques
ASSAY TYPE TEST MEASURE POINTS CALCULATION OF UNKNOWN
1-point 1 1 ≤ mp1 ≤ 35 Cx = [{K (Ax - Ab) + Cb} • IFA] + IFB
1-point (with 1 1 ≤ mp1 < mp2 ≤ 35 Cx = [{K (Ax - Ab) + Cb} • IFA] + IFB
Prozone check) Prozone Check:
[(Amp2 + Amp2 - 1) - d(Amp1 + A mp1 - 1)] / 2
2-point 1 1 ≤ mp1 < mp2 ≤ 35 Cx = [{K (Ax - Ab) + Cb} • IFA] + IFB
2-point (with 1 1 ≤ mp1 < mp3 < mp4 < mp2 ≤ 35 Cx = [{K (Ax - Ab) + Cb} • IFA] + IFB
Prozone check) mp4 < mp2' ≤ 35 Prozone Check:
[(∆A (mp2 • mp3) / ∆A (mp4 • mp3)] x 100
2-point rate 1 1 ≤ mp1 < mp2 ≤ 35 Cx = [{K (∆Ax - ∆Ab) + Cb} • IFA] + IFB
3-point 1&2 1 ≤ mp1 ≤ mp2 < mp3 ≤ 35 Cx = [{K (Ax - Ab) + Cb} • IFA] + IFB
1-point and rate 1 1 ≤ mp1 < mp2 ≤ mp3 < mp4 Cx = [{K (Ax - Ab) + Cb} • IFA] + IFB
< mp5 ≤ 35;
2 mp2 + 2 < mp3; mp4 + 2 < mp5 Cx = [{K (∆Ax - ∆Ab) + Cb} • IFA] + IFB
Rate A with 1 1 ≤ mp3 < mp4 < mp1 < mp2 ≤ 35; Cx = [{K (∆Ax - ∆Ab) + Cb} • IFA] + IFB
Sample Blank mp3 + 4 < mp4
Rate A 1 1 ≤ mp1 < mp2 ≤ 35; Cx = [{K (∆Ax - ∆Ab) + Cb} • IFA] + IFB
mp1 + 2 < mp2
Rate B 1 3 ≤ mp1 < mp2 < mp3 Cx = [{K (∆Ax - ∆Ab) + Cb} • IFA] + IFB
Mode 1 < mp4 ≤ 35;
1
2 mp1 + 2 < mp2; Cx = [{K (∆Ax - ∆Ab) + Cb} • IFA] + IFB
2
mp3 + 2 < mp4 Cx = [{K (∆Ax - ∆Ab) + Cb} • IFA] + IFB
Rate B 1 3 ≤ mp1 < mp2 < mp3 < mp4 Cx = [{K (∆Ax - ∆Ab) + Cb} • IFA] + IFB
Mode 2 < mp5 < mp6 ≤ 35;
2 mp1 + 2 < mp2; Cx = [{K (∆Ax - ∆Ab) + Cb} • IFA] + IFB

mp3 + 2 < mp4;
mp4 + 2 < mp5
1
Identical wavelengths to test 1.
2
Different wavelengths from test 1.

NOTES

Chapter 6
Calibration Types

6.1 Calibration Overview
Calibration Methods
The following calibration methods are available on this analyzer:
• Linear Calibration
- 1-point Linear Calibration
- 2-point Linear Caibration
• Nonlinear Calibration
- Logit-Log 4P Calibration
- Logit-Log 5P Calibration
- Spline Calibration
- Nonlinear Point to Point Calibration
The linear calibration methods are used for tests when the plotted absorbance
readings at different concentrations form a linear curve.
Nonlinear calibration is used for those tests whose assay absorbances at different
concentrations form a nonlinear, but reproducible, plot. At least three and a maxi-
mum of six calibrators are required for calibration.
A K factor is used in the calculation of unknown sample results. Any test requiring
more than a blank during calibration has its K factor calculated via the measured
absorbances of the blank and the other standard(s). A fixed K factor (established
during installation and unique to each analyzer) is used to calculate results of all
reactions using only a blank calibrator. The K factor can be applied to all samples
tested using the same reagent as that used in calibration (within the recommended
calibration interval).
Calibration Method
The calibration method is defined on the Test Parameter screen. Use parameter
field 21 to enter the calibration method. Select the calibration method from the list:
Linear, Logit-Log 4P, Logit-Log 5P, Spline, and Point to Point.
Weight
Use parameter field 22 to define the weight (0, 1 or 2) to be applied to the standard
solution. If zero is defined, no weighting will occur during the calibration.
Calibration Type
For RD chemistries, you may select from two different types of calibration.
According to the number of calibration points used, the following choices are
available:
• Blank calibration: Only standard 1/blank is calibrated.
• Full-point calibration: All standard solutions (more than 2) specified in the
parameters are calibrated.

Blank Calibration
Only standard 1 is calibrated for a reagent blank. The previously measured calibra-
tion curve is corrected for a change in absorbance or absorbance change rate
(through calculation of S1ABS). The calculation method for each calibration type is
listed below.
Calibration Type S1ABS Calculation
K Factor (1-point) (A11 + A12)/2

Linear (2-point) (A11 + A12)/2
Logit-log 4P {(A11 + A12)/2 - (A11’ + A12’)/2} + S1ABS'
Logit-log 5P (A11 + A12)/2
Spline {(A11 + A12)/2
Point to point (A11 + A12)/2
A11, A12 First and second bichromatic absorbance values of standard (1)
measured at this time
A11’, A12’ First and second bichromatic absorbance values of standard (1)
measured previously
S1ABS’ Previous S1ABS value
a(I) I = 1 to N, N representing the number of standards
Applicable calibration types are listed below:

1-point linear 2-point linear Logit-log 4P
Logit-log 5P Spline Point to point

Full-Point Calibration
Applicable calibration types are listed below:
Linear Logit-log 4P*
K Factor Logit-log 5P
Spline Nonlinear Point to Point
*except when calibration point is 2
As explained via examples in Chapter 5 of this guide, Assay Types, analyte con-
centrations in unknown samples are determined via the following formulae:
• endpoint assays Cx = K(Ax - Ab) + Cb
• rate assays Cx = K (∆Ax - ∆Ab) + Cb
Where:
Cx = concentration of the unknown
K = factor
Ax = absorbance of the unknown
∆Ax = absorbance change per minute of the unknown
Ab = absorbance of standard 1/blank
∆Ab = absorbance change per minute of standard 1/blank
Cb = concentration of the standard 1/blank
Within the above :

• absorbance is measured by the photometer
• Cb is programmed as part of the calibrator concentrations
• Cx is what is being determined
• K is a factor that can be preset for some tests while for others it is deter-
mined during calibration. K is the reciprocal of the slope and is referred to as
the K factor.

K, when determined during calibration, uses the basic formula of:
Cc - Cb Cc - Cb
K = or
Ac - Ab ∆Ac - ∆Ab
Where:
Cc = the concentration of the standard or calibrator
Ac = the absorbance of the standard’s reaction
∆Ac = the absorbance change per minute of the standard’s
reaction
K = factor
Ab = absorbance of the blank
∆Ab = the absorbance change per minute of the blank’s reaction
Cb = concentration of the blank
As noted on the previous page, some tests use preset K factors. Their slopes are
based upon known physical properties of the indicating species (e.g., NADH) such
as molar absorptivity.
K is determined at the time of installation via the formula:
TV X 1000 X [substrate]
K= SV X b X ε [product]
Where:
TV = total volume in ml of sample and reagent
SV = total volume of sample in ml
b = light path length in cm
ε = molar absorptivity

Using Calibration Values

The Calibration Monitor report is discussed in detail in Chapter 7 of the Software
Guide. An example of the report is shown below.
Calibration Monitor
97/01/17 10:08
Test Na
I S .EMF -43.0
S1 EMF -45.5
S2 EMF -37.8
S3 EMF -41.7
SLOPE 61.6
I S .C . 131.6
S3 C . 137.9
C . VAL. -6.7
Test K
I S .EMF -46.0
S1 EMF -57.6
S2 EMF -35.8
S3 EMF -43.5
SLOPE 59.2
I S .C . 4.72
S3 C . 5.21
C . VAL. -0.29
Test Cl
I S .EMF 137.0
S1 EMF 141.7
S2 EMF 134.3
S3 EMF 136.2
SLOPE -42.0
I S .C . 98.4
S3 C . 107.9
C . VAL. -6.1
1 BICAR
S1 -113 18575
-114 18434
S2 -699 17057
-689 17228
3 BUN
S1 -19 13207
-11 13166
S2 -656 13027
-657 13021
Calibration Monitor Report
The absorbance figures on the photometric portion of the Calibration Monitor report
are calculated differently, depending on the assay type used. The remainder of this
section outlines the bichromatic and monochromatic absorbance calculations for
each assay type.
After a successful calibration, the average S1 Abs./blank value is used to update
the S1 Abs shown on the Calibration screen. It is also used to update the first
column of the S1 values on the Calibration Monitor report.
The S2 value updates the first column of the S2 values on the Calibration Monitor
report.
The new values are used to calculate the K factor. When used in calculations, the K
factor is automatically rounded. For example, a K factor of 4617.45 will become
4617. In addition, the K factor used in calculations is adjusted to the correct power
of 10, depending on the decimal placement in the STD 1 concentration.

Calculation of Results
The absorbance of an unknown, when multiplied by a factor and corrected by a
reagent and/or sample blank, results in the calculation of the unknown’s concentra-
tion. The following examples use assumed absorbances that would be found on the
Calibration Monitor report or the Calibration screen.
Endpoint Assays: Cx = K(Ax - Ab) + Cb
Ex1 Cx = 907 (0.1891 - 0.0364) + 0 = 138 mg/dl
Ex2 Cx = 26.7 (0.3941 - 0.2642) + 0.0 = 3.5 mg/dl
Rate Assays: Cx = K(∆Ax - ∆Ab) + Cb
Ex3 Cx = 5272 (0.0721 - 0.0003) + 0 = 379 U/L
Ex4 Cx = 141.8 (0.0313 - 0.0009) + 0.0 = 4.3 mg/dl

Calibration Mode Chart
ENDPOINT, mp1
——S1—— ——S2——
Bichromatic ABS of Monochromatic ABS of Bichromatic ABS of Monochromatic ABS of
S1 + ΣR at mp1 S1 + ΣR at mp1 S2 + ΣR at mp1 S2 + ΣR at mp1
ENDPOINT, mp1• mp2 (sample blanked)

——S1—— ——S2——
Bichromatic ABS of Monochromatic ABS of Bichromatic ABS of Monochromatic ABS of
(S1 + ΣR at mp2 )- S1 + ΣR at mp2 (S2 + ΣR at mp2 )- S2 + ΣR at mp2
d (S1 + R at mp1) d (S1 + R at mp1)
RATE A, mp1 • mp2

——S1——
Bichromatic ∆ABS/MIN of Monochromatic ABS of
S1 + ΣR at mp1 • mp2 S1 + ΣR at mp1
RATE B, Mode 1 (Test 1)

——S1——
for Test 1 for Test 1
RATE B, Mode 1 (Test 2) (Test 2 wavelengths ≠ Test 1 wavelengths)

——S1——

RATE B, Mode 1 (Test 2) (Test 2 wavelengths = Test 1 wavelengths)

——S1——
(S1 + ΣR at mp1 • mp2) S1 + ΣR at mp1
for Test 2 - d (S1 + ΣR for Test 2
at mp1 • mp2) for Test 1
RATE B, Mode 2 (Test 1)

——S1——
RATE B, Mode 1 (Test 2 wavelengths = or ≠ Test 1 wavelengths)

——S1——
Bichromatic∆ABS/MIN of Monochromatic ABS of
for Test 2 - d (S1 + ΣR) for Test 2
LEGEND
S1 = Standard 1 (blank)
S2 = Standard 2
R1 = Reagent 1
R2 = Reagent 2
ΣR = The sum of all reagents dispensed
mp1 = Measure Point 1
mp2 = Measure Point 2
d = Correction for dilution
Sample Volume + ΣR volumes at mp1

d =
Sample Volume + ΣR volumes at mp2
Legend of Calculation Terms

6.2 1-Point Linear Calibration
Selecting Linear Calibration

This calibration method is used for sample constituents (e.g., LD, AST, ALP) whose
rate of change in absorbance at different concentrations forms a linear plot and the
slope of the plot is already known. Enzymes cannot be weighed out but their
activity can be determined. The slope is based on the molar absorptivity of the
absorbing species (e.g., NADH) of that particular chemistry’s reaction. The K factor
for most enzyme assays, and some substrate assays, is established by a Roche
Diagnostics representative at installation according to the following formula:
K= Cc - Cb
Ac - Ab
In 1-point linear calibration, a zero or blank calibrator is run and the absorbance and
concentration of this, as well as the predetermined K factor, are used in the calcula-
tion of final results of the sample (unknown). Saline is commonly used as a zero or
blank calibrator.
21. Calib Type (Type) Linear
23. Calib. Conc. 1 standard 1 concentration
24. Calib. Pos. 1 standard 1 position

1-Point Linear Calibration Graph

1-Point Linear Calculation

The final result of an unknown is calculated using the equation for a straight line:
(y - b) 1
y = ax + b or x= or x= (y - b)
a a
where:
x = concentration
y = absorbance
a = slope
b = y-intercept or offset
1
K = ; therefore: Cx = K (Ax - Ab)
a
where:
Cx = concentration of unknown
Ax = absorbance of unknown
Ab = blank absorbance
K = K factor
The final result of an unknown is calculated using the equations below:

when Cb = 0 :
1
b = Ab Cx = x Ax = y K=
a
Substituting our expressions:
Cx = [K (Ax - Ab) • IFA] + IFB
when Cb ≠ 0:
1
b = Ab - a • Cb Cx = x Ax = y K=
a
where:
Ax = measured absorbance of unknown
Cb = concentration of STD 1/Blank
K = K factor (reciprocal of slope)
Ab = STD 1/Blank absorbance
IFA, IFB = instrument constants, representing slope and intercept

Assay Types
Assay techniques possible with this type of calibration:
1-point assay
2-point assay
3-point assay
2-point rate assay
1-point and rate assay
Rate A assay
Rate B assay

Selecting 2-Point Linear Calibration

For 2-point linear calibration, saline is commonly used as a zero or blank calibrator.
A second calibrator with a known value is also run. These two points are used to
establish a linear plot and the slope of this “curve” is used in the calculation of
subsequent control and patient results.
21. Calib Type (Type) Linear
2-Point Linear Calibration Graph
When Cb = 0

When Cb ≠ 0

2-Point Linear Calculation

The slope for a 2-point linear calibration is calculated from the equation for a
straight line:
(y - b) 1
y = ax + b or x= or x= (y - b)
a a
where:
x = concentration
y = absorbance
a = slope
b = y-intercept or offset
Solving for the slope (a) using two points:

∆y As - Ab 1 Cs - Cb
a= = C -C K= =
∆x s b a As - Ab
Solving for y intercept (b) using two points:

when Cb = 0: b = Ab
when Cb ≠ 0: b = Ab - a • Cb
where:
As = absorbance of the second calibrator reaction
Ab = absorbance of the STD 1/Blank calibrator reaction
Cs = concentration of the second calibrator
Cb = concentration of the STD 1/Blank calibrator
The final result of an unknown is calculated using the equations below.

From the equation for a straight line:
1
x= (y - b) Therefore: x = K (y - b)
a
when Cb = 0:
1
b = Ab Cx = x Ax = y K=
a

Cx = K (Ax - Ab)
when Cb ≠ 0:
1
b = Ab - a • Cb Cx = x Ax = y K=
a
where:
Ax = measured absorbance of unknown
Cb = concentration of STD 1/blank
K = K factor (reciprocal of slope)
Ab = blank absorbance
Assay Types
Assay techniques possible with this type of calibration:
1-point assay
2-point assay
3-point assay
2-point rate assay
Rate A assay
Rate B assay
2-point assay

6.4 Nonlinear Logit-Log 4P Calibration
Selecting Nonlinear Logit-Log 4P Calibration

The nonlinear method, logit-log 4P, is applied to a calibration curve in which the
absorbance increases or decreases in a nonlinear manner as the concentration
increases. In the example shown, the absorbance is increasing with an increasing
concentration.
21. Calib Type (Type) Logit Log (4P)
22. Calib Type (Wght) enter the weighted value
Nonlinear Logit-Log 4P Calibration Graph

Nonlinear Logit-Log 4P Calculation

The math model for nonlinear logit-log 4P calibration curve approximation is shown
below:
a
AN = B +
1 + bCC
where:
AN = measured absorbance value or absorbance variation rate of
standard N
B = calibration curve parameter (predicted absorbance or
absorbance rate for infinite concentration)
a = calibration curve parameter; predicted span of absorbance
or absorbance rate between zero and infinite concentration
(A(0) - A(inf))
b = calibration curve parameter; b = 1/ED50, where ED50 is the
concentration where the absorbance or absorbance rate is
1/2 of the span AED50 = (A(inf) - A(0))/2 + A(0)
c = logit slope
C = concentration of STD 1
The formula for sample concentration calculation is shown below:

1
a - (Ax - B)
[b { 1
}]
c
C=
Ax - B
Cx = (C + C1) • IFA + IFB
a
Ax = B +
1 + bCC
where:
Cx = analyte concentration of sample
C1 = analyte concentration of STD 1/Blank
C = Cx - C1
a, b, c = calibration curve parameters
Ax = sample absorbance value
B = calibration curve parameter (STD 1/Blank measured
absorbance value or absorbance variation rate)

Assay Types
Nonlinear logit-log 4P calibration can be used with the following assay types:
1-point assay
2-point rate assay
2-point assay
Rate A assay

6.5 Use of Weighting in Nonlinear Calibration
Introduction
With the nonlinear logit-log 3P and 4P calibration models, it is possible to apply a
weighting function during the curve fitting process that favors those calibrator points
with a lower absorbance (or rate of change of absorbance). This may result in a
more accurate curve fit in that particular concentration range.
Calculation without Weighting

When weighting is not used (entry of 0 in parameter field 22 , Calib Type (Wght), on
the Test Parameters screen), the curve fit is optimized by varying the parameters of
the logit-log function to minimize the sum of the residuals. The residuals are the
squares of the differences between the actual absorbances for each calibrator and
the absorbance calculated from the logit-log function. In other words:
Σ[Ai - f(Ci)]2 • min
where:
Ai = the actual absorbance (or rate of change of absorbance)
of calibrator i
f(Ci) = the absorbance (or rate of change of absorbance) of
calibrator i calculated by the logit-log function from its
concentration (Ci)
n = number of calibrators used
Calculation with Weighting

When weighting is used (entry of 1 or 2 in parameter field 22 , Calib Type (Wght), on
the Test Parameters screen), each of the residuals is multiplied by a weight factor
during the curve fitting process thus:
Σwi[Ai - f(Ci)]2 • min
where: wi = the weight factor for calibrator point i

and all other symbols are as described above.

6.5 Use of Weighting in Nonlinear Calibration
Weighting Factors
The weight factor is inversely related to the absorbance of the calibrator, so that
those with a smaller absorbance will have a larger factor.
If... Then...
an entry of 1 is made in the the weight factor for calibrator point i will be:
Weight field wi = 1
Ai
an entry of 2 is made in the the weight factor for calibrator point i will be:
Weight field wi = 1
Ai2
To ensure that there is not too great a difference between the lowest and highest
weights, a constant factor F is added to each calibrator absorbance before the
curve fitting process is applied. F is calculated as follows:
1
F = (Amax - Amin)
9
Thus, when a weighting factor of 1 is selected, the actual weighting factor is:
1
wi =
Ai + F
When a weighting factor of 2 is selected, the actual weighting factor is:

1
wi =
(Ai + F)2
This mechanism ensures that the ratio of the highest weight to the lowest weight
never exceeds 10 for option 1 or 100 for option 2. After the curve fitting process is
complete, the factor F is subtracted from the B parameter of the logit-log equation
to ensure that the curve fits the actual absorbances obtained for the calibrators and
not the adjusted ones used in the weighted curve fitting process.

Selecting Nonlinear Logit-log 5P Calibration

The nonlinear method, logit-log 5P, is applied to a calibration curve in which the
absorbance increases or decreases in a nonlinear manner as the concentration
increases. In the example shown, the absorbance is increasing with an increased
concentration.
21. Calib Type (Type) Logit Log (5P)
Nonlinear Logit-Log 5P Calibration Graph

Nonlinear Logit-Log 5P Calculation

The math model for nonlinear logit-log 5P calibration curve approximation is shown
below:
Kc
AN = B +
1 + exp {-(a + b • lnC + c • C)}
where:
AN = measured absorbance value or absorbance variation rate of
standard N
B = measured absorbance value or calibration curve parameter
absorbance variation rate of STD1
Kc = predicted span of absorbance or absorbance rate between
zero and infinite concentration A(inf) - A(0)
a = calibration curve parameter (logit intercept)
b = calibration curve parameter (logit slope)
c = calibration curve parameter (asymmetry factor)
C = analyte concentration of standard solution
InC = natural log of C - C1
The formula for sample concentration calculation is shown below:

Ax - B
a + b lnC + c • C - In [ ]=0
K - (Ax - B)
Kc
AX = B +
1 + exp {-(a + b • lnC + c • C)}
CX = (C + C1) • IFA + IFB
where:
CX = sample concentration corrected for STD1/Blank concen-
tration and instrument factors
C1 = concentration of STD1/Blank
C = CX - C1; C is obtained by Newtons’s approximation
method
a, b, c = calibration curve parameters
AX = sample absorbance value
B = STD1/Blank measured absorbance value or calibration
curve parameter absorbance variation rate

The parameters in the Calibration Information window correspond in the following

way:
B = S1 Abs
K = Kc
a = A
b = B
c = C
where:
a = absorbance or absorbance change rate of sample
K = K in Calibration Information window (K factor)
a = A in Calibration Information window
b = B in Calibration Information window
c = C in Calibration Information window
Using the Weight Factors

The analyzer supports the use of no weights, or the selection of one of two weight
factors. Weight factors 1 and 2 are used for the calculation of the calibration param-
eter in the formula:
1 a
S ∆i2 = S { Ai - ( + B)}2
∆i 1 + bCC
where:
∆i = Ai for weight 1
∆i = Ai2 for weight 2
Ai = measured absorbance value or absorbance variation rate of
standard.
The application of these weights can be useful for analytes with a decision level in
the lower concentration range. The algorithm will produce a calibration function
which more closely follows the measurements in the lower concentration range.
This is achieved by using weight factor 1 and even more by weight factor 2. These
weight factors can be specified for the nonlinear logit-log 3P and nonlinear logit-log
4P calculation.

Assay types
Nonlinear logit-log 5P calibration can be used with the following assay types:
1-point assay
2-point assay
2-point rate assay
Rate A assay

6.7 Nonlinear Spline Calibration
Selecting Nonlinear Spline Calibration

Nonlinear method, Spline, is applied to a calibration curve in which the absorbance
increases as the concentration increases. The range between standard samples x
and x - 1 measure values are approximated and a curve is drawn.
21. Calib Type (Type) Spline
Nonlinear Spline Calibration Graph

Nonlinear Spline Calculation

The math model for nonlinear spline calibration curve approximation is shown
below:
A = a (I) + b (I)(C - C(I)) + c (I)(C - C(I))2 + B (I)(C - C(I))3
where:
A = measured absorbance value or absorbance variation rate of
standard (except STD1/Blank)
B = calibration curve parameter (measured absorbance value or
absorbance variation rate of STD1/Blank)
a,b,c = calibration curve parameters
C = concentration of standard
a(I), b(I),
c(I), d(I) = calibration curve parameters used only in model 5. These
parameters are determined according to the standard
solution numbers I and I + 1 where 1 ≤ I ≤ 5.
The formula for sample concentration is shown below:

CX = (C + C1) • IFA + IFB
a (I) + b (I)(CX - C(I)) + c (I)(CX - C(I))2 + B (I)(CX - C(I))3 - AX = 0
AX = a (I) + b (I)(CX - C(I)) + c (I)(CX - C(I))2 + B (I)(CX - C(I))3
where:
CX = sample concentration corrected for STD1 concentration
and instrument factors
C = sample concentration
C1 = concentration of STD1
a,b,c = calibration curve parameters
AX = sample absorbance value
B = calibration curve parameter (STD1 measured absorbance
value or absorbance variation rate)
K = scale parameter
In C = natural log of sample concentration
a(I), b(I),
c(I), d(I) = calibration curve parameters used only in Spline calibra-
tion. These parameters are determined according to the
standard numbers I and I + 1 where 1 ≤ I ≤ 5.

Assay types
Nonlinear spline calibration can be used with the following assay types:
1-point assay
2-point assay
2-point rate assay
Rate A assay

6.8 Nonlinear Point to Point Calibration
Selecting Nonlinear Point to Point Calibration

Nonlinear method 5, point to point, is applied to a calibration curve in which the
absorbance increases as the concentration increases. The range between standard
samples x and x - 1 measure values are approximated and a curve is drawn.
21. Calib Type (Type) point to point
Nonlinear Line-Graph Calibration Graph

6.8 Nonlinear Point to Point Calibration
Nonlinear Point to Point Calculation

The math model for nonlinear line graph calibration curve approximation is shown
below:
K = (C2-C1)/(STD (2)-STD(1))
where:
STD1 = measured absorbance value or absorbance variation rate of
STD1
STD2 = cmeasured absorbance value or absorbance variation rate
of STD1
The formula for sample concentration is shown below:

CX = [ KN(A-SNABS)+CN ]•IFA+IFB
where:
CX = sample concentration
CN = concentration of standard solution (N)
KN = K factor
A = sample absorbance value
SNABS = calculation absorbance or absorbance fluctuation value of
the standard solution (N)
Assay types
Nonlinear line-graph calibration can be used with the following assay types:
1-point assay
2-point assay
3-point assay
2-point rate assay
Rate A assay
Rate B assay

6.9 ISE Calibration
ISE Calibration
The ISE system requires full calibration once every 24 hours. Calibration of Na+, K+,
and Cl- in the ISE unit requires the ISE Standard 1 (Low) and ISE Standard 2 (High),
which are aqueous standards, and ISE Standard 3 (Precical), a protein-based
standard. If the analyzer is in the Operation mode and the ISE system has been
inactive for 10 minutes of operation, a single point calibration (using internal
standard [IS]) is automatically performed. The Electromotive Force (EMF) (voltage) is
measured after equilibration occurs at the electrode membrane as shown below.
Based upon these readings and the assay value of the standards, the instrument
computer then calculates a slope for the calibration. IS is the Internal Standard, and
its measured concentration value is calculated from its EMF as shown graphically
above. This value is stored in the computer memory for later reference.

6.9 ISE Calibration
Slope Calculation
The slope is calculated in millivolts per decade (mV/decade) from the aqueous low
and high standards. Ideally, the slope for an ion with a single charge is 61.6 mV/
decade of ion concentration at 37 oC. Due to factors such as the condition of the
electrodes, the measured slope may deviate from this ideal slope. Therefore, the
slope for the ISE accessory should fall within the following ranges:
Optimal Slope Prep Range Slope Range
Na+ 50 to 68 mV/decade 45 to 49.9 mV/decade < 45
K+ 50 to 68 mV/decade 45 to 49.9 mV/decade < 45
Cl- -40 to -68 mV/decade -35 to -39.9 mV/decade > -35
The slope is calculated according to the following formula:

EH-EL
S= = mV/decade
Log CH
CL
where:
S = slope
EH = voltage of high standard
EL = voltage of low standard
CH = concentration of high standard
CL = concentration of low standard

6.9 ISE Calibration
Internal Standard Calculation

In any ISE measurement system, junctions between lead wires, membranes, and
reagents exist. The internal standard compensates for the junction potential varia-
tions.
After the slope is established during calibration, the internal standard concentration
is measured. The calculated value of the internal standard, as well as the voltage,
is shown on the calibration report.
The concentration of Na+, K+, and Cl- in the internal standard is calculated from the
electromotive force (voltage) of each electrode measured during calibration accord-
ing to the formula below.
EIS-EL
CIS = CL • 10
S
where:
C IS = concentration of the specific ion in the internal standard
CL = input concentration of the low standard
EIS = electromotive force (voltage) for the same specific ion of
the internal standard
EL = electromotive force (voltage) of the low standard for the
specific ion
S = slope

6.9 ISE Calibration
Single Point Adjustment

An Internal Standard (IS), labeled as Internal Reference Solution, is measured as a
sample during routine calibration and before every patient sample. These measure-
ments are used to correct for drift due to junction potential, electrode condition,
etc., between samples and to provide a periodic single-point calibration adjustment
as shown below:

6.9 ISE Calibration
Compensation Overview
Because the low and high standards are aqueous, Precical calibrator serum is used
as a compensator to adjust the offset of the slope. This compensates for activity
differences between the aqueous standards and protein-based samples. This
difference between the calculated and actual values is referred to as the compen-
sate value (C. Value on the Calibration Monitor report).
Compensation Value Calculation

Serum-based Precical calibrator or RD-Human Compensator is recommended as a
compensator to adjust for differences in electrode response between aqueous and
protein-based samples.
The concentration of ions in the compensator is calculated according to the
following formula:
Equation:
EC-EIS
CX = CIS x 10 S
where:
CX = measured concentration of the specific ion in the
compensator (Precical)
C IS = concentration of the internal standard, determined during
calibration
EC = electromotive force (voltage) of the compensator for the
specific ion
EIS = electromotive force (voltage) of the internal standard for
the specific ion
S = slope

6.9 ISE Calibration
The formula for finding the compensated values is:

Compensated value = assigned value (Calibrator) - calculated value (Calibrator)
(This value is Cx in the equation above.)
The Compensated Value is displayed on the Calibration/Status/ISE Calibration
Information window. This value is automatically updated by the instrument following
successful calibration. If during calibration the percent difference in the current and
previous compensators is greater than the Compensated Limit set on the
Parameters/ISE Test screen, an alarm is issued.
Reference Cartridge
A 1N KCl solution is measured concurrently with each sample analysis. A reference
cartridge is used for this purpose. This function serves as a reference point for all
measurements and compensates for any electronic variations in the system. All
other voltages are reported using reference cartridge voltage as the zero point; i.e.,
the reference cartridge voltage is subtracted from all other measured voltages.
Nernst Equation
The Nernst equation is used to calculate the concentration for a specific ion in
solution as follows:
Equation 1:
f x Ct
E = EIS + RT x ln f x C
i
nF
where:
E = specific electrode (Na+, K+, Cl-)

electromotive force (EMF)
(voltage)
EIS = EMF of Internal Standard
R = gas constant
T = temperature
n = charge of the ion

6.9 ISE Calibration
Because the sodium, potassium, and chloride ions each carry a single charge, R, T,
n, and F are combined into a single value referred to as the slope (S). Also, because
the instrument dilutes the sample to approximately 1:50, the ionic strength and
activity coefficient (f) are essentially constant. These terms, then, can be factored
into the E'IS term. The Nernst equation can be rewritten to reflect the above stated
conditions as follows:
Equation 2:
E = E'IS + S x ln (Ct)
where:
E = specific electrode electromotive force (voltage)

E'IS = internal standard electromotive force (voltage) (with
constants)
S = slope
Ct = ion concentration in sample/diluent mixture
ln = natural log
This rewritten equation demonstrates that the electromotive force (voltage) of a

specific electrode is directly proportional to the log of the activity of the diffusible ion
in the sample/reagent mixture. This equation can be likened to the basic equation
used for linear, photometric chemistries, as follows:
Equation 3:
ISE: E = S • ln(Ct ) + E'IS
Photometric: y = ax + b
where:
E = y (y axis)
S = a (slope)
ln Ct = x (x axis)
E'IS = b (y intercept)
The Nernst equation can be rewritten again to express concentration as follows:

Equation 4:
E-E'IS
Ct = 10 S
where the definitions shown on the previous page are true.

6.9 ISE Calibration
Calculation of Unknown Sample Concentrations

The concentration of the sodium, potassium, and chloride in unknown samples is
calculated by determining the electromotive force (voltage) of the specific electrode
and calculating the results according to the following equation:
Equation:
Et-EIS
Ct = Compensated value + (CIS x 10 S )
where:
Ct =
concentration of the specific ion in the unknown
sample/diluent (test) mixture
Compensated value = compensation factor (Comp Concentration)
C IS = concentration of the internal standard, determined
during calibration
Et = electromotive force (voltage) of the unknown sample for
the specific ion
EIS = electromotive force (voltage) of the internal standard for
the specific ion
S = slope

NOTES

Chapter 7
Serum Index Function

7.1 Serum Index Function
Introduction
Serum indices (also referred to as serum indexes) are calculations of absorbance
measurements that provide a semi-quantitative representation of levels of icterus,
hemolysis, or lipemia (turbidity) present in unknown samples. Serum indices may
be determined in one of two ways:
• using an existing chemistry channel (AST or ALT)
• using a separate, dedicated saline channel.
The following are requirements for the channel selected:
• test must be a rate A reaction.
• test must read at a primary wavelength of 340 nm.
• test must have an R1 that is clear and essentially non-reactive.
• recommended tests to use are AST or ALT.
Definition of Serum Indices

The icterus index, I, is reported in icterus units that are linear, up to 60 mg/dl, and
semi-quantitative. For example, an icterus index of 20 is equivalent to a known
unconjugated bilirubin concentration of approximately 20 mg/dl.
The hemolysis index, H, is reported in hemolysis units that are linear, up to
1000 mg/dl, and semi-quantitative. For example, a hemolysis index of 500 is
equivalent to a known hemoglobin concentration of approximately 500 mg/dl.
The lipemia index, L, is reported in lipemia units corresponding to mg/dl of Intralipid
(Kabi-Pharmacia, Inc.), an artificial lipid material. These units are linear, up to 1000
mg/dl, and semi-quantitative. For example, a lipemia index of 1000 is equivalent to
a 1000 mg/dl Intralipid solution. This is a measurement of turbidity, not the amount
of triglycerides.

Serum Index Screen

Before running serum indices, make sure that the serum index channel has been
specified and parameters for icterus, hemolysis, and lipemia have been entered
on the Serum Index screen.
1. Touch Parameters on the
Home screen.
2. Touch Serum Index on the
Parameters screen.
3. Enter the channel number of
the test for serum index
measurement, then touch
enter.
4. Touch Constant on the Serum
Index screen to verify factors
A-F with the table below. The
factors are identical for ipemia,
hemolysis, and icterus.
Factor Saline Saline AST/ALT AST/ALT

Conv. Units* Int’l Units* Conv. Units** Int’l Units**
A 23 37 34 55
B 122000 122000 122000 122000
C 14 14 20 20
D 1700 94 2500 146
E 19000 19000 19000 19000
F 180000 180000 180000 180000
* Sample Volume 10 µl, R1 Volume 250 µl.
** Sample Volume 15 µl, R1 Volume 250 µl.
Using Existing Chemistry Channel

Enter the desired channel that is to be used in serum index measurement in the
Channel No field on the Serum Index screen. The recommended tests are AST or
ALT because their R1 reagents meet the requirements. Entering this test channel
number tells the analyzer to use that test’s R1 for running serum indices
(L, H, and I).
You must assign a print order for serum indices (L, H and I). Refer to Chapter 3 of
the Tutorial Guide for help with assigning a print order.

Using a Saline Channel

The following is a brief description of the procedure when a dedicated saline
channel is to be used for serum index measurement.
• Saline parameters are programmed during installation.
• Do not assign a print line (order) for the saline index channel.
• Factors A through F are entered on the Serum Index screen.
• You must assign a print order for serum indices (L, H and I).
Enter the saline channel number in the Channel No field on the Serum Index
screen.
Saline Parameters
The following table lists the parameters for the Saline (Index) Channel. For infor-
mation on how to change these parameters, refer section 3.1, “How to Program
Parameters for Photometric Chemistries,” in the Tutorial Guide.
Parameter Number/Name Parameter Setting

1. Test Name Index
2. Assay Code (Method) Rate A
3. Assay Code (Test) 0
4. Reaction Time 3
5. Assay Point 1 5
6. Assay Point 2 11
7. Assay Piont 3 0
8. Assay Point 4 0
9. Wavelength (Sub) 376
10. Wavelength (Wave) 340
11. Sample Volume 10.0
12. R1 Vol. 250
13. R1 Pos. User defined
14. R1 Bottle Size L
15. R2 Vol. 0
16. R2 Pos. 0
17. R2 Bottle Size S
18. R3 Vol. 0
19. R3 Pos. 0
20. R3 Bottle Size S


21. Calib. Type (Type) K Factor
22. Calib. Type (Wght) 0
23. Calib. Conc 1 0
24. Calib. Pos 1 36
25. Calib. Conc 2 0
26. Calib. Pos 2 0
27. Calib. Conc 3 0
28 Calib. Pos 3 0
29. Calib. Conc 4 0
30. Calib. Pos 4 0
31. Calib. Conc 5 0
32. Calib. Pos 5 0
33. Calib. Conc 6 0
34. Calib. Pos 6 0
35. S1 ABS 0
36. K Factor 1000
37. K2 Factor *
38. K3 Factor *
39. K4 Factor *
40. K5 Factor *
41. A Factor *
42. B Factor *
43. C Factor *
44. SD Limit 0.1
45. Duplicate Limit 100
46. Sens. Limit 0
47. S1 ABS Limit (L) -500
48. S1 ABS Limit (H) 500
49. ABS Limit 32000
50. ABS Limit (D/I) Increase
51 Prz. Limit 0
52. Prz. Limit (L/U) Lower**


53. Prz. (Endpoint) 35
54. Expect Value (L) -100
55. Expect Value (H) 1000
56. Inst. Factor (a) 1.0
57. Inst. Factor (b) 0.0
58. Key Setting User Defined
* These parameters default to a blank entry on the screen. When they are printed, the printed
entry shows as a default number (0, 1000) instead of being blank.
** “Lower Limit” does not appear on the printed parameters. It is substituted with the letter “D.”

Selecting Serum Indices

Touch Serum Index on the Start Conditions screen to request serum index mea-
surements on samples. When the Serum Index key is highlighted, serum index
measurements are carried out automatically for all routine and STAT samples. This
key can only be activated or deactivated when the analyzer is in STAND-BY.
Calibrate the Serum Indices

Serum Indices must be blanked once per month. The reagent channel assigned
for serum indices must be requested for calibration and the blanking will be
automatic. If the saline channel is used, you need only calibrate that channel once
during installation. Blank values should be within ± 30. Refer to the Monitor/
Calibration screen to view the blank values.
The measurement results of reagent blank solutions for icterus (480/505), for
hemolysis (570/600), and for lipemia (660/700) are automatically indicated as
S1Abs. on the screen.
Save Parameter Changes

Parameter changes must be written to the parameter disk on the Parameters
screen in the Maintenance menu.

Graphic Representation of Serum Indices

The bichromatic wavelength pairs used for serum index measurement are 480 nm
and 505 nm (range 1), 570 nm and 600 nm (range 2), and 660 nm and 700 nm
(range 3). The absorbance readings for the lipemia index are taken in range 3. The
absorbance readings for the hemolysis index are taken in ranges 2 and 3. The
absorbance readings for the icterus index are taken in ranges 1, 2, and 3. The
calculation formulas used for the serum indices include corrections to compen-
sate for the spectral overlap.
The figure below is a graphic representation of the spectral measurement of these
serum characteristics.
Lipemia
NADH Icterus
Absorbance
Hemolysis
340 480 505 546 570 600 660 700 (nm)
Wavelength Range 1 Range 2 Range 3
Serum Index Measurement

Calculation of Serum Indices

Icterus Index
The formula to calculate the icterus index (I) is:
1
I= • [(∆Abs1) - E • {(∆Abs2) - B • (∆Abs3)} - F • (∆Abs3)]
D
where:
I = icterus index
D = scaling factor for bilirubin
E = corrects bilirubin measurement (absorbance) for
hemoglobin
B = corrects hemoglobin measurement for lipemia
F = corrects bilirubin measurement for lipemia
∆Abs1,2,3 = absorbance values of the 480 - 505 nm, 570 - 600 nm,
and 660 - 700 nm bichromatic readings, respectively, in
relation to the blank absorbances.
Hemolysis Index
The formula to calculate the hemolysis index (H) is:
1
H= • [(∆Abs2) - B • (∆Abs3)]
A
where:
H = hemolysis index
A = scaling factor for hemoglobin
B = corrects hemoglobin measurement for lipemia
∆Abs2,3 = absorbance of the 570 - 600 nm and 660 - 700 nm
bichromatic readings, respectively, in relation to the blank
absorbances.

Lipemia Index
The formula to calculate the lipemia index (L) is:
L=
1 • (∆Abs3)
C
where:
L = lipemia index
C = scaling factor for lipemia
∆Abs3 = absorbance of the 660 - 700 nm bichromatic readings in
relation to the blank absorbances.
A, C and D (sample dilution-dependent) are scaling factors to provide semi-

quantitative interference levels.
B, E and F are correcting factors which correct overlapping interference spectra.
They are independent of sample dilution since they are based on ratios of
absorbances.

Chapter 8
Data Alarms

8.1 Data Alarms
Result Integrity Checks

Several methods are used by the system to ensure that final results are valid. The
messages found in Chapter 2, Data Alarms, in the User’s Guide, appear on the
results printout to indicate possible data errors. Some of these also activate the
audible alarm and initiate the display of instrument alarm messages on the screen.
Prozone Effect
Some tests (such as immunoassay methods) use the principle of antigen/antibody
complex formation (agglutination) as a measurement technique. The turbidity
caused by this specific agglutination can be measured by photometric means.
The antigen/antibody complex formation is predictable as long as an excess of
reagent (antibody) exists. In patient samples with very high levels of antigen,
however, the reaction may begin to reverse (deagglutination) because of the effect
of excess antigen. This is called a prozone effect and without checking for this
phenomenon, abnormally high samples may give incorrect or even falsely normal or
low results.
The RD/Hitachi 902 analyzer may perform a check for the prozone effect in a 1-point
assay by adding a dilution of the antigen as an additional reagent (R2 or R3).
(Prozone check can also be done on a 2-point assay.) If the reaction continues in
the same direction (increasing or decreasing absorbance) as in the initial reaction,
then prozone is not occurring. If the reaction proceeds in the opposite direction,
after additional reagent is added, then prozone is occurring and the result is invalid
and the corresponding data flag and prozone check value is printed on the patient
report (XXXXP).
When the Prozone Limit is entered in parameter field 51 on the Test Parameters
screen, Upper or Lower must also be specified in parameter field 52 to indicate
whether absorbance is expected to increase (reach the upper limit) or decrease
(reach the lower limit) (respectively) when prozone occurs.
The following applies to 1- and 2-point assays:
• 1-point assays are checked for prozone if two measure points are pro-
grammed
• 2-point assays are checked only if four measure points are programmed.

8.1 Data Alarms
Example: 1-Point Assay Prozone Check
Example: 2-Point Assay Prozone Check

8.1 Data Alarms
Linearity Verification (LIN.)
Linearity Verification - Lin.
When the read points are > 8, the linearity value obtained must be less than the
linearity limit defined on the Linearity/Rate as Chk screen in System Parameters.
If the value is above this number, a LIN. data alarm is issued. If any absorbance
reading taken during the programmed interval exceeds the Abs. Limit parameter,
that absorbance reading is excluded from the least squares rate calculation.

8.1 Data Alarms
Calculation for LIN. Data Alarm

If:
∆Ai - ∆Af • 100 > defined limit
∆A
then a LIN. alarm occurs,
where:
∆Ai = rate of absorbance change (∆A/min) during the initial six
measure points of the read period
∆Af = rate of absorbance change (∆A/min) during the final six
measure points of the read period
∆A = total change in absorbance per minute (∆A/min)
Linearity is checked by dividing the difference in absorbance change between the

first and last 6 photometric points (about 1.5 minutes each) by the average absor-
bance change for all. If the value thus obtained is beyond the linearity limit value,
the alarm (LIN.) is printed out with the result of measurement.

8.1 Data Alarms
Linearity Verification (LIN.8)
Linearity Verification - LIN. 8
When the read points are ≤ 8, the linearity value obtained must be less than the
linearity limit or a LIN.8 data alarm is issued. When the number of data points
available for this calculation is less than nine, the rate of absorbance change
during the last three read rotations of the reaction is subtracted from the rate of
absorbance change during the first three read rotations of the reaction. This is
then divided by the total change in absorbance (∆A) per minute. If this value (• 100)
is greater than the value entered on the Linearity/Rate as Chk screen in System
Parameters, a corresponding data alarm is issued (LIN.8). If any absorbance
reading taken during the programmed interval exceeds the Abs. Limit parameter,
that absorbance reading is excluded from the least squares rate calculation.
If the absorbance change per minute is less than 6 • 10-3, no linearity check is
made.

8.1 Data Alarms
Calculation of Lin.8
If:
∆Ai' - ∆Af' • 100 > defined limit
∆A
then a Lin.8 alarm occurs,
where:
∆Ai' = rate of absorbance change (∆A/min) during the initial three
read rotations of the reaction
∆Af' = rate of absorbance change (∆A/min) during the final three
read rotations of the reaction
∆A = total change in absorbance per minute (∆A/min)
Sensitivity Limit (SENS)

A minimum sensitivity limit is designated in parameter field 46 on the Test Param-
eters screen for each endpoint chemistry. This value specifies the minimum
absorbance changes that must be detected between the blank and span calibra-
tor during calibration of endpoint chemistries. If the absorbance/unit calculated
using the blank and span calibrators is not greater than the sensitivity limit, a
SENS alarm is issued indicating a failed calibration. The sensitivity observed
during calibration is calculated as follows:
Abs(Sn) - Abs(S1)
where Sn is the Span calibrator. By using the Span calibrator, all calibrations that
affect the factor setting for the test are error-checked against the sensitivity limit.

8.1 Data Alarms
S1 Absorbance Limit (S1ABS?)

An upper and lower absorbance range (S1 Abs Range) for calibrator 1 (S1) is
designated in parameter fields 47 and 48 on the Test Parameters screen. If the
absorbance for calibrator 1 falls outside these limits, the system issues a S1Abs?
alarm indicating a failed calibration.
Duplicate Limit (DUP)

A duplicate limit for calibrator acceptability is designated in parameter field 45 on
the Test Parameters screen. The Duplicate Limit field (parameter field 49) defines
the absorbance error limit:
Abs2 - Abs1
Substrate Depletion (LIMT.0, LIMT.1, LIMT.2)

An absorbance limit value is designated in parameter field 49 on the Test Param-
eters screen for each rate assay. This value is included with the recommended
instrument settings for each rate chemistry. This value specifies the absorbance of
the reaction mixture at which substrate concentration is too low for a reliable,
linear reaction to take place. The absorbance limit is usually reached as a result of
very high analyte concentration in the sample, but may occur when outdated or
improperly prepared reagent is used.
When excessive sample absorbance (caused by lipemia, icterus, etc.) is mea-
sured, the measured absorbance value is compared with the initial absorbance
level of the reaction. The difference (sample absorbance level - STD1 absorbance
level) is calculated and the absorbance limit value is adjusted accordingly when
checking for substrate depletion.
LIMT.0 - indicates that the reaction exceeded the absorbance limit

at all measured points.
LIMT.1 - indicates that the reaction exceeded the limit at all but
one measured point.
LIMT.2 - indicates that the reaction exceeded the limit at all but
two measured points.
These flags allow for an approximation of the sample dilution necessary to bring the
reaction into the measurable range. All data alarms are explained in detail in
Chapter 2 of the User’s Guide.

8.1 Data Alarms
LIMT.0 Substrate Depletion

8.1 Data Alarms

Software Guide
Roche Diagnostics/Hitachi 902 Analyzer Software Guide V1.2 SG - 1

Copyrights
Trademarks
Publisher
Sandhoferstr. 116
D-68305 Mannheim
Phone: +49 621 759 4445
Manual Version 1.2

Revised pages for this manual are provided by Roche Diagnostics when necessary.
No part of this publication may be reproduced in any form or by any means without
prior written permission.
Version 1.2 Sept, 2003 SG-2 to SG-4
SG - 2 Roche Diagnostics/Hitachi 902 Analyzer Software Guide V1.2

Intended use
the system.
Our instruments meet the protection requirements laid down in IVD Directive 98/79/
EC and the European Standard EN 591.
C ® US
Contact addresses
Manufacturer


D-68305 Mannheim
Germany
Roche Diagnostics/Hitachi 902 Analyzer Software Guide V1.2 SG - 3

NOTES
SG - 4 Roche Diagnostics/Hitachi 902 Analyzer Software Guide V1.2

Table of Contents
Chapter 1 - Software Basics
1.1 Overview _______________________________________________ 1-2

Introduction ____________________________________________________ 1-2
1.2 LCD Screen and Common Keys __________________________ 1-3

LCD Screen ____________________________________________________ 1-3
Common Keys _________________________________________________ 1-3
1.3 Home Screen ___________________________________________ 1-5

Home Screen ___________________________________________________ 1-5
1.4 Status _________________________________________________ 1-7

Status Screens _________________________________________________ 1-7
Status 1 Screen ________________________________________________ 1-7
Status 2 Screen ________________________________________________ 1-8
1.5 Start Conditions ________________________________________ 1-9

Start Condition Screens __________________________________________ 1-9
Start Condition 1 Screen _________________________________________ 1-9
Start Condition 2 Screen _________________________________________ 1-10
1.6 Software Flowchart _____________________________________ 1-11
Chapter 2 - Operational Screens
2.1 Batch Mode ____________________________________________ 2-2

Batch Mode Screens ____________________________________________ 2-2
2.2 Easy Mode _____________________________________________ 2-3

Easy Mode Screens _____________________________________________ 2-3
Easy 1 Screen __________________________________________________ 2-3
Easy 2 Screen __________________________________________________ 2-4
Easy 3 Screen __________________________________________________ 2-5
Roche Diagnostics/Hitachi 902 Analyzer Software Guide V1.1 i

2.3 Sample ID ______________________________________________ 2-6
Sample ID Screens ______________________________________________ 2-6
Sample ID Screen (Batch Mode) ___________________________________ 2-6
Sample ID Screen (Easy Mode) ___________________________________ 2-8
2.4 STAT Test Selection ____________________________________ 2-9

STAT Test Selection Screen ______________________________________ 2-9
2.5 Profile Selection ________________________________________ 2-10

Profile Selection Screen __________________________________________ 2-10
2.6 Test Selection __________________________________________ 2-11

Test Selection Screen ___________________________________________ 2-11
2.7 Calibration Selection ____________________________________ 2-12

Calibration Selection Screen ______________________________________ 2-12
2.8 ISE Calibration __________________________________________ 2-13

ISE Calibration Screen ___________________________________________ 2-13
2.9 Control Selection _______________________________________ 2-14

Control Selection Screen _________________________________________ 2-14
Chapter 3 - Monitor Menu
3.1 Monitor Menu __________________________________________ 3-2

Monitor Screen _________________________________________________ 3-2
3.2 Routine Samples ________________________________________ 3-3

Routine Samples Screens ________________________________________ 3-3
Routine Result, Disp. Screen _____________________________________ 3-4
Routine Result, Print Screen ______________________________________ 3-4
Routine Result, Send Screen _____________________________________ 3-5
Routine Result, Delete Screen ____________________________________ 3-5
Routine Result, ASCII Screen _____________________________________ 3-6
ii Roche Diagnostics/Hitachi 902 Analyzer Software Guide V1.1

3.3 STAT Samples __________________________________________ 3-7
STAT Samples Screens __________________________________________ 3-7
STAT Result, Disp. Screen _______________________________________ 3-8
STAT Result, Print Screen ________________________________________ 3-8
STAT Result, Send Screen _______________________________________ 3-9
STAT Result, Delete Screen ______________________________________ 3-9
STAT Result, ASCII screen _______________________________________ 3-10
3.4 Calibration Results _____________________________________ 3-11

Calibration Screen ______________________________________________ 3-11
3.5 ISE Calibration Results __________________________________ 3-12

ISE Calibration Screen ___________________________________________ 3-12
3.6 Control Samples ________________________________________ 3-13

Control Samples Screen _________________________________________ 3-13
Control Result, Print Screen ______________________________________ 3-14
Control Result, Send Screen ______________________________________ 3-14
Control Result, Delete Screen _____________________________________ 3-15
Chapter 4 - Parameters Menu
4.1 Parameters Menu _______________________________________ 4-2

Parameters Screen ______________________________________________ 4-2
4.2 Test Parameters ________________________________________ 4-4

Test Parameters Screen _________________________________________ 4-4
4.3 Carry Over Evasion ______________________________________ 4-10

Carry Over Evasion Screen _______________________________________ 4-10
Carry Over Evasion, Reagent Probe Screen _________________________ 4-10
Carry Over Evasion, Reaction Cells Screen _________________________ 4-12
Carry Over Evasion, Sample Probe Screen _________________________ 4-13
4.4 Calculated/Compensated Tests _________________________ 4-14

Calc. Test Screen _______________________________________________ 4-14
Calc. Test Parameters Screen ____________________________________ 4-14
Comp. Test Parameters Screen ___________________________________ 4-16
4.5 Serum Index ____________________________________________ 4-18

Serum Index Screen _____________________________________________ 4-18
Roche Diagnostics/Hitachi 902 Analyzer Software Guide V1.1 iii

4.6 Control Positions _______________________________________ 4-19
Control Positions Screen _________________________________________ 4-19
4.7 System Parameters _____________________________________ 4-20

System Parameters Screen _______________________________________ 4-20
Date Screen ____________________________________________________ 4-21
Com. Parameters screens ________________________________________ 4-22
Original ABS Screen _____________________________________________ 4-24
Options Screen _________________________________________________ 4-24
Rate As Chk Screen _____________________________________________ 4-25
Initial Screen ___________________________________________________ 4-25
STAT Pos. Screen _______________________________________________ 4-26
Check Digit Screen ______________________________________________ 4-26
4.8 ISE Tests _______________________________________________ 4-27

ISE Tests Screen _______________________________________________ 4-27
4.9 Print Order _____________________________________________ 4-29

Print Order Screen ______________________________________________ 4-29
4.10 Profiles _______________________________________________ 4-30

Profile Screen __________________________________________________ 4-30
Chapter 5 - Maintenance Menu
5.1 Maintenance Menu ______________________________________ 5-2

Maintenance Screen _____________________________________________ 5-2
5.2 Wash Function __________________________________________ 5-4

Wash Screen ___________________________________________________ 5-4
5.3 Parameter Read/Write/Print Function _____________________ 5-5

Parameters Screen ______________________________________________ 5-5
5.4 Photometer Check Function _____________________________ 5-6

Photometer Screen ______________________________________________ 5-6
5.5 Probe Adjust Function ___________________________________ 5-7

Probe Adjust Screen ____________________________________________ 5-7
iv Roche Diagnostics/Hitachi 902 Analyzer Software Guide V1.1

5.6 Cell Blank Function ______________________________________ 5-8
Cell Blank Screen _______________________________________________ 5-8
5.7 FD Utilities Function _____________________________________ 5-9

FD Utilities Screen ______________________________________________ 5-9
5.8 Incubation Water Exchange Function _____________________ 5-10

Incub. Water Screen _____________________________________________ 5-10
5.9 Precision Function ______________________________________ 5-11

Precision Screen ________________________________________________ 5-11
5.10 Reset Function ________________________________________ 5-12

Reset Screen ___________________________________________________ 5-12
5.11 ISE Prime Function _____________________________________ 5-13

ISE Prime Screen _______________________________________________ 5-13
Chapter 6 - Tools Menu
6.1 Tools Screen ___________________________________________ 6-2

Tools Menu ____________________________________________________ 6-2
6.2 Mechanism Check ______________________________________ 6-4

Mechanism Check Screen _______________________________________ 6-4
6.3 Program Check _________________________________________ 6-5

Program Check Screen __________________________________________ 6-5
6.4 Alarm Trace ____________________________________________ 6-6

Alarm Trace Screen _____________________________________________ 6-6
6.5 Test Summary __________________________________________ 6-7

Test Summary Screen ___________________________________________ 6-7
6.6 Communication Trace ___________________________________ 6-8

Communication Trace Screen _____________________________________ 6-8
Roche Diagnostics/Hitachi 902 Analyzer Software Guide V1.1 v

6.7 C-RAM R/W, Count Clear ________________________________ 6-9
C-RAM R/W ____________________________________________________ 6-9
Count Clear ____________________________________________________ 6-9
6.8 ISE Check ______________________________________________ 6-10

ISE Check Screen _______________________________________________ 6-10
6.9 Barcode Check _________________________________________ 6-11

Barcode Check Screen __________________________________________ 6-11
Chapter 7 - Reports
7.1 Overview _______________________________________________ 7-2
7.2 Data Monitor Report ____________________________________ 7-3
7.3 Requisition List _________________________________________ 7-5
7.4 Precision Check ________________________________________ 7-7
7.5 Volume Check Report ___________________________________ 7-9
7.6 Calibration Monitor Report ______________________________ 7-11
7.7 Daily Alarm Trace _______________________________________ 7-14
7.8 Cumulative Alarm Trace _________________________________ 7-16
7.9 Communication Trace ___________________________________ 7-17
7.10 Cumulative Operations List _____________________________ 7-18
7.11 Cell Blank Measurement ________________________________ 7-20
7.12 Program Check Report _________________________________ 7-22
7.13 Original Absorbance Report ____________________________ 7-23
7.14 Photometer Check Report ______________________________ 7-25
vi Roche Diagnostics/Hitachi 902 Analyzer Software Guide V1.1

7.15 ISE Check Report ______________________________________ 7-27
7.16 Barcode Reader Check Report _________________________ 7-29
7.17 Chemistry Parameters Report __________________________ 7-30
7.18 Test Parameters Report ________________________________ 7-31
7.19 System Parameters Report _____________________________ 7-32
Roche Diagnostics/Hitachi 902 Analyzer Software Guide V1.1 vii

NOTES
viii Roche Diagnostics/Hitachi 902 Analyzer Software Guide V1.1

Chapter 1
Software Basics
Roche Diagnostics/Hitachi 902 Analyzer Software Guide V1.1 1-1

1.1 Overview
Introduction
This Software Guide outlines the user interface screens found on the LCD of the RD/
Hitachi 902 analyzer. An example and a brief description of each is included. Before
discussing specific screens and how to use them, some general instructions
concerning software basics are necessary. These instructions apply to all RD/
Hitachi 902 analyzer screens.
The screen representations shown in this chapter and throughout this manual are for
n illustrative purposes only. The data shown may not reflect the same setup as your analyzer.
1-2 Roche Diagnostics/Hitachi 902 Analyzer Software Guide V1.1

1.2 LCD Screen and Common Keys
LCD Screen
The LCD touch screen is used to enter information into the analyzer and to display
information from the analyzer. Information is entered into the analyzer to control
analyzer functions.
Selections can be entered one of two ways: touch key or manual entry in an open
field. A selected touch key appears highlighted with a blue background. Enter
selections in an open field using the numeric keypad, then touch to register the
selection.
Common Keys
Numeric Keypad
Touch the numeric keypad to enter or change
information such as patient IDs and test
parameters.
Clear
Touch C to clear numbers that have been entered with the keypad. Move the
cursor to the field that is to be changed, then touch C until the error has been
cleared.
Space
Touch SP to insert a space between entries within a field.
Enter/Return
Touch to register all entries made in a field with the numeric keypad.
Down Arrow
Touch to move from field to field on the displayed screen.
Scroll Arrows
Touch or to scroll from screen to screen within a menu selection.
Page Up
Touch P.Up to display the previous screen selection.

