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REFERENCE MANUAL

Revision Table

Revision Table

Manual Date Software List of modifications


version version

V 1.A0 September 95 Preliminary version

V 1.A0 November 95 Update version except for Chapter n°7

V 1.0 January 96 103.xxx Original version

V 1.0 June 96 103.xxx Front page


Revision table:
Chapter n°1- Pages : 1 and 2
Chapter n°9 - Page : 35

V 1.0 November 96 xxx.xxx Revision table:


Chapter n°9 : Addendum (1 page)

V 1.0 November 96 104.xxx Revision table:


chapter n°1 - Page: 19
chapter n°2 - Pages: all and Table of contents
chapter n°3 - Pages: all and Table of contents
chapter n°4 - Page: 1
chapter n°6 - Pages: all and Table of contents
chapter n°9 - Pages: 66 and 67

V 1.0 January 97 104.xxx Revision table:


chapter n°9 - Addendum #2 (3 pages)

V1.0 March 97 104.xxx Revision table:


chapter n°9 - Pages: 35 and 36
Note: introduction of pages dated November 96
according to software release 104.

V1.0 November 97 104.xxx Revision table:


chapter n°9 - Page : 24
Notes : Modification of the procedure to change
the needles.

V1.0 February 98 104.xxx Revision table:


Front page:
Modification of the reference 0931033D
=>0931033E
chapter n°2 - Page 8, 9, and 13
chapter n°9 - Page 14

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Revision Table

Manual Date Software List of modifications


version version

V1.0 March 98 104.xxx Revision table:


Front page: Modification of the reference
0931033E => 0931033F
chapter n°1 - Pages: 15 and 16
chapter n°9 - Page: 6
Note: Modification of the procedure to clean the
sample and product drawers.

V 1.0 November 98 104.xxx Revision table:


Front page: Modification of the reference
0931033F => 0931033G
Signification of the symbols used on the STA
Compact: adding three symbols.
Chapter n°2 - Page: 15
Chapter n°9 - Pages: 8, 19 and 22

V 1.0 December 99 104.xxx Revision table:


Front page: Modification of the reference
0931033G =>0931033H
Chapter n°1 - Pages: 18 to 20, 22
Chapter n°9 - Pages: 1 and 18
Note:
- Adding of the patent numbers.

V 1.0 February 01 106.xxx Revision table:


Front page: Modification of the reference
0931033H =>0931033J
Chapter n°1 - Pages: 17, 18, 20 to 27
Chapter n°3 - Pages 3 to 8
Chapter n°9 - Pages 8, 38, 68 to 69
Note:
- Warnings concerning the test configuration
- Adding the material safety data sheet of the
cooling liquid
- Definition of the washings
- TDEX utility

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Revision Table

Manual Date Software List of modifications


version version

0931033K November 06 106.xxx Operator’ guide => Reference Manual


The order of the chapters is modified
Front page: Modification of the reference
0931033J =>0931033K
Note:
- Addenda are incorporated
- Interpretation of V>Vmax and V<Vmin is
modified
- Printer cable requirements
- Indoor use
- Modification of the technical specifications
relating to standards, to classification and to the
bar code reader
- Bar code reading when loading cuvette rolls
- Modification of the System Status screen
- Modification of the Product Status screen
- Modification of the "Liquid filters location" figure
- Warning concerning the expiration date
management for STA<-OWREN KOLLER, STA<
Desorb U and STA<-CaCl2
- Information concerning the cooling liquid color
- WEEE label

0931033L July 2009 107.03 Suppression of the Operator’s Manual


 207.03 (Cat.N° 27826) and of the addenda for STA
Compact< CT
Joint Reference Manual (Cat. N° 28217) for STA
Compact® and STA Compact< CT
Change of version 0931031K @ 0931031L

Additions:
Chapters 1.6, 1.8, 2.7.2 addenda 0931755
Chapter 4.5.2 description of the use of the stylets
Chapter 4.5.3 description of the two types of
knurled nuts fastening the needles
Chapter 1.1 symbols "biohazardous liquid",
"temperature", "precautions", "Caution, hot
surface"
Chapter 1.4 information on the ISI value
Chapter 1.5 On / Off procedure of the analyzer:
wait 30 sec. before turning the analyzer back on

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version version

Chapter 4.2.6 description of the preparation of


diluted ethanol
Chapter 4.2.6.2 cross section of a measurement
channel
Chapter 4.5.1 description of a drawer
decontamination
Chapter 4.5.4 precaution: do not press too hard
on the suction tip
Chapter 9.1 warning: risk of wrong results in case
of out of range quality control results
Chapter 10.1.2.4 information on the consequence
of selecting "not managed" for the level detection

Deletions:
Chapters 2.5.1, 2.7.4 description of the CRT
screen
Chapter 4 use of the metal mandrels
Chapter 12 list of tubes
Modifications:
Chapter 1.1 description of the symbol "warning"
Chapter 2.7.3 minimum diameter for 5 ml tubes:
11 mm (not 11.6 mm)
Chapter 4.1 maintenance schedule for a
laboratory performing up to 200 tests a day and
not more than 200 tests a day
Chapter 4.2.2 description of the preparation of
the decontamination solution
Chapters 7.4.9.2, 7.5.5 precautions concerning
the ISI
Minor modifications of the wording
Modification of some illustrations

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Table of contents

Chapter 1 : Symbols and warnings . . . . . . . . . . . . . . . . . . .1-1

Chapter 2 : Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . .2-1

Chapter 3 : Preparing the STA Compact® . . . . . . . . . . . . .3-1

Chapter 4 : Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . .4-1

Chapter 5 : Test Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-1

Chapter 6 : Loading Products and Samples. . . . . . . . . . . . .6-1

Chapter 7 : Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-1

Chapter 8 : Patient File Management . . . . . . . . . . . . . . . . .8-1

Chapter 9 : Quality Control . . . . . . . . . . . . . . . . . . . . . . . .9-1

Chapter 10 : STATUS and GLOBAL OPTIONS Screens . . . . .10-1

Chapter 11 : Troubleshooting. . . . . . . . . . . . . . . . . . . . . .11-1

Safety appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1

Index

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Table of contents

1 Symbols and warnings . . . . . . . . . . . . . . . . . . . . . . . 1

1.1 Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

1.2 General warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

1.3 Warnings regarding the handling of biological products . . . . 3

1.4 Warnings regarding test settings . . . . . . . . . . . . . . . . . . . . . 3

1.5 Warnings concerning the use of the access codes . . . . . . . . 5

1.6 Warnings concerning the STA Compact®system . . . . . . . . 5

1.7 Warning concerning the use of hazardous material . . . . . . . 6

1.8 Warning concerning the analyzer disposal . . . . . . . . . . . . . . 6

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1 Symbols and warnings


1.1 Symbols
ˆ On the analyzer

Alternating current Direct Current

Protective ground Refer to accompanying


documents

Off On

Part that may be contaminated Dangerous voltage


biologically

Name and adress of the Medical device used for in vitro


manufacturer diagnosis

Separate collection: do not discard Caution, hot surface


with other waste.
Product put on the market later
than 13 August 2005a
a.See chapter 1.8 for additional information about the disposal procedure.

ˆ Disposables

Single-use item Keep away from magnetic


fields

Protective goggles and mask Disposable gloves mandatory


mandatory

Liquid that may be contaminated Temperature limits for


biologically preservation

ˆ In the documents

Danger for the user or for the Additional information


patient (risk of injuries or of
incorrect results)

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Precautions to be observed in order


to use the analyzer in accordance Screen display
with its specifications and to avoid
damaging the analyzer.

" Shows an action to perform  Shows the result of an action

Initial situation
2

1.2 General warnings


The use of the STA Compact® requires training given either by Diagnostica Stago or by one of its
official distributors.
In order to ensure the correct operation of the STA Compact®, it is imperative to acknowledge and
to comply with any and all of the analyzer warnings, instructions and procedures contained in this
manual.
The compliance with any and all local legislations, regulations and norms related to biological acts
and/or to medical biology laboratories applicable in the territory where the STA Compact® system
is installed is required and in particular, for France, the GBEA (Guide to Correct Performance of
Medical Biology Analyses) published in its most recent version, the decree of April 26th 2002 (JO
[Journal Officiel] May 4ths 2002 n°104), and for the United States, the CLIA-88 in the most recent
version (Clinical Laboratory Improvement Act of 1988).
All information, warnings, instructions and procedures contained in this manual and/or in all later
versions updated by Diagnostica Stago as well as all legislation, regulations and norms relating to the
use of medical in vitro diagnostic equipment in force and applicable for users locally (by “locally”, we
understand the territory in which the STA Compact® system is installed) are hereinafter collectively
referred to as the “Recommendations”.
Under no circumstances Diagnostica Stago, its employees, its suppliers or the third parties
mentionned in this manual shall be hold responsible for an action of contractual liability, tort liability
or any other action, for the security and the efficiency of the STA Compact® system or for any
damage direct or indirect, material or immaterial, incidental or accessory, or of any kind, or of any
prejudice, in all the cases non restrictively listed below:

(I) in case of non respect of the Recommendations described in this manual as well as the
use of procedures that are not set forth by Diagnostica Stago,

(II) in case of use of reagents other than those manufactured by Diagnostica Stago even if
the use of said reagents associated with the STA Compact® system is specified in an
adaptation protocol,

(III) in case of use of tubes other than those specifically described in chapter 2.7.3 of this
manual,

(IV) in case of use of washed and/or used cuvettes, the reacting cuvettes being consumables
intended for a single use, as well as cuvettes other than those manufactured by
Diagnostica Stago and commercialized by Diagnostica Stago and/or by its official
distributors,

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(V) in case of non accomplishment of the current and regular maintenance operations,
calibration and support operations set forth in the present manual and permanently
required to ensure the correct functionning and security of the STA Compact® system,

(VI) in case the STA Compact® system has not been decontaminated in accordance with the
decontamination procedures described in this manual.

1.3 Warnings regarding the handling of biological products


For how to handle reagents, calibrator plasmas, control plasmas, and patients’ plasmas (hereinafter
referred to as “Products”), carefully read the notes that come with each Product.
Prior to any intervention on the STA Compact® system and to ensure the safety of the staff working
with biohazardous products, and to allow a proper execution of the biological assays, please observe
the following instructions:

(I) Oberve all Recommendations,

(II) Make sure that the STA Compact® is decontaminated in conformity with the
decontamination procedures described in this manual,

(III) Observe all standards and precautions that are imposed to laboratories for the
execution of biological assays involving biohazardous products in accordance
with the regulations in effect locally.

For instance, the following precautions must be observed:


ˆ Do not eat, drink or smoke on the premises where these products are handled
ˆ Immediately consult a physician if these products are ingested or put into contact with mucous
membranes or skin lesions (wounds, cuts, etc.),
ˆ Use disposable gloves and handle all products as potentially infectious materials.
ˆ Eliminate all these products as if they were infected, in accordance with the law and the
regulations locally in effect (for instance: autoclaving, incineration of disposable equipment,
elimination of liquid wastes, see the liquid waste management notice ref. 0931066x or local
regulation in force)

1.4 Warnings regarding test settings


The non-observance of the conditions regarding test settings may have consequences on
the result accuracy and on the execution of any biological assays on the STA Compact®
system, the following conditions must be observed:

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ˆ Pre-analytic conditions regarding the samples: in order to maintain the activity of various
coagulation factors, the sample should be taken with care and following the professional
standards in tubes with a specified concentration of citrate.
The quality of the centrifugation and the storage temperature of the sample should also be
carefully insured before the analysis:
- plasma that is hemolysed, partially coagulated (presence of micro-clots), damaged by
temperature changes or with bubbles on its surface may cause inaccurate results.
- plasma that has been frozen may contain interfering precipitates when thawed. These
precipitates should be removed before measurement is performed.

ˆ Pre-analytic conditions regarding the products and the reagents: the laboratory must strictly
comply with the instructions given by the manufacturer in the product and reagent inserts. Poor
preparation of the reagent regarding reconstitution volume, stabilization time, stirring as well as
the presence of bubbles or the accidental presence of a magnetic rod may lead to incorrect
results.
The ISI value of the thromboplastin used for the determination of the prothrombin time should
be the one indicated on the assay value insert of the STA product.
Any change in lot, any software update - like any intervention - should give rise to verification of
the ISI value.
ˆ Analyzer setup and condition: the laboratory must make sure that the test setting complies with
the instructions given by the reagent manufacturer in the inserts, especially regarding volumes to
be used, incubation times, rinsing solutions, buffers, etc. It is the laboratory's responsibility to
correctly enter the bar codes and to choose the appropriate test setting for a given test.
Moreover, the analyzer brings results from biological materials and although these materials are
implemented and measured by highly sophisticated computer-controlled automated systems in
order to optimize reliability and safety, it is impossible to guarantee an error rate of zero. The
laboratory must ensure that the maintenance is performed on a regular basis and in conformity
with the Recommendations described in this manual.

ˆ Conditions regarding the confirmation of the methods and of the procedures


- Test settings provided by Diagnostica Stago have been individually validated for the STA
Compact® analyzer and possible interference among products has been estimated.
If the laboratory decides to use other lines of reagents and methodologies that have not been
confirmed by Diagnostica Stago as compatible with the STA Compact® analyzer, a validation of
the new system is required. This confirmation will allow, on the one hand, to check the method
characteristics (see point 1 in the bibliography) and, on the other hand, to control the
interference of new products on existing ones and vice versa.
- When duplicate tests are carried out on the same sample, the error rate is mathematically of
about one in one hundred million, which is not null but can be considered to be negligible (see
point 2 in the bibliography).
For instance: Studies conducted on prothrombine using Neoplastin Plus reagent have shown
that the inconsistency rate (difference between two results >15%) on duplicate tests is less than
one in ten thousand. This rate can be compared with the error rate which could be observed for
tests in single determination. Note that when the incidence of error is below one in ten thousand,
it becomes difficult to qualify an error rate experimentally and accurately.
- Results given by the analyzer must always be analyzed according to the patient’s history, to the
clinical examination and to any other biological results.
BIBLIOGRAHPY
1 VASSAULT A. et al. :
“Protocole de validation de techniques”. (Protocol for validation of techniques)
Ann. Biol. Clin., 44, 686 - 745, 1985.

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2 KOEPKE J. A., McLAREN C. E., WIJETUNGA A. AND HOUWEN B. :


“A Method To Examine the Need for Duplicate Testing of Common Coagulation Tests”.
Am. J. Clin. Pathol., 102, 2, 242-246, 1994.

1.5 Warnings concerning the use of the access codes


The different functions of the STA Compact® analyzer can be sorted into 2 categories:
ˆ routine functions (example: launching calibration),
ˆ change functions (example: creation or modification of test configurations. See above,
chapter 1.4.).

All these functions are protected by access codes (see chapter 10.2.2.3). The use of routine functions
has no impact on the results obtained. However, the use of change functions may affect result
accuracy.
Therefore, it is required that each laboratory assesses the consequences of the use of the different
functions prior to the attribution of the access codes.

1.6 Warnings concerning the STA Compact®system


The STA Compact® may only be installed by personnel duly authorized by Diagnostica Stago or by
its authorized representatives.
Once the STA Compact® has been switched off, wait for 30 seconds, at least, before switching it
back on.
The STA Compact® was made and tested according to the CISPR 11 (International Special
Commitee On Radio Interference) for class A equipment. In a domestic environment, the STA
Compact® may cause radio interferences. In this case, measures will have to be taken to reduce
these interferences.
The analyzer conforms to the EN 61326-2-6:2006 standard.
The electromagnetic environment should be evaluated before turning on the analyzer.
Keep away from the analyzer all sources of high electromagnetic radiation (cellular phones,
unprotected sources of radiofrequency...) as they may interfere with the operating conditions of the
analyzer.
In order to avoid any risk of electrical shock, it is absolutely necessary to follow the
procedures described in this manual.
In order to avoid any electrical shocks when the STA Compact® is turned on, never
interfere with the power supply using your hands or any tool (or object).
Use caution when working with these components:
- LEDs (located behind the left front door),
- Fuses (located on the left side of the STA Compact®)

Make sure that the STA Compact® is positioned in such a way that it can be easily unplugged.
It is absolutely necessary to check that all covers, doors and drawers of the STA Compact® (listed
below) are closed before power is turned on. During operation, it is absolutely necessary to close
them as soon as any handling requiring them to be opened is finished.
- right side door

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- right front door


- left front door
- transparent panel
- products drawer
- sample drawer
For safety reasons; the transparent panel of the STA Compact® must be kept closed. If the
transparent panel of the STA Compact® is open, the STA Compact® detects it and
immediately stops ongoing tests.
Do not obstruct the switch detecting the transparent panel presence.
For most of the available screens on the STA Compact®, printing of the information is ordered either
by pressing a function key (F6) or by selecting the “Print” function.
However, in some cases, especially when there is a malfunction, it may be necessary to obtain a hard
copy of the screen. If testing is in progress on the STA Compact®, this type of command can disrupt
the smooth course of the test flow and may even lead to stoppage of the analyzer. For safety reasons,
screen hard copy can only be accessed by pressing the two keys: Alt and PrtSc simultaneously. This
command should only be used in case of absolute necessity, for instance, when such a
recommendation appears on the STA Compact® monitor and/or when such a request is made by
your local authorized Service Representative.
If the analyzer must be switched OFF for more than one week, follow the procedure described in
chapter 3.7.
Before switching the analyzer ON, follow the same decontamination procedure then place the used
liquid container and the cuvette waste back in their proper place. Check the Peltier reservoir level
too (see section 4.2.7).

1.7 Warning concerning the use of hazardous material


Security file for cooling liquid : Annex A.

1.8 Warning concerning the analyzer disposal


Waste Electrical and Electronic Equipment (WEEE).

