H50P - Operator's Manual - V7.0 - EN PDF

H50P Automated Glycohemoglobin Analyzer
Operator’s Manual
© 2015-2016 Shenzhen Mindray Bio-medical Electronics Co., Ltd. All rights Reserved.
For this Operator’s Manual, the issued Date is 2016-12.
Intellectual Property Statement

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called
Mindray) owns the intellectual property rights to this Mindray product and this manual. This
manual may refer to information protected by copyright or patents and does not convey any
license under the patent rights or copyright of Mindray, or of others.
Mindray intends to maintain the contents of this manual as confidential information.

Disclosure of the information in this manual in any manner whatsoever without the written
permission of Mindray is strictly forbidden.
Release, amendment, reproduction, distribution, rental, adaptation, translation or any other

derivative work of this manual in any manner whatsoever without the written permission of
Mindray is strictly forbidden.
, , are the trademarks, registered or otherwise, of Mindray in

China and other countries. All other trademarks that appear in this manual are used only for
informational or editorial purposes. They are the property of their respective owners.
Responsibility on the Manufacturer Party

Contents of this manual are subject to changes without prior notice.
All information contained in this manual is believed to be correct. Mindray shall not be liable
for errors contained herein nor for incidental or consequential damages in connection with the
furnishing, performance, or use of this manual.
Mindray is responsible for the effects on safety, reliability and performance of this product,
only if:
 all installation operations, expansions, changes, modifications and repairs of this product
are conducted by Mindray authorized personnel.
 the electrical installation of the relevant room complies with the applicable national and
local requirements; and
 the product is used in accordance with the instructions for use.
I
WARNING
 It is important for the hospital or organization that employs this equipment to carry
out a reasonable service/maintenance plan. Neglect of this may result in machine
breakdown or personal injury.
 Be sure to operate the analyzer under the situation specified in this manual;
otherwise, the analyzer will not work normally and the analysis results will be
unreliable, which would damage the analyzer components and cause personal
injury.
NOTE
 This equipment must be operated by skilled/trained clinical professionals.
II
Warranty
THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES,

EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR ANY PARTICULAR PURPOSE.
Exemptions
Mindray's obligation or liability under this warranty does not include any transportation or
other charges or liability for direct, indirect or consequential damages or delay resulting from
the improper use or application of the product or the use of parts or accessories not approved
by Mindray or repairs by people other than Mindray authorized personnel.
This warranty shall not extend to:
 Malfunction or damage caused by improper use or man-made failure.
 Malfunction or damage caused by unstable or out-of-range power input.
 Malfunction or damage caused by force majeure such as fire and earthquake.
 Malfunction or damage caused by improper operation or repair by unqualified or

unauthorized service people.
 Malfunction of the instrument or part whose serial number is not legible enough.
 Others not caused by instrument or part itself.
III
Customer Service Department
Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Address: Mindray Building, Keji 12th Road South, High-tech industrial park, Nanshan,
Shenzhen 518057,P.R.China
Website: www.mindray.com
E-mail Address: service@mindray.com
Tel: +86 755 81888998
Fax: +86 755 26582680
EC-Representative: Shanghai International Holding Corp. GmbH(Europe)
Address: Eiffestraβe 80, Hamburg 20537, Germany
Tel: 0049-40-2513175
Fax: 0049-40-255726
IV
Table of Contents
1 Using This Manual ............................................................................................... 1-1
1.1 Introduction ............................................................................................................ 1-1
1.2 Who Should Read This Manual ............................................................................. 1-2
1.3 How to Find Information ........................................................................................ 1-3
1.4 Safety Information ................................................................................................. 1-4
1.4.1 Protection from Biohazards ........................................................................... 1-4
1.4.2 Protection from Other Hazards ..................................................................... 1-5
1.4.3 Using the System .......................................................................................... 1-5
1.4.4 Maintaining the System ................................................................................. 1-6
1.4.5 Using Reagents ............................................................................................. 1-6
1.4.6 Disposing of Waste........................................................................................ 1-7
1.5 Symbols ................................................................................................................. 1-8
2 Understanding Your Analyzer ............................................................................ 2-1

2.1 Introduction ............................................................................................................ 2-1
2.2 Mode ...................................................................................................................... 2-2
2.3 Analyzer Components ........................................................................................... 2-3
2.3.1 Introduction .................................................................................................... 2-3
2.3.2 Major Components and Modules .................................................................. 2-3
2.3.3 Peripherals .................................................................................................... 2-7
2.3.4 Accessories ................................................................................................... 2-8
2.4 System Functions ................................................................................................ 2-12
2.4.1 User Management ....................................................................................... 2-12
2.4.2 Start-up, Standby and Shutdown ................................................................ 2-12
2.4.3 Analysis ....................................................................................................... 2-12
2.4.4 Quality Control ............................................................................................. 2-12
2.4.5 Calibration ................................................................................................... 2-12
2.4.6 Maintenance ................................................................................................ 2-12
2.4.7 Status Display ............................................................................................. 2-12
2.4.8 Error Flagging and Troubleshooting ............................................................ 2-12
2.4.9 Communication ........................................................................................... 2-13
2.4.10 Logs ........................................................................................................... 2-13
2.4.11 Printing....................................................................................................... 2-13
2.4.12 Auto Dispensing Hemolysis Solution ......................................................... 2-13
2.5 Software Interfaces and Operations .................................................................... 2-14
2.5.1 Software Interfaces ..................................................................................... 2-14
2.5.2 Software Operation ..................................................................................... 2-16
2.6 Reagents ............................................................................................................. 2-19
2.6.1 Reagents ..................................................................................................... 2-19
2.6.2 Controls and Calibrators.............................................................................. 2-19
1
Table of Contents
3 System Principles ................................................................................................ 3-1

3.1 Introduction ............................................................................................................ 3-1
3.2 Clinical Significance ............................................................................................... 3-2
3.3 Sample Collection and Storage Requirements ..................................................... 3-3
4 Installing Your Analyzer ...................................................................................... 4-1

4.1 Introduction ............................................................................................................ 4-1
4.2 Installation Requirements ...................................................................................... 4-2
4.2.1 Space Requirements ..................................................................................... 4-2
4.2.2 Power Requirements ..................................................................................... 4-2
4.2.3 Environment Requirements ........................................................................... 4-2
4.2.4 Moving and Installing the Analyzer ................................................................ 4-3
4.3 Connecting the System ......................................................................................... 4-4
5 Operating Your Analyzer ..................................................................................... 5-1

5.1 Introduction ............................................................................................................ 5-1
5.2 Inspection Before Startup ...................................................................................... 5-2
5.3 Startup ................................................................................................................... 5-3
5.3.1 Power Switch ................................................................................................. 5-3
5.3.2 System Self-Test ........................................................................................... 5-3
5.3.3 Login and Status Check ................................................................................ 5-3
5.4 Daily Quality Control .............................................................................................. 5-4
5.5 Sample Preparation ............................................................................................... 5-5
5.5.1 Whole Blood Samples ................................................................................... 5-5
5.5.2 Prediluted Sample ......................................................................................... 5-6
5.6 Sample Analysis Under Closed Tube Mode .......................................................... 5-7
5.6.1 Running the Samples .................................................................................... 5-7
5.6.2 Processing Analysis Results ......................................................................... 5-9
5.6.3 Replacing the Adapter ................................................................................. 5-10
5.7 Sample Analysis Under Autoloading Mode ......................................................... 5-11
5.7.1 Running the Samples .................................................................................. 5-11
5.7.2 Special Functions ........................................................................................ 5-13
5.7.3 Processing Analysis Results ....................................................................... 5-14
5.7.4 Barcode Labels ........................................................................................... 5-15
5.7.5 Replacing the Adapter ................................................................................. 5-17
5.8 Standby................................................................................................................ 5-18
5.9 Shut Down the Analyzer ...................................................................................... 5-19
5.9.1 Logout.......................................................................................................... 5-19
5.9.2 Shut Down the Analyzer .............................................................................. 5-19
5.10 Auto Dispensing Hemolysis Solution ................................................................... 5-20
6 Sample Review .................................................................................................... 6-1

6.1 Introduction ............................................................................................................ 6-1
6.2 Reviewing Sample Results .................................................................................... 6-2
2
Table of Contents
6.2.1 Table Review ................................................................................................. 6-2

6.2.2 Graph Review ................................................................................................ 6-9
7 Customizing Your Analyzer Software ................................................................ 7-1

7.1 Introduction ............................................................................................................ 7-1
7.2 Date/Time (Administrator) ("Setup" > "Date/Time") ............................................... 7-2
7.3 User Management ("Setup" > "User Management") ............................................. 7-3
7.3.1 Add User (Administrator) ............................................................................ 7-4
7.3.2 Change Password ......................................................................................... 7-4
7.3.3 Delete User (Administrator) ........................................................................... 7-5
7.4 Parameter (Administrator) ("Setup" > "Parameter") .............................................. 7-6
7.5 Shortcut Code ("Setup" > "Shortcut Code") .......................................................... 7-7
7.6 Auxillary (“Setup”> “Auxillary”) ............................................................................... 7-8
7.7 Barcode Setup (Administrator) ("Setup" > "Barcode Setup") .............................. 7-10
7.8 Maintenance (Administrator) ("Setup">"Maintenance") ...................................... 7-11
7.9 Print Setup (Administrator) ("Setup" > "Print Setup") .......................................... 7-12
7.10 Communication (Administrator) ("Setup" > "Communication") ............................ 7-13
7.11 Gains (Administrator) ("Setup" > "Gains") ........................................................... 7-14
7.12 Rack Type (Administrator) ("Setup" > "Rack Type") ............................................ 7-15
8 Using the QC Program ........................................................................................ 8-1

8.1 Introduction ............................................................................................................ 8-1
8.2 Quality Control Program of the Analyzer ............................................................... 8-2
8.2.1 QC Setup ("QC" > "Setup") ........................................................................... 8-2
8.2.2 QC Analysis ................................................................................................... 8-4
8.2.3 Reviewing QC Results .................................................................................. 8-6
9 Calibrate Your Analyzer ...................................................................................... 9-1

9.1 Introduction ............................................................................................................ 9-1
9.2 When to Calibrate .................................................................................................. 9-2
9.3 How to Calibrate .................................................................................................... 9-3
9.3.1 Preparing Your Analyzer ................................................................................ 9-3
9.3.2 Manual Calibration ("Calibrate">"Manual") ................................................... 9-3
9.3.3 Calibration with Calibrator ("Calibrate">"Calibrator") .................................... 9-4
9.4 Touch Screen Calibration (for administrators only) ............................................... 9-8
10 Servicing Your Analyzer .................................................................................... 10-1

10.1 Introduction .......................................................................................................... 10-1
10.2 Maintenance ........................................................................................................ 10-2
10.2.1 Consumables ("Maintenance">"Consumables") ....................................... 10-2
10.2.2 Fluidics Maintenance (Administrator) ("Maintenance" > "Fluidics") .......... 10-3
10.3 Log (Administrator) ("Maintenance">"Log")......................................................... 10-6
10.3.1 Viewing Logs ............................................................................................. 10-6
10.3.2 Exporting Logs .......................................................................................... 10-7
3
Table of Contents
10.4 Cleaning............................................................................................................... 10-8

10.4.1 When, Why and Tools Needed .................................................................. 10-8
10.4.2 Cover Cleaning .......................................................................................... 10-8
10.5 Replacing ............................................................................................................. 10-9
10.5.1 When to Replace and the Tools Needed ................................................... 10-9
10.5.2 Replacing Reagents .................................................................................. 10-9
10.5.3 Replacing Waste Container ..................................................................... 10-11
10.5.4 Replacing Analytical Column................................................................... 10-11
10.5.5 Replacing the Filter ................................................................................. 10-22
10.6 System Status ................................................................................................... 10-28
10.6.1 Temperature & Pressure ("Status" > "Temp.&Pressure") ........................ 10-28
10.6.2 Version Information ("Status" > "Version Info.") ...................................... 10-29
11 Troubleshooting ................................................................................................ 11-1

11.1 Introduction .......................................................................................................... 11-1
11.2 Error Information and Handling ........................................................................... 11-2
Annex I Operating with Extended Program ....................................................................... 1

I-1 Applicable Area ......................................................................................................... 1
I-2 Overview of Extended Program ............................................................................... 2
I-2.1 Clinical Significance .......................................................................................... 2
I-3 Software Interfaces and Operations ......................................................................... 3
I-3.1 Switch from Standard Program to Extended Program ...................................... 4
I-4 Operating Your Analyzer ........................................................................................... 5
I-4.1 Introduction ....................................................................................................... 5
I-4.2 Inspection before Startup .................................................................................. 7
I-4.3 Startup ............................................................................................................... 8
I-4.4 Daily Quality Control ......................................................................................... 9
I-4.5 Sample Preparation ........................................................................................ 20
I-4.6 Sample Analysis under Closed Tube Mode .................................................... 22
I-4.7 Sample Analysis under Autoloading Mode...................................................... 25
I-4.8 Processing Analysis Results ........................................................................... 30
I-4.9 Sample Review ............................................................................................... 31
I-4.10 Shut Down ..................................................................................................... 41
I-5 Calibrate Your Analyzer .......................................................................................... 43
I-5.1 Introduction ..................................................................................................... 43
I-5.2 When to Calibrate ........................................................................................... 44
I-5.3 How to Calibrate .............................................................................................. 45
Appendices ...........................................................................................................................A-1
A Index ...................................................................................................................... A-1
B Specification .......................................................................................................... B-1
C Communication Protocol .......................................................................................C-1
4
1 Using This Manual
1.1 Introduction
This chapter explains how to use your H50P operator’s manual, which is shipped with your
H50P Automated Glycohemoglobin Analyzer (hereinafter referred to “the analyzer") and
contains reference information about the analyzer and procedures for operating,
troubleshooting and maintaining the analyzer. Read this manual carefully before operating
your H50P analyzer and operate your H50P Automated Glycohemoglobin Analyzer strictly as
instructed in this manual.
1-1
Using This Manual
1.2 Who Should Read This Manual

This manual is intended to be read by clinical laboratory professionals to:
learn about the H50P hardware and software;
perform daily operating task;
perform system maintenance and troubleshooting.
1-2
Using This Manual
1.3 How to Find Information

This operator’s manual comprises 11 chapters and 3 appendices. Refer to the table below to
find the information you need.
If you want to „ See...

learn about the intended use, appearance, main modules, Chapter 2 Understanding
system settings and functions of the H50P Your Analyzer
learn about how the H50P works Chapter 3 System
Principles
learn about the installation requirements of the H50P Chapter 4 Installing Your
Analyzer
learn about the process of sample collection and analysis Chapter 5 Operating Your
Analyzer
learn about how to review samples with the H50P Chapter 6 Sample Review
learn about how to define/adjust system settings of the H50P Chapter 7 Customizing
Your Analyzer Software
learn about how to use the quality control programs of the Chapter 8 Using the QC
H50P Program
learn about how to calibrate the H50P Chapter 9 Calibrate Your
Analyzer
learn about how to maintain/service the H50P Chapter 10 Servicing Your
Analyzer
learn about how to solve the problems of H50P Chapter 11 Troubleshooting
learn about how to use the “Extended Program” (advanced Annex I Operating with
function, only available when ordered) to analyzer HbE sample Extended Program
learn about the technical specifications of the H50P Appendix B Specification
learn about the communication protocol of the H50P Appendix C
Communication Protocol
1-3
Using This Manual
1.4 Safety Information

You will find the following symbols in this manual:
Symbols: It means...
read the statement below the symbol . The statement is
alerting you to a potentially biohazardous condition.
read the statement below the symbol. The statement is

WARNING alerting you to an operating hazard that can cause
personnel injury.
CAUTION alerting you to a possibility of analyzer damage or unreliable
analysis results.
NOTE alerting you to information that requires your attention.
1.4.1 Protection from Biohazards
 All the samples, reagents, calibrators, controls, wastes and areas contacted by
them are potentially biohazardous. Wear proper personal protective equipment
(e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling
them in the laboratory.
 If leakage happens to the analyzer, the leaked liquid is potentially biohazardous.
 All the analyzer components and surfaces are potentially infectious, so take
proper protective measures for operation and maintenance.
 When the analyzer is with error and need servicing, it is recommended to put
warnings on the analyzer to prevent people touching it and avoid biohazard and
other hazards.
 The sample probe tip is sharp and may contain biohazardous materials. Exercise
caution to avoid contact with the sharp sample probe when working around it.
WARNING
 If the reagents accidentally spill on your skin, wash them off with plenty of water
and if necessary, go see a doctor; if the reagents accidentally spill into your eyes,
wash them off with plenty of water and immediately go see a doctor.
1-4
Using This Manual
1.4.2 Protection from Other Hazards
WARNING
 If any abnormal smell or fog are observed, power off the system and disconnect
the power plug immediately, or else fire, electric shock or other hazards may
occur.
 Do not touch the power cords inside the system, and make sure your hands are
dry when operating the system to avoid electric shock.
 Please check the firmness of all the doors, covers and boards before running the
system, and make sure they will not get open or loose during operation.
 Make sure all the safety measurements are adopted. It is prohibited to disable any
safety device or sensor.
 Do not touch the moving parts. Keep your clothes, hairs and hands away from the
moving parts to avoid injury.
1.4.3 Using the System
CAUTION
 Please use the analyzer strictly as instructed by this manual.
 Keep blood, reagent and any other metal substances from getting inside the
system, or fog may be generated due to short circuit.
 Using pinboard may bring the electrical interference and the analysis results may
be unreliable. Please place the analyzer near the electrical outlet to avoid using
pinboard.
 Do not damage the power cord, put any heavy object upon it or pull it forcefully.
 Power off the system before connecting it to external devices (e.g., computer), or
else fire or electric shock may occur.
 Please take action to any alarm and error messages immediately.
 If any of the pipes or fluidic components are worn out, stop using the analyzer and
contact Mindray customer service department immediately for inspection or
replacement.
 The user should ensure the data safety of the USB devices connecting to the
analyzer.
1-5
Using This Manual
1.4.4 Maintaining the System
WARNING
 It is important for the hospital or organization that employs this system to carry out
a reasonable service/maintenance plan. Neglect of this may result in machine
breakdown or injury of human health.
 Contact the manufacturer or authorized distributors in time if any damaged part is

found.
 Be sure to wear rubber gloves and use specified tools and accessories when
inspecting, servicing or maintaining the system. Wash your hands with disinfectant
after finishing the operations.
 Be careful when opening/closing and removing/installing the doors, covers and

boards of the system.
NOTE
 If the system stop running due to errors, the operator may deal with the errors as
instructed by the Operator's Manual; in case of errors not specified in the manual,
contact Mindray customer service department.
 Please use the system strictly as instructed by this manual.
1.4.5 Using Reagents
CAUTION
 Use the reagents specified by the manufacturer only. Store and use the reagents
as instructed by instructions for use of the reagents.
 Check if the reagent tubings are properly connected before using the analyzer.
 After installing a new bag of reagent, keep it still for a while before use.
 Do not use the reagents if it shows a sign of freezing.
 Do not use the reagents that have been contaminated or affected by other factors.
Replace it with normal one.
 The test may be interfered by the following factors: expired or invalid reagents;
reagents being contaminated by dust in the air; unclean samples; mix or
combined use with reagent produced by other factories; mix use of residual
reagent in the bag with newly opened reagent; and improper use under
undesirable conditions.
1-6
Using This Manual
1.4.6 Disposing of Waste
WARNING
 Discard the system according to government regulations.
 Be sure to dispose of reagents, waste, samples, consumables, etc. according to

government regulations.
1-7
Using This Manual
1.5 Symbols
Symbols used in this manual:
read the statement below the symbol . The statement is
alerting you to a potentially biohazardous condition.