1.2 LCD Screen and Common Keys
Home
Touch to display the Home screen.
Delete
Touch Del. to delete a selection.
STAT (Ambulance)
Touch to display the STAT Test Selection screen.
Status
Touch Status to display the Status screen.
Start
Touch Start to initiate sample runs, maintenance procedures, or functional
checks.
Stop
Touch Stop to terminate sample runs, maintenance procedures, or functional
checks.
Accept
Touch Accept. to save entries to system memory.
OK?
Touch to display the Start Condition screen.

1.3 Home Screen
Home Screen
The Home screen includes the main menu of options to operate the analyzer. The
Home screen is displayed by touching the Home key. If the screen currently
displayed does not have a Home key, touch the P. Up key to access the previous
screens until the Home key appears.
Home screen
Batch Mode
Touch key.
Use this key to display the Batch Mode screens.
Easy Mode
Touch key.
Use this key to display the Easy Mode screens.
Cal.
Touch key.
Use this key to display the photometric Calibration Selection screen.
ISE Cal.
Touch key.
Use this key to display the ISE Calibration screen.
Control
Touch key.
Use this key to display the Control Selection screen.
Monitor
Touch key.
Use this key to display the Monitor screens.
Param.
Touch key.
Use this key to display the Parameters screens.

1.3 Home Screen
Maint.
Touch key.
Use this key to display the Maintenance screens.
Tools
Touch key.
Use this key to display the Tools screens.

1.4 Status
Status Screens
The Status screens include several functional areas:
• status line
• instrument alarms
• host communication indicator
• printer indicator
• buzzer on/off key
The function of keys that appear on multiple screens is explained in the “LCD Screen and
n Common Keys” section of this guide.
Status 1 Screen
The Status 1 screen can be displayed by touching the Status key on most func-
tional screens.
Status 1 screen
The status line includes the current operational mode (for example, STAND-BY,
Operation, Emergency Stop), reaction bath temperature, date and time, as shown
in the above illustration. The buzzer that sounds at various times during a sample
run can be turned on/off by touching the Buzzer key.
Instrument/Data Alarms
Instrument/Data alarms and descriptions appear below the status line when an
alarm condition or an unusual situation has occurred in the instrument.
When you see an alarm on the Status 1 screen, refer to the User’s Guide for
detailed alarm descriptions and possible remedies.

1.4 Status
Status 2 Screen
The Status 2 screen displays the current printer and host communication status.
To display this screen, touch one of the scroll arrows on the Status 1 screen.
Status 2 screen

1.5 Start Conditions
Start Condition Screens

The Start Condition screens contain several keys that, when highlighted, perform
important sample run functions including:
• starting sequence number designation
• calibration
• control
• serum index
• reagent print
• host communication
• realtime print
• calibration print
• sample end buzzer.
Start Condition 1 Screen

The Start Condition 1 screen can be displayed by touching the OK? key on the
Batch Mode screen, the Easy 2 screen, and the Easy 3 screen.
Start Condition 1 screen
Sample No
Enter the sample number for the sample run. Touch .
Use this field to enter the beginning sequence number for the sample run.
Calibration
Touch key.
Use this key to activate/deactivate calibration with the sample run.
Control
Touch key.
Use this key to activate/deactivate controls with the sample run.

1.5 Start Conditions
Serum Index
Touch key.
Use this key to activate/deactivate serum index analysis with the sample run.
Reagent (Prnt)
Touch key.
Use this key to request a reagent Volume Check report. The report prints immedi-
ately and lists the number of remaining tests for each photometric reagent and the
current volume of the ISE reagents.
Start Condition 2 Screen

To display the Start Condition 2 screen, touch one of the scroll arrows on the Start
Condition 1 screen.
Start Condition 2 screen
Host Com.
Touch key.
Use this key to activate/deactivate the host communication port.
Realtime Print
Touch key.
Use this key to activate/deactivate realtime printing of patient and control results.
Cal. Print
Touch key.
Use this key to activate/deactivate realtime printing of calibration results.
S. End Buzzer
Touch key.
Use this key to turn on/off the buzzer at the end of a batch mode sample run.

1.6 Software Flowchart

NOTES

Chapter 2
Operational Screens
SG2S1-14.p65 1 07.10.2003, 14:01

2.1 Batch Mode
Batch Mode Screens

To display the Batch screen, touch the Batch Mode key on the Home screen. A
batch mode sample run is initiated from this screen. There are two Batch screens:
Batch Mode with Barcode Reader (BCR) and Batch Mode without BCR.
Batch Mode with BCR Batch Mode without BCR
Load sample from pos.

This field displays the start position number for the sample run. When the barcode
reader is enabled, samples can be placed randomly on the sample disk starting at
position 1. When the barcode reader is disabled, samples must be positioned on
the sample disk in the order that they are programmed starting at position 1.
Start No
Enter the sequence number, 1 to 400. Touch .
Use this field to designate the sequence number at which to begin sampling.
Batch
Enter the batch number, 0, 1-30. Touch .
Use this field to designate the number of routine or patient samples in the batch.
SG2S1-14.p65 2 07.10.2003, 14:01

2.2 Easy Mode
Easy Mode Screens

One of three Easy screens may be displayed by touching the Easy Mode key on
the Home screen: Easy 1, Easy 2, and Easy 3. The displayed screen is dependent
upon the Easy Mode setting established in the Parameters/System Parameters/
Init. screen.
Easy 1 Screen
The Easy 1 screen is displayed when Easy Mode 1 is given priority in System
Parameters and the Easy Mode key is touched on the Home screen.
Load sample in pos. 1 , and

touch “Profile” then “Start”.
PROF-A Profile
Profile Select
Start
Stop
Easy 1 screen
Load sample in pos.

This field displays the next available position number for the sample run. The
samples must be positioned on the sample disk in the order that they are pro-
grammed.
Default Profile
This key is named according to the profile order established on the Key Label
screen. The screen above displays “Liver Profile” as the default profile. (Refer to
“3.9 How to Define Profiles” in the Tutorial Guide.)
Profile Select
This key displays the Easy 2 screen. Touch this key to program profiles or tests
other than those included in the default profile.
SG2S1-14.p65 3 07.10.2003, 14:01

2.2 Easy Mode
Easy 2 Screen
Parameters and the Easy Mode key is touched on the Home screen. The Easy 2
screen is also displayed when the Profile Select key is touched on the Easy 1
screen or if the P.Up key is touched on the Easy Mode 3 screen. This screen
allows you to program profiles in the Easy Mode.
Position: 2 S.No: 11 Status

PROF-A PROF-B PROF-C PROF-D
PROF-E PROF-F PROF-G PROF-H
PROF-I PROF-J PROF-K Tests
Del. O?K
Start
Accept. Stop P.Up
Easy 2 screen
Position
This field displays the sample disk position.
S.No
This field displays the sequence number.
Profile Keys
Touch key.
These keys display the 11 user-defined profiles that may be selected for a sample.
Touch any of the profile keys to select the specific profile.
Tests Key
Touch key.
The Tests key displays the Easy 3 screen. Touch this key to program specific
tests for the sample.
ID
Touch key.
Use this key to display the Sample ID screen.
SG2S1-14.p65 4 07.10.2003, 14:01

2.2 Easy Mode
Easy 3 Screen
Parameters and the Easy Mode key is touched on the Home screen. The Easy 3
screen is also displayed when the Tests key is touched on the Easy 2 screen. This
screen allows you to program tests selectively in the Easy Mode.
Easy 3 screen
Position
This field displays the sample disk position for the sample.
S.No
This field displays the sequence number.
Test keys
These keys display the available tests (up to 38 total) that may be selected for a
sample. Touch the appropriate test key to select a specific test. Touch the scroll
arrows to view all tests.
ID
Touch key.
Use this key to display the Sample ID screen.
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2.3 Sample ID
Sample ID Screens
The Sample ID screens allow the entry of patient IDs with the numeric keypad. To
display a Sample ID screen, touch TS on the Batch Mode screen or touch ID on
the Easy 2 or Easy 3 screens.
Sample ID Screen (Batch Mode)

There are two Sample ID (Batch Mode) screens: Sample ID (Batch Mode with
barcode reader (BCR) enabled) and Sample ID (Batch Mode without barcode
reader, barcode reader disabled).
Sample ID Screen (Batch Mode with BCR) Sample ID Screen (Batch Mode without BCR)
Sample ID
Enter the patient ID number up to 13 digits. Touch .
Use this field to manually enter the patient ID number.
Batch Mode (with BCR only)
Enter the number of samples in the batch, 1-400. Touch .
Use this field to designate the total number of samples. You can choose to print,
delete, read or write test selections for these samples.
Sample No (without BCR only)
Enter the first sequence number. Touch . Enter the last sequence number.
Touch .
Use this field to designate the range of samples by sequence number. You can
choose to print, delete, read or write test selections for these samples.
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2.3 Sample ID
Wk. Sht.
Touch key.
Use this key to print a work sheet. This report contains patient ID, sequence
number and test selection information.
Profile
Touch key.
Use this key to display the Profile Selection screen.
Tests
Touch key.
Use this key to display the Test Selection screen.
Delete
Touch key.
Use this key to delete test selection information. In the barcode mode, test
selection information for the defined total number of samples is deleted. In the
non-barcode mode, test selection information for the defined range is deleted.
Read
Touch key.
Use this key to read test selection information from the parameter disk. In the
barcode mode, test selection information for the defined total number of samples
is read. In the non-barcode mode, test selection information for the defined range
is read.
Write
Touch key.
Use this key to write test selection information to the parameter disk. In the
barcode mode, test selection information for the defined total number of samples
is written. In the non-barcode mode, test selection information for the defined
range is written.
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2.3 Sample ID
Sample ID Screen (Easy Mode)
Sample ID screen (Easy Mode)
Position Number
This field displays the sample disk position number for the sample that you are
programming.
Sample No
This field displays the sequence number for the sample that you are programming.
Sample ID
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2.4 STAT Test Selection
STAT Test Selection Screen

The STAT Test Selection screen is displayed by touching on the Batch
Mode, Easy 2 or Easy 3 screen. Use this screen to enter test selections for STAT
sample analysis. STAT positions are reserved in System Parameters.
STAT Test Selection screen
Position
Touch key.
Use this key to select a previously programmed STAT position. Only reserved,
available positions are displayed.
Sample ID
Profile
Touch key.
Use this key to display the Profile Selection screen.
Tests
Touch key.
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2.5 Profile Selection
Profile Selection Screen

The Profile Selection screen is displayed with the Profile key on the Sample ID
(Batch Mode) screens or the STAT Test Selection screen. Use this screen to enter
profile selections for samples.
[Profile Selection]
PROF-E PROF-F PROF-G PROF-I
PROF-J PROF-K PROF-L Tests
Accept.
P.Up
Profile Selection
Profile keys
Touch keys. (e.g. Liver, Kidney, Heart, Lipid)
Use these keys to select profiles to be run on samples. A maximum of 11 profiles
can be programmed in Parameters/Profile/Key Label.
Tests key
Touch key.
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2.6 Test Selection
Test Selection Screen

The Test Selection screen is displayed with the Tests key on the Sample ID (Batch
Mode) screens, the Profile Selection screen, or the STAT Test Selection screen.
Use this screen to enter test selections for samples.
Test Selection
Test keys
Touch keys. (e.g. BICARB, MAG, BUN)
Use these keys to select tests to be run on samples. A maximum of 38 tests,
including ISEs, can be programmed in Parameters/Test Param. and Parameters/
ISE Test. Use the scroll arrows to view all programmed tests.
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2.7 Calibration Selection
Calibration Selection Screen

The Calibration Selection screen is displayed with the Cal. key on the Home
screen. Use this screen to select the type of calibration to be run on selected
photometric tests.
Calibration Selection
STD Type
Touch key (Blank, Full)
Use this key to select the calibration type, blank or full. “Blank” runs standard 1
only. “Full” runs all calibrators.
Test keys
Touch keys. (e.g. BICARB, MAG, BUN)
Use these keys to select tests for the calibration. Use the scroll arrows to view all
tests.
Once the calibration test selections are accepted, you do not need to re-program them unless you
n are change the test selections.
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2.8 ISE Calibration
ISE Calibration Screen

The ISE Calibration screen is displayed with the ISE Cal. key on the Home screen.
Use this screen to select the type of calibration to be run on ISEs. Only one type
of calibration can be highlighted at a time.
ISE Calibration
Low/High
Touch key.
Use this key to select a calibration using the low and high calibrators.
Calibration
Touch key.
Use this key to select a calibration using the standard 3 calibrator.
Full
Touch key.
Use this key to select a calibration using the low, high and standard 3 calibrators.
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2.9 Control Selection
Control Selection Screen

The Control Selection screen is displayed with the Control key on the Home
screen. Use this screen to program control tests.
Control Selection
Control No
Touch key, 1-5.
Use this key to select the control number. Control numbers and positions are
assigned in Parameters/Control Pos.
Test keys
Touch keys, e.g. BICARB, MAG, BUN.
Use these keys to select tests for the selected control analysis (1-5). Use the scroll
arrows to view all tests.
Once the control test selections are accepted, you do not need to re-program them unless you are
n change the test selections.
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Chapter 3
Monitor Menu

3.1 Monitor Menu
Monitor Screen
The Monitor screen is displayed with the Monitor key on the Home screen. Use
this screen to access data management options for patient results, control results,
and calibration results.
Monitor screen
Routine Samples
Touch key.
Use this key to display the Routine Samples screen.
STAT Samples
Touch key.
Use this key to display the STAT Samples screen.
Calibration
Touch key.
Use this key to display the Calibration screen.
ISE Calibration
Touch key.
Use this key to display the ISE Calibration screen.
Control Samples
Touch key.
Use this key to display the Control Samples screen.

3.2 Routine Samples
Routine Samples Screens

The Routine Samples screen is displayed with the Routine Samples key on the
Monitor screen. Use the touch keys on this screen to select data management
options for Routine sample results.
Routine Samples screen
Display
Touch key.
Use this key to display the Routine Result, Disp. screen.
Print
Touch key.
Use this key to display the Routine Result, Print screen.
Send
Touch key.
Use this key to display the Routine Result, Send screen.
Delete
Touch key.
Use this key to display the Routine Result, Delete screen
FD (ASCII)
Touch key.
Use this key to display the Routine Result, ASCII screen

3.2 Routine Samples
Routine Result, Disp. Screen

The Routine Result, Disp. screen is displayed with the Display key on the Routine
Samples screen. Use this screen to view routine results on the analyzer screen.
Routine Result, Disp. screen
First No
Enter the sequence number of the first sample to view, 1-400. Touch .
Use this field to enter the sequence number of the results you want to view. Use
the scroll arrows to view all results for that sample. To view the another sample’s
results, enter the sequence number, then touch .
Routine Result, Print Screen

The Routine Result, Print screen is displayed with the Print key on the Routine
Samples screen. Use this screen to print routine results.
Routine Result, Print screen
First No, Last No

Enter the sequence number of the first sample to print, 1-400. Touch .
Enter the sequence number of the last sample to print, 1-400. Touch .
Use these fields to designate the range of results to print. Touch Start to initiate
printing. Touch Stop to stop printing.

3.2 Routine Samples
Routine Result, Send Screen

The Routine Result, Send screen is displayed with the Send key on the Routine
Samples screen. Use this screen to upload routine results to the host.
Routine Results, Send screen
First No, Last No

Enter the sequence number of the first sample to send, 1-400. Touch .
Enter the sequence number of the last sample to send, 1-400. Touch .
Use these fields to designate the range of results to upload to the host. Touch
Start to initiate transmission. Touch Stop to stop transmission.
Routine Result, Delete Screen

The Routine Result, Delete screen is displayed with the Delete key on the Routine
Samples screen. Use this screen to delete routine samples.
Routine Result, Delete screen
First No, Last No

Enter the sequence number of the first sample to delete, 1-400. Touch .
Enter the sequence number of the last sample to delete, 1-400. Touch .
Use this field to designate the range of results to delete. Touch Start to initiate
deletion of results. Touch Start again to confirm deletion of routine samples.

3.2 Routine Samples
Routine Result, ASCII Screen

The Routine Result, ASCII screen is displayed with the ASCII key on the Routine
Samples screen. Use this screen to save Routine results in ASCII text to a PC-
formatted disk.
Routine Result, ASCII screen
First No, Last No

Enter the sequence number of the first sample to save in ASCII text, 1-400.
Touch .
Enter the sequence number of the last sample to save in ASCII text, 1-400.
Touch .
Use this field to designate the range of samples to save in ASCII text. Remove the
parameter disk from FDD1. Move the data disk from FDD2 to FDD1. Place a PC-
formatted disk in FDD2. Touch Start. When the Start key is no longer highlighted in
blue, remove the data disk from FDD1 and the new ASCII disk from FDD2. Replace
the parameter disk into FDD1 and the data disk in FDD2.
The system does not allow you to name the file. Use a new floppy disk each time
you save routine results.

3.3 STAT Samples
STAT Samples Screens

The STAT Sample screen is displayed with the STAT Samples key on the Monitor
screen. Use this screen to select data management options for STAT samples.
STAT Samples screen
Display
Touch key.
Use this key to display the STAT Result, Disp. screen.
Print
Touch key.
Use this key to display the STAT Result, Print screen.
Send
Touch key.
Use this key to display the STAT Result, Send screen.
Delete
Touch key.
Use this key to display the STAT Result, Delete screen.
FD (ASCII)
Touch key.
Use this key to display the STAT Result, ASCII screen.

3.3 STAT Samples
STAT Result, Disp. Screen

The STAT Result, Disp. screen is displayed with the Display key on the STAT
Samples screen. Use this screen to view STAT results on the analyzer screen.
STAT Result, Disp. screen
First No
Enter the sequence number of the first sample to view, 1-50. Touch .
Use this field to enter the sequence number of the STAT samples you want to
view. Use the scroll arrows to view all results for that sample. To view the next
sample results, enter the sequence number, then touch .
STAT Result, Print Screen

The STAT Result, Print screen is displayed with the Print key on the STAT
Samples screen. Use this screen to print STAT results.
STAT Result, Print screen
First No, Last No

Enter the sequence number of the first sample to print, 1-50. Touch .
Enter the sequence number of the last sample to print, 1-50. Touch .
Use this field to designate the range of samples to print. Touch Start to initiate

3.3 STAT Samples
STAT Result, Send Screen

The STAT Result, Send screen is displayed with the Send key on the STAT
Samples screen. Use this screen to upload STAT results to the host.
STAT Result, Send screen
First No, Last No

Enter the sequence number of the first sample to send, 1-50. Touch .
Enter the sequence number of the last sample to send, 1-50. Touch .
Use this field to designate the range of samples to upload to the host. Touch Start
to initiate transmission. Touch Stop to stop transmission.
STAT Result, Delete Screen

The STAT Result, Delete screen is displayed with the Delete key on the STAT
Samples screen. Use this screen to delete STAT results.
STAT Result, Delete screen
First No, Last No

Enter the sequence number of the first sample to delete, 1-50. Touch .
Enter the sequence number of the last sample to delete, 1-50. Touch .
Use this field to designate the range of samples to delete. Touch Start to initiate
deletion. Touch Start again to confirm deletion of STAT results.

3.3 STAT Samples
STAT Result, ASCII screen

The STAT Result, ASCII screen is displayed with the ASCII key on the STAT Samples
screen. Use this screen to save STAT results in ASCII text to a PC-formatted disk.
STAT Result, ASCII screen
First No, Last No

Enter the sequence number of the first sample to save in ASCII text, 1-50. Touch .
Enter the sequence number of the last sample to save in ASCII text, 1-50. Touch .
Use this field to designate the range of samples to save in ASCII text. Remove the
parameter disk from FDD1. Move the data disk from FDD2 to FDD1. Place a PC-
formatted disk in FDD2. Touch Start. When the Start key is no longer highlighted in
blue, remove the data disk from FDD1 and the new ASCII disk from FDD2. Replace
the parameter disk into FDD1 and the data disk in FDD2.
The system does not allow you to name the file. Use a new floppy disk each time you
save STAT results.

3.4 Calibration Results
Calibration Screen
The Calibration screen is displayed with the Calibration key on the Monitor screen.
Use this screen to view calibration results from the last successful calibration.
Calibration screen
Channel No
Enter the channel number, 1-36. Touch .
Use this field to designate the channel number of the calibration results to view.
The test name appears to the right of <1-36>. Use the scroll arrows to scroll from
channel to channel in numerical order.

3.5 ISE Calibration Results
ISE Calibration Screen

The ISE Calibration screen is displayed with the ISE Calibration key on the Monitor
screen. Use this screen to view calibration results.
ISE Calibration screen
Channel No
Touch key.
Use this key to select the ISE calibration results to view. The ISE test name
appears to the right of <38-40>.

3.6 Control Samples
Control Samples Screen

The Control Samples screen is displayed with the Control Samples key on the
Monitor screen. Use this screen to select data management options for Control
sample results.
Control Samples screen
Print
Touch key.
Use this key to display the Control Result, Print screen.
Send
Touch key.
Use this key to display the Control Result, Send screen.
Delete
Touch key.
Use this key to display the Control Result, Delete screen.

3.6 Control Samples
Control Result, Print Screen

The Control Result, Print screen is displayed with the Print key on the Control
Samples screen. Use this screen to print control results.
Control Results, Print screen
First No, Last No

Enter the number of the first control sample to print, 101-530. Touch .
Enter the number of the last control sample to print, 101-530. Touch .
Use this field to designate the range of samples to print. Touch Start to initiate
Control Result, Send Screen

The Control Result, Send screen is displayed with the Send key on the Control
Samples screen. Use this screen to upload control results to the host.
Control Result, Send screen
First No, Last No

Enter the number of the first control sample to send, 101-530. Touch .
Enter the number of the last control sample to send, 101-530. Touch .
Use this field to designate the range of samples to upload to the host. Touch Start
to initiate uploading. Touch Stop to stop uploading.

3.6 Control Samples
Control Result, Delete Screen

The Control Result, Delete screen is displayed with the Delete key on the Control
Samples screen. Use this screen to delete control results.
Control Result, Delete screen
First No, Last No

Enter the first control number for which results are to be deleted, 1-5. Touch .
Enter the last control number for which results are to be deleted, 1-5. Touch .
Use this field to designate the range of control numbers to be deleted. Touch Start
to initiate deletion of control results. Touch Start again to confirm deletion of
control results.
The control sequence number for all controls is reset when any control (1-5) result data is
n deleted.

NOTES

Chapter 4
Parameters Menu
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4.1 Parameters Menu
Parameters Screen
The Parameters screen is displayed with the Param key on the Home screen. Use
this screen to enter various parameters including test parameters, profiles, calcu-
lated tests, compensated tests, control positions, serum index parameters, print
order, and system parameters.
Parameters screen
Test Param.
Touch key.
Use this key to display the Test Parameters screen.
Carry Over
Touch key.
Use this key to display the Carry Over Evasion screen.
Calc. Test
Touch key.
Use this key to display the Calc. Test screen.
Serum Index
Touch key.
Use this key to display the Serum Index screen.
Control Pos.
Touch key.
Use this key to display the Control Positions screen.
System
Touch key.
Use this key to display the System Parameters screen.
Print Order
Touch key.
Use this key to display the Print Order screen.
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4.1 Parameters Menu
ISE Test
Touch key.
Use this key to display the ISE Test parameters screen.
Profile
Touch key.
Use this key to display the Profile screen.
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4.2 Test Parameters
Test Parameters Screen

The Test Parameters screen is displayed with the Test Param. key on the Param-
eters screen. Use this screen to manually enter test parameters for all photometric
chemistries.
Test Parameters screen
Channel No
Enter the channel number, 1-36, of the test in this field. Touch .
Use this field to assign a channel to a new chemistry or to display a previously
entered chemistry. There are 36 channels available on the analyzer.
Parameter No
Enter the parameter number, 1-58. Touch .
Use this field to display the parameter to be entered or updated. There are 58
parameters for each chemistry.
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4.2 Test Parameters
Contents
Enter the parameter information in this field. Touch .
OR
Touch the Select key until the correct parameter is displayed.
Use this field to define each parameter. The following table outlines the parameter
number, parameter name, description and input criteria.
Parameter Parameter Description Input Criteria

Number Name
1 Test Name Enter the name of the test using Maximum 5
screen below, then touch : characters
2 Assay Code Enter the measuring method 1 Point

(Mthd) using the Select key. 2 Point and Rate
2 Point End
3 Point
1 Point and Rate
Rate A
Rate B
3 Assay Code Enter the channel number of 0 to 36
(Test) the second test when two tests are 0=unspecified
run together.
4 Reaction Time Enter the reaction time in 3, 4, 5, 10
minutes using the Select key.
5 Assay Point 1 Enter the first measurement point. 1 to 35
6 Assay Point 2 Enter the second measurement 0 to 35
point.
7 Assay Point 3 Enter the third measurement 0 to 35
point.
8 Assay Point 4 Enter the fourth measurement 0 to 35
point.
9 Wave Leng. Enter the subordinate (secondary) 340, 376, 415,
(Sub) wavelength using the Select key. 450, 480, 505,
480, 505, 546,
570, 600, 660,
700, 800, 0
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4.2 Test Parameters

Number Name
10 Wave Leng. Enter the main (primary) wavelength 340, 376, 415
(Main) using the Select key. 450, 480, 505,
546, 570, 600,
660, 700, 800
11 Sample Enter the sample aspiration 2.0 to 50.0 µl
Volume volume.
12 R1 Volume Enter the R1 aspiration volume. 20-350 µl
0=no aspiration
999=stir only
13 R1 Pos. Enter the R1 position number 0 to 36
on the reagent disk.
14 R1 Bottle Enter the R1 bottle size with S=small (20 mL)
Size the Select key. L=large (50 mL)
15 R2 Volume Enter the R2 aspiration volume. 20 to 350 µl

0=no aspiration
999=stir only
17 R2 Bottle Enter the R2 bottle size with S=small (20 mL)
Size the Select key. L=large (50 mL)
18 R3 Volume Enter the R3 aspiration volume. 20 to 350 µl
0=no aspiration
999=stir only
20 R3 Bottle Enter the R3 bottle size with S=small (20 ml)
Size the Select key. L=large (50 ml)
21 Calib. Type Enter the calibration type using K Factor

(Type) the Select key. Linear
Logit log (4P)
Logit log (5P)
Spline
Point to Point
22 Calib. Type Enter the weight applied to the 0, 1, 2
(Wght) standard solution. 0=no weighting
23 Calib. Conc. 1 Enter the concentration of 0 to 999999
standard 1.
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4.2 Test Parameters

Number Name
24 Calib. Pos. 1 Enter the calibration position STD 1: 36-57
on the sample disk. 0=no aspiration
99=water
standard 2.
standard 3.
standard 4.
standard 5.
standard 6.
35 S1 ABS Enter the reagent blank absorbance -99999 to 999999
limit
36 K Factor Enter the K factor. -99999 to 999999
37 K2 Factor Enter the K2 factor. -99999 to 999999
41 A Factor Enter instrument factor A. -99999 to 999999
42 B Factor Enter instrument factor B. -99999 to 999999
43 C Factor Enter instrument factor C. -99999 to 999999
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4.2 Test Parameters

Number Name
44 SD Limit Enter the standard deviation (SD) 0.1 to 999.9
limit. When calibrating nonlinear
and multipoint linear chemistries,
the instrument compares the
measured absorbance of each
calibrator against its ideal absorbance
and calculated SD. If the calculated
SD is not less than this SD limit, the
SD? alarm is issued.
45 Duplicate Enter the Abs error limit. All 0 to 32000
Limit photometric calibrators are run
in duplicate. If the Abs error limit
is out of range, a DUP alarm is
issued.
46 Sens. Limit Enter the calibration sensitivity limit. 0 to 32000
This value specifies that a minimum
absorbance change must be detected
between the blank and span calibrator.
If the absorbance difference between
blank and span calibrator is not greater
than the sensitivity limit, a SENS alarm
is issued.
47 S1 ABS Enter the lower S1 ABS limit for 0 to 32000
Limit (L) calibrator 1.
48 S1 ABS Enter the upper S1 ABS limit for 0 to 32000
Limit (H) calibrator 1. If the absorbance
calibrator 1 falls outside the limits
defined in fields 47 and 48, the
system issues an S1ABS? alarm.
49 ABS Limit Enter the absorbance limit (x 104) 0 to 32000
for a rate assay.
50 ABS Limit Enter an increasing or decreasing Decrease,
(D/I) absorbance using the Select key. Increase
Select Increase to specify an
increasing absorbance rate assay.
Select Decrease to specify an
decreasing absorbance rate assay.
51 Prz. Limit Enter the prozone limit (Abs. x 104). -32000 to 32000
52 Prz. Limit Enter the upper or lower limit Upper, Lower
(U/D) designation for the prozone limit with
the Select key.
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4.2 Test Parameters

Number Name
53 Prz. Limit Enter the last measuring point of 1-35
the prozone limit.
54 Expect. Enter the lower limit of the -99999 to 999999
Value (L) expected values.
55 Expect. Enter the upper limit of the -99999 to 999999
Value (H) expected values.
56 Instr. Fact. (a) Enter the instrument factor a (slope). -99999 to 999999
57 Instr. Fact. (b) Enter the instrument factor b -99999 to 999999
(intercept).
58 Key Setting Enter the key number of the 1 to 38
test on the Test Selection screen. 0=cancel
This number determines the place-
ment of the test on the Test Selection
screen.
1 2 3 4 13 14 15 16
5 6 7 8 17 18 19 20
9 10 11 12 21 22 23 24
25 26 27 28 37 38
29 30 31 32
33 34 35 36
Test Selection screen layout
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4.3 Carry Over Evasion
Carry Over Evasion Screen

The Carry Over Evasion screen is displayed with the Carry Over key on the Param-
eters screen. Use this screen to access special wash programming screens for
reagent probe, reaction cells, and sample probe.
Carry Over Evasion screen
Reagent Probe
Touch key.
Use this key to access the Carry Over Evasion Reagent Probe screen.
Reaction Cells
Touch key.
Use this key to access the Carry Over Evasion Reaction Cells screen.
Sample Probe
Touch key.
Use this key to access the Carry Over Evasion Sample Probe screen.
Carry Over Evasion, Reagent Probe Screen

Use this screen to program carryover evasion for the reagent probe.
Carry Over Evasion, Reagent Probe screen
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Reagent Probe No
Touch key: 1-40.
Use this key to choose the carryover evasion program to be entered.
Test
Touch key: 1-36.
Use this key to select the test causing possible carryover.
Type
Touch key: R1, R2, R3.
Use this key to select the reagent type causing possible carryover.
–>Test
Touch key: 1-36, ISE, All.
Use this key to select the test affected by possible carryover.
Type
Touch key: R1, R2, R3.
Use this key to select the reagent type affected by possible carryover.
W
Touch key.
ISE Enabled: 1-36, 39, W1 (W1=system water)
ISE Disabled: 1-39, W1 (W1=system water)
Use this key to select the position of the detergent that is used for the additional
reagent probe wash.
µl
Touch key: 50, 60, 70, . . .340, 350.
Use this key to select the volume of detergent used in the additional reagent probe
wash.
Evasion
Touch key: Enable, Disable.
Use this key to disable or enable the carryover evasion. If enable is selected, then
carryover evasion is completed. If disable is selected, then carryover evasion is not
completed.
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Carry Over Evasion, Reaction Cells Screen

Use this screen to program carryover evasion for the reaction cells.
Carry Over Evasion, Reaction Cells screen
Reaction Cells No
Touch key: 1-10.
Use this key to select one of the carryover evasion programs.
Test
Touch key: 1-36.
W
Touch key.
ISE Enabled: 1-36, 39, W1 (W1=system water)
ISE Disabled: 1-39, W1 (W1=system water)
cell rinse.
µl
Touch key: 50, 60, 70, . . .340, 350.
Use this key to select the volume of detergent used in the additional cell rinse.
Evasion
Use this key to disable or enable the evasion programming. If enable is selected,
then carryover evasion is completed. If disable is selected, then carryover evasion
is not completed.
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Carry Over Evasion, Sample Probe Screen

Use this screen to program carryover evasion for the sample probe.
Carry Over Evasion, Sample Probe screen
Sample Probe No
Touch key: 1-8.
Use this key to select one of the carryover evasion programs.
Test
Touch key: 1-36.
W
Touch key: W1, W2, W3.
sample probe wash.
Evasion
Use this key to disable or enable the evasion programming. If enable is selected,
then carryover evasion is completed. If disable is selected, then carryover evasion
is not completed.
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4.4 Calculated/Compensated Tests
Calc. Test Screen

The Calc. Test screen is displayed with the Calc. Test key on the Parameters screen.
Use this screen to access parameter entry displays for calculated and compensated
tests.
Calc. Test screen
Calc. Test
Touch key.
Use this key to display the Calc. Test parameters screen. The calculated test
formula is also entered on this screen.
Comp. Test
Touch key.
Use this key to display the Comp. Test parameters screen. The compensated test
formula is also entered on this screen.
Calc. Test Parameters Screen

Use this screen to enter parameters for calculated tests.
Calc. Test parameters screen
Calc. No
Enter the calculated test number, 44-51. Touch .
Use this field to enter the calculated test number. Eight programs are available for
calculated tests.
Parameter No
Use this field to display the parameter to be entered or updated. There are eight
calculated test parameters.
SG4S1-32.p65 14 16.10.2003, 11:11

Contents
OR
Number Name
1 Test Name Enter the name of the calculated Maximum 5
test using screen below, then characters
touch :
2 Formula Enter the formula for the calculated aA-bB

test using the Select key. aA+bB
(aA/B)+b
(aA/(A+B))+b
(aA/(B-A))+b
(a(A-B)/A)+b
(a(A-B)/B)+b
(A-aB)/(b-a)
Disable
3 Assay Test A Enter the channel number of the 1 to 43
test that corresponds to A in the
formula.
4 Assay Test B Enter the channel number of the 1 to 43
test that corresponds to B in the
formula.
5 Variable Enter coefficient a in the formula. Maximum 6 digits
coefficient a including decimal
point and sign.
6 Variable Enter coefficient b in the formula. Maximum 6 digits
coefficient b including decimal
point and sign.
7 Expect. Enter the lower limit of the -99999 to 999999
8 Expect. Enter the upper limit of the -99999 to 999999
SG4S1-32.p65 15 16.10.2003, 11:11

Comp. Test Parameters Screen

Use this screen to enter parameters for compensated tests.
Comp. Test parameters screen
Comp. No
Enter the calculated test number, 1-8. Touch .
Use this field to enter the compensated test number. Eight programs are available
for compensated tests.
Parameter No
Use this field to display the parameter to be entered or updated. There are six
compensated test parameters.
SG4S1-32.p65 16 16.10.2003, 11:11

Contents
OR
Touch the select key until the correct parameter is displayed.

Number Name
1 Test Name Enter the channel number of the 0 to 36, 38 to 40
test to be compensated
2 Formula Enter the formula for the compensated aA-bB
test using the Select key. aA+bB
(aA/B)+b
(aA/(A+B))+b
(aA/(B-A))+b
(a(A-B)/A)+b
(a(A-B)/B)+b
(A-aB)/(b-a)
Disable
3 Assay Test A Enter the channel number of the 1 to 40
formula.
4 Assay Test B Enter the channel number of the 1 to 43, 0
test that corresponds to B in the Entry of 0 defaults
formula. to B=1 (numeric
value).
5 Variable Enter coefficient a in the formula. Maximum 6 digits
coefficient a including decimal
point and sign.
6 Variable Enter coefficient b in the formula. Maximum 6 digits
coefficient b including decimal
point and sign.
SG4S1-32.p65 17 16.10.2003, 11:11

4.5 Serum Index
Serum Index Screen

The Serum Index screen is displayed with the Serum Index key on the Parameters
screen. Use this screen to program serum index factors.
Serum Index screen
Channel No
Enter the channel number, 0, 1-36. Touch .
Use this field to define the channel number of the test for serum index
measurement.
Constant
Touch key: A-F.
Use this key to select the factor to be defined.
Factor
This field is accessed by touching .
Use this field to define the factor selected above. The following table shows the
recommended values.
Factor Saline Saline AST/ALT AST/ALT

Conv. Units* Int’l Units* Conv. Units** Int’l Units**
A 23 37 34 55
B 122000 122000 122000 122000
C 14 14 20 20
D 1700 94 2500 146
E 19000 19000 19000 19000
F 180000 180000 180000 180000
* Sample Volume 10 µl, R1 Volume 250 µl.
** Sample Volume 15 µl, R1 Volume 250 µl.
SG4S1-32.p65 18 16.10.2003, 11:11

4.6 Control Positions
Control Positions Screen

The Control Positions screen is displayed with the Control Pos. key on the Param-
eters screen. Use this screen to reserve sample disk positions for control solutions.
Control Positions screen
Control No
Enter the control number, 1-5. Touch .
Use this field to enter the control level number.
Position No
Enter the position number, 36-57. Touch .
Use this field to enter the sample disk position number for the selected control
level. Positions 55-57 are reserved for ISE calibrators when the ISE option is
enabled.
SG4S1-32.p65 19 16.10.2003, 11:11

4.7 System Parameters
System Parameters Screen

The System screens are displayed with the System Parameters screen. Use these
screens to program system parameters. Display the main System Parameters screen
with the System key on the Parameters screen.
System Parameters screen
Date
Touch key.
Use this key to display the Date screen.
Com. Param.
Touch key.
Use this key to display the Com. (Communication) Parameters screen.
Original ABS
Touch key.
Use this key to display the Original ABS screen.
Options
Touch key.
Use this key to display the Options screen.
Rate As Chk.
Touch key.
Use this key to display the Linearity Check screen.
Init. Screen
Touch key.
Use this key to display the Init. (Initial) Screen screen.
SG4S1-32.p65 20 16.10.2003, 11:11

STAT Pos.
Touch key.
Use this key to display the STAT Positions screen.
Check Digit
Touch key.
Use this key to display the Check Digit screen.
Date Screen
The Date screen is displayed with the Date key on the System Parameter screen.
Use this screen to establish the date format and to enter the correct date and time.
Date screen
Mode
Touch key: DD/MM/YY, MM/DD/YY, YY/DD/MM, YY/MM/DD.
Use this key to establish the date format. The system uses the format which is set
here for all screen displays and printouts. For example if the option MM/DD/YY
(month, day, year) is selected, June 28, 1997, is displayed or printed in this form:
06/28/97.
Date fields
Enter year, 0-99 (95-99: 19xx, 0-94: 20xx). Touch .
Enter month, 1-12. Touch .
Enter day, 1-31. Touch .
Enter hour, 0-23. Touch .
Enter minute, 0-59. Touch .
Use these five fields to define the system date and time. The first field is used to
define year, followed by month, day, hour, and minute. Touch after each entry.
SG4S1-32.p65 21 16.10.2003, 11:11

Com. Parameters screens

The Com. Parameters screens are displayed using the Com. Param. key on the
System Parameter screen. Use these screens to define host computer interface
parameters.
[Com. Parameters] Status

STAT Inquiry :Disable
P.Up
Com. Parameters screens
Baud Rate
Touch key: 4800, 9600.
Use this key to select the transmission speed used for host communication.
Parity
Touch key: Even No., Odd No., No Parity.
Use this key to select the parity code used for host communication.
Data Bits
Touch key: 7, 8.
Use this key to select the number of data bits used for host communication.
Stop Bits
Touch key: 1, 2.
Use this key to select the number of stop bits used for host communication.
End Code
Touch key: ETX+BBC, CR+LF+ETX, ETX, ETX+CR+LF, ETX+CKH+CKL+CR.
Use this key to select the end code used for host communication.
Text Length
Touch key: 256, 512.
Use this key to select the maximum text length for the transfer of a data set.
SG4S1-32.p65 22 16.10.2003, 11:11

Retry
Touch key: 1, 2, 3, 4.
Use this key to select the number of repeated transmissions from the RD/Hitachi
902 system to the host, in the event the host does not send an acknowledge signal.
Retry Time Out
Touch key: 1, 2, 3, 4.
Use this key to select the time interval in seconds between the individual attempts
to establish host communication. The number of attempts is defined with Retry.
Com. Cycle
Touch key: 2, 3, 5, 10.
Use this key to select the communication cycle time in seconds.
Result Only
Use this key to specify transmission of measured data results only (mono-directional
interface).
Com. Trace
Use this key to specify the analyzer to record the communication between the
analyzer and host. The recorded communication can be printed out on the Communi-
cation Trace report.
Simul. Inquiry
Use this key to select routine test selection inquiry to occur even when test
selections already exist in analyzer memory.
STAT Inquiry
Use this key to select STAT test selection inquiry.
SG4S1-32.p65 23 16.10.2003, 11:11

Original ABS Screen

The Original ABS screen is displayed with the Original ABS key on the System
Parameters screen. Use this screen to specify the printing of absorbance readings
for results.
Original ABS screen
Mode
Touch key: Enable, Disable
Use this key to specify printing of absorbance readings for results.
Options Screen
The Options screen is displayed with the Options key on the System Parameters
screen. Use this screen to enable/disable the ISE option and the barcode reader
option.
Options screen
ISE
Use this key to enable/disable the ISE option.
Sample ID
Use this key to enable/disable the sample barcode reader option.
SG4S1-32.p65 24 16.10.2003, 11:11

Rate As Chk Screen

The Rate As Chk screen is displayed with the Rate As Chk key on the System
Parameters screen. Use this screen to specify the linearity check limit values.
Rate As Chk screen
Linear Check (4-8)

Enter the limit, 0, 1-100, for the Lin.8 linearity flag. Touch .
Use this field to enter the linearity check limit (0-100%) for rate assays with four to
eight read points.
Linear Check (9- )
Enter the limit, 0, 1-100, for the Lin. linearity flag. Touch .
Use this field to enter the linearity check limit (0-100%) for rate assays with nine or
more read points.
Initial Screen
The Initial Screen is displayed with the Init. Screen key on the System Parameters
screen. Use this screen to prioritize the Easy Mode 1, 2, or 3 option.
Init. Screen
Mode
Touch key: Easy Mode 1, Easy Mode 2, Easy Mode 3.
Use this key to specify which Easy Mode option has priority. The Easy Mode
chosen is displayed when the Easy Mode key is touched on the Home screen.
SG4S1-32.p65 25 16.10.2003, 11:11

STAT Pos. Screen

The STAT Pos. screen is displayed with the STAT Pos. key on the System Param-
eters screen. Use this screen to reserve STAT positions on the sample disk. Up to
34 positions can be reserved for STAT samples.
STAT Pos. screen
First No
Enter the first sample disk position number, 2-35. Touch .
Use this field to define the first sample disk position number to be reserved for
STAT samples. The last number in the range, 35, is listed in the Last No field and
is not user-definable. No positions are reserved when “0” is entered the First No
field. However, ONLY these positions can be used for STAT samples.
Check Digit Screen

The Check Digit screen is displayed with the Check Digit key on the System
Parameters screen. Use this screen to select barcode digit checks. If the barcode
reader (Sample ID) option is disabled on the Options screen, the Check Digit screen
is not available.
Check Digit screen
NW-7
Touch key: Mode 10, Mode 16, Disable
CODE-39
ITF
Use these keys to enable or disable digit checks for the specified barcode types.
SG4S1-32.p65 26 16.10.2003, 11:11

4.8 ISE Tests
ISE Tests Screen

The ISE Tests screen is displayed with the ISE Test key on Parameters screen. Use
this screen to enter parameters for ISEs.
[ISE Tests] 7 8 9
Channel No : <38-4Ø > 4 5 6
Parameter No: <1-11> 1 2 3
Contents : 0 . -
C
P.Up
ISE Test screen
Channel No
Use this field to enter the channel number for the ISE test. Three channels exist for
ISE tests.
Parameter No
Use this field to display the parameter to be entered or updated. There are 11 ISE
test parameters.
SG4S1-32.p65 27 16.10.2003, 11:11

4.8 ISE Tests
Contents
OR
number, parameter name, description, and input criteria.

Number Name
1 Low Conc. Enter the low standard concentration. 0 to 999.99
2 High Conc. Enter the high standard concentration. 0 to 999.99
3 Calibrator Conc. Enter the calibrator concentration. 0 to 999.99
4 Ref. Volume Enter the volume of reference solution. 30 to 999
5 Expect. Enter the lower limit of the 0 to 999999
6 Expect. Enter the upper limit of the 0 to 999999
7 Instr.Fact (a) Enter the instrument factor a (slope). 0 to 999999
8 Instr.Fact (b) Enter the instrument factor -99999 to 999999
b (intercept).
9 Comp. Limit Enter the compensation tolerance range. 0.0 to 200.0
10 C Value Enter the correction coefficient. -99999 to 999999
11 Key Setting Enter the key number of the 1 to 38
test on the Test Selection screen. 0=cancel
This number determines the place-
ment of the test on the Test Selection
screen.
SG4S1-32.p65 28 16.10.2003, 11:11

4.9 Print Order
Print Order Screen

The Print Order screen is displayed with the Print Order key on the Parameters
screen. Use this screen to assign the printing order for each test.
Print Order screen
Channel No
Use this field to enter the channel number of the test. The test name appears to the
right of the Channel No field.
Print Order
Enter the position number, 0, 8-60. Touch .
Use this field to enter the line number of the result. No results print when “0” is
entered in the Print Order field. Lines 1-7 are reserved for the report header. The
print order assignments are displayed below the Print order field in the following
format: (1) BICAR 8
(1) - Channel Number
BICAR - Test Name
8 - Print LIne.
SG4S1-32.p65 29 16.10.2003, 11:11

4.10 Profiles
Profile Screen
The Profile screen is displayed with the Profile key on the Parameters screen. Use
this screen to assign tests to profiles and to establish profile order on the Profile
Selection screen.
[Profile] Status
Profile : PROF-A Key Label
BICARB MAG BUN PHOS
CREST CRERBL CRERB INDEX
CO2A MAGA BUNA
Accept. P.Up
Profile screen
Profile
Touch key.
Use this key to display a specific profile. There are 26 pre-determined profiles:
PROF-A to PROF-Z.
Test keys
Touch keys.
Use the test keys to select tests for the displayed profile. Selected tests appear
highlighted in blue.
SG4S1-32.p65 30 16.10.2003, 11:11

4.10 Profiles
Key Label
Touch key.
Use this key to display the Key Label screen.
[Key Label] Status

1 :PROF-A 6 :PROF-F 11:PROF-K
2 :PROF-B 7 :PROF-G
3 :PROF-C 8 :PROF-H
4 :PROF-D 9 :PROF-I
5 :PROF-E 10:PROF-J P.Up
Key Label screen
Use this screen to establish a profile display order on the Profile Selection screen.
Numeric Keys, 1-11
Touch keys.
Use these keys to assign the profile key order. Touch the key repeatedly until the
desired profile is assigned. There are 26 pre-determined profiles: PROF-A to PROF-
Z.
[Profile Selection]
Accept.
P.Up
Profile Selection screen
1 2 3 4
5 6 7 8
9 10 11
Profile Selection screen layout
SG4S1-32.p65 31 16.10.2003, 11:11

NOTES
SG4S1-32.p65 32 16.10.2003, 11:11

Chapter 5
Maintenance Menu

5.1 Maintenance Menu
Maintenance Screen
The Maintenance screen is displayed using the Maint. key on the Home screen.
Use this screen to perform maintenance functions including wash all/cells/ISE,
photometer check, cell blank, incubation bath exchange, reset, parameter read/
write/print, probe adjust, floppy disk utilities, precision check, and ISE prime.
Maintenance screen
Wash
Touch key.
Use this key to display the Wash screen.
Parameters
Touch key.
Use this key to display the Parameters screen.
Photometer
Touch key.
Use this key to display the Photometer screen.
Probe Adjust
Touch key.
Use this key to display the Probe Adjust screen.
Cell Blank
Touch key.
Use this key to display the Cell Blank screen.
FD Utitlites
Touch key.
Use this key to display the FD Utilities screen.
Incub. Water
Touch key.
Use this key to display the Incubation Water screen.

5.1 Maintenance Menu
Precision
Touch key.
Use this key to display the Precision screen.
Reset
Touch key.
Use this key to display the Reset screen.
ISE Prime
Touch key.
Use this key to display the ISE Prime screen.

5.2 Wash Function
Wash Screen
The Wash screen is displayed with the Wash key on the Maintenance screen. Use
this screen to perform the desired wash. Refer to the User’s Guide for additional
information concerning this function.
Wash screen
Mode
Touch key: Cells, ISE, All.
Use this key to define the desired wash. Select “Cells” to wash the reaction cells.
Select “ISE” to wash the ISE system. Select “All” to wash the reactions cells and
the ISE system. Touch the Start key to intiate the wash. During the wash proce-
dure, the Start key is highlighted in blue. At the conclusion of the wash procedure,
the Stop key is highlighted in blue.

5.3 Parameter Read/Write/Print Function
Parameters Screen
The Parameters screen is displayed with the Parameters key on the Maintenance
screen. Use this screen to perform a parameter read, write, or print.
Parameters (Print) screen Parameters (Read/Write) screen

Mode
Touch key: Read, Write, Print
Use this key to define the desired function. Select “Read” to read parameters from
a parameter disk. Select “Write” to write parameters to a parameter disk. Select
“Print” to print parameters.
First No, Last No
Enter the channel number of the first chemistry, 0-40, 99. Touch .
Enter the channel number of the last chemistry, 0-40, 99. Touch .
Use these fields to define the range of chemistries for which to print parameters. A
range of 0-0 prints a list of the parameter fields only without any specific chemis-
try parameters. A range of 99-99 prints a list of system parameters including
calculated test parameters, compensated test parameters, special wash program-
ming, and profiles.
Start
Touch key.
Use this key to initiate reading, writing, or printing of parameters.

5.4 Photometer Check Function
Photometer Screen
The Photometer screen is displayed with the Photometer key on the Maintenance
screen. Use this screen to perform a photometer check. A photometer check must
be performed daily. The results of this measurement must fall below 13,000. If
they are higher, the photometer lamp must be replaced and a cell blank measure-
ment must be performed. Refer to the User’s Guide for additional information
concerning this function.
Photometer screen
Start
Touch key.
Use this key to initiate a photometer check. During the photometer check, the
Start key is highlighted in blue. At the conclusion of the photometer check, the
Stop key is highlighted in blue.

5.5 Probe Adjust Function
Probe Adjust Screen

The Probe Adjust screen is displayed with the Probe Adjust key on the Mainte-
nance screen. Use this screen to select the type of probe adjust to perform and
execute the selected probe adjust. Refer to the User’s Guide for additional infor-
mation concerning this function.
Probe Adjust screen
Mode
Touch key: S. Probe (Horiz./Vert.), S. Probe (Vert.), R. Probe (Horiz.), R. Probe
(Vert.), Stirrer.
Use this key to define the desired function. Refer to the Maintenance chapter of
the User’s Guide for information on the probe adjust functions.
Pulse Adjust
Touch key.
Service function only.

5.6 Cell Blank Function
Cell Blank Screen

The Cell Blank screen is displayed with the Cell Blank key on the Maintenance
screen. Use this screen to perform a cell blank. A cell blank must be performed
weekly. The cell blank function measures the cell blanks for the reaction cells for
all 12 main and sub-wavelengths. A cell blank must be measured after replacing
the reaction cells and after changing the photometer lamp. Refer to the User’s
Guide for additional information concerning this function.
Cell Blank screen
Start
Touch key.
Use this key to initiate a cell blank. During the cell blank, the Start key is high-
lighted in blue. At the conclusion of the cell blank, the Stop key is highlighted in
blue.

5.7 FD Utilities Function
FD Utilities Screen
The FD Utilities screen is displayed with the FD Utilities key on the Maintenance
screen. Use this screen to format and copy floppy disks and clean the floppy disk
drives. You must use a double-sided high density disk on the 902 analyzer. Refer
to the User’s Guide for additional information concerning this function.
[FD Utilities] Status
Specify mode and touch “Start”.
Mode :Format & Copy
Start P.Up
FD Utilities screen
Mode
Touch key: Format & Copy, Cleaning 1, Cleaning 2
Use this key to select the desired utility function, then touch the Start key. A
second screen appears, as shown below, with instructions on performing the
function. Follow the instructions, then touch the Start key.
FD Format & Copy FDD Cleaning

5.8 Incubation Water Exchange Function
Incub. Water Screen

The Incubation Water screen is displayed with the Incub. Water key on the Main-
tenance screen. Use this screen to perform an incubation water exchange. This
procedure drains the incubation (reaction) bath water and replaces it with fresh
water while Hitergent is added with the reagent probe. The incubation bath water
is automatically replaced with fresh water and Hitergent when the instrument is
powered on. If the instrument remains on for more than 24 hours, an incubation
water exchange must be initiated manually. This procedure takes 4 minutes to
complete. Refer to the User’s Guide for additional information concerning this
function.
Incub. Water screen
Start
Touch key.
Use this key to initiate an incubation water exchange. During the exchange, the
Start key is highlighted in blue. At the conclusion of the exchange, the Start key is
gray.