The use of this symbol implies that the analyzer must not be disposed of with
household waste; that it must be subject to separate collection and that it has been
put on the market after 13 August 2005.

For more information about the appropriate disposal of the analyzer (waste sorting, collection,
processing of analyzer waste) contact the local authorities, the manufacturer or the distributor who
sold this analyzer.

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REFERENCE MANUAL 2
Table of contents

2 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

2.1 Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

2.2 Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
2.2.1 Installation Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
2.2.2 Installation Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

2.3 Principle of Clotting Methods . . . . . . . . . . . . . . . . . . . . . . . 2

2.4 Principle of photometric methods (not available on STA Com-


pact®CT) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

2.5 STA Compact® Description . . . . . . . . . . . . . . . . . . . . . . . . 7


2.5.1 STA Compact®, overall view . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
2.5.2 STA Compact®, front view . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
2.5.3 STA Compact®, rear view . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
2.5.4 STA Compact®, view from left side . . . . . . . . . . . . . . . . . . . . . . . . . . 11
2.5.5 STA Compact®, view from right side . . . . . . . . . . . . . . . . . . . . . . . . . 12

2.6 General principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13


2.6.1 Sample Drawer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
2.6.2 Product Drawer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
2.6.3 Measurement Plate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

2.7 STA Compact® Technical Specifications . . . . . . . . . . . . . . 18


2.7.1 STA Compact® technical specifications - Part 1 . . . . . . . . . . . . . . . . . 18
2.7.2 STA Compact® technical specifications - Part 2 . . . . . . . . . . . . . . . . . 19
2.7.3 STA Compact® technical specifications - Part 3 . . . . . . . . . . . . . . . . . 20
2.7.4 STA Compact® technical specifications - Part 4 . . . . . . . . . . . . . . . . . 21

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Introduction

2 Introduction

2.1 Definition
The STA Compact® system is a medical device for in vitro diagnosis, composed of a laboratory
analyzer and a software designed to be used with consumables and reagent products.
The STA Compact® system is designed to perform in vitro tests for diagnosis and monitoring of
pathologies linked to hemostasis.

2.2 Installation

2.2.1 Installation Requirements


Space Requirements:

Height 996 mm 39.2 in.

Width 2530 mm 99.6 in.

Depth 1100 mm 43.3 in.

Analyzer for indoor use.


Observe the ventilation space given by the two spacers fixed at the back of the analyzer.

Power Supply:

Voltage - Tolerance - Rating 100 V~ (r 10%) 1400 VA maximum


115 V~ (r 10%) 1000 VA maximum
230 V~ (r 10%) 1400 VA maximum

Frequency 50 to 60 Hz (47 to 65 Hz)

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Introduction

2.2.2 Installation Procedure


STA Compact® has to be installed only by an authorized representative of Diagnostica Stago or of its
official distributor. Moreover, if STA Compact® has to be moved, this must be imperatively
performed by an authorized representative of Diagnostica Stago or of its official distributor who has
the required tools to handle the analyzer.

2.3 Principle of Clotting Methods


The principle consists in measuring the variations of the ball oscillation amplitude through inductive
sensors.
The ball has a pendular movement obtained:
- thanks to the two curvated rail tracks of the cuvettes (patented design)
- and an alternate electro-magnetic field created by two independent coils

The oscillation amplitude is constant when the environment has a constant viscosity.
The oscillation amplitude decreases when the environment viscosity increases.

Fig. 1 - Principle of Measurement System

Legend:
1 Emitting measurement coil 2 Transmitting measurement coil
3 Motorization coils 4 Ball
5 Cuvette

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Introduction

The intensity of the magnetic field varies depending on the tests to be carried out (PT, APTT...) and
on the expected clot.
The detection system of the oscillation amplitude variations is based on two measurement coils.
The transmitting coil emits an electro-magnetic field. The signal received by the receiver coil depends
on the ball position in the cuvette.
An algorithm uses these magnetic field variations to calculate the oscillation amplitude variations and
to accurately determine the clotting times.
.

1 Ball oscillation amplitude

2 Clotting

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Introduction

2.4 Principle of photometric methods (not available on STA


Compact®CT)
The detection of chromogenic assays on the STA Compact® is based on the absorbance (optical
density: O.D.) of monochromatic (405 nm or 540 nm) light passing through the cuvette as a
chromogenic reaction takes place.
The principle of absorbance measurement is depicted by the diagram below. Incident light (I0)
entering the cuvette is partially absorbed by the reaction mixture as it passes through. The
transmitted light (I1 = I + Ip) is measured, and converted to absorbance by the following equation:

A = - log (I1/I0) Note: decimal logarithm

Fig. 2 - Principle of Absorbance Measurement

The effect of stray light (Ip) is eliminated by taking two fairly close measurements of the light
transmitted:
I1 = I + Ip (first measurement which includes incident light and stray light),
I2 = Ip (second measurement while blocking the incident light, corresponds to the stray light).
When I2 is substracted from I1, the result is I, which is only the light transmitted from the incident
light. Ip is assumed to remain constant between the two measurements.
Incident light is provided by a tungsten-halogen lamp, and is made monochromatic by passing through
a 405 nm, or 540 nm, interference filter placed in a mobile filter holder.
These items are inside the optical module. A system of optical fibers carries the monochromatic light
from the optical module to the measurement heads. Another set of optical fibers carries the
transmitted light from the measurement head to the photometry measurement board (see figure
hereafter).

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Introduction

Fig. 3 - Principle of Optical Module

1 Measuring head

2 Reference fiber

3 Sensor

4 Analog measurement board

5 Measurement CPU board

6 RS 232

7 PC

8 Harness of 9 optical fibers

9 Photometry module with set of switchable filters

From the measurements of optical density that are obtained, the Beer-Lambert law is applied:

A =H l C

A = Absorbance H = Molecular extinction coefficient

l = Optical path length C = Concentration

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Introduction

where the concentration of the chromogen sought is directly proportional to absorbance.


.

All the optical density measurements are done in relation to the reference fiber.

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Introduction

2.5 STA Compact® Description

2.5.1 STA Compact®, overall view

Fig. 4 - STA Compact®, overall view

Legend:

1 Transparent panel

2 Right front door (Access to the Syringe and to the Cuvette Roll)

3 Cuvette Disposal Drawer

4 Product Drawer

5 Sample Drawer

6 Barcode Reader

7 Left front door (Access to Floppy Disk Drive)

8 Keyboard

9 LCD SVGA color Monitor

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2.5.2 STA Compact®, front view

RISK OF BIOLOGICAL CONTAMINATION


Observe the universal precautions to manipulate tubes or waste containers which contain plasma
or biohazardous materials.

RISK OF INJURY
Do not touch the moving parts.

Fig. 5 - STA Compact®, front view

1 Floppy Disk Drive

2 Barcode Reader

3 Pipetting Head Equipped with 3 Needles

4 Cuvette Roll Drawer (To change the Cuvette Roll, see chapter 3)

5 Syringe (To change the Syringe Teflon Tip, see chapter 4)

6 Opened right front door

7 Cuvette Disposal Drawer

8 Product Drawer

9 Sample Drawer

10 Electronic Boards

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Introduction

2.5.3 STA Compact®, rear view

Fig. 6 - STA Compact®, rear view

1 External Communications (see detailed view on Fig.7, below)

2 Air Filter

3 Air Vents

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Introduction

Fig. 7 - External communications (details of zone 1, Fig 6)

Legend:

1 Not used

2 Printer Connector

3 Monitor Connector

4 Keyboard Connector

5 Host Computer Connector

Switch the devices off (STA Compact®, monitor and printer) when connecting the STA Compact®
to the monitor, the printer or the keyboard.

All the devices connected to the STA Compact®must comply with standards IEC 60950, EN
55022 class B and EN 55024.

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Introduction

2.5.4 STA Compact®, view from left side

Fig. 8 - STA Compact®, View from left side

Switch off the STA Compact®, the monitor and the printer before replacing the fuses.
Replace the fuses with fuses sharing the same reference.

Legend:

1 Air Vents 2 MS DOS license sticker

3 Identification sticker 4 WEEE label

5 Warning sticker 6 Main fuses sticker

7 Main fuses (see chapter 4.5.6) 8 ON/OFF Switch


(green LED ON = analyzer ON)

9 Power cord 10 Secondary fuses (see chapter 4.5.7)

11 Secondary fuses sticker

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Introduction

2.5.5 STA Compact®, view from right side

Fig. 9 - STA Compact®, view from right side

RISK OF BIOLOGICAL CONTAMINATION


Observe the universal precautions to manipulate tubes or waste containers which contain plasma
or biohazardous materials (for instance: wear disposable gloves).

RISK OF INJURY
Do not touch the moving parts.

1 STA<- Cleaner Solution Container

2 Used Liquid Container

3 Intermediate Reservoir

4 Vacuum Reservoir

5 Optical Module (to change the lamp, see chapter 4.5.5)

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Introduction

6 Peltier Reservoir

2.6 General principles


Fig. 10 - STA Compact®, Analytical Cycle

1 Pipetting Head Equipped with 3 Needles 9 Measurement area (4 positions)

2 Needle No.1 (Samples) 10 Cuvette Loading Station

3 Needle No.2 11 Suction Head

4 Needle No.3 12 Cuvette Roll Drawer

5 Pneumatic Jack 13 Cuvette Disposal Drawer

6 Washing Wells 14 Product Drawer

7 Measurement Station 15 Sample Drawer

8 Incubation area (16 positions)

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Introduction

The STA Compact® is an automated laboratory analyzer intended for hemostasis analysis. This
analyzer can carry out clotting assays (clotting time measurements) as well as chromogenic and
immunological assays on plasma samples.
The primary sample tubes and the dilution buffers are loaded in the sample drawer. The position of
each sample tube is automatically detected by the Positive Identification System.
The control plasma vials, the calibration plasma vials as well as the reagent vials are loaded in the
product drawer where the temperature is monitored between 15°C and 19°C by a system based on
Peltier elements. The position of each vial is also automatically detected by the Positive Identification
System.
Sample plasmas, control plasmas as well as calibrator plasmas are pipetted by needle No.1 of the
pipetting head, then they are added in a cuvette at an incubation position.
Reagents to be added before the first incubation are pipetted by needle No.2 of the pipetting head,
then they are distributed in the related cuvette in incubation position.
Reagents to be added after the first incubation (mainly the start reagents) are pipetted by needle
No.3 of the pipetting head. If a preheating to 37°C is necessary, the reagents are moved from needle
No.3 up to heating tube No.3 (this one being just above the tip). Then, with or without preheating,
those reagents are added in the related cuvette in measurement area.
A level detection system on each needle ensures accurate and precise dispensing of fluid volumes.
Carry over is minimized by rinsing the interior as well as the exterior of the needles, each in its own
well.
Test cuvettes are loaded onto the STA Compact® from a roll of 1,000 cuvettes. At the cuvette loading
station, they are placed one-by-one in a shuttle. This shuttle is then moved to the measurement
station by a system based on a pneumatic jack.
At this station, the suction head picks up the cuvette and transfers it to the incubation zone. This
same head then transfers the cuvette from the incubation zone to the measurement zone then from
the measurement zone to the cuvette disposal bag.
The incubation zone and the measurement zone are included in the same block which is monitored
at 37°C r 0.5°C by a system based on Peltier elements.
These operating principles enable the analyzer to process each test independently, and offer a
throughput that is virtually independent of the test time.

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Introduction

2.6.1 Sample Drawer


Fig. 11 - Sample Drawer Cassette

RISK OF INJURY
RISK OF BIOLOGICAL CONTAMINATION
Do not touch the drawer while opening or closing.
Observe the usual precautions for biohazardous material while manipulating tubes or cleaning the
sample drawer (for instance: wear disposable gloves).

1 Zone for Pediatric Tubes

2 Position for Dilution Buffer Bottle

3 Position for 5 ml tube

4 Status LED:

- LED on = Tube in progress


- LED off = No tube
- LED blinking = Analyses done for this tube

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2.6.2 Product Drawer


Fig. 12 - Product Drawer Cassette

RISK OF INJURY
RISK OF BIOLOGICAL CONTAMINATION
Do not touch the drawer while opening or closing.
Observe the usual precautions for biohazardous material while manipulating tubes or cleaning the
product drawer.

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Introduction

2.6.3 Measurement Plate


Fig. 13 - Measurement Plate

RISK OF BIOLOGICAL CONTAMINATION


Observe the usual precautions for biohazardous material while cleaning the measurement plate.

1 Incubation Zone, 16 positions


1-1: position #1
1-16: position #16

2 Measurement Zone, 4 measurement heads


2-1: position #1
2-4: position #4

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2.7 STA Compact® Technical Specifications

2.7.1 STA Compact® technical specifications - Part 1


Type:
• In vitro diagnosis analyzer
• Multi-test analyzer
• Operating mode: patient by patient
• Clotting time
• Photometry (not available on STA Compact®CT): colorimetry and immunology

Operating conditions:
• For indoor use
• Impact resistance: according to current standards
• Temperature: + 15°C to + 32°C(+ 59°F to + 89.5°F)
• Humidity: 20 % to 80 %
• Altitude: < 2000 m

Storage and Transport Conditions


• Temperature: - 20°C to +60°C(- 4°F to + 140°F)
• Maximum temperature deviation: 20°C per hour
• Relative Humidity: 20% to 80%

Environnement :
• Sound level: 70 dBA (maxi.)
• Heat dissipation when ambiant temperature is 20°C:
- 230V - 100V: 1400 Whr (4778 BTU)
- 115V: 1000 Whr (3413 BTU)

STA Compact® Dimensions:


• Height: 640 mm (26.5 in.)
• Width: 975 mm (38.4 in.)
• Depth: top 720 mm (28.3 in) - base 657 mm (25.9 in)

STA Compact® Weight:


• 140 kg (331 lbm)

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Introduction

Space to be reserved for the system:


• Height: 996 mm (39.2 in.)
• Width: 2530 mm (99.6 in.)
• Depth:1100 mm (43.3 in.)

Power supply:
• Voltage and tolerance: 230 V ( 10 %) - 115 V ( 10 %) - 100 V ( 10 %)
• Frequency and tolerance : 50/60 Hz (47 to 65 Hz)
• Rating: 1400 W at 230 V - 100 V
1000 W at 115 V
• Number and type of power sockets: 1 power sockets 16A
• 2 main fuses (refer to paragraph 2.5.4 in this chapter)
• 8 secondary fuses (refer to paragraph 2.5.4 in this chapter)
• Fuses protection: yes
• Inverter needed for micro-cuts: no
• Results of sudden loss of supply: tests in progress lost, possibility of change in hard disk.

2.7.2 STA Compact® technical specifications - Part 2


The STA Compact® system exclusively consists of the analyzer and the keyboard.
Standards:
• 230 V STA Compact®:
- EC marking (in accordance with European directive 98/79/EC)
- EN 61326-2-6 (Class A)
- IEC 61010-1 and IEC 61010-2-101
• 115 V STA Compact®:
- FCC: 47 CFR Part 15 (Class A)
UL 61010A-1
UL file No.E192098

Classification :
• Type of protection against electric shock: class I equipment
• Degree of protection against harmful ingress of water: ordinary equipment (enclosed equipment
without protection against ingress of water)
• Pollution level: 2
• Recommended disinfection method: see chapter 4.6
• Degree of safety of application: equipment not suitable for use in the presence of a flammable
anesthetic mixture with air or with oxygen or nitrous oxide

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• Mode of operation: continuous operation

All the devices connected to the STA Compact® must comply with standards IEC 60950, EN
55022 class B and EN 55024.

2.7.3 STA Compact® technical specifications - Part 3


Sample management:
• One drawer of 96 centrifuged primary tubes:
- diameter: 3ml tubes: 11 mm (0.43 in.)
5ml tubes: 11 to 13.4 mm (0.43 to 0.53 in.)
- length: 65 to 100 mm (2.56 to 3.94 in.)

• Label reading by barcode reader

Product management:
• 45 Positions for various vial sizes:

Products : controls, standards, reagents, diluters and decontamination solutions.