WARNING alerting you to an operating hazard that can cause
personnel injury.
CAUTION alerting you to a possibility of analyzer damage or unreliable
analysis results.
NOTE alerting you to information that requires your attention.
You may find the following symbols of the H50P analyzer:
CAUTION
 During the daily use of the system, especially the cleaning process, the operator
shall ensure the intactness of the labels.
CAUTION, CONSULT ACCOMPANYING

DOCUMENTS.
Note: suggesting the users consult to
accompanying documents to get important
safety information.
BIOLOGICAL RISK
PROTECTIVE EARTH
EARTH (GROUND)
ALTERNATING CURRENT
1-8
Using This Manual
FOR IN VITRO DIAGNOSTIC USE
SERIAL NUMBER
DATE OF MANUFACTURE
NETWORK INTERFACE
PRICKING DANGER
THE DEVICE IS FULLY CONFORMANCE

WITH THE COUNCIL DIRECTIVE
CONCERNING IN VITRO DIAGNOSTIC
MEDICAL DEVICES 98/79/EC.
AUTHORISED REPRESENTATIVE IN THE
EUROPEAN COMMUNITY.
1-9
Using This Manual
1.
Warning
1. Connect only to a properly earth grounded outlet.
2. To avoid electric shock, disconnect power cord prior to troubleshooting.
3. Replace fuses only with the type and rating specified.
2.
Biohazard
1-10
Using This Manual
Warning
The probe is sharp and may contain biohazardous material exercise caution when
working around the probe!
1-11
Using This Manual
To avoid personal injury, do not put your hand under the syringe or inside the slot!
1-12
2 Understanding Your Analyzer
2.1 Introduction
The H50P Automated Glycohemoglobin Analyzer is used for in vitro quantitative
determination of the percentage (%) and substance content (mmol/mol) of hemoglobin A1c
(HbA1c) in human blood samples.
The analyzer uses an analytical column to separate various hemoglobin components and
provides the analysis results of HbA1c (%, NGSP) and HbA1c (mmol/mol, IFCC), as well as a
chromatogram displaying various components of HbA1a, HbA1b, HbF, LA1c, SA1c (HbA1c)
and A0; in the mean while, the estimated average blood glucose (eAG) is calculated with a
formula produced by ADA, EASD and IDF (Diabetes Care 2008;31:1-6).
This chapter introduces the components, functions and user interface of H50P.
NOTE
 The purpose of this analyzer is to identify the normal patient, with all normal
system-generated parameters, and to flag or identify patient results that require
additional studies.
 The software screenshots, images and certain details related to the product are
for illustration purposes only, and may not exactly match your real product.
2-1
Understanding Your Analyzer
2.2 Mode
Loading Mode
The H50P provides two loading modes: the autoloading mode and closed-tube mode.
Sample Mode
The H50P supports two sample modes: the whole blood mode and the prediluted mode.
2-2
2.3 Analyzer Components

2.3.1 Introduction
The H50P consists of the main unit and the peripherals. The main unit mainly consists of the
sample loading system, the liquid chromatography separation system, the liquid
chromatography detection system, the mechanical system, as well as the hardware and
software systems. Peripherals mainly includes the barcode reader and the recorder. The
analyzer also includes the following accessories: the analytical column, the tube racks and
adapters, and the reagent bag cap assemblies.
2.3.2 Major Components and Modules
Figure 2-1 Front of the analyzer
1 ---- Status indicator 2 ---- Touch screen

3 ---- [OPEN] key 4 ---- Tube
5 ---- Tube rack 6 ---- Autoloader
 Touch screen
The touch screen locates on the front side of the main unit, which can be used to operate the
analyzer and display information.
2-3
CAUTION
 Do not use anything sharp on the touch screen or strike on it.
 Clean the touch screen with clean and soft cloth, as well as neutral cleanser or
ethanol rather than chemical solution, acid or alkali solution.
 Status indicator
The indicator locates on the top of the touch screen; and it tells you about the status of the
instrument including ready, running, error, standby and on/off, etc. See below table for details:
Indicator status Analyzer status

Stay in green Ready (without error)
Flicker in green Running without error
Stay in yellow Standby or shutdown, but the power is not turned off
Flicker in yellow Initializing
Stay in red Ready with error or paused
Flicker in red Running with error
Off Power off
2-4
Figure 2-2 Back of the analyzer
1 --- Waste connector 2 ---Power input socket
 Waste connector
The waste connector locates at the left side on the back of analyzer. It connects the waste
tube to discharge the waste liquid. You can select to use a waste container or discharge the
waste directly. For the setup of waste discharge method, please refer to 7.6 Auxillary (“Setup”>
“Auxillary”).
.
2-5
Figure 2-3 Left side of the analyzer
1 --- Illuminated power switch
2-6
Figure 2-4 Right side of the analyzer
1 --- Network interface 2 ---- USB port
2.3.3 Peripherals
Barcode reader
Recorder (optional)
2-7
2.3.4 Accessories
Analytical column
The analytical column is an important measurement component of the analyzer. It is installed
in the column temperature-control box.
Tube racks and adapters

Tube racks
The analyzer uses four types of tube racks: whole blood (WB) tube rack used under whole
blood mode, prediluted (PD) tube rack used under prediluted mode, control (CRL) tube rack
used under QC mode, and calibration (CAL) tube rack used under calibration mode. You can
identify the type of a tube rack by the marking between the number 9 and number 10 tube
positions. For example, the PD tube rack is marked as “PD”; the CRL tube rack is marked as
“CRL”, and the CAL tube rack is marked as “CAL”. However, the WB tube racks are marked
by figures (001-005).
The WB tube rack (see below) has a 3-digit number marking (for example 005) on both sides
of the tube rack, and a 2-digit number marking (for example 05) between the No. 9 and No.
10 tube positions.
2-8
The PD tube rack (see below) has the “PD” marking both on two sides of the tube rack and
between the No. 9 and No. 10 tube positions.
The CRL tube rack (see below) has the “CRL” marking both on two sides of the tube rack and
The CAL tube rack (see below) has the “CAL” marking both on two sides of the tube rack and
2-9
Adapters
3 types of adapters are used with the analyzer: φ13×75(mm) adapter for closed-tube mode;
and 12 × 27(mm) micro sample cup adapter and 1.5ml centrigual tube adapter for
autoloading mode. For more information regarding the replacing of the adapters, refer to
5.6.3 and 5.7.5 Replacing the Adapter.
Tubes/Sample Cup Adapters Applicable Modes

φ12×75（mm）~ 13×75（mm）(without φ13×75(mm) adapter Closed-Tube
the cap) evacuated blood collection tube +Whole Blood
1.5ml centrigual tube 1.5ml centrigual tube Autoloading+Predilute

adapter Quality Control
Calibration
φ12×27(mm) micro sample cup Sample cup adapter Autoloading+Predilute

Quality Control
Calibration
2-10
Reagent bag cap assemblies

The H50P analyzer is equipped with 3 reagent bag cap assembiles which seperately connect
the reagent bags of Eluent A, Eluent B and Hemolysis Solution.
2-11
2.4 System Functions

2.4.1 User Management
The analyzer supports two access levels: the “General User” level and the “Administrator”
level; and each level is provided with different operation authority.
2.4.2 Start-up, Standby and Shutdown

You may start or shutdown the analyzer, or make it enter standby mode.
2.4.3 Analysis
The analyzer supports the data collection (acquisition), storage, analysis and output (report)
functions under both whole blood and prediluted modes and outputs analysis results for
several parameters.
2.4.4 Quality Control

The analyzer supports quality control function.
2.4.5 Calibration
The analyzer supports calibration function; and users may define the calibration factors by
themselves.
2.4.6 Maintenance
The analyzer supports maintenance time reminding, maintenance recording and procedure
prompting functions.
2.4.7 Status Display

The analyzer shows status like temperatures and pressures, the residual volume of the
reagents, and the analytical column life-cycle; it also prompts about full waste container.
2.4.8 Error Flagging and Troubleshooting

The analyzer prompts about abnormal running status and suggests troubleshooting
procedures.
2-12
2.4.9 Communication
The analyzer supports LIS communication function.
2.4.10 Logs
The analyzer logs user operations and errors. The user may save and export such logs.
2.4.11 Printing
The user may print analysis reports.
2.4.12 Auto Dispensing Hemolysis Solution

The analyzer supports auto dispensing of Hemolysis Solutions.
2-13
2.5 Software Interfaces and Operations

2.5.1 Software Interfaces
Menu Shortcut buttons
Client area
Error
Auxiliary information System time
information area
area
Menu
Tap the menu icon on the upper left of the screen to display the system menu. Tap a
menu item to display the sub-menu or enter the corresponding menu screen or dialog box.
2-14
Menu Tree
No Level 1 Level 2 Level 3
1. Sample Analysis / /
2. Table Review / /
Setup /
3. QC Graph /
Table /
Manual (for administrators only) /
Calibrator (for administrators /
4. Calibrate only)
Touch Screen (for /
administrators only)
Date/Time (for administrators /
only)
User Management /
Parameter (for administrators /
only)
Shortcut Code /
Auxillary (for administrators /
only)
5. Setup Maintenance (for administrators /
only)
Barcode Setup (for /
Print Setup /
Communication /
Gains (for administrators only) /
Rack Type (for administrators /
only)
Consumables Reagents
Column (for
Filter (for administrators
6. Maintenance only)
Reagents /
Fluidics (for administrators only) Packup (for
Logs (for administrators only) /
Temp.&Pressure /
7. Status
Version Info. /
8. Logout / /
Shut Down the / /
9.
Analyzer
2-15
Shortcut Buttons
Name Icon Functions

Sample Analysis Tap to enter the "Sample Analysis" screen.
Review Tap to enter the "Review" screen.
QC Tap to enter the "QC" screen".
Reagent Tap to enter the "Reagent Management" screen.
Auto Dispensing Tap the button and the analyzer automatically

Hemolysis dispenses Hemolysis Solution.
Solution
Client area
Displays contents of the screens.
Auxiliary information area
Displays related information of the screen. For example, the "Sample Analysis" screen
displays "Next Sample ID" and "Presentation Mode".
Error information area
When error occurs, this area displays the error message.
System time
Displays current system time.
2.5.2 Software Operation

Pop-up Keyboard
Tap any text box to activate the pop-up keyboard (full keyboard or numeric keyboard,
depending on the contents to be entered into the text box), see the following figure. Tap
to close the pop-up keyboard.
2-16
Table
You will see tables on the screens like "Review". Tap the buttons on the right and below the
table to view information in the table. These buttons are: (previous page), (next
page), (previous row), (next row), (leftmost page), (rightmost
page), (left page), (right page), (left column), (right column).

Besides, you can also view information in the table by pressing the buttons ([←], [→], [↑],
[↓], [PgUp], [PgDn]) on the keyboard.
Date text box

The following figure is a date text box, and you can edit date per the preset date format in the
text box. The default ranges allowed are: Year [0, 9999]; Month [1, 12]; Date [1, 31].
You can shift the cursor in the text box by pressing [Tab] and [Shift]+[Tab].
Time text box

The following figure is a time text box, you can edit time in the text box, and the valid range is:
[00：00，23：59].
2-17
Check box
Tap the check box, a "√" mark appears in the frame, indicating the option is chosen.
Tap the option again, the “√” disappeared, it means the option is not chosen as shown
below.
Tab screen
Tab screen displays one page of the multipage information.
2-18
2.6 Reagents
You must only use the Mindray specified reagents in order to prevent analyzer damage and
achieve optimal system performance. All references related to reagents in this manual refer
to the reagents specifically formulated for this instrument.
Each reagent package must be examined before use. Product integrity may be compromised
in damaged packages. Inspect the package for signs of leakage or moisture. If there is
evidence of leakage or improper handling, do not use the reagent.
NOTE
 Store and use the reagents as instructed by instructions for use of the reagents.
 Pay attention to the expiration dates and open-bag stability days of all the
reagents. Be sure not to use expired reagents.
 After installing a new bag of reagent, keep it still for a while before use.
2.6.1 Reagents
 Eluent A and Eluent B (for HbA1c analysis)
Used with the HbA1c analysis system to determine the HbA1c percentage and substance
content in the blood samples.
 Hemolysis Solution
Used for the pre-process of blood sample before the HbA1c analysis.
2.6.2 Controls and Calibrators

The controls and calibrators are used to verify accurate operation of and calibrate the
analyzer.
The controls are commercially prepared whole-blood products used to verify that the analyzer
is functioning properly. They are available in low and high levels. Daily use of both levels
verifies the operation of the analyzer and ensures reliable results are obtained. The
calibrators are commercially prepared whole-blood products used to calibrate some
parameters of analyzer to build the metrological traceability of analysis results. For the use
and storage of controls and calibrators, please refer to the Instruction for Use of each
product.
All references related to controls and calibrators in this manual refer to the controls and
calibrators specifically formulated for this analyzer by Mindray. You must buy those controls
and calibrators from Mindray or Mindray-authorized distributors.
2-19
3 System Principles
3.1 Introduction
H50P uses the ion-exchange-based high-performance liquid chromatography (HPLC)
method to build the Hb chromatogram and calculate relevant parameters. With the HPLC
method, the blood sample containing various types of hemoglobin is loaded to an analytical
column. The HbA1c, which hardly has any positive charge, is the first being eluted by eluent
of the pre-defined low ionic strength and pH conditions; and the positive charged HbA0 is
eluted by the eluent of high ionic strength. In this way, the analyzer builds up the Hb
chromatogram, and calculates the ratio of HbA1c peak value to the total Hb.
3-1
System Principles
3.2 Clinical Significance

As a major component of glycated hemoglobin, HbA1c is a non-enzymatically formed,
reliable adduct between plasma glucose and the valine at the amino terminus of the β-chain
(e.g. Stable A1c, or SA1c). Once HbA1c is formed, it remains that way over the life span of
the erythrocytes, which is approximately 120 days in human blood. Therefore the measured
HbA1c value reflects the blood glucose level for the last 120 days. As HbA1c is not subject to
short term fluctuation of blood glucose level, the test does not require specific sample
collection time; and the results will not be affected no matter the patients take the tests before
or after meals, or if they have used insulin before the test. Strongly correlated to the chronic
complication of diabetes, the HbA1c level is commonly recognized as the “golden index” of
glycemic control, and also a good tool assessing the efficacy of the therapy for diabetes.
Besides, HbA1c is now acknowledged by the World Health Organization (WHO) and the
diabetes associations of many countries as an independent diagnostic criteria for diabetes.
3-2
System Principles
3.3 Sample Collection and Storage Requirements

To ensure accurate analysis results, the sample volume should be no less than 1mL under
whole blood mode, and no less than 0.5mL under prediluted mode.
For anticoagulants, EDTA, heparin, and NaF may be applicable; and the whole blood
samples may be stored under refrigeration condition for 7 days.
3-3
4 Installing Your Analyzer
4.1 Introduction
WARNING
 Installation by personnel not authorized or trained by Mindray may cause personal
injury or damage your analyzer. Do not install your system without the presence of
personnel authorized by Mindray.
 The installation, authorization, upgrade and modification of the analyzer software

must be performed by Mindray-authorized personnel.
The analyzer was carefully packaged and labels were placed to tell the carrier how to treat
this analyzer. When you receive your analyzer, carefully inspect the carton. If you see any
signs of mishandling or damage, contact Mindray customer service department or your local
distributor immediately.
4-1
Installing Your Analyzer
4.2 Installation Requirements
4.2.1 Space Requirements

While installing the analyzer, make sure there is enough space left for service and
maintaining operations, as well as for the analyzer to dissipate heat and for the fluidic tubing
to be properly placed without extrusion. Specific requirements shown as follows:
 at least 500mm to each side of the system;
 at least 600mm above the system;
 The supporting table where the instrument is placed shall be able to withstand at
least 100kg of weight.
4.2.2 Power Requirements
WARNING
 Make sure the analyzer is properly grounded.
 Before turning on the analyzer, make sure the input voltage meets the
requirements.
CAUTION
 Using pinboard may bring the electrical interference and the analysis results may
be unreliable. Please place the analyzer near the electrical outlet to avoid using
pinboard.
 Use the power cord provided by the manufacturer. Using the power cord other
than provided by the manufacturer may lead to system damage or unqualified
smear output.
Voltage Frequency Power

(100V-240V～) ±10% (50Hz/60Hz) ±3Hz 300VA
4.2.3 Environment Requirements
NOTE
 Only store and use this system in specified environmental conditions.
4-2
Working environment Storage environment

Ambient Temperature 10℃～32℃ -10℃～40℃
Relative Humidity 20%～85% 10%～90%
Atmospheric pressure 70kPa-106kPa 50kPa～106kPa
 The environment shall be as free as possible from dust, mechanical vibrations, loud
noises, and electrical interference.
 It is advisable to evaluate the electromagnetic environment prior to operation of this
analyzer.
 Do not use this analyzer in close proximity to sources of strong electromagnetic radiation
(e.g. unshielded intentional RF sources), as these may interfere with the proper
operation.
 Do not place the analyzer near brush-type motors, flickering fluorescent lights, and
electrical contacts that regularly open and close.
 Do not place the analyzer in direct sunlight or in front of a source of heat or drafts.
 The environment shall be well ventilated.
 Do not place the analyzer on a slope.
 Connect only to a properly earth grounded outlet.
 Only use this analyzer indoors.
4.2.4 Moving and Installing the Analyzer
WARNING
 Installation by personnel not authorized or trained by Mindray may cause personal
injury or damage your analyzer. Do not install your analyzer without the presence
of Mindray-authorized personnel.
Moving and installation of the analyzer shall be conducted by Mindray-authorized personnel.