5.9 Precision Function
Precision Screen
The Precision screen is displayed with the Precision key on the Maintenance
screen. Use this screen to print a precision check report for the designated
sample range. Refer to the Reports chapter of this guide for specific information
on the Precision Check report.
Precision screen
First No, Last No

Enter the sequence number of the first sample to print, 1-400. Touch
Enter the sequence number of the last sample to print, 1-400. Touch
Use this field to designate the range of samples for the Precision Check report.
The Precision Check report is described in the Reports section of this guide.

5.10 Reset Function
Reset Screen
The Reset screen is displayed with the Reset key on the Maintenance screen. Use
this screen to reset all mechanical components (sample probe, reagent probe, and
stirrer) back to their home positions. A reset occurs automatically during initializa-
tion or when the Start key is touched. This procedure takes 10 seconds to com-
plete.
Reset screen
Start
Touch key.
Use this key to initiate a reset. During the reset, the Start key is highlighted in blue.
At the conclusion of the reset, the Start key is gray.

5.11 ISE Prime Function
ISE Prime Screen

The ISE Prime screen is displayed with the ISE Prime key on the Maintenance
screen. Use this screen to select the type of ISE reagent to be primed and to
execute the selected ISE prime. Refer to the User’s Guide for additional informa-
tion concerning this function.
ISE Prime screen
Mode
Touch key: IS., REF.
Use this key to define the desired prime. Select “IS” to prime the internal reference
solution only. Select “REF” to prime the KCL and internal reference solution.
Touch the Start key to initiate the prime. During the prime, the Start key is high-
lighted in blue. At the conclusion of the prime, the Stop key is highlighted in blue.

NOTES

Chapter 6
Tools Menu

6.1 Tools Screen
Tools Menu
The Tools screen is displayed with the Tools key on the Home screen. Use this
screen to access various functions including mechanisms check, program check,
alarm trace, test summary, communication trace, ISE checks, and barcode check.
Tools screen
Mech. Check
Touch key.
Use this key to display the Mechanism Check screen.
Program
Touch key.
Use this key to display the Program Check screen.
Alarm Trace
Touch key.
Use this key to display the Alarm Trace screen.
Test Summary
Touch key.
Use this key to display the Test Summary screen.
Com. Trace
Touch key.
Use this key to display the Communication Trace screen.
C-RAM R/W
Touch key.
This screen is a service function screen.

6.1 Tools Screen
ISE Check
Touch key.
Use this key to display the ISE Check screen.
Count Clear
Touch key.
This screen is a service function screen.
Barcode
Touch key.
Use this key to display the Barcode Check screen.

6.2 Mechanism Check
Mechanism Check Screen

The Mechanism Check screen is displayed with the Mech. Check key on the Tools
screen. Use this screen to perform a mechanisms check. A mechanisms check
verifies the functionality of all mechanical units on the analyzer. If a malfunction
occurs, the system issues an alarm. You may be instructed to perform a mecha-
nisms check during troubleshooting of various instrument alarms.
Mechanisms Check screen
Start
Touch key.
Use this key to initiate a mechanisms check. During the mechanisms check, the
Start key is highlighted in blue. At the conclusion of the mechanisms check, the
Stop key is highlighted in blue.

6.3 Program Check
Program Check Screen

The Program Check screen is displayed with the Program key on the Tools
screen. Use this screen to print a program check report. This report prints the
version of software currently loaded in the analyzer memory.
Program Check screen
Start
Touch key.
Use this key to print the program check. During printing, the Start key is high-
lighted in blue. At the conclusion of printing, the Start key is highlighted in gray.

6.4 Alarm Trace
Alarm Trace Screen

The Alarm Trace screen is displayed with the Alarm Trace key on the Tools
screen. Use this screen to print or delete daily and cumulative alarm information.
Alarm Trace screen
Mode
Touch key: New Alarm Print, New Alarm Delete, All Data Print, All Data Delete
Use this key to select the print or delete function for the alarm data. New Alarm
Print prints a Daily Alarm Trace report. New Alarm Delete deletes the daily alarms
from the system. All Data Print prints a Cumulative Alarm Trace report. All Data
Delete deletes cumulative alarms from the system.

6.5 Test Summary
Test Summary Screen

The Test Summary screen is displayed with the Test Summary key on the Tools
screen. Use this screen to print a Cumulative Operations Trace report. This report
lists a cumulative count of tests run on each chemistry including routine, STAT,
calibration, and control samples.
Test Summary screen
Start
Touch key.
Use this key to print a Cumulative Operations Trace report. During the printing, the
Start key is highlighted in blue. At the conclusion of printing, the Start key is
highlighted in gray.

6.6 Communication Trace
Communication Trace Screen

The Communication Trace screen is displayed with the Com. Trace key on the
Tools screen. Use this screen to print or delete the record or system communica-
tion between the analyzer and the host computer.
Communication Trace screen
Mode
Touch key: Print, Delete
Use this key to select the print or delete function for the communication trace.
“Print” prints a Communication Trace report listing the communication between
the system and the host computer. “Delete” deletes the record of communication
between the system and the host computer.

6.7 C-RAM R/W, Count Clear
C-RAM R/W
Count Clear

6.8 ISE Check
ISE Check Screen

The ISE Check screen is displayed with the ISE Check key on the Tools screen.
Use this screen to verify the functionality of the ISE system. The electromotive
force (EMF) of the internal standard through the measuring cartridges is measured
and results are printed. Refer to the User’s Guide for additional information
concerning this function.
ISE Check screen
Start
Touch key.
Use this key to print the ISE check. During the check, the Start key is highlighted
in blue. Touch the Stop key to terminate printing the ISE Check report.

6.9 Barcode Check
Barcode Check Screen

The Barcode Check screen is displayed with the Barcode key on the Tools
screen. Use this screen to verify the functionality of the barcode reader.
Barcode Check screen
Start
Touch key.
Use this key to print the barcode check. During the check, the Start key is high-
lighted in blue. At the conclusion of the check, the Stop key is highlighted in blue.

NOTES

Chapter 7
Reports
SG7S1-34.p65 1 07.10.2003, 14:05

7.1 Overview
Introduction
Several reports are generated by the Roche Diagnostics/Hitachi 902 analyzer.
This chapter contains examples of the various printed reports and discusses their
content and use.
SG7S1-34.p65 2 07.10.2003, 14:05

7.2 Data Monitor Report
Data Monitor Report

Touch the Realtime Print key on the Start Condition screen to print a Data Monitor
report realtime. The selected key appears highlighted in blue.
The Data Monitor report can also be printed after the sample run from the Routine
Result, Print screen. Touch Monitor on the Home screen, then touch Routine
Samples/Print. Input the sequence number of the first result to print, then touch
the enter key. Input the sequence number of the last result to print, then touch the
enter key. Touch Start to print the Data Monitor report. A Data Monitor report
including control or STAT results can also be printed from the Control Result, Print
screen and the STAT Result, Print screen.
Sequence Number –––
–—
––––
—
— Sample Position
–—
——
—
––– Number
—– –––
–
Sample ID ––––
––
Number –––––––
–––
Test Name/Result –––––––––
–––––
–––– Data Alarm
Data Monitor Report
SG7S1-34.p65 3 25.11.2003, 12:56

7.2 Data Monitor Report
Date Time
The date and time when the report was printed is located at the top of the report.
Seq. No. [N004-04]
The seq. no. field displays sample type (N=routine, C=control, S=STAT), the
sequence number (007) and sample disk position number (07).
ID
This field displays the patient ID number as specified on the Test Selection screen.
Date Time
The date and time when the sample was run appears below the ID field.
Results Printout
Results for patient samples are printed in three columns below the date and time.
The test names appear in the first column. The test results appear in the second
column. Samples with H/L data flags are printed with the data alarms next to the
result. Test results print in the order defined on the Print Order screen.
Data Alarms
Data flags (such as CELL? and SAMPL) print in the third column.
SG7S1-34.p65 4 07.10.2003, 14:05

7.3 Requisition List
Requisition List
Touch Wk.Sht. on the Batch Mode Sample ID screen to print the Requisition List
report. This report lists the tests requested for all routine Batch Mode samples.
The report prints in two sections. The Requisition List with individual sample
information prints in the first section and the Requisition List Test Count prints in
the second section.
Sequence
Number –––––
––
––
–––
Sample ID
––
Sample ID Number ––––
––––––
Number
Requisition List Requisition List

Barcode Reader Disabled Barcode Reader Enabled
SG7S1-34.p65 5 25.11.2003, 12:59

7.3 Requisition List
Date Time
The date and time this report was printed is located at the top of the report.
S. No.
This field displays the sequence number as specified on the Sample ID screen.
The N, C, or S proceeding the sequence number indicate the following:
N=Routine sample, C=Control sample, S=STAT sample
ID
The patient identification number is shown in this row as entered on the Sample ID
screen. This field is blank when the sample barcode reader is disabled in System
Parameters and manual entry of a patient ID does not occur.
Channel Numbers
The channel numbers are listed in the following format on the report:
1- 5 6-10 11-15
16-20 21-25 26-30
31-35 36,ISE
Test Requests
N016
578943
-- * -- * -- * - -----
----- ----- -----
----- --
The test channels selected for the specific patient are listed horizontally below the
identification line (sequence number and/or patient ID). A “ ” in the channel
*
number grouping indicates that the test in that channel has been requested. A “-”
in the channel number grouping indicates that the test in that channel has not
been requested. For example, on the report on the previous page, the following
test channels have been requested for sample N016: 3, 6, and 9. Referring to the
Test Count section, the requested tests are AST, GLU, and PHOS.
TEST COUNT
The channel numbers, test names and a cumulative count test requests for the
range of samples printed is included in the second section of the report. Tests are
listed in numerical order according to channel number.
SG7S1-34.p65 6 07.10.2003, 14:05

7.4 Precision Check
Precision Check
Touch Precision on the Maintenance screen to display the Precision screen. Input
the sequence number of the first sample to include in the precision statistics, then
touch the enter key. Input the sequence number of the last sample to include in
the precision statistics, then touch the enter key. Touch the Start key to print the
Precision Check report.
The Precision Check report is a printout of statistical calculations performed on a
maximum of 39 programmed chemistries, for a maximum of 400 patient files. This
report can be used to troubleshoot chemistry problems or verify precision, par-
ticularly after performing maintenance.
Precision Check Report
Date Time
S. No.
This field lists the sequence number (1-400) of the tests in the precision check.
Test Name
This field lists the test name for the precision check, including Na+, K+, and Cl-.
Results with data alarms (other than H or L) are excluded from the calculation.
A maximum of 39 programmed chemistries can appear.
N
This field lists the number of replicate samples included in the calculation.
SG7S1-34.p65 7 07.10.2003, 14:05

7.4 Precision Check
MEAN
This field lists the calculated mean for each test.
RANGE
This field lists the difference between the highest and lowest results for each test.
MAX.
This field lists the maximum value for each test.
MIN.
This field lists the minimum value for each test.
SD
This field lists the calculated standard deviation (1 SD) for each test.
CV%
This field lists the calculated coefficient of variation, in percent, for each test.
SG7S1-34.p65 8 07.10.2003, 14:05

7.5 Reagent Volume Check
Volume Check Report

Touch Reagent (Prnt) on the Start Condition screen to print the reagent Volume
Check report.
Volume Check Report
Date Time
Ch.
This field displays the channel number of the test.
Name
This field displays the test name for each chemistry. Only programmed tests are
listed.
R1, R2, R3
The reagent type: R1, R2, R3, is printed in this field.
Pos.
This field indicates which position the reagent occupies on the reagent disk.
SG7S1-34.p65 9 07.10.2003, 14:05

7.5 Reagent Volume Check
Test
This field lists the number of tests remaining for each reagent in units of 10 tests.
This number is truncated to the lowest 10. For ISEs this number is milliliters
remaining and is truncated. Reference solution (KCl) values are not truncated on
the ISE Parameters screen.
[Wash]
This section displays the volume (milliliters) remaining in the wash solution bottles
located in positions 1 through 40 on the reagent disk. It also lists special wash
solutions for carryover evasions
SG7S1-34.p65 10 07.10.2003, 14:05

7.6 Calibration Monitor Report

Touch the Cal. Print key on the Start Condition screen to print the Calibration
Monitor report. When this key is highlighted, the report prints after calibration is
complete. The Calibration Monitor report can only be printed when this key is
highlighted.
The Calibration Monitor report includes two sections: ISE Calibration and Photo-
metric Chemistry Calibration. Calibration results are printed for the most recent
calibration.
SG7S1-34.p65 11 07.10.2003, 14:05

Date and Time

ISE Calibration Information

Test
This field lists the name of each ISE test.
IS EMF
This field lists the electromotive force (EMF) or electrical potential generated by
the internal reference solution at the specified electrolyte cartridge. The value
printed is in millivolts (mV).
S1 EMF
This field lists the electrical potential (mV) generated by the aqueous Low standard
for the specified electrolyte cartridge.
S2 EMF
This field lists the electrical potential (mV) generated by the aqueous High stan-
dard for the specified electrolyte cartridge.
S3 EMF
This field lists the electrical potential (mV) generated by the serum based calibrator
(Precical) for the specified electrolyte cartridge.
SLOPE
This field lists the sensitivity of the specified electrolyte cartridge. The slope
should gradually decrease with time, reflecting the aging of the cartridge.
When the slope falls outside of the optimal slope range values as presented
below, a PREP warning data flag (and instrument alarm, ISE PREP) is issued. The
Slope? data flag (and instrument alarm, ISE Slope ) is issued if the slope exceeds
the critical ranges.
Optimal Marginal Critical
ISE ISE Slope ISE Slope
Cartridge Slope (PREP) (SLOPE?)
Sodium 50.0 to 68.0 45 to 49.9, > 68 < 45.0
Potassium 50.0 to 68.0 45 to 49.9, >68 < 45.0
Chloride -68.0 to -40.0 -39.9 to -35, < -68 > -35.0
When a PREP warning is detected, check the control values. If controls are within
range, continue operation until the next convenient time to replace the cartridge.
When an ISE Slope alarm is displayed, replace the cartridge immediately, prime
and recalibrate.
SG7S1-34.p65 12 07.10.2003, 14:05

IS C.
This field lists the measured concentration of the internal reference solution
(mmol/l) determined during calibration.
S3 CONC.
This field lists the measured concentration (mmol/l) of the serum based calibrator
,determined during calibration.
C. VAL.
This column lists the compensation value (mmol/l) determined during calibration.
This value is the difference between the measured concentration of STD 3 shown
in the S3 Conc. column and the set value of STD 3. This value is added to all
subsequent control and patient values.
Photometric Chemistry Calibration Information

The channel number and test name are printed in the first row of the photometric
chemistry calibration section. Any data alarm that affects an entire test is printed
two rows below the test name. Some alarms include: STD?, SENS, and CALIB.
Refer to Chapter 2 of the User’s Guide for information about these alarms.
S1 through S6
Absorbance measurements (1 x 104) for standards 1 to 6 are printed in separate
rows down the page. Replicate absorbance measurements are printed, one below
the other, under the standard levels. Further information on assay type and
calibration method can be found in Chapter 5 of the Reference Guide.
Data alarms that affect individual standard measurements (such as DUP, S1ABS?,
SAMPL and REAGN) are printed beside the affected test or below the affected
standard (S1-S6).
SG7S1-34.p65 13 07.10.2003, 14:05

7.7 Daily Alarm Trace
Daily Alarm Trace

Touch the Alarm Trace key on the Tools screen to display the Alarm Trace screen.
Touch Mode to select New Alarm Print. Touch Start to print the Daily Alarm Trace
report.
Daily Alarm Trace
Date Time
Alarm Time
The first field in the first row lists the time (hour:minute) when the alarm occurred.
SG7S1-34.p65 14 07.10.2003, 14:05

7.7 Daily Alarm Trace
Instrument Status
The second field in the first row lists a code for each alarm representing the status
of the instrument when the alarm occurred. The following are the code assign-
ments:
1 Initialization 38 ISE Prime (IS)
2 STAND BY 41 ISE Prime (REF)
3 Preparation for Operation
4 Operation 43 Cell Blank
5 Routine Sample Stop
6 Routine Probe Wash 45 Incubation Bath Exchange
46 Reset
8 Routine Stop 47 Probe Adjust (S. Probe Horiz.)
48 Probe Adjust (S. Probe Horiz./Vert.)
49 Probe Adjust (R. Probe Horiz.)
29 T/M Stop 50 Probe Adjust (R. Probe Vert.)
30 Emergency Stop 51 Stirrer Adjust
52 Mechanisms Check
33 Wash (Cell)
34 Wash (ISE) 54 ISE Check
35 Wash (All)
62 Routine Sample Stop (No Restart)
37 Photometer Check
65 Mechanism Reset during operation
Frequency
The third field in the first row lists the number of successive cycles during which
each alarm has occurred since power on.
Alarm (A) or Retry (R)
The letter “A” in the second row indicates an instrument alarm. The letter “R”
indicates a retry code. Retry codes document analyzer functions as monitored by
the central processing unit (CPU). Not all retry codes indicate an abnormality.
Retry codes are intended for service use only and are not listed in this guide.
Alarm Code
The nine-digit number in the second row indicates the alarm code(s) for the
alarm(s) that occurred. This is the same code found in the Instrument Alarms table
in Chapter 3 of the User’s Guide. Explanation of each code and possible remedies
can be found in that table.
SG7S1-34.p65 15 07.10.2003, 14:05

7.8 Cumulative Alarm Trace
Cumulative Alarm Trace

Touch the Alarm Trace key on the Tools screen to display the Alarm Trace screen.
Touch Mode to select All Data Print. Touch Start to print the Cumulative Alarm
Trace report.
Analyzer Cumulative Alarm Trace Report
Date Time
The date and time the report is printed is located at the top of the report.
Alarm Date and Time
The first fields list the date and time when the alarm occurred.
Alarm (A) or Retry (R)
The letter “A” in the second column indicates an instrument alarm. The letter “R”
indicates a retry code. Retry codes document analyzer functions as monitored by
the central processing unit (CPU). Not all retry codes indicate an abnormality.
Retry codes are intended for service use only and are not listed in this guide.
Alarm Code
The nine-digit number in the second row indicates the alarm code(s) for the
alarm(s) that occurred. This is the same code found in the Instrument Alarms table
in Chapter 3 of the User’s Guide. Explanation of each code and possible remedies
can be found in that table.
SG7S1-34.p65 16 07.10.2003, 14:05

7.9 Communication Trace
Communication Trace
Touch Com. Trace on the Tools screen to display the Communication Trace
screen. Touch Start to print the Communication Trace report.
To print this report, Com. Trace must be enabled on the Com Parameters screen.
n
The Host Communication Trace provides a record of the information (communica-
tion) flow between the instrument and the host computer, and is used most often
by your Roche Diagnostics representative.
For information concerning the interpretation of this report, contact Technical
Support.
Host Communication Trace Report
SG7S1-34.p65 17 07.10.2003, 14:05

7.10 Cumulative Operations List
Cumulative Operations List

Touch Test Summary on the Tools screen to display the Test Summary screen.
Touch Start to print the Cumulative Operations List.
The Cumulative Operations List gives the test count for each test performed by
the analyzer, as well as power on time and time in the Operation mode. This
includes routine, STAT, control, and calibration tests.
Cumulative Operations List Report
SG7S1-34.p65 18 07.10.2003, 14:05

7.10 Cumulative Operations List
Date and Time

Power
This field indicates the cumulative number of hours the instrument has been
powered On. This includes stand by mode and instrument mechanical operation.
Operation
This field indicates the cumulative number of hours of instrument mechanical
operation.
Test Count
This section of the report includes the test name (Test), routine sample count
(Routine), calibration sample count (Calib.), control sample count (Cont.), and
STAT sample count (Stat).
Test Total
This section of the report includes the test name (Test) and the total test count for
each chemistry (Total).
No. of Samples
This section of the report includes a test count for routine samples (Routine) and
STAT (Stat) samples, as well as a total (Total) test count.
SG7S1-34.p65 19 07.10.2003, 14:05

7.11 Cell Blank Measurement
Cell Blank Measurement

Touch Cell Blank on the Maintenance screen to display the Cell Blank screen.
Touch Start to initiate the cell blank. The Cell Blank report prints after the cell
blank measurement.
The Cell Blank Measurement report lists the absorbance of all 48 reaction cells at
all 12 wavelengths. These absorbance readings are taken with the reaction cells
filled with deionized water.
Cell Blank Measurement Report
SG7S1-34.p65 20 07.10.2003, 14:05

7.11 Cell Blank Measurement
Date Time
The date and time the report was printed is located at the top of the report.
No.
This field displays the reaction cell number.
Results
The reaction cell number is indicated in the left column. Two absorbance (x 104)
readings of the first reaction cell at each of 12 wavelengths (340, 376, 415, 450,
480, 505, 546, 570, 600, 660, 700, 800) is printed first. Data for subsequent
reaction cells are computed as differences in absorbance, compared with the first
reaction cell. This information is automatically written to the parameter disk after
the 48 cells are blanked.
Data for reaction cell 1 must be < 13,000. If any data from reaction cells 2 to 48 exceed ± 800,
n refer to the User’s Guide for proper corrective procedures.
SG7S1-34.p65 21 07.10.2003, 14:05

7.12 Program Check Report
Program Check Report

Touch Program on the Tools screen to display the Program Check screen. Touch
Start to print the Program Check report.
This report prints the version of system software currently installed on the ana-
lyzer.
Program Check Report
Date Time
The date and time this report was printed is located in the upper right of the
report.
V.No.
This field indicates the system software version currently installed on the analyzer.
SG7S1-34.p65 22 07.10.2003, 14:05

7.13 Original Absorbance Report
Original Absorbance Report

Sample reports are printed in original absorbance units when the Original ABS
mode is enabled in System Parameters. In addition to result units, the report
indicates the actual absorbances read when the sample was processed in the
usual manner. When Original Absorbance mode is active, calibration and ISEs
cannot be performed and the original absorbance data is not saved to the data
disk; that is, results are only printed and/or sent to the host.
––––
–— Sample Position
Sequence Number
——
—– Number
–––––––—— ––––
———– ––
–––– –––––––––– Cell Number
Test Name/Result –––––––––
Cell Blanks ––––––––––––
Measurement
Cycles –––––––––––– ––––––––––
Absorbance Data
Original ABS. Report
Date Time
Seq. No.
The sample number consists of a sequence number and sample position number.
Cell Number
This field displays the reaction cell number (1-48) in which the reaction occurs.
ID
This field displays the sample ID number. This information is specified on the
Sample ID screen.
SG7S1-34.p65 23 25.11.2003, 13:07

7.13 Original Absorbance Report
Test Name and Results

The test name and calculated results appear below the ID field. If a data flag
exists, it appears to the right of the numeric result.
Cell Blank
This field displays the cell blank values for the four cell blanks.
Measurement Cycles
This field displays the photometric measurement points.
Absorbance Data
Absorbance (x 104) is printed for four cell blanks (deionized water blanks) and up
to 35 measurement cycles. The measurement data represents the bichromatic
absorbance (primary minus secondary wavelength) for each measurement taken
in the photometric read window. When the Original ABS mode is enabled, no
calibrations are performed and the data is not saved to the data disk.
ISE tests are not processed in this mode.
n
SG7S1-34.p65 24 07.10.2003, 14:05

7.14 Photometer Check Report
Photometer Check Report

Touch Photometer on the Maintenance screen to display the Photometer screen.
Touch Start to initiate a photometer check. The Photometer Check report is
printed when the photometer check is complete.
The Photometer Check is used to verify the light intensity of the photometer
allowing deterioration of the lamp output to be identified. Both the current mea-
surement and the previous measurement are printed on the report. Verify on the
report that the results for SUB and MAIN are similar for any given wavelength with
no value greater than 13,000.
Photometer Check Report
SG7S1-34.p65 25 07.10.2003, 14:05

7.14 Photometer Check Report
When performing the photometer check, the instrument fills two reaction cells
with deionized water and rotates them through the photometer lightpath. The
absorbance of both cells is determined at each of the 12 available wavelengths,
and their mean absorbance (at each wavelength) is printed. SUB (secondary) and
MAIN (primary) refer to the internal processing of absorbance data by the instru-
ment. The results at any given wavelength should be similar when comparing SUB
and MAIN.
Date Time
RESULTS
Previous and current photometer check results are printed under the appropriate
heading. These are used for comparison purposes; values should increase gradu-
ally from previous to current. Factors affecting the photometer check include:
insufficient Hitergent in bath, dirt in bath, reaction cell integrity and the photometer
lamp. If a sudden increase in values is observed, it must be investigated. If any
current value exceeds 13,000, the photometer lamp must be replaced, a cell blank
performed and all tests recalibrated. Refer to the User’s Guide for this procedure.
SG7S1-34.p65 26 07.10.2003, 14:05

7.15 ISE Check Report
ISE Check Report

Touch ISE Check on the Tools screen to display the ISE Check screen. Touch
Start to initiate the ISE check. The ISE Check report prints as the ISE check is
being performed.
You must touch the Stop key to stop printing the ISE Check report.
n
ISE Check Report
The ISE Check report is a printout of the EMFs of the internal reference solution,
measured for Na+, K+, and Cl-. The replicates should be within ± 2.0 mV.
Date Time
The date and time this report was printed is located in the upper right of the
report.
SG7S1-34.p65 27 07.10.2003, 14:05

7.15 ISE Check Report
Na EMF
This column lists the EMF for Na+ for each ISE check performed. The number
should fall within the range of -90 to -10 mV.
K EMF
This column lists the EMF for K+ for each ISE check performed. The number
should fall within the range of -90 to -10 mV.
CL EMF
This column lists the EMF for Cl- for each ISE check performed. The number
should fall within the range of 80 to 160 mV.
SG7S1-34.p65 28 07.10.2003, 14:05

7.16 Barcode Reader Check Report
Barcode Reader Check Report

Touch Barcode on the Tools screen to display the Barcode Check screen. Touch
Start to initiate the barcode check and print the Barcode Reader Check report.
To print this report, the sample ID mode must be enabled on the Options screen in System
n Parameters.
Barcode Reader Check Report
The Barcode Reader Check report prints out the barcode numbers read by the
sample barcode reader, if activated.
Date Time
The date and time at the time the report was printed is located at the top right of
the report.
P. No.
These columns indicate the position number in the sample disk.
ID
These columns list the barcode numbers read from the sample tubes. A blank ID
number indicates that the instrument tried but failed to read the barcode or that no
barcoded tube was in that position.
SG7S1-34.p65 29 07.10.2003, 14:05

7.17 Chemistry Parameters Report
Chemistry Parameters Report

Touch Parameters on the Maintenance screen to display the Parameters screen.
Touch Mode to select Print. Input the channel number of the first chemistry to
print, then touch the enter key. Input the channel number of the last chemistry to
print, then touch the enter key. Touch Start to initiate printing of the Chemistry
Parameters report.
Chemistry Parameters Report
Ch.
This field displays the channel number of the printed chemistry.
Parameters
The left column displays the parameter number (1-58). The right column displays
the parameter information for the selected chemistry. For more information
regarding specific parameter settings refer to section “4.2 Test Parameters” in this
guide.
SG7S1-34.p65 30 07.10.2003, 14:05

7.18 Test Parameters Report
Test Parameters Report

Touch Mode to select Print. Input 0 in the First No field, then touch the enter key.
Input 0 in the Last No field, then touch the enter key. Touch Start to initiate
printing of the Test Parameters report.
The Test Parameters report lists the names of all chemistry parameter fields for
photometric chemistries (1-58), ISE’s (1-11), calculated tests (1-8), and compen-
sated tests (1-6).
Test Parameters Report
SG7S1-34.p65 31 07.10.2003, 14:05

7.19 System Parameters Report
System Parameters Report

Touch Mode to select Print. Enter 99 in the First No field, then touch the enter key.
Enter 99 in the Last No field, then touch the enter key. Touch Start to initiate
printing of the System Parameters report.
The System Parameters report lists the following system parameters: entered
calculated test parameters, entered compensated test parameters, control posi-
tions, serum index factors, profiles, print order, evasion programming, and system
parameter settings, and dip switch settings (service function) from the System
Parameters screen. Refer to section 4.7 “System Parameters” for detailed infor-
mation on System Parameters.
SG7S1-34.p65 32 07.10.2003, 14:05

7.19 System Parameters Report
System Parameters Report
SG7S1-34.p65 33 07.10.2003, 14:05

NOTES
SG7S1-34.p65 34 07.10.2003, 14:05

Tutorial Guide
Roche Diagnostics/Hitachi 902 Analyzer Tutorial Guide V1.2 TG - 1

Copyrights
Trademarks
Publisher
Sandhoferstr. 116
D-68305 Mannheim
Phone: +49 621 759 4445
Manual Version 1.2

Version 1.2 Sept, 2003 TG-2 to TG-4, 2-3, 2-8, 2-36,

2-37, 2-38, 3-9, 3-34
TG - 2 Roche Diagnostics/Hitachi 902 Analyzer Tutorial Guide V1.2

Intended use
the system.
C ® US Issued by Underwriters Laboratories, Inc. (UL) for Canada and the US.
Contact addresses
Manufacturer


D-68305 Mannheim
Germany
Roche Diagnostics/Hitachi 902 Analyzer Tutorial Guide V1.2 TG - 3

NOTES
TG - 4 Roche Diagnostics/Hitachi 902 Analyzer Tutorial Guide V1.2

Table of Contents
Chapter 1 - Overview
1.1 Overview _______________________________________________ 1-2

Introduction ____________________________________________________ 1-2
Chapter 2 - Daily Operation
2.1 Daily Operational Checks ________________________________ 2-2

Introduction ____________________________________________________ 2-2
Check Hitergent Supply __________________________________________ 2-2
Check Multiclean _______________________________________________ 2-2
Check Water Supply ____________________________________________ 2-3
Check Waste Solution Reservoir __________________________________ 2-3
Check Disk Drives ______________________________________________ 2-4
Check Printer Paper _____________________________________________ 2-4
Power the Analyzer On __________________________________________ 2-5
2.2 Start-up Procedures ____________________________________ 2-6

Incubation Bath Exchange _______________________________________ 2-6
Photometer Check ______________________________________________ 2-6
ISE Prime ______________________________________________________ 2-7
Read/Record Incubation Bath Temperature _________________________ 2-8
Read/Record Reagent Compartment Temperature ___________________ 2-9
Reagent Volume Check __________________________________________ 2-10
2.3 Programming Photometric Test Calibration ______________ 2-11

Introduction ____________________________________________________ 2-11
Procedure _____________________________________________________ 2-11
2.4 Programming ISE Calibration ____________________________ 2-12

Introduction ____________________________________________________ 2-12
Procedure _____________________________________________________ 2-12
2.5 Programming Control Requests _________________________ 2-13

Introduction ____________________________________________________ 2-13
Procedure _____________________________________________________ 2-13
Roche Diagnostics/Hitachi 902 Analyzer Tutorial Guide V1.1 i
TGINHALT.p65 1 13.10.2003, 11:34

2.6 Programming Batch Mode Samples with BCR _____________ 2-14
Introduction ____________________________________________________ 2-14
Procedure _____________________________________________________ 2-14
2.7 Programming Batch Mode Samples without BCR __________ 2-18

Introduction ____________________________________________________ 2-18
Procedure _____________________________________________________ 2-18
2.8 Programming Easy Mode Samples _______________________ 2-22

Introduction ____________________________________________________ 2-22
Procedure 1- Programming and Initiating Easy Mode 1 Samples
(Default Profile) ____________________________________ 2-22
Procedure 2 - Programming Easy Mode 2 Samples (Profile Selections) __ 2-24
Procedure 3 - Programming Easy Mode 3 Samples (Test Selections) ___ 2-25
Procedure 4 - Initiating an Easy Mode 2 or 3 Sample
Run from Start Conditions __________________________ 2-26
2.9 Programming STAT Samples ____________________________ 2-28

Introduction ____________________________________________________ 2-28
Procedure _____________________________________________________ 2-28
2.10 Data Management _____________________________________ 2-29

Introduction ____________________________________________________ 2-29
Procedure-Printing Results in STAND-BY ___________________________ 2-29
Procedure-Uploading Results to the Host __________________________ 2-30
Procedure-Displaying Results ____________________________________ 2-31
Procedure-Saving Results as ASCII Text ___________________________ 2-32
Procedure-Deleting Results ______________________________________ 2-33
2.11 End of the Day Maintenance ____________________________ 2-34

Wash (Wash Cells, Wash ISE) ____________________________________ 2-34
Clean Instrument Surfaces _______________________________________ 2-36
Clean/Adjust Sample and Reagent Probes and Stirrer ________________ 2-36
ii Roche Diagnostics/Hitachi 902 Analyzer Tutorial Guide V1.1
TGINHALT.p65 2 13.10.2003, 11:34

Chapter 3 - How to...
3.1 How to Program Parameters for Photometric Chemistries 3-2

Introduction ____________________________________________________ 3-2
Procedure _____________________________________________________ 3-2
3.2 How to Program Parameters for ISEs _____________________ 3-6

Introduction ____________________________________________________ 3-8
Procedure _____________________________________________________ 3-8
3.3 How to Print Chemistry Parameters ______________________ 3-8

Introduction ____________________________________________________ 3-8
Procedure _____________________________________________________ 3-8
3.4 How to Assign Control Positions _________________________ 3-9

Introduction ____________________________________________________ 3-9
Procedure _____________________________________________________ 3-9
3.5 How to Update Photometric Calibrator Values ____________ 3-10

Introduction ____________________________________________________ 3-10
Procedure _____________________________________________________ 3-10
3.6 How to Update ISE Calibrator Values _____________________ 3-12

Introduction ____________________________________________________ 3-12
Procedure _____________________________________________________ 3-12
3.7 How to Program Special Washes _________________________ 3-14

Introduction ____________________________________________________ 3-14
Procedure _____________________________________________________ 3-14
Reagent Probe Wash ____________________________________________ 3-14
Reaction Cell Wash _____________________________________________ 3-15
Sample Probe Wash ____________________________________________ 3-16
3.8 How to Program Calculated Tests _______________________ 3-17

Introduction ____________________________________________________ 3-17
Procedure _____________________________________________________ 3-17
3.9 How to Program Compensated Tests ____________________ 3-19

Introduction ____________________________________________________ 3-19
Procedure _____________________________________________________ 3-19
Roche Diagnostics/Hitachi 902 Analyzer Tutorial Guide V1.1 iii
TGINHALT.p65 3 13.10.2003, 11:34

3.10 How to Define Profiles _________________________________ 3-21
Introduction ____________________________________________________ 3-21
Procedure _____________________________________________________ 3-21
3.11 How to Assign Print Order ______________________________ 3-23

Introduction ____________________________________________________ 3-23
Procedure-Assigning Print Order __________________________________ 3-23
Procedure-Printing a Print Order List _______________________________ 3-24
3.12 How to Change Normal Ranges _________________________ 3-25

Introduction ____________________________________________________ 3-25
Procedure-Photometric Normal Ranges ____________________________ 3-25
Procedure-ISE Normal Ranges ____________________________________ 3-26
3.13 How to Manage Floppy Disks ___________________________ 3-28

Introduction ____________________________________________________ 3-28
Procedure-Formatting/Copying a Floppy Disk _______________________ 3-28
Procedure-Reading/Writing Parameters ____________________________ 3-29
3.14 How to Program System Parameters ____________________ 3-30

Introduction ____________________________________________________ 3-30
Procedure _____________________________________________________ 3-30
Set Time and Date ______________________________________________ 3-30
Set Initial Easy Mode Screen _____________________________________ 3-31
Turn ISE System or Barcode Reader On or Off ______________________ 3-31
Define STAT Reserve Positions ___________________________________ 3-32
Define Original ABS Printing ______________________________________ 3-32
Program Check Digits for Barcode Reader __________________________ 3-32
Define Linearity Limits ___________________________________________ 3-33
Define Host Communication Settings ______________________________ 3-34
Print a System Parameters List ___________________________________ 3-35
iv Roche Diagnostics/Hitachi 902 Analyzer Tutorial Guide V1.1
TGINHALT.p65 4 13.10.2003, 11:34

Chapter 1
Overview
Roche Diagnostics/Hitachi 902 Analyzer Tutorial Guide V1.1 1-1
TG1S1-2.p65 1 07.10.2003, 14:22

1.1 Overview
Introduction
This Tutorial Guide contains quick reference procedures for operating the Roche
Diagnostics/Hitachi 902 Analyzer. This Tutorial Guide can be used for training
purposes. More detailed information can be found in the Reference Guide,
Software Guide, and User’s Guide.
In the Tutorial Guide, you will find:
• daily operating procedures in step by step format
• daily maintenance procedures
• step-by-step instructions for procedures that are not part of the daily
operating routine, but are tasks an average operator is required to perform.
1-2 Roche Diagnostics/Hitachi 902 Analyzer Tutorial Guide V1.1
TG1S1-2.p65 2 07.10.2003, 14:22

Chapter 2
Daily Operation
TG2S1-17.p65 1 16.10.2003, 10:42

2.1 Daily Operational Checks
Introduction
Before processing any samples, you must perform the following pre-operational
procedures:
• check Hitergent supply
• check Multiclean supply
• check the water supply
• empty the waste container
• check that the floppy disks are in the analyzer disk drives
• check the printer paper supply
• turn the analyzer on.
Check Hitergent Supply

Hitergent is located in position 40 on the reagent disk. It is a non-ionic, bacterio-
static detergent solution that is automatically dispensed into the incubation bath by
the reagent probe during an incubation water exchange.
Hitergent:
• acts as a surfactant to minimize the formation of bubbles on reaction cells
• reduces microbial growth in the tepid water
• enhances electrical conductivity used by the water level sensor.
Procedure
1. Remove the reagent disk compartment lid.
2. Check the level of detergent in the Hitergent bottle (position 40) to ensure
that at least 10 mL are present. Replace bottle with full bottle, if necessary.
3. Replace the reagent disk compartment lid.
Check Multiclean
Multiclean is used by the analyzer to automatically rinse the reaction cells during
the cell wash. It is located in position 39 on the reagent disk. A full 50 ml bottle
contains enough detergent for one cell wash (Wash All). Replace the bottle when the
cell wash is complete.
TG2S1-17.p65 2 16.10.2003, 10:42

Check Water Supply

The external water supply for the analyzer must be on for the analyzer to function
properly.
Procedure
1. Locate the external water supply connection at the rear of the analyzer.
2. Check to be sure that the water supply valve is turned on.
Check Waste Solution Reservoir

The waste solution reservoir is located at the rear of the analyzer. It receives sample
waste from the reaction cell rinse unit. Use the following procedure when the
reservoir needs to be emptied.
It is not necessary to check the waste solution reservoir when a waste drain connection is
n installed.
Procedure
Contents of the waste solution reservoir, and subsequently the water used to rinse the
container, are potentially biohazardous. This waste should be handled, and disposed of, in an
appropriate manner. Wear rubber gloves when performing this procedure.
1. Locate the waste solution reservoir at
the back of the analyzer.
2. Lift the liquid-level sensor assembly
from the waste reservoir and place it
on paper towels or other absorbent
material.
Waste solution reservoir
3. Remove the drain hose from the waste reservoir, making sure any residual
waste in the hose drains into the waste container. Place the hose by the
liquid-level sensor on the paper towels.
4. Remove the waste container and dispose of its contents according to your
facility’s protocol for biohazardous waste disposal.
TG2S1-17.p65 3 16.10.2003, 10:42

5. Rinse the waste container thoroughly with water and dispose of the rinse
water in the same manner.
6. Pour disinfection solution into the waste container until it is approximately 1
cm deep.
7. Place the waste container back in its original position at the back of the
analyzer.
8. Place the liquid level sensor assembly and drain hose back in the waste
container.
9 Properly dispose of the paper towels.
Check Disk Drives

Check that the parameter disk is in drive 1 and the data disk is in drive 2. The disk
drives are located behind the front analyzer doors.
Floppy disk drives
Check Printer Paper

Check that sufficient paper is loaded in the printer for the ensuing run. If not, refer to
the Load Printer Paper procedure in the Maintenance section of the User’s Guide for
step-by-step instructions.
TG2S1-17.p65 4 16.10.2003, 10:42

Power the Analyzer On

The analyzer is powered on/off by the operation switch located on the front panel.
Place the switch in the on position by pressing the top of the switch. The power
light is illuminated on the upper left corner of LCD screen area when the system is
on.
Operation switch location
If the analyzer is already on, but in the screen saver mode, touch the LCD screen to activate
n the screen.
TG2S1-17.p65 5 16.10.2003, 10:42

2.2 Start-up Procedures
Incubation Bath Exchange

Introduction
An incubation bath exchange is required daily. This procedure is performed
automatically when the analyzer is powered on. If the analyzer power is not cycled
on/off in a 24 hour period, the incubation bath exchange must be initiated manually
using the following procedure.
Procedure
1. Touch on the Home screen.
2. Touch on the Maintenance screen.
3. Touch to initiate the incubation bath exchange.
4. Touch to display the Status screen. When the procedure is com-

plete, the Status screen displays STAND-BY.
5. Touch two times to return to the Maintenance screen.
Photometer Check
Introduction
A Photometer Check verifies that the photometer lamp output remains at an accept-
able level (<13,000). The analyzer performs a check of the photometer and light
path.
A Photometer Check Report is automatically printed. Verify on the report that the
results for SUB and MAIN are similar for any given wavelength with no value greater
than 13,000.
Procedure
The photometer check is not performed automatically and must be initiated using
the following procedure.
3. Touch to initiate the photometer check.

TG2S1-17.p65 6 16.10.2003, 10:42

ISE Prime
Introduction
The ISE Prime should be performed daily when the ISE function is enabled on the
analyzer. The KCl line, sipper line, and cartridges are primed to remove air that may
have leeched into the system from nonuse. This should also be performed after
replacing any ISE components or reagents.
ISE priming volumes: Internal standard 636 µl
KCl 5.2 ml
Procedure
Use the following procedure to initiate the ISE Prime function.
3. Touch to select REF.
4. Touch to initiate ISE Prime.
5. Touch to display the Status screen. When the procedure is

complete, the Status screen displays STAND-BY.
TG2S1-17.p65 7 16.10.2003, 10:42

Read/Record Incubation Bath Temperature

Introduction
Because incubation bath temperature is continuously monitored and displayed,
manual verification is not mandatory. This procedure is provided for your conve-
nience. The incubation bath temperature is displayed on the Status screen. The
temperature tolerance is 37 ± 0.1 °C.
Procedure
1. Ensure that the analyzer is in STAND-BY. If the analyzer has just been
powered on, allow 10 minutes for the bath temperature to stabilize.
2. Remove the acrylic cover.
3. Place a thermometer in the reaction

bath through the circular opening
used by the reagent probe to dis-
pense Hitergent into the incubation
bath. Use the thermometer in accor-
dance with the manufacturer’s
instructions.
4. Read and record the temperature. The
acceptable temperature range is 37 ±
0.1 °C.
5. Replace the acrylic cover.
Record incubation bath temperature
Do not start the system while measuring the temperature of the reaction bath. The movement
of the reagent probe may damage your thermometer and/or the reagent probe.
If the temperature is out of range, correct any instrument alarm conditions. If no instrument
n alarms are present, call Customer Technical Support.
TG2S1-17.p65 8 16.10.2003, 10:42

Read/Record Reagent Compartment Temperature

Introduction
Manual verification of the reagent compartment temperatures is not mandatory. This
procedure is provided for your convenience.
Procedure
1. Ensure that the analyzer is in STAND-BY.
2. Remove the reagent compartment lid.
3. Thoroughly clean the thermometer tip
to ensure there is no reagent contami-
nation. Place the thermometer in the
Hitergent bottle in position 40. The
Hitergent must have been on the
analyzer long enough for its tempera-
ture to have stabilized to the reagent
compartment temperature. Ensure
there is adequate Hitergent volume in
the bottle to obtain an accurate
reading.
Insert thermometer
4. Read and record the temperature. The acceptable temperature range

is 5 - 15 °C.
5. Replace the reagent compartment lid.
If the temperature is out of range, correct any alarm conditions. If no alarm conditions exist,
n call Customer Technical Support.
TG2S1-17.p65 9 16.10.2003, 10:42

Reagent Volume Check

Confirm adequate reagent and wash solution volumes on the Reagent Volume
Check Report.
Procedure
2. Touch on the Batch screen.
3. Touch on the Start Conditions screen. The selected key appears

highlighted in blue while the reagent Volume Check report is printing.
• If reagent volumes are insufficient, replace the reagent bottle in the appropriate position
n on
the reagent disk.
• KCl reagent information prints as reagent volume on the Reagent Volume Check report.
Update KCl volume information in ISE Test when the KCl bottle is replaced.
• Refill the 50 ml IS and DIL bottles as needed. Replace the appropriate IS and DIL bottles
on
the reagent disk once a month or when a new 2 liter bottle of reagent is mixed, whichever
comes first.
4. Use this report to determine which reagents need to be replenished.

5. Prepare the required reagents and allow them to equilibrate according to
manufacturer’s recommendations.
6. Load the reagents on the reagent disk in the appropriate places.
TG2S1-17.p65 10 16.10.2003, 10:42

2.3 Programming Photometric Test Calibration
Introduction
To ensure the proper operation of your 902 analyzer, calibrate each photometric
assay using the interval and type specified by the manufacturer. Calibration is
requested when the Calibration key is highlighted on the Start Conditions screen.
Procedure
1. Touch or to display the
Home screen.
3. Touch to select appropriate calibration (blank or full).

4. Touch the individual test keys to select the tests. When the key is high-
lighted in blue, calibration has been requested for that test. Touch and
to scroll through the complete test menu.
5. Touch to register calibration requests.

6. Repeat steps 4 and 5 to program remaining calibrations (blank or full).
• The Calibration key must be highlighted on the Start Condition screen to process the
n calibration requests.
• Calibration results can be viewed from the Calibration screen (Monitor/Calibration).
• Calibration results are printed realtime when the Cal. Print key on the second page of
the Start Condition screen is highlighted.
TG2S1-17.p65 11 16.10.2003, 10:42

2.4 Programming ISE Calibration
Introduction
Program ISE calibration according to the manufacturer’s recommendation. ISE
calibration is requested when the Calibration key is highlighted on the Start Condi-
tions screen.
Procedure
This procedure is necessary to program ISE calibration.

Home screen.
3. Touch the appropriate calibration key to select the calibration type.

4. The highlighted key is the selected calibration type. ISE calibration is
initiated when calibration is selected on the Start Conditions screen.
• ISE Calibration results can be viewed from the ISE Calibration screen (Monitor/ISE
Calibration).
• ISE Calibration results are printed realtime when the Cal. Print key on the second page
of the Start Condition screen is highlighted.
TG2S1-17.p65 12 16.10.2003, 10:42

2.5 Programming Control Requests
Introduction
Controls must be run at least once during each 24-hour time period and following
calibration. If a test is calibrated more frequently than every 24 hours, controls must
be run at least once after each calibration. Control testing is requested when the
Control key is highlighted on the Start Conditions screen.
Procedure
Home screen.
3. Touch to select the control number, <1-5>.

4. Touch the individual test keys to select the tests. When the key is high-
lighted in blue, control tests have been requested for that test. Touch
and to scroll through the complete test menu.
5. Touch to register control test requests for each control number.

6. Repeat steps 3 through 5 for each control level.
• Control results print realtime when the Realtime Print key is highlighted on the Start
Condition screen.
TG2S1-17.p65 13 16.10.2003, 10:42

2.6 Programming Batch Mode Samples with BCR
Introduction
In the Batch Mode, the analyzer processes a predetermined number of routine
samples and always begins sampling at position 1. When analysis is complete, the
analyzer returns to STAND-BY. Additional samples must be programmed as a new
batch.
Procedure
Home screen.
3. Touch to enter the sample ID.
4. Enter the sample ID or barcode number in

the Sample ID field, then touch .
5. Touch or to select
the tests to be run on this sample.
TG2S1-17.p65 14 16.10.2003, 10:42

If... then...
The Profile key is selected the Profile Selection screen appears:
[Profile Selection]
Accept.
P.Up
The Tests key is selected the Tests Selection screen appears:
6. Touch the desired keys on the Profile Selection and/or Test Selection
screens. Selected tests/profiles appear highlighted in blue.
To move from the Profile Selection screen to the Test Selection screen, touch Tests on the
n Profile Selection screen.
Additional tests are available on the test selection screen by touching or .

n
7. Touch to register the selected tests/profiles. The cursor defaults to
the Sample ID field for entry of the next sample ID number. Repeat steps
4 through 7 until all sample information has been entered.
When all samples have been programmed, print a Requisition List report.
8. Enter the sample ID number of the first
sample in the Sample ID field, then
touch .
9. Enter the total number of samples in the
Batch field, then touch .
10. Touch .
11. Touch to print the Requisitions List.
TG2S1-17.p65 15 16.10.2003, 10:42

12. Touch to return to the Sample ID

screen.
After printing a Requisition List, initiate the batch mode sample run.
13. Touch to display the Batch Mode

screen.
14. Load the samples randomly starting at
position 1.
15. Enter the number of samples in the Batch
field, then touch .
16. Touch to display the Start Condition

screen.
17. Touch , , and/or
to request calibrators, controls,
or serum indices to be run with this batch.
Selected keys appear highlighted in blue.
18. Touch or to display the second
page of the Start Condition screen.
19. Touch , , ,
and/or to select these options
for this batch. Selected keys appear
• Cal. Print must be selected to obtain a Calibration Report.
n • Realtime Print must be selected to obtain realtime patient and control reports.
20. Touch to check for alarms on the
Status screen. If alarms are present, refer
to the User’s Guide for troubleshooting
instructions.
TG2S1-17.p65 16 16.10.2003, 10:42

page of the Status screen. This screen

verifies the printer and host status.
22. Load the calibrators and controls, as needed, in the required positions on
the sample disk.
Refer to the How to... section of the Tutorial Guide for detailed instructions on assigning
n positions for calibrators and controls.
23. Touch to return to the Batch Mode
screen.
24. Touch to initiate the run.
TG2S1-17.p65 17 16.10.2003, 10:42

2.7 Programming Batch Mode Samples without BCR
Introduction
In the Batch Mode, the analyzer processes a predetermined number of routine
samples and always begins sampling at position 1. When analysis is complete, the
analyzer returns to STAND-BY. Additional samples must be programmed as a new
batch.
Procedure
1. Touch P.Up or to display the
Home screen.
3. Touch to make profile and test

selections.
4. Enter the sequence number in the

Sample No field, then touch .
5. Enter the sample ID in the Sample ID
field, then touch . (optional)
6. Touch or to select
the tests to be run on this sample.
TG218-33.p65 18 07.10.2003, 11:51

If... then...
The Profile key is selected the Profile Selection screen appears:
[Profile Selection]
Accept.
P.Up
The Tests key is selected the Tests Selection screen appears:
7. Touch the desired keys on the Profile Selection and/or Test Selection
screens. Selected tests/profiles appear highlighted in blue.
To move from the Profile Selection screen to the Test Selection screen, touch Tests on the Profile
n Selection screen.
Additional tests are available on the test selection screen by touching or .

n
8. Touch Accept. to register the selected tests/profiles. The cursor defaults to
the Sample ID field for entry of the next sample ID number. Repeat steps
4 through 8 until all sample information has been entered.
When all samples have been programmed, print a Requisition List report.
9. Touch two times to move the cursor

to the Sample No field.
10. Enter the sequence number of the first
sample in Sample No field, then touch
. The cursor advances to the Sample
ID field.
11. Touch to move the cursor to the second Sample No field.
TG218-33.p65 19 07.10.2003, 11:51

12. Enter the sequence number of the last batch sample, then touch .
13. Touch , then touch to print the Requisitions List.
14. Touch P.Up two times to return to the Sample ID screen.

After printing a Requisition List, initiate the batch mode sample run.
15. Load the samples in the order that
they were programmed starting at
position 1.
16. Touch to move the cursor to the
Batch field.
17. Enter the number of samples in the batch
in the Batch field, then touch .
18. Touch to display the Start Condition

screen.
19. Touch , , and/or
or serum indices to be run with this
batch. Selected keys are highlighted in
blue.
21. Touch , , ,
and/or to select these options
for this batch. Selected keys are high-
lighted in blue.
• Cal. Print must be selected to obtain a Calibration Report.

n • Realtime Print must be selected to obtain realtime patient and control reports.
TG218-33.p65 20 07.10.2003, 11:51

22. Touch Status to check for alarms on the

to your operator’s manual for trouble-
shooting instructions.

the sample disk.
Refer to the How to... section of the Tutorial Guide for detailed instructions on assigning
25. Touch P.Up to return to the Batch Mode
screen.
26. Touch Start to initiate the sample run.
TG218-33.p65 21 07.10.2003, 11:51

2.8 Programming Easy Mode Samples
Introduction
In Easy Mode, the analyzer begins sampling at position 1 and stays in operation
until you touch the Stop key. Positions can be reused immediately after sampling,
allowing additional samples to be processed without resetting the analyzer. This
procedure is divided into four parts:
• Procedure 1 - Programming and Initiating Easy Mode 1 Samples
• Procedure 2 - Programming Easy Mode 2 Samples
• Procedure 3 - Programming Easy Mode 3 Samples
• Procedure 4 - Initiating an Easy Mode Sample Run from Start Conditions
Three Easy Modes are available and can be prioritized from the Parameters menu.
(See the How to... section of the Tutorial Guide for details.) The Easy Mode priority
allows you to choose which Easy screen appears when you touch the Easy Mode
key on the Home screen.
If... then...
Easy Mode 1 has priority you can select a predetermined default profile on
the primary screen. You can also choose from a
menu of profiles or a menu of individual tests on
subsequent screens. Go to Procedure 1.
Easy Mode 2 has priority you can select from a menu of profiles on the
primary screen. Or, you can choose from a menu
of individual tests on subsequent screens. You
also have sample ID options and Start Condition
accessibility in Easy Mode 2. Go to Procedure 2.
Easy Mode 3 has priority you can select from a menu of individual tests on
the primary screen. You also have sample ID
options and Start Condition accessibility in Easy
Mode 3. Go to Procedure 3.
Load samples as they are programmed in the position designated on the screen.
n
Procedure 1- Programming and Initiating Easy Mode 1 Samples (Default
Profile)
Home screen.
TG218-33.p65 22 07.10.2003, 11:51

2. Touch Easy Mode on the Home screen to

display the Easy 1 screen.
3. Load the first sample onto the sample

disk in the position specified in the Load
sample in pos. field.
4. Touch the left profile key to select the default profile or touch the right
profile key, “Profile Select,” to display the Easy 2 screen for choosing
multiple profiles.
Touch Start to begin sample processing from the Easy 1 screen. Easy Mode 1 does not include
n Start Conditions options: Calibration, Control, and Serum Index. To select these options, access
the Start Condition screen in Easy Mode 2 or 3.
If... then...
the default profile key is touched The Load sample in pos. field incre-
ments to the next available position and
the next sample can be programmed.
Return to step 4.
the Profile Select key is touched the Easy 2 screen is displayed.
Go to Procedure 2, step 4.
TG218-33.p65 23 07.10.2003, 11:51

Procedure 2 - Programming Easy Mode 2 Samples (Profile Selections)

Home screen.
2. Touch on the Home screen to

display the Easy 2 screen. PROF-A PROF-B PROF-C PROF-D
3. Load the sample onto the sample disk in Del. O?K
Start
the position specified in the Position Accept. Stop P.Up
field.
4. Touch on the Easy 2 screen to enter
a sample ID number (optional).
5. Enter the sample ID number in the Sample ID field, then touch

(optional).
6. Touch P.Up to return to the Easy 2
screen. PROF-A PROF-B PROF-C PROF-D
Del. O?K
Start
Accept. Stop P.Up
7. Touch the individual profile keys to select the profiles for this sample.
TG218-33.p65 24 07.10.2003, 11:51

If... then...
only profiles are to be touch Accept. . The Position and S.No fields
assayed on this increment to the next available sample disk position
sample and sequence number. The next sample can be
programmed and loaded. To initiate the sample run,
go to step 8. To program additional samples, return
to step 3.
profiles and tests are to touch to display the Easy 3 screen. Go to

be assayed on this step Procedure 3, step 5.
sample
8. To initiate a sample run without calibrators, controls, or serum indices,

touch Start . To initiate a sample run including calibrators, controls and/
or serum indices, go to Procedure 4.
Procedure 3 - Programming Easy Mode 3 Samples (Test Selections)

Home screen.
2. Touch on the Home screen to

display the Easy 3 screen.
3. Load the first sample onto the sample

disk in the position specified in the
Position field.
4. Touch to enter a sample ID number
on the Easy 3 screen (optional).
5. Enter the sample ID number in the Sample ID field, then touch

(optional).
TG218-33.p65 25 07.10.2003, 11:51

6. Touch P.Up to return to the Easy 3

screen.
7. Touch Accept. to register all tests for the
sample.
8. The Position and S.No fields increment to the next available sample
disk position and sequence number. The next sample can be pro-
grammed. Repeat steps 3 through 7 until all sample information has been
entered.
9. To initiate a sample run without calibrators, controls, or serum indices,
touch Start . To initiate a sample run including calibrators, controls and/
or serum indices, go to Procedure 4.
Procedure 4 - Initiating an Easy Mode 2 or 3 Sample Run from Start

Conditions
1. Touch on the Easy 2 or Easy 3
screen to display the Start Condition
screen.
2. Touch Calibration , Control , and/or
or serum indices to be run. Selected keys
appear highlighted in blue.