- 11 positions for vials of 10/15/20 ml (diam. 30 mm)


- 12 positions for vials of 4/6 ml (diam. 23 mm)
- 22 positions for vials of 1/2 ml (diam. 18 mm)
• Label reading by barcode reader
• Temperature control (between 15°C and 19 °C)
• Management of the stability and volume of the products

Bar code reader:


• Maximum peak power: 4.6 mW
• Pulse of 1 ms at 100 Hz
• Standard IEC 60825-1.2: Class 1M

Measurement principle:
• Analytical modes: photometry (colorimetry and immunology) (not available on STA
Compact®CT), clotting
• Clotting: change in medium’s viscosity detected by electromagnetic sensors

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Introduction

• Photometry (not available on STA Compact®CT):


- Light Source: Tungsten-halogen lamp
- Colorimetry and immunology: measurement of Optical Density at 405 nm and 540 nm

Test settings:
• 80 user defined test settings

Pipetting Unit:
• based upon 250 —l Hamilton syringe
Cuvettes:
• The cuvette is used for incubation and measurement
• Rolls of 1,000 cuvette with predispensed stainless steel ball
- Maximum usable volume: 400 Pl
- Minimum usable volume: 150 Pl, clotting assays and 250 Pl, photometry assays
- Identification by bar code reader

Patents:
• Allows swinging movement of the ball (STAGO patent)
Patent number :
- FR 8718348
- FR 8809151
- US 4918984
- JP 1939942
- EP 0325874

Test Performance:
• Intra-assay Reproducibility with Diagnostica Stago Products:

Coefficient of Variation

Normal Plasmas Pathological Plasmas

PT (sec) < 1,5 % <2%

APTT (sec) < 1,5 % <2%

Fibrinogen (sec) <4% <5%

2.7.4 STA Compact® technical specifications - Part 4


Data processing:
• Microprocessor: type 486
• Memory: 4 MB RAM (Minimum)

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Introduction

• Hard disk: 32 Mo (Minimum)


• Floppy disk: 3’’1/2
• Operating system: DOS
• Connection plugs to an external monitor, a standard external keyboard, an external printer

Connexion:
• Serial interface RS232C
• ASTM protocol

LCD screen

Technology LCD

Active surface diagonal 15" (38 cm) or 17" (43 cm)

Minimum resolution 640 x 480

Power supply 100 V to 240 V


< 1 A at 110V
50Hz to 60Hz

Power input < 110W

Electromagnetic compatibility Measurement: class B (EN 55022 class B)


Immunity: residential (or EN 55024)

Security IEC60950

Video bandwidth > 75 MHz

Horizontal frequency 20 to 85 KHz

Vertical frequency > 50 Hz

Netting <0.30 mm
Horizontal view angle > 120 °
Vertical view angle >90 °
Luminosity > 200 cd/m²
Contrast 100 : 1 to 400 : 1
<40 ms
Response time

Keyboard:
• Cherry keyboard (AZERTY or QWERTY depending on the language)
• Dimensions: 210 x 490 mm(8.3 x 19.3 in.)
Approved: CSA, UL.
Printer:
• List of compatible printers: contact Diagnostica Stago or one of its official distributors
• The printer cable must meet the printer notice requirements

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Table of contents

3 Preparing the STA Compact< . . . . . . . . . . . . . . . . . 1

3.1 Power-on Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1


3.1.1 Access the Test Panel (Continue) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
3.1.2 Modifying the System Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
3.1.3 Modifying the System Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
3.1.4 Deleting all the files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

3.2 The TEST PANEL Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

3.3 Loading the Roll of Cuvettes . . . . . . . . . . . . . . . . . . . . . . . . 8


3.3.1 Access the cuvette roll change Window . . . . . . . . . . . . . . . . . . . . . . . . 9
3.3.1.1 Access the cuvette roll change Window from the Error Window . . . . . . . . . . . . . . . . 9
3.3.1.2 Access the cuvette roll change Window from the TEST PANEL . . . . . . . . . . . . . . . 10
3.3.2 New cuvette roll identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
3.3.3 Remove the empty roll . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
3.3.4 Install the New Cuvette Roll . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

3.4 Cuvette Disposal Bag Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . 14


3.4.1 Removal of the Used Cuvette Disposal Bag . . . . . . . . . . . . . . . . . . . . . 15
3.4.2 Loading of the New Cuvette Disposal Bag . . . . . . . . . . . . . . . . . . . . . 15

3.5 Loading the Washing Solution Bottle . . . . . . . . . . . . . . . . . 16


3.5.1 Access the WASHING SOLUTION LOADING Window . . . . . . . . . . . . . . 16
3.5.1.1 Access the WASHING SOLUTION LOADING Window from the Error Window . . . . . 17
3.5.1.2 Access the WASHING SOLUTION LOADING Window from the TEST PANEL . . . . . . 18
3.5.2 Remove the Used Liquid Container . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
3.5.3 Replace the Used Liquid Container . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
3.5.4 Install the Washing Solution Bottle . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

3.6 Power-down Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . 21


3.6.1 Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
3.6.2 Power-Off Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

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3.7 Extended stop of the STA Compact< . . . . . . . . . . . . . . . . 22

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Preparing the STA Compact<

3 Preparing the STA Compact<

3.1 Power-on Procedure


The STA Compact< is designed to work around the clock.

ACTIONS RESULTS

" Switch the ON/OFF switch of the printer to  Printer is in stand-by.


the ON position

" Switch the ON/OFF switch of  The ON/OFF switch lamp on the
STA Compact< to the ON position (I). This STA Compact< lights up (green color) as
switch is located on the left side of the well as the one on the monitor.
STA Compact< (see chapter 2.5.4)
 The following messages pop up:
" Switch the monitor on
Please wait during loading databases. It could
take 1 minute ...

STA Compact System


Press Del to access
MAINTENANCE routine

 The STA Compact< does a software and a


system check.
If the STA Compact< finds an error, an error
window will be displayed according to the
problem which has been detected.
 The STA Compact< logo appears.
 Then, the STA Compact< displays the
GLOBAL VERIFICATION DONE window:

GLOBAL VERIFICATION DONE


Modify the System Date
Modify the System Time
Delete the Working File
Continue
with the cursor on Continue.

" Wait for 25 minutes so that the product  STA Compact< is ready for use.
drawer temperature is stabilized

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3.1.1 Access the Test Panel (Continue)

2GLOBAL VERIFICATION DONE window displayed. Cursor positioned on Continue.

ACTIONS RESULTS

" To proceed, press the  key (Continue)  The TEST PANEL screen is displayed (see
description chapter 3.2).
 The message: “Desorb Solutions (for
cleaning the needles) are missing”
appears.

" Load the STA< Desorb U solutions (see


chapter 6.5)

3.1.2 Modifying the System Date

2GLOBAL VERIFICATION DONE window displayed. The cursor positioned on Continue.

The date modification can also be made from the SYSTEM STATUS screen (see description
chapter 10.1.2.2).

ACTIONS RESULTS

" To correct the date, press the K key to  The following window is displayed:
reach Modify the System Date, then
confirm with the  key TYPE NEW DATE
(Format mm * dd * yyyy)
 The separator (*) and the date display
format are defined within the Global
Options menu (see chapter 10.2.3.4).

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ACTIONS RESULTS

" Type the new date according to the  The new date is displayed in the upper right
displayed format and separator, then corner of the screen.
confirm with the  key.  The GLOBAL VERIFICATION DONE window
In this example: type the month (2
is displayed:
numbers), the displayed separator, the day
(2 numbers), the displayed separator and
the year (4 numbers), then confirm with GLOBAL VERIFICATION DONE
the  key Modify the System Date
Modify the System Time
Delete the Working File
Continue
with the cursor on Modify the System
Date

3.1.3 Modifying the System Time

2GLOBAL VERIFICATION DONE window displayed. The cursor positioned on Continue.

The time modification can also be made from the SYSTEM STATUS screen (see description
chapter 10.1.2.3).

ACTIONS RESULTS

" To correct the time, press the K key to  The following window is displayed:
reach Modify the System Time, then
confirm with the  key TYPE NEW TIME
(Format hh : mm : ss )
The separator and the time display format
are defined within the Global Options
menu (see chapter 10.1.2.4).

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ACTIONS RESULTS

" Type the new time according to the  The new time is displayed in the upper right
displayed format and separator, then corner of the screen.
confirm with the  key.  The GLOBAL VERIFICATION DONE window
In this example: type the hour (2 digits), the
is displayed:
displayed separator, the minutes (2 digits),
the displayed separator and the seconds
GLOBAL VERIFICATION DONE
(2 digits), then confirm with the key
Modify the System Date
Modify the System Time
Delete the Working File
Continue
with the cursor on Modify the System
Time.

3.1.4 Deleting all the files

2GLOBAL VERIFICATION DONE window displayed. Cursor positioned on Continue.

Verify that all the “confirm” or “to confirm” files have been transmitted and/or printed before doing
this operation.
There is no selection available here: all the files of the Working File will be deleted if this option is
chosen. To partly delete the Working File, access the TEST PANEL, then see chapter 8.6.

ACTIONS RESULTS

" To erase all the files of the Working File,  The following window appears:
press the K key to reach Delete the
Working File, then confirm with the  key DELETION OF THE WORKING FILE
Please type Y to confirm

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ACTIONS RESULTS

" Press the Y key to confirm deletion of the  The GLOBAL VERIFICATION DONE window
Working File is displayed:

GLOBAL VERIFICATION DONE


Modify the System Date
All patient files of the Working File will be Modify the System Time
erased. Delete the Working File
Continue
with the cursor on Modify the System
Time.
Note: Delete the Working File is
displayed in grey; this option is no
longer available.
 The patient files of the Working File are
erased.

3.2 The TEST PANEL Screen


The TEST PANEL screen is one of the main screens of the STA Compact<.
It allows you to:
- See the evolution of the running of the tests for all Patient Files (tubes loaded)
- Process the file selected by the cursor (validation, transmission, printout...)
- Access the FILE MODIFICATION screen
- Display the Main Menu
It is the return point for all the other menus of the STA Compact<.

Fig. 1 - TEST PANEL Screen

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Preparing the STA Compact<

Légende :

1 Available keys:

IJ Use these keys to display the following tests (J) or the previous ones (I)

KL Use these keys to display the following files (down: L) or the previous ones (up:K)

 To proceed with patient file processing: to add/delete/rerun the tests, etc. (see
description chapter 8.3)

 Options; press this key to access:


- The HELP screen which describes the color codes used in the TEST PANEL screen
- The FILE MODIFICATION screen which selects block / unblock, rerun or delete one
or more tests of the Working File (see description chapter 8.7)

F11 Download of Working Lists


With this key, it is possible for the STA Compact® to request once again to the host
computer the working lists for all tubes already loaded which have not received their list
during loading step (see description chapter 8.9).

Esc To select the Main Menu display:

Status - Loading - Files - Calib./Control - Setup - Maintenance - Halt

F1 To request opening of the sample drawer so long as the Main Menu is not displayed
(Key not documented on the screen).

F2 To request opening of the product drawer so long as the Main Menu is not displayed
(Key not documented on the screen).

2 Name of the screen

3 Complementary information (Name, First name, ... see description chapter 10.2.3.3) for the file
on which the cursor is positioned.

4 Identification of patient files; a color code indicates status:

White : Routine sample

Yellow: STAT sample

Grey: File for which a tube has been loaded but the list of tests is unknown (waiting for
downloading from the host computer)

Green: A liquid level detection error has been detected

Red: An error has been detected on one or several tests (see description in zone 8 below)

The patient files are classified by chronological order of creation.

5 Position occupied by each tube within the sample drawer. The P symbol is displayed after the
indication of the tube position if the micro tube option has been chosen.

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6 Abbreviated name of each test

7 Primary units for reporting results defined in the TEST SETUP screens (see chapter 5.1.1.7)

8 Zone for results display: several codes indicate the test status:

- “xxx.x” displayed in black: Requested test pending

- “---.-” displayed in black: Test in process

- ”---.-” displayed in red: Test rerun, for example following a technical error (no ball
detected...), less than minimum time (< V min.) or greater
than maximum time (>V max.)

- Result displayed in black: Result is technically correct (validated or to validate)

- Result displayed in blue: Result obtained by a redilution

- Result displayed in dark red: An error has been detected for this result

- Result displayed in light red: Result obtained with an out of range quality control or with a
quality control not done

- "Block" displayed in dark Test blocked from the FILE MODIFICATION screen (see
red: description chapter 8.7)

- "Err." displayed in dark red: Technical error

- "> V max." displayed in dark For clotting tests; raw measure above the maximum time
red: defined in the TEST SETUP screens (see description,chapter
5.1.1.6).
For calibration modes graphic 2nd order polynomial or
graphic 3rd order polynomial, raw data greater than raw data
obtained for the highest calibration point.
For colorimetric tests (not available on STA Compact®CT),
raw measure above the calibration maximum O.D.
For immunological tests (not available on STA Compact®CT)
in kinetic 2-points with calibration mode: 2nd order
polynomial or 3rd order polynomial, after redilution with the
parameter “Dilution 1" (if over limit), (see description chapter
5.1.1.6), raw measure obtained once again out of ranges.
This message can and must be interpreted only after the
colorimetric graph and the raw measure of the first point as
defined in the test settings are examined.

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- "< V min" displayed in dark For clotting tests, raw measure below the minimum time
red: defined in the TEST SETUP screens (see description chapter
5.1.1.6).
For calibration modes: graphic 2nd order polynomialor
graphic 3rd order polynomial, raw data below the raw data
obtained for the lowest calibration point.
For colorimetric tests (not available on STA Compact®CT),
raw measure below the calibration minimum O.D.
This message can and must be interpreted only after the
colorimetric graph and the raw measure of the first point as
defined in the test settings are examined.

- "Lin" displayed in dark red: Insufficient linearity (see description, chapter 5.1.1.6) for
colorimetric or immunological tests (not available on STA
Compact®CT).

- “QNS” displayed in dark Quantity of plasma not sufficient


red:

Note: For results displayed in TEST PANEL, the printout limits have not been applied (see description
chapter 5.1.3.3).

9 The “BLOCKED SAMPLE PIPETTING” message is displayed in white on a red background at the
bottom of the screen when the sample pipetting is blocked whether:

- Voluntarily by the operator (Stop Sample Pipetting function, see description chapter 10.1.5.1)
- Or automatically by the STA Compact< after the consistency check; if the required assays cannot
be done.

3.3 Loading the Roll of Cuvettes

RISK OF BIOLOGICAL CONTAMINATION


RISK OF INCORRECT RESULTS
The reagent cuvettes are disposable consumables. Diagnostica Stago cannot be liable for any
damages whatever, direct, indirect, material or immaterial if washed and/or reused cuvettes and/or
cuvettes other than those manufactured and distributed by Diagnostica Stago or distributed by its
official distributors are used.

In order to avoid any risk of contamination and of incorrect results:


- Only use cuvettes that are manufactured by Diagnostica Stago and distributed by Diagnostica
Stago or by its official distributors.
- Never use the same cuvette several times.

Note: The bar code tracking option is now active for the cuvette rolls.
To change a roll of cuvettes, the operator should:
" First, access the cuvette roll change window

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" Second, identify the new cuvette roll by means of its bar codes
" Third, remove the empty cuvette roll
" Fourth, install the new cuvette roll
The operating mode is detailed in a descriptive note delivered with the analyzer (see Fig.2).

Cuvette roll loading must be followed by cuvette disposal bag replacement (see below chapter 3.4).

3.3.1 Access the cuvette roll change Window


There are two possibilities to access the cuvette roll change window:
- From an error window
- From the Main Menu from the TEST PANEL screen

The error window is systematically displayed when the theoretical counter for the number of
cuvettes reaches the zero value.

3.3.1.1 Access the cuvette roll change Window from the Error Window

2The following error window is displayed:


CUVETTE FEED
Cuvette Missing
Esc=Continue F1= Load

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ACTIONS RESULTS

" Press the F1 key  The following window is displayed:

CUVETTES: CUVETTE ROLL CHANGE


The loaded cuvette roll has not enough
cuvettes to proceed with the resquested
test
Space bar: Continue

If this window is not displayed, press the


Esc key to access the TEST PANEL.

" Press the Space bar  The cuvette roll change window appears:

CUVETTES: CUVETTE ROLL CHANGE


Cuvette roll replacement procedure
Space bar Confirm ESC Abort

" Proceed with the new cuvette roll


identification (see detailed explanations that
follow)

3.3.1.2 Access the cuvette roll change Window from the TEST PANEL

2TEST PANEL screen displayed.


3

ACTIONS RESULTS

" Press the Esc key  The Main Menu is displayed:

Status - Loading - (...) - Halt


cursor positioned on Status

" Press the L key (Loading)  The sub-menu is displayed :


" Or press the J key to reach Loading, then
confirm with the  key Samples F1
Products F2
Cuvettes
Washing Solution
with the cursor on Samples

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ACTIONS RESULTS

" Press the C key (Cuvettes)  The following window is displayed:


" Or press the L key to reach Cuvettes then
confirm with the  key CUVETTES: CUVETTE ROLL CHANGE
Cuvette roll replacement procedure
Space Bar: Confirm ESC: Abort

" Proceed with the new cuvette roll


identification (see detailed explanations that
follow)

3.3.2 New cuvette roll identification


2The cuvette roll change window is displayed:
CUVETTES: CUVETTE ROLL CHANGE
Cuvette roll replacement procedure
Space Bar: Confirm ESC: Abort

ACTIONS RESULTS

" Press the space bar.  The following window is displayed:

CUVETTES : cuvette roll identification


Identify the cuvette roll with the codebar
reader
CODE 1
CODE 2
F10 Validate Return Next field

" One after the other, pass the two cuvette  When a bar code passes in front of the
roll bar codes in front of the bar code reader, the system beeps.
reader.  When a bar code is read, the corresponding
area of the window is filled in.

" In case of failure of the bar code reading,  The two bar codes are displayed.
type in the data printed under the bar
codes

Manual identification may lead to typing errors.


It is used under complete responsibility of the
user.

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ACTIONS RESULTS

" Validate with F10.  The following window is displayed:

CUVETTES : Cuvette roll data


Number of cuvettes in the cuvette roll
(Maximum : x x x x )
Cuvette roll ID:
F10 Validate ESC Abort

" In the field Number of cuvettes in the  The following window is displayed:
cuvette roll, indicate the number of
cuvettes remaining in the cuvette roll if it is CUVETTES: CHANGE OF THE CUVETTE ROLL
less than what appears in the window. Please remove the empty roll
" Validate with F10. Space bar : Confirm Esc : Quit

" Change the cuvette roll (see copy of help


diagram n°1 and detailed explanations)

Help diagram No.1can be found :


- inside the right front door, for analyzers with a serial number inferior or equal to xxx1219,
- inside the right side door, for analyzers with a serial number superior to xxx1219.