Do not move or install your analyzer without the presence of Mindray-authorized personnel.
4-3
4.3 Connecting the System

CAUTION
 There are 2 ways of waste connection, one is using waste container, another is
discharging waste directly.
 Make sure that the top of the waste container is lower than the analyzer desk. If
the waste is discharged directly, make sure the waste pump is at a lower position
than the waste outlet on the analyzer.
Figure 4-1 Connecting the eripherals 1
4-4
Figure 4-2 Connecting the peripherals 2
Figure 4-3 Connecting the reagents 1
4-5
Figure 4-4 Connecting the reagents 2
4-6
5 Operating Your Analyzer
5.1 Introduction
This chapter provides step-by-step procedures for operating H50P analyzer on a daily basis.
A flow chart indicating the common daily operating process is presented below.
Initial Checks
See 5.2 Inspection Before

Startup
Power On
See 5.3 Startup
Daily Quality Control
See 5.4 Daily Quality Control
Sample Preparation
See 5.5 Sample Preparation
Sample Analysis
Closed Tube Mode Autoloading Mode
See 5.6 Sample Analysis Under See 5.7 Sample Analysis Under
Shutdown
See 5.9 Shut Down the Analyzer
5-1
Operating Your Analyzer
5.2 Inspection Before Startup

Perform the following checks before turning on the analyzer.
WARNING
Checking the reagents
Check whether there are enough reagents for the test of the day. If not, replace the reagents.
If the reagents run out during analysis, the analyzer will pause working automatically and
prompt the operator to replace the reagents. Please follow the instruction to replace the
reagents.
Checking tubing and power connections
Check and make sure the reagent, waste and pneumatic unit tubes are properly connected
and not bent.
Check and make sure the power cord of the analyzer is properly plugged into the power
outlet.
Checking the waste container
Check and make sure the waste container is empty.
5-2
5.3 Startup
5.3.1 Power Switch
Press the [Start] button on the analyzer.
5.3.2 System Self-Test

Once the power is turned on, the analyzer will automatically run the self-test procedure
including system checks, startup checks and mechanic initialization.
If any error occurs during the initialization, the analyzer will display the error message. Follow
the instructions to remove the error. See Chapter 11 Troubleshooting for troubleshooting
solutions.
NOTE
 You should remove all the errors before proceeding with any operation.
 When the analyzer has been idle for more than 72 hours, the analyzer self-test will
take longer time.
5.3.3 Login and Status Check

When the analyzer completes its self-test, a login dialog box will display. Enter the user ID
and the password, and then tap "Login" to enter the system main screen.
Check the status area at the lower part of the screen, and make sure all the reagents are
sufficient; and the analytical column does not reaches their maximum uses.
5-3
5.4 Daily Quality Control

Before running any samples, run the controls to ensure reliable results of the analyzer.
Please see Chapter 8 Using the QC Program for details.
5-4
5.5 Sample Preparation
 All the samples, controls, calibrators, reagents, wastes and areas contacted them
are potentially biohazardous. Wear proper personal protective equipment (e.g.
gloves, lab coat, etc.) and follow safe laboratory procedures when handling them
in the laboratory.
WARNING
 Do not contact the patients' sample blood directly.
CAUTION
 Do not reuse disposable products such as collection tubes, test tubes, capillary
tubes and so on.
 Prepare samples following the recommend procedure of the manufacturer.
NOTE
 Be sure to use clean anticoagulant collection tubes (recommended
anticoagulants: K2EDTA, K3EDTA, heparin lithium salt, sodium citrate, potassium
oxalate monohydrate/sodium fluoride), fused silica glass/plastic test tubes,
centrifugal tubes and borosilicate glass capillary tubes.
 Be sure to use the Mindray-specified disposable products including evacuated

blood collection tube, anticoagulant collection tubes and capillary tubes etc.
5.5.1 Whole Blood Samples

Use recommended anticoagulant collection tubes to collect venous blood samples.
1.
Mix the sample immediately according to your laboratory’s protocol.
2.
CAUTION
 To ensure accurate analysis results, the sample volume should be no less than
1mL under whole blood mode.
5-5
 The samples stored under refrigeration condition (2℃-8℃) must be kept at room
temperature for at least 30 minutes before analysis.
 When a sample has been kept for a while after preparation, be sure the mix it
again before running it.
5.5.2 Prediluted Sample

Pick up a clean centrifugal tube, and add the Hemolysis Solution and blood sample
successively in accordance with the standard procedure of your laboratory. Mix the
Hemolysis Solution and sample properly.
In case of insufficient sample volume or very low hemoglobin concentration, the analyzer may
report “Chromatogram area too small”. Predilute the sample as required, and run the
sample using predilute mode.
When the analyzer reports “Chromatogram area too small” for a sample, predilute the
sample as required, and run the sample again using predilute mode.
Add certain amount of sample blood (recommended: 10ul) into a 1.5ml centrifugal tube
1. (or micro sample cup);
If the small area flag is reported because of sample volume is insufficient, use a
2. pipette to dispense lyse into the sample at the ratio of 1:100 (lyse to blood sample) and
well mix it;
If the small area flag is reported because the HGB of the whole blood sample is
too low, use a pipette to dispense lyse into the sample at the ratio of 1:50 (lyse to
blood sample) and well mix it.
The analyzer supports auto dispensing of Hemolysis Solution. For more information, please
refer to 5.10 Auto Dispensing Hemolysis Solution.
CAUTION
 Take methods to prevent the diluent from dust; otherwise the results may be
unreliable.
 Be sure to run the prediluted samples within 30 minutes after the dilution;
otherwise the results may be unreliable.
 Be sure to mix any sample that has been prepared for a while before running it.
 Be sure to evaluate predilute stability based on your laboratory’s sample

population and sample collection techniques or methods.
0.5mL under predilute mode.
5-6
5.6 Sample Analysis Under Closed Tube Mode

5.6.1 Running the Samples
gloves, lab coat, etc.) and follow safe laboratory procedures when handling them in
the laboratory.
caution to avoid contact with the probe when working around it.
CAUTION
tubes and so on.
 Repeatedly piercing the cap of the evacuated blood collection tube may damage
the cap, and the scraps produced may result in inaccurate analysis results. It is
recommended that each tube is pierced for no more than 3 times.
 To ensure the correctness of analysis results, do not run prediluted samples under
the Closed Tube mode.
NOTE
 Proper reference range shall be entered on the "Setup"- “Parameter” screen before
analysis. Otherwise, the results may be flagged erroneously.
 If the 2-way LIS/HIS mode is selected, then after the sample ID is entered/scanned
and saved, all the corresponding information will be obtained from the LIS/HIS, and
then the analyzer starts running per the obtained information. Once the running is
finished, the result, graph and sample/patient information will be uploaded to the
LIS/HIS.
5-7
When it is ready to run a sample (i.e. the analyzer indicator stays in green), shake the
1. tube of whole blood sample as instructed by the picture below to mix the sample
thoroughly.
Press the [Open] key on the analyzer to open the sample compartment door. Install
2. theФ13×75 (mm) adapter into the sample compartment. Place the sample into the
adapter.
3. Close the sample compartment door.
Tap the "Mode" button on the "Sample Analysis" screen, and the "Mode Setup"
4. screen will display.
Check the "CT" radio button for "Mode" and enter the "Start Sample ID".
5. If necessary, check "Auto Increase", and the subsequent sample IDs will
automatically increase by 1 based on the previous one.
6. Tap "OK" on the dialog box or simply press [Enter] on the keyboard to finish setup.
Tap the "Start" button to start the analysis. After the analyzer finishes sample
7. aspiration, the sample compartment door opens automatically, and the analyzer
indicator flickers in green.
When the analysis completes, the analyzer indicator returns to "Ready" status (stay in
8. green).
9. Repeat above steps to run other samples.
5-8
5.6.2 Processing Analysis Results

Saving of analysis results
The analyzer automatically saves sample results. When the maximum number has been
reached, the newest result will overwrite the oldest. At most 50,000 sample results can be
saved at the same time.
Parameter flags
If the parameter is marked by a high/low flag ("H"/"L"), it means the analysis result has
exceeded the upper or lower limit of the reference range, but still within the display range.
If a result is indicated by “****”, it means the result is invalid or out of the display range.
If a result is indicated by “@”, it means the result is out of the linear range.
Chromatogram flags
Messages Meanings
Analysis not completed Analysis not completed
Abnormal signal The analyzer signals may become abnormal
The analyzer does not aspirate sample properly; or the
Chromatogram area too small
hemoglobin concentration of the sample may be too low
The hemoglobin concentration of the sample may be too
Chromatogram area too large
high
Abnormal peak number Abnormal variant may be present
SA1c peak not properly
The measured HbA1c% value may be inaccurate
separated
HbA0 peak abnormal The measured HbA1c% value may be inaccurate
Chromatogram abnormal The measured HbA1c% value may be inaccurate
Shorter SA1c retention time The analyzer may be in abnormal status
Longer SA1c retention time The analyzer may be in abnormal status
Shorter HbA0 retention time The analyzer may be in abnormal status
Longer HbA0 retention time The analyzer may be in abnormal status
5-9
5.6.3 Replacing the Adapter

In closed-tube sampling mode, the model of the tube and the corresponding adapter are the
followings:
φ12×75 (mm) ~ 13×75 (mm) (without the cap) evacuated blood collection tube, used for
Ф13×75 (mm) adapter.
Different adapters should be replaced according to the model of the tubes.
5-10
5.7 Sample Analysis Under Autoloading Mode

5.7.1 Running the Samples
the laboratory.
CAUTION
tubes and so on.
 When a sample has been kept for a while after preparation, be sure the mix it again
before running it.
 Be sure that the entered sample ID, rack No., tube No. and the analysis mode are
strictly in accordance with the sample to be run.
NOTE
 Proper reference range shall be entered on the "Setup"-“Parameter” screen before
analysis. Otherwise, the results may be flagged erroneously.
 If the 2-way LIS/HIS mode is selected, then after the sample ID is entered/scanned
and saved, all the corresponding information will be obtained from the LIS/HIS, and
then the analyzer starts running per the obtained information. Once the running is
finished, the result, graph and sample/patient information will be uploaded to the
LIS/HIS.
5-11
When it is ready to run a sample (i.e. the analyzer indicator stays in green), shake
1. the tube of whole blood sample as instructed by the picture below to mix the
sample thoroughly.
2. Tap the "Mode" button on the "Sample Analysis" screen, and the "Mode Setup"
dialog box will display.
3. Make sure "AL" is selected for the presentation mode.
4. Enter the "Start Sample ID" (skip the step if you are using the whole blood mode
and have selected "Auto Scan ").
5. To run a whole blood sample, directly place the prepared sample tube into the
whole blood sample rack.
To run a prediluted sample, fit the prepared sample tube (or micro sample cup)
uncapped into a corresponding adapter (clip the tube cap into the adapter notch)
and place the tube together with the adapter into an even-numbered position of the
PD tube rack.
6. Place the rack with tubes on the right tray of the autoloader, with the side with
openings facing the analyzer.
5-12
8. Tap "Start" and the analyzer will automatically start to run in order from the preset
starting position. During this process, the analyzer indicator is flickering in green.
9. After every analysis cycle, the results will be saved to the sample database
10. When the analyses are finished, a statistical result dialog box will display.
11. Tap "Return" to return to the “Sample Analysis” screen, the analyzer indicator will
return to green.
12. When the autoloading analyses are finished, all the tube racks are moved to the
left tray of the autoloader automatically, and then you can remove the racks of
tubes safely.
NOTE
 If more racks are needed when running the samples, you should load the rack from
the right of the autoloader while removing the completed rack from the left of the
autoloader in time.
5.7.2 Special Functions
Stop Running
During the analysis process, the "Start" button will turn into "End" button. Tap the "End"
button, the analyzer will stop running after the current sample is analyzed, and the rack of the
5-13
sample will move to the unloading tray one the left of the autoloader.
STAT
Use the function to insert STAT samples during the analysis process.
1. Press the [Open] key on the analyzer to open the sample compartment door, and
place the uncapped STAT sample into the compartment. Close the compartment
door.
2. Wait for the analyzer to complete the analysis of current sample and convert to the
STAT mode. You will know that the STAT mode is ready when a “Cancel STAT”
button appears.
3. Tap “Mode” to enter the sample ID. Tap “OK” to close the dialog box.
Tap “Start” to start the analysis.

4.
When the compartment door opens, it means the analyzer aspirates enough
5. sample. You can remove the sample then; but it will still take a little time for the
analyzer finishes the analysis.
If necessary, repeat above steps to analyzer other STAT samples.
6.
NOTE
 The STAT mode only supports whole blood samples.
Cancel STAT
After the running is finished, you can tap the “Cancel STAT” button to cancel the STAT, and
then the analyzer will judge whether to switch to the analysis mode before the inserted STAT
accordingly, and then proceed with autoloading.
5.7.3 Processing Analysis Results
Saving of analysis results

Parameter flags
5-14
If the parameter is marked by the suspect flag ("?"), it means the analysis result is suspicious.
If a result is indicated by “***”, it means the result is invalid or out of the display range.
Chromatogram flags
Messages Meanings
Abnormal Signal The analyzer signals may become abnormal
The analyzer does not aspirate sample properly; or the
Chromatogram area too small
hemoglobin concentration of the sample may be too low
The hemoglobin concentration of the sample may be too
Chromatogram area too large
high
separated
Chromatogram abnormal The measured HbA1c% value may be inaccurate
Shorter SA1c retention time The analyzer may be in abnormal status
Longer SA1c retention time The analyzer may be in abnormal status
Shorter HbA0 retention time The analyzer may be in abnormal status
Longer HbA0 retention time The analyzer may be in abnormal status
5.7.4 Barcode Labels
CAUTION
 The following errors may cause misreading of barcodes:
The barcode is not stuck upright.

Use of unqualified barcodes.
There are blood, powder or other contaminators on the surface of the barcode.
 To ensure good readability of barcodes, do as follows:
Stick the barcode correctly, as shown in Figure 5-1.

Use qualified barcodes mentioned in Appendix B 15 Barcode Specifications;
Keep the surface of the barcode clean and free of dust.
To ensure good readability of the barcode, you must place the label right on the region
marked by X as shown in Figure 5-1, and place the label correctly as shown in Figure 5-2.
5-15
Figure 5-1 Where to place the barcode label
NOTE
 If several labels are stuck to one tube, or the label is misplaced, peeled or
wrinkled, it may cause autoloading error. To avoid such error, the notes below
shall be followed:
The label shall be stuck properly, as shown in Figure 5-1.

Do not stick several labels to one tube.
The surface of the label shall not be wrinkled.
Do not use barcode label which is easily peeled to prevent the label from peeling.
Ensure that the tube with barcode label can be taken out from and placed back to
the rack easily.
Figure 5-2 How to place the barcode label
5-16
5.7.5 Replacing the Adapter

In autoloading sampling mode, the model of the tubes and the corresponding adapters are
the followings:
2ml micro sample cup (standard hitachi cup), used with φ12×27(mm) micro sample cup
adapter.
1.5ml centrifugal tube, used with φ11×40 (mm) 1.5ml adapter.
Different adapters should be replaced according to the model of the tubes.
5-17
5.8 Standby
When the time for which the analyzer is free from fluidic operations reaches standby waiting
time, a dialog box will display, prompting " Backing up data. Please wait…". When data
backup completes, the analyzer prompts “Entering standby…” and enters the standby
status. The screen blacks out and prompts "Analyzer in standby status. Tap the screen to
exit."
NOTE
 If it is time for standby, current operations will pause. After the analyzer exits the
standby status, the operations will be continued.
To exit the standby status, simply tap the screen.
5-18
5.9 Shut Down the Analyzer

5.9.1 Logout
Tap “Logout” from the menu, a dialog box will display.
1.
2. Tap “Yes” to enter the “Login” screen.
5.9.2 Shut Down the Analyzer

Tap “Shut Down” from the menu, and a dialog box will display asking if you want to shut
1. down the analyzer.
2. Tap “Yes” and turn off the main power as instructed.
5-19
5.10 Auto Dispensing Hemolysis Solution

The analyzer supports auto dispensing of Hemolysis Solution. With this function, you can
collect the needed volume of Hemolysis Solution for the dilution of blood samples, controls
and calibratiors fastly, accurately and safely.
1. Tap the button, and the following dialog box pops up.
2. Place a cleanφ12×75（mm）~ 13×75（mm）evacuated blood collection tube into the

first tube position of the WB tube rack, and then place the tube rack on the autoloader.
Tap “OK” on the screen, and the following dialog box pops up. In the meanwhile, the
3. analyzer automatically transports the WB tube rack, until its first tube position is just
under the sample probe.
Tap “Add Hemolysis Solution”, and the analyzer will dispense 1mL of Hemolysis
4. Solution into the tube.
When the screens displays the message box “Added 1ml, maximum: 5ml”, tap “Add
5. Hemolysis Solution” again to collect additional Hemolysis Solution, or tap “Completed”
to exit the function. When you tap “Completed”, the analyzer will push out the WB tube
rack, and you may remove the tube safely.
5-20
NOTE
 The analyzer dispenses 1mL of Hemolysis Solution each time; and one tube can
only collect 5mL of Hemolysis Solution at most.
 Use a pipette to aspirate needed volume of Hemolysis Solution from the tube and
add it to the blood samples, controls or calibrators for dilution. Follow the
standard procedure of your laboratory to mix the Hemolysis Solution and sample
properly
For the preparation of pre-dilute samples, please refer to 5.5.2 Prediluted Sample;
For the preparation of controls, please refer to the Instruction for Use of the
controls;
For the preparation of calibrators, please refer to the Instruction for Use of the
calibrators.
5-21
6 Sample Review
6.1 Introduction
After every analysis cycle, the analyzer will save the analysis result automatically including
sample information, parameter results, flag messages as well as the chromatograms. The
analyzer can store up to 50,000 analysis results.
You can review all the sample information, parameter results, flag messages as well as the
chromatograms in table or graph modes.
NOTE
 The sample result data must have proper backup in case of data lost caused by
hardware or software error.
6-1
Sample Review
6.2 Reviewing Sample Results

You can review the sample results either in table or graph review mode.
6.2.1 Table Review

Tap the "Table Review" button on the menu to enter the "Table Review" screen.
The table displays a list of analyzed samples with basic sample information like sequence no.,
sample ID, analysis mode, analysis date and time, tube position, status and the test panel.
Above the sample result table, you may find the following function buttons: "Print", "Search",
"Comm." and "Export"; below the sample result table is the function button area, where you
may find the following buttons: (from left to right) "Graph ", "Edit", "Validate", "Cancel Val."
and "Delete". The "Validate", "Cancel Val." and "Delete" buttons are only available for
administrators. You can tap the buttons to perform corresponding functions.
Switch to the "Graph Review" screen

Tap the "Graph " button to switch to the "Graph Review" screen. For detailed information
about the "Graph Review" screen, see 6.2.2 Graph Review.
6-2
Sample Review
Edit information
NOTE
 Make sure you enter the patient information carefully and correctly.
You can edit the information displayed on the "Table Review" screen.
Tap the desired record you want to edit, and the selected record will be highlighted. Tap the
"Edit" button, below dialog box will display. You do not need to enter the patient age, the
validator and operator.
 Enter the sample ID

Enter the "Sample ID" in the box.
NOTE
 You can enter letters, digits and all other characters on the keyboard (including
special characters) for sample ID.
 1 to 20 characters are allowed. It cannot be left empty.
 The sample ID must end with a digit; and it cannot only consist of "0".
 Enter the patient ID

Enter the patient ID to the "Patient ID" box.
6-3
Sample Review
 Enter the department name

You can either enter the department name in the "Dept." box, or select the desired
department from the "Dept." pull-down list (if there are previous entries saved in the list). At
most 30 entries can be automatically saved to the "Dept." pull-down list.
 Enter the patient name

Enter the “First Name” and “Last Name” of the patient.
 Enter the patient gender

Select the desired item (Male or Female, or null) from the "Gender" pull-down list. The default
option is "null".
 Enter the birth date

Enter the birth date of the patient into the "Birth Date" box, the birth date format being the
same of the system date.
 Enter the patient age

Enter the patient age into the “Age” box.
NOTE
 When you enter the patient birth date, the system will automatically calculate the
patient age using the entered "Birth Date" and current "System Date" and display
the result in the "Age" box. The "Age" box will then be greyed, and will become
editable again when the "Date of Birth" is cleared.
 The patient birth date should be no later than current system date.
 OK
When you have finished entering the sample information, tap "OK" to save the information
and return to the "Table Review" screen.
 Cancel
If you do not want to save the entered sample information, tap "Cancel" to return the "Table
Review" screen without saving the changes.
Validate/cancel validate (for administrators only)