4. Touch , , or
to select these options. Selected keys
appear highlighted blue.
• Cal. Print must be highlighted to obtain a Calibration Report.

n • Realtime Print must be highlighted for routine, STAT and control results to be printed
realtime.
• Host Com. must be highlighted for results to be automatically uploaded to the host.
TG218-33.p65 26 07.10.2003, 11:51

5. Touch to check for alarms on the

to the User’s Guide for troubleshooting
instructions.

7. Touch P.Up to return to the Easy 2 or 3 screen.

Del. O?K
Start
Accept. Stop P.Up

the sample disk.
Refer to the How to... section in the Tutorial Guide for detailed instructions on assigning
Start
9. Touch to initiate the sample run.
TG218-33.p65 27 07.10.2003, 11:51

2.9 Programming STAT Samples
Introduction
STAT samples can be loaded into reserved positions on the sample disk. STAT
tests are processed with priority and results are printed upon completion of
analysis. Refer to the How to... section in the Tutorial Guide for instructions on
reserving sample disk positions for STAT samples.
Procedure
1. Touch on the Easy 2, Easy 3 or
Batch Mode screen.
Easy 1 does not have a STAT option.
n
2. Load the STAT sample onto the sample
disk in the position indicated in the
Position field.
3. Enter the patient ID in the Sample ID field, then touch (optional).
4. Touch or to display the Profile Selection or Test

Selection screen.
[Profile Selection]
Accept.
P.Up
5. Touch the profile or test keys to be analyzed.

6. Touch Accept. to register the profiles/
tests. The STAT Test Selection screen is
displayed. The Position field incre-
ments to the next available STAT posi-
tion.
7. Registered STAT samples are processed with priority.

8. Repeat procedure to program multiple STAT samples.
If the analyzer is in Sample Stop or STAND-BY, you must touch Start to process the STAT
n sample. Touch P.Up to return to the Easy Mode 2, Easy Mode 3, or Batch Mode screen, then
touch Start to initiate analysis.
TG218-33.p65 28 07.10.2003, 11:51

2.10 Data Management
Introduction
Results can be reviewed, deleted, printed, and archived.
The format for printing of results depends on the status of the Realtime Print key
on the Start Condition screen. When this key is highlighted, routine, STAT, and
control results print realtime.
Routine, STAT and control results can be printed in STAND-BY, uploaded to the
host, and deleted as explained in the following procedures. Routine and STAT
results can also be saved as ASCII text on a floppy disk and viewed on the
analyzer screen.
Procedure-Printing Results in STAND-BY

Home screen.
2. Touch Monitor on the Home screen.
3. Touch Routine Samples for routine results, touch

Control Samples for control results, or touch
STAT Samples for STAT results.
4. Touch to display the Print

Result screen.
sample to print, then touch .
6. Enter the sequence number of the last
sample to print, then touch .
TG218-33.p65 29 07.10.2003, 11:51

7. Touch Start to initiate printing.
8. Touch P.Up two times to display the Monitor screen.

9. Repeat steps 3 through 8 to print each report: Routine, STAT, and Control.
Procedure-Uploading Results to the Host

To upload results to the host realtime, touch and highlight on the second page of the
n
Host Com.
Start Condition screen.

Home screen.

4. Touch to display the Send

Result screen.
sample to be uploaded, then touch .
sample to be uploaded, then touch .
7. Touch Start to initiate uploading.
TG218-33.p65 30 07.10.2003, 11:51


9. Repeat steps 3 through 8 to upload all information: Routine, STAT, and
Control.
Procedure-Displaying Results
Home screen.
3. Touch Routine Samples for patient results or

touch STAT Samples for STAT results.
4. Touch to display the Display

Result screen.
sample to be displayed in the First No
field, then touch .
6. The results of the first sample are dis-
played. To scroll through the results for
this sample, touch or .
7. Touch to move to the next sample or enter the sequence number of

the next sample you want to view, then touch .

9. Repeat steps 3 through 8 to display all information: Routine and STAT.
TG218-33.p65 31 07.10.2003, 11:51

Procedure-Saving Results as ASCII Text

Home screen.
3. Touch Routine Samples for routine results or

touch STAT Samples for STAT results.
4. Touch to display the ASCII

Result screen.
sample to be saved in the First No
field, then touch .
sample to be saved in the Last No field,
then touch .
7. Place the data disk in drive 1 and place a target formatted disk in drive 2.
8. Touch Start to save the results in ASCII format.

10. Repeat steps 3 through 9 to save all information: Routine and STAT.
TG218-33.p65 32 07.10.2003, 11:51

Procedure-Deleting Results
Home screen.

4. Touch to display the Delete

Result screen.
sample to be deleted in the First No
field, then touch .
sample to be deleted in the Last No
field, then touch .
Control results are deleted by level, (1-5), rather than sequence number.
n 7. Touch Start to deleted the results, then touch Start to confirm the
deletion of results.
9. Repeat steps 3 through 8 to delete other information: Routine, STAT, or
Control.
TG218-33.p65 33 07.10.2003, 11:51

2.11 End of the Day Maintenance
Wash
These procedures should be performed at the conclusion of the daily run. The
following analyzer parts are cleaned: reaction cells, sample probe, reagent probe,
rinse unit nozzles, and stirrer.
Procedure-Wash Cells
1. Place a sample cup containing 1 ml of System Cleaning Solution (Multiclean)
in the “W1” position on the inner ring of the sample disk.
2. Place System Cleaning Solution (Multiclean)/1% Hitergent in a 50 ml bottle in
position 39 of the reagent disk.
4. Touch Wash .
5. Touch Mode to select Cells.
6. Touch Start to execute the wash.
7. Touch Status to display the Status screen. When the procedure is com-
8. Touch P.Up to return to the Wash screen.
Procedure-Wash ISE
1. If ISE tests were run, place 1 ml of 4 N NaOH/System Cleaning Solution (ISE
Cleaning Solution) in position W2 of the sample disk.
3. Touch Wash .
4. Touch Mode to select ISE.
5. Touch Start to initiate the wash.
6. Touch Status to display the Status screen. When the procedure is com-
7. Touch P.Up to return to the Wash screen.
TG234-40.p65 34 07.10.2003, 11:58

If... then...
the analyzer is idle for four perform an ISE calibration and
hours or more after the run controls.
ISE Wash is performed
the analyzer is NOT idle for go to step 8.
four hours or more after the
8. Run 5 cups of serum pool or quality control material, then perform an ISE
calibration and run controls.
9. If the calibration results and/or control results are not acceptable, repeat
step 8.
ISE patient samples and ISE calibration must not be performed prior to completing step 8.
n
TG234-40.p65 35 07.10.2003, 11:58

Clean Instrument Surfaces

Use a cloth or paper towel moistened with 2% Hitergent or 10% bleach solution to
clean spills from the surface of the analyzer.
Do not use alcohol to clean the instrument surfaces as alcohol may damage the finish.
Clean/Adjust Sample and Reagent Probes and Stirrer

Clean and adjust the sample probe, reagent probe and stirring paddle once a day
to remove residue. After cleaning the probes and paddle, verify their alignment.
Probe and Stirrer Cleaning Procedure
1. Turn the analyzer power off.
2. Move the sample probe forward.
3. Place a paper towel between the
probe tip and analyzer surface.
Moisten a small gauze square with
ethanol or isopropyl alcohol and wipe
the probe from top to bottom in a
downward motion, the entire length of
the probe.
Clean probe
• Do not touch the probe tip with your hands.

• Do not place an alcohol pad on the surface of the analyzer as it may damage the finish.
• Use a new gauze pad for each probe to prevent cross contamination.
• Verify the probe has maintained its correct horizontal adjustment after cleaning. If
necessary, readjust the probe to the center of the reaction cell.
4. Move the probe into the home position over the rinse bath.
5. Repeat the steps for the other probe and the stirrer.
TG234-40.p65 36 07.10.2003, 11:58

Sample Probe Alignment Procedure

1. Turn analyzer power on.
2. Touch from the Home screen.
3. Touch .
4. Touch to select S. Probe (Horiz./Vert.).
5. Touch to initiate the sample

probe adjustment. The probe moves
over the reaction cells. Check the
sample probe for correct alignment
over the cells. The probe tip must be
placed over the reaction cells, as
shown.
Sample probe alignment
Do not bend the probe sharply. This can crimp the probe, thereby requiring replacement.
The correct alignment of all probes is critical for proper functioning of the analyzer. Failure
to align each probe can result in damage to the analyzer and/or incorrect test results.
6. While firmly supporting the probe arm, gently bend the probe over its entire
length in an arc to center its tip over the reaction cell beneath it.
7. Initiate the horizontal/vertical adjustment using the table below. Check
sample probe alignment at each position. Touch to interrupt probe
adjustment.
Step Action
Touch . Sample probe moves to reaction cell.
Touch . Sample probe moves to sample disk, position 1.
Touch . Sample probe moves to home position.
TG234-40.p65 37 07.10.2003, 11:58

Reagent Probe Alignment Procedure

2. Touch .
3. Touch to select R Probe (Horiz.).
4. Touch to initiate the reagent

reagent probe for correct alignment
centered over the reaction cells, as
shown.
Reagent probe alignment
6. Initiate the horizontal adjustment using the table below. Check reagent
probe alignment at each position. Touch to interrupt probe adjust-
ment.
Step Action
Touch . Reagent probe moves to reaction cell.
Touch . Reagent probe moves to rinse bath.
Touch . Reagent probe moves to reagent disk, position 1.
Touch . Reagent probe moves to home position.
TG234-40.p65 38 07.10.2003, 11:58

Stirrer Alignment Procedure

1. From the Home screen, touch .
2. Touch .
3. Touch to select Stirrer.
4. Touch to initiate the stirrer adjustment. The stirrer moves over a

reaction cell on the reaction disk.
5. Visually confirm that the stirring
paddle is centered over the reaction
cell, as shown. If the stirring paddle is
not centered over the reaction cell,
contact Technical Support.
6. Verify that the tip of the stirring
paddle is 6 mm from the top of the
reaction cell.
Stirrer alignment
6. Touch to end the adjustment. The stirrer moves to the home

position.
TG234-40.p65 39 07.10.2003, 11:58

NOTES
TG234-40.p65 40 07.10.2003, 11:58

Chapter 3
How to....
TG3S1-16.p65 1 07.10.2003, 12:05

3.1 How to Program Parameters for Photometric Chemistries
Introduction
Use the following procedure to program parameters for new photometric chemistries
or update parameters for current photometric chemistries.
In this menu, the scroll arrows and down arrow function as follows:
Touch When the cursor is in the Channel No field, the Channel No

scrolls to the next channel while Parameter No remains un-
changed. When the cursor is in the Parameter No field, Param-
eter No scrolls to the next parameter while Channel No remains
unchanged.

scrolls to the previous channel while Parameter No remains
unchanged. When the cursor is in the Parameter No field,
Parameter No scrolls to the previous parameter while Channel No
remains unchanged.
Touch Move the cursor from field to field: Channel No, Parameter
No, Contents.
Procedure
Home screen.
3. Touch on the Parameters

screen.
TG3S1-16.p65 2 07.10.2003, 12:05

4. Enter the channel number, <1-36>, for the test in the Channel No field,
then touch .
5. Enter the parameter number, <1-58>, for the parameter to be added or
updated in the Parameter No field, then touch . Use the table below and
on the following pages to identify the parameter fields.
6. Enter the parameter information in the Contents field, then touch .
Parameters marked by an asterisk on the table below are entered by touching Select
n instead of by manual entry in the Contents field. It is not necessary to touch
is used.
when Select
7. When all parameter entries are complete, save the changes to the param-
eter disk. Touch on the Home screen. Touch Parameters , then
touch Mode to select “Write.” Touch Start to save the changes to the
parameter disk.
For more details on the Test Parameters menu, refer to the Software Guide. For specific
n chemistry information, refer to the manufacturer’s specifications.
Parameter Number Parameter Name

1 Test Name
2 Assay Code (Mthd)*
3 Assay Code (Test)
4 Reaction Time*
5 Assay Point 1
6 Assay Point 2
7 Assay Point 3
8 Assay Point 4
9 Wavelength (Sub)*
10 Wavelength (Main)*
11 Sample Volume
12 R1 Volume
13 R1 Position
TG3S1-16.p65 3 07.10.2003, 12:05


14 R1 Bottle Size*
15 R2 Volume
16 R2 Position
17 R2 Bottle Size*
18 R3 Volume
19 R3 Position
20 R3 Bottle Size*
21 Calibration Type (Type)*
22 Calibration Type (Wght)
23 Calibrator 1 Concentration
24 Calibrator 1 Position
35 S1 ABS.
36 K Factor
37 K2 Factor
38 K3 Factor
39 K4 Factor
40 K5 Factor
TG3S1-16.p65 4 07.10.2003, 12:05


41 A Factor
42 B Factor
43 C Factor
44 SD Limit
45 Duplicate Limit
46 Sensitivity Limit
47 S1 ABS Limit (Low)
48 S1 ABS Limit (High)
49 ABS Limit
50 ABS Limit (Decrease/Increase)*
51 Prozone Limit
52 Prozone Limit (Upper/Lower)*
53 Prozone Limit (Endpoint)*
54 Expected Value (Low)
55 Expect Value (High)
56 Instrument Factor a
57 Instrument Factor b
58 Key Setting/Assignment
A list similar to the table above may be printed with the System Parameters report using the
n Maintenance/Parameters screen. See “How to Program System Parameters” in the How to...
section of the Tutorial Guide.
TG3S1-16.p65 5 07.10.2003, 12:05

3.2 How to Program Parameters for ISEs
Introduction
Use the following procedure to program parameters for ISEs.
In this menu, the scroll arrows and down arrow function as follows:

scrolls to the next channel while Parameter No remains un-
changed. When the cursor is in the Parameter No field, Param-
eter No scrolls to the next parameter while Channel No remains
unchanged.

scrolls to the previous channel while Parameter No remains
unchanged. When the cursor is in the Parameter No field,
Parameter No scrolls to the previous parameter while Channel No
remains unchanged.
Touch Move the cursor from field to field: Channel No, Parameter
No, Contents.
Procedure
Home screen.
3. Touch ISE Test on the Parameters [ISE Tests] 7 8 9

screen. Channel No : <38-4Ø > 4 5 6
Contents : 0 . -
C
P.Up
TG3S1-16.p65 6 07.10.2003, 12:05

3.2 How to Program Parameters for ISEs
4. Enter the channel number, <38-40>, for the test in the Channel No field,
then touch .
Channel 38 Na+
Channel 39 K +
Channel 40 Cl-
5. Enter the parameter number, <1-11>, for the parameter to be added or

updated in the Parameter No field, then touch . Use the table below
to identify the parameter fields.
6. Enter the parameter information in the Contents field, then touch .

7. When all parameter entries are complete, save the changes to the param-
eter disk. Touch on the Home screen. Touch Parameters , then
touch Select to select “Write.” Touch Start to save the changes to the
parameter disk.
For more details on the ISE Test menu, refer to the Software Guide. For specific chemistry
n information, refer to the manufacturer’s specifications.

1 Low Concentration
2 High Concentration
3 Calibrator Concentration
4 Reference Solution Volume
5 Low Expected Value
6 High Expected Value
7 Instrument Factor a
8 Instrument Factor b
9 Compensation Tolerance Range
10 Compensation Value
11 Key Setting/Assignment
A list similar to the table above may be printed with the System Parameters report using the
n Maintenance/Parameters screen. See “How to Program System Parameters” in this guide.
TG3S1-16.p65 7 07.10.2003, 12:05

3.3 How to Print Chemistry Parameters
Introduction
Use the following procedure to print parameters for photometric and ISE chemis-
tries.
Procedure
Home screen.
3. Touch Parameters on the Maint screen.
4. Touch Mode to select Print.

5. Enter the channel number of the first chemistry to print in the First No field,
then touch .
6. Enter the channel number of the last chemistry to print in the Last No field,
then touch .
7. Touch Start to print the Chemistry Parameters report for the chemistries in
the selected channel number range.
TG3S1-16.p65 8 07.10.2003, 12:05

3.4 How to Assign Control Positions
Introduction
Use the following procedure to designate control positions on the sample disk.
Procedure
Home screen.
3. Touch on the Parameters screen.

4. Enter the control number in the
Control No field, <1-5>, then touch .
5. Enter the sample disk position number,
<36-57>, in the Position No field then
touch .
Do not assign 55-57 as control positions if the ISE option is enabled. These are reserved for ISE
calibrators when the ISE option is enabled.
6. Repeat steps 4 and 5 for all control levels.
If... then...
no further parameter save the changes now. Touch
updates are required on the Home screen. Touch Parameters , then
touch Mode two times to select “Write.” Touch
Start to save the changes to the parameter FD.
calibrator updates go to the next section.
are required
TG3S1-16.p65 9 17.10.2003, 08:36

3.5 How to Update Photometric Calibrator Values
Introduction
Use this procedure when using new lots of calibrator material.
Procedure
Home screen.
3. Touch Test Param . on the Parameters

screen.
4. Enter the channel number <1-36> of the test affected by the new calibrator
lot in the Channel No field, then touch . The cursor advances to the
Parameter No field.
Calibrator information is contained in parameters 23-34. Odd numbered parameters in this

n series contain calibrator concentrations. Even numbered parameters in this series contain
calibrator position numbers on the sample disk.
TG3S1-16.p65 10 07.10.2003, 12:05

3.5 How to Update Photometric Calibrator Values
5. Enter the parameter number corresponding to the calibrator concentration or

calibrator position to be updated in the Parameter No field, then touch
. (See table below.)
Calibrator No. Concentration Position

Parameter No. Parameter No.
1 23 24
2 25 26
3 27 28
4 29 30
5 31 32
6 33 34
6. Enter the calibrator concentration or position, then press . The cursor

moves to the Parameter No field.
If... then...
editing another calibrator repeat steps 5 and 6.
concentration or position
for this same test
editing the calibrator press two times to move the cursor to

concentration or position Channel No field and repeat steps 4-6.
field for another test
7. If no other parameter changes are required, save the changes now. Touch
on the Home screen. Touch Parameters , then touch Mode two
times to select “Write.” Touch Start to save the changes to the parameter
disk.
TG3S1-16.p65 11 07.10.2003, 12:05

3.6 How to Update ISE Calibrator Values
Introduction
Use this procedure when using new lots of ISE calibrator material. ISE calibrators
are loaded in the following sample disk positions: 55 - low standard, 56 - high
standard, and 57 - serum-based calibrator.
Procedure
Home screen.
3. Touch on the Parameters [ISE Tests] 7 8 9

4. Enter channel number in the Channel No Contents : 0 . -
field, <38-40>, then touch . The cursor C
P.Up
advances to the Parameter No field.
See table below.
Channel Number ISE

38 Na+
39 K+
40 Cl-
TG3S1-16.p65 12 07.10.2003, 12:06

3.6 How to Update ISE Calibrator Values
5. Enter the parameter number corresponding to the calibrator concentration to

be updated in the Parameter No field, then touch . See table below.
Parameter Number Concentration

1 Low
2 High
3 Calibrator
6. Enter the calibrator concentration, then touch . The cursor moves to the
Parameter No field.
If... then...
editing another calibrator repeat steps 4 and 5.

concentration for this same test
editing this calibrator touch two times to move the cursor
concentration field for another to the Channel No field. Enter the
test channel number of another ISE test and
repeat steps 3-5 to change the
calibration concentration.
on the Home screen. Touch , then touch two
times to select “Write.” Touch to save the changes to the parameter
disk.
TG3S1-16.p65 13 07.10.2003, 12:06

3.7 How to Program Special Washes
Introduction
Use these procedures to program any special wash functions recommended by the
reagent manufacturer.
Procedure
Home screen.

screen.
Reagent Probe Wash

1. Touch on the Carry Over
Evasion screen.
2. Touch on the Carry Over Evasion screen to select the

reagent probe list number.
3. Touch to select the test name of the causal test.
4. Touch to select the appropriate reagent type.
5. Touch to select the test name of the affected test.
TG3S1-16.p65 14 07.10.2003, 12:06

6. Touch to select the appropriate

reagent type.
7. Touch to select the detergent
position.
8. Touch to select the detergent volume.
9. Touch to enable or disable the evasion program.
10. Touch to save the changes to system memory.

disk.
Reaction Cell Wash

Evasion screen.
Evasion screen to select the reaction cell
list number.
3. Touch to select the test name.
4. Touch to select the detergent position.
5. Touch to select the detergent volume.

disk.
TG3S1-16.p65 15 07.10.2003, 12:06

Sample Probe Wash

Evasion screen.
Evasion screen to select the sample
probe list number.
3. Touch to select the test name.
4. Touch to select the detergent position.

disk.
TG3S1-16.p65 16 07.10.2003, 12:06

3.8 How to Program Calculated Tests
Introduction
Calculated test results are derived from applying a calculated test formula to the
results of tests performed on the analyzer. Use the following procedure to pro-
gram a calculated test.
Procedure
Home screen.
3. Touch Calc.Test on the Parameters

screen.
Calc.
4. Touch Test on the Calc. Test
screen.
5. Enter the test number of the calculated
test, <44-51>, in Calc. No field, then
touch .
6. Enter the parameter number, <1-8>, in
the Parameter No field, then touch .
In contrast to ordinary test results, calculated test results are not stored by the analyzer.
n Instead, the results are recalculated each time they are viewed, reprinted, or resent to the host
computer. Therefore, it is important to remember that the results reflect the calculated test
equation in effect at the time they are calculated. This equation may be different from the one in
effect when the calculated test result was originally created. Please ensure that the appropriate
calculation factors are being used when the test results are “retrieved” from memory.
TG317-29.p65 17 07.10.2003, 12:24

3.8 How to Program Calculated Tests
7. Enter the settings for the parameters according to the table below, then
touch .
For more details on the calculated test parameters, refer to the Software Guide.
n
Parameter Number Parameter Name Description
1 Test Name Touch alpha keys to enter
calculated test name, maximum
of 5 characters.
2 Formula Touch Sel. to select the

method for calculation, then
touch twice to move the
Parameter No field.
3 Test A Enter the channel number of the
formula.
4 Test B Enter the channel number of the
test that corresponds to B in the
formula.
5 Coefficient a Coefficient a in the formula
6 Coefficient b Coefficient b in the formula.
7 Lower Expected Value Lower limit of expected value
range.
8 Upper Expected Value Upper limit of expected value
range.
8. Repeat steps 6-7 until all parameters have been entered.

9. Touch to return to the Calc. No field.
10. Touch P.Up or to display the Home screen.

11. Assign a print order to the calculated test using the procedure “3.11 How
to Assign a Print Order” in this guide.
12. If no other changes are required, save the changes now. Touch
on the Home screen. Touch Parameters , then touch Mode two times to
select “Write.” Touch Start to save the changes to the parameter disk.
TG317-29.p65 18 07.10.2003, 12:24

3.9 How to Program Compensated Tests
Introduction
Test results can be adjusted by applying a compensated test formula. Use the
following procedure to program a compensated test.
Procedure
Home screen.
3. Touch Calc.Test on the Parameters

screen.
Comp.
4. Touch Test on the Calc. Test
screen.
5. Enter the test number of the compen-
sated test, <1-8>, in the Comp. No field,
then touch .
6. Enter the parameter number, <1-6>, in
the Parameter No field, then touch .
TG317-29.p65 19 07.10.2003, 12:24

3.9 How to Program Compensated Tests
7. Enter the settings for the first parameters according to the table below,
then touch .
For more details on the compensated test parameters, refer to the Software Guide.
n
Parameter Number Parameter Name Description
1 Channel Number Enter the channel number of
the test to be compensated.
2 Formula Touch Sel. to select the

method for compensation,
then touch twice to move
the Parameter No field.
3 Test A Enter the channel number of
the test that corresponds to A
in the formula. If no test is
chosen, the function is dis-
abled.
4 Test B Enter the channel number of
the test that corresponds to B
in the formula.
5 Coefficient a Coefficient a in the formula
6 Coefficient b Coefficient b in the formula.
8. Repeat steps 6-7 until all parameters have been entered.

9. Touch to return to the Comp. No field.
TG317-29.p65 20 07.10.2003, 12:24

3.10 How to Define Profiles
Introduction
Use the following procedure to define profiles.
Procedure
Home screen.

screen.
If... then...
you are assigning profile order go to step 4.
you are assigning profile contents go to step 7.
4. Touch Key Label on the Profile screen.

5. Touch the numerical keys, <1-11>, on the
Key Label screen to scroll through the
available profiles and assign a key order
for the Profile Selection screen. For a
complete list of available profiles, refer to
the Software Guide.
The profile assigned to key label 1 is the default profile that appears on the Easy 1 screen.
n
TG317-29.p65 21 07.10.2003, 12:24

3.10 How to Define Profiles
6. Touch P.Up to return to the Profile

screen.
7. Touch to select the appropriate
profile.
8. Touch the individual test keys to
assign tests to the selected profile.
Selected tests appear highlighted in
blue.
Touch or to scroll through the complete test menu.
n
9. When all tests have been selected, touch Accept. to save the profile to the
system memory.
10 Repeat steps 7-9 to establish each profile.
TG317-29.p65 22 07.10.2003, 12:24

3.11 How to Assign Print Order
Introduction
Use the following procedures to assign a print order and obtain a print order list.
Procedure-Assigning Print Order

Home screen.

screen.
4. Enter the channel number, <1-51>, of the
assigned test in the Channel No field,
then touch .
5. Enter the line number, <0, 8-60>, of the
result in the Print Order field, then
touch .
No results print when “0” is entered in the Print Order field.
n
6. The print order assignments are displayed below the Print Order field
in the following format:
1: Channel Number BICAR: Test Name 8: Print Line
To scroll through the entire menu, touch or .

on the Home screen. Touch Parameters , then touch Mode to select
“Write.” Touch Start to save the changes to the parameter disk.
TG317-29.p65 23 07.10.2003, 12:24

3.11 How to Assign Print Order
Procedure-Printing a Print Order List

Home screen.
3. Touch Parameters on the Maintenance

screen.
4. Touch Mode to select print.
5. Enter 99 in the First No field, then touch .
6. Enter 99 in the Last No field, then touch .
7. Touch Start to print a system parameters report. This report contains a

list of the assigned print order.
TG317-29.p65 24 07.10.2003, 12:24

3.12 How to Change Normal Ranges
Introduction
Normal value ranges are defined in the parameters you receive from the reagent
manufacturer. Use the following steps to change the normal ranges for a chemis-
try. Follow your laboratory procedures for establishing normal ranges.
Procedure-Photometric Normal Ranges

Home screen.
3. Touch Test Param . on the Parameters

screen.
4. Enter the channel number for the test to
be updated in the Channel No field,
then touch .
5. Enter the parameter number, <54>, for the lower expected value param-
eter in the Parameter No field, then touch .
6. Enter the revised low expected value in the Contents field, then touch
.
7. Enter the parameter number, <55>, for the upper expected value param-
eter in the Parameter No field, then touch .
8. Enter the revised upper expected value in the Contents field, then touch
.
To move the cursor to the Channel No field, touch until the cursor appears in the Channel
n No field.
TG317-29.p65 25 07.10.2003, 12:24

Procedure-ISE Normal Ranges

Home screen.
3. Touch ISE Test on the Parameters [ISE Tests] 7 8 9

4. Enter the channel number for the test to
Contents : 0 . -
be updated in the Channel No field,
C
then touch . P.Up
5. Enter the parameter number, <5>, for the lower expected value parameter
in the Parameter No field, then touch .
6. Enter the revised low expected value in the Contents field, then touch
.
7. Enter the parameter number, <6>, for the upper expected value parameter
in the Parameter No field, then touch .
8. Enter the revised upper expected value in the Contents field, then touch
.
TG317-29.p65 26 07.10.2003, 12:24

To move the cursor to the Channel No field, touch until the cursor appears in the Channel
n No field.
TG317-29.p65 27 07.10.2003, 12:24

3.13 How to Manage Floppy Disks
Introduction
Use the following procedures to read and write parameters, format and/or copy
floppy disks. The target disk used in the formatting/copying procedure must be a
double-sided, 3.5 inch, high density, double track, 135 TPI floppy disk.
Procedure-Formatting/Copying a Floppy Disk

Home screen.
3. Touch FD Utilities on the Maintenance

screen.
4. Touch Mode to select Format & Copy.

5. Remove current disks from floppy drives.
6. Insert original disk in drive 1 and target
disk in drive 2.
7. Touch Start .
8. Remove disks when formatting/copying is complete. Insert original disks
into floppy drives.
TG317-29.p65 28 07.10.2003, 12:24

3.13 How to Manage Floppy Disks
Procedure-Reading/Writing Parameters
Home screen.

screen.
4. Touch Mode to select Read to read
parameters from the parameter disk.
5. Insert the parameter disk containing the
parameters into the disk drive 1, then
touch Start .
OR
6. Touch Mode to select Write to write
parameters to the parameter disk.
7. Insert a parameter disk into the disk drive
1, then touch Start .
TG317-29.p65 29 07.10.2003, 12:24

3.14 How to Program System Parameters
Introduction
Many system parameter settings on your analyzer can be customized according to
your needs. Your Roche Diagnostics representative programs these settings
according to your specifications during installation. Use the following procedures to
adjust these settings.
Procedure
Home screen.
3. Touch on the Parameters screen

to display the System Parameters screen.
Set Time and Date

1. Touch Date on the System Param-
eters screen.
2. Touch Mode to choose the date format.
3. Enter the year in the Year field, then
touch .
4. Enter the month in the Month field, then touch .
5. Enter the day in the Day field, then touch .
6. Enter the hour in the Hour field, then touch .

7. Enter the minute in the Minute field, then touch .
8. Touch P.Up to return to the System Parameters screen.
9. If no other changes are required, save the changes now. Touch on

the Home screen. Touch Parameters , then touch Mode two times to select
Set Initial Easy Mode Screen

1. Touch Init.Screen on the System Param-
eters screen.
2. Touch Mode to select the Easy Mode
screen to appear when Easy Mode is
touched on the Home screen during
normal operation.

Turn ISE System or Barcode Reader On or Off

1. Touch Options on the System Param-
eters screen.
2. Touch ISE to enable or disable the ISE
system.
3. Touch to enable or disable the
barcode reader.
4. Touch P.Up to return to the System
Parameters screen.

Define STAT Reserve Positions

1. Touch STAT Pos . on the System Param-
eters screen.
2. Enter the position number for first re-
served STAT position, <0, 2-35>, in the
First No field, then touch . The last
reserved position in the range is 35. An
entry of “0” reserves no STAT positions.

Define Original ABS Printing

1. Touch on the System
Parameters screen.
2. Touch Mode on the Original ABS screen
to enable or disable printing of the
absorbance reading for results.
Parameters screen.
Program Check Digits for Barcode Reader

This screen is not accessible when the ISE option is disabled
n
Parameters screen.
2. Determine the type of barcodes you
are using (NW-7, CODE-39, or ITF).
3. Touch the NW-7, CODE-39, or ITF key
to select the appropriate digit check-
ing for your barcode type.


Define Linearity Limits

Parameters screen.
2. Enter the limit <0, 1-100> for the Lin.8
linearity flag in the Linear Check
(4-8) field, then touch .
3. Enter the limit <0, 1-100> for the Lin. linearity flag in the Linear Check
(9- ) field, then touch .


Define Host Communication Settings

1. Touch Com.Param. on the System Param-
eters screen.
2. Use the information in the RD/Hitachi 902
Host Interface Document to verify your
host communications settings are correct.
Before changing any settings, ensure the change
will not interfere with your host communication.
3. To change the settings touch the respec-

tive keys of the host parameters listed on
the screens, as shown, until the revised
settings appear.
Touch or to scroll from screen to screen.

n
Parameters screen.
[Com. Parameters] Status
STAT Inquiry :Disable
P.Up


Print a System Parameters List

Home screen.

screen.
4. Touch Mode to select print.
5. Enter 99 in the First No field, then touch .
6. Enter 99 in the Last No field, then touch .
7. Touch Start to print a system parameters report. This report contains a list
of all system parameters.

NOTES

User's Guide
Roche Diagnostics/Hitachi 902 Analyzer User’s Guide V1.2 UG - 1

Copyrights
Trademarks
Publisher
Sandhoferstr. 116
D-68305 Mannheim
Phone: +49 621 759 4445
Manual Version 1.2

Version 1.2 Sept, 2003 UG-2 to UG-4, 1-19, 3-6, 3-8, 4-7,
4-15, 4-16, 4-18, 4-20, 4-21, 4-26,
4-28, 4-29, 4-32, 4-35, 4-39 bis 4-41,
4-46, 4-50, 4-55 bis 4-58, 4-60,
4-64, 4-65, 4-71, 4-73 bis 4-75,
4-83, 4-84, 4-94
UG - 2 Roche Diagnostics/Hitachi 902 Analyzer User’s Guide V1.2

Intended use
the system.
C ® US
Contact addresses
Manufacturer


D-68305 Mannheim
Germany
Roche Diagnostics/Hitachi 902 Analyzer User’s Guide V1.2 UG - 3

NOTES
UG - 4 Roche Diagnostics/Hitachi 902 Analyzer User’s Guide V1.2

Table of Contents
Chapter 1 - General Troubleshooting
1.1 Troubleshooting Procedures ____________________________ 1-2

Introduction ____________________________________________________ 1-2
1.2 Troubleshooting at Power Up ____________________________ 1-3

Introduction ____________________________________________________ 1-3
Troubleshooting Instrument Power Up ______________________________ 1-3
1.3 Chemistry Troubleshooting ______________________________ 1-4

Introduction ____________________________________________________ 1-4
Check Preparation of Reagents, Calibrators, Controls ________________ 1-5
High Test Results _______________________________________________ 1-6
Low Test Results _______________________________________________ 1-7
Erratic Test Results _____________________________________________ 1-8
Single Sample or Control _________________________________________ 1-9
Single Chemistry ________________________________________________ 1-10
All Chemistries with More Than One Set Point _______________________ 1-11
Multiple Chemistries, Photometrics Only ___________________________ 1-11
All Chemistries, Including ISEs ____________________________________ 1-12
Chemistries with One Set Point ___________________________________ 1-13
ISE, All Results Are Erratic, Excessive Air in Sipper Syringe ___________ 1-13
ISE, Results Are Erratic __________________________________________ 1-14
ISE, High Internal Standard Values ________________________________ 1-15
ISE, High Sodium or Low Chloride Values __________________________ 1-16
Low ISE Values _________________________________________________ 1-16
Biased Enzymes ________________________________________________ 1-18
1.4 Instrument Troubleshooting _____________________________ 1-19

General Considerations __________________________________________ 1-19
General Mechanical Problem Isolation _____________________________ 1-19
Types of Alarms ________________________________________________ 1-19
Chapter 2 - Data Alarms
2.1 Data Alarms ____________________________________________ 2-2
Roche Diagnostics/Hitachi 902 Analyzer User’s Guide V1.2 i

Chapter 3 - Instrument Alarms
3.1 Instrument Alarms ______________________________________ 3-2
Chapter 4 - Maintenance
4.1 Maintenance Overview __________________________________ 4-2

Introduction ____________________________________________________ 4-2
Required Cleaning Solutions ______________________________________ 4-2
4.2 Tracking Maintenance ___________________________________ 4-4

Recommended Scheduled Maintenance ___________________________ 4-4
4.3 Scheduled Maintenance _________________________________ 4-5

Structure of the Procedures ______________________________________ 4-5
Spare Parts ____________________________________________________ 4-5
4.4 Pre-operational Procedures _____________________________ 4-6

Check Hitergent Supply __________________________________________ 4-6
Check Waste Solution Reservoir __________________________________ 4-7
Check Multiclean _______________________________________________ 4-8
Check Printer Paper _____________________________________________ 4-8
Check Disk Drives ______________________________________________ 4-8
Check Water Supply ____________________________________________ 4-9
4.5 Incubation Water Exchange ______________________________ 4-10

Introduction ____________________________________________________ 4-10
Procedure _____________________________________________________ 4-10
4.6 Photometer Check ______________________________________ 4-11

Introduction ____________________________________________________ 4-11
Procedure _____________________________________________________ 4-11
4.7 Wash Cells/Wash ISE ___________________________________ 4-12

Introduction ____________________________________________________ 4-12
Procedure-Wash Cells ___________________________________________ 4-12
Procedure-Wash ISE ____________________________________________ 4-13
4.8 ISE Prime ______________________________________________ 4-14

Introduction ____________________________________________________ 4-14
Procedure _____________________________________________________ 4-14
ii Roche Diagnostics/Hitachi 902 Analyzer User’s Guide V1.2

4.9 Clean/Adjust Sample and Reagent Probes and Stirrer ______ 4-15
Introduction ____________________________________________________ 4-15
Probe and Stirrer Cleaning Procedure ______________________________ 4-15
Sample Probe Alignment Procedure _______________________________ 4-16
Reagent Probe Alignment Procedure _______________________________ 4-18
Stirrer Alignment Procedure _______________________________________ 4-19
4.10 Clean Instrument Surfaces ______________________________ 4-20

Introduction ____________________________________________________ 4-20
Procedure _____________________________________________________ 4-20
4.11 Read/Record Incubation Bath Temperature ______________ 4-21

Introduction ____________________________________________________ 4-21
Procedure _____________________________________________________ 4-21
4.12 Weekly Wash Cells _____________________________________ 4-22

Introduction ____________________________________________________ 4-22
Procedure _____________________________________________________ 4-22
4.13 Execute Cell Blank _____________________________________ 4-23

Introduction ____________________________________________________ 4-23
Procedure _____________________________________________________ 4-23
4.14 Clean Cell Rinse Unit Nozzles ___________________________ 4-24

Introduction ____________________________________________________ 4-24
Procedure _____________________________________________________ 4-24
4.15 Clean Probe/Stirrer Rinse Baths ________________________ 4-25

Introduction ____________________________________________________ 4-25
Procedure _____________________________________________________ 4-25
4.16 Replace Reaction Cells/Clean Bath and Filter ____________ 4-26

Introduction ____________________________________________________ 4-26
Procedure 1 - Remove Reaction Cells _____________________________ 4-27
Procedure 2 - Clean Photometer Window and Incubation Bath _________ 4-28
Procedure 3 - Clean Reaction Bath Filter ___________________________ 4-29
Procedure 4 - Install New Reaction Cells ___________________________ 4-30
Procedure 5 - Perform Cell Wash __________________________________ 4-31
Procedure 6 - Perform Cell Blank __________________________________ 4-31
Roche Diagnostics/Hitachi 902 Analyzer User’s Guide V1.2 iii

4.17 Clean Deionized Water Tank ____________________________ 4-32
Introduction ____________________________________________________ 4-32
Procedure _____________________________________________________ 4-32
4.18 Clean Sample and Reagent Disk Compartments __________ 4-35

Introduction ____________________________________________________ 4-35
Procedure 1 - Clean Sample Disk Compartment _____________________ 4-35
Procedure 2 - Clean Reagent Disk Compartment ____________________ 4-37
4.19 Clean ISE Drain Plate ___________________________________ 4-39

Introduction ____________________________________________________ 4-39
Procedure _____________________________________________________ 4-39
4.20 Clean Refrigerator Condenser Filter _____________________ 4-40

Introduction ____________________________________________________ 4-40
Procedure _____________________________________________________ 4-40
4.21 Replace ISE Suction Tubing and Joint Tubing ____________ 4-41
Introduction ____________________________________________________ 4-41
Procedure 1 - Disassemble ISE compartment _______________________ 4-41
Procedure 2 - Replace Suction Tubing _____________________________ 4-43
Procedure 3 - Replace Joint Tubing _______________________________ 4-44
Procedure 4 - Reassemble the ISE Compartment ____________________ 4-45
Procedure 5 -ISE Prime/Calibrate __________________________________ 4-45
4.22 Clean Inlet Water Filters ________________________________ 4-46

Introduction ____________________________________________________ 4-46
Procedure-Clean Water Tank Filter ________________________________ 4-46
4.23 Replace Syringe Seals __________________________________ 4-50

Introduction ____________________________________________________ 4-50
Procedure 1 - Disassemble Syringe _______________________________ 4-51
Procedure 2 - Expose Syringe Seal ________________________________ 4-53
Procedure 3 - Replace Serum Syringe Seals ________________________ 4-54
Procedure 4 - Replace Reagent and SIP Syringe Seals _______________ 4-55
Procedure 5 - Reassemble Syringe ________________________________ 4-57
4.24 Replace ISE Reference Cartridge _______________________ 4-60

Introduction ____________________________________________________ 4-60
Procedure 1 - Remove Old Cartridge ______________________________ 4-60
Procedure 2 - Install New Cartridge ________________________________ 4-62
Procedure 3 - Prime ISE and Calibrate _____________________________ 4-63
iv Roche Diagnostics/Hitachi 902 Analyzer User’s Guide V1.2

4.25 Replace Nozzle Tip of Cell Rinse Unit ____________________ 4-64
Introduction ____________________________________________________ 4-64
Procedure _____________________________________________________ 4-64
4.26 Replace Photometer Lamp _____________________________ 4-65

Introduction ____________________________________________________ 4-65
Procedure 1 - Remove Reaction Disk ______________________________ 4-65
Procedure 2 - Replace Photometer Lamp ___________________________ 4-66
Procedure 3 - Reinstall Reaction Disk ______________________________ 4-70
Procedure 4 - Check Performance/Calibrate ________________________ 4-70
4.27 Replace ISE Measuring Cartridges ______________________ 4-71

Introduction ____________________________________________________ 4-71
Procedure 1 - Remove Old Cartridges _____________________________ 4-72
Procedure 2 - Install New Cartridge ________________________________ 4-73
Procedure 3 -ISE Prime/Calibrate __________________________________ 4-74
4.28 Replace Sample Probe _________________________________ 4-75

Introduction ____________________________________________________ 4-75
Procedure 1 - Remove Sample Probe ______________________________ 4-75
Procedure 2 - Install New Sample Probe ___________________________ 4-81
Procedure 3 - Check/Adjust Probe Alignment _______________________ 4-83
4.29 Replace Reagent Probe ________________________________ 4-84

Introduction ____________________________________________________ 4-84
Procedure 1 - Remove Damaged Reagent Probe ____________________ 4-85
Procedure 2, Install Reagent Probe ________________________________ 4-91
Procedure 3 - Check/Adjust Probe Alignment _______________________ 4-93
4.30 Replace Stirrer Paddle _________________________________ 4-94

Introduction ____________________________________________________ 4-94
Procedure 1 - Replace Stirrer Paddle ______________________________ 4-94
Procedure 2 - Check Stirrer Action _________________________________ 4-95
4.31 Load Printer Paper _____________________________________ 4-96

Introduction ____________________________________________________ 4-96
Procedure _____________________________________________________ 4-96
4.32 Clean Floppy Disk Drives _______________________________ 4-98

Introduction ____________________________________________________ 4-98
Procedure _____________________________________________________ 4-98
Roche Diagnostics/Hitachi 902 Analyzer User’s Guide V1.2 v

Chapter 5 - Spare Parts
5.1 Spare Parts ____________________________________________ 5-2

Overview ______________________________________________________ 5-2
Ordering Information _____________________________________________ 5-2
Sample and Reagent Probes _____________________________________ 5-3
Serum Syringe __________________________________________________ 5-4
Reagent/SIP Syringes ___________________________________________ 5-5
ISE Parts ______________________________________________________ 5-6
Fuses _________________________________________________________ 5-7
Cell Rinse Unit _________________________________________________ 5-8
Miscellaneous Parts _____________________________________________ 5-9
Tools __________________________________________________________ 5-10
Consumables __________________________________________________ 5-11
vi Roche Diagnostics/Hitachi 902 Analyzer User’s Guide V1.2

Chapter 1
General Troubleshooting
Roche Diagnostics/Hitachi 902 Analyzer User’s Guide V1.2 1-1

1.1 Troubleshooting Procedures
Introduction
To identify and isolate problems effectively, you must understand the theory of
operation, operating procedures, emergency procedures and chemistry reaction
descriptions covered in this manual. Follow a sequence of steps to isolate a
problem in one or more of the following areas:
Chemistry problems:
• reagents
• samples, controls or calibrators
• operating error.
Instrument problems:
• electrical/electronic problems
• mechanical problems
• operator error.
Computer problems:
• incorrect parameters, faulty parameter disk, faulty calibrator disk
• faulty system parameter on disk or disk load problems
• operator error.
Facility problems:
• heat
• humidity
• power supply
• water supply
• drain.
The operator’s primary troubleshooting responsibility lies in the following areas that
are detailed in the operator’s manual.
• reagent preparation and storage
• sample preparation
• instrument mechanical alignments and adjustments
• computer parameters and general computer input/output operations
• basic component replacement
• basic operator technique, including computer operation
• maintenance, as outlined in Chapter 4 of this User’s Guide.
The basic operator is not responsible for troubleshooting electrical problems
except as covered in the operator’s manual, and should not attempt removal
of printed circuit boards unless specifically instructed to do so by a
Roche Diagnostics representative.
1-2 Roche Diagnostics/Hitachi 902 Analyzer User’s Guide V1.2

1.2 Troubleshooting at Power Up
Introduction
Conditions that can affect instrument power up are presented in the table below.
To troubleshoot a problem, find the category below that best describes the prob-
lem, and follow the recommended remedy. If all remedies are unsuccessful, call
Customer Technical Support.
Troubleshooting Instrument Power Up
Cause or Description Remedy

PROBLEM: The instrument does not power up.
1. Instrument unplugged. 1. Plug instrument power cord
into socket.
2. Main circuit breaker in OFF 2. Switch main circuit breaker
position. to the ON position.
3. The circuit breaker for the instrument 3. Have your facility electrician
line is in the off position. check the appropriate
circuit breaker.

1.3 Chemistry Troubleshooting
Introduction
Mechanical problems can be identified by visual inspection or when the analyzer
shows an alarm message. A chemistry problem may display a data flag or may
only become evident with an unexpected result.
The following situations require troubleshooting:
• calibration error
• data flag for samples
• quality control sample results outside defined ranges
• patient tests yield unexpected results.
To troubleshoot effectively, eliminate extraneous information and pinpoint the
problem. Using the calibration report, quality control results, or patient results,
decide which of the following conditions apply and perform the checks associated
with them (as outlined in the following sections):
• high test results
• low test results
• erratic test results
• single sample affected—all tests
• single chemistry affected—all samples
• multiple chemistries affected:
-all photometric chemistries
-only photometric chemistries using multiple reagents
-only photometric chemistries using one reagent
-all chemistries including ISEs (Na+, K+, Cl-)
-all chemistries using two calibrators
-only rate chemistries (enzymes and DAUs)
-sporadic errors
-systematic errors.
• only ISE (Na+, K+, Cl-) chemistries affected.

Check Preparation of Reagents, Calibrators, Controls

To identify the cause of high, low, or erratic test results, first verify the preparation
of your reagents, controls and calibrators. Answer the following questions and
review the corresponding sections of the manual.
When preparing reagents, controls and calibrators, always read and follow the
directions provided by the manufacturer.
When preparing reagents:
Has the catalog number changed?
What is the correct preparation procedure?
When does the prepared reagent expire?
When does the reagent lot expire?
Was fresh, bacteria-free, deionized water or the proper diluent used in
reconstitution?
Is the application on board the analyzer?
When reconstituting controls:
Was the control stored properly?
Are the target values correct, especially if the lot number has changed?
Was the correct reconstitution volume used?
When does the reconstituted material expire?
Was a volumetric pipette used to reconstitute?
Was the appropriate diluent used in reconstitution?
When does the control lot expire?
When reconstituting calibrators:
Has the lot number changed?
If the lot number has changed, have calibrator set points been updated in
Test Parameters?
What is the correct reconstitution volume?
What is the recommended storage?
When does the reconstituted material expire?
Was a volumetric pipette used to reconstitute?
Was the appropriate diluent used in reconstitution?
When does the calibrator lot expire?
After verifying the above information, proceed to the next sections, which list
additional causes for high, low, and erratic results.

High Test Results

The following may cause high test results:
1. Incubation bath temperature too high.
• Insert thermometer in the Hitergent addition port. If the bath
temperature does not read 37 ± 0.1 °C, call Technical Support.
2. Poor calibration results.
• Check calibrator preparation.
• Check proper calibration programming. Repeat calibration if
necessary.
3. Calibrators not properly prepared and positioned.
• Check calibrator preparation and position on the sample disk.
Repeat calibration if necessary.
4. Evaporation of sample, calibrator, or control.
• Repeat analysis with fresh sample, calibrator, and/or control.
5. Reagents not properly prepared.
• Check reagent preparation.
6. Incorrect sampling.
• Check correct assembly of sample probe and pipettor parts.
• Check all fittings for leaks.
• Replace O-rings and seals.
7. Insufficient reagent volume.
• Check reagent pipetting system for leaks.
• Check residual reagent volume on Reagent Volume Check report and
reagent volume programming in Test Parameters.
• Replace reagent bottle and repeat analysis.
8. Check Test Parameters, parameter field 11, against manufacturer’s recom-
mendations for correct sample volume.
9. Check Test Parameters, parameter fields 12, 15, 18, to verify the correct
reagent volume is entered according to manufacturer’s recommendations.
10. Check sample probe for barbs.

Low Test Results

The following may cause low test results:
1. Reagents expired.
• Prepare new reagents (see manufacturer’s recommendations for stability
of the prepared reagent).
2. Reagents not properly stored.
• Prepare new reagents (see manufacturer’s recommendations for proper
storage).
3. Reagents not properly prepared.
• Prepare new reagents (see manufacturer’s recommendations for proper
preparation instructions).
4. Incubation bath temperature low.
• Insert a thermometer in the Hitergent addition port. If the bath
temperature does not read 37 ± 0.1 °C, call Technical Support.
5. Calibrators not properly prepared and positioned.
• Check calibrator preparation.
• Check calibrator positions sample disk.
6. Check to ensure that there is sufficient sample in container.
7. Check sample for fibrin clotting.
8. Check sample pipetting system for leaks and air bubbles.
9. Check sample probe for contaminants and obstructions.
10. Check Test Parameters, parameter field 11, against manufacturer’s recom-
mendations for correct sample volume.
11. Check Test Parameters, parameter fields 12, 15, 18, to verifty the correct
reagent volume is entered according to manufacturer’s recommendations.
12. Repeat analysis with appropriate sample volume.
13. Check sample probe for barbs.

Erratic Test Results

The following may cause erratic test results:
1. Fibrin clot in one sample cup or in sample probe (if low values printed for
several samples).
• Check sample for fibrin clot; rerun with additional sample, if
necessary.
• Check sample probe for fibrin; clean probe as outlined in Chapter 4,
Maintenance, of this User’s Guide. Rerun necessary samples.
• Replace sample probe and sample probe seal.
2. Sample probe does not reach the bottom of the reaction cell when dispens-
ing sample.
• Perform mechanism check and verify that the probe reaches the
bottom of the cell.
• Check the spring mechanism to make sure the probe moves up and
down freely.
• Check the sample probe for barbs.
3. Maintenance not performed properly or at recommended frequency on
sample or reagent pipettors or probes.
• Check the operator’s manual and perform all overdue
maintenance functions.
• If maintenance was recently performed on the sample or reagent
probes or pipettors:
Were all parts correctly assembled?
Have all tubings and seals been checked for air leaks?
Were sample and reagent probe seals replaced?
4. Information not correct in Test Parameters.
• Check Test Parameters entries against manufacturer’s
recommendations.
5. Insufficient sample volume.
• Repeat analysis with sufficient sample.

6. Contaminated incubation bath.

• Check for particles in the incubation bath. If particles exist, perform
the incubation cleaning procedure as directed in Chapter 4,
Maintenance, of this User’s Guide.
• Check for foaming, perform incubation bath exchange.
• Check for sufficient Hitergent in position 40 on the reagent disk.
Perform incubation bath exchange.
7. Check for sufficient volumes of detergents, i.e., Hitergent or System Cleaning
Solution (Multiclean) /1% Hitergent on the reagent Volume Check report.
Single Sample or Control

For problems with a single sample or control, follow the steps below:
1. Are samples and controls placed in the proper positions?
If yes, go to step 3.
If no, go to step 2.
2. Correct the sample or control placement and rerun the sample.
3. Is the sample volume sufficient?
4. Increase the sample volume and rerun the sample.
5. Is the sample integrity acceptable (fibrin, lipemia, hemolysis, icterus)?
6. Collect fresh sample if necessary and rerun, using the Serum Index function.
7. Was the appropriate sample type used? Was the specimen collection
appropriate?
8. Use an appropriate sample type; check manufacturer’s recommendations for
acceptable specimen types. Check specimen collection; check
manufacturer’s recommendations for acceptable specimen collection
methods.

9. Was the collection time and date of the sample appropriate?

10. Check sample collection date and time; collect fresh sample if necessary.
11. Were incorrect test selections made?
12. Check test selections on the Profile Selection/Test Selection screens for that
sample. Correct any selections and rerun the sample.
13. Call Technical Support.
Single Chemistry
For problems with a single chemistry, follow the steps below:
1. Are reagents prepared properly?
2. Prepare new reagents using the application sheet instructions.
3. Are reagents expired, contaminated or discolored?
4. Prepare new reagents using the application sheet instructions.
5. Is the correct information entered in Test Parameters?
6. If the parameters are not correct, reenter them and repeat the calibration.
7. Are the reagent positions and volumes entered correctly. Print the reagent
Volume Check report and confirm that the reagents are properly positioned
8. Correct the reagent positions and volumes entered in Test Parameters.

9. Check the Special Wash program, if required. Make sure it is programmed

correctly by comparing the Carry Over Evasion screens with the
manufacturer’s recommendations
All Chemistries with More Than One Set Point

For problems with all chemistries with more than one set point, follow the steps
below:
1. Were calibrators properly prepared and stored?
2. Prepare new calibrators and recalibrate.
3. Are assigned calibrators in the correct position?
4. Place calibrator(s) in correct position(s), recalibrate and rerun samples.
5. Check proper set points on the Calibration/Installation screen.
Multiple Chemistries, Photometrics Only

For problems with multiple photometric chemistries, follow the steps below:
1. Are there sufficient volumes of detergents, i.e., Hitergent or System Cleaning
Solution (Multiclean)/1% Hitergent? (Check volumes on Reagent Volume
Check report.)
2. Replace needed detergent and rerun samples.
3. Is the incubation bath free of debris?
4. Perform incubation bath maintenance.
5. Perform photometer check. Is the photometer check report within acceptable
limits (< 13000)?