Fig. 2 - Help Diagram No.1 for Loading the Roll of Cuvettes

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3.3.3 Remove the empty roll


(See figure 2 above)
Step 1: Open the right side door
Step 2: Pull the cuvette roll drawer
Step 3: Raise the catch holding the reel and the catch holding the cuvette roll
Step 4: Remove the reel by sliding it off its spindle
Step 5: While holding the reel with one hand, guide the plastic film under the
positioning rollers
Step 6: While still holding the reel with one hand, remove the cuvette roll by sliding
it off its spindle. Throw the empty roll away. Remove the plastic foam (which
levels the cuvettes) out of the loading rail if necessary

3.3.4 Install the New Cuvette Roll


New cuvette rolls are always connected to a reel by means of a plastic film on which the cuvettes are
attached. (See figure 2 above).
Step 7: Grasp the cuvette roll so that it is on the left and the reel is on the right
Slide the cuvette roll along its spindle, lower the catch which holds the roll
Step 8: Guide the film under the two positioning rollers. Do not twist it (the film will take
up its own position in the slide)
Step 9: Slide the reel onto its spindle and lower the catch which holds the reel on it
Proceed with cuvette loading:

2The following window is displayed:


CUVETTES: CHANGE OF THE CUVETTE ROLL
Please remove the empty roll
Space bar: Confirm ESC: Abort

ACTIONS RESULTS

" Press the Space Bar  The following window is diplayed:

CUVETTE ROLL CHANGE


Please rotate the reel manually
until the first cuvette is engaged
in the loading rail
ESC: Abort F10 Confirm

" Turn the reel (arrow direction) until the  The cuvettes are in the loading rail.
cuvettes are engaged correctly in the
loading rail

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ACTIONS RESULTS

" Push back the cuvette roll drawer  If the STA Compact< is in stand-by, the
following window is displayed:
" Close the right side door (step 10, refer to
help diagram No.1) then confirm with the
F10 key CUVETTE ROLL CHANGE
TESTING
 = Begin
Space Bar = EMERGENCY STOP

" Press the key to start automatically the  The following window is displayed:
loading test
Note: In case of problems, press the CUVETTE ROLL CHANGE
Space Bar to stop the roll motor. TESTING
TEST IN PROGRESS
SPACE BAR = EMERGENCY STOP
 Then, the following window is displayed:

RISK OF BIOLOGICAL CONTAMINATION


Biohazardous waste.
In order to avoid any risk of contamination:
Observe the proper precautions (for
instance: wear disposable gloves) for
handling biohazardous materials, in
accordance with the local regulations.

" Proceed with the cuvette disposal bag


replacement (see detailed explanations
below)

3.4 Cuvette Disposal Bag Replacement

After each cuvette roll replacement, the cuvette disposal bag shall be systematically replaced.

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RISK OF BIOLOGICAL CONTAMINATION


The cuvette disposal plastic bag contains potentially infectious biological materials.

In order to avoid any risk of contamination:


Observe the proper precautions (for instance: wear disposable gloves) for handling
biohazardous materials, in accordance with the local regulations.

3.4.1 Removal of the Used Cuvette Disposal Bag

There are several types of cuvette disposal bag closings.

Procedure:
Step 1: Remove the cuvette disposal drawer
Step 2: Pull up the folded portion of plastic bag so that the bag can be closed
Step 3: Remove the red band from the plastic bag and close the top of the plastic
bag tightly by tying a knot with the red band
Step 4 : Lift the plastic bag completely off the cuvette disposal drawer and
discard in accordance with local existing regulations.

3.4.2 Loading of the New Cuvette Disposal Bag


" Take one of the plastic bags supplied with the box containing the cuvette rolls
Procedure:
Step 5 : Open the plastic bag and insert it into the cuvette disposal drawer
Step 6: Push the bottom of the bag so that it reaches the bottom of the
metal container
Step 7: Fold the plastic bag over the edges of the cuvette disposal drawer
Step 8: Place the plastic bag while avoiding folds
Step 9: Push back fully home the cuvette disposal drawer

Do not interfere with the function of the switch designed to detect the presence of the cuvette
disposal drawer.

" Press the F10 key to confirm the replacement of the cuvette disposal bag.

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 The following window is displayed:

CUVETTES: CUVETTE ROLL CHANGE


The loading procedure of a cuvette roll is over
Space bar: Quit
" Press the space bar.
 Back to the TEST PANEL screen.

3.5 Loading the Washing Solution Bottle


Cat. No.: 00973 (STA< - Cleaner Solution).
To load the Washing Solution, the operator should:
" Access the WASHING SOLUTION LOADING window
" Remove the waste bottle
" Move the used liquid container
" Replace the used liquid container with the new bottle of STA< - Cleaner Solution

RISK OF BIOLOGICAL CONTAMINATION


Handling of potientially infectious biological material.

In order to avoid any risk of contamination:


To perform the operations described hereafter, observe local existing regulations: use disposable
gloves, mask and protective goggles.

3.5.1 Access the WASHING SOLUTION LOADING Window


There are two possibilities to access the WASHING SOLUTION LOADING window:
- From an error window (see chapter 3.5.1.1)
- From the Main Menu, from the TEST PANEL screen (see chapter 3.5.1.2)

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3.5.1.1 Access the WASHING SOLUTION LOADING Window from the Error Window

2The following error window is displayed:


BACKGROUND TASK
WASHING SOLUTION EMPTY
Intermediate reservoir not full
Esc=Retry F1=Load

ACTIONS RESULTS

" Press F1 key to change the Washing  The following window is displayed:
Solution.

RISK OF BIOLOGICAL CONTAMINATION


Biohazardous Waste.
In order to avoid any risk of contamination:
Observe the proper precautions (for
instance: wear disposable gloves) for
handling biohazardous materials, in
accordance with the local regulations.

If this window is not displayed, press the


Esc key to access the TEST PANEL.

" Proceed with the Washing Solution loading


(see the following)

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3.5.1.2 Access the WASHING SOLUTION LOADING Window from the TEST PANEL

2TEST PANEL screen is displayed.

ACTIONS RESULTS

" Press the Esc Key  The Main Menu is displayed:

Status - Loading - (...) - Halt

" Press the L key (Loading)  The sub-menu is displayed:


" Or press the J key to reach Loading, then
confirm with the  key Samples F1
Products F2
Cuvettes
Washing Solution
with the cursor on Samples.

" Press the W key (Washing Solution)  The following window appears:
" Or press the L key to reach Washing
Solution, then confirm with the  key

RISK OF BIOLOGICAL CONTAMINATION


Biohazardous Waste.
In order to avoid any risk of contamination:
Observe the proper precautions (for
instance: wear disposable gloves) for
handling biohazardous materials, in
accordance with the local regulations.

" Proceed with the Washing Solution loading


(see the following)

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3.5.2 Remove the Used Liquid Container

RISK OF BIOLOGICAL CONTAMINATION


The used liquid container contains potentially infectious biological material and should be disposed
of in accordance with the local regulations.

" Open the right side door of the analyzer


" Carefully pull up the used liquid container (the one on the right), symbolized in yellow on the
WASHING SOLUTION LOADING window

" As soon as possible, remove the plug from this container


" Then, fully remove the used liquid container
" Press the F10 key to confirm the end of this operation
" Refit the original plug on the used liquid container
" Dispose of it in accordance with the local regulations.

RISK OF INCORRECT RESULTS


Appropriately mark this used liquid container, never use it as new STA< Cleaner Solution
bottle. This can lead to wrong results.

3.5.3 Replace the Used Liquid Container

The empty STA< Cleaner Solution bottle becomes the new used liquid container. The message
“Please, EMPTY then displace this bottle” is displayed.

" Carefully pull out the empty STA< Cleaner Solution bottle (the one on the left)
" As soon as possible, remove the plug from the bottle. To avoid any possible contamination of
tubing, place the end of the tubing in a receptacle
" Empty the STA< Cleaner Solution bottle

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" Insert the plug of the right position into the empty bottle
" Then, replace the empty bottle in the right position. The closing of the switch detecting the
presence of the bottle should be heard

Do not interfere with the function of the switch designed to detect the presence of the used liquid
container.

" Press the F10 key to confirm the end of this operation

3.5.4 Install the Washing Solution Bottle

2The message "Please, install a new bottle" is displayed.


" Take a new STA< - Cleaner Solution bottle

The new STA< Cleaner Solution bottle must be at room temperature.

RISK OF INJURY
Do not swallow the STA< Cleaner Solution (in-vitro usage only).

RISK OF INCORRECT RESULTS


Do not modify the formulation of the STA< Cleaner Solution; this can lead to wrong results.

" Remove the cap of the bottle of the STA< Cleaner Solution
" Insert the system cap (left position) into the STA< Cleaner Solution bottle
" Then replace the bottle in the left position. The switch which detects the presence of the
container will close audibly
" Press the F10 key to confirm the end of this operation
" If using a new bottle: confirm the indicated volume (2500 ml) with the  key
Otherwise, enter the remaining volume, then confirm with the  key
" Close the right side door of the analyzer

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3.6 Power-down Procedure

3.6.1 Reminders
The STA Compact®’s monitor switches off automatically after 20 minutes whether the STA
Compact® analyzer is executing measurements or not. If an error is detected then, the STA
Compact®’s monitor comes back on to display the error message.
When all the tests are completed, the STA Compact® goes to stand-by. All automatic functions stop
except for the temperature regulations.
It is recommended not to switch off the analyzer or to unload the products. The STA Compact® is
then able to automatically manage the stability of the products.
To temporarily stop sample pipetting, the Stop Sample Pipetting function should be used (see
description chapter 10.1.5.1).

3.6.2 Power-Off Procedure


To switch off the STA Compact®, proceed as follows:
" Unload all samples from the sample drawer
" Unload all bottles from the product drawer
For both operations: see chapter 6.10.

2TEST PANEL screen displayed.

ACTIONS RESULTS

" Press the Esc key  The Main Menu is displayed:

Status - Loading - (...) - Halt


with the cursor on Status.

" Press the H key (Halt)  The following window is displayed:


" Or press the J key to reach Halt, then
confirm with the  key END OF APPLICATION
Y = Yes N = No

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ACTIONS RESULTS

" Press the Y key  Saving of the analyzer’s status.


 The following window is displayed:

END OF APPLICATION
Saving ...
Please wait
DO NOT SWITCH OFF

 Then, the window becomes

END OF APPLICATION
Recording complete
you can switch the system off

" Switch the ON/OFF switch of the  The STA Compact<, the monitor and the
STA Compact< to the OFF position (O). printer are switched off.
This switch is located on the left side of the
STA Compact< (see chapter 2.5.4)
" Switch OFF the monitor
" Switch OFF the printer.

3.7 Extended stop of the STA Compact<


If the analyzer is to be turned off for more than 8 days, use the following procedure :
" Remove all the tubes from the sample drawer (see chapter 6.10)
" Remove all the vials from the product drawer (see chapter 6.10)
" Remove bottles (used liquid container and STA Compact® Solution bottle)
" Eliminate waste containers (used liquid container and cuvette disposal bag) in accordance with
local regulations.
" Decontaminate the analyzer:
- Purging of the needles and cleaning of the washing wells (see chapter 4.2.4)
- Cleaning of the product drawer, of the sample drawer and of the measurement plate (see
chapter 4.2.5 and 4.2.6)
" Switch the STA Compact® off (see chapter 3.6)

Before switching the analyzer back on:


" Follow the same decontamination procedure
" Put the liquid waste container and the cuvette disposal bag back in place
" Check the liquid level of the Peltier reservoir (see chapter 4.2.7)

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Table of contents

4 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

4.1 Preventive Maintenance Schedule . . . . . . . . . . . . . . . . . . . . 1

4.2 Weekly User Preventive Maintenance . . . . . . . . . . . . . . . . . 2


4.2.1 Drying the Product Drawer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
4.2.2 Preparation of the decontamination solution . . . . . . . . . . . . . . . . . . . . . 2
4.2.3 Cleaning Air Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
4.2.4 Cleaning of the Washing Wells and Needle Purge . . . . . . . . . . . . . . . . . 4
4.2.5 Cleaning Sample and Product Drawers . . . . . . . . . . . . . . . . . . . . . . . . . 8
4.2.6 Cleaning the Measurement Plate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
4.2.6.1 Preparation of diluted ethanol between 20% and 40% . . . . . . . . . . . . . . . . . . . . . . . . 9
4.2.6.2 Measurement Plate Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
4.2.7 Peltier Reservoir Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
4.2.8 Cleaning the Suction Tip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

4.3 Monthly User Preventive Maintenance: Replacement of Syringe


Teflon Tip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

4.4 Quarterly User Preventive Maintenance: Air Filter Replacement


23

4.5 Curative Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24


4.5.1 Decontaminating a drawer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
4.5.2 Passing the stylet inside a clogged needle . . . . . . . . . . . . . . . . . . . . . . 25
4.5.3 Replacing a Sampling Needle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
4.5.4 Replacing the Suction Tip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
4.5.5 Replacing the Halogen Lamp (not available on STA Compact< CT) . . 43
4.5.6 Replacing the Main Fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
4.5.7 Replacing the Secondary Fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
4.5.8 Dirty Liquid filters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

4.6 Decontamination Procedure . . . . . . . . . . . . . . . . . . . . . . . 55

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4.7 Maintenance Utility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56


4.7.1 How to Access the User Maintenance Menu . . . . . . . . . . . . . . . . . . . . 57
4.7.2 Rinsing Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
4.7.2.1 How to Access the Rinsing Pump Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
4.7.2.2 Rinsing Needle No.1, No.2, No.3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
4.7.2.3 Exiting the Rinsing Pump Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
4.7.3 Bar Code Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
4.7.3.1 How to access the Bar Code Test menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
4.7.3.2 Bar Code Reader Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
4.7.3.3 Quit the Bar Code Test menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
4.7.4 Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
4.7.4.1 How to Access the Printer Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
4.7.4.2 Connection Checking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
4.7.4.3 Testing the printout of characters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
4.7.4.4 Testing the printout of graphics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
4.7.4.5 Quit the Printer Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
4.7.4.6 Printer Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
4.7.5 Saving . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
4.7.5.1 How to Access Saving Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
4.7.5.2 Selection of Items . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
4.7.5.3 Loading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
4.7.5.4 Saving . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
4.7.5.5 Formatting a diskette . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
4.7.5.6 Quit the Saving Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
4.7.6 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
4.7.6.1 How to Access the Maintenance Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
4.7.6.2 Needle Purge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
4.7.6.3 Needle Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
4.7.6.4 Syringe Tip/Syringe Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
4.7.6.5 Suction Tip Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
4.7.6.6 Halogen Lamp Replacement (not available on STA Compact< CT) . . . . . . . . . . . . . . 77
4.7.6.7 Dates of Recent Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
4.7.6.8 Quit the Maintenance Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
4.7.7 Photometry Graphics (not available on STA Compact< CT) . . . . . . . 80
4.7.7.1 How to access the Photometry Graphics menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
4.7.7.2 Eliminating or Restoring Points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
4.7.7.3 STA Compact® Calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
4.7.7.4 Printing the curve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
4.7.7.5 Printing the List of Measurement Values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85

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Table of contents

4.7.7.6 Modifying the Calculation window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85


4.7.7.7 Loading Another Measurement File . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
4.7.7.8 Quitting the Photometry Graphics Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
4.7.8 Error History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
4.7.8.1 How to access the Error History Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
4.7.8.2 Parameter Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
4.7.8.3 Quitting the Error Message Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
4.7.9 Host Computer Communications . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
4.7.10 Data Update . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
4.7.11 Utilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
4.7.11.1 TDEX utilities (computerized exportation of patient files) . . . . . . . . . . . . . . . . . . . . 89
4.7.11.2 Update of the parameter backup diskettes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
4.7.12 Return to the Main Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91

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REFERENCE MANUAL 4
Maintenance

4 Maintenance

4.1 Preventive Maintenance Schedule


This maintenance schedule is recommended for a laboratory performing up to 200 tests a day:

See Required parts


Frequency MAINTENANCE
chap. (designation/Cat. number)

Weekly Drying of the product drawer 4.2.1 / /

Cleaning of the air filter at the back 4.2.3 / /


of the analyzer

Cleaning of the Air Filter, in the 4.2.3 / /


Optical Module (not available on
STA Compact< CT)

Needle purge 4.2.4 / /


Cleaning of the washing wells

Cleaning of the Sample and 4.2.5 / /


Product drawers

Cleaning of the Measurement 4.2.6 / /


Plate

Check of the Peltier Reservoir 4.2.7 / /

Cleaning of the Suction Tip 4.2.8 / /

Saving of data 4.7.5 / /

Quarterly Replacement of the air filter at the 4.4 Filters air 27420
back of the analyzer (x2)

Replacement of the Air Filter, in 4.4 Filter colorimetry 26538


the Optical Module (not available box (x1)
on STA Compact< CT) or
or
Filter colorimetry
38125
box V3 (x1)

A preventive maintenance procedure is to be done by an authorized Service Representative


according to the analyzer output and its maintenance type.
For all maintenance operations, see detailed procedure below.

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4.2 Weekly User Preventive Maintenance

4.2.1 Drying the Product Drawer


Depending on the temperature and the humidity level of the laboratory, condensation may occur in
the Product drawer. To avoid false vial detections due to the water droplets, it is recommended to
dry the drawer whether daily or weekly.
" Open the Product drawer (F2 key from the TEST PANEL)
" Remove all vials or adaptors from the Product drawer
" Go back to the TEST PANEL
" Switch off the STA Compact® (Power off procedure, chapter 3.6.2)
" Pull the drawer cassette upwards and remove it completely
" Use a sponge to dry the black surface
" Place the cassette back in the drawer by pushing it down carefully
" Switch the STA Compact® on again

4.2.2 Preparation of the decontamination solution


Prepare a decontamination solution at 0.37% (approximatively) of active chlorine.