Users of the administrator level may tap "Validate" to validate current or selected record. The
icon would appear at the “Status” cell box of the record. Tap "Cancel Val." to cancel
the validation.
6-4
Sample Review
Delete (administrator)
Users of the administrator level may delete desired records by tapping the "Delete" button.
Tap the "Delete" button, below dialog box will display:
Select "Selected Records" or "All Records" and tap "OK", below dialog box will display. Tap
"Yes" to perform deletion, or tap "No" to cancel deletion.
NOTE
 If you tap the "Delete" button when the system is communicating or printing certain
records, a dialog box will display prompting "System busy. Please try again later!".
 If no record is selected, when you choose to delete "Selected Records", a dialog

box will display prompting "Please select a sample".
Select
You can select one or more sample records to perform certain operations like "Comm." or
"Print".
 Select/deselect a single record

Tap any cell in a sample record to select it. The selected record will be highlighted and a "*"
will be marked next to the sequence no. of the record. Tap again to deselect the record.
 Select/deselect multiple records

Tap the desired records to select (or deselect) them.
The selected records will be highlighted and the last selected record will be marked by an "*"
next to the sequence no. of the record.
6-5
Sample Review
Search Sample Record(s)

You can search for records based on certain conditions in the sample database.
1. Tap "Search", the following dialog box will display.
2. Enter "Sample ID", “Patient ID”, patient “Name”, "Date", and Sample "No.", and check
the needed “Sample Status” (“Not Vali.”, “Not Pri.” and “Not Com.”) as necessary to
specify the searching conditions.
3. Check "Select sample(s) found" if necessary, then the samples found will be selected.
4. Tap "OK" to start searching.
If no results are found, a dialog box will display prompting "No sample found!". Tap
"OK" to close the dialog box.
On the found results screen, all the buttons are the same as of the "Table Review" screen,
only the original "Search" button is replaced by the "Return" button. Tap the "Return" button to
return to the "Table Review" screen.
6-6
Sample Review
Print
Select (a) sample record(s) and tap "Print", the following dialog box will display.
You can "Print Selected" or "Print All" records. Up to 700 records can be printed at the same
time. Tap "OK" to start print. During the printing process, the print icon flickers. Tap "Cancel"
to cancel the print.
Communicate
You can transmit selected sample results to an eternal computer.
Select one or more samples and tap the "Comm." button, below dialog box will display.
You can transmit selected or all records. Tap the "OK" button to start communication. During
the communication process, the communication icon flickers. Tap "Cancel" to close the dialog
box.
Export
You can export selected sample data to a USB card.
NOTE
 The USB port locates at the right side of the analyzer. Please refer to Figure 2-4
Right side of the analyzer for reference.
 Do not pull out the USB before the export process completes.
6-7
Sample Review
Tap "Export", the following dialog box will display.
You can choose to export the selected records or all records. Besides, check “Chromatogram”
for “Export Content” if you want to export the chromatograms. Tap "OK" to start export; tap
"Cancel" to cancel the export. When the export process completes, the system will prompt
whether the operation completes successfully or fails; and a log will created if you select to
export "Sample Data".
6-8
Sample Review
6.2.2 Graph Review

Tap "Graph " on the "Table Review" screen to enter the graph review screen, which displays
sample information, parameter results, chromatogram, chromatogram flags, and detailed
peak information for the hemoglobin components.
Sample
information
Sample
results
Chromatogram Flags
Peak
information
Figure 6-1 "Graph Review" screen
6-9
Sample Review
Interpretation of chromatogram
The chromatogram shows the peaks of various hemoglobin components in order of the
sequence they are eluted from a sample (from left to right: A1a, A1b, F, LA1c, SA1c (HbA1c),
and A0). The peak identified as SA1c(HbA1c) is shaded. The x-axis shows the retention
times (the elapsed time between the start of the run and the apex of the peaks) for these
components. The unit is in seconds.
Detailed peak information for hemoglobin components
The table below the chromatogram displays detailed information for each hemoglobin
component peak.
Name
The name of the hemoglobin component.
Time
Retention time (in seconds), the elapsed time between the start of the run and the apex of the
peaks.
Area
The area of a peak corresponds to the volume of the corresponding component. The unit is
OD.s.
6-10
Sample Review
Total Area
This is the sum area for the peaks of all hemoglobin components. The acceptable range is
30~300. In case of insufficient sample volume or very low hemoglobin concentration, the total
area may drop under 30, and the analyzer will report “Chromatogram area too small”.
Predilute the sample as required, and run the sample using predilute mode.
%
The percentage is the ratio of a peak area against the total area.
You can perform the following operation on the screen:

Browse the results
Tap the buttons to browse the sample results.
Return to the "Table Review" screen

You can tap the "Return" button on the upper part of the screen to return to the "Table
Review" screen.
Validate/Cancel Validate (for Administors only)

Users of the administrator level may tap "Validate" to validate current record. Tap "Cancel
Val." to cancel the validation.
6-11
7 Customizing Your Analyzer
Software
7.1 Introduction
The analyzer is a flexible laboratory instrument that can be tailed to your work environment.
You can customize the software options as introduced in this chapter.
When you finishes the setup, tap other menu options or other icon buttons. A dialog box will
display asking if you want to save the new settings. Tap "Yes" to save the settings.
7-1
Customizing Your Analyzer Software
7.2 Date/Time (Administrator) ("Setup" >

"Date/Time")
You can customize the date, time and the date format of the analyzer. The date and time on
the screens and the printout will change if the settings are changed. Only users at the
administrator level can perform the date/time setup.
Tap "Setup"  “Date/Time" to enter the "Date/Time Setup" screen.
Follow below instruction to set date/time:
 Set the system date
Tap the "Date" box to enter the system date.

If you entered a date out of the range of 1970-01-01~2036-12-31, when you save the settings,
a dialog box will display prompting the entry is invalid and cannot be saved.
 Set time
Tap the "Time" box to enter system time.
 Setting the date format
You can select any of the 6 date formats: YYYY-MM-DD, YYYY/MM/DD, MM-DD-YYYY,
MM/DD/YYYY, DD-MM-YYYY and DD/MM/YYYY. Select the desired date format from the
pull-down list.
7-2
7.3 User Management ("Setup" > "User

Management")
You can add, delete or modify User ID, Name, password and Access Level on this screen.
While general users may only change their own passwords; administrators may
add/modify/delete the information of other users.
The screen displays information of all users of both general user and administrator level. The
top row displays current user information by default. General users may only see their own
information; while administrators may see the information of all general users and
administrators.
7-3
7.3.1 Add User (Administrator)
1. Tap the "New" button on the "User Management" screen, and the following text box
pops out.
2. Enter the "User ID" (required) and "Name" (if needed); set a "Password" and confirm
it in the "Confirm Password" text box. At last, select the "Access Level" as "General
User" or "Administrator".
3. When you complete the information, tap "OK" to save the new record (if the setting is
valid). A new user account will be added to the user list.
NOTE
 You must enter a User ID, otherwise the new user account cannot be saved.
 Up to 20 administrators and 30 general users can be added.
 User IDs cannot be duplicated.
 Protect your passwords from being misused.
7.3.2 Change Password

You can change your password on the "User Management" screen.
1. Select a user record on the "User Management" screen and tap "Change Password".
Below dialog box pops up.
7-4
2. Enter your old password first, then set a new one and confirm it. Tap "OK" to save the
new password (if it is valid).
7.3.3 Delete User (Administrator)
1. Select the user to be deleted (current user cannot be deleted) on the "User
Management" screen and tap "Delete". The following dialog box pops out.
2. Tap "Yes" to delete the user.
7-5
7.4 Parameter (Administrator) ("Setup" >

"Parameter")
You can set the reference range and unit for each parameter on the screen, and select to
apply the parameters or not. Only the selected parameters will display on the "Sample
Analysis" and "Sample Review" screens and be available for print.
7-6
7.5 Shortcut Code ("Setup" > "Shortcut Code")
You can set up shortcut code for departments to facilitate quick information input.
 Add shortcut codes
Tap the "Add" button, a blank row will become available for edit. Enter the name of the
department and the desired shortcut code accordingly.
 Delete shortcut codes
Select the shortcut codes you want to delete in the table and tap "Delete". Below dialog box
will display.
Tap "Yes" to delete the shortcut code.
7-7
7.6 Auxillary (“Setup”> “Auxillary”)
You can set up below items on the “Auxillary” setup screen.
 Set if the analyzer will start analysis automatically after startup
When “Start analysis after startup” is checked, place the tube racks on the autoloader, and
enter the “First Sample ID”; the analyzer will start the analysis automatically when the
initialization process is completed.
 Set how to handle a sample if 2-way LIS inquiry for it fails (when 2-way LIS is used)
When using the 2-way LIS, set up whether to “Continue Analysis” or “Skip the Sample” when
the 2-way LIS inquiry for the sample fails.
 Set how to handle next samples when QC analysis fails
You can set whether to “Continue Analysis” or “Stop Analysis” when QC results fall out the
acceptable range.
7-8
 Set waste discharge method
You can either choose to use a “Waste Container” or choose “Direct Discharge”.
NOTE
 When you select “Waste Container”, you need to prepare the waste containers by
yourself.
 When you select to use “Waste Container”, the analyzer will give warning when the
container is full.
 Be sure to dispose of waste according to government regulations.
 Set whether to monitor reagent expiration dates
When “Monitor Reagent Exp. Date” is checked, the analyzer will give warnings when the
reagents are expired.
NOTE
 When “Monitor Reagent Exp. Date” is not checked, the analyzer will not give
warnings when the reagents are expired. Examine the reagent status regularly and
do not use expired reagents. For more information about reagent management and
replacement, refer to 10.5.2 Replacing Reagents.
7-9
7.7 Barcode Setup (Administrator) ("Setup" >

"Barcode Setup")
You can set the code system for the analyzer.

Totally 6 code systems are supported by the analyzer, namely, CODE39, CODE93,
CODEBAR, CODE128, UPC/EAN and ITF.(Interleaved 25).
 Setting the code system and digits
1. Select the check box of the desired code system to enable the code system.
2. Select the number of digits used on site in the “Digits” area or select "No length
limit".
3. Set other code systems if needed.
For the length limits and check bit of different code system, please see Appendix B.15
Barcode Specifications.
NOTE
 The code systems and length limits set on the analyzer shall be those used in your
laboratory. Do not select the code systems that are not used, which may increase
the rate of misreading.
 Barcodes longer than 20 digits will not be read correctly.
7-10
7.8 Maintenance (Administrator)

("Setup">"Maintenance")
 Standby Setup
Tap the "Wait" text box and enter the waiting time before entering the standby status. The
range allowed is [1, 30] minutes.
 Preheating Time Setup

Tap the "Preheating Time" text box and enter how long the analyzer performs the preheating
process after startup. The range allowed is [0, 5] minutes; and the default setting is 2 minutes
7-11
7.9 Print Setup (Administrator) ("Setup" > "Print

Setup")
 Print Setup
Enter the title you want to display on the printed reports to the "Report Title" text box.
Select the print template direction as "Landscape" or "Portrait".
 Printing Content
Check/uncheck the content to be printed in the "Printing Content" area.
 Auto Print
Set the auto print function to:
 Off
 Auto Print after Analysis
or
 Auto Print after Validation
7-12
7.10 Communication (Administrator) ("Setup" >

"Communication")
 Protocol Setup
Tap the text boxes to enter the correct "IP Address", "Subnet Mask", "Gateway" and "Mac
Address".
ACK Synchronous Transmission

Tap the "ACK synchronous transmission" check box to activate the function.
When the function is activated, you can enter a value for “ACK overtime”. The default setting
is 2 seconds.
 Transmission Mode
Select the chromatogram transmission method from the pull down list:
 Not to be transmitted
 Bitmap
 Data
You can select the functions based on your needs by tapping on the check boxes.
 2-Way LIS (when it is checked, you can enter the “Overtime” value for 2-Way LIS)
 Auto Retransmit (this function can only be activated when "ACK Synchronous
Transmission" is checked. If you enable auto retransmit, the analyzer will continue
to retransmit data until it receives response from ACK.)
 Auto Communication (when this function is checked, the sample results will be
transmitted to LIS automatically)
7-13
7.11 Gains (Administrator) ("Setup" > "Gains")
You can adjust certain gain values as necessary. When the value entered is out of allowed
range or any gain is left empty, a dialog box will display prompting "Invalid entry", and the
gains will be restored to the original ones before edit.
7-14
7.12 Rack Type (Administrator) ("Setup" > "Rack Type")
The analyzer automatically identifes tube rack types by scanning tube rack information; but
when it fails to identify a rack type, you can also select to specify the rack type yourself. Tap
“User Specify” and select the correct rack type.
7-15
8 Using the QC Program
8.1 Introduction
Quality Control (QC) consists of strategies and procedures that measure the precision and
stability of the analyzer. The results imply the reliability of the sample results.
Analysis of the results with statistical methods allows the inference that sample results are
reliable. Mindray recommends you run the QC program daily with low and high level controls.
A new lot of controls should be analyzed in parallel with the current lot prior to their expiration
dates.
8-1
Using the QC Program
8.2 Quality Control Program of the Analyzer

You can run the QC program against only one parameter HbA1c. You can set up at most 12
QC files to save QC parameters and results. Up to 350 QC can be saved for each QC file.
8.2.1 QC Setup ("QC" > "Setup")
General users may only review the QC file settings. Administrators may select the QC file to
be used by checking the "In Use" check box of it. The QC results will then be saved to the
selected file.
Edit a QC file
Select the QC file you want to edit in the QC file list and tap "Edit" to enter the "QC File Setup"
screen.
8-2
 Set lot No. of control

Enter the lot number into the "Lot No." text box.
 Set control level

Select "CRL-1" or " CRL-2" control level from the "Level" pull down list.
 Enter the expiration date

You can enter the expiration date of the control to the "Exp. Date" text box in the format you
set in 7.2 Date/Time (Administrator) ("Setup" > "Date/Time").
NOTE
 Refer to the Instruction for Use of the control for its lot no., expiration date,
parameter reference values and limits.
 The entered expiration date should be either the expiration date printed on the
labeling or the open-bag expiration date, whichever is earlier. The open-bag
expiration date is calculated as follows: the date that bag is opened + the
open-bag stability days.
 Set target and limit for the parameter

Enter the target and limit into the "Target" and "Limit" text boxes.
 Set reference method

Select suitable reference method (NGSP or IFCC) based on the trace system used in your
laboratory.
8-3
 Set limit format

Select "Absolute Value" or "Percentage" from the "Limit Format" pull down list.
NOTE
 Only valid parameter targets and limits can be saved.
 Save the settings

When you complete the settings, tap "OK" to save the settings and return to the "QC Setup"
screen.
Clear a QC file (Administrator)

You may clear the data in a QC file as needed.
Select the QC file to be cleared, and tap the "Clear" button. Below dialog box will display.
Tap "Yes" to clear all the sample data in the QC file.
8.2.2 QC Analysis
When a QC file is selected as "In Use" (only one file may be selected for each level), all the
QC results will be saved to the file.
the laboratory.
caution to avoid contact with the sharp sample probe when working around it.
 The sample may spill from the uncapped collection tubes and cause biohazard.
Exercise caution to the uncapped collection tubes.
8-4
WARNING
 Collection tubes broken may cause personal injury and/or biohazard. Exercise
caution when loading the collection tubes to the rack or getting the collection tubes
from the rack, be sure not to break the tubes.
 The reagents are irritating to eyes, skin and airway. Wear proper personal
protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory
procedures when handling them in the laboratory.
CAUTION
tubes and so on.
 Gently shake and mix the prepared control to avoid bubbles. Do not use a
mechanical mixer.
NOTE
 Use the controls and reagents specified by the manufacturer only. Store and use
the controls and reagents as instructed by their instructions for use.
Prepare a control of CRL-1 level and another of CRL-2 level as instructed by instructions
1. for use of the controls.
NOTE
The analyzer supports auto dispensing of Hemolysis Solution. You can use the
function to dilute and prepare controls. For more information, refer to 5.10
Auto Dispensing Hemolysis Solution.
When the controls are completely dissolved, take 200ul of each level of control into two
2. specified containers (1.5ml centrifugal tube or the micro sample cup).
NOTE
 The remaining controls can be stored at 2～8℃ for 14 days. When you
intend to use them, take the controls out from the low temperature
environment and place them at room temperature for 15 minutes.
8-5
 Mark the open-bag date of every vial of control on the vial. Enter the
parameter target value, lot no. and expiration date of the control to the
analyzer software when a vial of control is newly opened.
When the analyzer is ready to run the QC program, place the tube or micro sample cup
3. into the specified positions of the CRL tube rack (CRL-1 should be place at the 2
th
nd
tube
position, and CRL-2 at the 4 tube position), and put the tube rack onto the autoloader.
NOTE
 You must place the controls to the control tube rack to run the QC
program; otherwise the analyzer cannot recognize them as controls.
Enter the "Sample Analysis" screen and tap the "Start" button. The analyzer will
4. automatically recognize and run the controls. The QC results will be saved to the "In
Use" control files of corresponding levels.
8.2.3 Reviewing QC Results

You can review the QC results in the following ways:
 QC Graph
 QC Table
QC graph review
Tap "Graph" on the "QC Setup" screen to enter the graph screen of the latest used QC file.
8-6
Select the file number from the "File No." pull down list and switch the screen to the QC graph
of the selected QC file.
NOTE
 When there are less than 3 QC results, the Mean, SD and CV values on the right
side of the QC graph will not display.
Introduction to the QC graph:
 The x-axis of the graph represents the number of QC results, and the y-axis represents
the QC results.
 The blue vertical line indicates the current selected QC result.
 The three figures on the left side of the graph corresponds to the three cross lines on the
graph, which from bottom to up demonstrate the lower limit, target and upper limit of the
parameter results.
Upper limit: Target of the control＋ limit

Target: Reference value of the control
Lower limit: Target of the control – limit
 The three values on the right side of the graph indicates:
Mean - the mean value of the parameter QC results

SD - standard deviation
CV% - coefficient of variation
n
x i
Mean ＝ i1
n
SD 
 X i  Mean
2
n 1
SD
CV%   100
Mean
Among which, n indicates QC runs, Xi indicates the number i measurement result for the
parameter.
Different colors of the points have different meanings:

Black points: the points are within the expected range;
Red points: the points are out of controlled range.
You can perform the following operations on the QC Graph screen:
8-7
 Review the results
The QC results are displayed in order of their saved time: from left to right, the earliest to the
latest. Tap the arrow buttons on the lower part of the graph to review the results.
 Exit
Tap any other menu button or icon to exit the screen.
QC table review
Tap "Table" on the "QC Setup" screen to enter the table screen of the latest used QC file.
Select the file number from the "File No." pull down list and switch the screen to the QC table
You can perform the following operations on the QC Table screen:
You can tap the arrow buttons on the right side to review the QC results. The QC results are
displayed in order of save times. The latest is displayed at the top row.
 Communicate
Tap the "Comm." button to transmit the results to an eternal computer.
8-8
 Export
Tap the "Export" button to export the QC information in current QC table to a USB connected
to the analyzer.
NOTE
 Delete (administrator)
Users at administrator level may delete selected or all QC results in a QC file.