6. Replace photometer lamp. Perform a cell blank. Calibrate all photometric

tests.
All Chemistries, Including ISEs

For problems with all chemistries, including ISEs, follow the steps below:
1. Is the reagent probe aligned properly?
2. Perform probe adjust. Check the reagent probe for barbs, obstructions or
leaks (drops). (Maint./Probe Adjust/R. Probe (Horiz.))
3. Is the reagent system leaking?
4. Check connections in the reagent probe arm and syringe. Check seal integ-
rity.
5. Is the sample probe obstructed or does it have barbs?
6. Clean/replace probe. Check proper dispense. Perform a probe adjust.
7. Is sample system leaking?
8. Check tubings and connections. Check if there are air bubbles in the syringe.
9. Were controls/calibrators properly prepared and stored?
10. Prepare new controls/calibrators.

Chemistries with One Set Point

For problems with chemistries with one set point, follow the steps below:
1. Was standard 1 properly prepared and stored?
2. Check calibrator stability and rerun samples.
3. Check that the incubation bath temperature is correct (37 ± 0.1 °C).
4. Perform an incubation water exchange, allow the temperature to stabilize and
recheck the bath temperature. Check that bath temperature is at 37 ± 0.1 °C.
If the temperature is still unacceptable, call Technical Support.
5. Perform photometer check. Is the photometer check report within acceptable
limits (<13000)?
6. Replace photometer lamp. Perform a cell blank. Calibrate all photometric
chemistries.
ISE, All Results Are Erratic, Excessive Air in Sipper Syringe

For problems with erratic ISE results and there is excessive air in the sipper sy-
ringe, follow the steps below:
1. Check reagent volumes in reagent bottles. Are reagent volumes sufficient and
is the KCl reagent line in the bottle?
2. Replenish reagent if necessary. Make sure the KCl reagent line is at the
bottom of the bottle. Perform an ISE prime of the relevant reagent(s).
3. Is the system leaking?
4. Check all tubings and connections for leaks. Tighten loose fittings. Check
seals of the SERUM, REAGENT, and SIP syringes. Touch Maint./ISE Prime/
Start and perform ISE Prime (REF.).

5. Check position of the measuring cartridges. Are measuring cartridges placed

properly?
6. Place cartridge in correct position. Touch Maint./ISE Prime/Start and perform
ISE Prime (REF.).
7. Check reference cartridge placement. Is the reference cartridge placed
properly?
8. Place cartridge in its proper position. Touch Maint./ISE Prime/Start and
perform ISE Prime (REF.).
ISE, Results Are Erratic

For problems with erratic ISE results, follow the steps below:
1. Is the KCl reagent line correctly placed in the bottle?
2. Check line placement, prime reagents and rerun samples.
3. Is there salt buildup on electrodes or syringes, or are there any loose connec-
tions?
4. Tighten any loose or leaky connections, then clean all salt buildup with wet
gauze and rerun samples.
5. Check sipper line tubing for kinks or occlusions and remove them.
If it is fine, go to step 6.
6. Perform an ISE check (Tools/ISE Check/Start). The Ref. EMF is allowed to be
within -7 mV to +7 mV. The maximum deviation for the entire cycle range
should be no more than +/- 2 mV for Ref. EMF. The measurement-to-mea-
surement difference within the 30 cycle interval should not be larger than 0.2
mV for Na, K and Cl.
If results are not within range, go to step 7.
If results are within range, go to step 8.

7. Replace ISE reference cartridge. Touch Maint./ISE Prime (REF.)/Start and

perform ISE Prime (REF.), recalibrate, and rerun samples.
8. Are there air bubbles in the SIP syringe?
9. Replace seal in SIP syringe and prime the IS reagent.
(Maint./ISE Prime (IS)/Start)
10. Is microbial growth present in the reagent system?
ISE, High Internal Standard Values

For problems with high ISE internal standard values, follow the steps below:
1. Is the IS EMF value and the IS concentration value higher than normal?
The Internal Standard EMF deviated +/- 2 mV maximum from the mean value
between the Standard Low and Standard High. The concentration of the
Internal Standard ideally lies at:
Na: 140 mmol/l
K: 5 mmol/l
Cl: 100 mmol/l
2. Check the IS reagent preparation. Check that the ISE standards are correctly
prepared and placed on the system.
Replace reagent or calibrators, if required and prime the IS and calibrate.
3. Check the IS syringe assembly. Are there leaks?
4. Replace the seals and prime the IS.

5. Perform an ISE Check. The EMF of the reference electrode must be between
-7 mV and +7 mV. The maximum deviation for the entire cycle range should
be no more than +/- 2 mV.
a) If all values (Na, K and Cl) are too high or too low, replace the reference
cartridge. The Level alarm is displayed in the printout adjacent to the
respective EMF if the following limits are exceeded:
Na: -90 to -10 mV
K: -90 to -10 mV
Cl: 80 to 160 mV
b) If only single values (Na, K or Cl) are outside the range, replace the
respective electrode.
ISE, High Sodium or Low Chloride Values

For problems with high sodium and low chloride values, follow the steps below:
1. Were fresh low and high calibrators used?
2. Recalibrate with fresh calibrators and rerun the samples.
3. Prepare fresh IS and Diluent reagents.
• Replace the old IS and Diluent reagents with the fresh reagent.
• Perform a Wash (Maint./Wash (All)/Start).
• Prime the fresh IS reagents (Maint./ISE Prime (IS)/Start).
• Recalibrate two times with fresh ISE standard.
• Rerun the sample.
4. If problem recurs, call Technical Support.
Low ISE Values

For problems with low ISE values, follow the steps below:
1. Were fresh low and high calibrators used?
2. Recalibrate with fresh calibrators and rerun the samples.

3. Were fresh ISE reagents used?

4. Prepare fresh Internal Standard and Diluent.
a) Replace the old IS and Diluent reagents with fresh reagent.
b) Perform Wash (Maint./Wash (All)/Start).
c) Prime the fresh IS reagent (Maint./ISE Prime (IS)/Start).
d) Run 10 dummy samples, then recalibrate two times with fresh ISE stan-
dard and verify the results on the ISE calibration screen (Monitor/ISE
Calibration).
e) Rerun the sample.
5. Is the correct compensator value entered in ISE Test, parameter field 10?
6. Correct the compensator value.
7. If problem recurs, call Technical Support.

Biased Enzymes
For problems with biased enzymes, follow the steps below:
1. Is the incubation bath level above the photometer lens?
2. Perform incubation bath exchange (Maint./Incub. Water/Start).
3. Is the incubation bath temperature displayed on the Status screen
37 ± 0.1 °C?
4. Perform incubation bath exchange (Maint./Incub. Water/Start).
5. Are the sample and reagent syringe seals and connections correct?
6. Correct any loose syringe fittings. Change the syringe seals, if needed.
7. Were controls prepared using volumetric pipettes?
8. Prepare new controls using a volumetric pipette.
9. Perform a full calibration.

1.4 Instrument Troubleshooting
General Considerations
You are required to troubleshoot the instrument only to the extent of the procedures
covered in this guide (see Chapter 4, Maintenance). With more complex problems
you may be able to isolate and identify the problem, but may not be able to correct
it yourself. In such cases, contact Customer Technical Support.
General Mechanical Problem Isolation

The computer controls and monitors all mechanical functions of the instrument.
When a mechanical problem arises within the instrument, it is immediately recog-
nized by the computer. An audible alarm sounds and the alarm is displayed on the
Status screen, alerting you to a problem.
If a problem affects the instrument’s performance, the computer terminates the
Operation mode and enters the Sampling Stop or Stop mode. In the Sampling Stop
mode, the computer allows completion of the samples in process unaffected by the
failure. If the problem affects all samples in process, the computer immediately
terminates the Operation mode with a Stop or Emergency Stop.
Chapters 2 and 3 of this guide provide a complete listing of data and instrument
alarms and suggested remedies for each.
Certain instrument problems may arise that the computer does not monitor. There will be no
alarm on the Status screen to alert you. Such problems include worn parts, air leaks in the
pipettor system, reagent contamination, etc. When you encounter these types of problems,
you must decide whether to continue to process samples or to terminate the Operation mode,
according to the possibility of causing damage to the analyzer or reporting erroneous test
results.
Types of Alarms
The instrument issues two types of alarms: data alarms and instrument alarms. The
instrument alarms can be viewed on the Status screen when they occur. The Daily
Alarm Trace and Cumulative Alarm Trace reports also list the alarms.

NOTES

Chapter 2
Data Alarms
2-1 Boehringer Mannheim/Hitachi 902 Analyzer User’s Guide V1.0

2.1 Data Alarms
Printout Screen Name Remedy

Message Display and
Description
??? X Calculation Test Disabled a. Check the test that is flagged with an
1. During calculation, the denominator error message in the calculation.
became zero. b. Dilute the sample, if applicable, and
2. An overflow occurred in logarithmic rerun the sample.
or exponential calculation. c. Check the Calibration Type parameter in
Tests Parameters, parameter field 21.
d. Resume operation. If alarm recurs, call
Technical Support.
>AMAX > Convergence Absorbance Over Dilute the sample, if applicable, and rerun.
For the logistic methods 4P and 5P
Logit-Log, the absorbance value for the
sample will be assessed prior to result
calculation. If the absorbance of the
sample is found equal or greater than
the maximum theoretical concentration
(a sample with infinite concentration),
the data alarm >AMAX is printed out.
The result field will be left blank on the

report. This blank result along with the
alarm code “>” is transmitted to the
host.
ABS? Z Absorbance Over a. If only one sample is affected:

The absorbance value to be used for Check whether sample is grossly
calculation after cell blank correction lipemic or has an extremely high value.
exceeded 3.3 ABS. Follow laboratory protocol for this
situation.
b. If only one test is affected:
Check reagent preparation for that test.
c. If all samples are affected:
• Remove any obstructions in the optical
path of the photometer. Make sure the
lamp is on.
• Perform a bath exchange. Touch
Maint./Incub. Water/Start to execute.
• Clean the incubation bath if it is
contaminated, following the instructions
in the User’s Guide, Chapter 4,
Maintenance.
• Perform a photometer check and check
the printout, Abs. <13,000.

2.1 Data Alarms

Message Display and
Description
ABS?, Z Absorbance Over • Replace the photometer lamp, if
cont. The absorbance value to be used for necessary, following the instructions in
calculation after cell blank correction the User’s Guide, Chapter 4.
exceeded 3.3 ABS. • Resume operation. If alarm recurs, call
Technical Support.
d. If all samples are affected
intermittently:
The error message CELL? is displayed.
If any reaction cells are scratched,
replace the cells.
ADC? A ADC Abnormal a. If other instrument alarms exist,

The ADC (analog digital coverter) value of correct those alarms and resume
the main or secondary wavelength is 0. operation.
b. Touch Maint./Reset/Start to execute a
reset.
c. If alarm recurs, remove the reaction
disk and check for water droplets or
dust on sensors. Clean if necessary.
d. Resume operation. If problem recurs,
call Technical Support.
CALC? Calculation Test Error a. Correct the condition causing the

A data alarm occurred for the test alarm that occurred.
needed in the calculation. This is not b. Recalibrate.
valid for the errors: c. Resume operation. If alarm recurs, call
- Calculation disabled (???) Technical Support.
- Test-to-test compensation disabled
(CMPT!)
- Expected value limit over (H, L)
CALIB Calibration Error a. Correct any other instrument and/or

For photometric assay: during data alarms.
calibration, there is a difference in the b. Check standards, reagents, and
compensate limit of ±20% or more controls. If controls are in range, and
between the current K factor and the standards and reagents are
previous K factor value. For ISEs, the acceptable, resume operation.
calibrator concentration or slope level Otherwise, correct abnormalities and
does not satisfy the following expression: recalibrate.
Previous Value-Current Value x 100 c. Resume operation. If alarm recurs, call
(Previous Value+Current Value)/2 Technical Support.
> Compensate
Level
±10% n The CALIB alarm is a warning only, not
necessarily indicative of a problem with
the calibration. Check the test’s control
recovery before accepting the new
calibration result.

2.1 Data Alarms

Message Display and
Description
CELL? Q Cell Blank Abnormal a. Check that the reaction cell is not
The difference between the current contaminated or cracked.
passed cell blanks and the previous cell b. Touch Maint./Wash (Cells)/Start to
blank measured by the cell blank execute wash cells. Follow the
function on the Maintenance screen is procedure for Wash in Chapter 4 of the
greater than 0.1 ABS. User’s Guide.
c. Ensure that there is no excessive
foaming or particles in the incubation
bath.
d. Wipe the outside of the reaction cells
with gauze moistened with incubation
bath water.
e. Resume operation. If alarm recurs,
ensure there is adequate rinse water
and cell blank water from the rinse
mechanism.
f. Perform incubation bath exchange.
g. Resume operation. If alarm recurs,
touch Maint./Cell Blank/Start to
perform a cell blank. If cells are out of
specification (>13,000), replace
reaction cells. Repeat the cell blank
procedure.
h. Resume operation. If alarm recurs, call
Technical Support.
CMP.T C Test to Test Compensation Error Correct the data alarm on the test to be
In test-to-test compensation calculation, used for compensation calculation. Rerun
a data alarm other than those shown the sample.
below is indicated for the compensation
test data: ???, CMP.T!, H, L.

2.1 Data Alarms

Message Display and
Description
CMP.T! M Test to Test Compensation Disabled Correct the data alarm of the test to be
1. During test-to-test compensation used for compensation. Rerun the sample.
calculation, the denominator became
zero.
2. The test used for test-to-test
compensation has not been
measured yet.
3. Any test used for test-to-test
compensation has data alarm
calculation disabled (???) or test-to-
test compensation error (CMP.T).
4. Any test used in the compensation
formula has a data alarm that leaves
the result blank.
DUP Duplicate Error a. Recalibrate.

During calibration, the difference b. Check reagent preparation and
between the replicate measured expiration date. Prepare new reagent if
absorbances of any standard was larger necessary and recalibrate.
than the test’s duplicate limit. c. Check Duplicate Limit field in Test
Parameters, parameter field 45.
Technical Support.
n The DUP alarm is triggered when the

replicate assays of a standard are
outside of the limits as programmed via
the Duplicate Limit field in Test
Parameters.
If this alarm occurs for a standard (for

example S1, S2), it results in a Std? alarm
being issued. The Std? alarm prevents
updating of calibration for the affected test
and can be caused by other calibration-
specific alarms such as Dup and Sens.

2.1 Data Alarms

Message Display and
Description
H or L Expected Value Upper Limit Exceeded Verify expected value in Test Parameters,
H: For patient samples, the calculated parameter fields 54 and 55.
concentration is higher than the
upper limit of the expected value.
Expected Value Lower Limit Exceeded
L: For patient samples, the calculated
concentration is lower than the
lower limit of the expected value.
I. STD Internal Standard Conc. Error a. If any other ISE alarms occurred,
The concentration of the Internal correct these alarm conditions first.
Standard solution was not within the b. If the EMF of the IS solution is
following range: abnormal on the Calibration Monitor
Na+: 120 mmol/l to 160 mmol/l report, check the Internal Standard
K+ : 3.0 mmol/l to 7.0 mmol/l reagent volume and preparation. If
Cl- : 80 mmol/l to 120 mmol/l necessary, prepare fresh reagent,
prime and recalibrate.
c. If the EMF of IS solution is normal on
the calibration report, check ISE
standards and reagent syringe.
d. Resume operation. If alarm recurs,
LEVEL L ISE Level Error a. Check for sufficient ISE reagent

During measurement of internal volume and make sure KCl reagent
reference, the EMF was not within the line is in the bottle.
following range (Internal Standard b. Check for excess air in the KCl
Solution): reagent line. Examine syringes and
Na+: -90.0 mV to -10 mV cartridges for leaks.
K+ : -90.0 mV to -10 mV c. Check reference cartridge placement.
Cl- : 80.0 mV to 160.0 mV d. Check for salt bridges and clean if
necessary.
e. Exchange KCl reagent, perform ISE.
Prime (REF.) and recalibrate.
f. Resume operation. If alarm recurs,

2.1 Data Alarms

Message Display and
Description
LIMT0 I All Reaction Limit Over a. Dilute and rerun the sample, if
The main wavelength absorbance applicable.
exceeded the calculation limit at all b. Check “ABS. Limit” parameter in Test
photometric points used for calculation. Parameters, parameter field 49.
n If the entered assay points [l] and [m]
do not satisfy ‘l + 2 < m’, the
c. Check the stability and preparation of
the reagent. Replace the reagent, if
reaction limit is always exceeded. necessary.
Technical Support.
LIMT1 J Reaction Limit Over exc. 1 point a. Dilute and rerun the sample, if
exceeded the reaction limit at the second b. Check “ABS. Limit” parameter in Test
and subsequent photometric points used Parameters, parameter field 49.
for calculation. c. Check the stability and preparation of
necessary.
reaction limit is always exceeded. d. Resume operation. If alarm recurs, call
Technical Support.
LIMT2 K Reaction Limit Over exc. 2-3 points a. Dilute and rerun the sample, if
exceeded the reaction limit at the third or b. Check “ABS. Limit” parameter in Test
fourth and subsequent photometric Parameters, parameter field 49.
points used for calculation. c. Check the stability and preparation of
necessary.
reaction limit is always exceeded. d. Resume operation. If alarm recurs, call
Technical Support.
LIN. W Linearity Abnormal at 9 points or over a. Rerun the sample with a reduced
When the number of photometric points sample volume.
within the reaction limit range is nine or b. Check the photometer lamp, Maint./
more, a comparison of the absorbance Photometer/Start.
change rates at both the first and last six c. Ensure that the incubation bath is free
points exceeded the linearity limit value. of debris. Clean the incubation bath, if
necessary, following the instructions
in Chapter 4 of the User’s Guide.
d. Check the stirring mechanism by
executing a mechanism check. Touch
Tools/Mech. Check/Start to execute.
e. Check linearity limit values. Touch
Param/System/Rate As Chk.
f. Resume operation. If alarm recurs, call
Technical Support.

2.1 Data Alarms

Message Display and
Description
LIN. 8 F Linearity Abnormal at 8 points or a. Rerun the sample with a reduced
below sample volume.
When the number of photometric points b. Check the photometer lamp, Maint./
within the reaction limit range is eight or Photometer/Start.
less, a comparison of the absorbance c. Ensure that the incubation bath is free
change rates at both the first and last of debris. Clean the incubation bath, if
three points exceeded the linearity limit. necessary, following the instructions in
d.. Check linearity limit values. Touch
Param/System/Rate As Chk.
e. Check the stirring mechanism by
executing a mechanism check. Touch
Tools/Mech. Check/Start to execute.
f. Resume operation. If alarm recurs, call
Technical Support.
NOISE N Noise Error a. Check for sufficient reagent volume

The difference between the maximum and make sure KCl reagent line is in
and minimum EMF values exceeded the the bottle.
following values during measurement: b. Check for excess air in the KCl reagent
Na+: 0.7 mV line. Examine syringes and cartridges
K+: 1.0 mV for leaks and salt bridges. If only one
Cl- : 0.8 mV test is affected, check the individual
cartridge. If all tests are affected,
check the reference cartridge.
c. Check ISE cartridge placement.
d. If alarm occurred during calibration,
correct problem and recalibrate.
e. Resume operation. If alarm recurs, call
Technical Support.
OVER O Overflow Dilute the sample, if applicable, and rerun.

The result cannot be output in the
specified number of digits.
n Blank space is left for result on the
report.

2.1 Data Alarms

Message Display and
Description
PREP. R Prepare Error If the slope value is:
Electrode preparation is abnormal. The Na+, K+ ≥ 68.1 mV
slope for the specified electrolyte Cl- ≤ -68.1 mV
cartridge is not within the following and you have recently installed a new
range: cartridge:
Na+, K+: 45.0 mV ≤ Slope ≤ 49.9 mV a. Run 10 dummy samples of human
or 68.1 mV ≤ Slope serum.
Cl-: -39.9 mV ≤ Slope ≤ -35.0 mV b. Recalibrate the ISEs.
or -68.1 mV ≥ Slope c. Resume operation. If alarm recurs, call
The electrode performance has Technical Support.
deteriorated. If the slope value is:
Na+, K+: 45.0 mV ≤ Slope ≤ 49.9 mV
Cl-: -39.9 mV ≤ Slope ≤ -35.0 mV
a. Check control values. Are they in
range? If Yes go to b.
If No, stop routine analysis and go to c.
b. Continue routine analysis. Continue
with c. following the end of the routine
analysis for the day.
c. Is the slope value within the marginal
range above? If Yes go to d.
If No go to f.
d. Did the slope value decrease gradually
over time? If Yes go to e.
If NO go to f.
e. Replace the appropriate ISE cartridge
following the instructions in Chapter 4
of the User’s Guide.
f. If the slope value has either decreased
suddenly or is still in the optimal range
(Na+, K+ - ≥ 49.9 mV or
Cl- - ≤ -39.9 mV), touch Maint./Wash
(All)/Start to exceute a wash.
g. Run 10 dummy samples of human
serum.
h. Recalibrate the ISEs.
i. Resume operation. If the alarm recurs,
change the appropriate ISE cartridge

2.1 Data Alarms

Message Display and
Description
*****P P Prozone Error a. Check the reagent preparation.
In a one-point or two-point assay with b. Check the upper/lower limit ‘Prozone
prozone check, the prozone check value Limit’ in Test Parameters, parameter
(PC value) exceeds the specified upper/ fields 51 & 52.
lower limit. Shown below is the c. Resume operation. If alarm recurs, call
relationship between the PC value and Technical Support.
upper/lower limit on occurrence of the
alarm.
If LOWER, PC value < Limit value
If UPPER, PC value > Limit value
n PC Value is defined as:
One point assay:

1/2 x {(Am+Am-1)-k(Al+Al-1)}
Two point assay:
[(Am-An)/(m-n)]/[(Ap-An)/(p-n)]
x 100
l, m, n and p are photometric read
cycles.
R.OVER & Sample Value Abnormal

The sample concentration was outside
the following range:
Na+: 10 mmol/l to 250 mmol/l
K+ : 1 mmol/l to 100 mmol/l
Cl- : 10 mmol/l to 250 mmol/l

2.1 Data Alarms

Message Display and
Description
REAGN T Reagent Short Call Technical Support.
There is insufficient reagent volume in For photometrics:
the reagent bottle (photometric). a. Print Reagent Volume Check report
from Start Conditions. Replace low
There is insufficient ISE reagent volume reagent, as necessary.
when alarm is associated with sodium, b. If adequate reagent volumes are
potassium or chloride values. present and alarm recurs, ensure that
the reagent probe is correctly aligned
and both the probe wires are attached
correctly.
c. Resume operation. If alarm recurs, call
Technical Support.
For ISEs:
a. Print Reagent Volume Check report
from Start Conditions. Replace low DIL,
IS reagent, as necessary. Replace low
KCl as necessary. Update KCl reagent
volumes in Parameters/ISE Test. Prime
new reagent and recalibrate.
Technical Support.
SAMPL. V Sample Short a. Add sample and rerun.

There is insufficient sample volume in b. If alarm recurs, check sample probe
the sample cup. alignment and sample probe electrical
connections. Refer to Chapter 4 of the
User’s Guide.
Technical Support.
SD? SD Error a. Check the standard concentrations and

During nonlinear or multipoint linear positions in Test Parameters, parameter
calibration the SD value was larger than fields 23-34.
the SD limit programmed in Test b. Check the SD limit in Test Parameters,
Parameters. parameter field 44.
c. Check the preparation of the manually
prediluted samples and the expiration
dates of standards and reagents;
recalibrate the affected tests.
Technical Support.

2.1 Data Alarms

Message Display and
Description
SENS Sensitivity Error a. Check preparation and expiration
Sensitivity is checked for linear (2 to 6 dates of calibrators and reagents.
points) or nonlinear calibration. This Recalibrate affected test.
error is indicated if the difference in b. Check sample pipettor for leaks and
absorbance per unit of the test between recalibrate affected test.
Std 1 and Std N* is smaller than the c. Check the Sensitivity Limit in Test
sensitivity limit (input value). Parameters, parameter field 46 and
recalibrate affected test.
*N: = 2 for 2-point linear d. Resume operation. If alarm recurs, call
= 2 to 6 for nonlinear logit-log 4P Technical Support.
= 3 to 6 for nonlinear logit-log 5P,
nonlinear point to point calibration.
SLOPE? ISE Slope a. Is the slope value beyond the critical

The slope for the specified electrolyte value specified in the alarm
cartridge is outside of the acceptable description? If Yes go to b.
range. If No go to d.
Na+, K+: Slope < 45.0 mV b. Did the slope value decrease gradually
Cl-: Slope > - 35.0 mV over time? If Yes go to c.
If NO go to d.
c. Replace the appropriate ISE cartridge
d. If the slope value has either decreased
suddenly or is still in the optimal range
(Na+, K+ - ≥ 49.5 mV or
Cl- - ≤ -39.9 mV), touch Maint./Wash
(All)/Start.
e. Run 10 dummy samples of human
serum.
f. Recalibrate the ISEs.
g. Resume operation. If the alarm recurs,
change the appropriate ISE cartridge

2.1 Data Alarms

Message Display and
Description
STD? S STD Error a. Correct any other instrument and/or
1. During photometric calibration, any other data alarms.
one of the following alarms was b. Prepare fresh calibrator; place on the
encountered: ADC? abnormal, cell sample disk and recalibrate.
blank abnormal, sample short, c. Prepare fresh reagent; place on the
reagent short, absorbance over, system and recalibrate.
reaction limit over, linearity d. Check parameters in Test Parameters
abnormal, prozone error, duplicate and ISE Test screens.
error, calculation disabled or e. Resume operation. If alarm recurs, call
standard 1 absorbance abnormal. Technical Support.
2. During calibration, calculation was
disabled.
3. During nonlinear calibration, an
extreme value appeared.
4. During ISE calibration, any one of
the following alarms were
encountered: ADC? abnormal,
sample short, calculation disabled,
noise error, or level error. Calibration
is invalid.
S1Abs? STD1 Absorbance Abnormal a. Check reagent preparation and

During calibration, expected absorbance calibration.
of STD 1 is outside the S1 Abs Limit. S1 b. Recalibrate.
is read bichromatically for endpoint c. Check S1 Abs Range values in Test
assays, monochromatically for rate Parameters, parameter fields 47, 48.
assays. d. Resume operation. If alarm recurs, call
Technical Support.

NOTES
2-14 Boehringer Mannheim/Hitachi 902 Analyzer User’s Guide V1.0

Chapter 3
Instrument Alarms
UG3S1-26.p65 1 06.10.2003, 17:32

3.1 Instrument Alarms
Alarm Code Levels Description Remedy
STIRRER 1-1 STOP The stirrer does not reach its a. Touch Tools/Mech. Check/Start
highest position when ascending at and execute the check 10
the rinse bath. times.
b. Resume operation. If alarm
1-2 STOP The stirrer does not reach its recurs, call Technical Support.
highest position when ascending at
the reaction cell.
1-3 STOP The stirrer does not descend into

the reaction cell from its highest
position.
1-4 STOP The stirrer does not reach the rinse

bath position when rotating toward
the rinse bath.
1-5 STOP The stirrer does not move

horizontally to the reaction cell.
1-6 STOP When reset, the stirrer does not Touch Maint./Reset/Start to execute
return to the rinse bath (home) the reset.
position.
1-7 STOP When reset, the stirrer does not

leave the rinse bath (home)
position.
1-8 STOP The stirrer does not remain in its

highest position, during horizontal
movement.
RINSE 3-1 STOP The rinse mechanism does not a. Touch Tools/Mech. Check/Start
reach its highest position when and execute the check 10
ascending. times.
3-2 STOP The rinse mechanism does not recurs, call Technical Support.
descend into the reaction cell from
its highest position.
UG3S1-26.p65 2 06.10.2003, 17:32

R. DISK 5-1 STOP Reaction disk does not detect its stop a. If reaction disk has recently
position. been washed, check for water
droplets on bottom of disk. Dry
5-2 STOP Reaction disk does not stop at the thoroughly.
correct position. b. Check for water droplets on the
detector below reaction disk.
5-3 STOP Reaction disk does not detect its Dry thoroughly.
home position when reset. c. Resume operation. If alarm
recurs, call Technical Support.
5-4 STOP First reaction cell does not stop at the
correct position when reset.
5-5 STOP When reaction disk rotates, the a. Touch Maint./Reset/Start and
sample probe, reagent probe, stirrer, execute Reset.
or cell rinse mechanism is not set at b. Resume operation. If alarm
the highest point at the reaction cell. recurs, call Technical Support.
n This alarm may occur with
other alarms (e.g. rinse station
alarms.)
S. PROBE 6-1 S. STOP/ Sample probe does not ascend to the a. Touch Tools/Mech. Check/Start
STOP highest point when leaving any and execute the check 10
position other than the reaction cell. times.
6-2 STOP Sample probe does not ascend to the recurs, call Technical Support.
highest point when leaving the
reaction cell.
6-3 S. STOP/ Sample probe descends abnormally a. Touch Tools/Mech. Check/Start

STOP at any position other than at reaction and execute the check 10
cell. times.
b. Inspect probe where it is
attached to the sample probe
arm. The probe is spring-
mounted and should travel
freely up and down.
c. Inspect cup bottom for proper
height.
d. Check sample cup for
distortion.
e. Touch Maint./Probe Adjust/S.
Probe (Horiz./Vert.)/Start and
execute the probe adjustment.
f. Resume operation. If alarm
UG3S1-26.p65 3 06.10.2003, 17:32

S. PROBE 6-4 STOP The sample probe descends a. Touch Tools/Mech. Check/Start
(cont’d) abnormally into the reaction cell. and execute the check 10
times.
freely up and down.
c. Touch Maint./Probe Adjust/S.
Probe (Horiz./Vert.)/Start and
execute the probe adjustment.
d. Resume operation. If alarm
6-5 S. STOP/ Sample probe does not descend at a. Touch Tools/Mech. Check/Start
STOP any position other than at reaction and execute the check 10
cell. times.
6-6 STOP Sample probe does not descend into recurs, call Technical Support.
the reaction cell.
6-7 S. STOP/ Sample probe continues to detect an Inspect probe where it is attached
STOP abnormal descent condition. to the sample probe arm. The
probe is spring-mounted and
should travel freely up and down.
Grasp the probe between your
thumb and forefinger and gently
move it up. Upon releasing your
grasp, the probe should spring
downward. If the probe does not
respond as described, remove the
sample arm cover and check the
lead wires to make sure they do
not impede movement of the
probe.
6-8 S. STOP/ Sample probe cannot detect the cell a. Touch Tools/Mech. Check/Start
STOP position as it rotates to the reaction and execute the check 10
disk. times.
6-9 S. STOP/ Sample probe does not leave reaction recurs, call Technical Support.
STOP cell position when trying to rotate
toward another mechanism.
UG3S1-26.p65 4 06.10.2003, 17:32

S. PROBE 6-11 S. STOP/ Liquid level detector is not reset. a. Clean the probe tip and the
(cont’d) STOP liquid level sensor.
b. Verify that the distance
between the probe tip and the
liquid level sensor wire is
2 mm.
c. Touch Maint./Reset/Start and
execute Reset.
recurs, replace the sample
probe.
e. Resume operation. If alarm
6-12 S. STOP Sample probe descends abnormally a. Touch Tools/Mech. Check/Start

when rotating during Probe Adjust. and execute the check 10
times.
6-13 S. STOP/ Sample probe does not rotate in its a. Touch Tools/Mech. Check/Start
STOP highest position. and execute the check 10
times.
6-14 STOP Sample probe does not rotate from b. Resume operation. If alarm
the reset position. recurs, call Technical Support.
6-15 STOP Sample probe does not rotate to the

reset position.
UG3S1-26.p65 5 06.10.2003, 17:32

S. DISK 8-1 S. STOP/ Sample disk cannot detect the stop

Do not touch the sample disk
STOP position on outer ring. during operation.
a. Remove anything obstructing
8-2 S. STOP/ Sample disk does not stop at the sample disk movement.
STOP correct position on outer ring. b. Touch Tools/Mech. Check/
Start and execute the check
8-3 S.STOP/ Sample disk cannot detect the stop 10 times.
STOP position on Inner ring. c. Resume operation. If alarm
8-4 S. STOP/ The sample disk does not stop at
STOP the correct position on Inner ring.
8-5 STOP Sample disk does not detect the

home position at reset.
8-6 STOP Sample disk does not stop at the

home position at reset.
8-7 STOP Sample disk does not leave the

home position at rest.
S. SHORT 11-1 WARNING There is insufficient sample volume Add sample and rerun.
to in the sample cup.
11-60*
*Subcode indicates sample disk
position number (W1-W3: 58-60).
S. SYRINGE 15-1 S. STOP/ Sample syringe does not ascend to a. Touch Tools/Mech. Check/
STOP its highest point. Start and execute the check
10 times.
15-2 S. STOP/ Sample syringe does not descend b. If sample pipettor was recently
STOP from its highest point. serviced, verify that retaining
screw is not overtightened.
c. Verify that sample pipettor
plunger is not bent.
UG3S1-26.p65 6 06.10.2003, 17:32

R. PROBE 16-1 S. STOP The reagent probe does not ascend a. Touch Tools/Mech. Check/Start
to the highest position. and execute the check 10
times.
16-2 S. STOP The reagent probe descends b. Touch Maint./Probe Adjust
abnormally. (Horiz.) to execute a probe
adjust.
c. Inspect probe where it is
freely up and down.
16-3 S. STOP The reagent probe does not descend a. Verify that reagent bottle is
from its highest position. uncapped.
b. Verify that reagent disk cover
is in proper position.
c. Verify that reagent probe is
not bent.
16-4 S. STOP The reagent probe continues to a. Touch Tools/Mech. Check/Start

detect an abnormal descent and execute the check 10
condition. times.
16-5 STOP The reagent probe cannot detect the attached to the sample probe
reaction cell position as it rotates to arm. The probe is spring-
the reaction cell. mounted and should travel
freely up and down.
16-6 STOP The reagent probe does not leave the c. Resume operation. If alarm
reaction cell position when trying to recurs, call Technical Support.
rotate.
16-7 STOP Liquid level detector cannot be reset. a. Clean the probe tip and the
liquid level sensor.
16-8 STOP The reagent probe does not stay in b. Verify that the distance
highest position when rotating. between the probe tip and the
liquid level sensor wire is
2 mm.
c. Touch Maint./Reset/Start and
execute Reset.
recurs, replace the sample
probe.
UG3S1-26.p65 7 06.10.2003, 17:32

R. DISK 18-1 STOP The reagent disk does not detect its
Do not touch the reagent
stop position. disk during operation.
a. Remove item(s) that may be
18-2 STOP The reagent disk does not stop at its obstructing disk rotation.
specified position. b. Ensure reagent bottles are
inserted properly.
18-3 STOP The reagent disk does not detect its c. Touch Tools/Mech. Check/
home position. Start and execute the check
10 times.
R. SYRINGE 22-1 STOP The reagent syringe does not reach a. Verify that the retaining screw
its highest position when ascending. of the reagent syringe is not
overtightened.
22-2 STOP The reagent syringe does not b. Resume operation. If alarm
descend from its highest position. recurs, call Technical Support.
ISE SIPPER 24-1 WARNING/ ISE sipper nozzle does not reach a. Touch Tools/ISE Check/Start
STOP the highest position during reset or and execute the check 10
operation. times.
24-2 WARNING/ The ISE sipper nozzle does not recurs, call Technical Support.
STOP descend from its highest position.
ISE SYRNG. 26-1 WARNING/ ISE sipper syringe does not reach a. If syringe was recently
STOP the highest point. reassembled, check for proper
assembly (Chapter 4).
26-2 WARNING/ ISE sipper syringe cannot leave the b. Touch Tools/ISE Check/Start
STOP highest position. and execute the check 10
times.
c. Resume operation. If alarm
ISE STOP? 27-1 WARNING/ ISE function stopped due to an Remedy the additional ISE
STOP alarm. alarm(s), then resume operation.
UG3S1-26.p65 8 06.10.2003, 17:32

TEMP 28-1 STOP Water temperature in the incubation a. Ensure that condenser filter
CONT. bath exceeds 45 °C. on the back of instrument is
not clogged with dust.
28-2 STOP Water temperature in the b. Ensure that room temperature
incubation bath is outside a is 15 to 32 °C.
range of 37 ± 0.5 °C. c. Verify that incubation bath
n This alarm occurs only during
operation.
water is circulating.
d. Touch Maint./Incub. Water/
Start and exchange incubator
water several times.
e. Monitor the Status screen to
make sure the temperature
returns to 37 °C.
f. If alarm recurs, call Technical
Support.
INC.WATER 29-1 STOP Incubation bath water level is too low. a. Check that Hitergent is
present in position 40 on the
reagent disks.
b. Verify that both lead wires for
the liquid level sensor (located
at the 11 o’clock position on
the reaction disk) are plugged
in.
c. Touch Maint../Incub. Water/
Start and exchange incubator
water several times.
d. Monitor the Status screen to
make sure the temperature
returns to 37 °C.
REF. 30-1 WARNING More than 24 hours have elapsed Touch Maint./Incub. Water /Start
WATER since the last incubation bath water and execute the bath exchange.
exchange.
UG3S1-26.p65 9 06.10.2003, 17:32

DIST. 31-1 STOP Water reservoir level is too low. If using an external water source:
WATER a. Ensure that water supply is
31-2 WARNING Water reservoir level is too low. ON.
b. Ensure that water supply
pressure is 15-25 psi.
c. Ensure that external supply
water flow rate is 100 liters
(26.4 gallons) per hour.
d. Clean inlet water filter.
If using water tank:

a. Refill water tank.
b. Clean inlet water filter.
DIST. 32-1 WARNING Water level sensor in water tank is a. Check float switches located in
SENS. malfunctioning. water tank cap assembly.
Turn off external water
supply, remove water tank
and ensure floats move freely.
b. Call Technical Support.
RESERVOIR 34-1 WARNING Waste reservoir is full. a. Empty waste reservoir.

b. Ensure that liquid level sensor
wires in drain tubing cap are
at least one applicator stick
width apart and not touching
the cap.
SIPPER 37-1 STOP Vacuum pump is not supplying Call Technical Support.
enough negative pressure.
VAC. TANK 38-1 S. STOP Liquid detected in vacuum tank. Call Technical Support.
UG3S1-26.p65 10 06.10.2003, 17:32

LAMP 41-1 WARNING During normal operation, the a. If incubation bath is not full, or
stopped cell blank absorbance if the bath water is cloudy,
measurement for one of the 4 cell clean the incubation bath
balnk measurements is greater than (Chapter 4).
3.3 ABS. b. Touch Utility/Maint./Inc. Bath
n This cell is not used for
analysis.
Exchange/Start and execute
the bath exchange.
c. Ensure that lamp leads are
41-2 S. STOP During normal operation, the not touching and that lead
stopped cell blank absorbance wires are securely fastened.
measurements for all wavelengths d. Replace photometer lamp.
are greater than 3.3 ABS.
n STOP appears if this alarm is
issued in any mode other than
Operate. This cell is not used
for analysis.
41-3 S. STOP Alarm code 41-1 has been

generated 10 consecutive times.
n STOP appears if this alarm is
issued in any mode other than
Operate.
CELL BNK1 45-1 S. STOP Absorbance of the cell blank a. Verify that reaction cell is not
measurement of ten consecutive cell contaminated or cracked.
differs by more than 0.1 ABS from b. Verify that there are no air
the reference absorbance of the cell bubbles formed in the water
blank measurement. contained in the reaction cell.
n This cell is not used for
analysis.
c. Ensure that no dust particles
are in the incubation bath.
d. Touch Maint./Wash (Cells)/
CELL BNK2 46-1 WARNING Absorbance of the cell blank Start and execute the wash.
to measurement of one cell differs by e. Touch Maint./Cell Blank/Start
46-48* more than 0.1 ABS from the and execute the cell blank.
reference absorbance of the cell f. Ensure that there is an
blank measurement for 2 out of 4 adequate amount of rinse
consecutive measurements. water.
* Subcode 1 - 48 indicates the g. Verify that there are no air
reaction cell number. bubbles formed in the
**STOP occurs if this alarm is issued incubation bath.
in any mode other than Operate.
UG3S1-26.p65 11 06.10.2003, 17:32

ADC1? 47-1 WARNING Analog/digital converter (ADC) for a. Touch Maint./Reset/Start and
photometric measurements failed to execute the Reset.
operate normally. b. Resume operation. If alarm
47-2 WARNING Analog/digital converter (ADC) count a. Correct any other alarm
value for photometric measurements conditions shown on the
remains at 0. Alarm screen that appeared
before ADC1?
47-3 WARNING Analog/digital converter (ADC) count b. Touch Maint./Reset/Start and
value for photometric measurements execute the Reset.
does not become zero. c. If reaction disk was removed
recently, dry detectors as
47-4 WARNING Analog/digital converter (ADC) shown in Chapter 4, Clean
reference voltage for photometric Reaction Bath.
measurements produced an d. Resume operation. If alarm
abnormal count. recurs, call Technical Support.
ADC2? 48-1 WARNING Analog/digital converter (ADC) for ISE a. Touch Maint./Reset/Start and
measurements failed to operate execute the Reset.
normally. b. Resume operation. If alarm
48-2 WARNING Analog/digital converter (ADC) count a. Correct any other alarm
value for ISE measurements remains conditions shown on the
at 0. Alarm screen that appeared
before ADC2?
48-3 WARNING Analog/digital converter (ADC) count b. Touch Maint./Reset/Start and
value for ISE measurements does not execute the Reset.
become zero. c. If reaction disk was removed
recently, dry detectors as
48-4 WARNING Analog/digital converter (ADC) shown in Chapter 4, Clean
reference voltage for ISE Reaction Bath.
measurements produced an d. Resume operation. If alarm
abnormal count. recurs, call Technical Support.
UG3S1-26.p65 12 06.10.2003, 17:32

ADC3? 49-1 WARNING Analog/digital converter (ADC) count a. Correct any other alarm
value for temperature conditions shown on the
measurements remains at 0. Alarm screen that appeared
before ADC3?
49-2 WARNING Analog/digital converter (ADC) b. Touch Maint./Reset/Start and
reference voltage for temperature execute the Reset.
measurements produced an c. If reaction disk was removed
abnormal count. recently, dry detectors as
shown in Chapter 4, Clean
Reaction Bath.
Barcode 1 50-1 WARNING Barcode reader is unable to read the a. Verify that barcode label is not
to barcode label. obscured or removed.
50-35* * Subcode indicates sample b. Touch Tools/Barcode/Start to
position. execute a barcode check.
c. Call Technical Support.
Barcode 2 54-3 WARNING Communication error with barcode Call Technical Support.
reader
REAG. 57-1 WARNING Remaining reagent/wash solution a. Print reagent Volume Check
SHORT to volume is insufficient report from the Start
57-40* * Subcode indicates reagent Conditions screen.
position. b. Replace low reagent or wash
solution.
REAG. 59-1 WARNING Reagent/wash solution volume less a. Print reagent Volume Check
LEVEL to than residual check volume. report from Start Conditions
59-40* * Subcode indicates reagent screen.
position. b. Replace low reagent with a
new one.
TS OVER 67-1 WARNING Tests for more than 400 samples After completing the analysis of
have been requested. New the first 400 samples, program
information cannot be entered from the remaining samples.
the host.
UG3S1-26.p65 13 06.10.2003, 17:32

PAINT 68-1 WARNING Tests for more than 400 samples After completing the analysis of
OVER have been requested. New the first 400 samples, program
information cannot be entered on the the remaining samples.
analyzer.
DC 71-1 STOP 15 V DC power abnormality. a. Turn instrument OFF, then

POWER back ON.
71-2 STOP -15 V DC power abnormality. b. Resume operation. If alarm
71-3 WARNING 12 V DC power abnormality (for
lamp).
71-4 STOP 5 V DC power abnormality (for

mechanism controller).
71-11 E. STOP 24 V DC power abnormality (for

mechanism controller).
FUSE 72-1 E. STOP Fuse has blown. Check fuses. Note which fuse
exhibits a white flag (if any) then
DO NOT REPLACE ANY FUSE
UNLESS SO DIRECTED BY
TECHNICAL SUPPORT.
POWER 73-1 WARNING AC power is abnormal (analyzer Resume operation. If alarm recurs,
FAIL unit). call Technical Support.
This alarm is normally seen following
a power failure (including a
momentary power failure.)
UG3S1-26.p65 14 25.11.2003, 13:56

MOTOR 75-1 STOP Data was not transmitted to the Call Technical Support.
CONT to controller motor properly.
75-18* * Subcode indicates specific
controller motor.
1. Reaction disk
2. Sample disk
3. Reagent disk
4. Rinse up/down
5. Sample arm up/down
6. Sample arm rotation
7. Reagent arm up/down
8. Reagent arm rotation
9. Stirrer up/down
10. Stirrer rotation
11. ISE sipper up/down
12. (Reserved)
13. Sample syringe
14. Reagent syringe
15. ISE Syringe
16. (Reserved)
17. GMCNT
18. (Reserved)
MOTOR 76-1 E. STOP Motor controller did not recognize Call Technical Support.
OUT to any command other than stop.
76-18* * Subcode indicates specific
controller motor, see code 75
above.
UG3S1-26.p65 15 25.11.2003, 13:56

STANDARD? 83-1 WARNING Photometric assay: Photometric:

to 1. During calibration, the standard a. Verify Duplicate Limit and
83-40 absorbance was abnormal. Sensitivity Range values in
2. During calibration, calculation Test Parameter, parameter
was disabled. fields 45 and 46.
b. Check quantity of standard,
ISE assay: sample, and reagents.
1. During calibration, the standard c. Check to see if a cell blank
or internal standard solution alarm has been issued.
indicated with one of the d. Check to see if the absorbance
following ADC2? error, is 3.3 ABS or more.
insufficient sample alarm, noise e. Check to see if the reaction
alarm, or level alarm. limit value was exceeded.
2. During calibration, calculation is f. Check to see if the Linearity
disabled. Abnormal alarm is issued.
n Calibration with this alarm does
not update calibration data nor
g. Call Technical Support.
store data to the floppy drive. ISE:

* Subcode indicates the channel Check to see if the analog/digital
assignment. converter (ADC) alarm (48) has
been issued. Correct the alarm
condition. If no other alarm
condition exists, call Technical
Support.
CALIB. 84-1 WARNING K factor determined through a. If alarm occurred at same time
to calibration differed from the previous as other alarms, correct the
84-40* value by more than ± 20%. other alarm condition(s).
Display values for ISE calibration or b. Check standards, reagents,
slope differed from the previous and controls. Correct
calibration by a value greater than abnormalities and recalibrate.
the compensation limit (%). c. If alarm recurs, call Technical
* Subcode indicates the channel Support.
assignment.
CALIB. SD? 85-1 WARNING During multipoint calibration, the a. Verify SD Limit in Test
to mean remainder was larger than the Parameters, parameter field
85-36* entered SD limit. 44.
* Subcode indicates the channel b. Check preparation and
assignment. expiration dates of standards
and reagents.
c. Recalibrate affected test.
d. Call Technical Support.
UG3S1-26.p65 16 25.11.2003, 13:56

SENS.? 86-1 WARNING In linear or nonlinear calibration, the a. Verify Sensitivity Limit in Test
to difference between mean STD (1) Parameters, parameter field
86-36* absorbance and mean STD (N) was 46.
smaller than the sensitivity limit b. Check reagent and calibrators.
entered in Test Parameters. c. Check sample pipettor for
n *N:= 2 for 2-point linear
N= 2 to 6 for nonlinear
leaks.
d. Recalibrate affected test.
logit-log 4P
N= 3 to 6 for nonlinear logit-
log 5P, nonlinear point to point
calibration.
If only STD (1) or STD (N) was
measured, the previous absorbance
is used for sensitivity check.
* Subcode indicates the channel
assignment.
ISE LEVEL 90-1 WARNING During measurement of internal a. Touch Tools/ISE Check/Start
to reference, potential was not within and execute the check.
90-3* the following range: b. Check for air in sipper line.
Na+: -90 to -10 mV c. Check internal reference
K+: -90 to -10 mV solution.
Cl-: 80 to 160 mV d. Check ISE cartridge for
* Subcode: 1=Na+, 2=K+, 3=Cl- leakage.
e. Check reference cartridge and
ground electrodes for leakage.
ISE NOISE 91-1 WARNING Noise level exceeded the following a. Touch Tools/ISE Check/Start
to values during measurement: and execute the check.
91-3* Na+: 0.7 mV b. Resume operation. If alarm
K+: 1.0 mV recurs, call Technical Support.
Cl-: 0.8 mV
* Subcode: 1=Na+, 2=K+, 3=Cl-
UG3S1-26.p65 17 25.11.2003, 13:56

ISE PREP 92-1 WARNING During calibration, the slope If the slope value is:
to exceeded the following limits: Na+, K+ - ≥ 68.1 mV
92-3* Na+: 45.0 to 49.9 mV, or ≥ 68.1 Cl- - ≤ -68.1 mV
and you have recently
K+: 45.0 to 49.9 mV, or ≥ 68.1 installed a new cartridge:
a. Run 10 dummy samples of
Cl-: -39.9 to -35.0 mV, or ≤ -68.1 human serum.
b. Recalibrate the ISEs.
* Subcode: 1=Na+, 2=K+, 3=Cl- c. Resume operation. If alarm
If the slope value is:

Na+, K+: 45.0 mV ≤ Slope ≤
49.9 mV
Cl-: -39.9 mV ≤ Slope ≤ -
35.0 mV
a. Check control values. Are they
in range? If Yes go to b.
If No, stop routine analysis
and go to c.
b. Continue routine analysis.
Continue with c. following the
end of the routine analysis for
the day.
c. Is the slope value within the
marginal range above? If Yes
go to d.
If No go to f.
d. Did the slope value decrease
gradually over time? If Yes go
to e.
If NO go to f.
e. Replace the appropriate ISE
cartridge following the
instructions in Chapter 4 of
the User’s Guide.
f. If the slope value has either
decreased suddenly or is still
in the optimal range (Na+, K+ -
≥ 49.5 mV or Cl- - ≤ -39.9
mV), touch Maint./Wash (ISE)/
Start.
(continued on next page)
UG3S1-26.p65 18 25.11.2003, 13:56

ISE PREP 92-1 WARNING g. Run 10 dummy samples of

(cont.) to human serum.
92-3* h. Recalibrate the ISEs.
i. Resume operation. If the alarm
recurs, change the
appropriate ISE cartridge
following the instructions in
ISE SLOPE 93-1 WARNING During calibration, the slope a. Is the slope value beyond the
to exceeded the following limits: critical value specified in the
93-3* Na+: < 45.0 mV alarm description? If Yes go to
K+: < 45.0 mV b.
Cl-: > -35.0 mV* If No go to d.
* Subcode: 1=Na+, 2=K+, 3=Cl- b. Did the slope value decrease
gradually over time? If Yes go
to c.
If NO go to d.
c. Replace the appropriate ISE
cartridge following the
instructions in Chapter 4 of
the User’s Guide.
d. If the slope value has either
decreased suddenly or is still
in the optimal range (Na+, K+ -
49.5 mV or
Cl- - ≤ -39.9 mV), touch
Maint./Wash (ISE)/Start.
e. Run 10 dummy samples of
human serum.
f. Recalibrate the ISEs.
g. Resume operation. If the alarm
recurs, change the
appropriate ISE cartridge
following the instructions in
ISE I. STD 94-1 WARNING Internal reference (IS) concentration If slope is acceptable, touch Maint./
to calculated from a generated Wash (ISE)/Start and execute a
94-3* calibration curve was not within the wash.
following range: a. Check ISE standards on
Na+: 120 to 160 mEq/L sample disk.
K+: 3.0 to 7.0 mEq/L b. Check ISE reagents.
Cl-: 80 to 120 mEq/L c. Correct any other alarms.
* Subcode: 1=Na+, 2=K+, 3=Cl- d. Recalibrate.
UG3S1-26.p65 19 25.11.2003, 13:56

REF SHORT 95-3 WARNING ISE reference solution (KCl) volume a. Check KCl reagent volume on
< 30 mL. Reagent Volume Check report.
b. If volume is insufficient,
replace reagent bottle. Update
the volume of the KCl reagent
in ISE Test, KCl Channel,
parameter field 4. Execute
ISE Prime (REF.), and
recalibrate.
TWN 96-1 WARNING 1. With twin test mode selected, the a. Check the manufacturer’s
TEST? to second test was not specified. recommendations to ensure
96-36* 2. With twin test mode deselected, that the first test and second
a second test was specified. test are specified correctly in
3. In twin test mode, the two tests the twin test mode.
differed from each other in Test b. Verify that parameters are
Parameters in at least one of the correct in Test Parameters.
following parameters: assay
code-method, assay point,
reaction time, sample volume,
R1-R3 pipetting volume,
calibration type, calibration
concentration, calibration
position.
assignment.
CHEM. 98-1 WARNING 1. Relationship between analysis a. Verify the Assay Code (Mthd)
PARAM to method and measure point was and Assay Points 1-4 in Test
98-36* invalid. Parameters, parameter fields
2. Assigned photometric point 2 and 5-8.
lagged behind the specified b. Check the specified reaction
reaction time. time in Test Parameters,
* Subcode indicates the channel parameter field 4.
assignment.
UG3S1-26.p65 20 25.11.2003, 13:56

CLB. 99-1 WARNING 1. Relationship between assay a. Enter parameters, as indicated

PARAM to code and calibration type was by the manufacturer, in Test
99-36* invalid. Parameters.
2. Calibration points necessary for b. When running a nonlinear
calibration type have not been assay, assign three or more
entered. standards for that test.
3. Standard code necessary for
calibration has not been entered
or differs from the code in Test
Parameters.
4. Relationship between calibration
type and calibration method was
invalid.
5. Concentration value of standard
solution is not set in ascending
order.
7. ‘99’ (code reserved for water)
was specified for standard
position 2 and the concentration
is not equal to zero.
8. The code or position was not
assigned in Test Parameters.
assignment.
VOLUME? 100-1 WARNING 1. Total liquid volume up to the last Touch Parameters/Test Param.
to measuring point was >500 µl. and verify parameters are correct.
100-36* 2. Volumes of R1-R3 reagents
were all 0.
3. Some volume of reagent was
programmed to be pipetted after
the reaction time was completed.
4. Total liquid volume was <250 µl.
assignment.
UG3S1-26.p65 21 25.11.2003, 13:56

COMP. 103-1 WARNING Compensated test specifications are Touch Parameter/Test Param./
TEST to incorrect: Calc. Test/Comp. Test and verify
103-8* 1. A test used in compensation was that parameters are correct.
not measurable.
2. A compensated test was not
included in the formula.
3. A photometric compensated test
was specified as an ISE test.
* Subcode indicates the
compensated test formula
numbers.
S.INDEXES? 104-1 WARNING 1. The test used for serum index a. Specify Rate A assay in Test
to measurement did not have the Parameters for the test used
104-36* Rate A assay code specified. for serum index
* Subcode indicates the channel measurement.
assignment. b. When sample blank is
indicated, do not specify R2
discharge for test used for
serum index measurement.
ON 106-1 WARNING There is no channel for which Verify the necessary reagents are
BOARD? necessary reagents are prepared. available on the reagent disk.
REAG. 107-1 WARNING 1. The reagent positions entered in a. Verify that reagent positions
POS? to Test Parameters for one test are are entered in Test
107-38* the same as reagent positions Parameters.
entered for a different test. b. Verify carryover evasion
2. The reagent position entered in programming.
Carry Over Evasion is the same
as the reagent for the designated
test.
* Subcode indicates reagent
position.
CLB(IS)POS 108-1 WARNING Photometric calibrator or control Verify calibrator and control
positions entered as positions 55-57 positions in Test Parameters.
on the sample disk in Test When the ISE option is enabled,
Parameters with the ISE option positions 55-57 are reserved for
enabled. ISE calibrators.
UG3S1-26.p65 22 25.11.2003, 13:56

ACI ERROR 114-1 ºWARNING The barcode reader controller was a. Turn instrument OFF, then
to initialized unsuccessfully. back ON.
114-6* * Subcodes indicate: b. Resume operation. If alarm
1: Reserved recurs, call Technical Support.
2: Reserved
3: Sample
4: Reserved
5: Reserved
6: Transfer
FD WRITE? 119-1 WARNING A hardware error occurred when a. Clean the floppy disk drive as
writing the result data for routine described in Chapter 4 of the
samples. User’s Guide.
b. The useful life of a floppy disk
119-2 WARNING A hardware error occurred when is about 100,000 accesses.
writing the result data for STAT Replace the disk if you have
samples. exceeded 100,000 accesses.
119-3 WARNING A hardware error occurred when recurs, call Technical Support.
writing control result data.
119-4 WARNING A hardware error occurred when

writing within run and daily alarms.

writing parameters.

executing FD formatting, FD
copying, or FD cleaning.

writing cell blank data.

writing test selections for routine
samples.
UG3S1-26.p65 23 06.10.2003, 17:32

FD READ? 120-1 WARNING A hardware error occurred when a. Clean the floppy disk drive as
reading the result data for routine described in Chapter 4 of the
samples. User’s Guide.
b. The useful life of a floppy disk is
120-2 WARNING A hardware error occurred when about 100,00 accesses.
reading the result data for the STAT Replace the disk if you estimate
samples. the useage over 100,000
accesses.
120-3 WARNING A hardware error occurred when c. Resume operation. If alarm
reading the control result data. recurs, call Technical Support.

reading within run and daily alarms.

reading parameters.

reading cell blank data.

reading test selections for routine
samples.
NO FD 121-1 WARNING Incorrect disk is inserted in drive 1. a. Ensure that both floppy disks
are correctly inserted in the
121-2 WARNING Incorrect disk is inserted in drive 2. proper drives.
FD 123-1 WARNING The disk inserted in floppy disk a. Ensure that you are writing
PROTECT drive 1 is write-protected. appropriate information on the
correct disk.
123-2 WARNING The disk inserted in floppy disk b. Uncover the write protect notch
drive 2 is write-protected. on the disk.
PRINTER 125-1 WARNING Printer cables are disconnected. Contact Technical Support.
125-2 WARNING The printer lever is forward or the a. Verify that the printer lever is
printer is out of paper. pushed back.
b. Replace printer paper.
125-4 WARNING Printer hardware error occurred. Contact Technical Support.
125-5 WARNING Printer time-out error occurred.
UG3S1-26.p65 24 06.10.2003, 17:32

SYSTEM I/F 126-1 WARNING The text cannot be received from a. Verify that host computer is on.
the system within the b. Verify Host Com. on Start
predetermined period of time. Conditions screen 2.
c. Check cable connections
126-2 WARNING Data cannot be sent to the system between instrument and host
within the predetermined time computer.
period. d. Check host computer transmit
condition.
126-3 WARNING BCC or checksum error occurred. e. Verify that host computer and
instrument are using the same
126-4 WARNING A parity error occurred during data baud rate.
reception. f. Contact Technical Support.
126-5 WARNING Framing error occurred during data

reception.
126-6 WARNING Overrun error occurred during data

reception.
126-7 WARNING Frame error occurred.
126-8 WARNING The character count in the test

received is out of range.
126-9 WARNING The received text contains an illegal

character.
126-10 WARNING Sample information error occurred.
126-11 WARNING Test selection error occurred.
126-12 WARNING Comment information error

occurred.
126-13 WARNING Host received unusual characters

and could not receive until the final
code.
UG3S1-26.p65 25 06.10.2003, 17:32

WATER 130-1 WARNING Hitergent was not added to a. Place Hitergent in position 40
EXG. incubation bath during water on the reagent disk.
exchange. b. Touch Maint./Incub. Water/Start
to execute a bath exchange.
PANEL I/F 140-1 WARNING LCD communication error occurred. Contact Technical Support.
REAGENT? 141-1 WARNING Reagent volume for R1-R3 entered Verify reagent volumes for R1-R3 in
to as 0. Test Parameters.
141-36* *Subcode indicates channel
assignment.
CELL C.O. 145-1 WARNING More than 2 cell carryover evasions Verify carryover evasion information
to are specified for 1 test. specified in Parameters/Carry Over/
145-10* *Subcode indicates types of carry- Carry Over Evasions.
over evasions.
UG3S1-26.p65 26 06.10.2003, 17:32

Chapter 4
Maintenance

4.1 Maintenance Overview
Introduction
The following maintenance procedures are written for a trained operator with a
working knowledge of all instrument mechanical functions, LCD and software
functions. The instrument must be provided with proper care and maintenance to
ensure consistent and accurate functioning. As always, sample and reagent spills
should be cleaned up as they occur.
This chapter contains an overview of maintenance on the RD/Hitachi 902 analyzer
that includes discussions of the following:
• types of required cleaning solutions
• types of maintenance.
Also included in this chapter are scheduled (for example daily, weekly) and un-
scheduled (other) maintenance procedures, presented in order of Recommended
frequency. These recommendations are based on using the analyzer 8 hours per
day, 5 days per week. You may adjust your maintenance frequency based on your
laboratory’s actual use.
The procedures give step-by-step directions for performing the required mainte-
nance. The maintenance instructions are frequently divided into smaller procedure
blocks to help you organize your approach to maintenance.
A replacement part may be needed for a specific maintenance procedure. Part
descriptions and Roche Diagnostics catalog numbers are included in the Materials
Required table of each procedure and a complete list is supplied at the end of the
chapter.
Required Cleaning Solutions

To perform some maintenance procedures contained in this chapter, you must
prepare the specified cleaning solutions. Brief preparation instructions for the
required cleaning solutions are included below:
• Alcohol Ethanol or Isopropyl Alcohol
• Hitergent Roche Diagnostics catalog number 1223879 (1l)

must be added to a clean 50 ml bottle and placed in
position 40 on the reagent disk.
• Multiclean Roche Diagnostics catalog number 1360418 (2l)

is recommended for some maintenance procedures.
• ISE Cleaning Roche Diagnostics catalog number 1298500 (5x100ml),

Solution is required for the Wash ISE maintenance procedure.