To obtain a decontamination solution at 0.37% (approximatively) of active chlorine from a bleach


solution and distilled water at ambient temperature:
add N parts of water to 1 part of bleach according to the following formula:
B
N = --------------- – 1 where B = % of active chlorine in the bleach you use
0,37

For example:
- Bleach at 2.6% of active chlorine:
Mix 1 part of 2.6% active chlorine solution with 6 parts of water.
- Bleach at 6.25% of active chlorine:
Mix 1 part of 6.25% active chlorine solution with 16 parts of water.
- Bleach at 9.6% of active chlorine:
Mix 1 part of 9.6% active chlorine solution with 25 parts of water.
or
Mix 1 part of bleach at 9.6% of active chlorine with 3 parts of water to obtain bleach at 2.6% of active
chlorine. Then mix 1 part of bleach at 2.6% of active chlorine with 6 parts of water.

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Maintenance

RISK OF BIOLOGICAL CONTAMINATION

In order to avoid any risk of contamination:


Allow the decontamination solution to operate on the potentially contaminated area for
15 minutes.

4.2.3 Cleaning Air Filter


Purpose: To prevent internal overheating.
Procedure:
" Switch the STA Compact® off (see Power-off procedure, chapter 3.6.2)
" Remove the air filter from the back of the STA Compact®
" Open the right side door of the STA Compact< and remove the air filter from the optical module
(not available on STA Compact< CT)
" Remove the debris from the filter(s)
" Vacuum the dust
" Reinstall the air filter(s)

Make sure that the correct assembly direction is observed: the word EXTERIEUR should face
outwards.

" Switch the STA Compact® back on.

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Fig. 1 - Location of the air filters

Legend:

1 Air filter, at the back of the analyzer

2 Air filter, in the optical module (not available on STA Compact< CT)

4.2.4 Cleaning of the Washing Wells and Needle Purge


Purpose:
- Purge of the needles.
- Cleaning of the wells and the downstream rinse circuits (Vacuum Reservoir) to ensure perfect
suction and avoid contamination on the outside of the needles.

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Maintenance

RISK OF BIOLOGICAL CONTAMINATION

In order to avoid any risk of contamination:


Observe the proper precautions (for instance: wear disposable gloves) for handling
biohazardous materials, in accordance with the local regulations.

2TEST PANEL screen displayed:

ACTIONS RESULTS

Access the User Maintenance menu:  The Main Menu appears:


" Press the Esc key
Status - Loading (...) - Halt
with the cursor on Status.

" Press the M key: Maintenance  The following window appears:


" Or press the J key to reach
Maintenance, then press the  key to Initializing
confirm Please wait...
 The User Maintenance menu appears:

Rinsing Pump
Bar Code Test
Printer
Saving
Maintenance
Photometry Graphics
Error History
Host Computer Communications
Data Update
Utilities
Return to Previous Menu
with the cursor on Rinsing Pump.

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Maintenance

ACTIONS RESULTS

Access the Maintenance menu:  The following window is displayed:


" Press the L key to reach Maintenance,
then confirm with the  key Initialization in progress
Please wait...
 The Maintenance menu appears:

Needle Purge
Needle Replacement
Syringe Tip/Syringe Replacement
Suction Tip Replacement
Halogen Lamp Replacement
Dates of Recent Maintenance
Return to the Previous Menu
with the cursor on Needle Purge.

Access the Needle Purge menu:  The NEEDLE PURGE screen appears:
" Press the  key Needle Purge  The following windows appear:

Checks in progress
Please wait...

Home position in progress


Please wait...

Positioning in well
Please wait...

" Press the F6 key  The following window appears :

Open Drawer
Please wait...
 The product drawer is opening.
 The pipetting head moves forwards.

" Raise the transparent panel  Cleaning of wells in progress.


" Fill each washing well to 3/4 full with
decontamination solution (see chapter
4.2.2). Be careful that the wells do not
overflow on the electrical parts
" Wait for 10 minutes
" Close the transparent panel

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Maintenance

ACTIONS RESULTS

" Press the F6 key  The following window appears :

Close Drawer
Please wait...
 The product drawer is closing.
 The pipetting head moves above the
washing wells and the 3 needles go down in
their wells.

" Press the F1 key  Purge of Needle No.1.

" Press the F2 key  Purge of Needle No.2.

" Press the F3 key  Purge of Needle No.3.

Exit the NEEDLE PURGE screen:  The following window is displayed:


" Press the Esc key
Do you want to return
to the previous menu
Y/N?
Esc = Cancel

" Press the Y key  Home positions of the arms.


 The Maintenance menu appears.

Access the DATES OF RECENT MAINTENANCE  The DATES OF RECENT MAINTENANCE


screen: screen appears.
" Press the L key to reach DATES OF RECENT
MAINTENANCE then confirm with the
 key

" Press the keys ALT and PrtSc  Printout of the DATES OF RECENT
MAINTENANCE screen.

Exit the DATES OF RECENT MAINTENANCE  The following window is displayed:


screen:
" Press the Esc key Do you want to return
to the previous menu
Y/N?
ESC = Cancel

" Press the Y key  The Maintenance menu is displayed.

" Press the K key to Return to the  Back to User Maintenance menu.
Previous Menu, then confirm with the
 key

Return to the Main Menu:  See chapter 3.2.


" Press the KKey to Return to the
Previous Menu, then confirm with the
 key

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ACTIONS RESULTS

" Run quality controls for the routine tests  If the quality control results are consistent
" Compare results with the previous ones with the previous ones, STA Compact® can
be used.
 If not, redo the procedure.
In case of problem, call your local authorized
Service Representative.

4.2.5 Cleaning Sample and Product Drawers


Purpose: To prevent accumulation of dirt.

2TEST PANEL screen displayed (as described in chapter 3.2).

RISK OF BIOLOGICAL CONTAMINATION

In order to avoid any risk of contamination:


Observe the proper precautions (for instance: wear disposable gloves) for handling
biohazardous materials, in accordance with the local regulations.

" Open sample drawer by pressing the F1 key


" Clean the top with a soft cloth or paper tissue slightly moistened with warm water. Wipe with
a dry cloth
" Close the sample drawer (see chapter 6.12)
" Open the product drawer by pressing the F2 key and repeat the cleaning procedure

In case a tube or a vial has been broken:


RISK OF BIOLOGICAL CONTAMINATION
RISK OF INJURY
In order to avoid any risk of contamination and/or injury:
- Observe the proper precautions (for instance: wear disposable gloves) for handling
biohazardous materials, in accordance with the regulations in force locally.
- Decontaminate the drawer (see procedure chapter 4.5.2).

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Maintenance

4.2.6 Cleaning the Measurement Plate


Purpose: To prevent accumulation of dirt.

4.2.6.1 Preparation of diluted ethanol between 20% and 40%


Diluted ethanol is used to clean the measurement channels and the incubation cells.
Prepare the diluted ethanol from ethanol and reagent grade water at ambient temperature.

C C
R = ------------- or N = ---- – 1
N+1 R
where
R = concentration after dilution
C = concentration of the ethanol
N = number of added parts of water

For example:

when using ethanol at 90%:


" Mix 1 part of ethyl alcohol at 90% with 3 parts of reagent grade water.
 The result is ethyl alcohol at 22%.

when using ethyl alcohol at 70%:


" Mix 1 part of ethyl alcohol at 70% with 2 parts of reagent grade water.
 The result is ethyl alcohol at 23%.

4.2.6.2 Measurement Plate Cleaning


2TEST PANEL screen displayed.

ACTIONS RESULTS

Access the User Maintenance menu  The Main Menu appears:


" Press the Esc key
Status - Loading (...) - Halt
with the cursor on Status.

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Maintenance

ACTIONS RESULTS

" Press the M key: Maintenance  The following window appears


" Or press the J key to reach
Maintenance, then press the  key to Initializing
confirm Please wait...
 Then, the User Maintenance menu
appears:

Rinsing Pump
Bar Code Test
Printer
Saving
Maintenance
Photometry Graphics
Error History
Host Computer Communications
Data Update
Utilities
Return to Previous Menu
with the cursor on Rinsing Pump.

RISK OF BIOLOGICAL CONTAMINATION

In order to avoid any risk of contamination:


Observe the proper precautions (for instance: wear disposable gloves) for handling
biohazardous materials, in accordance with the local regulations.

Fig. 2 - Cross section of a measurement channel

Legend:

1 Optical fiber (not available on STA Compact®CT)

2 Motorization coil

" Raise the transparent panel


" Remove any possible debris from each measurement channel and from each incubation cell

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REFERENCE MANUAL 4
Maintenance

" Clean each measurement channel and each incubation cell with swabs slightly moistened with
ethanol between 20% and 40%

Do not use solvents like Acetone or Trichlorethylene as they may damage the optical fibers.

" Clean the black panel of the measurement plate with a soft cloth or paper tissue slightly
moistened with warm water, then wipe with a dry cloth. Do not use ethanol on the measurement
plate

RISK OF INCORRECT RESULTS


With the measurement plate, do not allow water to run into the measurement and incubation cells.

ACTIONS RESULTS

Return to the Main Menu:  Same results as described in chapter 3.2.


" Press the K key to Return to the
Previous Menu, then confirm with the
 key

" Run quality controls for the routine tests  If the quality control results are consistent
" Compare results to the previous ones with the previous ones, STA Compact® can
be used.
 If not, redo the procedure.
In case of problem, call your local authorized
Service Representative.

4.2.7 Peltier Reservoir Check


Purpose: To avoid analyzer over heating conditions.
" Open the right side door of STA Compact®
" Check that the liquid level in the Peltier reservoir is above the mark indicated on the bottle

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Maintenance

Fig. 3 - Location of the Peltier Reservoir

Legend:

1 Peltier Reservoir

" If the liquid level is below the mark, switch off the STA Compact®
" Open the Peltier Reservoir
" Fill it with the cooling liquid (Ref.: 38640)*
" Switch on the STA Compact®

RISK OF INJURY
Harmful product that contains methanol !

In order to avoid any injury or intoxication:


- Do not inhale or swallow.
- It is necessary to wear disposable gloves, protective clothing and protective goggles (see
safety data sheet, Appendix A).
- Do not dispose of the product down the drain !
- Discard the empty container and any product in accordance with local, regional and national
legislation.

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Maintenance

4.2.8 Cleaning the Suction Tip


Purpose: To prevent accumulation of dirt inside the suction tip in order to prevent suction errors.

2TEST PANEL screen displayed.

ACTIONS RESULTS

Access the User Maintenance menu:  The Main Menu appears:


" Press the Esc key
Status - Loading (...) - Halt
with the cursor on Status.

" Press the M key: Maintenance  The following window appears:


" Or press the J key to reach
Maintenance, then press the  key to Initializing
confirm Please wait...
 The User Maintenance menu appears:

Rinsing Pump
Bar Code Test
Printer
Saving
Maintenance
Photometry Graphics
Error History
Host Computer Communications
Data Update
Utilites
Return to Previous Menu
with the cursor on Rinsing Pump.

Access the Maintenance menu:  The following window is displayed:


" Press the L key to reach Maintenance,
then confirm with the  key Initialization in progress
Please wait...
 The Maintenance menu appears:

Needle Purge
Needle Replacement
Syringe Tip/Syringe Replacement
Suction Tip Replacement
Halogen Lamp Replacement
Dates of Recent Maintenance
Return to the Previous Menu
with the cursor on Needle Purge.

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Maintenance

ACTIONS RESULTS

Access the Suction Tip Replacement menu:  The following window is displayed:
" Press the L key to reach Suction Tip
Replacement, then confirm with the SUCTION TIP REPLACEMENT
 key Initialization in progress
Please wait...
 The Suction Tip Replacement menu
appears:

SUCTION TIP REPLACEMENT


Suction Tip Test
Return to Previous Menu
with the cursor on Suction Tip
Replacement.

Access the Suction Tip Replacement menu:  The following windows are displayed:
" Press the  key Suction Tip
Replacement SUCTION TIP REPLACEMENT
Home position in progress...

SUCTION TIP REPLACEMENT


For this operation, you must have:
- a new suction tip
F10: Continue - Esc: Abort

" Press the F10 key  Home positions.


 Suction head moves forwards.
 The following screen appears:

SUCTION TIP REPLACEMENT


Once the transparent panel is raised,
you can replace the suction tip
according to the procedure described in
the manual. When this operation is
finished, validate by pressing
F10: Validate - Esc: Cancel

" Proceed to the dismantling, cleaning and


reassembly of the suction tip (see procedure
hereafter)

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Maintenance

Procedure: Dismantling, Cleaning and Reassembly of the Suction Tip

RISK OF BIOLOGICAL CONTAMINATION

In order to avoid any risk of contamination:


Observe the proper precautions (for instance: wear disposable gloves) for handling
biohazardous materials, in accordance with the local regulations.

" Raise the transparent panel


" Remove the cuvette disposal drawer
" Remove the suction tip by pulling it out gently
" Clean the suction tip with warm water
" Dry it
" Fit the new suction tip in place
" Replace the cuvette disposal drawer

ACTIONS RESULTS

" Press the Esc key  The following window appears:

SUCTION TIP REPLACEMENT


The procedure has been aborted.
Before resuming, verify that all
is correct; if not, please
restart the procedure.
Press a key...

" Press any key  The Suction Tip replacement menu


appears:

SUCTION TIP REPLACEMENT


Suction Tip Test
Return to previous menu

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Maintenance

ACTIONS RESULTS

" Press the L key to Suction Tip Test then  The following window appears:
confirm with the  key
SUCTION TIP REPLACEMENT
Home position in progress
Please wait...
 Test of the suction tip on the measurement
plate.
 The following window appears:

SUCTION TIP REPLACEMENT


The procedure was
successful :
Detection has succeeded
Space Bar to proceed...

" Press the Space Bar to proceed  The Suction Tip Replacement menu
appears

" Press the K key to Return to Previous  The Maintenance menu appears.
Menu, then confirm with the  key

" Press the K key to Return to Previous  The User Maintenance menu appears.
Menu, then confirm with the  key

Return to the Main Menu:  See chapter 3.2.


 Press the K key to Return to the
Previous Menu, then confirm with the
 key

4.3 Monthly User Preventive Maintenance: Replacement of


Syringe Teflon Tip

Cat. No.: 27530 (contains 6 Teflon tips and 6 O-rings)

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Maintenance

Purpose: To optimize pipetting for each arm and prevent leaks.

It is recommended that this replacement be performed monthly, although this frequency can be
adjusted depending on the laboratory workload. In any event, do not exceed the software-
controlled limits, the latter being shown in the SYSTEM STATUS screen, see description in
chapter 10.1.2.1.

If the entire syringe has to be replaced, use glass syringe Cat. No.: 27538 supplied by Diagnostica
Stago only. All other syringes will give the wrong results.

2TEST PANEL screen displayed.

ACTIONS RESULTS

Access the User Maintenance menu:  The Main Menu appears:


" Press the Esc key
Status - Loading (...) - Halt
with the cursor on Status.

" Press the M key: Maintenance  The following window appears:


" Or press the J key to reach
Maintenance, then press the  key to Initializing
confirm Please wait...
 The User Maintenance menu appears:

Rinsing Pump
Bar Code Test
Printer
Saving
Maintenance
Photometry Graphics
Error History
Host Computer Communications
Data Update
Utilities
Return to Previous Menu
with the cursor on Rinsing Pump.

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Maintenance

ACTIONS RESULTS

Access the Maintenance menu:  The following window is displayed:


" Press the L key to reach Maintenance,
then confirm with the  key Initialization in progress
Please wait...
 The Maintenance menu appears:

Needle Purge
Needle Replacement
Syringe Tip/Syringe Replacement
Suction Tip Replacement
Halogen Lamp Replacement
Dates of Recent Maintenance
Return to the Previous Menu
with the cursor on Needle Purge.

Access the Syringe Tip/Syringe  The following window is displayed:


Replacement menu:
" Press the L key to Syringe Tip/Syringe Initializing
Replacement menu then confirm with the Please wait...
 key  The Syringe Tip/Syringe Replacement
menu appears:

Tip or Syringe
Return to Previous Menu
with the cursor on Tip or Syringe.

" Press the  key  The following window is displayed:

REPLACEMENT OF TIP OR SYRINGE


For this operation, you must have:
- a newTeflon syringe tip or a new syringe
F10: Continue - Esc : Abort

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Maintenance

ACTIONS RESULTS

" Take a new syringe tip or a new syringe  The following windows appear:
according to the element which has to be
changed REPLACEMENT OF TIP OR SYRINGE
" Press the F10 key to proceed Home position in progress...
Please wait...

REPLACEMENT OF TIP OR SYRINGE


Arm movement
towards washing well
Please wait...

REPLACEMENT OF TIP OR SYRINGE


You can change the tip or the syringe
according to the procedure described
in the manual.
When this operation is finished,
validate by pressing F10.
F10: Validate - Esc: Abort

" Follow the steps shown in help diagram No. 3 (see Figure 3), this help diagram can be found
inside the right front door in a plastic sleeve. For analyzers with serial number above xxx1219, it
can be found inside the right side door.
Procedure:
" Step 1: Open the right front door of the STA Compact®
" Step 2: Lower the syringe piston and loosen the bottom thumb screw
" Step 3: Unscrew the syringe from its support
" Step 4: Remove the syringe from its clamp
" Step 5:
- 1. Pull the piston out of the syringe
- 2. Remove the O-ring
- 3. Remove the Teflon tip with a blunt instrument

" Step 6: Place the new tip on a flat surface as shown in the diagram and press the syringe piston
fully home into the new tip

Ensure that the tip remains vertical during this operation.

" Step 7:
- 1. Dip the Teflon tip in distilled water
- 2. Reinstall the piston in the syringe
- 3. Replace the O-ring

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RISK OF INCORRECT RESULTS

In order to avoid any risk of wrong results:

- Do not forget to put the O-ring in place.


- Make sure that there is no bubble on the Teflon tip.