Tap any cell in the row of the QC result you want to delete, below dialog box will display:
Tap "Selected Records" or "All Records", and then tap "OK" to delete. The operation will be
logged in the system log. Tap "Cancel" to cancel the delete.
 Exit
When QC fails
When any QC result falls out the controlled range, the QC button on the top of the screen
lights in red:
8-9
NOTE
 If you have selected “Stop Analysis” when QC fails on “Setup”-“Auxillary” screen,
the analyzer will not analyze following samples. For more information, refer to 7.6
Auxillary (“Setup”> “Auxillary”).
If any QC point falls out of the controlled range, follow below steps to solve the problem. If the
problem cannot be solved, contact Mindray Customer Service Department.
1. Check the error information area on the screen. If any error exists, see Chapter 11
Troubleshooting for solutions.
2. Check the settings of QC file and correct any wrong information that may exist.
3. Run the QC analysis again.
4. Run the QC analysis with a new vial of control.
5. When the QC results are still out of range, re-calibrate the analyzer.
8-10
9 Calibrate Your Analyzer
9.1 Introduction
Calibration is a procedure to standardize the analyzer by determining its deviation under
certain specified conditions. In order to get accurate sample analysis results, you should
calibrate the analyzer per the procedure below when necessary.
There are two calibration programs available on this analyzer: manual calibration and auto
calibration using calibrators.
NOTE
 Calibration procedures can only be performed by users of the administrator-level.
 Use the calibrators and reagents specified by the manufacturer only. Store and
use the calibrators and reagents as instructed by their instructions for use.
9-1
Calibrate Your Analyzer
9.2 When to Calibrate

This analyzer is calibrated at the factory just before shipment. It is electronically stable and
does not require frequent recalibration if you operate and maintain it as instructed by this
manual. You only need to recalibrate this analyzer if:
 you are going to use this analyzer for the first time (usually done by a
Mindray-authorized representative when installing the analyzer).
 a major component (for example, the analytical column) has been changed.
 you are going to re-use the analyzer after a long-term storage.
 the QC results are out of control due to non-QC causes.
NOTE
 All of the measured parameters must be calibrated before readings of this analyzer
can be used as valid analysis results.
9-2
9.3 How to Calibrate

NOTE
9.3.1 Preparing Your Analyzer

Check and make sure the analyzer works properly and enough reagents have been prepared
for the calibration. You need to start over the calibration if the reagents run out during the
process.
It is recommended that you create a log table for your analyzer. This log table should contain
all necessary information that is pertinent to your analyzer. Suggested items that you may
want to include in the log table are: calibration date, supplier of calibrator, lot number,
expected results and limits.
NOTE
 Be sure to use the evacuated collection tubes recommended in the Appendix.
9.3.2 Manual Calibration ("Calibrate">"Manual")
9-3
You can manually modify the calibration factor on this screen.
 HbA1c calibration factor
Select the suitable reference method (“NGSP”, “IFCC” or “Mono-S”) in accordance with your
laboratory procedure from the pull-down list.
Enter values for “a” and “b” as needed.
In the formula Y=aX+b, Y means the results finally shown on the screen, Y means the raw
result measured by the analyzer.
 HbF calibration factor

In the formula Y=aX+b, Y means the results finally shown on the screen, Y means the raw
 Return to factory setup
Tap “Factory Setup” and set the calibration factors back to factory setup.
9.3.3 Calibration with Calibrator ("Calibrate">"Calibrator")
Enter calibration information

From the “Menu” tab, tap “Calibration”-“Calibrator” to enter the “Calibration with Calibrators”
screen.
 Lot No.
Enter the lot No. of both the “CAL-1” and “CAL-2” level calibrators into the "Lot No." boxes.
9-4
 Expiration Date
Enter the expiration dates into the "Exp. Date" boxes.
 Runs
Select a number from the "Runs" pull down list. The analyzer will run the calibrators for the
number of times you selected. For example, if you select "2" runs, then the calibrators of both
levels will be run twice each.
 Reference Method
Select the suitable reference method (“NGSP” or “IFCC”) in accordance with your laboratory
procedure from the pull-down list.
 Parameter Target
Enter the targets of the CAL-1 and CAL-2 calibrators into the corresponding "Target" boxes
NOTE
 See the instruction for use and the target sheet of the calibrators for the lot No.,
expiration dates and the targets.
labeling or the open-bag expiration date, whichever is earlier. The open-bag
expiration date is calculated as follows: the date that bag is opened + the open-
bag stability days.
 If you start the calibration analysis before you complete the calibrator information,
a dialog box will display prompting "Invalid entry!". Tap "OK" and enter complete
calibrator information to start calibration analysis.
Run the calibration

After you complete the calibration settings, prepare the calibrators for the calibration.
 Samples, controls, calibrators and waste are potentially infectious. Wear proper
personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe
laboratory procedures when handling them and the contacted areas in the
laboratory.
9-5
NOTE
 Only Mindray-specified calibrators shall be used. Mindray will not be responsible
for any erroneous result caused by using other calibrators.
 Refer to the instructions for use of the calibrators for their use and storage.
 Use clean 1.5mL centrigual tube or the micro sample cup to run the calibration.
 Use the CAL tube rack and corresponding tube or sample cup adapters.
CAUTION
tubes and so on.
Do as follows to calibrate the analyzer with calibrators.

Make sure the analyzer indicator shows that the analyzer is ready for analysis.
1. Prepare a calibrator of CAL-1 level and a calibrator of CAL-2 level as instructed by

instructions for use of the calibrators.
NOTE
 The analyzer supports auto dispensing of Hemolysis Solution. You can
use the function to dilute and prepare controls. For more information, refer
to 5.10
 Auto Dispensing Hemolysis Solution.
2. Place the well-mixed calibrators into the specified calibrator tube rack (CAL-1 level
calibrator should be placed at the 2
nd
tube position, and CAL-2 level calibrator at the
th
4 tube position), and put the tube rack loaded with the calibrators onto the
autoloader.
3. Tap “Calibration”-“Calibrator” screen, and make sure the calibration information and
parameter targets are correct.
4. Tap “Start”, and the analyzer will run the both levels of calibrators for the “Runs” you
specified.
5. After the analysis is done, the calibration results will display on the screen.
NOTE
 If the ambient temperature is out of the specified operating range, the analyzer will
9-6
alarm you for abnormal ambient temperature and the analysis results may be
unreliable. When temperature errors are reported in the error information area
after analysis, see Chapter 11 Troubleshooting Your Analyzer for solutions.
Save calibration results

After the analysis, the analyzer will have different responses to different analysis results:
 if any of the results is invalid, a dialog box will display prompting the results are invalid.
Tap "OK" to clear the calibration results.
 if the results are valid, the analyzer will display the new calibration factors automatically.
 when you switch to another screen, a dialog box will display asking if you want to save
the calibration results. Tap “OK” to save the calibration results, or tap “Cancel” to give
up.
When calibration has been performed for specified times, the analyzer will calculate and
display the CV value and calibration factors (a and b) automatically.
The calculated calibration factors calculated under different reference systems shall be within
the ranges as below:
Factor NGSP IFCC
a [0.5000, 2.0000], default setting: 1 [5.0000, 20.0000], default setting: empty
b [-5.0000, 5.0000], default setting:0 [-20.0000, 20.0000], default setting:

empty
When the calculated factors are out of above ranges, a dialog box will display prompting the
results are invalid. Check if there is any error. If you cannot solve the problem, contact
Mindray Customer Service Department.
Verify calibration factors

After calibration, run the remaining calibrators of both levels again using the “AL-PT” mode,
and check the analysis results against the target sheet of the calibrator to make sure they fall
in the acceptable ranges. For more information of the analysis under “AL-PT” mode, refer to
5.6.1 Running the Samples.
If the results falls out of the acceptable ranges, re-calibrate the analyzer. If the problem
cannot be solved, contact Mindray Customer Service Department.
Other functions
 Print
Tap "Print" to print the contents on the screen.
9-7
9.4 Touch Screen Calibration (for administrators

only)
From the menu, tap “Calibration”-“Touch Screen” to enter the touch screen calibration screen.
CAUTION
 Do not use anything sharp on the touch screen or strike on it.
If the touch screen does not correctly respond to the positions you touched, perform the
procedure to calibrate the touch screen.
Do as follows:
1. Tap the “Touch Screen” button in the middle of the screen.
Tap the black plus sign at the upper left corner of the screen as instructed by the screen
2. display to start the calibration.
Then tap the black plus successively displayed at the lower left corner, lower right
3. corner, upper right corner and in the centre of the screen.
When the calibration is finished, the screen displays “Calibration succeeded.” Tap any
4. other menu option to exit touch screen calibration.
9-8
10 Servicing Your Analyzer
10.1 Introduction
To ensure the good operating condition of the system, operators shall follow this chapter to
maintain and troubleshoot the system.
10-1
Servicing Your Analyzer
10.2 Maintenance
10.2.1 Consumables ("Maintenance">"Consumables")
Reagents
When a reagent runs out or reaches expiration date, tap “Maintenance” > “Consumables” >
“Reagents” or tap the icon on the menu bar directly to enter the reagent
management screen.
Tap the “Replace” button for the reagent to be replaced. The following dialog box pops up:
10-2
Follow the instructions on the screen to install a new bag of reagent (for more details, please
refer to 10.5.2 Replacing Reagents), and tap “OK”. The reagent information will be
automatically loaded and displayed.
Column (Administrators)
Users at the administor level may tap “Maintenance” > “Consumables” > “Column” to enter
the Column Information screen and check relevant information of the analytical column.
When the analytical column has reached its expiration date, you will be prompted to install a
new one. Tap “Replace” to install a new column.
For detailed instructions, refer to 10.5.4 Replacing Analytical Column in this manual.
10.2.2 Fluidics Maintenance (Administrator) ("Maintenance" >
"Fluidics")
Pack-up
If the analyzer is not to be used for over 2 weeks, you should perform this procedure.
Do as follows to pack up:
1. Tap the “Packup” button, and then a message box will display:
10-3
2. Remove the analytical column from the column box (refer to 10.5.4 Replacing
Analytical Column for instructions), and install a 2-way fitting instead. Fasten the two
screws on both sides of the fitting, then tap “OK”. A dialog box will display:
NOTE
 The 2-way fitting was given to you when the analyzer was first installed by
our service people. Please restore it properly.
2-way fitting
3. Place all reagent bag cap assemblies into a clean and empty container; then tap
“OK”. The analyzer will start to empty fluidics:
10-4
4. After the emptying is complete, a message box will display.
5. Place all reagent bag cap assemblies into the pure water, and then tap "OK" to start
cleaning.
6. After the cleaning is done, a message box will display.
7. Take out the cap assemblies and place them into a cleam and empty container again
as instructed, and then tap "OK" to drain the fluidics.
8. After the emptying is complete, a message box will display. Tap “OK” and turn off the
power switch according to the prompt displayed on the screen.
10-5
10.3 Log (Administrator) ("Maintenance">"Log")
The log records the key operations performed on the analyzer. It provides the operators an
access to review the operating history and service personnel the facilitation of
troubleshooting.
The analyzer can save logs of the recent two years. If number of logs exceeds the upper limit,
the latest log will overwrite the oldest one. You can browse and print logs, but cannot delete
them.
10.3.1 Viewing Logs

Tap the tabs ("All Logs", "Setup Adjustment", "Analyzer Calibration" or "Error Info.") on the
upper part of the screen to display the log lists.
Some logs may contain details too long to be completely displayed on current view. Tap the
"Details" button to display complete log details in a popped up window.
10-6
10.3.2 Exporting Logs

1.
To export the logs of a selected time range, enter the starting and ending number in the
2. "From" and "To" text boxes.

To export all logs, check the "All" check box.
3. Tap "OK" to start exporting.
When the "Export succeeded" message box pops up, tap "OK" to close it and return to
4. the log screen.
10-7
10.4 Cleaning
10.4.1 When, Why and Tools Needed
Procedure When to replace Why to Clean Tools needed
Cover cleaning As needed Remove contaminators on Disinfectant (see 10.4.2
the cover Cover for types of
disinfectant)
10.4.2 Cover Cleaning

The user shall perform daily cleaning and sterilization to the cover of the analyzer. Use the
specified materials to sterilize the equipment only. For any damage to the instrument or other
accidents caused by using materials other than specified, Mindray will not provide any
warranty.
Mindray does not claim the validity of the listed chemicals in infection control. For effective
control of infection, please consult the Infection Prevention Department of the hospital or the
epidemic professionals.
The cleaning may damage the system to some extent. It is recommended to perform the
cleaning only when necessary according to your laboratory protocol.
Recommended disinfectant: 70％ ethanol; 70％ isopropyl alcohol; Cidex 2% Glutaral +

Activator.
Prohibited disinfectant: 3% hydrogen peroxide; Aerodesin 2000, Cidex OPA .
10-8
10.5 Replacing
 Samples and waste are potentially infectious. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when
handling them and the contacted areas in the laboratory.
WARNING
10.5.1 When to Replace and the Tools Needed

Procedure When to replace Tools needed
Replacing As needed /
reagent bag
Replacing waste Waste container full /
container
Replacing When the column expires; Tissues
analytical column You may also need to consider column replacement
when the column pressure is abnormal; or you
frequently receive flags of abnormal retention time
or abnormal chromatographs”
Replacing filter Every 500 tests Tissues and glove
10.5.2 Replacing Reagents
WARNING
10-9
NOTE
 After replacing the reagent bag, check the tubing connected to the cap assembly
and make sure it is not bent over.
The reagent shelf is separated into 3 compartments for different reagents. There are marks
on the right side of the main unit to indicate the connection of different reagents.
1. Tap “Maintenance”-“Consumables”-“Reagents” to enter the “Reagent

Management” screen, and tap the “Replace” button of the reagent needed to be
replaced.
2. Open the reagent replacing window on the left side of the analyzer.
3. Turn the cap of the old bag counterclockwise, and then take out the cap
assembly with caution. Remove the old reagent bag.
4. Place the new reagent bag on the corresponding compartment, the side with the
RFID card facing the front.
5. Insert the pickup tube of the cap assembly into the new bag, and then turn the
cap clockwise until it is secured.
6. Cap the old bag with the cap of the new one, and then dispose of the waste
properly.
7. When the reagent bag is installed, the analyzer will automatically scan the
reagent bag and enter the reagent information to the system.
10-10
10.5.3 Replacing Waste Container
WARNING
 Remove the waste container cap and replace the waste container only when the
power indicator is not flickering, in order not to make the waste overflow from the
container.
1. Get an empty waste container, remove the cap and place it next to the one to be
replaced.
2. Turn the cap counterclockwise and remove the cap assembly from the old container
with caution.
3. Insert the old cap assembly into the new container as vertically as possible, and secure
the cap by turning it clockwise.
4. Cap the old container with the cap of the new one, and then dispose of the waste
properly.
10.5.4 Replacing Analytical Column
NOTE
 When installing the analyzer, make sure the direction of the arrow on the column
is the same as that on the column box.
Analytical column The arrow mark on the column box
10-11
1) Enter "Maintenance" > “Consumables” > "Column" screen.

1.
2) Tap the "Replace" button on the screen; the analyzer prepares for
replacement.
When the analyzer is ready, a dialog box will display prompting about how to
2. remove the old column:
1) Open the front door of the analyzer.
10-12
2) Lift the latch on the inner side on the top of the box, the locking ring on the
outer side will be released, and the column box will be opened.
3) Pull the locking ring to its back side, and place it as well as the latch on the
top of the box.
4) Place a piece of tissue under the column.
3. You can see the column inside the box. Take it out from its slot.
10-13
4. 1) Loosen the fittings and the tubings on both inlet and outlet sides of the
column successively, and detach the column.
2) Push the tubes in both the inlet and outlet fittings, until they protrude at
least 3mm out of the fittings.
10-14
NOTE
 When you remove the column, there may be a small amount of
liquid dropping down from the fixing position on the column. Put a
piece of tissue under the column to absorb the liquid.
3) After you remove the old column, tap “OK” on the screen, and a dialog box
will display prompting about how to connect the inlet end of the column.
5. 1) Remove the plugs from both ends of the new column.
10-15
2) Screw the inlet fitting loosely into the column inlet for about 3 rounds. Do
not tighten it tightly.
3) Use a piece of tissue to wrap the connecting position of the tube fitting and
column inlet; then tap “OK”.
4) Tap the "Prime" button on the screen.
10-16
5) When there is liquid flowing out the the column inlet, tap "Stop", and screw
the fitting tightly into the column inlet.
6) Remove the tissue wrapping the inlet, and wipe the liquid from the
connection.
NOTE
 If there is no liquid flowing from the connection, loosen the fitting a little,
and repeat steps 4) to 6).
7) Tap “OK”, and a dialog box will display prompting about how to install the
outlet side of the column.
10-17
1) Screw the other fitting tightly into the outlet of the column.
6.
2) Place the connected column into the slot.
10-18
NOTE
 The ring form on the column should be aligned with the groove in
the center of the slot.
3) Tap “OK” and the “Leakage Self-Test” screen pops up.
1) Tap the "Prime" button on the screen; and wait for 1 minute to tap the
7. "Stop" button (a timer will display on the screen);
2) Make sure there is no liquid leaking from either the inlet or outlet of the
column.
10-19
NOTE
 When you see liquid leakage, tap the “Stop” button, and make sure
the two fittings on the outlet and inlet of the column are tightly
fastened. Then repeat above steps.
8. 1)
2)
Remove the tissue under the column, and wipe any liquid away.
Close the column box and lock the latch.
3) Close the analyzer front cover.
4) Tap “OK” on the screen, and the “Load Column Information” screen will
display.
9. Take out the new RFID card of the new column from its package box, and
present the card to the card reader located near the analyzer autoloader. The
analyzer will automatically scan the RFID card and load the information.
10-20
10. Make sure the column information displayed on the screen is correct. Tap “OK”,
and the analyzer starts to prime the column tubings. A progress bar will show.
11. After priming, a dialog box will display prompting “Column replacement
succeeded”. Make sure to close the analyzer front cover and re-calibrate the
analyzer. Tap “OK” to return to the “Load Column Information” screen.
NOTE
 When there is any error during the column replacement, tap “Cancel” to end the
replacement procedure. Restore the tubes and the column to their original status, and
close the analyzer front cover; remove the error and try again. When you cannot solve
the problem, contact Mindray Customer Service Department.
10-21
10.5.5 Replacing the Filter
NOTE
 The filter Wear gloves when you replace the filter.
1. Preparation
1) Tap Menu -"Maintenance" > “Consumables” > “Filter” to enter the filter
reaplcement screen.
2) Tap the "Replace" button on the screen; the analyzer prepares for
replacement.
2. Remove the old filter

When the analyzer preparation completes, the “Remove Old Filter” screen displays.
10-22
1) Open the two front covers of the analyzer.
2) Remove the tube fitting connecting to the filter by rotating it clockwisely.
3) Remove the lower part of the filter by rotating it clockwisely; then remove the
10-23
filter element.
4) Push the tube in the fitting, until it protrude at least 3mm out of the fitting.
5) Tap “OK” on the screen.
3. Install a new filter
After you remove the old filter and tap “OK” on the screen. The following screen
displays.
10-24
1） Place a new filter element into the lower part of the filter.
2） Tighlty screw up the lower part of the filter to the upper part of the filter by
roating the lower part counter-clockwisely；then tightly screw up the tube fitting
to the lower part of the filter.
3） Tap “OK” on the screen.
10-25
4. Leakage self-test
When you have installed a new filter element and tapped “OK” on the screen, the
following screen displays.
1) Tap “Prime” and make sure there is no liquid leakage.
NOTE
 If you observe liquid leakage, tap “Stop” on the screen. Maker sure the fitting
is tightly screwed , and repeat the step.
2) Tap “OK” when prime completes.
5. Complete replacement
10-26
1) Wipe off the leaked liquid with a tissue, and close the two front covers of the
analyzer.
2) Tap “OK” on the screen. The new filter information displays.
10-27
10.6 System Status

You can check analyzer status at real time on the system status screen, including:
 Temp.&Pressure
 Version Info.
You cannot modify but only browse the status information at the Status Screen. To check the
status information at the Status Screen is significant for you to locate and remove errors of
the analyzer.
10.6.1 Temperature & Pressure ("Status" >
"Temp.&Pressure")
The screen displays the current value of each item and the corresponding normal range, and
if the out-of-range results are highlighted by the red background, which is significant for you
to judge and locate errors of the analyzer.
10-28
10.6.2 Version Information ("Status" > "Version Info.")
You can check the current version information of the analyzer software and hardware.
10-29
11 Troubleshooting
11.1 Introduction
This chapter contains information that is helpful in locating and correcting problems that may
occur during operation of your analyzer.
NOTE
 This chapter is not a complete service manual and is limited to problems that are
readily diagnosed and/or corrected by the user of the analyzer.
11-1
Troubleshooting
11.2 Error Information and Handling

The possible errors and their troubleshooting information are listed in the following table:
Error Message Troubleshooting
1. Tap the “Remove Error” button to remove the error.