4.1 Maintenance Overview
• ISE Washing Multiclean or ISE Cleaning Solution, depending on the used

Solution ISE reagents. Please contact your local Roche Diagnostics
organisation for detailed information.

4.2 Tracking Maintenance
Recommended Scheduled Maintenance

The following categories are listed on the analyzer log so that maintenance can be
updated or checked off as it is completed. The following list of scheduled mainte-
nance is based on operating 8 hours per day, 5 days per week. If your analyzer’s
operation exceeds this frequency, some items may need to be done more often.
Recommended Operator Analyzer
Procedure Frequency Time Time
Daily
Perform Daily Checks
Check Hitergent , pos. 40 Once a day 1 min. 0
Check waste solution reservoir Once a day 1 min. 0
Check printer paper Once a day 1 min. 0
Check Multiclean, pos. 39 Once a day 1 min. 0
Check water supply Once a day 1 min. 0
Incubation water exchange Once a day 1 min. 4 min.
Photometer Check Once a day 1 min. 2 min.
WashAll (end of workload) with Multiclean in reagent
pos. 39 and ISE washing solution in pos. W2 Once a day 1 min. 22 min.
ISE Prime(REF)/conditioning/calibration Once a day 2 min. 25 min.
Clean/adjust sample and reagent probes and stirrer Once a day 2 min. 1 min.
Clean instrument surfaces Once a day 1 min. 0
Read/Record incubation bath temperature Once a day 1 min. 0
Weekly
Wipe surface of reaction cell ring with wet gauze Once every 7 days 1 min. 0
Clean reaction cells with ISE Cleaning Solution pos. 39 Once every 7 days 2 min. 32 min.
Execute Cell Blank Once every 7 days 1 min. 10 min.
Clean cell rinse unit nozzles Once every 7 days 5 min. 0
Clean probe/stirrer rinse baths Once every 7 days 5 min. 0
Clean deionized water reservoir Once every 7 days 3 min. 0
Monthly
Replace reaction cells/clean bath and filter Once a month 15 min. 25 min.
Clean sample and reagent disk compartments Once a month 5 min. 0
Clean ISE drain plate Once a month 3 min. 0
Clean refrigerator condenser filter Once a month 5 min. 0
Replace ISE suction tubing and joint tubing Every 3 months 5 min. 10 min.
Quarterly
Clean inlet water filter Every 3 months 10 min. 0
Replace syringe seals Every 3 months 10 min. 5 min.
Semiannually
Replace ISE reference cartridge Every 6 months 5 min. 10 min.
Replace Nozzle Tip of Cell Rinse Unit Every 6 months 1 min. 0
As Needed
Replace photometer lamp As needed 5 min. 10 min.
Replace ISE measuring cartridges (Na+, K+, Cl-) As needed 5 min. 6 min.
Replace sample probe As needed 5 min. 1 min.
Replace reagent probe As needed 5 min. 1 min.
Replace stirrer paddle As needed 3 min. 1 min.
Load printer paper As needed 2 min. 0
Clean floppy disk drives As needed 1 min. 2 min.

4.3 Scheduled Maintenance
Structure of the Procedures

Each maintenance procedure is divided into two parts: Introduction and Procedure.
The Introduction provides important information about the procedure and includes:
• frequency
• materials required
• time required
• precautions.
The Procedure gives step-by-step directions for performing the required mainte-
nance. Notes, precautions, cautions, and warnings are included in the procedures,
when appropriate.
Spare Parts
A spare part may be needed for a specific maintenance procedure. The part’s
description and Roche Diagnostics catalog number are included in the Materials
Required table of each procedure’s Introduction. The catalog number is included to
help you locate replacement parts in your accessory box or ISE accessory case.
Refer to Chapter 5, Spare Parts, for a complete listing of spare parts. Use the
catalog number when ordering replacement parts.
For most efficient use of time, gather all required materials before starting a mainte-
nance procedure.
Introduction

4.4 Pre-operational Procedures
Check Hitergent Supply

Introduction
Hitergent is located in position 40 on the reaction disk. It is a non-ionic, bacterio-
static detergent solution that is automatically dispensed into the incubation bath by
the reagent probe during an incubation water exchange. Hitergent:
• acts as a surfactant to minimize the formation of bubbles on reaction cells
• reduces microbial growth in the tepid water
• enhances electrical conductivity used by the water level sensor.
Recommended frequency: daily

Operator time: approximately 1 minute
Analyzer time: none
Procedure
2. Check the level of detergent in the Hitergent bottle (position 40) to ensure
that at least 10 ml are present. Replace bottle with full bottle, if necessary.
3. Replace the reagent disk compartment lid.

Check Waste Solution Reservoir

Introduction
The waste solution reservoir is located at the rear of the analyzer. It receives sample
waste from the reaction cell rinse unit. Use the following procedure when the
reservoir needs to be emptied.
It is not necessary to check the waste solution reservoir when a waste drain connection is
n installed.

Materials Required
Disinfection Solution
Water for rinsing
Paper towels
Procedure
Contents of the waste solution reservoir, and subsequently the water used to rinse the
container, are potentially biohazardous. This waste should be handled, and disposed of, in an
appropriate manner. Wear rubber gloves when performing this procedure.
1. Locate the waste solution reservoir at
the back of the analyzer.
2. Lift the liquid-level sensor assembly
from the waste reservoir and place it
on paper towels or other absorbent
material.
3. Remove the drain hose from the waste reservoir, making sure any residual
waste in the hose drains into the waste container. Place the hose by the
liquid-level sensor on the paper towels.
4. Remove the waste container and dispose of its contents according to your
facility’s protocol for biohazardous waste disposal.
5. Rinse the waste container thoroughly with water and dispose of the rinse
water in the same manner.

6. Pour disinfection solution into the waste container until it is approximately 1

cm deep.
7. Place the waste container in its original position at the back of the analyzer.
8. Place the liquid level sensor assembly and drain hose in the waste con-
tainer.
9 Properly dispose of the paper towels.
Check Multiclean
Multiclean solution is used by the analyzer to automatically rinse the reaction cells
during the cell wash. It is located in position 39 on the reagent disk. A full 50 ml
bottle contains enough detergent for one cell wash (Wash All).
Materials Required Catalog Number

Multiclean 1360418 (2 l)
Check Printer Paper

Check that sufficient paper is loaded in the printer for the ensuing run. If not, refer to
the Load Printer Paper procedure in the Maintenance section for step-by-step
instructions.
Check Disk Drives

Check that the correct disks are installed in the floppy disk drives behind the right
front panel: parameter disk in drive 1, data disk in drive 2.

Check Water Supply

Introduction
Procedure
1. Locate the external water supply connection at the rear of the analyzer.
2. Check to be sure that the water supply valve is turned on.

4.5 Incubation Water Exchange
Introduction
An incubation bath exchange is required daily. This procedure is performed
automatically when the analyzer is powered on. If the analyzer power is not cycled
on/off in a 24 hour period, the incubation bath exchange must be initiated manually
as using the following procedure.
Recommended frequency: once every 24 hours
Analyzer time: approximately 4 minutes
Procedure
Use the following procedure to initiate the incubation water exchange function.
3. Touch to initiate the incubation bath exchange.


4.6 Photometer Check
Introduction
A Photometer Check verifies that the photometer lamp output remains at an accept-
able level (<13,000). The analyzer performs a check of the photometer and light
path.
A Photometer Check Report is automatically printed. Verify on the report that the
results for SUB and MAIN are similar for any given wavelength with no value greater
than 13,000.
Recommended frequency: once every 24 hours following the incubation bath
exchange
Procedure
Use the following procedure to initiate the Photometer Check function.
3. Touch to initiate the photometer check.


4.7 Wash Cells/Wash ISE
Introduction
This procedure should be performed at the conclusion of the daily run. The following
analyzer parts are cleaned:
• reaction cells
• sample probe
• reagent probe
• rinse unit nozzles
• stirrer.

Operator time: 1 minute
Analyzer time: 22 minutes
Materials Required: Catalog Number:

Sample Cup 394246
Wash Cells:
Multiclean 1360418 (2 l)
Wash ISE:
ISE Washing Solution - Multiclean 1360418 (2 l)
or
ISE Cleaning Solution 1298500 (5x100 ml)
The use of Multiclean or ISE Cleaning Solution is depending on the used ISE reagents. Please
n contact your local Roche Diagnostics organisation for detailed information.
Procedure-Wash Cells
1. Place 1 ml of Multiclean in position W1 of the sample disk.
2. Place a full 50 ml bottle of Multiclean in position 39 of the reagent disk.
4. Touch .
5. Touch to select Cells.
6. Touch to initiate the wash.

8. Touch to return to the Wash screen.

4.7 Wash Cells/Wash ISE
Procedure-Wash ISE
1. If ISE tests were run, place 1 ml of Multiclean (ISE Cleaning Solution) in
position W2 of the sample disk.
3. Touch .
4. Touch to select ISE.

If... then...
the analyzer is idle for four perform an ISE calibration and
hours or more after the run controls.
the analyzer is NOT idle for go to step 8.
four hours or more after the
8. Run 5 cups of serum pool or quality control material, then perform an ISE
calibration and run controls.
9. If the calibration results and/or control results are not acceptable, repeat
step 8.
ISE patient samples and ISE calibration must not be performed prior to completing step 8.
n

4.8 ISE Prime
Introduction
The ISE Prime should be performed daily when the ISE function is enabled on the
analyzer. The KCl line, sipper line and cartridges are primed to remove air that may
have leeched into the system from nonuse. This function should also be performed
after replacing any ISE components or ISE reagents.
Procedure
Use the following procedure to initiate the ISE Prime function.
4. Touch to initiate ISE Prime.


4.9 Clean/Adjust Sample and Reagent Probes and Stirrer
Introduction
The sample and reagent probes and stirring paddle should be cleaned and ad-
justed once a day to remove residual solution and precipitation and verify
alignment.
Operator time: approximately 2 minutes
Analyzer time: approximately 1 minute
Materials Required
Ethanol or Isopropyl Alcohol
Gauze squares
Probe and Stirrer Cleaning Procedure

1. Turn the analyzer power off.
2. Move the probe or stirrer forward.
3. Place a paper towel between the
probe tip/stirrer and analyzer surface.
4. To clean the probe, moisten a small
gauze square with ethanol or isopro-
pyl alcohol and wipe the probe from
top to bottom in a downward motion,
the entire length of the probe.
5. To clean the stirrer, moisten a small
gauze square with a Ethanol or
Isopropyl Alcohol and gently wipe the
stirrer in a downward motion. Moisten
another gauze square with deionized Clean Probe
water and remove any excess
detergent from the stirrer.
• Do not touch the probe tip with your hands.
• Do not place an alcohol pad on the surface of the analyzer as it may damage the finish.
• Use a new gauze pad for each probe to prevent cross contamination.
• Verify the probe has maintained its correct horizontal adjustment after cleaning. If
necessary, readjust the probe to the center of the reaction cell.
6. Move the probe/stirrer into the home position over the rinse bath.

Sample Probe Alignment Procedure

3. Touch .
4. Touch to select S. Probe (Horiz./Vert.).
5. Touch to initiate the sample

sample probe for correct alignment
positioned over the reaction cells, as
shown.
Sample probe alignment
length in an arc to position its tip over the reaction cell beneath it.
7. Initiate the horizontal/vertical adjustment using the table below. Check
sample probe alignment at each position. Touch to interrupt probe
adjustment.
Step Action
Touch . Sample probe moves to reaction cell.
Touch . Sample probe moves to home position.

When the sample probe is being replaced or when the sample cup configuration is
being change, a vertical probe adjustment must also be performed.
3. Touch .
4. Touch to select S Probe (Vert.).

5. Place empty tubes and/or cups on the sample disk according your
laboratory’s assigned sample container configuration. Use the table below
as a guide.
Sample Cup Configuration

Position Cup-on- Standard Test Standard Cup/ Standard Cup/ Test Tube/
Tube Cup Tube Test Tube Cup-on-tube Cup-on-tube
S1 Standard Standard Test Test Standard Test
Cup Cup Tube Tube Cup Tube
S2 Cup- Standard Test Standard Cup-on-tube Cup-on-tube
on-Tube Cup Tube Cup
W1 Standard Standard Standard Standard Standard Standard
Cup Cup Cup Cup Cup Cup
For example, if your laboratory’s sample cup configuration is cup-on-tube,

place the following configuration on the sample disk,
• Position 1, sample cup

• Position 2, cup-on-tube
• Position W1, sample cup
6. Touch to initiate the sample probe adjustment. The sample probe

automatically moves to the following positions when Start is touched and
then returns to the home position at the end of the cycle:
• Sample disk, position 1
• Sample disk, position 2
• Sample disk, position W1
7. The adjustment automatically stops after the probe returns to the home
position.

Reagent Probe Alignment Procedure

2. Touch .
3. Touch to select R Probe (Horiz.).
4. Touch to initiate the reagent

reagent probe for correct alignment
centered over the reaction cells, as
shown.
Reagent probe alignment
6. Initiate the horizontal adjustment using the table below. Check reagent
probe alignment at each position. Touch to interrupt probe adjust-
ment.
Step Action
Touch . Reagent probe moves to reaction cell.
Touch . Reagent probe moves to rinse bath.
Touch . Reagent probe moves to reagent disk, position 1.
Touch . Reagent probe moves to home position.

When the reagent probe is replaced, a vertical probe adjustment must also be
performed.
2. Touch .
3. Touch to select R Probe (Vert.).

4. Remove the reagent bottle from position 1 of the reagent disk.
5. Touch to initiate the vertical probe adjustment. The probe moves
over position 1 of the reagent disk and descends to the bottom of
position 1.
6. The adjustment stops automatically after the probe returns to the home
position.
7. Return the reagent bottle to position 1 on the reagent disk.
Stirrer Alignment Procedure

2. Touch .
3. Touch to select Stirrer.
4. Touch to initiate the stirrer adjustment. The stirrer moves over a

reaction cell on the reaction disk.
5. Visually confirm that the stirring
paddle is centered over the reaction
cell, as shown. If the stirring paddle is
not centered over the reaction cell,
contact Technical Support.
6. Verify that the tip of the stirring
paddle is 6 mm from the top of the
reaction cell.
Stirrer alignment
6. Touch to end the adjustment. The stirrer moves to the home

position.

4.10 Clean Instrument Surfaces
Introduction
All obvious spills should be cleaned up immediately. Use this procedure to ensure
that all instrument surfaces are clean.
Materials Required
Disinfection Solution
Cloth or paper towel
Procedure
Use a cloth or paper towel moistened with 2% Hitergent or 10% bleach solution to
clean spills from the surface of the analyzer.
Do not use alcohol to clean the instrument surfaces as alcohol may damage the finish.

4.11 Read/Record Incubation Bath Temperature
Introduction
Because incubation bath temperature is continuously monitored and displayed,
manual verification is not mandatory. This procedure is provided for your conve-
nience. The incubation bath temperature is displayed on the Status screen. The
temperature tolerance is 37 ± 0.1 °C.

NBS traceable thermometer Obtain from local source
Procedure
1. Ensure that the analyzer is in STAND-BY. If the analyzer has just been
powered on, allow 10 minutes for the bath temperature to stabilize.
3. Place the thermometer in the reaction
bath through the circular opening
used by the reagent probe to
dispense Hitergent into the incubation
bath. Use the thermometer in
accordance with the manufacturer’s
instructions.
4. Replace acrylic cover.
Record incubation bath temperature
Do not start the system while measuring the temperature of the reaction bath. The movement
of the reagent probe may damage your thermometer.
If the temperature is out of range, correct any instrument alarm conditions. If no instrument
n alarms are present, call Technical Support .

4.12 Weekly Wash Cells
Introduction
The following reaction cell washes should be performed weekly.
Recommended frequency: weekly
ISE Cleaning Solution 1298500 (5x100 ml)
Procedure
1. Replace Multiclean in position 39 of the reagent disk with a full 50 ml bottle
of ISE Cleaning Solution.
3. Touch .
4. Touch to select Cells.

8. Replace the ISE Cleaning Solution in position 39 of the reagent disk with a
full 50 ml bottle of Multiclean.
9. Repeat steps 5 through 7.
10. Perform a cell blank immediately following this procedure. See the next
section “4.14 Execute Cell Blank.”

4.13 Execute Cell Blank
Introduction
The analyzer’s reaction cells are made of plastic and must be replaced periodically
(monthly). Perform a cell blank once a week to ensure their integrity. A cell blank is
also performed after replacing the reaction cells or the photometer lamp, and after
cleaning the photometer window. During a cell blank, the analyzer adds water to
each reaction cell and reads the absorbance at all 12 wavelengths.
Procedure
2. Touch .
3. Touch to initiate the cell blank. The cell blank is complete when the
analyzer returns to STAND-BY.
4. Verify, on the report that is automatically printed, that the cell blank results
are:
• 13,000 or less for reaction cell #1
• ± 800 for reaction cells #2 through #48
for all wavelengths.
If the results do not fall within these ranges:
• perform a Wash (Cells) using the instructions in the this chapter,
and repeat the cell blank
• replace the reaction cells (if they have been used more than 1 month).

4.14 Clean Cell Rinse Unit Nozzles
Introduction
Use the following procedure to ensure that the cell rinse units are properly cleaned.

Ethanol or Isopropyl Alcohol
Gauze squares
Procedure
1. Remove the acrylic probe assembly cover and reaction system cover.
2. Moisten a small gauze square with Ethanol or Isopropyl Alcohol and gently
wipe, in a downward motion, the tips of the cell rinse unit nozzles.
3. Apply deionized water to another gauze square and wipe any excess
detergent from the nozzles.
4. Replace covers.

4.15 Clean Probe/Stirrer Rinse Baths
Introduction
Rinse baths are cleaned to prevent bacterial growth or precipitation that may clog
the bath.
Materials Required
50 cc syringe with tubing
0.5% sodium hypochlorite solution
Deionized water
Procedure
If the probes or stirrers are in the way, making it difficult to reach the rinse bath drain holes,
n perform a Probe Adjust (S. Probe, R. Probe or Stirrer) for that component on the Mainte-
nance screen. This moves the component out of the way.
1. Fill a 50 cc syringe (with tubing
attached) with 0.5% sodium hy-
pochlorite solution.
2. Inject the solution (empty the syringe)
into the drain hole of the sample
probe rinse bath as shown.
Clean rinse bath
3. Fill a 50 cc syringe with deionized water.

4. Inject the water (empty the syringe) into the drain hole of the sample probe
rinse bath.
5. Repeat steps 1 through 4 for the reagent probe rinse bath and the stirrer
rinse bath.

4.16 Replace Reaction Cells/Clean Bath and Filter
Introduction
The reaction cells are made of plastic and should be replaced monthly. At the same
time, the incubation (reaction) bath and bath filter are cleaned. This maintenance is
divided into six procedures and must be performed in the order specified:
1.. Remove Reaction Cells
2.. Clean Photometer Window and Incubation Bath
3.. Clean Incubation Bath Filter
4.. Install New Reaction Cells
5.. Perform a Cell Wash
6. Perform a Cell Blank
New reaction cells should be soaked overnight, completely submerged, in 2% Hitergent and
n rinsed with deionized water before installation. If an emergency makes this impossible, wipe
the outside of the new cells with full strength Hitergent, then rinse the cells with deionized
water before installation.
Recommended frequency: monthly

Precautions:
• Handle the reaction cells and reaction disk carefully.
• Do not scratch the photometer windows.
• Do not touch optical surfaces.
• Clean only the photometer window sides that are in contact with reaction bath water.
• Wear clean gloves when cleaning the reaction bath to prevent the introduction of
contaminants into the system.

Reaction cell set 1809407
Deionized water
Gauze squares
Reaction bath drain filter (if required)

Procedure 1 - Remove Reaction Cells

1. Remove the acrylic cover, the small
sipper nozzle cover, and reaction
system cover.
2. Loosen the three retaining nuts
securing the rinse unit. Carefully lift
the entire unit off of the mounting
bracket and set it aside.
Remove cell rinse unit
3. Loosen the sipper nozzle retaining nut

and remove the nozzle.
Retaining nut
––––
–––
–––
–
Loosen retaining nut
4. Loosen and remove the thumbscrew

on each reaction cell section and set
them aside. (The thumbscrews will be
reused when new reaction cells are
installed.)
5. Lift each reaction cell section out of
the reaction disk and discard it.
Loosen thumbscrews

Procedure 2 - Clean Photometer Window and Incubation Bath

3. Touch to initiate the water exchange; the reaction bath begins to

drain, however, just before all the water drains, power off the instrument to
keep it from filling up again.
An alternate method of draining the reaction bath is to use a 50 cc syringe to manually
n remove the water. The instrument must be powered off.
Do not scratch the photometer windows. Clean only where they come into contact with the
reaction bath water. Use only gauze moistened with 2% Hitergent.
4. Loosen the three retaining nuts and
remove the reaction disk from the
analyzer.
Remove reaction disk
5. Using a clean moistened gauze

square, carefully wipe the photometer
windows.
Clean photometer window

6. Using a clean moistened gauze

square, carefully wipe the inside
surfaces of the reaction bath.
Clean reaction bath
Procedure 3 - Clean Reaction Bath Filter

1. Remove the reaction bath drain filter
located at the outlet port inside the
reaction bath.
2. Wash (backflush) the filter with

deionized water and reinstall into the
outlet port.
Clean reaction bath filter
3. Using a beaker, fill the reaction bath with 500 ml of deionized water. This
eliminates foaming that may occur at power on.
Do not spill water into the instrument as this could damage sensors or internal mechanisms.

Procedure 4 - Install New Reaction Cells

1. Reinstall the reaction disk and tighten the three retaining nuts ensuring that
the pin on the analyzer aligns with the hole in the top of the reaction disk.
2. Place the new reaction cell sections in

the reaction disk, handling them by
their edges only. Do not touch the
optical surfaces.
Install new reaction cells
3. To ensure that each reaction cell

section is seated properly, align the
pins.
Align pins
4. Reinstall the thumbscrews securely.

5. Reinstall the sipper nozzle.
6. Reinstall the rinse unit into its proper position over the reaction disk.
7. Finger-tighten the retaining nut on the rinse unit mounting bracket.
7. Replace the reaction system cover, the sipper nozzle cover, and the acrylic
cover.
8. Turn the instrument power on.

Procedure 5 - Perform Cell Wash

2. Touch to select “Cells” on the Wash screen.
3. Touch the button to perform the cell wash.
Procedure 6 - Perform Cell Blank

1. Perform a Cell Blank from the Maintenance screen to check the integrity of
the reaction cells, prior to operating the analyzer. This is most efficiently
performed after all monthly maintenance procedures have been completed.
2. Check the printed Cell Blank report. If cell #1 is not < 13,000, or the remain-
ing cells #2 through #48 are not within ± 800, perform the Wash (Cells)
function from the Maintenance screen and repeat the cell blank.

4.17 Clean Deionized Water Tank
Introduction
The deionized water tank may or may not require frequent cleaning depending upon
the quality of the water supply. As a precaution, clean the water tank weekly.
Precautions:
• The instrument must be off.
• The external analyzer water supply must be off.
• Wear clean gloves when handling internal water system components to
assist in preventing the introduction of contaminants into the system.
Materials Required
Paper towels
Deionized water
Procedure
1. Turn the power switch to the off position.
2. Open the front doors of the analyzer.
Open the analyzer doors

3. Place paper towels under the hose

unit to absorb extra water. Turn off
the water supply by closing the
manual valve on the water hose.
Close the manual valve
4. Separate the joint that connects the

water supply tank and the water
hose.
Separate the water hose joint
5. Remove the water supply tank.
Remove water supply tank

6. Remove the float assembly from the

tank and place it on a paper towel,
then empty the water from the tank.
k
–
Remove float assembly
If... then...
quarterly maintenance go to section 4.21, step 7.
is being performed at this
time
quarterly maintenance step 7 on this page.
is not being performed at
this time
7. Rinse the reservoir several times with deionized water.

8. Refill the tank with deionized water.
9. Replace the float assembly and place the tank inside the analyzer.
10. Reconnect the water hose to the water supply tank and open the manual
valve.
11. Power the analyzer on

4.18 Clean Sample and Reagent Disk Compartments
Introduction
The sample and reagent disk compartments should be cleaned monthly to eliminate
residue from condensation and sample and reagent spills. Spills should be cleaned
up when they occur. If excessive condensation occurs, the disk compartments may
need to be cleaned more frequently.
This maintenance includes two procedures:
1 Clean Sample Disk Compartment
2 Clean Reagent Disk Compartment

Operator time: Approximately 5 minutes
Precautions:
• The instrument must be in STAND-BY or off.
• Handle the sample and reagent disks carefully.
• Do not scratch the barcode reader window.
Materials Required
Paper towels
Gauze squares
DI water
Procedure 1 - Clean Sample Disk Compartment

1. Remove the sample disk compartment lid.
2. Grasp each of the white snap fasten-

ers on the inner ring of the sample
disk and pull upward to unfasten the
snaps.
Unfasten snaps

4.18 Clean Sample/Reagent Disk Compartment
3. Lift the sample disk from the analyzer

and place it on a flat surface.
Remove sample disk
4. Wipe the barcode reader with a clean

gauze square using deionized water.
Clean sample barcode reader
5. Wipe the inside of the sample disk

compartment with gauze or a paper
towel.
Clean sample disk compartment
4-36 Roche Diagnostics/Hitachi 902 Analyzer User’ Guide V1.2

6. Replace the sample disk and press down on the white snap fasteners to
secure the disk. Make sure the hole in the sample disk aligns with the
sample disk pins.
7. Replace the sample disk compartment lid.
Procedure 2 - Clean Reagent Disk Compartment

2. Grasp each of the white snap fasten-
ers on the reagent disk and pull
upward to unfasten the snaps.
Unlock snap fasteners
3. Remove the reagent disk from the

analyzer and place it on a flat, stable
surface.
Remove reagent disk

4. Wipe the inside surface of the reagent

disk compartment with paper towels
or other absorbent material to remove
any foreign material (for example,
spills, condensation).
Clean reagent disk compartments
5. Reinstall the reagent disk. Make sure the hole in the reagent disk aligns with
the reagent disk pin.
6. Press each white snap fastener down to secure the disk.
7. Replace the reagent disk compartment lid. Verify that the opening in the
reagent cover is in the proper position between the guide bars on the top of
the analyzer to allow the reagent probe access to the reagent bottles.

4.19 Clean ISE Drain Plate
Introduction
Performance of this procedure prevents clogging of the ISE drain.

Operator time: 3 minutes

• Wear disposable gloves when handling the ISE drain plate. Contents passing through
the drain plate are potentially biohazardous.
Materials required
Gauze
Deionized water
Procedure
1. Loosen the thumb screws and
remove the ISE drain plate.
Loosen thumb screws
2. Wipe the bottom of the ISE drain plate

using gauze soaked in deionized
water. Be sure to remove all crystals.
3. Replace the ISE drain plate and

tighten the thumb screws.
Clean ISE drain plate

4.20 Clean Refrigerator Condenser Filter
Introduction
The refrigerator condenser filter must be kept free of dust and dirt accumulation.
Perform this procedure monthly.
Precautions:
• Instrument power must be in STAND-BY or off.
• Take care not to bend the condenser cooling fins.
• DO NOT use compressed air to clean the condenser cooling fins as
this will blow dust and dirt into the analyzer.
Materials Required
Paper towels
Water for rinsing
Vacuum cleaner
Procedure
1. Turn instrument power off or wait for STAND-BY.
2. Remove the refrigerator condenser
filter from its retaining bracket in front
of the condenser.
3. Rinse the filter with water, or vacuum.
Blot dry with paper towels.
Remove condenser filter
Avoid touching the cooling fins on the condenser unit as they are very sharp and can cause
personal injury.
4. Reinstall the condenser filter.

5. Turn the instrument power on, if powered off during the procedure.

4.21 Replace ISE Suction Tubing and Joint Tubing
Introducton
The ISE pinch valve and joint tubing must be replaced quarterly.
Recommended frequency: quarterly
This maintenance includes four procedures:

1 Disassemble ISE compartment
2 Replace Suction Tubing
3 Replace Joint Tubing
4 Reassemble ISE compartment
5 ISE Prime/Calibrate
Precaution:
The instrument must be in STAND-BY or off.

Sipper tube set 1 1809725
Sipper tube set 2 1809733
Procedure 1 - Disassemble ISE compartment

2. Loosen the screw on the ISE
compartment door by turning it
counterclockwise, then raise the door.
Remove ISE cover

3. Press the ISE locking lever to the right

to release the cartridges in the
mounting block.
Press ISE locking lever
4. Remove the silver bracket by loosen-

ing the black thumbscrews. (Do not
remove the black thumbscrews.)
Remove silver bracket
5. Disconnect the lead wires from each

measuring cartridge and remove the
measuring cartridges.
Disconnect lead wires

Procedure 2 - Replace Suction Tubing

1. Remove the sipper nozzle cover.
Remove the sipper nozzle cover
2. Remove the clear acrylic block

seated below measuring cartridges
with the suction tube attached.
Remove suction tube cartridge
3. Disconnect the suction tube from the

block.
Disconnect suction tube

4. Disconnect the suction tube from the

sipper nozzle and remove the suction
tube from the pinch valve.
Sipper Nozzle
5. Connect the new suction tube to the
––––
––––
suction nozzle.
6. Thread the suction tube through the
stabilizing unit and connect it to the
clear cartridge.
Pinch Valve
Pinch valve/sipper nozzle
7. Replace the clear block with the

suction tube to the left.
8. Replace the measuring cartridges and
reconnect the lead wires.
9. Press the ISE locking lever to the left
to secure the measuring cartridges in
the mounting block.
Replace suction tube and block
Procedure 3 - Replace Joint Tubing

1. Disconnect both lead wires from the
reference cartridge.
2. Remove the reference cartridge.

3. Disconnect the joint tubing and Joint tubing

replace it with new tubing.
4. Replace the reference cartridge.
5. Reconnect the lead wires.
Disconnect and replace joint tubing
Procedure 4 - Reassemble the ISE Compartment

1. Replace the silver bracket and tighten
the black thumbscrews to secure the
bracket. The black wire from the
reference electrode should be in front
of the silver bracket.
2. Close the ISE compartment door and
secure it by turning the screw
clockwise.
Tighten black thumbscrews
3. Replace the acrylic cover and suction tube cover.

4. If the instrument was off during cartridge replacement, turn the power switch
back on.
Procedure 5 -ISE Prime/Calibrate

1. Perform an ISE Prime from the Maintenance screen. On the ISE Prime
screen, touch Mode to select REF. Perform the ISE Prime - (REF.) two times.
2. Calibrate the ISE system before assaying samples. Follow the instructions
for ISE calibration found in the Daily Start Up section of the Tutorial Guide. If
calibration fails, a problem is indicated and should be investigated. Refer to
the Troubleshooting and Alarms sections of the User’s Guide.

4.22 Clean Inlet Water Filters
Introduction
Performance of this procedure prevents clogging of the water system and the
reaction bath drain.
Recommended frequency: quarterly
Precautions:
• The instrument must be off.
• The external analyzer water supply must be off.
• Wear clean gloves when handling internal water system components to
assist in preventing the introduction of contaminants into the system.

Water tank filter 1809245
(if replacement is required)
Paper towels
Deionized water
500 ml beaker
The deionized water tank must be cleaned weekly. Refer to section 4.17 “Clean Deionized
n Water Tank,” of this guide for detailed instructions.
Procedure-Clean Water Tank Filter

1. Turn the power switch to the off position.
2. Open the front doors of the analyzer.
Open the analyzer doors

3. Place paper towels under the hose

unit to absorb extra water. Turn off
the water supply by closing the
manual valve on the water hose.
Close the manual valve
4. Separate the joint that connects the

water supply tank and the water
hose.
Separate the water hose joint
5. Remove the water tank.
Remove water supply tank

6. Remove the float assembly from the

tank and place it on a paper towel,
then empty the water from the tank.
Remove float assembly
7. Remove the round plastic lip from the

water tank opening.
Remove round plastic lip
8. Reach into the water supply tank and

remove the filter assembly by turning
it counterclockwise.
Remove filter assembly

9. Remove the water filter from the

filter assembly and rinse it with
deionized water.
–
–––––––
Removing water filter
10. Replace the filter into the filter assembly and screw the filter assembly
into the water supply tank.
11. Replace the round plastic lip on the water supply tank.
12. Fill the tank with deionized water.
13. Replace the float assembly and place the tank inside the analyzer.
14. Reconnect the water hose to the water supply tank and open the manual
valve.
15. Power the analyzer on.

4.23 Replace Syringe Seals
Introduction
Syringe seals should be replaced every 500 hours of operation. Based on the
analyzer working 8 hours per day, 5 days per week this frequency is every three
months. If your analyzer’s work load is higher, syringe seals may require more
frequent replacement.
This maintenance includes five procedures:
1 Disassemble Syringe
2 Expose Syringe Seal
3 Replace Sample Syringe Seal
4 Replace Reagent and SIP Syringe Seal
5 Reassemble Syringe
Recommended frequency: quarterly or every 500 hours, whichever comes first

Precautions:
• The instrument must be in STAND-BY or Off.
• Do not crimp (bend) syringe tubing.
• Perform the entire seal replacement procedure on one syringe before
proceeding to the next.
• Wear gloves when handling syringe components and tubing to
prevent introduction of contaminants into the system.

Sample syringe:
Syringe barrel O-ring 0685917
Syringe Holder O-ring 1900404
Upper Seal Piece 1568477
Lower Seal Piece 1568485
Press Piece 1568523
Collar 1703838
Reagent and SIP syringe:
Syringe barrel O-ring 0685917
Syringe Holder O-ring 0989142
Upper Seal Piece 1568493
Lower Seal Piece 1568507
Press Piece 1568531
Spanner wrench 0778427

Absorbent towels
Gauze squares

Procedure 1 - Disassemble Syringe

1. Open the front analyzer panels.
2. Hold a dry gauze square or other
absorbent material next to the side
tubing on the pipettor, then discon-
nect this tubing by turning its retaining
nut counterclockwise. Disconnect the
top tubing by turning it counterclock-
wise. Use a gauze square to absorb
water as it drains from the tubing.
Disconnect syringe tubing
IF YOU ARE REPLACING.... THEN...
a sample pipettor seal proceed to step 3.
a reagent or SIP pipettor seal proceed to step 6.
3. Loosen the blue knurled locking

screw from the top of the syringe
assembly by turning it counterclock-
wise.
Loosen locking screw

4. Carefully pull the syringe assembly

out of its mounting block. With one
hand, support the glass barrel. With
the other hand, grasp the syringe
holder and lift up, then out to remove
the assembly. Make sure the plunger
is removed from the U-shaped slot.
Remove syringe assembly
5. Remove the glass syringe barrel.

Remove the O-ring from the top of the
barrel. Set them aside in a safe place.
Remove the O-ring that fits below the
syringe barrel and set in a safe place.
Proceed to Expose Syringe Seal on
next page.
Remove O-ring
6. Completely unscrew the knurled

locking screw from the top of the
pipettor assembly by turning it
counterclockwise.
Loosen locking screw

7. Carefully lift the syringe barrel out of

the top of the pippetor assembly.
Remove syringe assembly
8. Remove the plunger from the U-shaped slot and lift the plunger assembly
out..
9. Set the syringe and plunger aside in a safe place. Remove the O-ring that
fits below the syringe barrel and set aside to be reinstalled. Proceed to
Expose Syringe Seal.
Procedure 2 - Expose Syringe Seal

1. Turn the syringe holder upside down and expose the plunger retaining
screw.
2. Apply the spanner wrench to the plunger retaining screw and turn the screw
counterclockwise until it is loose.
Remove reagent plunger Remove sample plunger

retaining screw retaining screw
3. Turn the syringe holder right side up and carefully lift the syringe holder off
the plunger. Leave all of the parts on the plunger.

IF YOU ARE REPLACING... THEN...

the sample syringe seal continue with Procedure 3,
Replace Sample Syringe Seal.
the reagent or SIP syringe seal proceed to Procedure 4,

Reagent and SIP Syringe Seal.
Procedure 3 - Replace Sample Syringe Seals

1. Remove the upper seal (1) from the
plunger. Slide off the metal collar (2),
then remove the press piece (3) and
the lower seal (4).
2. Wipe the plunger with a gauze square
to remove any debris. 3 1
4 2
The lower seal has a thicker base than the
n upper seal.
Remove sample syringe seals
3. Ensure that the retaining screw (7), the

plunger holder (6) and spring (5) are
positioned on the plunger, then place
a new lower seal (4) onto the plunger,
closed end first. 7
5 3 1
4. Thread the new press piece (3) onto
the plunger, and follow it with the 6 4 2
metal collar (2).
5. Replace the upper seal (1), open end
first, onto the plunger. The upper seal
should fit into the narrower end of the
metal collar. Replace sample syringe seals

Do not overtighten the syringe retaining screw. If the retaining screw is overtightened, the seal
piece wears out quickly and the plunger may bend, requiring replacement.
6. Place the plunger back into the

syringe holder. With the syringe
oriented vertically, tighten the retain-
ing screw with the spanner wrench
until it is just snug with the syringe
holder.
7. Proceed to Procedure 5, Reassemble
Syringe.
Replace retaining screw
Procedure 4 - Replace Reagent and SIP Syringe Seals

1. Remove the upper seal piece (1),
press piece (2) and lower seal piece
(3) from the plunger.
2. Wipe the plunger with a gauze square 1
3
or other absorbent material to remove
any debris.
2
Remove syringe seals

3. Ensure that the retaining screw (5) and

spring (4) are positioned on the
plunger and place a new lower seal 5
2
(3) onto the plunger, with its rounded 4
end up.
3
4. Place the new press piece (2) on the
plunger.
The lower seal has a thicker base than the
n upper seal.
Replace syringe seal
5. Replace the upper seal piece on the

plunger, making sure the rounded end
is down.
Do not overtighten the syringe retaining screw. If the retaining screw is overtightened, the seal
piece wears out quickly and the plunger may bend, requiring replacement.
6. Place the plunger back into the

syringe holder. With the syringe
oriented vertically, as shown, tighten
the retaining screw with the spanner
wrench until the screw is just snug
with the syringe holder. The syringe
screw will be about 1.5 to 2 cm
above the edge of the syringe holder.
Reinstall retaining screw
7. Proceed to Procedure 5, Reassemble Syringe.

Procedure 5 - Reassemble Syringe

1. Inspect the O-ring on the syringe holder. If the O-ring is damaged, replace
it.
2. Inspect the syringe barrel for chips or cracks at the top and bottom. If the
syringe barrel is etched or damaged in any way, it should be replaced.
3. Place the syringe barrel O-ring on top of the syringe barrel, if needed. It is
easier to place the O-ring back on the barrel if the O-ring is wet.
If the syringe holder is not properly seated in its mounting block recess, damage to the syringe
assembly may occur.
IF YOU ARE REPLACING.... THEN...
a reagent or IS pipettor seal proceed to step 4.
a sample pipettor seal proceed to step 5.
4. Place the syringe holder back onto its

mounting block by tilting the top of
the syringe toward the analyzer. The
notched (bottom) end of
the plunger must be secured
within the U-shaped notch of the
stepper motor. Insert the glass barrel
through the top bracket. Ensure that
the syringe holder is in the recess on
the top surface of the mounting block.
Carefully insert the syringe barrel into
the top of the pipettor assembly.
Proceed to step 7. Reinstall barrel and holder

5. Place the syringe barrel over the

piston, onto the syringe holder, as
shown. It is easier to place the barrel
back on if the barrel and syringe
holder are dry. Place the syringe
holder back onto its mounting block
by tilting the top of the syringe toward
the instrument. Ensure that the
syringe holder is in the recess on the
top surface of the mounting block.
Carefully insert the syringe barrel into
the top of the pipettor assembly. Replace syringe assembly
6. Rotate the syringe holder until the

side tube port is positioned to accept
the syringe tubing.
7. Finger-tighten the top knurled locking
screw. Ensure that the syringe
assembly is seated correctly (not
loose or crooked) and the O-ring is
properly positioned. The O-ring
should be centered in the hole at the
top of the knurled locking screw.
Finger-tighten locking screw
The top and side tubing retaining nuts can be damaged if excessive force is applied when
replacing them. Take care not to cross-thread these nuts.
8. Reconnect the syringe’s top tubing and finger-tighten its retaining nut.
9. Reconnect the side tubing and finger-tighten its retaining nut.
10. If the analyzer is powered off, turn the power on.

For Sample and Reagent Pipettors

3. Touch to initiate analyzer reset.
For SIP Pipettors

4. Touch to initiate ISE prime.

4.24 Replace ISE Reference Cartridge
Introduction
The reference cartridge should be replaced if the slope values of the Na+, K+ and Cl-
measuring cartridges are out of acceptable limits or unstable.
This maintenance includes three procedures:
1 Remove Old Cartridge
2 Install New Cartridge
3 Perform ISE Prime/Calibrate
Recommended frequency: semiannually

Precautions:
• Wait until a requested function is complete before attempting another
keyboard entry.
• Wear disposable gloves when handling internal ISE system components
to assist in preventing the introduction of contaminants into the system.

Reference cartridge 1403826
Large tweezers obtain locally
Phillips screwdriver obtain locally
Paper towels obtain locally
Procedure 1 - Remove Old Cartridge

1. Remove acrylic cover.
2. Loosen the screw on the ISE compart-
ment door by turning it counterclock-
wise, then raise the door.
Loosen compartment door screw

3. Remove the silver bracket by loosen-

ing the black thumbscrews. (Do not
remove the black thumbscrews.)
Loosen black thumbscrews
Remove silver bracket
4. Disconnect the lead wire from the

reference cartridge, then remove the
cartridge.
Disconnect lead wire

Procedure 2 - Install New Cartridge

1. Hold the joint tubing away from the
reference cartridge seating and place
the new reference cartridge into the
seating.
Install new cartridge
2. Reconnect the lead wire.
Reconnect lead wire
3. Replace the silver bracket and tighten

the black thumbscrews to secure the
bracket. The black wire from the
reference electrode should be in front
of the silver bracket.
Replace silver bracket

4. Close the ISE compartment door and secure it by turning the screw clock-
wise.
6. If the instrument was off during cartridge replacement, turn the power switch
back on.
Procedure 3 - Prime ISE and Calibrate

1. Perform an ISE Prime from the Maintenance screen. On the ISE Prime
screen, touch Mode to select REF. Perform the ISE Prime - REF two times.
2. Perform an ISE check (5 cycles) from the Tools screen and check the printed
report. Verify that the ranges are within those indicated in the Reports
section of the Software Guide.
calibration fails, a problem is indicated and should be investigated (refer to
the Troubleshooting and Alarms sections of the User's Guide).

4.25 Replace Nozzle Tip of Cell Rinse Unit
Introduction
The nozzle tip of the cell rinse unit should be replaced semiannually.

Nozzle Tip (Teflon Block) 1900587
• Instrument power must be off.
Procedure
1. Remove the rinse unit by releasing the retaining screw and lifting the unit
up.
2. Pull the Nozzle tip off the probe, as illustrated in the diagram and fit a new
tip.
3. Refit the rinse unit and check if the probe with the Nozzle tip sits correctly in
the reaction cell.

4.26 Replace Photometer Lamp
Introduction
The photometer lamp should be replaced if any of the daily photometer check
values exceed 13,000.
This maintenance includes four procedures:
1 Remove Reaction Disk
2 Replace Photometer Lamp
3 Reinstall Reaction Disk
4 Check Performance/Calibrate
Recommended frequency: as needed

Precautions:
• Instrument power must be off.
• Allow old lamp to cool before replacing.
• Do not touch or clean the glass surface of the new photometer lamp.
• Take care not to damage the reaction cells while the reaction disk is off
the analyzer.

Photometer lamp 0641600
Phillips screwdriver obtain locally
Gauze squares obtain locally
Procedure 1 - Remove Reaction Disk

1. Turn the instrument power switch off.
2. Remove the acrylic cover and the reaction system cover.
3. Turn the retaining nut on the reaction
cell rinse unit counterclockwise. When
the nut is loosened completely,
carefully remove and place the entire
unit aside.
Remove cell rinse unit

4. Loosen the retaining nut on the reaction disk and remove the reaction disk.
5. Carefully lift the reaction disk from the analyzer. Place the disk on a flat,
stable surface on a paper towel.
Procedure 2 - Replace Photometer Lamp

1. Remove the black and red photom-
eter lamp lead wire connector nuts.
Set them aside in a safe place.
Remove lead wire connector nuts
2. Remove the lead wires from the

connector posts.
Remove lead wires

3. Loosen the screws on top of the

photometer water jacket with a
Phillips screwdriver.
Loosen water jacket screws
4. Lift the water jacket containing the

photometer lamp from the analyzer.
Remove water jacket
5. Loosen screws on the lamp base with

a Phillips screwdriver
Loosen lamp screws

6. When both screws are sufficiently

loosened, the lamp can be removed
from its water jacket. The lamp
mounting screws are threaded so that
they are not easily removed from the
lamp base plate. This prevents them
from falling into the interior of the
analyzer.
Remove photometer lamp
7. Remove the new lamp from its

packaging. Do not touch or clean the
glass surface of the lamp.
8. Insert the new lamp into the water
jacket.
9. The alignment pin on the side of the
water jacket must be inserted into the
pin alignment in the lamp’s mounting
base.
Align pin on mounting base
10. Tighten the lamp mounting screws

until snug; do not overtighten them.
Tighten Lamp Screws

11. Replace the water jacket on the

analyzer. Tighten the water jacket
screws.
Tighten water jacket screws
12. Place the lamp lead wires on the

threaded connector posts. The lamp
lead wires are not color coded and
either wire may be connected to
either post.
Replace lead wires
13. Replace the black and red lead wire

connector nuts and finger-tighten. Do
not allow the lead wires to rotate as
the connector nuts are tightened. It
does not matter which connector nut
is placed on which lead wire.
Replace connector nuts

14. With a clean, dry gauze square,

carefully wipe the inside surfaces
of the U-shaped reaction disk photo
detectors.
Clean reaction disk detectors
Procedure 3 - Reinstall Reaction Disk

1. Reinstall the reaction disk, aligning the guide pin on the reaction disk shaft
with the pin hole in the reaction disk.
2. Return the reaction cell rinse unit to its proper position over the reaction
disk.
3. Finger-tighten the knurled nut on the cell rinse unit mounting bracket.
4. Replace the reaction system cover and the acrylic cover.
Procedure 4 - Check Performance/Calibrate

1. Turn the analyzer power switch on and wait for the analyzer to enter STAND-
BY and for the temperature to stabilize. Check the Status screen for the
incubation bath temperature when the analyzer is in STAND-BY.
2. Perform a cell blank from the Maintenance screen. The cell blank is com-
plete when the analyzer returns to STAND-BY.
Check the printed Cell Blank report to verify that cell #1 is <13000, and that
the remaining cells (#2 through #48) are within ± 800.
3. Recalibrate all photometric chemistries prior to assaying controls and other
samples (refer to the How to... section of the Tutorial Guide).

4.27 Replace ISE Measuring Cartridges
Introduction
The electrical response of each measuring cartridge decreases gradually with the
length of time it is in use, and is dependent upon proper maintenance. An ISE
cartridge must be replaced when its slope falls outside of the critical slope values:
Cartridge Optimal Slope Critical Slope

Sodium (Na+) 50.0 to 68.0 < 45
Potassium (K+) 50.0 to 68.0 < 45
Chloride (Cl-) -40.0 to -68.0 > -35
When the slope is outside the optimal value range listed above, an ‘ISE Prepare’
alarm is displayed on the screen and a ‘PREP’ alarm is printed. This alarm alerts
you that a cartridge may need to be replaced. The cartridge that caused the alarm
may continue to be used if all controls are still in range. If any controls are out of
range or the slope falls outside the critical value, the cartridge must be replaced. An
‘ISE Slope’ alarm is displayed on the screen and a ‘SLOPE?’ alarm is printed when
the values exceed the critical slope listed above.
This maintenance is divided into three procedures:
1 Remove Old Cartridge(s)
2 Install New Cartridge(s)
3 Prime Lines/Check Performance

Precautions:
keyboard entry.
• Wear clean gloves when handling internal ISE system components to
assist in preventing the introduction of contaminants into the
system.
+
Sodium (Na ) cartridge 0825468
Potassium (K+) cartridge 0825441
Chloride (Cl-) cartridge 1069004
Large tweezers obtain locally

Procedure 1 - Remove Old Cartridges

2. Loosen the screw on the ISE compart-
ment door by turning it counterclock-
wise, then raise the door.
Remove ISE cover
3. Press the ISE locking lever to the right

to release the cartridges in the
mounting block.
Press ISE locking lever
4. Disconnect the lead wires from each

measuring cartridge.

4. Remove the cartridges from the

mounting block.
Remove cartridges
Check the expiration date on the new cartridge. Do not use any outdated cartridge.
Procedure 2 - Install New Cartridge

1. Replace the expired cartridge with a new one, keeping all three cartridges in
their original order.
If the cartridges are not seated properly, the ISE assembly may leak, resulting in a malfunc-
tion.
2. Make certain that the O-ring on the upper side of each cartridge and the
base is dry when the cartridges are fitted together.
3. The cartridges must be stacked in the following order, from top to bottom:
Type Color Position
Chloride (green) Top
Sodium (yellow) Middle
Potassium (red) Bottom

4. Install the cartridges in the correct orientation.

5. Push the locking lever to the left to secure the cartridges.
6. Reconnect the color-coded lead wires to their respective cartridges. The
lead wires must be connected to the proper cartridges.
If any spilled or leaked liquid is visible in the ISE compartment, clean and dry the compart-
ment as thoroughly as possible. Liquid and air leaks can prevent the ISE system from
operating properly.
7. Close the ISE compartment door and tighten the screw.
Procedure 3 -ISE Prime/Calibrate

1. If the analyzer was off during cartridge replacement, turn the power switch
back on.
2. Perform an ISE Prime (REF.) from the Maintenance screen. The prime is
complete when the analyzer returns to STAND-BY.
3. Perform an ISE check (5 cycles) from the Tools screen and check the printed
report. Verify that the ranges are within those indicated in the Reports
section of the Software Guide.
calibration fails, a problem is indicated and should be investigated (refer to
the Troubleshooting and Alarms sections of the User's Guide).