" Step 8: Reposition the bottom of the syringe in the clamp while holding it vertically
" Step 9: Screw the syringe on its support by hand, still holding it vertically
" Step 10: Once again position the piston syringe in the upper position
" Step 11: Hand-tighten the thumb screw while supporting the clamp with your free hand

Do not close the right front door since a test is going to be performed on the syringe by the
software.

Fig. 4 - Help Diagram No.2


(Replacement of the Syringe Teflon Tip)

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Maintenance

ACTIONS RESULTS

" Press the F10 key to validate this  The following window appears:
procedure
Reservoir filling in progress
Please wait
 The following screen appears:

REPLACEMENT OF TIP OR SYRINGE


You have replaced the tip or the
syringe. This is installed on its
support. To ensure that all has been
performed correctly, do a Fluidics
circuit purge.
Please monitor the syringe during this
purge. If leaks appear, press Alt-F10
to stop everything.
F10 to continue

" Press the F10 key to proceed  The following window appears
" Observe the syringe during the purge and
press the Alt + F10 keys simultaneously in REPLACEMENT OF TIP OR SYRINGE
case of a problem Fluidics circuit purge in process,
please monitor the syringe.
Alt-F10: Emergency Stop
 The following windows appear:

REPLACEMENT OF TIP OR SYRINGE


Home position in progress... Please wait...

REPLACEMENT OF TIP OR SYRINGE


If a problem
occurred during circuit purge,
please perform the procedure again
Space Bar to proceed
 The purge is effected.
 If any problem occurs, perform once again
the fluidics circuit purge.

Step 12: Close the right front door of the STA Compact®

ACTIONS RESULTS

" Press the Space Bar to proceed  In the SYSTEM STATUS screen, the syringe
timer is reset to 100%.
 The Syringe Tip/Syringe Replacement
menu appears.

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ACTIONS RESULTS

" Press the L key to reach Return to  The Maintenance menu appears.
Previous Menu then confirm with the 
key

Access the DATES OF RECENT MAINTENANCE  The DATES OF RECENT MAINTENANCE


screen: screen appears.
" Press the L key to reach DATES OF RECENT
MAINTENANCE then confirm with the
 key

" Press the keys Alt and PrtSc  Printout of the DATES OF RECENT
MAINTENANCE screen.

Quit the DATES OF RECENT MAINTENANCE  The following window is displayed:


screen:
" Press the Esc key Do you want to return
to the previous menu
Y/N?
ESC = Cancel

" Press the Y key  The Maintenance menu is displayed.

" Press the K key to reach Return to  The User Maintenance menu appears.
Previous Menu, then confirm with the
 key

Return to the Main Menu:  Same results as described in chapter 3.2


" Press the K key to Return to the
Previous Menu, then confirm with the
 key

" Run quality controls for the routine tests  If the quality control results are consistent
" Compare results to the previous ones with the previous ones, STA Compact® can
be used.
 If not, redo the procedure.
In case of problem, call your local authorized
Service Representative.

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4.4 Quarterly User Preventive Maintenance: Air Filter


Replacement

Cat. No.: 27420, air filter for rear panel (2 per bag).
Cat. No.: 26538, filter for optical module (see figure hereafter), not available on STA
Compact®CT
OR
Cat. No.: 38125, filter for optical module V3 type (see figure hereafter), not available on STA
Compact®CT

Fig. 5 - Optical module air filter (not available on STA Compact®CT)

Cat. No.: 26538 Cat. No.: 38125

" Switch the STA Compact® off (see Power-off procedure chapter 3.6.2)
" Remove the air filter on the back of the STA Compact® and discard

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Fig. 6 - Air Filter on the back of the analyzer

" Open the right side door of the STA Compact®, remove the optical module air filter (not
available on STA Compact< CT) and discard

Fig. 7 - Air Filter, in the Optical Module (not available on STA Compact< CT)

" Install the new filter(s)

Make sure that the correct assembly direction is observed: the word EXTERIEUR should face
outwards.

" Switch the STA Compact® back on

4.5 Curative Maintenance

4.5.1 Decontaminating a drawer


Purpose: To decontaminate the drawer after a tube or vial was broken or turned upside down.

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Maintenance

RISK OF BIOLOGICAL CONTAMINATION

In order to avoid any risk of contamination:


Observe the proper precautions (for instance: wear disposable gloves) for handling
biohazardous materials, in accordance with the local regulations.

2TEST PANEL screen displayed (as described in chapter 3.2).


" Sample Drawer:
Open the sample drawer by pressing F1
Empty the drawer
" Product Drawer:
Make a print out of the products in order to know their stability and volume
Open the product drawer by pressing F2
Empty the drawer
" Clean the top of the drawer with the decontamination solution (see chapter 4.2.2)
" Use swabs moistened with decontamination solution to clean the dirty positions
" Go back to the TEST PANEL
" Turn the STA Compact® off (see procedure in chapter 3.6.2)
" Pull the drawer cassette upwards and remove it completely
" If necessary: clean the cassette with decontamination solution
" Clean the bottom of the drawer with decontamination solution
" Rinse and dry
" Place the cassette back in the drawer by pushing it down carefully
" If necessary, reload the products and enter the stabilities and volumes printed previously.

4.5.2 Passing the stylet inside a clogged needle


Purpose: To unclog a needle.

Cat. No.: 80343 (pack of 10 single use stylets)

RISK OF BIOLOGICAL CONTAMINATION

In order to avoid any risk of contamination:


Observe the proper precautions (for instance: wear disposable gloves) for handling
biohazardous materials, in accordance with the local regulations.

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2TEST PANEL screen displayed.

ACTIONS RESULTS

Access the User Maintenance menu:  The Main Menu appears:


" Press the Esc key
Status - Loading (...) - Halt
with the cursor on Status.

" Press the M key: Maintenance  The following window appears:


" Or press the J key to reach
Maintenance, then press the  key to Initializing
confirm Please wait...
 The User Maintenance menu appears:

Rinsing Pump
Bar Code Test
Printer
Saving
Maintenance
Photometry Graphics
Error History
Host Computer Communications
Data Update
Utilities
Return to Previous Menu
with the cursor on Rinsing Pump.

Access the Maintenance menu:  The following window is displayed:


" Press the L key to reach Maintenance,
then confirm with the  key Initialization in progress
Please wait...
 The Maintenance menu appears:

Needle Purge
Needle Replacement
Syringe Tip/Syringe Replacement
Suction Tip Replacement
Halogen Lamp Replacement
Dates of Recent Maintenance
Return to the Previous Menu
with the cursor on Needle Purge.

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ACTIONS RESULTS

Access the Needle Purge menu:  The NEEDLE PURGE screen appears:
" Press the  key Needle Purge  The following windows appear:

Checks in progress
Please wait...

Home position in progress


Please wait...

Positioning in well
Please wait...

" Press the F6 key  The following window appears :

Open Drawer
Please wait...
 The product drawer is opening.
 The pipetting head moves forwards.

" Raise the transparent panel


" Use decontamination solution (see chapter
4.2.2) to fill the clogged needle washing
well to 3/4 full. Be careful that the well does
not overflow on the electrical parts
" Pass the stylet through the clogged needle
" Lower the transparent panel

" Press the F6 key  The following window appears :

Close Drawer
Please wait...
 The product drawer is closing.
 The pipetting head moves above the
washing wells and the 3 needles go down in
their wells.

" Press the F1 key  Purge of Needle No.1.

OR
" Press the F2 key  Purge of Needle No.2.

OR
" Press the F3 key  Purge of Needle No.3.

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ACTIONS RESULTS

Exit the NEEDLE PURGE screen:  The following window is displayed:


" Press the Esc key
Do you want to return
to the previous menu
Y/N?
Esc = Cancel

" Press the Y key  Home positions of the arms.


 The Maintenance menu appears.

Access the DATES OF RECENT MAINTENANCE  The DATES OF RECENT MAINTENANCE


screen: screen appears.
" Press the L key to reach DATES OF RECENT
MAINTENANCE then confirm with the
 key

" Press the keys ALT and PrtSc  Printout of the DATES OF RECENT
MAINTENANCE screen.

Quit the DATES OF RECENT MAINTENANCE  The following window is displayed:


screen:
" Press the Esc key Do you want to return
to the previous menu
Y/N?
ESC = Cancel

" Press the Y key  The Maintenance menu is displayed.

" Press the K key to Return to the  Back to User Maintenance menu.
Previous Menu, then confirm with the
 key

Return to the Main Menu:  See chapter 3.2.


" Press the KKey to Return to the
Previous Menu, then confirm with the
 key

" Run quality controls for the routine tests  If the quality control results are consistent
" Compare results with the previous ones with the previous ones, STA Compact® can
be used.
 If not, redo the procedure.
In case of problem, call your local authorized
Service Representative.

RISK OF BIOLOGICAL CONTAMINATION


Discard the stylet soiled with biohazardous material in accordance with the local
regulations.

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4.5.3 Replacing a Sampling Needle

Cat. No.: 38646 for needle No.1


Cat. No.: 27354 for needle No.2
Cat. No.: 27307 for needle No.3

2TEST PANEL screen displayed.


ytu

ACTIONS RESULTS

Access the User Maintenance menu:  The Main Menu appears:


" Press the Esc key
Status - Loading (...) - Halt
with the cursor on Status.

" Press the M key: Maintenance  The following window appears:


" Or press the J key to reach
Maintenance, then press the  key to Initializing
confirm Please wait...
 The User Maintenance menu appears:

Rinsing Pump
Bar Code Test
Printer
Saving
Maintenance
Photometry Graphics
Error History
Host Computer Communications
Data Update
Utilities
Return to Previous Menu
with the cursor on Rinsing Pump.

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ACTIONS RESULTS

Access the Maintenance menu:  The following window is displayed:


" Press the L key to reach Maintenance,
then confirm with the  key Initialization in progress
Please wait...
 The Maintenance menu appears:

Needle Purge
Needle Replacement
Syringe Tip/Syringe Replacement
Suction Tip Replacement
Halogen Lamp Replacement
Dates of Recent Maintenance
Return to the Previous Menu
with the cursor on Needle Purge.

Access the Needle Replacement menu:  The following window is displayed:


" Press the L key to reach Needle
Replacement, then confirm with the Initializing
 key Please wait...
 The Needle Replacement menu appears:

Needle No. 1
Needle No. 2
Needle No. 3
Return to Previous Menu
with the cursor on Needle No. 1.

" Use the L key to select the needle which  The following window is displayed:
has to be changed.
" Confirm with the  key NEEDLE REPLACEMENT
For this operation, you must have:
- a new needle
- the mapping cuvette
F10: Continue - Esc: Abort

" Take a new needle and the mapping  Home positions in progress.
adjustment cuvette
 The following window is displayed:
" Press the F10 key
NEEDLE REPLACEMENT
Drawer is going to open
Press any key
to proceed

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ACTIONS RESULTS

" Press any key to proceed  Opening of the Product Drawer.


 Pipetting head moves forwards.
 The following window is displayed:

NEEDLE REPLACEMENT
once the transparent panel is raised,
you can change the needle according
to the procedure described in the
manual. When this operation is
finished, validate by pressing F10.
F10: Validate - Esc: Abort

" Proceed to the dismantling and reassembly


of the needle (see procedure hereafter)

Procedure: Dismantling of the Sampling Needle

RISK OF BIOLOGICAL CONTAMINATION

In order to avoid any risk of contamination:

- Observe the proper precautions (for instance: wear disposable gloves) for handling
biohazardous materials, in accordance with local regulations.
- Observe a procedure in accordance with local regulations to discard the potentially contaminated
needles.

" Raise the transparent panel


" Place a paper towel under the needle
" For Needles No.1 and No.2: Disconnect the tubing from the metal junction tubing at the top of
the head as shown in figure 8
" For Needle No.3: Do not disconnect the tubing at the top of the head

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Fig. 8 - Dismantling of Needles No.1 and No.2

Legend:

1 Tubing 2 Metal junction tubing

" At the bottom of the needle holder assembly, fully unscrew the knurled nut (see Fig.7 below)
" Remove this nut
" Lower the needle-tubing assembly by gently pushing on the top of the tubing
" For Needle No.3: Pull on the needle to disconnect the small tubing from the end of the heating
tube
" Remove the needle-tubing assembly
" Needle with a yellow knurled nut:
- Dispose of the needle-tubing assembly in accordance with the locally applicable regulation for
collection needles.
- Reuse the knurled nut.

" Needle with a black knurled nut:


- Dispose of the knurled nut and of this assembly in accordance with the locally applicable
regulation for collection needles.

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Fig. 9 - Needle and Knurled Nut

Legend:

1 Needle 2 Nut

Procedure: Needle Re-Assembly:

For Needles No.1 and No.2:

Cat. No.: 38646 for needle No.1


Cat. No.: 27354 for needle No.2

" If the new needle is provided with no nut: use the yellow nut of the needle that has just been
dismantled
" If the new needle is provided with a metal mandrel:
- remove the mandrel from inside the needle
- discard this mandrel

" Push the tubing into the needle holder from below
" Check that the tubing is not stuck in the needle holder
" Fully retighten the knurled nut by hand while holding the needle holder with the other hand
" Reconnect the tubing to the metal junction tubing at the top of the head (see figure 8 above)

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For Needle No.3:

Cat. No.: 27307 for needle No.3

Fig. 10 - Needle No.3

Legend:

1 End of the heating tube

2 Tubing of needle N°3

3 Needle N°3

" If the new needle is provided with no nut: use the yellow nut of the needle that has just been
dismantled
" If the new needle is provided with a metal mandrel:
- remove the mandrel from inside the needle
- discard this mandrel

" Remove some of the thermal grease in order to clearly see the end of the heating tube
" Make sure that there is no thermal grease on the end of the heating tube
" Attach the tubing of the needle to the end of the heating tube fully home (see figure 10 above)
" Push the needle-tubing assembly fully home into the needle holder
" Fully retighten the knurled nut by hand

For all the Needles:


" Check the positioning of the tubing and cables at the top to avoid any interference with arm
movements

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" Check the connections of the level detection cable from the needle holder to the electronic
circuit board
" Remove the paper towel and discard it in accordance with the locally applicable regulation
 Replacement is completed

ACTIONS RESULTS

" Press the F10 key to validate this  Needle replacement is validated.
procedure
 The following window is only displayed if the
level detection for the required arm is
managed:

NEEDLE REPLACEMENT
Level detection test.
Please use finger to touch the needle
you have just installed.
You have 19 seconds...

" Take the needle with your fingers (ensure  The following screen is displayed whether
the needle is new and not contaminated) the level detection is managed or not:

NEEDLE REPLACEMENT
Please follow these instructions:
There are only 20 seconds to perform this 1° Place the mapping cuvette in
operation. the incubation position No.16.
2° Lower the transparent panel.
F10 to continue

" Place the mapping adjustment cuvette in  Home positions.


the incubation position No.16 (see  The following window appears:
chapter 2)
" Lower the transparent panel NEEDLE REPLACEMENT
" Press the F10 key to validate this Please follow these instructions:
procedure 1° Raise the transparent panel.
2° Adjust the X and Y positions
of the needle with keyboard.
3° When the adjustment is finished,
validate.
K / L : Y adjustment - I/ J: X adjustment
F10 : Validation

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ACTIONS RESULTS

" Raise the transparent panel  The following window appears:


" Manually lower the selected needle holder
to see if the needle can enter the middle NEEDLE REPLACEMENT
hole of the mapping adjustment cuvette. Manually adjust the Z position.
Lower the transparent panel, then
If YES, press the F10 key.
validate with F10 when all is finished.
If NO, nudge the needle (1 millimeter F10 : Validation
max.) until it can enter the middle hole of
the mapping adjustment cuvette, then
confirm with the F10 key. If the problem
persists, call your local authorized Service
Representative.

DO NOT USE the moving cursor keys (K,


L, I, J) to move the needle AND
DO NOT MOVE the needle carriage arm
along the X and Y axis during these
adjustments.

" Manually lower the needle to the target  Home positions.


hole of the mapping adjustment cuvette
 Then, the following window appears:
" Continue to lower the needle until it
bottoms in the mapping cuvette NEEDLE REPLACEMENT
" Close the transparent panel Drawer is going to close,
Press any key
" Press the F10 key to validate the above
to proceed
operations

" Press any key to close the product drawer  The Drawer is closing
 The following window appears:

NEEDLE REPLACEMENT
Please raise transparent panel
to retrieve mapping cuvette.
Then lower transparent panel.
F10 to proceed

" Raise the transparent panel  The following window is displayed:


" Retrieve the mapping adjustment cuvette
NEEDLE REPLACEMENT
" Lower the transparent panel
The procedure was
" Press the F10 key to validate the above successful.
operations F10 to proceed

" Press the F10 key to proceed  The Needle Replacement menu appears

" Press the K key to Return to Previous  The Maintenance menu appears.
Menu, then confirm with the  key

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ACTIONS RESULTS

Access the Needle Purge menu:  The NEEDLE PURGE screen appears.
" Press the  key Needle Purge  Home positions.
 The needles go to their own washing wells

Needle 1 Purge:  Purge of Needle No. 1


" Press the F1 key

Needle 2 Purge:  Purge of Needle No. 2


" Press the F2 key.

Needle 3 Purge:  Purge of Needle No. 3


" Press the F3 key

Exit the Needle Purge menu:  The following window is displayed:


" Press the Esc key
Do you want to return
to the previous menu
Y/N ?
Esc = Cancel

" Press the Y key  Home positions.


 The Maintenance menu appears.

Access the DATES OF RECENT MAINTENANCE  The DATES OF RECENT MAINTENANCE


screen: screen appears.
" Press the L key to reach DATES OF RECENT
MAINTENANCE then confirm with the
 key

" Press the keys ALT and PrtSc  Printout of the DATES OF RECENT
MAINTENANCE screen.