Optical signal abnormal 2. If the error still exists, contact our Customer Service
Department.
Left edge of autoloading
2. If the error still exists, contact our Customer Service
position notch overrun
Department.
Right edge of autoloading
Department.
Pressure building-up
overtime
Department.
Left edge of closed-tube
Department.
Right edge of closed-tube
Department.
1. Please contact our Customer Service Department to
Filter failed replace the filter soon.
Filter uses out of limit 2. If the error still exists, contact our Customer Service
Department.
1. Please contact our Customer Service Department to
Plunger pump use out of
replace the Eluent A plunger pump soon.
time limit
Left edge of lyse position
notch overrun
Department.
Right edge of lyse position
notch overrun
Department.
1. Check whether the sample compartment door can be
opened.
Opening sample
compartment door failed
Department.
11-2
Troubleshooting

Abnormal pressure 2. If the error still exists, contact our Customer Service
Department.
2. If the error still exists, replace the analytical column with a
Abnormal pressure new one.
Department.
Waste buffer cistern
pressure abnormal
Department.
Eluent A info. abnormal 2. If the error still exists, contact our Customer Service
Department.
1. Place the new reagent at the correct position.
Eluent A info. abnormal
Department.
Eluent B info. abnormal 2. If the error still exists, contact our Customer Service
Department.
Eluent B info. abnormal
Department.
Hemolysis Solution info.
abnormal
Department.
Hemolysis Solution info. 2.Tap the “Remove Error” button to remove the error.
abnormal 3. If the error still exists, contact our Customer Service
Department.
Tube rack info. abnormal 2. If the error still exists, contact our Customer Service
Department.
1. Please contact our Customer Service Department to replace
Sample Probe uses out of
the sample probe soon.
limit
Fluidic initialization not
performed
Department.
Column temperature
abnormal
Department.
11-3
Troubleshooting

Optical flow cell
temperature abnormal
Department.
1. Please remove the tube racks on the unloading tray.
Unloading tray is full
Department.
EEPROM write error 2. If the error still exists, contact our Customer Service
Department.
1. Please make sure the cover for the optical system is properly
mounted; and restart the analyzer.
Dark voltage abnormal
Department.
1. Empty the waste container or use a new waste container.
Waste container full
Department.
Sampling syringe
abnormal
Department.
Sample probe mechanism
abnormal
Department.
Rotation valve abnormal 2. If the error still exists, contact our Customer Service
Department.
Feeding valve abnormal 2. If the error still exists, contact our Customer Service
Department.
Plunger pump B abnormal 2. If the error still exists, contact our Customer Service
Department.
Plunger pump A abnormal 2. If the error still exists, contact our Customer Service
Department.
1. Install a new bag of Hemolysis Solution, and the error will be
removed automatically.
No Hemolysis Solution
2.If the error still exists, contact our Customer Service
Department.
1. Install a new bag of Eluent B, and the error will be removed
automatically.
No Eluent B
Department.
11-4
Troubleshooting
1. Install a new bag of Eluent A, and the error will be removed

automatically.
No Eluent A
2.If the error still exists, contact our Customer Service
Department.
1. Please install a new analytical column.
Column uses out of limit 2. If the error still exists, contact our Customer Service
Department.
1. Install a new bag of Hemolysis Solution.
Replacing Hemolysis 2. Tap the “Remove Error” button to remove the error.
Solution failed 3. If the error still exists, contact our Customer Service
Department.
Hemolysis Solution floater
status abnormal
Department.
Hemolysis Solution cistern
is empty
Department.
1. Replace the Hemolysis Solution.
Lyse expired
Department.
1. Install a new bag of Eluent B.
Eluent B expired
Department.
1. Install a new bag of Eluent A.
Eluent A expired
Department.
Column expired 2. If the error still exists, contact our Customer Service
Department.
1. Install a new bag of Eluent B.
Replacing Eluent B failed
Department.
1. Install a new bag of Eluent A.
Replacing Eluent A failed
Department.
Eluent A floater status
abnormal
Department.
11-5
Troubleshooting

Eluent A cistern is empty 2. If the error still exists, contact our Customer Service
Department.
Hemolysis Solution
syringe abnormal
Department.
Degasser off 2. If the error still exists, contact our Customer Service
Department.
Degasser pressure not in
control range
Department.
Column information
loading failed
Department.
Optical system blank
voltage signal abnormal
Department.
Autoloader board
communication error
Department.
1. Please remove the tube rack(s) from the autoloader.
Autoloader mechanism 2. Tap the “Remove Error” button to remove the error.
action error 3. If the error still exists, contact our Customer Service
Department.
Mix mechanism action
error
Department.
1. Check if the barcode is properly placed, intact and readable.
2. If there is no problem with the barcode, tap the "Remove
Scanner error Error" button to test the built-in barcode scanner.
Department.
Action abnormal 2. If the error still exists, contact our Customer Service
Department.
11-6
Annex I Operating with Extended
Program
I-1 Applicable Area
This annex provides the instruction for operating with the Extended Program of the
Automated Glycohemoglobin Analyzer (hereafter the "analyzer"). The Extended program is
an advanced and optional feature of the H50P analyzer.
For the operations with Standard Program, the setup and maintenance of the analyzer, as
well as other information, check the main part of the Operator's Manual.
For the configuration of the Extended Program, contact your sales representative.
1
Operating with Extended Program
I-2 Overview of Extended Program

This annex provides daily operation instructions with the Extended program of the analyzer.
Under the Extended program, the analyzer not only performs quantitative determination of
the percentage (%) and substance content (mmol/mol) of hemoglobin A1c (HbA1c) in human
blood samples; but also alarms about the possible present of HbE variant.
I-2.1 Clinical Significance

HbA1c is a non-enzymatically formed, reliable adduct between plasma glucose and the
valine at the amino terminus of the β-chain. The HbA1c level reflects the blood glucose level
over the life span of the erythrocyte, and is commonly recognized as the golden index of
long-term glycemic control. In the meanwhile, abnormal hemoglobins are common
interference during the HbA1c tests.
Abnormal hemoglobins are hemoglobins with abnormal molecular structures due to genetic
defects. So far, over a thousand types of hemoglobin variants have been found worldwide.
Hemoglobin E (HbE) is an abnormal hemoglobin with a single point mutation at position 26 in
the β-chain, where the glutanic acid is substituted by lysine. HbE is most prevalent in India
and South East Asia, and it is found in South China too. It mainly causes β-Thalassemia; and
when combined with α-Thalassemia, β-Thalassemia and abnormal Hb Constant Spring, it
may cause HbE syndrome with complex clinical manifestations.
The Extended program of the H50P analyzer is able to detect the HbE traits, and alarm the
presence of HbE variant.
2
I-3 Software Interfaces and Operations

If your analyzer is equipped with the Extended program, the "Sample Analysis" icon on the
menu bar of the software interface will either display "S" for Standard program, or "E" for
Extended mode accordingly. You can use either Standard program or Extended program
depending on different scenarios. When operating the Standard program, all the operation is
the same as that for a regular analyzer; and the analyzer will not alarm about the possible
presence of HbE. The HbE traits would only be detected when you use the Extended
program.
Analysis Screen-Standard Program
3
Analysis Screen-Extended Program
I-3.1 Switch from Standard Program to Extended Program

Follow below procedures to switch to Extended program:
1. Tap the menu icon -"Setup"-"Analysis Program" to enter the "Analysis Program"
screen.
From the "Analysis Program" pull-down list, select "Extended (E)" program.
2.
NOTE
 If you want to go back to the standard program, select "Standard (S)"
on this screen.
4
Tap another icon on the menu bar. A dialog box displays asking if you want to save
3. the change.
Tap "Yes" to save your setting.

4. When the setting is saved successfully, The "Sample Analysis" icon on the menu
bar will display an "E" to indicate that the "Extended" program is selected.
NOTE
 To ensure the accuracy and reliability of sample analysis results, every time you
have switched the analysis program, be sure to perform the QC procedure with
both CRL-1 and CRL-2.
I-4 Operating Your Analyzer

I-4.1 Introduction
This chapter provides step-by-step procedures for operating H50P analyzer on a daily basis.
A flow chart indicating the common daily operating process is presented below.
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Initial Checks
See I-4.2 Inspection Before

Startup
Power On
See I-4.3 Startup
Daily Quality Control
See I-4.4 Daily Quality Control
Sample Preparation
See I-4.5 Sample Preparation
Sample Analysis
See I-4.6 Sample Analysis Under See I-4.7 Sample Analysis Under
Shutdown
See I-4.10 Shut Down the
Analyzer
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I-4.2 Inspection before Startup

Perform the following checks before turning on the analyzer.
WARNING
and if necessary, go see a doctor; if the reagents accidentally spill into your
eyes, wash them off with plenty of water and immediately go see a doctor.
 Do not touch the moving parts. Keep your clothes, hairs and hands away from
the moving parts to avoid injury.
Checking the reagents
Check whether there are enough reagents for the tests of the day. If not, replace the
reagents.
If the reagents run out during analysis, the analyzer will pause working automatically and
prompt the operator to replace the reagents. Please follow the instruction to replace the
reagents.
Checking tubing and power connections
Check and make sure the reagent, waste and pneumatic unit tubes are properly connected
and not bent.
Check and make sure the power cord of the analyzer is properly plugged into the power
outlet.
Checking the waste container
Check and make sure the waste container is empty.
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I-4.3 Startup
I-4.3.1 Power Switch
Press the [Start] button on the analyzer.
I-4.3.2 System Self-Test

Once the power is turned on, the analyzer will automatically run the self-test procedure
including system checks, shutdown checks and mechanic initialization.
If any error occurs during the initialization, the analyzer will display the error message. Follow
the instructions to remove the error. See Chapter 11 Troubleshooting for troubleshooting
solutions.
NOTE
 You should remove all the errors before proceeding with any operation.
 When the analyzer has been idle for more than 72 hours, the analyzer self-test
will take longer time.
I-4.3.3 Login and Status Check

When the analyzer completes its self-test, a login dialog box will display. Enter the user ID
and the passport, and then tap "Login" to enter the system main screen.
8
Make sure the Extended program is selected. When the "Extended" program is selected, the
"Sample Analysis" icon on the menu bar will display an "E".
Check the status area at the lower part of the screen, and make sure all the reagents are
sufficient; and the analytical column does not reaches their maximum uses.
I-4.4 Daily Quality Control
NOTE
 If you are using the Extended Program, be sure to perform the quality control
under the same program.
I-4.4.1 Introduction
Quality Control (QC) consists of strategies and procedures that measure the precision and
stability of the analyzer. The results imply the reliability of the sample results.
Analysis of the results with statistical methods allows the inference that sample results are
reliable. Mindray recommends you to run the QC program daily with both CRL-1 and CRL-2
levels of controls. A new lot of controls should be analyzed in parallel with the current lot prior
to their expiration dates.
This may be accomplished by running the new lot of controls twice a day for five days using
any empty QC file. The QC files calculate the mean, standard deviation and coefficient of
variation for each selected parameter.
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I-4.4.2 Quality Control Program of the Analyzer

You can set up at most 12 QC files to save QC parameters and results. Up to 350 QC can be
saved for each QC file.
QC Setup ("QC" > "Setup")
General users may only review the QC file settings. Administrators may select the QC file to
be used by checking the "In Use" check box of it. The QC results will then be saved to the
selected file.
Edit a QC file
Select the QC file you want to edit in the QC file list and tap "Edit" to enter the "QC File Setup"
screen.
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 Set lot No. of control
Enter the lot number into the "Lot No." text box.
 Set control level
Select "CRL-1" or " CRL-2" control level from the "Level" pull down list.
 Enter the expiration date
You can enter the expiration date of the control to the "Exp. Date" text box in the format you
set in 7.2 Date/Time.
NOTE
 Refer to the Instruction for Use of the control for its lot no., expiration date,
parameter reference values and limits.
labeling or the open-container expiration date, whichever is earlier. The
open-container expiration date is calculated as follows: the date that container is
opened + the open-container stability days.
 Set target and limit for the parameter
Enter the target and limit into the "Target" and "Limit" text boxes.
 Set reference method
Select suitable reference method (NGSP or IFCC) based on the trace system used in your
laboratory.
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 Setting limit format
Select "Absolute Value" or "Percentage" from the "Limit Format" pull down list.
NOTE
 Only valid parameter targets and limits can be saved.
 Save the settings
When you complete the settings, tap "OK" to save the settings and return to the "QC Setup"
screen.
Clear a QC file (Administrator)

You may clear the data in a QC file as needed.
Select the QC file to be cleared, and tap the "Clear" button. Below dialog box will display.
Tap "Yes" to clear all the sample data in the QC file.
QC analysis
When a QC file is selected as "In Use" (only one file may be selected for each level), all the
QC results will be saved to the file.
 All the samples, controls, calibrators, reagents, wastes and areas contacted
 The sample probe tip is sharp and may contain biohazardous materials.
Exercise caution to avoid contact with the sharp sample probe when working
around it.
 The sample may spill from the uncapped collection tubes and cause biohazard.
Exercise caution to the uncapped collection tubes.
12
WARNING
 Collection tubes broken may cause personal injury and/or biohazard. Exercise
caution when loading the collection tubes to the rack or getting the collection
tubes from the rack, be sure not to break the tubes.
 Do not touch the moving parts. Keep your clothes, hairs and hands away from
the moving parts to avoid injury.
 The reagents are irritating to eyes, skin and airway. Wear proper personal
protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory
procedures when handling them and the contacted areas in the laboratory.
 If reagents accidentally spill on your skin or in your eyes, rinse the area with
ample amount of clean water; seek medical attention immediately.
CAUTION
tubes and so on.
 Gently shake and mix the prepared control to avoid bubbles. Do not use a
mechanical mixer.
NOTE
 Use the controls and reagents specified by the manufacturer only. Store and use
the controls and reagents as instructed by their instructions for use.
Prepare a control of CRL-1 level and another of CRL-2 level as instructed by instructions
1. for use of the controls.
NOTE
 The H50P analyzer supports auto dispensing of Hemolysis Solution. You
can use the function to dilute and prepare controls. For more information,
refer to 5.10 Auto Dispensing Hemolysis Solution.
When the controls are completely dissolved, take 200ul of each level of control into two
2. specified containers (1.5ml centrifugal tube or the micro sample cup (included)).
NOTE
 The remaining controls can be stored at 2～8℃ for 14 days. When you
intend to use them, take the controls out from the low temperature
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environment and place them at room temperature for 15 minutes.
 Mark the open-container date of every vial of control on the vial. Enter the
parameter target value, batch no. and expiration date of the control to the
analyzer software when a vial of control is newly opened.
When the analyzer is ready to run the QC program, place the tube or micro sample cup
3. into the specified positions of the CRL tube rack (CRL-1 should be place at the 2nd tube
position, and CRL-2 at the 4th tube position), and put the tube rack onto the autoloader.
NOTE
 You must place the controls to the control tube rack to run the QC
program; otherwise the analyzer cannot recognize them as controls.
Enter the "Sample Analysis" screen and tap the "Start" button. The analyzer will
4. automatically recognize and run the controls. The QC results will be saved to the "In
Use" control files of corresponding levels.
Reviewing QC Results
You can review the QC results in the following ways:
 QC Graph
 QC Table
QC graph review
Tap "Graph" on the "QC Setup" screen to enter the graph screen of the latest used QC file.
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Select the file number from the "File No." pull down list and switch the screen to the QC graph
NOTE
 When there are less than 3 QC results, the Mean, SD and CV values on the right
side of the QC graph will not display.
Introduction to the QC graph:
 The x-axis of the graph represents the number of QC results, and the y-axis represents
the QC results.
 The blue vertical line indicates the current selected QC result.
 The three figures on the left side of the graph corresponds to the three cross lines on the
graph, which from bottom to up demonstrate the lower limit, target and upper limit of the
parameter results.
Upper limit: Target of the control＋ limit

Target: Reference value of the control
Lower limit: Target of the control - limit
 The three values on the right side of the graph indicates:
Mean - the mean value of the parameter QC results

SD - standard deviation
CV% - coefficient of variation
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x i
Mean ＝ i1
n
SD 
 X i  Mean
2
n 1
SD
CV%   100
Mean
Among which, n indicates QC runs, Xi indicates the number i measurement result for the
parameter.
Different colors of the points have different meanings:

Black points: the points are within the expected range;
Red points: the points are out of controlled range.
You can perform the following operations on the QC Graph screen:
The QC results are displayed in order of save times: from left to right, the earliest to the latest.
Tap the "Next Page" button on the lower part of the graph to review the results.
 Exit
QC table review
Tap "Table" on the "QC Setup" screen to enter the table screen of the latest used QC file.
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Select the file number from the "File No." pull down list and switch the screen to the QC table
You can perform the following operations on the QC Table screen:
You can tap the "Next Page" button on the right side to review the QC results. The QC results
are displayed in order of save times. The latest is displayed at the top row.
 Communicate
Tap the "Comm." button to transmit the results to an eternal computer.
 Export
Tap the "Export" button to export the QC information in current QC table to a USB connected
to the analyzer.
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NOTE
 The USB port locates at the right side of the analyzer. Refer to Figure 2-4 Right
side of the analyzer for reference.
 Delete (administrators)
Users at administrator level may delete selected or all QC results in a QC file.