4.28 Replace Sample Probe
Introduction
Replacing the sample probe is necessary only when a sample probe is bent or
otherwise damaged. You may, however, need to remove the probe for cleaning.
This maintenance includes three procedures:
1 Remove Sample Probe
2 Install New Sample Probe
3 Check/Adjust Probe Alignment

Analyzer time: approximately 1 minute
Precautions:
• The instrument must be in STAND-BY or off during probe replacement.
keyboard entry.
• Wear disposable gloves when handling probe seals to assist in preventing the introduc-
tion of contaminants into the system.

Sample probe 1809288
Cleaning wire kit 0641766
Procedure 1 - Remove Sample Probe

1. Ensure that the instrument is in STAND-BY or off. Remove the acrylic probe
assembly cover.
2. Remove the probe arm cover by
grasping the front with your thumb
and forefinger and lifting up gently.
This exposes the two lead wires and
the retaining nut as the illustration on
the following page shows.
Remove sample probe arm cover

Remove sample probe arm cover

3. Disconnect the two lead wires. Hold

the end of the lead wire contained in
the mounting bracket with the thumb
and forefinger of one hand. Gently
pull the other end of the lead wire out,
as shown, with the thumb and
forefinger of your free hand until it
disconnects.
Disconnect lead wire
4. Loosen the sample probe retaining

nut by turning it counterclockwise.

Disconnect lead wires and loosen retaining nut

5. Remove the probe from the probe arm.

6. Locate the probe seal either on the
end of the probe or in the retaining
nut.
Locate probe seal

Probe seal
–––
–––
–––
––
Remove sample probe

If… then…
you are removing the sample proceed with Step 7.

probe to clean it
you are removing the sample proceed to Procedure 2,

probe to replace it Install Sample Probe.
7. Place the probe seal in a safe place.

8. Run the thin stainless steel wire stylet
through the probe from the bottom, as
shown.
Clean sample probe
9. Rinse the inside of the probe thoroughly with deionized water, then wipe the
probe with clean gauze squares.
10. Replace the probe seal on the probe.
11. Proceed to Procedure 2, Install New Sample Probe, Step 2.

Procedure 2 - Install New Sample Probe

1. Insert the new probe seal (packaged with the new probe) into the sample
probe, as shown on the next page.
2. Insert the probe and seal into the sample probe arm.
3. Tighten the retaining nut, making sure the probe seal is in place.
4. Reconnect the lead wires, as shown
here and in the illustration on the next
page.
Reconnect lead wires
5. Replace the sample probe arm cover,

making sure the spring inside the
cover faces the front of the sample
probe arm.
Replace Probe Arm Cover
6. Verify proper spring return action of the probe. Grasp the probe between
your thumb and forefinger and gently move it up. Upon releasing your grasp,
the probe should spring downward. If the probe does not respond as
described, remove the sample arm cover and check the lead wires to make
sure they do not impede movement of the probe.

––
–––
––
––
––
––
––
–––
–––
Probe seal
Reconnect lead wires and tighten retaining nut

Procedure 3 - Check/Adjust Probe Alignment

1. If the instrument was powered off during probe replacement, turn the
analyzer power switch on.
2. Check/adjust the horizontal/vertical sample probe alignment using the
Sample Probe Alignment procedure found in the section 4.9 of this guide.
During routine sampling, visually verify alignment of the sample probe over the sample cup.
Proper alignment of the probe over the reaction cell (horizontal probe adjust) ensures that the
sample probe is also centered over the sample cup.

4.29 Replace Reagent Probe
Introduction
Replacing the reagent probe is necessary only when a reagent probe is bent or
otherwise damaged. The reagent probe may need to be removed for cleaning.
This maintenance is divided into three procedures:
1 Remove Damaged Reagent Probe
2 Install New Reagent Probe
3 Check/Adjust Probe Alignment

Analyzer time: Approximately 1 minute
Precautions:
• The instrument must be in STAND-BY or off during probe replacement.
keyboard entry.
• Wear disposable gloves when handling probe seals to assist in preventing
the introduction of contaminants into the system.

Reagent probe 1809296
Cleaning wire kit 0641766

Procedure 1 - Remove Damaged Reagent Probe

1. Ensure that the instrument is in STAND-BY or off.
3. Remove the reagent probe arm cover
by grasping the front with your thumb
and forefinger and gently lifting up.
This exposes the lead wire and the
retaining nut, as shown. Refer also to
the illustration on the following page.
Remove reagent probe arm cover

Remove reagent probe cover

4. Disconnect the lead wires. Hold the

end of the lead wires contained in the
end of the lead wire contained in the
mounting bracket with the thumb and
forefinger of one hand. With your free
hand, gently pull the other end of the
lead wire out until it disconnects.
5. Loosen the retaining nut by turning it

counterclockwise.

Disconnect lead wires and loosen retaining nut

6. Lift the reagent probe and seal out of

the guide piece from the reagent
probe arm.
Remove reagent probe
Remove reagent probe

If… then…
you are removing the reagent continue with step 7.

probe to clean it
you are replacing the reagent proceed to Procedure 2,

probe Install New Reagent Probe.
7. Run the thin stainless steel wire stylet

through the probe from the bottom
until the probe is clear, as shown.
8. Rinse the inside of the probe thor-
oughly with deionized water, then
wipe the probe with clean gauze
squares.
Clean reagent probe
9. Continue with Procedure 2, Install New Reagent Probe.

Procedure 2, Install Reagent Probe

1. Insert the probe into the reagent
probe arm
2. Tighten the retaining nut until it is
snug.
Replace reagent probe
3. Reconnect the lead wires. Refer also

to the illustration on the following
page.
Reconnect lead wires
4. Replace the reagent probe arm cover,

making sure the wire and tubing is in
place and that the spring on the under
side of the cover aligns with the front
of the reagent probe arm, as shown.
Refer also to the illustration on the
next page.
Replace reagent probe arm cover

Reconnect lead wires and tighten retaining nut

5. Verify proper spring return action of the probe. Grasp the probe between
your thumb and forefinger and gently move it up. Upon releasing your grasp,
the probe should spring downward. If the probe does not respond as
described, remove the sample arm cover and check the lead wires to make
sure they do not impede movement of the probe.
Procedure 3 - Check/Adjust Probe Alignment

1. If the instrument was powered off during probe replacement, turn the
analyzer power switch on.
2. Check/adjust the horizontal/vertical reagent probe alignment using the
Reagent Probe Alignment procedure found in section 4.9 of this guide.

4.30 Replace Stirrer Paddle
Introduction
This procedure is necessary only when a stirring paddle is bent or otherwise
damaged.
This maintenance is divided into two procedures:
1 Replace Stirrer Paddle
2 Check Stirrer Action

Analyzer time: Approximately 1 minute
Precaution:
The instrument must be in STAND-BY or Off during paddle replacement.

Stirring paddle 1900072
Small metric Phillips
screwdriver obtain locally
Procedure 1 - Replace Stirrer Paddle
1. While holding the stirring paddle,

loosen (but do not remove) the two
Phillips set screws that secure the
paddle to its drive shaft, as shown.
2. Pull the stirring paddle down and off
its drive shaft.
3. Insert a new stirring paddle onto the
drive shaft until its top is even with
the bottom of the stirring motor
mounting plate, then tighten the set
screws.
Loosen stirring paddle set screws
Visually inspect the new stirrer paddle. If it appears bent or misaligned, you may wish to
n install an old reaction cell section at the stirring position before testing the stirrer action.
Damage could result if a bent or misaligned paddle comes into contact with a reaction cell.

4.30 Replace Stirrer Paddle
Procedure 2 - Check Stirrer Action

1. If instrument power was off during paddle replacement, turn the instrument
power switch on. When the analyzer reaches STAND-BY, continue with Step
2.
2. Check/adjust the stirrer alignment using the Stirrer Alignment Procedure in
section 4.9 of this guide.

4.31 Load Printer Paper
Introduction
When the red line appears on the printer paper, use this procedure to replace the
paper in the printer.
Materials Required: Catalog Number

Printer Paper 1900943
Procedure
1. Place the printer paper in the paper receptacle. Paper should be released
from the bottom of the roll, not over the top.
2. Release the printer head by pushing

the printer lever forward.
Release printer head
3. Insert the paper into the paper slot 1 inch behind the print head.
4. Push the paper through the slot until it appears just behind the print head.

4.31 Load Printer Paper
5. Push the printer lever back to secure

the paper.
Secure printer paper
6. Replace the printer cover and pull the

paper through the printer cover slot.
Replace printer cover
7. Advance the paper as needed by

pressing on the black paper advance
button.

4.32 Clean Floppy Disk Drives
Introduction
The read/write heads inside the disk drives must be cleaned and the floppy disks
replaced when the disks have been accessed 100,000 times. DO NOT clean the
read/write heads more often than specified in the manufacturer’s instructions.
Excessive cleaning may decrease the life expectancy of the disk drives.
Use a non-abrasive, wet-type cleaning disk. Follow the manufacturer’s instructions
for preparation and use of the disk. Cleaning disks may be purchased from most
office supply or computer supply stores.
Copies of the parameter disk and data disk should be made onto formatted blank
diskettes. (Refer to the How to.... section of the Tutorial Guide for instructions on
formatting a floppy disk.) Blank diskettes may be purchased from most office
supply or computer supply stores and must meet the following specifications:
• double-sided, unformatted, 3.5 inch
• high density (2.0 Megabytes)
• double track (80 sectors/track)
• 135 TPI

Materials Required: Catalog Number

Blank disks obtain locally
Cleaning disks obtain locally
Procedure
3. Touch on the FD Utilities screen to select FDD Cleaning 1 if cleaning

drive 1 or FDD Cleaning 2 if cleaning drive 2.
4. Replace the disk in drive 1 or 2 with the cleaning disk.
5. Touch to initiate disk drive cleaning. When the cleaning process is
complete, the Start key is highlighted in gray.
6. Touch to display the FD Utilities screen.
7. Repeat steps 3-5 to clean the second disk drive, if desired.
8. After approximately 5 minutes, reinstall the parameter disk in drive 1 and the
data disk in drive 2.

Chapter 5
Spare Parts
Roche Diagnostics/Hitachi 902 User’s Guide V1.1 5-1

5.1 Spare Parts
Overview
A spare part may be needed for a specific maintenance procedure. The part’s
description and Roche Diagnostics catalog number are included in the Materials
Required table of each procedure’s Introduction.
The catalog number is included to help you locate spare parts in your accessory
box or ISE accessory case. Also, use the catalog number when ordering replace-
ment parts. Remember, you are responsible for maintaining an adequate spare
parts inventory.
Ordering Information
When ordering replacement parts, please use the catalog number and reference
name for each item to ensure that you receive the correct part.
5-2 Roche Diagnostics/Hitachi 902 User’s Guide V1.1

5.1 Spare Parts
Sample and Reagent Probes
Catalog
Item Number Reference Name Common Name
1 ♦ 1809288 Sample Probe Sample Probe

2 ♦ 1809296 Reagent Probe Reagent Probe
3 1900820 Sample Nozzle Seal Sample Probe Seal
4 ♦ 0641766 Cleaning Wire Kit Probe Cleaning Wire
1 2
4
(2 sizes)
♦Parts contained in the Accessory Parts
Box and/or ISE Accessory Parts Case.

5.1 Spare Parts
Serum Syringe
Catalog
1 0685917 O-ring Syringe Barrel O-ring

2 0909106 Nut Locking Screw
3 1900170 Glass Barrel Syringe Glass Barrel Syringe
4 1900404 O-ring Syringe Holder O-ring
5 0986364 Holder Plunger Syringe Holder
6 1568477 Seal Piece (upper) Upper Seal Piece
7 ♦ 1703838 Collar Collar
8 1568523 Press Piece Press Piece
9 1568485 Seal Piece (lower) Lower Seal Piece
10 1700235 Spring Spring
11 1700022 Plunger Holder Holder
12 1703820 Pushing Screw Retaining Screw
13 1566245 Plunger Plunger
1
2
4
5
6
7
8
9
10
11
12
13 Box and/or ISE Accessory Parts Case.

5.1 Spare Parts
Reagent/SIP Syringes
Catalog
1 0685917 O-ring Syringe Barrel O-ring

2 0909106 Nut Locking Screw
3 1071998 Cylinder Glass Glass Barrel Syringe
4 0989142 O-ring Syringe Holder O-ring
5 0990027 Holder Syringe Holder
6 ♦ 1568493 Seal Piece (upper) Upper Seal
7 1568531 Press Piece Press Piece
8 1568507 Seal Piece (lower) Lower Seal
9 0859575 Spring Spring
10 1700499 Pushing Screw Retaining Screw
11 0610143 Plunger Plunger
1
2
4
5
6
7
8
9
10
11


5.1 Spare Parts
ISE Parts
Catalog
1 1403826 ISE Ref Electrode Reference Cartridge

2 0825468 Na+ Elect Cartridge Na+ Electrode Cartridge
3 0825441 K+ Elect Cartridge K+ Electrode Cartridge
4 1069004 Cl- Elect Cartridge Cl- Electrode Cartridge
5 ♦ 1900897 O-ring O-ring (3x1)
♦ 1809733 Sipper Tube Joint Tubing
1809725 Sipper Tube Suction Tubing
1 2 3 4


5.1 Spare Parts
Fuses
Catalog
6 ♦ 1067800 Alarm Fuse 3A 3 Amp Fuse

7 ♦ 1067818 Alarm Fuse 5A 5 Amp Fuse
8 ♦ 1067826 Alarm Fuse 7.5A/250V 7.5 Amp Alarm Fuse
9 ♦ 1072013 LM Fuse 3.2A/250V 3.2 Amp Alarm Fuse
10 ♦ 1566601 LM Fuse 5A 5 Amp Alarm Fuse
6 7 8
9 10


5.1 Spare Parts
Cell Rinse Unit
Catalog
1 1228994 Rinse Nozzle (1) Nozzle #1

2 1229001 Nozzle (2) Nozzle #2
7 1900587 Nozzle Tip (1 ea) Squeegee (1 ea)
8 1900919 Spring Nozzle Spring
9 1709933 Spring Holder Spring Clip
6 2 4 5 1 1
3
7 8


5.1 Spare Parts
Miscellaneous Parts
Catalog
1 ♦ 0641600 Halogen Lamp Photometer Lamp

2 1900072 Stirring Rod Stirring Paddle
1809245 Inlet Water Filter Inlet Water Filter (Tank)
1402587 Bath Filter Reaction Bath Filter
2
1


5.1 Spare Parts
Tools
Catalog
1 ♦ 0778427 Syringe Tool Spanner Wrench

♦ Metric Screw Driver Phillips Screwdriver


5.1 Spare Parts
Consumables
Catalog
Number Reference Name Common Name
1809407 Reaction Cuvettes Reaction Cell Set

1223879 Hitergent Hitergent
1360418 Multiclean Multiclean (1N NaOH)
0900478 Adapter 20/50 ml bottle 20 ml Round Bottle Adapter
1900943 Printer Paper Printer Paper
0394246 Sample Cups Sample Cups
1900587 Nozzle Tip Teflon Block

NOTES

Index
n
Page numbers begin with the abbreviation of the Operators Manual guide that contains the
reference. Abbreviations include: RGReference Guide, SGSoftware Guide,
UGUsers Guide and TGTutorial Guide.
Roche Diagnostics/Hitachi 902 Analyzer Operators Manual V1.1 I-1

Symbols graph, RG 527
sample calculations, RG 528
*****P data alarms, UG 210 sample program/prozone check value
??? data alarms, UG 22 calculation, RG 529 - 530
0.5 amp alarm fuse, UG 57 2-point linear calibration
0.5 amp fuse, UG 57 assay types, RG 617
0.525% Sodium Hyperchlorite, UG 43 calculations, RG 616 - 617
1 N NaOH/1% Hitergent Solution, UG 43 graph, RG 614, RG 615
1-point endpoint and rate assay selecting, RG 614
characteristics, RG 534 Test Parameters screen, RG 614
graph-R1 and R3 timing, RG 535 2-point rate assay
sample calculations, RG 535 - 536 characteristics, RG 537
Test Parameters screen, RG 534 graph-R1 and R2 timing, RG 539
1-point endpoint assay - one reagent graph-R1 timing, RG 538
characteristics, RG 513 sample calculations, RG 539 - 540
graph-R1 timing, RG 514 20 ml reagent disk adapter, UG 511
sample calculations, RG 515 20 ml round bottle adapter, UG 511
1-point endpoint assay - two reagents 3 amp alarm fuse, UG 57
assay characteristics, RG 516 3-point endpoint assay
sample program and calculations, characteristics, RG 531
RG 517 - 518 graph, RG 532
Test Parameters screen, RG 516 sample calculations, RG 532 - 533
1-point endpoint assay with prozone Test Parameters screen, RG 531
check 3.2 amp fuse, UG 57
characteristics, RG 519 5 amp alarm fuse, UG 57
graph, RG 520
sample program and results calculation,
RG 520 - 521 A
sample program/prozone check value
calculation, RG 521 - 522 ABS? data alarms, UG 22
1-point linear calibration absorbance measure points over time,
assay types, RG 613 RG 48
calculations, RG 612 Accept. key, SG 14
graph, RG 611 ACI ERROR instrument alarms, UG 323
selecting, RG 610 ADC? data alarms, UG 23
Test Parameters screen, RG 610 ADC1 instrument alarms, UG 312
10 amp alarm fuse, UG 57 ADC2 instrument alarms, UG 312
2% Hitergent, UG 42 ADC3 instrument alarms, UG 313
2-point endpoint assay additional training, P3
characteristics, RG 523 addresses, changing, P6
graph-R1 and R2 timing, RG 524 Alarm Trace screen, SG 62
sample calculations, RG 524 - 525 Mode key, SG 66
2-point endpoint assay with prozone
check
characteristics, RG 526
I-2 Roche Diagnostics/Hitachi 902 Analyzer Operators Manual V1.1

alarms precautions on use of, RG 35 - 37
data, UG 119 printing record or system communica-
instrument, UG 119 tion between host and, SG 68
printing daily or cumulative information, programmable, RG 42
SG 66 reaction cells, RG 37
allen wrench, UG 510 reaction disk, RG 36
ambulance key, G1 reaction disk positions, RG 45
analyte, G1 reaction processing components,
analytical unit, G1 RG 44
operating principles, RG 18 reaction processing sequence, RG 46,
analyzer, RG 13 RG 47
absorbance measure points over time, reagent disk, RG 36
RG 48 required materials, RG 14
additional training, P3 sample disk, RG 36
alcohol damaging finish, UG 420 selective, RG 42
analytical unit operating principles, sequential, RG 42
RG 18 service, RG 16
applications, RG 35 spilling water into, UG 430
characteristics, RG 14 starting while recording incubation
cleaning surfaces, TG 236, UG 420 bath temperature, UG 421
computerized, RG 42 switching on, RG 37
control system, RG 19 troubleshooting, UG 119
customer training, RG 16 troubleshooting power up, UG 13
daily cleaning, TG 234, UG 412 - 413 troubleshooting problems, UG 12
damaging finish, TG 236 unused for long time, RG 37
discrete, RG 42 verifying mechanical units, SG 64
displaying information from, SG 13 analyzer specifications
entering information into, SG 13 dimensions, RG 22
fully automated, RG 43 electrical, RG 22
general characteristics, RG 42, RG 43 facility specifications, RG 23
installation, RG 16 interface, RG 22
installation requirements, RG 35 test modes, RG 22 - 23
instrument covers, RG 36 application sheet, G1
introducing contaminants, UG 485 ASCII Result Screen
introducing contaminants into, UG 476 First No field, TG 232
maintenance, RG 35 Last No field, TG 232
maintenance overview, UG 42 - 43 P.Up key, TG 232
mechanical cycle, RG 44 - 48 Start key, TG 232
moving parts, RG 36 ASCII text
operational systems, RG 17 saving results as, TG 232
operations, RG 35 saving routine results as, SG 36
operator qualification, RG 35 saving STAT results as, SG 310
ordering information, RG 16
powering on, TG 25

aspirate reaction mixture to waste photo- turning on or off, TG 331
metric sample processing, RG 412 verifying functionality of, SG 611
assay techniques, RG 55 - 512 Barcode Reader Check Reports
Calibration screen, RG 510 Date field, SG 729
Cell Blank report, RG 58 ID field, SG 729
endpoint assay entry example, P. No. field, SG 729
RG 56 - 57 Time field, SG 729
endpoint assay without sample blanking Batch Mode, G1, TG 215, TG 218
sample program, RG 511 - 512 initiating sample run, SG 22
selecting type and measure points, number of samples, SG 26
RG 55 - 56 turning off buzzer in sample run,
summary, RG 551 SG 110
symbols utilized in formulas, RG 59 batch mode samples
assay types calibrators, TG 216, TG 220
1-point linear calibration, RG 613 controls, TG 216, TG 220
2-point linear calibration, RG 617 initiating run, TG 215, TG 221
nonlinear logit-log 4P calibration, programming with BCR, TG 214 - 217
RG 620 programming without BCR,
nonlinear logit-log 5P calibration, TG 218 - 221
RG 626 sequence number, TG 220
nonlinear point to point calibration, serum indices, TG 216, TG 220
RG 631 Batch Mode screen
nonlinear spline calibration, RG 629 Batch field, SG 22, TG 216
assays, G1 displaying, SG 15
calibrating, TG 211 Load sample from pos. field, SG 22
assigning OK? key, SG 19, TG 210, TG 216
control positions, TG 39 P.Up key, TG 216
print order, TG 323 - 324 Sample ID field, TG 214
Start key, TG 217, TG 221, TG 228
B Start No field, SG 22
STAT key, TG 228
bar code labels, UG 511
TS key, TG 218
barcode
Batch Mode with BCR (Barcode Reader)
digit checks, SG 426
screen, SG 22
programming check digits for reading,
Batch Mode without BCR (Barcode
TG 332 - 333
Reader) screen, SG 22
Barcode 1 instrument alarms, UG 313
biased enzymes, troubleshooting, UG 118
Barcode 2 instrument alarms, UG 313
bichromatic absorbance, G1, RG 54
Barcode Check screen, SG 63
biohazardous materials potential hazards
Start key, SG 611
and safety precautions, RG 32
barcode reader, G1
blank calibration, RG 63
enabling/disabling sample option,
RD/Hitachi 902 Host Interface Document,
SG 424
TG 334
scratching window, UG 436
RD/Hitachi 902 system, RG 13

Roche Diagnostics sodium hyperchlorite full-point, RG 64 - 65
Wash Solution, UG 43 methods, RG 62
mode chart, RG 68 - 69
C printing realtime results, SG 110
c (Clear) key, SG 13 printing results, TG 211
C-RAM R/W, Count Clear screen processing requests, TG 211
C-RAM R/W key, SG 69 selecting for ISEs, SG 213
Count Clear key, SG 69 selecting for photometric tests, SG 212
Calc. Test Parameters screen, SG 414 selecting type, TG 212
Calc. No field, SG 414 type, RG 62, SG 212
Contents field, SG 415 values, RG 66
Parameter No field, SG 414 viewing results, SG 312, TG 211
Select key, SG 415 viewing results from last success
Calc. Test screen, SG 42 ful, SG 311
Calc. No field, TG 317, TG 318 weight, RG 62
Calc. Test key, SG 414, TG 317 Calibration Monitor report, RG 66
Comp. No. field, TG 319, TG 320 Calibration Monitor Reports
Comp. Test key, SG 414, TG 319 C. VAL field, SG 713
Home key, TG 318, TG 319, TG 320 Date field, SG 712
P.Up key, TG 318, TG 319, TG 320 IS C. field, SG 713
Parameter No field, TG 317, TG 318, IS EMF field, SG 712
TG 319 ISE Calibration Information section,
Sel. key, TG 318 SG 712
CALC? data alarms, UG 23 Photometric Chemistry Calibration
calculated tests, G1 Information section, SG 713
defining parameters, SG 414 S1 EMF field, SG 712
number of, SG 414 S1 through S6 fields, SG 713
parameter entry display, SG 414 - 415 S2 EMF field, SG 712
parameter listing, TG 318 S3 CONC. field, SG 713
parameter to be entered or updated, S3 EMF field, SG 712
SG 414 SLOPE field, SG 712
parameters, SG 415 Test field, SG 712
programming, TG 317 - 318 Time field, SG 712
CALIB data alarms, UG 23 Calibration Report, TG 216
CALIB. instrument alarms, UG 316 printing, TG 220, TG 226
CALIB. SD? instrument alarms, UG 316 Calibration screen, RG 510, SG 32
calibrating Accept. key, TG 211
assays, TG 211 Channel No field, SG 311
ISE system, UG 475 current calibration values, RG 510
calibration, G1 STD Type key, TG 211
blank, RG 63 Calibration Selection screen
calculation of results, RG 67 displaying, SG 15
calculation terms, RG 69 STD Type key, SG 212
current values, RG 510 Test keys, SG 212

calibrators, G1 Test key, SG 413
batch mode samples, TG 216, TG 220 W key, SG 413
concentrations, TG 310 carryover evasion
Easy Mode samples, TG 226 reaction cells, SG 412
high and low, SG 213 reagent probe, SG 411 - 412
new lots of material, TG 310 - 311 sample probe, SG 413
position numbers on sample disk, cartridges, priming, TG 27
TG 310 caution, G1
reconstituting, UG 15 CAUTION icon, RG 33
standard, SG 213 CEDIA (Cloned Enzyme Donor Immunoas-
Carry Over Evasion screen, SG 42 say), G1
µl key, TG 315 cell blank, G2, RG 124 - 125
-> Test key, TG 314 execution of, UG 424
Accept. key, TG 316 performing, SG 58, UG 432, UG 471
Evasion key, TG 315, TG 316 report automatically printed on, UG 424
Reaction Cells key, SG 410, TG 315 Cell Blank Measurements screen
Reaction Cells No key, TG 315 Date field, SG 721
Reagent Probe key, SG 410, TG 314 No. field, SG 721
Reagent Probe No key, TG 314 Results field, SG 721
Sample Probe key, SG 410, TG 316 Time field, SG 721
Sample Probe No key, TG 316 Cell Blank report, RG 58, UG 432,
Test key, TG 314, TG 316 UG 471
Type key, TG 314, TG 315 Cell Blank screen, SG 52
W key, TG 315, TG 316 Start key, SG 58
Carry Over Evasion, Reaction Cells screen, CELL BNK1 instrument alarms, UG 311
SG 410 CELL BNK2 instrument alarms, UG 311
µl key, SG 412 CELL data alarms, UG 24
Evasion key, SG 412 cell rinse system, RG 122 - 125
Reaction Cells No key, SG 412 cell blanking, RG 124 - 125
Test key, SG 412 cell rinse unit, RG 122 - 124
W key, SG 412 cell rinse unit, G2, RG 122 - 124,
Carry Over Evasion, Reagent Probe UG58
screen, SG 410 arrangement of rinse nozzles,
µl key, SG 411 RG122 - 123
->Test key, SG 411 cleaning nozzles, UG 425
Evasion key, SG 411 vacuum system, RG 125
Reagent Probe No key, SG 411 water supply, RG 125
Test key, SG 411 cell rinse unit nozzles, cleaning, UG 425
Type key, SG 411 cell wash
W key, SG 411 performing, UG 432
Carry Over Evasion, Sample Probe screen, rinsing reaction cells, TG 22
SG 410 CFR (Code of Federal Regulations), P5
Evasion key, SG 413 Check Digit screen, SG 421
Sample Probe No key, SG 413 CODE-39 key, SG 426, TG 332

ITF key, SG 426, TG 332 Chemistry Parameters report
NW-7 key, SG 426, TG 332 Ch. field, SG 730
P.Up key, TG 333 Parameters field, SG 730
CHEM. PARAM instrument alarms, printing, TG 38
UG 320 chemistry tests, specific information on,
chemicals potential hazards and safety RG 16
precautions, RG 32 Cl- electrode Cartridge, UG 56
chemistries CLB(IS)POS instrument alarms, UG 322
checking preparation of reagents, CLB. PARAM instrument alarms, UG 321
calibrators, and controls, UG 15 cleaning
count of tests run on, SG 67 analyzer surfaces, TG 235
erratic test results causes, UG 18 - 19 floppy disk drives, SG 59, UG 499
high test results causes, UG 16 ISE compartment, UG 475
low test results causes, UG 17 reagent probe, TG 236, UG 491
printing parameters, TG 38 sample probe, TG 236, UG 481
problems with single sample or control, stirrer, TG 236
UG 19 - 110 cleaning solutions, UG 42 - 43
range for printing parameters, SG 55 0.525% Sodium Hyperchlorite, UG 43
reading parameters, SG 55 1 N NaOH/1% Hitergent Solution,
specific information for tests, P3 UG 43
troubleshooting all with more than one 2% Hitergent, UG 42
set point, UG 111 - 112 Roche Diagnostics sodium
troubleshooting all, including ISEs, hyperchlorite Wash Solution, UG 43
UG 112 full-strength Hitergent, UG 42
troubleshooting biased enzymes, System Cleaning Solution/1% Hitergent
UG 118 (Multiclean), UG 43
troubleshooting ISEs with erratic results, CLIA 88 (Clinical Laboratories Improve-
UG 114 - 115 ment Act), P5
troubleshooting ISEs with excessive air CMP.T data alarms, UG 24
in syringe and erratic results, CMP.T! data alarms, UG 25
UG 113 - 114 collar, UG 54
troubleshooting ISEs with high internal Com. (Communication) Parameters
standard values, UG 115 - 116 screen, SG 420
troubleshooting ISEs with high sodium Baud Rate key, SG 422
or low chloride values, UG 116 Com. Cycle key, SG 423
troubleshooting ISEs with low values, Com. Trace key, SG 423
UG 116 - 117 Data Bits key, SG 422
troubleshooting one set point chemis End Code key, SG 422
tries, UG 113 P.Up key, TG 334
troubleshooting problems, UG 12, Parity key, SG 422
UG 14 - 118 Results Only key, SG 423
troubleshooting single, UG 110 - 111 Retry key, SG 423
writing parameters, SG 55 Retry Time Out key, SG 423
chemistry application sheets, P3 Simul. Inquiry key, SG 423

STAT Inquiry key, SG 423 Control Result, Delete screen, SG 313
Stop Bits key, SG 422 First No field, SG 315
Text Length key, SG 422 Last No field, SG 315
common keys, SG 13 - 14 Control Result, Print screen, SG 313
Communication Trace screen, SG 62 First No field, SG 314
Mode key, SG 68 Last No field, SG 314
COMP. TEST instrument alarms, UG 322 Control Result, Send screen, SG 313
Comp. Test Parameters screen, SG 414 First No field, SG 314
Comp. No field, SG 416 Last No field, SG 314
Contents field, SG 417 control results, TG 230, TG 233
Parameter No field, SG 416 deleting, SG 315, TG 233
Select key, SG 417 printing, SG 314
compensated tests, G2 printing in STAND-BY, TG 229 - 230
defining parameters, SG 417 realtime printing, TG 226
number of, SG 416 uploading to host, SG 314,
parameter entry display, SG 414, TG 230 - 231
SG 416 - 417 control samples
parameter listing, TG 320 data management options for, SG 313
parameter to be entered or updated, Control Samples screen, SG 32
SG 416 Delete key, SG 313, TG 233
programming, TG 319 - 320 Print key, SG 313
compensation overview, RG 636 Send key, SG 313, TG 230
compensation value calculation, Control screen
RG 636 - 637 Control No. key, TG 213
computer, troubleshooting problems, Control Selection screen
UG 12 Control No key, SG 214
condenser cooling fins displaying, SG 15
bending, UG 441 Test keys, SG 214
compressed air and, UG 441 control solutions
consumables, G2, UG 511 reserving sample disk positions,
contact names SG 419
changing, P6 control system, RG 19
contaminants controls, G2
introducing into system, UG 472, assigning positions, TG 39
UG 485 batch mode samples, TG 216
Control Positions screen, SG 42 Easy Mode samples, TG 226
Control No field, SG 419, TG 39 level number, SG 419
Position No field, SG 419, TG 39 printing realtime results, SG 110
Control Report, TG 216 programming tests, SG 214
printing, TG 220, TG 230 reconstituting, UG 15
control requests troubleshooting single, UG 19 - 110
printing, TG 213 cooling fans
processing, TG 213 cautions, RG 37
programming, TG 213 copying floppy disks, SG 59, TG 328

Count Clear screen, SG 63 waste solution reservoir, TG 23 - 24
Cumulative Alarm Trace report water supply, TG 23
Alarm (A) or Retry (R) field, SG 716 Data Alarm Trace report
Alarm Code field, SG 716 Alarm (A) or Retry (R) field, SG 715
Alarm Date field, SG 716 Alarm Code field, SG 715
Alarm Time field, SG 716 Alarm Time field, SG 714
Date field, SG 716 Date field, SG 714
listing alarms, UG 119 Frequency field, SG 715
Time field, SG 716 Instrument Status field, SG 715
Cumulative Operations Lists report Time field, SG 714
Date field, SG 719 data alarms, G2, SG 17, UG 119
No. of Samples section, SG 719 *****P, UG 210
Operation field, SG 719 ???, UG 22
Power field, SG 719 ABS?, UG 22
Test Count section, SG 719 ADC?, UG 23
Test Total section, SG 719 CALC, UG 23
Time field, SG 719 calculation for LIN., RG 85
Cumulative Operations Trace calculation for LIN.8, RG 87
report, SG 67 CALIB, UG 23
customer bulletin index, P4 CELL, UG 24
customer bulletins, P4 CMP.T, UG 24
customer communications CMP.T!, UG 25
customer bulletin index, P4 DUP, UG 25
customer bulletins, P4 duplicate limit (DUP), RG 88
customer letters, P5 H or L, UG 26
customer letters, P5 I. STD, UG 26
Customer Service LEVEL, UG 26
contacting sales representatives, P4 LIMT0, UG 27
Customer Technical Support, P3 LIMT1, UG 27
contacting service representatives, P4 LIMT2, UG 27
missing customer bulletins, P4 LIN., UG 27
customer training, RG 16 LIN. 8, UG 28
cuvette, G2 linearity verification (LIN.), RG 84
linearity verification (LIN.8), RG 86
D NOISE, UG 28
Daily Alarm Trace report, UG 119 OVER, UG 28
daily operational checks PREP, UG 29
disk drives, TG 24 prozone effect, RG 82 - 83
floppy disk drives, TG 24 R.OVER, UG 210
Hitergent, TG 22 REAGN, UG 211
powering analyzer on, TG 25 result integrity checks, RG 82
printer paper, TG 24 S1 absorbance limit (S1ABS?), RG 88
System Cleaning Solution (Multiclean), S1Abs?, UG 213
TG 22 SAMPL, UG 211

SD?, UG 211 quarterly maintenance, UG 435
SENS, UG 212 weekly cleaning, UG 433
sensitivity limit (SENS), RG 87 Del. (Delete) key, SG 14
SLOPE?, UG 212 Delete Result screen
STD?, UG 213 First No field, TG 233
substrate depletion (LIMT.O, LIMT.1, Last No field, TG 233
LIMT.2), RG 88 - 810 P.Up key, TG 233
data disk, copies of, UG 499 Start key, TG 233
data management deleting
deleting results, TG 233 control results, SG 315
displaying results, TG 231 results, TG 233
printing results in STAND-BY, routine samples, SG 35
TG 229 - 230 selections, SG 14
saving results as ASCII text, TG 232 STAT results, SG 39
uploading results to host, test selection information, SG 27
TG 230 - 231 detergent
Data Monitor reports checking, UG 48
Data Alarms field, SG 74 daily checks, TG 22
Data field, SG 74 handling, RG 37
ID field, SG 74 diluent, G2
Results Printout field, SG 74 diluted ISE sample aspiration, RG 415
Seq. No. field, SG 74 dimensions, RG 22
Time field, SG 74 disk drives
date checking, TG 24
entering, SG 421 checking disks in, UG 48
format of, SG 421 dispense, G2
setting, TG 330 - 331 Display Result screen
Date screen, SG 420 First No field, TG 231
Day field, SG 421, TG 330 P.Up key, TG 231
Hour field, SG 421, TG 330 displaying results, TG 231
Minute field, SG 421, TG 331 DIST. SENS instrument alarms, UG 310
Mode key, SG 421, TG 330 DIST. WATER instrument alarms, UG 310
Month field, SG 421, TG 330 documentation, electronic copies, P6
P.Up key, TG 331 Down Arrow key, SG 13
Year field, SG 421, TG 330 drain plate and biohazardous materials,
DC POWER instrument alarms, UG 314 UG 440
defining DUP data alarms, UG 25
host communication settings, TG 334 duplicate limit, G2
linearity limits, TG 333 duplicate limit (DUP) data alarms, RG 88
original ABS printing, TG 332
profiles, TG 321 - 322 E
STAT reserve positions, TG 332 Easy 1 screen
deionized water, G2 Default Profile key, SG 23
deionized water tank Load sample in pos. field, SG 23,
cleaning, UG 433 - 435 TG 223

Profile Select key, SG 23, TG 223 Easy Mode screen, SG 23 - 25
Start key, TG 223 displaying, SG 15
Easy 2 screen, TG 223 setting initial, TG 331
Accept key, TG 225 electrical
ID key, SG 24, TG 224 analyzer specifications, RG 22
OK? key, SG 19, TG 226 potential hazards and safety precau-
Position field, SG 24, TG 224, tions, RG 32
TG 225 preventing shock, RG 34
Profile keys, SG 24 EMC-Class A, RG 34
S. No. field, TG 225 Emergency Stop (E. STOP) operational
S.No field, SG 24 mode, RG 128
Start key, TG 227, TG 228 Emergency Stop mode, G2, UG 119
STAT key, TG 228 emptying waste solution reservoir,
Tests key, SG 24, TG 225 UG 47 - 48
Easy 3 screen, TG 225 end of day maintenance
Accept. key, TG 226 cleaning instrument surfaces, TG 236
ID key, SG 25, TG 225 cleaning/adjusting sample and reagent
OK? key, SG 19, TG 226 probes and stirrer, TG 236 - 239
Position field, SG 25, TG 225, wash, TG 234
TG 226 endpoint assay, G3
S. No field, TG 226 entry example, RG 56 - 57
S.No field, SG 25 without sample blanking sample pro
Sample ID field, TG 225 gram, RG 511 - 512
Start key, TG 226, TG 227, TG 228 Enter/Return key, SG 13
STAT key, TG 228 external water supply
Test keys, SG 25 checking, TG 23
Easy Mode, G2, TG 222 cleaning filter, UG 445 - 446
prioritizing, SG 425, TG 222
Easy Mode 1 samples F
programming and initiating, facility
TG 222 - 223 specifications, RG 23
Easy Mode 2 samples troubleshooting, UG 12
initiating run from Start Condition factor setting, G3
screen, TG 226 - 227 FD drive (analyzer unit), RG 19
profile selection, TG 224 - 225 FD PROTECT instrument alarms, UG 324
programming, TG 224 - 225 FD READ? instrument alarms, UG 324
Easy Mode 3 samples FD Utilities screen, SG 52
initiating run from Start Condition FDD Cleaning 1 option, UG 499
screen, TG 226 - 227 FDD Cleaning 2 option, UG 499
programming, TG 225 - 226 Format & Copy option, TG 328
Easy Mode samples Mode key, SG 59, TG 328, UG 499
calibrators, TG 226 Start key, UG 499
controls, TG 226 FD WRITE? instrument alarms, UG 323
programming, TG 222 - 227 feedback, P5
serum indices, TG 226

fields full-strength, UG 42
clearing numbers, SG 13 operations of, UG 46
moving between, SG 13 System Cleaning Solution/1% (Multi
registering entries, SG 13 clean), UG 43
space between entries in, SG 13 holder, UG 54
flammables potential hazards and safety Home key, SG 14
precautions, RG 34 Home screen, TG 222
floppy disk drives Batch Mode key, SG 15, SG 22,
checking, TG 24 TG 210, TG 214, TG 218
cleaning, SG 59, UG 499 Cal. key, SG 15, TG 211
read/write head, UG 499 Control key, SG 15, TG 213
wet-type cleaning disk, UG 499 displaying, SG 14
floppy disks, G3 Easy Mode key, SG 15, SG 23 - 25,
copying, SG 59, TG 328 TG 223, TG 224, TG 225
formatting, SG 59, TG 328 ISE Cal. key, SG 15, TG 212
managing, TG 328 - 329 Maint. key, SG 16, TG 26, TG 234,
reading or writing parameters, TG 329 TG 236, TG 237, TG 238, TG 33,
replacing, UG 499 TG 37, TG 38, TG 39, TG 311,
Format & Copy screen TG 313, TG 315, TG 316, TG 318,
Start key, TG 328 TG 320, TG 322, TG 323, TG 324,
formatting floppy disks, SG 59, TG 328 TG 326, TG 328, TG 329, TG 331,
formulas, symbols utilized in, RG 59 TG 333, TG 334, TG 335, UG 410,
full-point calibration, RG 64 - 65 UG 411, UG 412, UG 414,
full-strength Hitergent, UG 42 UG 416, UG 417, UG 419,
functional checks, initiating, SG 14 UG 424, UG 429, UG 432,
FUSE instrument alarms, UG 314 UG 461, UG 499
fuses, UG 57 Monitor key, SG 15, TG 229, TG 230,
TG 231, TG 232, TG 233
G Param. key, RG 55, RG 73, SG 15,
General Laboratory Practices and Safety TG 32, TG 36, TG 39, TG 312,
Guidelines, P5 TG 314, TG 317, TG 319, TG 321,
glass syringe barrel, UG 55 TG 322, TG 323, TG 326, TG 330
grommet (snap), UG 59 Routine Samples key, TG 231
STAT Samples key, TG 231
H Tools key, SG 16
Wash key, UG 412
H or L data alarms, UG 26 host
HCFA (Health Care Financing Administra- automatically uploading results, TG 226
tion), P5 defining communication settings,
high calibrators, SG 213 TG 334
Hitergent, G3, RG 119, UG 511 defining interface parameters,
1 N NaOH/1% Solution, UG 43 SG 422 - 423
2% solution, UG 42 printing record or system communica-
checking supply, UG 46, UG 48 tion between analyzer and, SG 68
daily checks, TG 22

uploading control results to, SG 314 program special washes,
uploading results to, TG 229 - 230 TG 314 - 316
uploading routine results to, SG 35 program system parameters,
uploading STAT results to, SG 39 TG 330 - 335
verifying status, TG 216, TG 221, update ISE calibrator values,
TG 227 TG 312 - 313
host communication, G3 update photometric calibrator values,
activating/deactivating port, SG 110 TG 310 - 311
communication cycle in seconds,
SG 423 I
data set maximum length, SG 422 I. STD data alarms, UG 26
interval between attempts to establish, in vitro qualitative assay, G3
SG 423 in vitro quantative assay, G3
number of data bits, SG 422 INC.WATER instrument alarms, UG 39
number of repeated transmissions to, Incub. Water screen
SG 423 Start key, SG 510
number of stop bits, SG 422 incubation bath, G3
parity code, SG 422 acceptable temperature, UG 421
recording communication with, SG 423 checking water exchange, UG 410
selecting end code, SG 422 cleaning, UG 427 - 432,
selecting routine test selection inquiry, UG 429 - 430
SG 423 cleaning filters, UG 427 - 432
selecting STAT test selection inquiry, exchange, TG 26
SG 423 manually exchanging water, UG 410
status, SG 18 reading/recording temperature, TG 28,
transmission speed, SG 422 UG 421
transmitting measured data results only, temperature of, UG 471
SG 423 temperature out of range, UG 421
host interface, RG 19 water exchange, SG 510
Host Interface Document, TG 334 Incubation Water screen, SG 52
how to Init. (Initial) screen
assign control positions, TG 39 Mode key, SG 425
assign print order, TG 323 - 324 Init. (Initial) Screen screen, SG 420
change normal ranges, TG 325 - 327 Init. Mode screen
define profiles, TG 321 - 322 Mode key, TG 331
manage floppy disks, TG 328 - 329 P.Up key, TG 331
print chemistry parameters, TG 38 initialization, G3
program calculated tests, initialization (INITIAL) operational mode,
TG 317 - 318 RG 126
program compensated tests, initiating Easy Mode 1 samples,
TG 319 - 320 TG 222 - 223
program parameters for ISEs, inlet water filter
TG 36 - 37 (back), UG 59
program parameters for photometric (tank), UG 59
chemistries, TG 32 - 35 cleaning, UG 442 - 446

installing ISE STOP?, UG 38
new ISE measuring cartridges, ISE SYRNG., UG 38
UG 474 - 475 LAMP, UG 311
new reaction cells, UG 431 MOTOR CONT., UG 315
new reference cartridge, UG 464 - 4- 65 MOTOR OUT, UG 315
reagent probe, UG 492 - 494 NO FD, UG 324
sample probe, UG 482 - 483 PAINT OVER, UG 314
instrument PM BOARD?, UG 322
alcohol damaging finish, UG 420 POWER FAIL, UG 314
cleaning surfaces, TG 236, UG 420 PRINTER, UG 324
general mechanical problem isolation, R. DISK, UG 33, UG 38
UG 119 R. PROBE, UG 37
spilling water into, UG 430 R. SYRINGE, UG 38
troubleshooting, UG 119 REAG. LEVEL, UG 313
troubleshooting power up, UG 13 REAG. POS?, UG 322
instrument alarms, G3, SG 17, UG 119 REAG. SHORT, UG 313
ACI ERROR, UG 323 REF SHORT, UG 320
ADC1, UG 312 REF.WATER, UG 39
ADC2, UG 312 RESERVOIR, UG 310
ADC3, UG 313 RINSE, UG 32
Barcode 1, UG 313 S. DISK, UG 36
Barcode 2, UG 313 S. PROBE, UG 33 - 35
CALIB., UG 316 S. SHORT, UG 36
CALIB. SD?, UG 316 S. SYRINGE, UG 36
CELL BNK1, UG 311 S.INDEXES?, UG 322
CELL BNK2, UG 311 SENS.?, UG 317
CHEM. PARAM, UG 320 SIPPER, UG 310
CLB(IS)POS, UG 322 STANDARD?, UG 316
CLB. PARAM, UG 321 STIRRER, UG 32
COMP. TEST, UG 322 SYSTEM I/F, UG 324
DC POWER, UG 314 TEMP CONT., UG 39
DIST. SENS, UG 310 TS OVER, UG 313
DIST. WATER, UG 310 TWIN TEST?, UG 320
FD PROTECT, UG 324 VAC. TANK, UG 310
FD READ?, UG 324 viewing, UG 119
FD WRITE?, UG 323 VOLUME?, UG 321
FUSE, UG 314 instrument covers, RG 36
INC.WATER, UG 39 instrument specifications
ISE I. STD, UG 319 ISE system, RG 24
ISE LEVEL, UG 317 photometric measuring system, RG 24
ISE NOISE, UG 317 reagent system, RG 24
ISE PREP, UG 318 - 319 sampling system, RG 24
ISE SIPPER, UG 38 interface, RG 22
ISE SLOPE, UG 319 internal reference solution, G3

internal standard calculation, RG 634 ISE compartment
internal standard dispense cleaning, UG 475
ISE sample processing, RG 415 disassembling, UG 447 - 449
internal water system leaks, UG 475
introducing contaminants into system, reassembling, UG 451
UG 433 ISE diluent aspiration, RG 414
ISE parts, UG 56 ISE diluent dispense, RG 414
ISE (Ion Selective Electrode), G3 ISE drain
ISE calibration, RG 631, UG 451 cleaning plate, UG 440
compensation overview, RG 636 ISE I. STD instrument alarms, UG 319
compensation value calculation, ISE joint tubing, replacing, UG 447 - 451
RG 636 - 637 ISE LEVEL instrument alarms, UG 317
initiating, TG 212 ISE measuring cartridges
internal standard calculation, RG 634 installing new, UG 474 - 475
Nernst equation, RG 637 - 638 leaks, UG 474
printing results, TG 212 removing, UG 473 - 474
programming, TG 212 replacing, UG 472 - 475
reference cartridge, RG 637 slope outside critical slope values,
single point adjustment, RG 635 UG 472
slope calculation, RG 633 types, UG 474
unknown sample concentrations calcu- ISE NOISE instrument alarms, UG 317
lation, RG 639 ISE pinch valve, replacing, UG 447
viewing results, TG 212 ISE PREP instrument alarms,
ISE Calibration screen, SG 32 UG 318 - 319
Calibration key, SG 213 ISE Prepare alarm, UG 472
Channel No field, SG 312 ISE prime, G3
displaying, SG 15 ISE Prime, TG 27, UG 414, UG 451,
Full key, SG 213 UG 475
Low/High key, SG 213 ISE Prime screen, SG 53
ISE calibrators, TG 312 - 313 ISE Prime - (REF.) option, UG 451
updating values, TG 312 - 313 Mode key, SG 513, UG 451, UG 465
ISE cartridges, priming, TG 27 REF. option, UG 465
ISE Check report ISE probe rinse, RG 414
CL EMF field, SG 728 ISE reagents, selecting and executing,
Date field, SG 728 SG 513
K EMF field, SG 728 ISE reference cartridge, replacing,
Na EMF field, SG 728 UG 462 - 465
Time field, SG 728 ISE sample aspiration, RG 413 - 414
ISE Check screen, SG 63 ISE sample dispense, RG 414
Start key, SG 610 ISE sample processing, RG 413 - 417
ISE chemistries diluted ISE sample aspiration, RG 415
normal ranges, TG 326 - 327 internal standard dispense, RG 415
printing parameters, TG 38 ISE diluent aspiration, RG 414
ISE diluent dispense, RG 414
ISE probe rinse, RG 414

ISE sample aspiration, RG 413 - 414 selecting calibration for, SG 213
ISE sample dispense, RG 414 troubleshooting erratic results,
KCI and reference cartridge flowpath, UG 114 - 115
RG 416 troubleshooting excessive air in syringe
measuring cartridge flowpath, and erratic results, UG 113 - 114
RG 416 - 417 troubleshooting high internal standard
reagent probe rinse, RG 415 values, UG 115 - 116
sample and diluent stirring, RG 415 troubleshooting with high sodium or low
ISE SIPPER instrument alarms, UG 38 chloride values, UG 116
ISE SLOPE instrument alarms, UG 319, troubleshooting with low values,
UG 472 UG 116 - 117
ISE STOP? instrument alarms, UG 38
ISE suction tubing, replacing, J
UG 447 - 451 joint tubing, UG 56
ISE SYRNG. instrument alarms, UG 38
ISE system
calibrating, UG 475 K
instrument specifications, RG 24
turning on or off, TG 331 k factor, G4
verifying functionality of, SG 610 K+ electrode cartridge, UG 56
ISE system components introducing KCI and reference cartridge flowpath,
contaminants into system, UG 472 RG 416
ISE Test Parameters screen, SG 43 KCI line, priming, TG 27
ISE Test screen Key Label screen
Channel No field, TG 312, TG 313, numeric keys, SG 431
TG 326 P.Up key, TG 322
Contents No field, TG 326, TG 327 profile order, SG 23
Home key, TG 327 scrolling through profiles, TG 321
Maint. key, TG 327 keypad, clearing numbers, SG 13
P.Up key, TG 327 keys, common, SG 13 - 14
Parameter No field, TG 312, TG 313,
TG 326
ISE Tests screen L
Channel No field, SG 427 LAMP instrument alarms, UG 311
Contents field, SG 428 LCD touch screen, SG 13
Parameter No field, SG 427 manual entry, SG 13
Select key, SG 428 touch key, SG 13
ISEs LCD touchscreen, RG 19
channel number for tests, SG 427 LEVEL data alarms, UG 26
enabling/disabling option, SG 424 LIMT0 data alarms, UG 27
entering parameters for, SG 427 LIMT1 data alarms, UG 27
parameter entered or updated, SG 427 LIMT2 data alarms, UG 27
parameter listing, TG 37 LIN. data alarms, UG 27
programming parameters for, calculation for, RG 85
TG 36 - 37

LIN.8 data alarms, UG 28 cleaning external water supply filter,
calculation for, RG 87 UG 445 - 446
linear calibration methods, RG 62 cleaning floppy disk drives, UG 499
linearity check limit cleaning incubation bath, UG 429,
defining, TG 333 UG 429 - 430
rate assays with 4 to 8 read points, cleaning incubation bath and incubation
SG 425 bath filters, UG 427 - 432
rate assays with 9 or more read points, cleaning inlet water filters,
SG 425 UG 442 - 446
values, SG 425 cleaning instrument surfaces, TG 236,
Linearity Check screen UG 420
Linear Check (4-8) field, TG 333 cleaning ISE drain plate, UG 440
Linear Check (9- ) field, TG 333 cleaning photometer window,
P.Up key, TG 333 UG 429 - 430
Linearity screen, SG 420 cleaning probe/stirrer rinse baths,
linearity verification (LIN.8) data alarms, UG 426
RG 86 cleaning reaction bath filter, UG 430
liquid level detection, G4 cleaning refrigerator condenser filter,
loading UG 441
printer paper, UG 497 - 498 cleaning sample and reagent disk
reagents, RG 36 compartments, UG 436 - 439
samples, RG 36 cleaning water tank filter,
locking screw, UG 54, UG 55 UG 442 - 445
low calibrators, SG 213 cleaning/adjusting sample and reagent
lower seal, UG 55 probes and stirrer, TG 236 - 239,
lower seal piece, UG 54 UG 415 - 419
end of day, TG 234 - 239
incubation bath water exchange,
M UG 410
initiating procedures, SG 14
maintenance, RG 35 installing new ISE measuring cartridges,
cell blank, UG 424, UG 432 UG 474 - 475
cell wash, UG 432 installing new reaction cells, UG 431
checking detergent, UG 48 installing reagent probe, UG 492 - 494
checking disks in disk drives, UG 48 installing sample probe, UG 482 - 483
checking Hitergent supply, UG 46 ISE Prime, UG 414
checking printer paper, UG 48 loading printer paper, UG 497 - 498
checking stirrer paddle, UG 496 operational modes, RG 127
checking waste solution reservoir, overview, UG 42 - 43
UG 47 - 48 Photometer Check, UG 411
checking water supply, UG 49 pre-operational procedures,
cleaning analyzer daily, TG 234 UG 46 - 49
cleaning cell rinse unit nozzles, UG 425 reading/recording incubation bath
cleaning deionized water tank, temperature, UG 421
UG 433 - 435

reading/recording reagent compartment Parameters key, SG 52, TG 33,
temperature, UG 422 TG 37, TG 38, TG 39, TG 311,
recommended scheduled, UG 44 TG 313, TG 315, TG 316, TG 318,
reinstalling reaction disk, UG 471 TG 320, TG 322, TG 323, TG 324,
removing reaction cells, UG 428 TG 325, TG 327, TG 329, TG 331,
removing reaction disk, UG 466 - 467 TG 333, TG 334, TG 335
removing reagent probe, Photometer key, SG 52, TG 26,
UG 486 - 491 UG 411
removing sample probe, UG 476 - 481 Precision key, SG 53
replacing ISE measuring cartridges, Probe Adjust key, SG 52, TG 237,
UG 472 - 475 TG 238, UG 416, UG 417,
replacing ISE pinch valve, UG 447 UG 418, UG 419
replacing ISE reference cartridge, R Probe (Horiz.) option, TG 238,
UG 462 - 465 UG 418
replacing ISE suction tubing and joint R Probe (Vert.) option, UG 419
tubing, REF option, TG 26, TG 27, UG 414,
UG 447 - 451 UG 461
replacing photometer lamp, Reset key, SG 53, UG 461
UG 466 - 471 S Probe (Vert.) option, UG 417
replacing reagent probe, UG 485 - 494 S. Probe (Horiz./Vert.) option, TG 237,
replacing sample probe, UG 476 - 484 UG 416
replacing stirrer paddle, UG 495 - 496 Start key, TG 26, TG 27, TG 237,
replacing syringe seals, UG 452 - 461 TG 238, TG 239, UG 410,
required cleaning solutions, UG 411, UG 414, UG 416,
UG 42 - 43 UG 417, UG 418, UG 419,
spare parts, UG 45 UG 424, UG 429, UG 461
structure of procedures, UG 45 Status key, TG 26, TG 27, UG 410,
tracking, UG 44 UG 411, UG 414
Wash Cells operation, UG 412 - 413 Stirrer option, TG 239
Wash ISE operation, UG 4-12 - 4-13 Stop key, TG 237, TG 238, TG 239,
Maintenance screen UG 416, UG 419
Cell Blank, UG 432, UG 471 Wash key, SG 52, TG 234
Cell Blank key, SG 52, UG 424 managing floppy disks, TG 328 - 329
displaying, SG 16 Material Safety Data Sheets, P4
FD Utilities key, SG 52, UG 499 mean, G4
Incub. Water key, SG 52, TG 26, measure point, G4
UG 410, UG 429 measurement principles of general pho-
ISE Prime, UG 451, UG 465 tometer characteristics, RG 52 - 53
ISE Prime (REF.) option, UG 475 measuring cartridges
ISE Prime key, SG 53, TG 27, flowpath, RG 416 - 417
UG 414, UG 461 installing new, UG 474 - 475
Mode key, TG 26, TG 27, TG 237, leaks, UG 474
TG 238, TG 239, UG 414, removing, UG 473 - 474
UG 416, UG 417, UG 419, replacing, UG 472 - 475
UG 461

slope outside critical slope values, NOISE data alarms, UG 28
UG 472 nonlinear calibration
types, UG 474 calculation with weighting, RG 621
measuring principles calculation without weighting, RG 621
assay techniques, RG 55 - 512 methods, RG 62
bichromatic absorbance, RG 54 weighting, RG 621 - 622
overview, RG 54 weighting factors, RG 622
mechanical nonlinear logit-log 4P calibration
potential hazards and safety precau- assay types, RG 620
tions, RG 32 calculations, RG 619
resetting components, SG 512 selecting, RG 618
Mechanism Check screen, SG 62 Test Parameters screen, RG 618
Start key, SG 64 nonlinear logit-log 5P calibration
mechanisms assay types, RG 626
check, SG 64 calculations, RG 624 - 625
potential hazards and safety precau- weight factors, RG 625
tions, RG 34 nonlinear point to point calibration
memory, saving entries to, SG 14 assay types, RG 631
miscellaneous parts, UG 59 calculations, RG 631
Monitor screen, TG 229, TG 231, graph, RG 630
TG 232, TG 233 selecting, RG 630
Calibration key, SG 32 Test Parameters screen, RG 630
Control Samples key, SG 32, TG 229, nonlinear spline calibration
TG 230, TG 233 assay types, RG 629
displaying, SG 15 calculations, RG 628
ISE Calibration key, SG 32 graph, RG 627
Routine Samples key, SG 32, TG 229, selecting, RG 627
TG 230, TG 232, TG 233 Test Parameters screen, RG 627
STAT Samples key, SG 32, TG 229, normal ranges
TG 230, TG 232, TG 233 changing, TG 325 - 327
monochromatic, G4 note, G4
MOTOR CONT. instrument alarms, NOTE icon, RG 33
UG 315 nozzle #1, UG 58
MOTOR OUT instrument alarms, UG 315 nozzle #2, UG 58
moving parts, RG 36 nozzle #3, UG 58
multiple photometric chemistries, trouble- nozzle #4, UG 58
shooting, UG 111 - 112 nozzle #5, UG 58
nozzle #6, #7, UG 58
N nozzle spring, UG 58
Na+ electrode cartridge, UG 56 numeric keypad, SG 13
NCCLS (National Committee for Clinical
Laboratory Standards), P5
Nernst equation, RG 637 - 638
NO FD instrument alarms, UG 324