Exit the DATES OF RECENT MAINTENANCE  The following window is displayed:


screen:
" Press the Esc key Do you want to return
to the previous menu
Y/N?
ESC = Cancel

" Press the Y key  The Maintenance menu is displayed.

" Press the K key to Return to the  Back to User Maintenance menu.
Previous Menu, then confirm with the
 key

Return to the Main Menu:  Same results as described in chapter 3.2


" Press the K key to Return to the
Previous Menu, then confirm with the
 key

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ACTIONS RESULTS

" Run quality controls for the routine tests  If the quality control results are consistent
" Compare results to the previous ones with the results run previously, the STA
Compact® is now ready for use.
 If not, redo the procedure.
In the event you encounter a problem, call
your local authorized Service
Representative.

4.5.4 Replacing the Suction Tip

Cat. No.: 27421 (supplied in pairs).

2TEST PANEL screen displayed.

ACTIONS RESULTS

Access the User Maintenance menu:  The Main Menu appears:


" Press the Esc key
Status - Loading (...) - Halt
with the cursor on Status.

" Press the M key: Maintenance  The following window appears:


" Or press the J key to reach
Maintenance, then press the  key to Initializing
confirm please wait...
 The User Maintenance menu appears:

Rinsing Pump
Bar Code Test
Printer
Saving
Maintenance
Photometry Graphics
Error History
Host Computer Communications
Data Update
Utilities
Return to Previous Menu
with the cursor on Rinsing Pump.

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Maintenance

ACTIONS RESULTS

Access the Maintenance menu:  The following window is displayed:


" Press the L key to reach Maintenance,
then confirm with the  key Initialization in progress
Please wait...
 The Maintenance menu appears:

Needle Purge
Needle Replacement
Syringe Tip/Syringe Replacement
Suction Tip Replacement
Halogen Lamp Replacement
Dates of Recent Maintenance
Return to the Previous Menu
with the cursor on Needle Purge.

Access the Suction Tip Replacement menu:  The following window is displayed:
" Press the L key to reach Suction Tip
Replacement, then confirm with the SUCTION TIP REPLACEMENT
 key Initialization in progress
Please wait ..
 The Suction Tip Replacement menu
appears:

Suction Tip Replacement


Suction Tip Test
Return to Previous Menu
with the cursor on Suction Tip
Replacement.

Access the Suction Tip Replacement menu:  The following windows are displayed:
" Press the  key Suction Tip
Replacement SUCTION TIP REPLACEMENT
Home position in progress

SUCTION TIP REPLACEMENT


For this operation, you must have:
- a new suction tip
F10: Continue - Esc: Abort

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ACTIONS RESULTS

" Take a new suction tip  Home positions.


" Press theF10 key  Suction head moves forwards.
 The following screen appears:

SUCTION TIP REPLACEMENT


Once the transparent panel is raised,
you can replace the suction tip
according to the procedure described in
the manual. When this operation is
finished, validate by pressing F10.
F10: Validate - Esc: Cancel

" Proceed to the replacement of the suction


tip (see the following procedure)

Procedure: replacement of the Suction Tip

RISK OF BIOLOGICAL CONTAMINATION

In order to avoid any risk of contamination:


Observe the proper precautions (for instance: wear disposable gloves) for handling
biohazardous materials, in accordance with the local regulations.

" Raise the transparent panel


" Remove the cuvette disposal drawer
" Remove the suction tip by pulling it
" Dispose of the suction tip.
" Fit the new suction tip in place

Do not press the suction tip too hard: the suction tip test may fail.

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Fig. 11 - Replacement of the Suction Tip

Legend:

1 Suction tip

" Put the cuvette disposal drawer back in place.

ACTIONS RESULTS

" Press the F10 key to validate the  The following window appears:
replacement
SUCTION TIP REPLACEMENT
You have replaced the suction tip.
Please lower the transparent panel in
order to run automatic
tests that are necessary to validate
the installation.
F10 to validate the installation

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ACTIONS RESULTS

" Lower the transparent panel  The following window appears:


" Press the F10 key to run the suction test
SUCTION TIP REPLACEMENT
Home position in progress ...
 Test of the suction tip on the measurement
plate
 The following window appears:

SUCTION TIP REPLACEMENT


The procedure was
successful:
Detection has succeeded
Space Bar to proceed ...
 If the test fails, redo the procedure:
" Remove the suction tip;
" Check that it is not damaged:
- if the suction tip is damaged, replace it and
redo the test
- if the suction tip is not damaged, re-install it
and redo the test

" Press the Space Bar to proceed  The Suction Tip Replacement menu
appears.

" Press the K key to Return to Previous  The Maintenance menu appears.
Menu, then confirm with the  key

Access the DATES OF RECENT MAINTENANCE  The DATES OF RECENT MAINTENANCE


screen: screen appears.
" Press the L key to reach DATES OF RECENT
MAINTENANCE then confirm with the
 key

" Press the keys ALT and PrtSc  Printout of the DATES OF RECENT
MAINTENANCE screen.

Exit the DATES OF RECENT MAINTENANCE  The following window is displayed:


screen:
" Press the Esc key Do you want to return
to the previous menu
Y/N?
ESC = Cancel

" Press the Y key  The Maintenance menu is displayed.

" Press the K key to Return to Previous  The User Maintenance menu appears.
Menu, then confirm with the  key

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Maintenance

ACTIONS RESULTS

Return to the Main Menu:  See chapter 3.2.


" Press the K key to Return to the
Previous Menu, then confirm with the
 key

4.5.5 Replacing the Halogen Lamp (not available on STA Compact< CT)

Cat.No.26699

2TEST PANEL screen displayed.

ACTIONS RESULTS

Access the User Maintenance menu:  The Main Menu appears:


" Press the Esc key
Status - Loading (...) - Halt
with the cursor on Status.

" Press the M key: Maintenance  The following window appears:


" Or press the J key to reach
Maintenance, then press the  key to Initializing
confirm Please wait...
 The User Maintenance menu appears:

Rinsing Pump
Bar Code Test
Printer
Saving
Maintenance
Photometry Graphics
Error History
Host Computer Communications
Data Update
Utilities
Return to Previous Menu
with the cursor on Rinsing Pump.

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Maintenance

ACTIONS RESULTS

Access the Maintenance menu:  The following window is displayed:


" Press the L key to reach Maintenance,
then confirm with the  key Initialization in progress
Please wait...
 The Maintenance menu appears:

Needle Purge
Needle Replacement
Syringe Tip/Syringe Replacement
Suction Tip Replacement
Halogen Lamp Replacement
Dates of Recent Maintenance
Return to the Previous Menu
with the cursor on Needle Purge.

Access the Halogen Lamp Replacement  The following window is displayed:


menu:
" Press the L key to reach Halogen Lamp Initializing ...
Replacement, then confirm with the  The Halogen Lamp Replacement menu
 key appears:

Lamp Replacement
Lamp Test
Return to Previous Menu
with the cursor on Lamp Replacement.

" Press the  key to Lamp Replacement  The following window is displayed:

LAMP REPLACEMENT
For this operation, you must have:
- a new halogen Lamp
- a screwdriver
F10: Continue - Esc: Abort

" Take a Philips screwdriver and a new  The following window is displayed:
halogen lamp
" Press the F10 key HALOGEN LAMP REPLACEMENT
You can replace halogen lamp
according to the procedure described in
the manual
Caution!
The lamp may be hot!
F10: Validate - Esc: Abort

" Proceed to the replacement of the halogen


lamp (see following procedure)

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Procedure: Replacement of the halogen Lamp

RISK OF INJURY

In order to avoid any risk of burn:


Allow the lamp holder to cool down before handling it.

1 Open the right side door of the STA Compact<


2 Loosen the milled screw

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3 Remove the small door


4 Raise the lamp holder

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5 Hold the lamp holder up with one hand


Remove the used lamp from its holder with the other hand while using dry paper tissue or cloth
in order to avoid burn or possible injury

Do not touch the new lamp with your bare fingers. Always use paper tissue or dry cloth when
handling a new lamp.

6 Raise the lamp holder


Hold it up with one hand
Take the new lamp with the other hand without touching it directly (use a paper tissue or a dry
cloth)
Fit the new lamp to its holder

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7 Gently release the lamp holder


8 Replace the small door

9 Tighten the milled screw


10 Close the right side door of the STA Compact<

ACTIONS RESULTS

" Press the F10 key to validate the lamp  The following window is displayed:
replacement
HALOGEN LAMP REPLACEMENT
You have replaced the lamp.
Please validate in order to
perform a photometric test
F10 to start test

" Press the F10 key  Halogen lamp test in process.


 At the end of this test, the following window
appears:

LAMP REPLACEMENT
The procedure was successful
Space Bar to proceed...
 The lamp maintenance timer is reset to
100% (see SYSTEM STATUS screen).
 If a problem occurs during the procedure,
redo the procedure.

" Press the Space Bar to proceed  The Halogen Lamp Replacement menu
appears.

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ACTIONS RESULTS

" Press the K key to Return to Previous  The Maintenance menu appears.
Menu, then confirm with the  key

Access the DATES OF RECENT MAINTENANCE  The DATES OF RECENT MAINTENANCE


screen: screen appears.
" Press the L key to reach DATES OF RECENT
MAINTENANCE then confirm with the
 key

" Press the keys Alt and PrtSc  Printout of the DATES OF RECENT
MAINTENANCE screen.

Exit the DATES OF RECENT MAINTENANCE  The following window is displayed:


screen:
" Press the Esc key Do you want to return
to the previous menu
Y/N?
ESC = Cancel

" Press the Y key  The Maintenance menu is displayed.

" Press the K key to Return to Previous  The User Maintenance menu appears.
Menu, then confirm with the  key

Return to the Main Menu:  See chapter 3.2.


" Press the K key to Return to the
Previous menu, then confirm with the
 key

4.5.6 Replacing the Main Fuses

230 V STA Compact® :


serial n° < 5255: Cat.No. 27037 (set of ten slow blow 4A fuses, 6,3x32)
serial n° 5255: Cat.No. 39784 (set of ten slow blow 4A fuses, 5x20)

100 V / 115 V STA Compact®:


serial n° < 5396: Cat.No. 27225 (set of ten slow blow 8A fuses, 6,3x32)
serial n° 5396: Cat.No. 39785 (set of ten slow blow 8A fuses, 5x20)

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RISK OF INJURY

In order to avoid any risk of electrocution:


Turn the analyzer off before proceeding.

Fig. 12 - Fuses location

Legend:

1 Main fuses

2 Secondary fuses

The main fuses are in two fuse holders, near the ON/OFF switch on the left hand panel of the STA
Compact® (see figure 12).
" Switch off the STA Compact® (the green indicator switched off)
" Insert a screwdriver into the slot of the fuse holder. Fully unscrew the fuse holder (in direction
shown by the arrow, counterclockwise); the fuse holder will come free
" Remove and replace each fuse with a fuse sharing the same Catalog Number (see above)
" Reinstall each fuse holder by screwing it fully home (reverse arrow direction, clockwise)
" Switch ON the STA Compact® (green indicator switched on)

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4.5.7 Replacing the Secondary Fuses

230 V STA Compact®, serial n° < 5255


and 95 V / 115 V STA Compact® ,serial n° < 5396:
Cat.No. 27034 (set of ten slow blow 0,3A fuses, 6,3x32)
Cat.No. 27579 (set of ten slow blow 1 A fuses, 6,3 x 32)
Cat.No. 27037 (set of ten slow blow 4 A fuses, 6,3 x 32)
Cat.No. 27575 (set of ten slow blow 6,25A fuses, 6,3 x 32)
Cat.No. 27225 (set of ten slow blow 8 A fuses, 6,3 x 32)
Cat.No.. 27224 (set of ten slow blow 10 A fuses, 6,3 x 32)

230 V STA Compact®, serial n° 5255


and 95 V / 115 V STA Compact®, serial n° 5396:
Cat.No. 39783 (set of 10 slow blow 0,315A fuses, 5x20)
Cat.No. 39880 (set of 10 slow blow 1A fuses, 5x20)
Cat.No. 26681 (set of 10 slow blow 6,3A fuses, 5x20)
Cat.No. 39785 (set of 10 slow blow 8A fuses, 5x20)
Cat.No. 39863 (set of 10 slow blow 10A fuses, 5x20)
Cat.No. 39784 (set of 10 slow blow 4A fuses, 5x20)

RISK OF INJURY

In order to avoid any risk of electrocution:


Turn the analyzer off before proceeding.

The secondary fuses are on the left panel of the STA Compact® (see Fig. 12 -).
" Switch off the STA Compact®
" If necessary, unscrew the protective fuse plate
" Insert a screwdriver into the slot of the fuseholder containing the fuse to be replaced
" Press in fully and rotate in the direction shown by the arrow (counterclockwise): the fuseholder
will come free
" Remove and replace teach fuse with a fuse sharing the same Catalog Number (see above)
" Reinstall the fuseholder by turning in the reverse direction (clockwise)
" If necessary, screw the fuse protective plate back on
" Switch ON the STA Compact®

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4.5.8 Dirty Liquid filters


This operation cannot be done without service Maintenance authorization.
Probable causes :
- For the liquid filter related to the STA<-Cleaner Solution bottle: inversion between the STA<-
Cleaner Solution bottle and the used liquid bottle.
- For the liquid filter related to the suction tip: contamination due to suction of plasmas

Cat.No. 27458

RISK OF BIOLOGICAL CONTAMINATION

In order to avoid any risk of contamination:


Observe the proper precautions (for instance: wear disposable gloves) for handling
biohazardous materials, in accordance with the local regulations.

" Switch the STA Compact® off (see chapter 3.6.2).


" Open the right side door.
" Remove the STA<-Cleaner Solution bottle and the used liquid bottle.
" Remove the bottle support.

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Fig. 13 - Liquid filters location (two possible cases)

Legend:

1 Suction liquid filter

2 STA<-Cleaner Solution bottle liquid filter

" Remove the old filter (avoid STA<-Cleaner Solution drop to fall on the electrical parts).
See their location on figure 13.
" Dispose of the filter in accordance with local existing regulations.
" Fit the new filter by positionning it according to figure 13.
" Put the various parts back in place.
" Switch on the STA Compact® and press the Delete key to access the User Maintenance
menu.
" Proceed with the needle purges (see below), those are very important to eliminate the air
bubbles.

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2User Maintenance menu displayed.

ACTIONS RESULTS

Access the Maintenance menu:


" Press the L key to reach Maintenance,  The following widow appears:
then press the  key to confirm.
Initialization in progress
Please wait...
 The Maintenance menu appears:

Needle Purge
Needle Replacement
Syringe Tip / Syringe Replacement
Suction Tip Replacement
Halogen Lamp Replacement
Dates of Recent Maintenance
Return to the Previous Menu
with the cursor on Needle Purge.

Access to the Needle Purge menu:


" Press the  key (Needle Purge) to  The Needle Purge screen appears.
confirm.
 The following windows appears:

Checks in progress
Please wait...

Home position in progress


Please wait...

Positionning in well
Please wait...

Needle N°1 Purge:


" Press the F1 key  Purge of Needle N°1
" Repeat Purge N°1

Needle N°2 Purge:


" Press the F2 key  Purge of Needle N°2

Needle N°3 Purge:


" Press the F3 key  Purge of Needle N°3

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ACTIONS RESULTS

Exit the Needle Purge screen:


" Press the Esc key  The following window appears:

Do you want to return


to the previous menu
Y/N ?
ESC = Cancel

" Press the Y key  Home positions of the arms.


 The Maintenance menu appears.

" Press the K key to Return to the  Back to the User Maintenance menu
previous menu, then confirm with the 
key

Return to the Main Menu:


" Press the K key to Return to the  See chapter 3.2
Previous menu, then confirm with the 
key.

4.6 Decontamination Procedure

RISK OF BIOLOGICAL CONTAMINATION

In order to avoid any risk of contamination and in compliance with international laws and standards
concerning health and security at the working place:
Before any intervention of a field service engineer, perform the decontamination
procedure of the analyzer.

The decontamination procedure consists of the following:


- Cleaning of the sample drawer, the product drawer and the measurement plate: see
chapter 4.2.5. and 4.2.6.
- Cleaning of the washing wells: see chapter 4.2.4.

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4.7 Maintenance Utility


This Maintenance Utility will help the operator to maintain the analyzer in good operating condition.
After each replacement, a test is performed automatically.
If a problem occurs, this program allows the user to diagnose the problem or the defect.
The organization of the Maintenance utility is described in the flowchart below:

Fig. 14 - Organization of the Maintenance Utility

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4.7.1 How to Access the User Maintenance Menu


There are three ways to access this menu:

2TEST PANEL screen displayed.

ACTIONS RESULTS

" Press the Esc key " The Main Menu appears:

Status - Loading (...) - Halt


with the cursor on Status.

" Press the M key: Maintenance  The following window appears:


" Or press the J key to Maintenance and
then confirm with the  key Initializing
Please wait...
 The User Maintenance menu appears:

Rinsing Pump
Bar Code Test
Printer
Saving
Maintenance
Photometry Graphics
Error History
Host Computer Communications
Data Update
Utilities
Return to Previous Menu
with the cursor on Rinsing Pump.

2When switching on the analyzer.

ACTIONS RESULTS

" Switch ON the STA Compact®  The following window and message appear:

STA Compact SYSTEM

Press Delete to access the Maintenance


menu.

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ACTIONS RESULTS

" Press the Delete key to access the User  The User Maintenance menu appears:
Maintenance menu
Rinsing Pump
Bar Code Test
Printer
Saving
Maintenance
Photometry Graphics
Error History
Host Computer Communications
Data Update
Utilities
Return to Previous Menu
with the cursor on Rinsing Pump.