Tap any cell in the row of the QC result you want to delete, below dialog box will display:
Tap "Selected Records" or "All Records", and then tap "OK" to delete. The operation will be
logged in the system log. Tap "Cancel" to cancel the delete.
 Exit
When QC fails
When any QC result falls out the controlled range, the QC button on the top of the screen
lights in red:
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NOTE
 If you have selected “Stop Analysis” when QC fails on “Setup”-“Axillary” screen,
the analyzer will not analyze following samples. For more information, refer to
7.6 Auxillary (“Setup”> “Auxillary”)
If any QC point falls out of the controlled range, follow below steps to solve the problem. If the
problem cannot be solved, contact Mindray Customer Service Department.
1. Check the error information area on the screen. If any error exists, see Chapter 11
Troubleshooting for solutions.
2. Check the settings of QC setup and correct any wrong information that may exist.
3. Run the QC analysis again.
4. When the QC results are still out of range, run the QC analysis with a new vial of control.
5. When the QC results are still out of range, re-calibrate the analyzer.
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I-4.5 Sample Preparation
WARNING
 Do not contact the patients' sample blood directly.
CAUTION
tubes and so on.
 Prepare samples following the recommend procedure of the manufacturer.
NOTE
 Be sure to use clean anticoagulant collection tubes (recommended
anticoagulants: K2EDTA, K3EDTA, heparin lithium salt, sodium citrate,
potassium oxalate monohydrate/sodium fluoride), fused silica glass/plastic test
tubes, centrifugal tubes and borosilicate glass capillary tubes.
 Be sure to use the Mindray-specified disposable products including evacuated

blood collection tube, anticoagulant collection tubes and capillary tubes etc.
I-4.5.1 Sample Collection and Storage Requirements

For anticoagulants, EDTA, heparin, and NaF may be applicable; and the whole blood
samples may be stored under refrigeration condition for 7 days.
I-4.5.2 Whole Blood Samples
1. Use recommended anticoagulant collection tubes to collect venous blood samples.
Mix the sample immediately according to your laboratory’s protocol.

2.
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CAUTION
1mL under whole blood mode.
 The samples stored under refrigeration condition (2℃-8℃) must be kept at room
temperature for at least 30 minutes before analysis.
again before running it
I-4.5.3 Prediluted Sample

In case of insufficient sample volume or very low hemoglobin concentration, the analyzer may
report “Chromatogram area too small”. Predilute the sample as required, and run the sample
using predilute mode.
1. Add certain amount of sample blood (10ul) into a 1.5ml centrifugal tube (or micro
sample cup) .
If the small area flag is reported because of sample volume is insufficient,, use a
2. pipette to dispense lyse into the sample at the ratio of1：100 (lyse to blood sample)
and well mix it;
If the small area flag is reported because the HGB of the whole blood sample is
too low, use a pipette to dispense lyse into the sample at the ratio of1：50 (lyse to
blood sample) and well mix it.
The H50P analyzer supports auto dispensing of Hemolysis Solution. You can use the function
to dilute and prepare controls. For more information, refer to 5.10 Auto Dispensing Hemolysis
Solution.
CAUTION
 Take methods to prevent the diluent from dust; otherwise the results may be
unreliable.
 Be sure to run the prediluted samples within 30 minutes after the dilution;
otherwise the results may be unreliable.
 Be sure to mix any sample that has been prepared for a while before running it.
 Be sure to evaluate predilute stability based on your laboratory’s sample

population and sample collection techniques or methods.
0.5mL under prediluted mode.
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I-4.6 Sample Analysis under Closed Tube Mode

I-4.6.1 Running the Samples
Exercise caution to avoid contact with the probe when working around it.
CAUTION
tubes and so on.
 Repeated piercing the cap of the evacuated blood collection tube may damage
 To ensure the correctness of analysis results, do not run prediluted samples

under the Closed Tube mode.
NOTE
 Proper reference range shall be entered on the "Setup"- “Parameter” screen
before analysis. Otherwise, the results may be flagged erroneously.
 If the 2-way LIS/HIS mode is selected, then after the sample ID is

entered/scanned and saved, all the corresponding information will be obtained
from the LIS/HIS, and then the analyzer starts running per the obtained
information. Once the running is finished, the result, graph and sample/patient
information will be uploaded to the LIS/HIS.
When it is ready to run a sample (i.e. the analyzer indicator stays in green), shake the
1. tube of whole blood sample as instructed by the picture below to mix the sample
thoroughly.
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Press the [Open] key on the analyzer to open the sample compartment door. Install
2. theФ13×75 (mm) adapter into the sample compartment. Place the sample into the
adapter.
3. Close the sample compartment door.
Tap the "Mode" button on the "Sample Analysis" screen, and the "Mode Setup"
4. screen will display.
Check the "CT" radio button for "Presentation Mode" and enter the "Start Sample ID".
5. If necessary, check "Auto Increase", and the subsequent sample IDs will
automatically increase by 1 based on the previous one.
Tap the "Start" button to start the analysis. After the sample probe finishes sample
7. aspiration, the sample compartment door opens automatically, and the analyzer
indicator flickers in green.
When the analysis completes, the analyzer indicator returns to "Ready" status (stay in
8. green).
9. If necessary, repeat above steps to run other samples.
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I-4.6.2 Replacing the Adapter

In closed-tube sampling mode, the model of the tubes and the corresponding adapters are
the followings:
φ12×75 (mm) ~ 13×75 (mm) (without the cap) evacuated blood collection tube, used for
Ф13×75 (mm) adapter.
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I-4.7 Sample Analysis under Autoloading Mode

I-4.7.1 Running the Samples
Exercise caution to avoid contact with the probe when working around it.
CAUTION
tubes and so on.
again before running it.
 Repeated piercing the cap of the evacuated blood collection tube may damage
 Be sure that the entered sample ID, rack No., tube No. and the analysis mode
are strictly in accordance with the sample to be run.
NOTE
 Proper reference range shall be entered on the "Setup"-“Parameter” screen
before analysis. Otherwise, the results may be flagged erroneously.
 If the 2-way LIS/HIS mode is selected, then after the sample ID is

entered/scanned and saved, all the corresponding information will be obtained
from the LIS/HIS, and then the analyzer starts running per the obtained
information. Once the running is finished, the result, graph and sample/patient
information will be uploaded to the LIS/HIS.
1. When it is ready to run a sample (i.e. the analyzer indicator stays in green), shake
the tube of whole blood sample as instructed by the picture below to mix the
sample thoroughly.
25
2. Tap the "Mode" button on the "Sample Analysis" screen, and the "Mode Setup"
dialog box will display.
3. Check "AL" for the presentation mode.
4. Enter the "Start Sample ID" (skip the step if you are using the whole blood mode
and have selected "Auto Scan ").
5. To run a whole blood sample, directly place the prepared sample tube into the
whole blood sample rack.
To run a prediluted sample, fit the prepared sample tube (or micro sample cup)
uncapped into a corresponding adapter (clip the tube cap into the adapter notch)
and place the tube together with the adapter into an even-numbered position of the
PD tube rack.
6. Place the racks with tubes on the right tray of the autoloader, with the side opening
facing the analyzer.
8. Tap "Start" and the analyzer will automatically start to run in order from the preset
starting position. During this process, the analyzer indicator is flickering in green.
9. After every analysis cycle, the results will be saved to the sample database
10. When the analyses are finished, a statistical result dialog box will display.
26
11. Tap "Return" to return to the “Sample Analysis” screen, the analyzer indicator will
return to green.
12. When the autoloading analyses are finished, all the tube racks are moved to the
left tray of the autoloader automatically, and then you can remove the racks of
tubes safely.
NOTE
 If more racks are needed when running the samples, you should load the rack
from the right of the autoloader while removing the completed rack from the left
of the autoloader in time.
I-4.7.2 Special Functions
Stop Running
During the analysis process, the "Start" button will turn into "End" button. Tap the "End"
button, the analyzer will stop running after the current sample is analyzed, and the rack of the
sample will move to the unloading tray one the left of the autoloader.
STAT
Use the function to insert STAT samples during the analysis process.
27
1. Press the [Open] key on the analyzer to open the sample compartment door, and
place the uncapped STAT sample into the compartment. Close the compartment
door.
2. Wait for the analyzer to complete the analysis of current sample and convert to the
STAT mode. You will know that the STAT mode is ready when a “Cancel STAT”
button appears.
3. Tap “Mode” to enter the sample ID. Tap “OK” to close the dialog box.
4. Tap “Start” to start the analysis.
5. When the compartment door opens, it means the analyzer aspirates enough
sample. You can remove the sample then; but it will still take a little time for the
analyzer finishes the analysis.
6. If necessary, repeat above steps to analyzer other STAT samples.
NOTE
 The STAT mode only supports whole blood samples.
Cancel STAT
After the running is finished, you can tap the “Cancel STAT” button to cancel the STAT, and
then the analyzer will judge whether to switch to the analysis mode before the inserted STAT
accordingly, and then proceed with autoloading.
I-4.7.3 Barcode Labels
CAUTION
 The following errors may cause misreading of barcodes:
The barcode is not stuck upright.

Use of unqualified barcodes.
There are blood, powder or other contaminators on the surface of the barcode.
 To ensure good readability of barcodes, do as follows:
Stick the barcode correctly, as shown in Figure 5-1.

Use qualified barcodes mentioned in B 15 Barcode Specifications;
Keep the surface of the barcode clean and free of dust.
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To ensure good readability of the barcode, you must place the label right on the region
marked by X as shown in Figure 5-1, and place the label correctly as shown in Figure 5-2.
Figure 1 Where to place the barcode label
NOTE
 If several labels are stuck to one tube, or the label is misplaced, peeled or
wrinkled, it may cause autoloading error. To avoid such error, the notes below
shall be followed:
The label shall be stuck properly, as shown in Figure 5-1.

Do not stick several labels to one tube.
The surface of the label shall not be wrinkled.
Do not use barcode label which is easily peeled to prevent the label from
peeling.
Ensure that the tube with barcode label can be taken out from and placed back
to the rack easily.
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Figure 2 How to place the barcode label
I-4.7.4 Replacing the Adapter

In autoloading sampling mode, the model of the tubes and the corresponding adapters are
the followings:
2ml micro sample cup (standard hitachi cup), used with φ12×27(mm) micro sample cup
adapter.
1.5ml centrifugal tube, used with φ11×40 (mm) 1.5ml adapter.
I-4.8 Processing Analysis Results

I-4.8.1 Saving of analysis results
I-4.8.2 Parameter flags

If the parameter is marked by the suspect flag ("?"), it means the analysis result is suspicious.
If a result is indicated by “***”, it means the result is invalid or out of the display range.
I-4.8.3 Chromatogram flags

Messages Meanings
Abnormal signal The analyzer signals may become abnormal
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Messages Meanings
The analyzer does not aspirate sample properly; or
Chromatogram area too
the hemoglobin concentration of the sample may be
small
too low
Chromatogram area too The hemoglobin concentration of the sample may
large be too high
separated
Chromatography
abnormal
Shorter SA1c retention
The analyzer may be in abnormal status
time
Longer SA1c retention
time
Shorter HbA0 retention
time
Longer HbA0 retention
time
Suspected HbE HbE variant may be present
I-4.9 Sample Review
I-4.9.1 Introduction
After every analysis cycle, the analyzer will save the analysis result automatically including
sample information, parameter results, flag messages as well as the chromatographies. The
analyzer can store up to 50,000 analysis results.
You can review all the sample information, parameter results, flag messages as well as the
chromatographies either in table or graph mode.
NOTE
 The sample result data must have proper backup in case of data lost caused by
hardware or software error.
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I-4.9.2 Reviewing Sample Results

You can review the sample results either in table or graph review mode.
Table Review
Tap the "Table Review" button on the menu to enter the "Table Review" screen.
The “Mode” row

displays the
“Analysis
Program” (S or
E) and the
sample mode
(WB or PD)
The table displays a list of analyzed samples with basic sample information like sequence no.,
sample ID, analysis mode, analysis date and time, tube position, status and the test panel.
Above the sample result table, you may find the following function buttons: "Print", "Search",
"Comm." and "Export"; below the sample result table is the function button area, where you
may find the following buttons: (from left to right) "Graph ", "Edit", "Validate", "Cancel Val."
and "Delete". The "Validate", "Cancel Val." and "Delete" buttons are only available for
administrators. You can tap the buttons to perform corresponding functions. The "Validate",
"Cancel Val." and "Delete" buttons are only available for administrators. You can tap the
buttons to perform corresponding functions.
Switch to the "Graph Review" screen
Tap the "Graph Review" button to switch to the "Graph Review" screen. For detailed
information about the "Graph Review" screen, see 6.2.2 Graph Review.
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Edit information
NOTE
 Make sure you enter the patient information carefully and correctly.
You can edit the information displayed on the "Table Review" screen.
Tap the desired record you want to edit, and the selected record will be highlighted. Tap the
"Edit" button, below dialog box will display. You do not need to enter the patient age, the
validator and operator.
Enter the sample ID
Enter the ID "Sample ID" in the box.
NOTE
 You can enter letters, digits and all other characters on the keyboard (including
special characters) for sample ID.
 1 to 20 characters are allowed. It cannot be left empty.
 The sample ID must end with a digit; and it cannot only consist of "0".
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Entering the patient ID
Enter the patient ID to the "Patient ID" box.
Entering the department name
You can either enter the department name in the "Dept." box, or select the desired
department from the "Dept." pull-down list (if there are previous entries saved in the list). At
most 30 entries can be automatically saved to the "Dept." pull-down list. At most 30 entries
can be automatically saved to the "Clinician" pull-down list.
Entering the patient name
Enter the patient name in the "Patient" box.
Entering the patient gender
Select the desired item (Male, Female, or null) from the "Gender" pull-down list. The default
option is "null".
Entering the date of birth

Enter the birth date of the patient into the "Date of Birth" box, the birth date format being the
same of the system date.
Entering the patient age

Enter the patient age into the “Age” box. When you enter the patient birth date.
NOTE
 The system will automatically calculate the patient age using the entered "Birth
Date" and current "System Date" and display the result in the "Age" box. The
"Age" box will then be greyed, and will become editable again when the "Date of
Birth" is cleared.
 The patient birth date should be no later than current system date.
OK
When you have finished entering the sample information, tap "OK" to save the information
and return to the "Table Review" screen.
Cancel
If you do not want to save the entered sample information, tap "Cancel" to return the "Table
Review" screen without saving the changes.
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Validate/cancel validate (administrators)
Users of the administrator level may tap "Validate" to validate current or selected record. The
icon would appear at the “Status” cell box of the record. Tap "Cancel Val." to cancel the
validation.
Delete (administrators)
Users of the administrator level may delete desired records by tapping the "Delete" button.
Tap the "Delete" button, below dialog box will pop out:
Select "Selected Records" or "All Records" and tap "OK", below dialog box will pop out. Tap
"Yes" to perform deletion, or tap "No" to cancel deletion.
NOTE
 If you tap the "Delete" button when the system is communicating or printing
certain records, a dialog box will pop out prompting "System busy. Please try
again later!".
 If no record is selected, when you choose to delete "Selected Records", a dialog

box will pop out prompting "Please select a sample".
Select
You can select one or more sample records to perform certain operations like "Comm." or
"Print".
35
Select/deselect a single record
Tap any cell in a sample record to select it. The selected record will be highlighted and a "*"
will be marked next to the sequence no. of the record. Tap again to deselect the record.
Select/deselect multiple records
Tap the desired records to select (or deselect) them.

The selected records will be highlighted and the last selected record will be marked by an "*"
next to the sequence no. of the record.
Search for Sample Record(s)
You can search for records based on certain conditions in the sample database.
1. Tap "Search", the following dialog box will display.
2. Enter "Sample ID", “Patient ID”, patient “Name”, "Date", and Sample "No.", and check
the needed “Sample Status” (“Not Vali.”, “Not Pri.” and “Not Com.”) as necessary to
specify the searching conditions.
3. Check "Select sample(s) found" if necessary, then the samples found will be selected.
4. Tap "OK" to start searching.
If no results are found, a dialog box will pop out prompting "No sample found!". Tap
"OK" to close the dialog box.
On the found results screen, all the buttons are the same as of the "Table Review" screen,
only the original "Search" button is replaced by the "Return" button. Tap the "Return" button to
return to the "Table Review" screen.
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Print
Select (a) sample record(s) and tap "Print", the following dialog box will display.
You can "Print Selected" or "Print All" records. Up to 700 records can be printed at the same
time. Tap "OK" to start print. A progress bar will display. Tap "Cancel" to cancel the print.
Communicate
You can transmit selected sample results to an eternal computer.

Select one or more samples and tap the "Comm." button, below dialog box will pop out.
Select to transmit "Selected" or "All" records. Tap the "OK" button to start communication. A
progress bar will display. Tap "Cancel" to close the dialog box.
Export
You can export selected sample data to a USB card.
NOTE
37
You can choose to export the selected records or all records. Besides, check “Chromatogram”
for “Export Content” if you want to export the chromatograms. Tap "OK" to start export; tap
"Cancel" to cancel the export. When the export process completes, the system will prompt
whether the operation completes successfully or fails; and a log will created if you select to
export "Sample Data".
I-4.9.3 Graph Review

Tap "Graph" on the "Table Review" screen to enter the graph review screen, which displays
sample information, parameter results, chromatogram, chromatogram flags, and detailed
peak information for the hemoglobin components.
38
Sample
Information
Sample
results
Chromatogram Chromatogram
flag message
Peak
information
Chromatogram
Normal blood sample

The chromatogram shows the peaks of various hemoglobin components in order of the
sequence they are eluted from a sample (from left to right: A1a, A1b, F, LA1c, SA1c (HbA1c),
and A0). The peak identified as SA1c(HbA1c) is shaded. The x-axis shows the retention
times (the elapsed time between the start of the run and the apex of the peaks) for these
components. The unit is in seconds.
39
Sample with HbE variant
For a sample with the HbE variant, you may see the characteristic peak of HbE between the
SA1c peak and the A0 peak.
Detailed peak information for hemoglobin components
The table below the chromatogram displays detailed information for each hemoglobin
component peak.
Name
The name of the hemoglobin component.
Time
Retention time (in seconds), the elapsed time between the start of the run and the apex of the
peaks.
Area
The area of a peak corresponds to the volume of the corresponding component. The unit is
OD.s.
Total Area
This is the sum area for the peaks of all hemoglobin components. The acceptable range is
30~300. In case of insufficient sample volume or very low hemoglobin concentration, the
analyzer may report “Chromatogram area too small”. Predilute the sample as required, and
run the sample using predilute mode.
40
%
The percentage is the ratio of a peak area against the total area.
You can perform the following operation on the screen:
Browse the results
Tap the buttons to browse the sample results.
Return to the "Table Review" screen
You can tap the "Return" button on the upper part of the screen to return to the "Table
Review" screen.
Validate/cancel validate (administrators)
Users of the administrator level may tap "Validate" to validate current record. Tap "Cancel
Val." to cancel the validation.
I-4.10 Shut Down

I-4.10.1 Logout
1. Tap "Logout" from the menu, a dialog box will pop out.
2. Tap "Yes" to enter the "Login" screen.
41
I-4.10.2 Shut Down the Analyzer
1. Tap "Shutdown" from the menu.
2. After the cleaning, follow the screen instructions to turn off the analyzer.
42
I-5 Calibrate Your Analyzer
I-5.1 Introduction
Calibration is a procedure to standardize the analyzer by determining its deviation under
certain specified conditions. In order to get accurate sample analysis results, you should
calibrate the analyzer per the procedure below when necessary.
There are two calibration programs available on this analyzer: manual calibration and auto
calibration using calibrators.
NOTE
 Calibration procedures can only be performed by users of the administrator-level.
 Use the calibrators and reagents specified by the manufacturer only. Store and
use the calibrators and reagents as instructed by their instructions for use.
43
I-5.2 When to Calibrate

This analyzer is calibrated at the factory before shipment. It is electronically stable and does
not require frequent recalibration if you operate and maintain it as instructed by this manual.
You only need to recalibrate this analyzer if:
you are going to use this analyzer for the first time (usually done by a Mindray-authorized
representative when installing the analyzer).
a major component (for example, the analytical column) has been changed.
you are going to re-use the analyzer after a long-term storage.
the QC results are out of control due to non-QC operation causes.
NOTE
 All of the measured parameters must be calibrated before readings of this analyzer
can be used as valid analysis results.
44
I-5.3 How to Calibrate
NOTE
 Repeated piercing the cap of the evacuated blood collection tube may damage the
cap, and the scraps produced may result in inaccurate analysis results. It is
I-5.3.1 Preparing Your Analyzer

Check and make sure the analyzer works properly and enough reagents have been prepared
for the calibration. You need to start over the calibration if the reagents run out during the
process.
It is recommended that you create a log table for your analyzer. This log table should contain
all necessary information that is pertinent to your analyzer. Suggested items that you may
want to include in the log table are: calibration date, supplier of calibrator, lot number,
expected results and limits.
NOTE
 Be sure to use the evacuated collection tubes recommended in the Appendix.
I-5.3.2 Manual Calibration ("Calibrate">"Manual")
Tap the menu icon -"Calibrate"-“Manual” to enter the manual calibration screen.
1.
45
Confirmed "Extended(E)" is selected for "Analysis Program".