O Seq. No., SG 723
Test Name field, SG 724
O-ring, UG 56 Time field, SG 723
OK? key, SG 14 OVER data alarms, UG 28
operation, G4
operational modes, RG 126 - 128 P
Emergency Stop (E. STOP), RG 128
initialization (INITIAL), RG 126 P.Up (Page Up) key, SG 13
maintenance, RG 127 PAINT OVER instrument alarms, UG 314
Parameter Check (PARAM. CHK.), parameter check, G4
RG 126 Parameter Check (PARAM. CHK.) opera-
RESET, RG 126 tional mode, RG 126
Sampling Stop (S. STOP), RG 127 parameter disk
Screen Saver, RG 128 copies of, UG 499
STAND-BY, RG 126 reading test selection information,
STOP, RG 127 SG 27
terminating to prevent problems, writing test selection information,
UG 119 SG 27
operator parameters, G4
qualifications, RG 35 printing, SG 55
troubleshooting responsibilities, UG 12 reading, SG 55
operators manual writing, SG 55
Reference Guide, RG 15 Parameters menu and prioritizing Easy
revisions, RG 16 Modes, TG 222
set-up of, RG 16 Parameters screen, SG 52
Software Guide, RG 15 Calc. Test key, SG 42, TG 317,
Tutorial Guide, RG 15 TG 319
Users Guide, RG 15 Carry Over key, SG 42, TG 314
Options screen, SG 420 Channel No field, RG 55, TG 32,
ISE key, SG 424, TG 331 TG 33, TG 36, TG 37
P.Up key, TG 331 Constant key, RG 73
Sample ID key, SG 424, TG 331 Contents field, RG 55, RG 56, TG 32,
ordering information, P4, RG 16 TG 33, TG 36, TG 37
Original ABS screen, SG 420 Control Pos. key, SG 42, TG 39
Mode key, SG 424, TG 332 displaying, SG 15
P.Up key, TG 332 First No field, SG 55, TG 38, TG 324,
original ABS, defining printing, TG 332 TG 335
Original Absorbance report Home key, TG 324
Absorbance Data field, SG 724 ISE Test key, SG 43, TG 36, TG 312,
Cell Blank field, SG 724 TG 326
Cell Number field, SG 723 Last No field, SG 55, TG 38, TG 324,
Date field, SG 723 TG 335
ID field, SG 723 Mode key, SG 55, TG 33, TG 38,
Measurement Cycles field, SG 724 TG 39, TG 311, TG 313, TG 315,
Results field, SG 724

TG 316, TG 318, TG 320, TG 322, RESULTS field, SG 726
TG 323, TG 324, TG 326, TG 327, Time field, SG 726
TG 329, TG 331, TG 333, TG 334, photometer lamp, UG 59
TG 335 cautions, RG 37
P.Up key, TG 324, TG 335 checking output, UG 411
Parameter No field, RG 55, RG 56, potential hazards and safety precau-
TG 32, TG 33, TG 36, TG 37, tions, RG 34
TG 311 replacing, UG 466 - 471
Print option, TG 38, TG 335 verifying output, TG 26
Print Order key, SG 42, TG 322, Photometer screen, SG 52
TG 323 Start key, SG 56
Profile key, SG 43, TG 321 photometric assay, G4
Read option, TG 329 photometric assays, calibrating, TG 211
Select key, TG 33, TG 37 photometric calibrators, updating values,
Serum Index key, RG 73, SG 42 TG 310 - 311
Start key, SG 55, TG 33, TG 37, photometric chemistries
TG 38, TG 39, TG 311, TG 313, assigning chanel to, SG 44
TG 315, TG 316, TG 318, TG 320, displaying parameters, SG 44
TG 322, TG 323, TG 324, TG 326, displaying previously entered, SG 44
TG 327, TG 329, TG 331, TG 333, normal ranges, TG 325 - 326
TG 334, TG 335 parameter listing, TG 33 - 35
System key, SG 42, TG 330 printing parameters, TG 38
Test Param. key, RG 55, SG 42, programming parameters for,
TG 32, TG 325 TG 32 - 35
Write option, TG 33, TG 37, TG 39, test parameters, SG 45 - 49
TG 311, TG 313, TG 315, TG 316, test parameters for, SG 44
TG 318, TG 320, TG 322, TG 323, photometric measuring system,
TG 326, TG 327, TG 329, TG 331, RG 118 - 121
TG 333, TG 334 Hitergent, RG 119
patients instrument specifications, RG 24
ID number, SG 26 photometer, RG 120 - 121
printing realtime results, SG 110 reaction bath, RG 119
results, TG 231 reaction disk, RG 118
phillips screwdriver, UG 510 photometric sample processing
photometer, G4, RG 120 - 121 aspirate reaction mixture to waste,
cleaning window, UG 427, RG 412
UG 429 - 430 R1 aspiration, RG 410
general characteristics, RG 52 - 53 R1 dispense, RG 411
scratching windows, UG 427, UG 429 R1 reagent probe rinse, RG 411
photometer check, UG 411 reagent dispense at R2 timing, RG 411
performing, SG 56 reagent dispense at R3 timing, RG 411
Photometer Check report, TG 26, sample and R1 stirring, RG 411
UG 411 sample aspiration, RG 49
Date field, SG 726 sample dispense, RG 410

sample probe rinse, RG 410 First No field, SG 511
sampling end, RG 412 Last No field, SG 511
photometric tests, selecting calibration for, PREP data alarms, UG 29, UG 472
SG 212 preparing reagents, UG 15
plunger, UG 54, UG 55 press piece, UG 54, UG 55
plunger (snap), UG 59 print order
PM BOARD? instrument alarms, UG 322 assigning, TG 323 - 324
potential hazards and safety precautions printing list, TG 324
accuracy/precision of measured results, Print Order screen, SG 42
RG 35 Channel No field, SG 429, TG 323
biohazardous materials, RG 32 Print Order field, SG 429, TG 323
CAUTION icon, RG 33 Print Result screen, TG 229
chemical, RG 32 Start key, TG 229
electrical, RG 32 printer, RG 19
EMC-Class A, RG 34 checking paper, TG 24
flammables, RG 34 checking paper in, UG 48
mechanical, RG 32 loading paper, UG 497 - 498
mechanisms, RG 34 paper, UG 511
NOTE icon, RG 33 status, SG 18
photometer lamp, RG 34 verifying status, TG 216, TG 221,
preventing electrical shock, RG 34 TG 227
samples, RG 34 PRINTER instrument alarms, UG 324
visual cues, RG 33 printing
WARNING icon, RG 33 absorbance readings for results,
waste solution, RG 34 SG 424
potentiometric assay, G4 Calibration Report, TG 220, TG 226
POWER FAIL instrument alarms, UG 314 calibration results, TG 211
powering analyzer on, TG 25 chemistry parameters, TG 38
pre-operational maintenance procedures, Chemistry Parameters report, TG 38
UG 46 - 49 Control Report, TG 220, TG 230
Precision Check report control requests, TG 213
CV% field, SG 78 control results realtime, TG 226
Date field, SG 77 daily or cumulative alarm information,
MAX. field, SG 78 SG 66
MEAN field, SG 78 defining original ABS, TG 332
MIN. field, SG 78 ISE calibration results, TG 212
N field, SG 77 parameters, SG 55
printing for sample range, SG 511 Patient Report, TG 220
RANGE field, SG 78 Precision Check report for sample
S. No. field, SG 77 range, SG 511
SD field, SG 78 print order list, TG 324
Test Name field, SG 77 realtime calibration results, SG 110
Time field, SG 77 realtime patient and control results,
Precision screen, SG 53 SG 110

record or system communication key order, SG 431
between analyzer and host, SG 68 order of, SG 23
Requisition List report, TG 215, programming, SG 23
TG 219, TG 220 samples, TG 223
results in STAND-BY, TG 229 - 230 selecting, TG 215
Routine Report, TG 230 selecting tests for, SG 430
routine results, SG 34 selection of, TG 224 - 225
STAT Report, TG 230 user-defined, SG 24
STAT results, SG 38 Profiles screen
STAT results realtime, TG 226 Key Label key, SG 431
system parameters list, TG 335 Program Check report, SG 65
test order, SG 429 Date field, SG 722
version of software, SG 65 Time field, SG 722
work sheet, SG 27 V.No. field, SG 722
Probe Adjust screen, SG 52 Program Check screen
Mode key, SG 57 Start key, SG 65
Pulse Adjust key, SG 57 programming
probe cleaning wire, UG 53 batch mode samples with BCR,
probe wash, G4 TG 214 - 217
probe/stirrer rinse baths, cleaning, batch mode samples without BCR,
UG 426 TG 218 - 221
probes calculated tests, TG 317 - 318
adjusting, SG 57 check digits for barcode reader,
cleaning/adjusting, UG 415 - 419 TG 332 - 333
damaging, UG 416, UG 418 compensated tests, TG 319 - 320
interrupting adjustment, UG 418 control requests, TG 213
Profile screen, SG 43 control tests, SG 214
Accept. key, TG 322 Easy Mode 1 samples, TG 222 - 223
Home key, TG 322 Easy Mode 2 samples, TG 224 - 225
Key Label key, TG 321 Easy Mode 3 samples, TG 225 - 226
P.Up key, TG 322 Easy Mode samples, TG 222 - 227
Profile key, SG 430, TG 322 ISE calibration, TG 212
Test keys, SG 430 parameters for ISEs, TG 36 - 37
Profile Selection screen, SG 29, TG 215, parameters for photometric chemistries,
TG 219 TG 32 - 35
Accept key, TG 215, TG 219, TG 228 photometric test calibration, TG 211
displaying, SG 27 profiles, SG 23
key order, TG 321 serum index factors, SG 418
Profile keys, SG 210 special washes, TG 314 - 316
Tests key, SG 210, TG 215 STAT samples, TG 228
profiles, G5 system parameters, SG 420 - 426,
assigning tests to, SG 430 - 431 TG 330 - 335
defining, TG 321 - 322 tests, SG 23
displaying, SG 430

R damaged stirrer paddle and, UG 495
enabling/disabling evasion
R. DISK instrument alarms, UG 33, programming, SG 412
UG 38 handling, UG 427
R. PROBE instrument alarms, UG 37 installing new, UG 431
R. SYRINGE instrument alarms, UG 38 monthly replacement of, UG 427
R.OVER data alarms, UG 210 removing, UG 428
R1 aspiration, RG 410 replacing, UG 427 - 432
R1 dispense, RG 411 rinse unit nozzles, G5
R1 reagent probe rinse, RG 411 rinse unit probes, G5
rate A assay selecting carryover evasion program,
characteristics, RG 541 SG 412
graph-R1 and R2 timing, RG 542 selecting detergent position for cell
graph-R1 timing, RG 541 rinse, SG 412
sample calculations, RG 542 selecting detergent volume for cell rinse,
Test Parameters screen, RG 541 SG 412
rate A assay with sample blank selecting test causing carry over,
characteristics, RG 543 SG 412
graph-R1 and R2 or R3 timing, RG 543 selecting test causing carryover,
sample calculations, RG 544 SG 412
Test Parameters screen, RG 543 set, UG 511
Rate As Chk screen soaking before replacing, UG 427
Linear Check (4-8) field, SG 425 washing, TG 315
Linear Check (9- ) field, SG 425 reaction disk, G5, RG 118, RG 36
rate assays, G5 handling, UG 427
linearity check limit, SG 425 positions, RG 45
rate B assay - Mode 1 reinstalling, UG 471
graph-R1 and R3 timing, RG 546 removing, UG 466 - 467
sample calculations, RG 546 - 547 reaction processing components, RG 44
Test Parameters screen, RG 545 reading
rate B assay - Mode 2 floppy disk parameters, TG 329
characteristics, RG 548 parameters, SG 55
graph-R1 and R3 timing, RG 549 REAG. LEVEL instrument alarms, UG 313
sample calculations, RG 550 REAG. POS? instrument alarms, UG 322
Test Parameters screen, RG 548 REAG. SHORT instrument alarms,
reaction bath, G5, RG 119 UG 313
cleaning filter, UG 430 reagent compartment
draining, UG 429 acceptable temperature, UG 422
filter, UG 430, UG 59 reading/recording temperature, UG 422
introducing contaminants from, UG 427 temperature out of range, UG 422
starting system while measuring tem- reagent disk compartment
perature, TG 28 cleaning, UG 436 - 439
temperature out of range, TG 28 spills, UG 436
reaction cells, G5, RG 37
carryover evasion, SG 412

reagent disks, G5, RG 114, RG 36 reagent solutions
handling, UG 436 handling, RG 36
location of Hitergent, TG 22 restrictions, RG 35
reagent dispense at R2 timing, RG 411 reagent syringe seals, replacing,
reagent dispense at R3 timing, RG 411 UG 457 - 458
reagent pipettors, G5, UG 461 reagent syringes, UG 55
removing seal, UG 453 reagent syringes/pipettor, RG 116
reagent probe, G5, RG 115, UG 53 reagent system, RG 114 - 117
alignment procedure, TG 238, flowpath, RG 117
UG 418 - 419 instrument specifications, RG 24
bending, TG 238 reagent disks, RG 114
carryover evasion, SG 411 - 412 reagent probe, RG 115
checking/adjusting alignment, UG 494 reagent probe arm, RG 115
cleaning, TG 236, UG 491 reagent probe rinse station, RG 116
cleaning/adjusting, UG 415 - 419 reagent syringes/pipettor, RG 116
damaged, UG 485 stirring unit, RG 117
damaging, TG 238, UG 418 reagent tray, G5
disconnecting lead wires and loosening Reagent Volume Check report, TG 210
retaining nut, UG 488 - 489 [Wash] field, SG 710
enabling/disabling carryover evasion, Ch. field, SG 79
SG 411 Date field, SG 79
installing, UG 492 - 494 ISE values, TG 210
interrupting adjustment, UG 418 Name field, SG 79
removing, UG 486 - 491 Pos. field, SG 79
removing arm cover, UG 486 - 487 R1, R2, R3, R4 fields, SG 79
replacing, UG 485 - 494 Test field, SG 710
selecting carry over evasion program, Time field, SG 79
SG 411 reagents
selecting detergent position for reagent checking volume, TG 210
probe wash, SG 411 insufficient volume, TG 210
selecting detergent volume for reagent loading, RG 36
probe wash, SG 411 preparing, UG 15
selecting reagent type affected by carry special wash functions, TG 314 - 316
over, SG 411 Volume Check Report, SG 110
selecting test affected by carry over, REAGN data alarms, UG 211
SG 411 realtime, G5
selecting test causing carry over, Realtime Patient report, TG 216
SG 411 recalibration, G5
touching tip of, TG 236 reconstituting calibrators, UG 15
washing, TG 314 - 315 reconstituting controls, UG 15
reagent probe arm, G5, RG 115 REF SHORT instrument alarms, UG 320
reagent probe rinse, RG 415 REF.WATER instrument alarms, UG 39
reagent probe rinse station, G5, RG 116 reference cartridge, G6, RG 637, UG 56
installing new, UG 464 - 465
removing, UG 462 - 463
replacing, UG 462 - 465

Reference Guide, RG 15 required cleaning solutions,
reference solution, G6 UG 42 - 43
refrigerator condenser filter, cleaning, Requisition List report
UG 441 Channel Numbers field, SG 76
regent probes Date field, SG 76
vertical adjustment, UG 419 printing, TG 215, TG 219, TG 220
reinstalling reaction disk, UG 471 S. No. field, SG 76
removing TEST COUNT section, SG 76
reaction cells, UG 428 Test Requests field, SG 76
reaction disk, UG 466 - 467 Time field, SG 76
reagent probe, UG 486 - 491 RESERVOIR instrument alarms, UG 310
sample probe, UG 476 - 481 reset, G6
replacing RESET operational mode, RG 126
floppy disks, UG 499 Reset screen, SG 53
ISE measuring cartridges, Start key, SG 512
UG 472 - 475 results
photometer lamp, UG 466 - 471 accuracy/precision of measured, RG 35
reagent probe, UG 485 - 494 control, TG 229, TG 230, TG 233
sample probe, UG 476 - 484 deleting, TG 233
stirrer paddle, UG 495 - 496 displaying, TG 231
reports patient, TG 231
Barcode Reader Check, SG 729 printing absorbance readings, SG 424
Calibration Monitor, RG 66, SG 711, printing in STAND-BY, TG 229 - 230
SG 712, SG 713 printing in STAND-BY mode,
Cell Blank, RG 58 TG 229 - 230
Cell Blank Measurement, SG 720, routine, TG 229, TG 230, TG 233
SG 721, SG 722 saving as ASCII text, TG 232
Chemistry Parameters, SG 730 STAT, TG 229, TG 230, TG 231,
Communication Trace, SG 717 TG 233
Cumulative Alarm Trace, SG 716 uploading to host, TG 229 - 230
Cumulative Operations List, SG 718, retaining screw, UG 54, UG 55
SG 719 rinse baths, G6
Cumulative Operations Trace, SG 67 cleaning, UG 426
Data Alarm Trace, SG 714, SG 715 RINSE instrument alarms, UG 32
Data Monitor, SG 73, SG 74 Routine report
ISE Check, SG 727, SG 728 printing, TG 230
Original Absorbance, SG 723, SG 724 Routine Result, ASCII screen, SG 33
Photometer Check, SG 725, SG 726 First No field, SG 36
Precision Check, SG 77, SG 78 Last No field, SG 36
Program Check, SG 65, SG 722 Routine Result, Delete screen, SG 33
Reagent Volume Check, SG 79, First No field, SG 35
SG 710 Last No field, SG 35
Requisition List, SG 75, SG 76 Routine Result, Disp. screen, SG 33
System Parameters, SG 732, SG 733 First No field, SG 34
Test parameters, SG 731

Routine Result, Print screen, SG 33 configuration, UG 417
First No field, SG 34 verifying alignment of sample probe
Last No field, SG 34 over, UG 484
Routine Result, Send screen, SG 33 sample disk, G6, RG 110, RG 36
First No field, SG 35 cleaning compartment, UG 436 - 439
Last No field, SG 35 compartment spills, UG 436
routine results, TG 229, TG 230, designating control positions, TG 39
TG 233 displaying position, SG 24
deleting, TG 233 handling, UG 436
displaying, TG 231 placing tubes or cups on, UG 417
printing, SG 34 position number for control level,
printing in STAND-BY, TG 229 - 230 SG 419
saving as ASCII text, SG 36, TG 232 position of sample, SG 25
uploading to host, SG 35, reserved positions, TG 228
TG 230 - 231 reserving positions for control solutions,
viewing on-screen, SG 34 SG 419
routine samples reserving STAT positions on, SG 426
data management options for results, sample position number, SG 28
SG 33 sample dispense, RG 49
deleting, SG 35 Sample ID screen, SG 25, SG 26 - 28
Routine Samples screen, SG 32 Batch field, TG 220
Delete key, SG 33, TG 233 displaying, SG 24
Display key, SG 33, TG 231 OK? key, TG 220
FD (ASCII) key, SG 33, TG 232 P.Up key, TG 216, TG 224, TG 226
Print key, SG 33, TG 229 Profile key, TG 218, TG 219
Send key, TG 230 Sample ID field, TG 219, TG 224,
TG 225
S Sample No. field, TG 218, TG 219
S. DISK instrument alarms, UG 36 Start key, TG 215, TG 220
S. PROBE instrument alarms, Tests key, TG 218, TG 219
UG 33 - 35 TS key, TG 214
S. SHORT instrument alarms, UG 36 Wk.Sht. key, TG 215, TG 220
S. SYRINGE instrument alarms, UG 36 Sample ID screen (Batch Mode with
S.INDEXES? instrument alarms, UG 322 barcode reader (BCR)), SG 26 - 27
s.stop, G6 Sample ID screen (Batch Mode without
S1 absorbance limit (S1ABS?) data alarms, barcode reader (BCR)), SG 26 - 27
RG 88 Sample ID screen (Batch Mode)
S1Abs? data alarms, UG 213 Batch Mode (with BCR only) field,
sales representatives, contacting, P4 SG 26
SAMPL data alarms, UG 211 Delete key, SG 27
sample and diluent stirring, RG 415 Profile key, SG 27
sample and R1 stirring, RG 411 Read key, SG 27
sample aspiration, RG 49 Sample ID field, SG 26
sample cups, UG 511 Sample No (without BCR only) field,
SG 26

Tests key, SG 27 sample run
Wk.Sht key, SG 27 activating/deactivating calibration,
Write key, SG 27 SG 19
Sample ID screen (Easy Mode) activating/deactivating serum index
Position Number field, SG 28 analysis, SG 110
Sample ID field, SG 28 beginning sequence number, SG 19
Sample No field, SG 28 initiating, SG 14, SG 22
sample pipettor, G6 initiating batch mode, SG 22
sample predilution, G6 next available position number for,
sample probe, G6, RG 111, UG 53 SG 23
alignment procedure, TG 237, turning off batch mode buzzer, SG 110
UG 416 - 417 sample solutions restrictions, RG 35
bending, TG 237 sample syringe/pipettor, RG 112
carryover evasion, SG 413 sample tray, G6
checking/adjusting alignment, UG 484 sample waste, TG 23
cleaning, TG 236, UG 481 samples
cleaning procedure, UG 415 available tests for, SG 25
cleaning/adjusting, UG 415 - 419 deleting test selection information,
cross contamination, TG 236 SG 27
damage to, UG 476 displaying sequence number, SG 24,
damaging, TG 237, UG 416 SG 25
disconnecting lead wires and loosening enabling/disabling barcode reader
retaining nut, UG 478 - 479 option, SG 424
enabling/disabling evasion entering ID, TG 214
programming, SG 413 entering profile selections, SG 210
installing, UG 482 - 483 incrementing sample disk position,
interrupting adjustment, UG 416 TG 225
removing, UG 476 - 481 incrementing sample sequence number,
removing arm, UG 480 TG 225
removing arm cover, UG 476 - 477 initiating run, TG 221
replacing, UG 476 - 484 loading, RG 36
selecting carryover evasion program, number in batch mode, SG 26
SG 413 patient ID number, SG 28
selecting position of detergent for potential hazards and safety
sample probe wash, SG 413 precautions, RG 34
selecting test causing carryover, printing Precision Check report for
SG 413 range, SG 511
touching tip of, TG 236 profile selection, TG 224 - 225
verifying alignment, UG 484 profiles, TG 223
washing, TG 316 programming batch mode with BCR,
sample probe arm, G6, RG 111 TG 214 - 217
sample probe rinse, RG 410 programming Easy Mode,
sample probe rinse station, G6, RG 112 TG 222 - 227

programming without BCR, select, G7
TG 218 - 221 selections, deleting, SG 14
range by sequence number, SG 26 Send Result screen
sample disk position number, SG 28 P.Up key, TG 231
sample disk position of, SG 25 Start key, TG 230
selecting tests for, SG 211 SENS data alarms, RG 87, UG 212
selecting tests to run on, TG 214 SENS.? instrument alarms, UG 317
sequence number, SG 28, TG 220 serum index factor
test selections, TG 225 - 226 calculation of serum indices,
troubleshooting single, UG 19 - 110 RG 79 - 710
turning off buzzer in batch mode run, calibrating serum indices, RG 77
SG 110 graphic representation of serum
sampling end, RG 412 indices, RG 78
Sampling stop (S. STOP) operational serum index function
mode, G6 definition of serum indices, RG 72
Sampling Stop (S. STOP) operational existing chemistry channel usage,
mode, RG 127, UG 119 RG 73
sampling system, RG 110 - 113 factors, RG 73
flowpath, RG 113 saline channel usage, RG 74
instrument specifications, RG 24 saline parameters, RG 74 - 76
sample disk, RG 110 selecting serum indices, RG 77
sample probe, RG 111 Serum Index screen, RG 73
sample probe arm, RG 111 Serum Index screen, SG 42
sample syringe/pipettor, RG 112 Channel No field, SG 418
saving Constant key, SG 418
results as ASCII text, TG 232 Factor field, SG 418
routine results as ASCII text, SG 36 serum index function, RG 73
STAT results as ASCII text, SG 310 serum indices, G7
scheduled maintenance batch mode samples, TG 216, TG 220
recommended, UG 44 calculation of, RG 79 - 710
spare parts, UG 45 calibrating, RG 77
structure of procedures, UG 45 channel number of test, SG 418
Screen Saver operational mode, G6, defining factor, SG 418
RG 128 definition of, RG 72
screens Easy Mode samples, TG 226
moving between, SG 13 factor to be defined, SG 418
previous, SG 13 graphic representation of, RG 78
scroll, G6 hemolysis index, RG 79
Scroll Arrow keys, SG 13 icterus index, RG 79
SD (standard deviation), G7 lipemia index, RG 710
SD? data alarms, UG 211 programming factors, SG 418
selecting, RG 77
serum pipettors, UG 461
removing seal, UG 453

serum syringe, UG 54 cell rinse unit, UG 58
replacing seals, UG 456 - 457 Cl- electrode Cartridge, UG 56
service, P3, RG 16 collar, UG 54
service representatives consumables, UG 511
contacting, P4 fuses, UG 57
single chemistry troubleshooting, glass syringe barrel, UG 54, UG 55
UG 110 - 111 grommet (snap), UG 59
single point adjustment, RG 635 Hitergent, UG 511
SIP pipettors, UG 461 holder, UG 54
removing seal, UG 453 inlet water filter (back), UG 59
SIP syringe seals, replacing, inlet water filter (tank), UG 59
UG 457 - 458 ISE parts, UG 56
SIP syringes, UG 55 joint tubing, UG 56
SIPPER instrument alarms, UG 310 K+ electrode cartridge, UG 56
sipper line, priming, TG 27 locking screw, UG 54, UG 55
slope calculation, RG 633 lower seal, UG 55
SLOPE? alarm, UG 472 lower seal piece, UG 54
SLOPE? data alarms, UG 212 maintenance, UG 45
sodium hyperchlorite miscellaneous parts, UG 59
0.525% solution, UG 43 Na+ electrode cartridge, UG 56
Roche Diagnostics Wash Solution, nozzle #1, UG 58
UG 43 nozzle #2, UG 58
software nozzle #3, UG 58
flowchart, SG 111 nozzle #4, UG 58
printing version of, SG 65 nozzle #5, UG 58
Software Guide, RG 15 nozzle #6, #7, UG 58
SP (space) key, SG 13 nozzle spring, UG 58
spanner wrench, UG 510 O-ring, UG 56
spare parts ordering information, P4, RG 16,
0.5 amp alarm fuse, UG 57 UG 52
0.5 amp fuse, UG 57 overview, UG 52
10 amp alarm fuse, UG 57 phillips screwdriver, UG 510
20 ml reagent disk adapter, UG 511 photometer lamp, UG 59
20 ml round bottle adapter, UG 511 plunger, UG 54, UG 55
3 amp alarm fuse, UG 57 plunger (snap), UG 59
3.2 amp fuse, UG 57 press piece, UG 54, UG 55
5 amp alarm fuse, UG 57 printer paper, UG 511
allen wrench, UG 510 probe cleaning wire, UG 53
bar code labels (000), UG 511 reaction bath filter, UG 59
bar code labels (001-500), UG 511 reaction cell set, UG 511
bar code labels (1001-1500), UG 511 reagent probe, UG 53
bar code labels (2001-2500), UG 511 reagent syringes, UG 55
bar code labels (2501-3000), UG 511 reference cartridge, UG 56
bar code labels (501-1000), UG 511 retaining screw, UG 54, UG 55

sample cups, UG 511 displaying, SG 14
sample probe, UG 53 Host Com. key, TG 216, TG 220,
serum syringe, UG 54 TG 226
SIP syringes, UG 55 initiating Easy Mode 2 or Easy Mode 3
spanner wrench, UG 510 sample run, TG 226 - 227
spring, UG 54, UG 55 Realtime Print key, TG 212, TG 216,
spring clip, UG 58 TG 220, TG 226
squeegee (1 ea), UG 58 S. End Buzzer key, TG 216, TG 220
stirring paddle, UG 59 Serum Index key, TG 216, TG 220,
suction tubing, UG 56 TG 226
syringe barrel O-ring, UG 55 Status key, TG 216, TG 221, TG 227
syringe holder, UG 54, UG 55 Start Conditions 1 screen
syringe holder O-ring, UG 54, UG 55 Reagent (Prnt) key, SG 110
System Cleaning Solution Serum Index key, SG 110
(1.05 N NaOH), UG 511 Start Conditions screen
tools, UG 510 Calibration key, TG 211, TG 212
upper seal (4 ea), UG 55 Control key, TG 213
upper seal piece, UG 54 Home key, TG 211, TG 212
special washes P.Up key, TG 211, TG 212, TG 213
programming, TG 314 - 316 Reagent (Prnt) key, TG 210
spring, UG 54, UG 55 Start key, SG 14
spring clip, UG 58 start-up procedures
squeegee (1 ea), UG 58 incubation bath exchange, TG 26
STAND-BY operational mode, G7, incubation bath temperature, TG 28
RG 126 ISE Prime, TG 27
printing results in, TG 229 - 230 Photometer Check, TG 26
standard calibrators, SG 213 reagent volume, TG 210
STANDARD? instrument alarms, UG 316 STAT (short turn around time), G7
Start Condition 1 screen STAT key, G7, SG 14
Calibration key, SG 19 STAT Positions screen, SG 421
Control key, SG 19 First No field, SG 426, TG 332
Sample No field, SG 19 P.Up key, TG 332
Start Condition 2 screen STAT report
Cal. Print key, SG 110 printing, TG 230
Host key, SG 110 STAT reserve positions
Realtime Print key, SG 110 defining, TG 332
S. End Buzzer key, SG 110 STAT Result, ASCII screen, SG 37
Start Condition screen First No field, SG 310
Cal. Print key, TG 212, TG 216, Last No field, SG 310
TG 220, TG 226 STAT Result, Delete screen, SG 37
Calibration key, TG 216, TG 220, First No field, SG 39
TG 226 Last No field, SG 39
Control key, TG 212, TG 213, STAT Result, Disp. screen, SG 37
TG 216, TG 220, TG 226 First No field, SG 38
STAT Result, Print screen, SG 37

First No field, SG 38 incubation bath temperature, TG 28,
Last No field, SG 38 UG 421, UG 471
STAT Result, Send screen, SG 37 P.Up key, TG 26, TG 27, TG 216,
First No field, SG 39 TG 221, TG 227, TG 234, UG 410,
Last No field, SG 39 UG 411, UG 413, UG 414,
STAT results, TG 229, TG 230, TG 231, UG 499
TG 233 STAND-BY message, TG 26, TG 27,
deleting, SG 39, TG 233 TG 234, UG 410, UG 411,
displaying, TG 231 UG 413, UG 414
printing, SG 38 verifying host and printer status,
printing in STAND-BY, TG 229 - 230 TG 216, TG 221
realtime printing, TG 226 viewing instrument alarms, UG 119
saving as ASCII text, SG 310, TG 232 STD? data alarms, UG 213
uploading results to host, stirrer
TG 230 - 231 alignment procedure, TG 239, UG 419
uploading to host, SG 39 cautions, RG 37
viewing on-screen, SG 38 centering, UG 419
STAT samples cleaning, TG 236
data management options for, SG 37 cleaning procedure, UG 415
entering test selections, SG 29 cleaning/adjusting, UG 415 - 419
patient ID number, SG 29 STIRRER instrument alarms, UG 32
previously programmed position, SG 29 stirrer paddle, UG 59
programming, TG 228 checking, UG 496
STAT Samples screen, SG 32 damaged, UG 495
Delete key, SG 37, TG 233 replacing, UG 495 - 496
Display key, SG 37, TG 231 testing, UG 495
FD (ASCII) key, SG 37, TG 232 stirrer, stirring paddle, G7
Print key, SG 37, TG 229 stirring unit, RG 117
Send key, SG 37, TG 230 stop, G7
STAT Test Selection screen Stop key, SG 14
displaying, SG 14 STOP operational mode, RG 127,
P.Up key, TG 228 UG 119
Position field, TG 228 substrate depletion (LIMT.O, LIMT.1,
Position key, SG 29 LIMT.2) data alarms, RG 88 - 810
Profile key, SG 29, TG 228 suction tubing, UG 56
Sample ID field, SG 29, TG 228 syringe barrel O-ring, UG 55
Tests key, SG 29, TG 228 syringe holder, UG 54, UG 55
Status 1 screen syringe holder O-ring, UG 54, UG 55
Instrument/Data alarms, SG 17 syringe seals
Status 2 screen, SG 18 exposing, UG 455 - 456
Status key, SG 14 replacing, UG 452 - 461
Status screen syringes
checking for alarms, TG 216, TG 221, crimping tubing, UG 452
TG 227 disassembling, UG 453 - 455
displaying, SG 14

exposing seals, UG 455 - 456 Rate As Chk key, TG 333
preventing introduction of contaminants Rate As Chk. key, SG 420
into system, UG 452 STAT Pos. key, SG 421, TG 332
reassembling, UG 459 - 461
replacing seals, UG 452 - 461 T
system Technical Publications Group, P5
introducing contaminants, UG 485 TEMP CONT. instrument alarms, UG 39
introducing contaminants into, UG 476 temperature
System Cleaning Solution, G7 reading/recording incubation bath,
checking, UG 48 TG 28
System Cleaning Solution (1.05 N NaOH), Test Parameters screen, SG 42
UG 511 1-point endpoint and rate assay,
System Cleaning Solution (Multiclean), RG 534
TG 234, UG 43 1-point linear calibration, RG 610
daily checks, TG 22 2-point linear calibration, RG 614
SYSTEM I/F instrument alarms, UG 324 3-point endpoint assay, RG 531
system parameters assay type and measure points, RG 55
defining host communication settings, calibration methods, RG 62
TG 334 Channel No field, SG 44, TG 325
defining linearity limits, TG 333 Contents field, SG 45, TG 325
defining original ABS printing, TG 332 Home key, TG 326
defining STAT reserve positions, nonlinear logit-log 4P calibration,
TG 332 RG 618
printing list of, TG 335 nonlinear point to point calibration,
programming, SG 420 - 426, RG 630
TG 330 - 335 nonlinear spline calibration, RG 627
programming check digits for barcode P.Up key, TG 326
reader, TG 332 - 333 Parameter field, RG 62
setting initial Easy Mode screen, Parameter No field, SG 44, TG 325
TG 331 rate A assay, RG 541
time and date, TG 330 - 331 rate A assay with sample blank,
turning ISE system or barcode reader RG 543
on or off, TG 331 rate B assay - Mode 1, RG 545
System Parameters report, TG 324 rate B assay - Mode 2, RG 548
ISE parameters, TG 37 Select key, SG 45
photometric chemistry parameter Test Selection screen, SG 29, SG 210,
listing, TG 35 TG 215, TG 219
System Parameters screen, SG 42 Accept key, TG 215, TG 219
Check Digit key, SG 421, TG 332 Accept. key, TG 228
Com. Param. key, SG 420, TG 334 displaying, SG 27
Date key, SG 420, TG 330 Profile key, TG 214, TG 215
Init. Screen key, SG 420, TG 331 Test keys, SG 211
Options key, SG 420, TG 331 Tests key, TG 214, TG 215
Original ABS key, SG 420, TG 332 Test Summary screen, SG 62
Start key, SG 67

test-specific information, RG 16 all chemistries with more than one set
testing stirrer paddle, UG 495 point, UG 111
tests all chemistries, including ISEs, UG 112
assay type and measure points, analyzer, UG 12
RG 55 - 56 biased enzymes, UG 118
assigning to profiles, SG 430 - 431 checking preparation of reagents,
available for sample, SG 25 calibrators, and controls, UG 15
deleting selection information, SG 27 chemistries with one set point, UG 113
modes, RG 22 - 23 chemistry, UG 12, UG 14 - 118
parameters for photometric chemistries, computer, UG 12
SG 44 erratic test results causes, UG 18 - 19
photometric chemistry parameters, general mechanical problem isolation,
SG 45 - 49 UG 119
printing order, SG 429 high test results causes, UG 16
programming, SG 23 instrument, UG 119
programming controls, SG 214 instrument power up, UG 13
reading selection information, SG 27 ISEs with erratic results, UG 114 - 115
registering, TG 215 ISEs with excessive air in syringe and
sample selections, TG 225 - 226 erratic results, UG 113 - 114
selecting for profiles, SG 430 ISEs with high internal standard values,
selecting for sample, TG 214, TG 215 UG 115 - 116
specific information for, P3 ISEs with high sodium or low chloride
writing selection information, SG 27 values, UG 116
time ISEs with low values, UG 116 - 117
entering, SG 421 low test results causes, UG 17
setting, TG 330 - 331 multiple photometric chemistries,
tools, UG 510 UG 111 - 112
Tools screen operator's responsibilities, UG 12
Alarm Trace key, SG 62 single sample or control, UG 19 - 110
Barcode key, SG 63 TS OVER instrument alarms, UG 313
C-RAM R/W key, SG 62 Tutorial Guide, RG 15
Com. Trace key, SG 62 overview, TG 12
Count Clear key, SG 63 TWIN TEST? instrument alarms, UG 320
displaying, SG 16
ISE Check key, SG 63 U
ISE Check option, UG 475 updating
Mech. Check key, SG 62 ISE calibrator values, TG 31 - 313
Program key, SG 62 photometric calibrator values,
Test Summary key, SG 62 TG 310 - 311
touchscreen. See LCD touchscreen uploading
tracking maintenance, UG 44 control results to host, SG 314
trademarks, RG 14 routine results to host, SG 35
training, additional, P3 STAT results to host, SG 39
troubleshooting upper seal (4 ea), UG 55
upper seal piece, UG 54

User's Guide, RG 15 water
user-defined profiles, SG 24 checking incubation bath exchange,
UG 410
V checking supply, RG 125, TG 23,
VAC. TANK instrument alarms, UG 310 UG 49
vacuum system, RG 125 cleaning tank filter, UG 442 - 445
Volume Check Report, SG 110 work sheet, printing, SG 27
VOLUME? instrument alarms, UG 321 writing
floppy disk parameters, TG 329
W parameters, SG 55
warning, G8
WARNING icon, RG 33
warranty, P2
wash procedure, end of day, TG 234
Wash screen, SG 52
Cells option, TG 234, UG 413,
UG 432
ISE option, TG 234, UG 413
Mode key, SG 54, TG 234, UG 413,
UG 432
Start key, TG 234, UG 413, UG 432
Status key, TG 234, UG 413
Wash Solution, UG 43
wash solution volume, TG 210
washes
defining, SG 54
performing, SG 54
washing
reaction cell, TG 315
reagent probe, TG 314 - 315
sample probe, TG 316
waste solution potential hazards and
safety precautions, RG 34
waste solution reservoir, G8
biohazardous material, TG 23
checking, TG 22 - 23
emptying, UG 47 - 48
potentially biohazardous materials in,
UG 47

NOTES

Glossary
A
ambulance key see STAT key.
analyte a specific constituent to be measured.
analytical unit the hardware unit containing the sampling, reagent, cell
rinse, photometric and ISE systems.
application sheet a document that lists all information necessary to
perform a specific assay or test on the analyzer.
assay a specific test.
the process of measuring a substance.
B
barcode reader the device that reads the code from a sample barcode
label.
bichromatic absorbance the absorbance at the primary wavelength minus the
absorbance at the secondary wavelength.
Batch Mode analyzer mode in which a predetermined number of
routine samples are processed. The analyzer returns
to STAND-BY at the conclusion of the sample run.
Additional samples must be programmed as a new
batch.
C
calculated test a test result not actually run on the analyzer, but calcu-
lated from other test results that have been run on the
analyzer.
calibration The process to standardize the instrument with samples
of known concentration. This process establishes factors
and or updates baselines to enable conversion of the
response of the instrument to concentration (or activity)
for the constituent being measured.
calibrator a substance with known values used in the calibration of
clinical chemistry assays.
caution a statement in this operators manual called out to make
the operator aware of conditions that could result in
instrument damage.
CEDIA® a homogeneous enzyme immunoassay system.
(Cloned Enzyme Donor
Immunoassay)
Roche Diagnostics/Hitachi 902 Analyzer Reference Guide G-1

Glossary
cell blank process measuring absorbance of all 48 reaction cells,

containing water, at all 12 wavelengths.
cell rinse unit a set of nozzles that clean the reaction cells.
chemistry analyzer a set of interrelated systems capable of in vitro, quanti-
tative and qualitative determinations of a wide range of
analytes through potentiometric and photometric
assays.
compensated test a test that has the result modified by a compensating
formula.
consumables items that are used during test processing and must be
replaced on a regular basis by the customer, i.e. reac-
tion cells, printer paper, sample tubes etc.
control a substance with known values used to verify calibra-
tion and processing of chemistry assays.
cuvette the plastic cell where sample and reagent are delivered
to process results for a specific analyte. (Same as
reaction cell.)
D
data alarms printed or displayed alarms that indicate unusual
reaction conditions (i.e. insufficient sample or reagent,
substrate depletion, etc.). (Same as data flags.)
deionized water (DI water) water from which ions have been removed.
diluent an agent used to make an analyte less concentrated.
dispense delivery of a sample or reagent by the appropriate
probe to a reaction cell.
duplicate limit the limit, which if exceeded by replicate assays of the
standards causes a Dup alarm.
E
Easy Mode analyzer mode in which sampling begins at position 1
and stays in operation until the Stop key is touched.
Positions can be reused immediately after sampling,
allowing additional samples to be processed without
resetting the analyzer.
emergency stop an instrument alarm level that could result in damage to
the instrument. All functions stop immediately.
G-2 Roche Diagnostics/Hitachi 902 Analyzer Reference Guide

Glossary
endpoint assay a determination in which measurements are taken after

a reaction has stopped. The intensity of the colored or
turbid product is an indicator of the sample analyte
concentration.
F
factor setting a factor used in conversion of absorbance values to
concentration values. (Same as K Factor.)
floppy disk (FD) a small plastic disk coated with magnetic material
on which data from a computer can be stored. (Same as
diskette.)
H
Hitergent a surfactant:
- used to reduce foaming in the reaction bath.
- diluted for use in some cleaning procedures.
host communication information exchange with a Laboratory Information
System (host computer).
I
in vitro qualitative assay a determination, outside the living body, of constituents
of a substance without regard to quantity.
in vitro quantitative assay a determination, outside the living body, of constituents
of a substance with regard to a specified number or
amount.
incubation bath temperature-controlled, water-filled reservoir that
surrounds the reaction cells. (Same as reaction bath.)
Initialization operational mode that occurs immediately following
power ON.
instrument alarms displayed alarms that indicate unusual instrument
conditions (i.e. abnormal reaction bath temperature,
mechanical malfunctions, etc.).
internal reference solution (internal standard) solution assayed between every ISE
sample to compensate for electronic drift.
ISE (Ion Selective Electrode) a measuring device that is
selective for the quantitation of an electrolyte such as
sodium, potassium or chloride.
ISE prime procedure that fills the ISE reagent lines and pipettors/
syringes with reagent.

Glossary
K
K Factor a factor used in conversion of absorbance values to
concentration values.
L
liquid level detection ability to sense liquid by the sample and reagent
probes.
M
mean the average value of a set of numbers, used in quality
control evaluations.
measure point mechanical cycle during which absorbance reading is
taken and used to calculate results.
monochromatic absorbance measurement at one wavelength, repre-
senting absorbance due to the absorbance of the
analyte and any interfering substances.
N
note statement in the operators manual called out to make
the operator aware of specific information.
O
Operation the operational mode during which the instrument
processes samples.
P
Parameter Check the operational mode of the analyzer where the com-
puter checks internal parameters (automatically occurs
after Start is pressed).
parameters a set of criteria used to establish how an assay is
performed.
photometer device that measures the intensity of light or determines
the light threshold.
photometric assay assays in which analytes are measured by a photom-
eter.
potentiometric assay assays in which analytes are measured in millivolts by
electrodes.
probe wash the operational mode the analyzer enters while washing
sample and reagent probes.

Glossary
profile individual chemistry tests programmed into a group of

tests that is performed on a sample by pressing only
one analyzer key.
R
rate assay a determination in which measurements based on
change in absorbance per minute are taken as the
reaction proceeds. The rate of the reaction is propor-
tional to the sample component being analyzed.
reaction bath temperature-controlled, water-filled reservoir that
surrounds the reaction cells.
reaction cell plastic cell where sample and reagent are delivered to
process result for a specific analyte. (Same as cuvette.)
reaction cell rinse unit nozzles part of the cell rinse unit that dispenses and aspirates
water used to clean reaction cells. (Same as reaction
cell rinse unit probes.)
reaction cell rinse unit probes see reaction cell rinse unit nozzles.
reaction disk A large rotatable disk holding 48 reusable plastic
reaction cells upright around the outside perimeter of
the disk that are used in sample processing.
reagent disk refrigerated compartment holding chemistry reagents.
reagent pipettor positive displacement syringe that aspirates and dis-
penses reagent.
reagent probe slender metal tube used to carry reagent from the
reagent disk to the reaction cells.
reagent probe arm moves the reagent probe between the reagent disk and
reaction disk.
reagent probe rinse station area located between the reagent disk and reaction disk
where the reagent probe is rinsed both internally and
externally with water.
reagent tray refrigerated compartment holding chemistry reagents.
(Same as reagent disk.)
realtime display of information on the monitor at the moment a
change, altering such information, occurs.
recalibration repeat calibration.

Glossary
reference cartridge the cartridge through which the reference solution flows
to set the electronic baseline for ISE measurement.
reference solution (KCl) the solution pulled through the reference cartridge
to set the electronic baseline for ISE measurement.
Reset the operational mode during which the analyzer sets
and aligns all mechanical parts to Home position.
rinse bath area where the sample and reagent probes are rinsed
both internally and externally.
S
S.Stop an instrument alarm level that indicates a problem with
the sampling system. Sampling stops, but sample
processing continues.
sample disk disk containing samples, standards and controls to be
processed.
sample predilution dilution of sample prior to analysis.
sample pipettor positive displacement syringe that aspirates and dis-
penses sample.
sample probe slender tube used to carry sample from the sample
diskto the reaction cells and between reaction cells.
sample probe arm moves the sample probe between the sample disk and
reaction disk.
sample probe rinse station area located between the sample disk and reaction disk
where the sample probe is rinsed both internally and
externally with water. (Same as sample probe rinse
bath.)
sample tray disk containing samples to be processed. (Same as
sample disk.)
Sampling Stop (mode) operational mode of the analyzer during which the
aspiration of sample for analysis has been completed,
but the testing and washing processes continue. The
period of time between Operation and STAND-BY.
Screen Saver (mode) idle mode the analyzer automatically goes into after
being idle approximately 10 minutes. During this mode,
the LCD screen is blank.
scroll to move through screens (up or down) in order to see
parts of the menu that cannot fit on the screen.

Glossary
SD standard deviation, statistic used as a measure of the

dispersion or variation in a distribution, equal to the
square root of the arithmetic mean of the squares of the
deviations from the arithmetic mean.
select to highlight an item so that a subsequent action can be
carried out on that item. You usually select an item by
touching it on the screen. A selected key appears
serum indexes function by which the absorbance characteristics of the
samples are determined, in the absence of any photo-
chemical reaction, to semi-quantitatively evaluate the
presence of lipemia, hemolysis and icterus.
STAND-BY operational mode of the analyzer during which power is
on, but no sample analysis or maintenance procedures
are being performed.
STAT emergency sample processing.
(Short Turn Around Time)
STAT key (ambulance) button used to display the Stat screen for programming
samples for STAT (emergency) processing.
stirrer, stirring paddle small Teflon-coated paddles that lower into the reaction
cells to mix the contents of the reaction cell.
Stop the transitional instrument mode immediately prior to
STAND-BY.
an instrument alarm level that indicates a situation that
prevents completion of analysis in process.
All mechanical functions stop at the end of the current
cycle.
System Cleaning Solution sodium hydroxide solution placed with 1% Hitergent in
postion 39 on the reagent disk used to clean reagent
probes and wash cells.
sodium hydroxide solution placed in position W1 and
W2 of the sample disk used to clean the sample probe
and ISE system.

Glossary
W
warning a statement called out in this manual to make the
operator aware of conditions that could cause
personal injury.
an instrument alarm level that does not interrupt
operation.
waste solution reservoir container that collects reaction waste.

Manual H-902

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Reference Guide

Roche Diagnostics/Hitachi 902 Analyzer Reference Guide V1.2 RG - 1

Revised Manual Pages

Publication Reference No. Date Pages Affected

Version 1.1 June, 2000 All

Version 1.2 Sept, 2003 RG-2 to RG-4, 2-4, 3-1 to 3-10

RG - 2 Roche Diagnostics/Hitachi 902 Analyzer Reference Guide V1.2

Compliance is demonstrated by the following marks:

Complies with the IVD directive 98/79/EC.

Hitachi High-Technologies Corporation

Roche Diagnostics GmbH

Roche Diagnostics/Hitachi 902 Analyzer Reference Guide V1.2 RG - 3

RG - 4 Roche Diagnostics/Hitachi 902 Analyzer Reference Guide V1.2

1.1 Introduction ____________________________________________ 1-2

1.2 General Overview _______________________________________ 1-4

1.3 Sampling System _______________________________________ 1-10

Roche Diagnostics/Hitachi 902 Analyzer Reference Guide V1.2

1.5 Photometric Measuring System __________________________ 1-18

1.6 Cell Rinse System _______________________________________ 1-22

1.7 Operational Modes _____________________________________ 1-26

ii Roche Diagnostics/Hitachi 902 Analyzer Reference Guide V1.2

2.1 Instrument Specifications _______________________________ 2-2

Chapter 3 - Potential Hazards and Safety Precautions

3.1 Safety Classification ____________________________________ 3-2

Chapter 4 - Mechanical Theory

4.1 Overview _______________________________________________ 4-2

4.2 Begin Operation ________________________________________ 4-4

Roche Diagnostics/Hitachi 902 Analyzer Reference Guide V1.2

4.4 ISE Sample Processing __________________________________ 4-13

iv Roche Diagnostics/Hitachi 902 Analyzer Reference Guide V1.2

5.1 Overview _______________________________________________ 5-2

5.2 Assay Techniques ______________________________________ 5-5

5.3 1-Point Endpoint Assay - One Reagent ___________________ 5-13

5.4 1-Point Endpoint Assay - Two Reagents __________________ 5-16

5.5 1-Point Endpoint Assay with Prozone Check ______________ 5-19

5.6 2-Point Endpoint Assay _________________________________ 5-23

5.7 2-Point Endpoint Assay with Prozone Check ______________ 5-26

Roche Diagnostics/Hitachi 902 Analyzer Reference Guide V1.2

5.9 1-Point Endpoint and Rate Assay ________________________ 5-34

5.10 2-Point Rate Assay ____________________________________ 5-37

5.11 Rate A Assay __________________________________________ 5-41

5.12 Rate A Assay with Sample Blank ________________________ 5-43

5.13 Rate B Assay - Mode 1 _________________________________ 5-45

5.14 Rate B Assay - Mode 2 _________________________________ 5-48

5.15 Summary of Assay Techniques __________________________ 5-51

vi Roche Diagnostics/Hitachi 902 Analyzer Reference Guide V1.2

6.1 Calibration Overview ____________________________________ 6-2

6.2 1-Point Linear Calibration _______________________________ 6-10

6.3 2-Point Linear Calibration _______________________________ 6-14

6.4 Nonlinear Logit-Log 4P Calibration _______________________ 6-18

6.5 Use of Weighting in Nonlinear Calibration _________________ 6-21

6.6 Nonlinear Logit-Log 5P Calibration _______________________ 6-23

Roche Diagnostics/Hitachi 902 Analyzer Reference Guide V1.2

6.8 Nonlinear Point to Point Calibration ______________________ 6-30

6.9 ISE Calibration __________________________________________ 6-32

Chapter 7 - Serum Index Function

7.1 Serum Index Function ___________________________________ 7-2

viii Roche Diagnostics/Hitachi 902 Analyzer Reference Guide V1.2

8.1 Data Alarms ____________________________________________ 8-2

Roche Diagnostics/Hitachi 902 Analyzer Reference Guide V1.2

x Roche Diagnostics/Hitachi 902 Analyzer Reference Guide V1.2

Roche Diagnostics/Hitachi 902 Analyzer Reference Guide V1.1

1-2 Roche Diagnostics/Hitachi 902 Analyzer Reference Guide V1.1