2.
NOTE
 If you want to calibrate the Standard program, select "Standard (S)" for
the "Analysis Program".
You can manually modify the calibration factor on this screen.
 HbA1c calibration factor
Select the suitable reference method (“NGSP”, “IFCC” or “Mono-S”) in accordance with your
laboratory procedure from the pull-down list.
In the formula Y=aX+b, Y means the results finally shown on the screen, X means the raw
 HbF calibration factor

In the formula Y=aX+b, Y means the results finally shown on the screen, X means the raw
 Return to factory setup
Tap “Factory Setup” and set the calibration factors back to factory setup.
46
I-5.3.3 Calibration with Calibrator ("Calibrate">"Calibrator")
Enter calibration information
From the “Menu” tab, tap “Calibration”--"Calibrator" to enter the “Calibration with Calibrators”
screen.
 Lot No.
Enter the lot No. of both the “CAL-1” and “CAL-2” level calibrators into the "Lot No." boxes.
 Expiration Date
Enter the expiration dates into the "Exp. Date" boxes.
 Runs
Select a number from the "Runs" pull down list. The analyzer will run the calibrators for the
number of times you selected. For example, if you select "2" runs, then the calibrators of both
levels will be run twice each.
 Reference Method
Select the suitable reference method (“NGSP” or “IFCC”) in accordance with your laboratory
procedure from the pull-down list.
 Parameter Target
Enter the targets of the CAL-1 and CAL-2 calibrators into the corresponding "Target" boxes.
47
NOTE
 See the instruction for use and the target sheet of the calibrators for the lot No.,
expiration dates and the targets.
labeling or the open-container expiration date, whichever is earlier. The
open-container expiration date is calculated as follows: the date that container is
opened + the open-container stability days.
 If you start the calibration analysis before you complete the calibrator information,
a dialog box will pop up prompting "Invalid entry!". Tap "OK" and enter complete
calibrator information to start calibration analysis.
Run the calibration
After you complete the calibration settings, prepare the calibrators for the calibration.
 Samples, controls, calibrators and waste are potentially infectious. Wear proper
personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe
laboratory procedures when handling them and the contacted areas in the
laboratory.
NOTE
 Only Mindray-specified calibrators shall be used. Mindray will not be responsible
for any erroneous result caused by using other calibrators.
 Refer to the instructions for use of the calibrators for their use and storage.
 Use clean 1.5mL centrigual tube or the micro sample cup to run the calibration.
 Use the CAL tube rack and corresponding tube or sample cup adapters.
CAUTION
tubes and so on.
Make sure the analyzer indicator shows that the analyzer is ready for analysis. Do as follows
to calibrate the analyzer with calibrators.
48
1. Prepare a calibrator of CAL-1 level and a calibrator of CAL-2 level as instructed by

instructions for use of the calibrators.
NOTE
 The H50P analyzer supports auto dispensing of Hemolysis Solution. You
can use the function to dilute and prepare controls. For more information,
refer to 5.7 Sample Analysis Under Autoloading Mode.
2. Place the well-mixed calibrators into the specified calibrator tube rack (CAL-1 level
calibrator should be placed at the 2nd tube position, and CAL-2 level calibrator at the
4th tube position), and put the tube rack loaded with the calibrators onto the
autoloader.
3. Tap “Calibration”-“Calibrator” screen, and make sure the calibration information and
parameter targets are correct.
4. Tap the "Start" button, the analyzer will run the calibrator of each level for the number
of times you set.
5. After the analysis is done, the calibration results will display on the screen.
NOTE
 If the ambient temperature is out of the specified operating range, the analyzer will
alarm you for abnormal ambient temperature and the analysis results may be
unreliable. When temperature errors are reported in the error information area
after analysis, see Chapter 11 Troubleshooting Your Analyzer for solutions.
Save calibration results
After the analysis, the analyzer will have different responses to different analysis results:
 if any of the results is invalid, a dialog box will pop up prompting the results are invalid.
Tap OK to clear the calibration results.
 if the results are valid, the analyzer will display the new calibration factors automatically.
When you switch to another screen, a dialog box will display asking if you want to save the
calibration results. Tap “OK” to save the calibration results, or tap “Cancel” to give up.
When calibration has been performed for specified times, the analyzer will calculate and
display the CV value and calibration factor automatically.
The calculated calibration factors calculated under different reference systems shall be within
the ranges as below:
49
Factor NGSP IFCC

a [0.5000, 2.0000], default setting: 1 [5.0000, 20.0000], default setting: empty
b [-5.0000, 5.0000], default setting: 0 [-20.0000, 20.0000], default setting:
empty
When the calculated factors are out of above ranges, a dialog box will display prompting the
results are invalid. Check if there is any error. If you cannot solve the problem, contact
Mindray Customer Service Department.
Verify calibration factors
After calibration, run the remaining calibrators of both levels again using the “AL-PT” mode,
and check the analysis results against the target sheet of the calibrator to make sure they fall
in the acceptable ranges. For more information of the analysis under “AL-PT” mode, refer
to5.7.1 Running the Samples.
If the results falls out of the acceptable ranges, re-calibrate the analyzer. If the problem
cannot be solved, contact Mindray Customer Service Department.
Other Functions
 Print
Tap "Print" to print the contents on the screen.
50
Appendices
A Index
accessories, 2-8 linearity range, B-2
analyzer components, 2-3 repeatability, B-2
barcode specifications, B-5 stability, B-2
calibrate, 9-1 peripherals, 2-7
calibration power requirements, B-4
auto calibration, 9-4 Reagent, B-1
manual calibration, 9-3 reagents, 2-19
classification, B-1 replacing
collection tube types, B-1 replacing waste container, 10-11
communication protocol, C-1 safety information, 1-4
connecting the system, 4-4 sample analysis under autoloading
contraindication, B-8 mode, 5-11
Dimensions and Weight, B-5 sample analysis under closed tube mode,
EMC description, B-4 5-7
environment requirements, B-4 sample collection and storage
error information and handling, 11-2 requirements, 3-3
Extended Program, 1, 2 sample preparation, 5-5
fluidics maintenance, 10-3 sample review, 6-1
HbE sampling features, B-2
HbE variant, 2 analysis rate, B-2
Hemoglobin E, 2 minimum sample volume, B-2
how to find information, 1-3 sample volumes required for each
input/output devices, B-3 analysis, B-2
inspection before startup, 5-2 setting up the analyzer, 7-1
installation requirements, 4-2 shut down the analyzer, 5-19
environment requirements, 4-2 software interfaces and operations, 2-14
power requirements, 4-2 sound pressure, B-4
space requirements, 4-2 standby, 5-18
interfaces, B-3 startup, 5-3
limitations, B-8 status
major components and modules, 2-3 temperature & pressure, 10-27
moving and installing the analyzer, 4-3 version information, 10-28
operating your analyzer, 5-1 storage environment requirements, B-5
parameter Symbols:, 1-8
loading modes, 2-2 system functions, 2-12
sample mode, 2-2 system principles, 3-1
parameters, 2-2, B-1 system status, 10-27
performance specifications, B-2 touch screen calibration, 9-8
accuracy, B-2 using the QC program, 8-1
carryover, B-2 when to calibrate, 9-2
A-1
B Specification
B.1 Classification
According to the CE classification, the H50P automated glycohemoglobin analyzer belongs to
In vitro diagnostic medical devices other than those covered by Annex II and devices for
performance evaluation.
Electric Safety Classification
Level of transient overvoltage: Category II.
Rated pollution degree: 2
B.2 Reagents
Name Model
Hemolysis Solution /
Eluent A /
Eluent B /
Hemoglobin A1c Calibrator /
Hemoglobin A1c Control /
B.3 Units
Fetal Hemoglobin (HbF), represented in %;
Hemoglobin A1c (A1c), represented in % and mmol/mol;
Total Hemoglobin (HbA1), represented in %;
Estimated Average Blood Glucose (eAG), represented in mg/dL and mmol/L.
B.4 Collection Tube Types

 Tube for whole blood samples: φ12×75（mm）~ 13×75（mm）(without the cap)
evacuated blood collection tube
 Tube/Sample cup used for diluted samples: Micro sample cup: 16mm (outer
diameter) ×38mm (Hitachi); 1.5ml centrigual tube
B-1
Specification
B.5 Sampling Features

B.5.1 Sample volumes required for each analysis
Whole blood mode ≤16uL
Prediluted Mode ≤4uL
B.5.2 Minimum Sample Volume

B.5.3 Analysis Rate

The analysis rate is not lower than 1.2min/test.
B.6 Performance Specifications

B.6.1 Accuracy
Running reference sample on the analyzer, and the relative deviation between the measured
HbA1c result and the reference result shall not exceed ±6%.
B.6.2 Repeatability
Running an HbA1c sample with the concentration of 4.0% ～ 6.5% (20.2mmol/mol ～
47.5mmol/mol) for several times, the coefficient variation (CV) between different measured
results should not be higher than 1.0%.
B.6.3 Linearity Range

With the HbA1c within the 3% ～ 20% measuring range, the linearity coefficient "r" of
measured results should be no less than 0.9900.
B.6.4 Carryover
The HbA1c carryover of the analyzer should not be higher than 1.5%.
B.6.5 Stability
During the 8 hours after analyzer normal startup, the relative variation between the measured
HbA1c results of the same normal sample should be no higher than ±3%.
B-2
Specification
B.7 Input/Output Devices
NOTE
 Be sure to use the specified devices only.
B.7.1 Touch Screen

TFT color touch screen, supporting 16 bit color at highest, with display resolution of 800×600.
B.7.2 Indicator
The indicator indicates analyzer the status of the analyzer, including on/off, running or stanby.
B.7.3 Keyboard (Optional)

101-Key alpha-numeric USB keyboard
B.7.4 Mouse
USB mouse.
B.7.5 Barcode Reader
B.7.6 Recorder (Optional)
B.7.7 Buzzer
The buzzer sounds when there is an error. Tap the touch screen or when the error is removed,
the buzz alarm will be silent automatically,
B.8 Interfaces
 1 10M/100M network interface
 4 USB 2.0 interfaces
B-3
Specification
B.9 Power supply

Voltage Frequency Power
(100V-240V～) ±10% (50Hz/60Hz) ±3Hz 300VA
B.10 EMC Description

 Do not use this device in close proximity to sources of strong electromagnetic radiation
(e.g. unshielded intentional RF sources), as these may interfere with the proper
operation.
 This equipment complies with the emission and immunity requirements of the EN
61326-1:2013 and EN 61326-2-6:2013.
 This equipment has been designed and tested to CISPR 11 Class A. In a domestic
environment it may cause radio interference, in which case, you may need to take
measures to mitigate the interference.
 It is advisable to evaluate the electromagnetic environment prior to operation of this

analyzer.
NOTE
 It is the manufacturer's responsibility to provide equipment electromagnetic
compatibility information to the customer or user.
 It is the user's responsibility to ensure that a compatible electromagnetic

environment for the equipment can be maintained in order that the device will
perform as intended.
B.11 Sound Pressure

Maximal sound pressure: 85dBA
B.12 Environment Requirements

 Ambient temperature: 10℃～32℃
 Operating humidity: 20%～85%
 Atmospheric pressure: 70kPa～106kPa
B-4
Specification
B.13 Storage Environment

 Ambient temperature: -10℃～40℃
 Relative humidity: 10%～90%
 Atmospheric pressure: 50kPa～106kPa
NOTE
 Only store and use this system in specified environmental conditions.
B.14 Dimensions and Weight
Height
Depth
Width
Width (mm) ≤560
Height(mm) ≤530
Depth(mm) ≤572
Weight(Kg) ≤65
B.15 Barcode Specifications

The analyzer can read barcodes that are stuck to the test tubes. The sample ID read from the
barcode will be stored and used as the only identification of the sample.
The barcodes used shall meet the specifications stated in this section.
 Supported barcode types
All code types and check digit supported by the analyzer are listed as follows.
B-5
Specification
Supported Barcodes
Code Type Digits
CODE128 No more than 20 digits (sample ID)

UPC/EAN Fixed length: 8 or 13 digits
ITF No more than 20 digits (sample ID)
CODABAR No more than 20 digits (sample ID)
 Barcode label dimensions
Barcode height: A≥10mm

Label width: B≤45mm
Clear area width: C≥5mm
Wide-to-narrow ratio: between 2.5:1 and 3.0:1

Width of the narrowest bar: above 0.127mm
Code quality: According to ANSI MH10.8M standard, the code quality shall be Level C or
above.
3. Samples of valid and invalid barcode labels:

Use of invalid barcode labels shown in the following figures will increase the possibility of
misreading. To ensure good readability, use valid labels.
B-6
Specification
B-7
Specification
B.16 Contraindication
None
B.17 Limitations
NOTE
 Following information is based on the tests running with Standard Program.
The criteria used to determine whether or not a method shows interference that is clinically
significant (indicated by “Yes”) is >±7% at 6 and/or 9% HbA1c.
It is verified against the criteria that the following elements within the stated ranges won’t
present significant interference to the HbA1c results of the H50P analyzer:
 Lipemia≤33g/L;
 Unconjugated/conjugated bilirubin≤20 mg/dL;
 Glucose≤1000mg/dL;
 Aldehyde sulfoxylate≤25 mg/dL;
 Aspirin≤65 mg/dL;
 Sodium cyanate≤5 mg/dL
In accordance with the above mentioned criteria, various hemoglobin variants may interfere
the HbA1c results of the H50P analyzer.
Hemoglobin variants Interfere or not

Note1
HbS, HbC, HbD, HbE Yes
HbF No up to the level of 15%
Other variants Possible

Note2
In according to The Guideline for Glycosylated Hemoglobin Laboratory Assay of China ,
under certain circumstances the HbA1c results will not reflect the actual blood glucose level,
no matter what measurement methods are used.
The following circumstances will result in lower HbA1c results:

 Haemolytic anaemia
 Massive loss of blood
 Splenomegaly
 Rheumatoid arthritis
 Chronic liver diseases
 Receiving huge doses of Vitamin C and E for a long term
 Preganancy
B-8
Specification
The following circumstances will result in higher HbA1c results:

 Splenectomy
 Aplastic anemia
 Vitamin B12 deficiency
 Kidney injury
 Kidney disease
 Receiving huge doses of acetyl salicylate for a long term
 Alcoholic
 Receiving huge doses of chronic anesthetic for a long term
 Receiving huge doses of hydroxyurea for a long term
Note1: The “Extended Program” of H50P may exclude the interference of hemoglobin variant
HbE to the HbA1c results.
Note2: The Guideline for Glycosylated Hemoglobin Laboratory Assay of China: China J
Diabetes, August 2013, Vol. 21, No. 8.
B-9
C Communication Protocol
The LIS/HIS communication function of H50P enabled the communication between the
analyzer and the PC in laboratory through Ethernet. For details about the connection control,
and the introduction, message definition and examples, please contact Mindray Customer
Service Department or your local distributor.
C-1
P/N: 046-007132-00 (7.0)

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H50P Automated Glycohemoglobin Analyzer

Intellectual Property Statement

Mindray intends to maintain the contents of this manual as confidential information.

Release, amendment, reproduction, distribution, rental, adaptation, translation or any other

, , are the trademarks, registered or otherwise, of Mindray in

Responsibility on the Manufacturer Party

 the product is used in accordance with the instructions for use.

THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES,

This warranty shall not extend to:

 Malfunction or damage caused by improper use or man-made failure.

 Malfunction or damage caused by unstable or out-of-range power input.

 Malfunction or damage caused by force majeure such as fire and earthquake.

 Malfunction or damage caused by improper operation or repair by unqualified or

 Others not caused by instrument or part itself.

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Fax: +86 755 26582680

EC-Representative: Shanghai International Holding Corp. GmbH(Europe)

Address: Eiffestraβe 80, Hamburg 20537, Germany

2 Understanding Your Analyzer ............................................................................ 2-1

3 System Principles ................................................................................................ 3-1

4 Installing Your Analyzer ...................................................................................... 4-1

5 Operating Your Analyzer ..................................................................................... 5-1

6 Sample Review .................................................................................................... 6-1

6.2.1 Table Review ................................................................................................. 6-2

7 Customizing Your Analyzer Software ................................................................ 7-1

8 Using the QC Program ........................................................................................ 8-1

9 Calibrate Your Analyzer ...................................................................................... 9-1

10 Servicing Your Analyzer .................................................................................... 10-1

10.4 Cleaning............................................................................................................... 10-8

11 Troubleshooting ................................................................................................ 11-1

Annex I Operating with Extended Program ....................................................................... 1

1.2 Who Should Read This Manual

learn about the H50P hardware and software;

perform daily operating task;

perform system maintenance and troubleshooting.

1.3 How to Find Information

If you want to „ See...

1.4 Safety Information

read the statement below the symbol. The statement is

1.4.1 Protection from Biohazards

 If leakage happens to the analyzer, the leaked liquid is potentially biohazardous.

1.4.2 Protection from Other Hazards

1.4.3 Using the System

 Please take action to any alarm and error messages immediately.

1.4.4 Maintaining the System

 Contact the manufacturer or authorized distributors in time if any damaged part is

 Be careful when opening/closing and removing/installing the doors, covers and

 Please use the system strictly as instructed by this manual.

1.4.5 Using Reagents

 Do not use the reagents if it shows a sign of freezing.

1.4.6 Disposing of Waste

 Be sure to dispose of reagents, waste, samples, consumables, etc. according to

read the statement below the symbol. The statement is

You may find the following symbols of the H50P analyzer:

CAUTION, CONSULT ACCOMPANYING

FOR IN VITRO DIAGNOSTIC USE

THE DEVICE IS FULLY CONFORMANCE

2.3 Analyzer Components

2.3.2 Major Components and Modules

Figure 2-1 Front of the analyzer

1 ---- Status indicator 2 ---- Touch screen

Indicator status Analyzer status

Figure 2-2 Back of the analyzer