2Error message displayed.

ACTIONS RESULTS

" Press the Alt + F10 keys simultaneously  The User Maintenance menu appears:

Rinsing Pump
Bar Code Test
Printer
Saving
Maintenance
Photometry Graphics
Error History
Host Computer Communications
Data Update
Utilities
Return to Previous Menu
with the cursor on Rinsing Pump.

4.7.2 Rinsing Pump


This program enables checking of the good functioning of:
- The liquid level detection for the 3 needles
- The “Valcor” pump

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4.7.2.1 How to Access the Rinsing Pump Menu

2User Maintenance displayed.

ACTIONS RESULTS

" Press the  key Rinsing Pump  The following window is displayed:

Sample Needle Cleaning


Verification of rinsing volume
Return to the Previous Menu
with the cursor on Sample Needle
Cleaning

" Press the L key Verification of the  The Rinsing Pump menu appears:
rinsing volume and validate with the 
key Rinsing Needle No.1
Rinsing Needle No.2
Rinsing Needle No.3
Return to Previous Menu
with cursor on Rinsing Needle No.1.

4.7.2.2 Rinsing Needle No.1, No.2, No.3

2Rinsing Pump menu displayed.

ACTIONS RESULTS

" Press the  key Rinsing Needle No.1  The following window appears :
" Or press the L key Rinsing Needle No.2
then confirm with the  key VOLUME PUMP TEST
INFORMATIONS
" Or press the L key Rinsing Needle No.3
VIAL POSITION
then confirm with the  key
Needle used : 1
Vial Position :
Pulse Number :
Pump Volume :
Drawer No.2 will open.
Press a key
to continue
1: Needle Number

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ACTIONS RESULTS

" Press any key to continue  Product drawer is opening.


 A new message is displayed at the bottom of
the preceding window:

VOLUME PUMP TEST


INFORMATIONS
VIAL POSITION
Needle used : 1
Vial Position :
Pulse Number :
Pump Volume :
Place a vial in Drawer No.2

" Place an empty vial in the product drawer  The vial position is displayed.
in a position corresponding to its diameter  A confirmation message appears at the
bottom of the window:

VOLUME PUMP TEST


INFORMATIONS
VIAL POSITION
Needle used : 1
Vial Position : 33
Pulse Number :
Pump Volume :
Validate the position
Esc: Quit F10: Validate

" Check the vial position then press the F10  A message requesting the closing of the
key to confirm drawer appears at the bottom of the screen:

VOLUME PUMP TEST


INFORMATIONS
VIAL POSITION
Needle used : 1
Vial Position : 33
Pulse Number :
Pump Volume :
Drawer No.2 will close.
Press a key
to continue

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ACTIONS RESULTS

" Press any key to continue  Product drawer is closing.


 Test in progress.
 The pulse number decrements to reach 0.
 GOOD appears near Pump Volume in the
window:

VOLUME PUMP TEST


INFORMATIONS
Needle used : 1
Vial Position : 33
Pulse Number : 0
Pump Volume : GOOD
Press a key
to continue
 Call your local authorized Service
Representative, if GOOD does not appear
in the window.

" Press any key  Home position in progress.


 Back to Rinsing Pump menu.

" Remove the vial

RISK OF BIOLOGICAL CONTAMINATION


In order to avoid any risk of contamination:
Observe the proper precautions (for
instance: wear disposable gloves) for
handling biohazardous materials, in
accordance with local existing regulations.
" Discard the vial in accordance with local
existing regulations.

4.7.2.3 Exiting the Rinsing Pump Menu

2Rinsing Pump menu displayed

ACTIONS RESULTS

" Press the K key to reach Return to  The User Maintenance menu appears.
Previous Menu, then confirm with the
 key

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4.7.3 Bar Code Reader


This program checks for accurate reading of bar codes.
This program can be used after the bar code reader set up (see your local authorized Service
Representative for this operation) to define the characters which have to be deleted by the bar code
reader during the reading (access this option via the Global Options menu, see chapter 10.2.2.4).
Deletion of characters is performed while using Sample Loading menu but not in this menu.

RISK OF INCORRECT RESULTS

In order to avoid barcode reading errors:


- Only activate the barcodes that are currently used.
- Deactivate the barcodes that are not used, if necessary.

4.7.3.1 How to access the Bar Code Test menu

2User Maintenance menu displayed.

ACTIONS RESULTS

" Press the L key to reach Bar Code Test,  The BAR CODE READER screen appears (see
then confirm with the  key Fig.15 below).

Fig. 15 - BAR CODE READER Screen

Legend:

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1 Results of bar code readings


A cross appears in the box “STA Codes” when bar codes from Diagnostica Stago are used

2 List of possible codes

3 Enable: Bar Code Reader is set to read the code


Disable: Bar Code Reader is not set to read the code

4.7.3.2 Bar Code Reader Testing

2BAR CODE READER screen displayed.

ACTIONS RESULTS

" Take a vial of any STA< product and  When the vial is identified:
identify it with the bar code reader
- audible beep;
- display of the product identification
and name;
- display of a cross in the box “STA Codes”.

" Take a label used in the laboratory  When the label is detected:
- audible beep;
- display of the identified value.

 If the label is not detected:


- code not set;
- call your local authorized Service
Representative

4.7.3.3 Quit the Bar Code Test menu

2BAR CODE READER screen displayed, bar code reader waiting for a test.

ACTIONS RESULTS

" Press the Esc key to return to the User  The following window appears:
Maintenance menu
Do you want to return to the
previous menu
Y/N ?
Esc = Cancel

" Press the Y key  The User Maintenance menu appears.

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4.7.4 Printer
This program allows to check:
- The printer connection
- The printout of texts or graphics
For the printer maintenance: replacement of the toner cartridge or ribbon, refer to the printer
manual.

4.7.4.1 How to Access the Printer Menu

2User Maintenance menu displayed.

ACTIONS RESULTS

" Press the L key to reach Printer, then  The Printer menu is displayed:
confirm with the  key
Connection Checking
Test of the Characters
Graphics
Return to Previous Menu
with the cursor on Connection Checking.

4.7.4.2 Connection Checking

2Printer menu displayed.

ACTIONS RESULTS

" Press the  key Connection Checking If the printer is correctly connected:
 The message "Printer connected" is
displayed.
Otherwise:
 An error message is displayed.

In case of error message:  If Printer problems persist, call your local


" Press Esc to delete the error message authorized Service Representative.

" Check the connection of the printer with


the STA Compact®
" Perform this test again

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4.7.4.3 Testing the printout of characters

2Printer menu displayed.

ACTIONS RESULTS

" Press the L key to reach Test of the  The PRINTER CHARACTER SET TEST screen
Characters, then confirm with the  key appears (see figure 16 below).

Fig. 16 - PRINTER CHARACTER SET TEST Screen

ACTIONS RESULTS

" Press simultaneously the Control + I keys  A window is displayed, it indicates that the
to print out this screen printer is connected.
 The whole displayed screen prints out.

" Check the printout  If problems on the printout occur, the user
should:
• Check printer configuration (switches) by
means of chapter 4.7.4.6.
• Check printer itself (paper, ribbon tape,
cleanliness, etc.).

" Press the Esc key to return to the Printer  The Printer menu appears.
menu

4.7.4.4 Testing the printout of graphics

2Printer menu displayed.

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ACTIONS RESULTS

" Press the L key to reach Graphics, then  The GRAPHICS screen appears (see figure 17
confirm with the  key below).

Fig. 17 - GRAPHICS Screen

ACTIONS RESULTS

" Press simultaneously the Control + I keys  A window appears indicating that the printer
to print out this screen is connected.
 The whole displayed screen prints out.

" Check the printout  If problems on the printout occur, the user
should:
• Check printer configuration (switches) by
means of chapter 4.7.4.6
• Check printer itself (paper, ribbon tape,
cleanliness, etc.).

" Press the Esc key to return to the Printer  The Printer menu appears.
menu

4.7.4.5 Quit the Printer Menu

2Printer menu displayed.

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ACTIONS RESULTS

" Press the L key to Return to the previous  The User Maintenance appears.
menu and then, confirm with the key

4.7.4.6 Printer Configuration


For an IBM or EPSON generic printer, see printer manual and observe the following
recommendations.

PARAMETER CHOICE REMARKS

Emulation mode IBM Proprinter X24E Primordial, any other choice will lead to
unpredictable results in graphic mode.

Character Set Code Page 437 Primordial for all semi-graphic


characters (table printout).

Interface Type Parallel STA Compact® cannot control printout


through serial mode.

Image Density High Density (t300dpi) If applicable.

Auto Line Feed No No automatic line feed after a carriage


return.

Form Length 11 or 12 inches According to paper format.

Line Spacing 6 lines per inch Si applicable.

Print Quality Normal mode If applicable, to speed up the printout.

Skip-Over Perforation No If applicable.

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4.7.5 Saving
This program allows to save or to load the following parameters:

Diagnostica Stago cannot be held responsible in case of data-processing contamination or/and


malfunction of user’s equipment resulting from the use of floppy disks or any other material in
particular during the saving and/or file transfers as described in this manual.

Before saving, format the diskette with the STA Compact® (see below, chapter 4.7.5.5).
To avoid computer viruses, do not use the saving diskette on any other PC system.

RISK OF INCORRECT RESULTS

When the parameters are loaded, saved data are transfered and data in the base are overwritten.

In order to avoid any risk of loss of data, any risk of wrong results:
Do not load parameters if you do not have the authorized Service Representative
agreement beforehand.

SAVING LOADING

Tests Configuration After each modification in the According to the local


Test Setup or in the Global authorized Service
Options. Representative.

System Parameters After each modification of the According to the local


system parameters or after each authorized Service
Service call. Representative.

Error Messages Only for Service Representative. Only for Service


Representative.

4.7.5.1 How to Access Saving Menu

2User Maintenance menu displayed.

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ACTIONS RESULTS

" Press the L key to reach Saving, then  The SAVE/REREAD THE PARAMETERS screen
confirm with the  key appears (see figure 18 below) with the
cursor on Selection of Items.

Fig. 18 - SAVE/REREAD THE PARAMETERS Screen

4.7.5.2 Selection of Items

2SAVE/REREAD THE PARAMETERS screen displayed.

ACTIONS RESULTS

" Press the  key to select the items  The cursor goes to the Test
Configurations area.
 A help window for selection appears at the
left bottom of the screen.
 The following items can be selected:
- Test Configuration
- System Parameters
- Error Messages

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ACTIONS RESULTS

Select the items:  Selection of Items done.


" Press theK orL keys to move the cursor
" Press the Space Bar key to select/
unselect an item
" Press the F8 key to select/unselect all the
items
" Press the Esc key to cancel the selection

" Press the F10 key to confirm the selection  Selection of Items validated

4.7.5.3 Loading
" Select the items which have to be loaded (see chapter 4.7.5.2).

RISK OF INCORRECT RESULTS

Loading brings about the deletion of the data of the selected files (Test Configurations, System
parameters and/or Error messages).

In order to avoid any risk of loss of data, any risk of wrong results:
- Do not load parameters if you do not have the authorized Service Representative
agreement beforehand.
- Never load Error messages: this option is exclusively for the authorized Service
Representative agreement. Make sure that the item ERROR MESSAGES has not been selected by
mistake.

2SAVE/REREAD THE PARAMETERS screen displayed.

ACTIONS RESULTS

" Press the L key to Load then confirm with  The following windows will be displayed
the  key according to the selected parameters:

Do you want to re-read


selected parameters ?
Return: Valid - Esc: Cancel
or

Caution: This operation


will erase set up
on the STA Compact<
Return: Valid - Esc: Cancel

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ACTIONS RESULTS

" Press the  key to confirm  The following window appears:

SAVING/LOADING PARAMETERS
Please insert load diskette
in the drive.
Return: Valid - Esc: Cancel

" Insert the required diskette into the floppy  The following windows appear during the
drive then confirm with the  key loading:

Diskette Control in Progress


Please wait

Loading
Please wait

Advance %
/__/__/__/__/__/__/__/

Loading OK
 Then, the SAVE/REREAD THE PARAMETERS
screen appears at the end of the loading.

4.7.5.4 Saving
Prior: Select the items which have to be saved (see section 4.7.5.2).

2SAVE/REREAD THE PARAMETERS screen displayed.

ACTIONS RESULTS

" Press the L key to reach Save, then  The following window appears:
confirm with the  key
SAVING/LOADING PARAMETERS
Do you want to save
selected parameters ?
Return: Valid - Esc: Cancel

" Press the  key to confirm  The following window is displayed:

Please insert save diskette


in the drive.
Return: Valid - Esc: Cancel

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ACTIONS RESULTS

" Insert a 3 1/2", 1.44 Mo diskette into the  The following window appears:
floppy drive, then confirm with the  key
Diskette Control in Progress
Please wait
 If all items have been selected, the following
window is displayed:

SAVING/LOADING PARAMETERS
Valid to start diskette format;
Caution! This operation will
erase all data on the diskette
Return: Valid - Esc: Cancel

" If all items have been selected, press the  The following windows appear during
 key formatting (if all items have been selected):

Format in progress
Please wait

Advance %
/__/__/__/__/__/__/__/
 The following windows appear in any case:

Saving
Please wait

Advance %
/__/__/__/__/__/__/__/

Saving OK
 Then, the SAVE/REREAD THE PARAMATERS
screen appears at the end of the Parameters
Saving.

4.7.5.5 Formatting a diskette

Erases all data (all files) of the diskette. This operation enables to re-use a diskette with full capacity.

2SAVE/REREAD THE PARAMATERS screen displayed.

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ACTIONS RESULTS

" Press the L key to reach Format a Diskette,  A warning indication appears in the
then confirm with the  key displayed window:

Saving/loading parameters
Please insert in the drive
the diskette to format
Caution: this operation
will erase all data
on the diskette !
Return: Valid - Esc: Cancel

" Insert a 3 1/2" into the floppy drive, then  The following windows appear while
confirm with the  key formatting:

Format in progress
Please wait

Advance %
/__/__/__/__/__/__/__/
 Then, the SAVE/REREAD THE PARAMETERS
screen appears at the end of the formatting.

4.7.5.6 Quit the Saving Menu

2SAVE/REREAD THE PARAMETERS screen displayed.

ACTIONS RESULTS

" Press the L key to reach Return to  The following window is displayed:
Previous Menu, then confirm with the
 key Updating files
Please wait...
 The User Maintenance menu appears.

4.7.6 Maintenance
This program helps the operator to replace:
- The Needles
- The SyringeTip and/or the Syringe
- The Suction Tip
- The Halogen Lamp of the optical module (not available on STA Compact< CT)

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It also enables to facilitate some maintenance procedures and to have access to a history of the recent
maintenances.

4.7.6.1 How to Access the Maintenance Menu

2Maintenance menu displayed

ACTIONS RESULTS

" Press the L key to reach Maintenance,  The following window is displayed:
then confirm with the  key
Initialization in progress
Please wait...
 The maintenance menu appears:

Needle Purge
Needle Replacement
Syringe Tip/Syringe Replacement
Suction Tip Replacement
Halogen Lamp Replacement
Dates of Recent Maintenance
Return to the Previous Menu
with the cursor on Needle Purge.

4.7.6.2 Needle Purge


This program allows to purge the hydraulic circuit to exclude bubbles from tubings.

How to Access the Needle Purge Menu

2Maintenance menu displayed.

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ACTIONS RESULTS

" Press the  key Needle Purge  The NEEDLE PURGE screen appears.
 The following windows appear:

Checks in progress
Please wait...

Home position in progress


Please wait...

Positioning in well
Please wait...

Fig. 19 - NEEDLE PURGE Screen

How to perform a Needle Purge

RISK OF BIOLOGICAL CONTAMINATION

In case a problem occurs during the purge:


- Do not proceed to any operation on the analyzer
- Make an emergency stop of the analyzer by pressing simultaneously the Alt and F10 keys.
- Call your local authorized Service Representative.

2NEEDLE PURGE screen displayed.

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ACTIONS RESULTS

" Press the F1 key  Purge of Needle No.1.

" Press the F2 key  Purge of Needle No.2.

" Press the F3 key  Purge of Needle No.3.

Quit the Needle Purge Menu

2NEEDLE PURGE screen displayed.

ACTIONS RESULTS

" Press the Esc key  The following window is displayed:

Do you want to return to the


previous menu
Y/N ?
Esc = Cancel

" Press the Y key  Home positions.


 The Maintenance menu appears.

4.7.6.3 Needle Replacement


See description in chapter Replacing Components, chapter 4.5.3.

4.7.6.4 Syringe Tip/Syringe Replacement


See description in chapter Monthly User Preventive Maintenance, chapter 4.3.

4.7.6.5 Suction Tip Replacement

2Maintenance menu displayed.

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ACTIONS RESULTS

" Press the L key to reach Suction Tip  The following window is displayed:
Replacement, then confirm with the
 key Initializing...
 The Suction Tip Replacement menu
appears:

SUCTION TIP REPLACEMENT


Suction Tip Test
Return to Previous Menu
with the cursor on Suction Tip
Replacement.

Suction Tip Replacement


See description in chapter Replacing Components, chapter 4.5.4.
Suction Tip Test

2Suction Tip Replacement menu displayed.

ACTIONS RESULTS

" Press the L key to Suction Tip Test then  The following window appears:
confirm with the  key
Home position in progress
 Test of the suction tip on the measurement
plate.
 The following window appears:

SUCTION TIP REPLACEMENT


The procedure was
successful :
Detection has succeeded
Space Bar to proceed...

" Press the Space Bar to proceed  The Suction Tip Replacement menu
appears

4.7.6.6 Halogen Lamp Replacement (not available on STA Compact< CT)

2Maintenance menu displayed

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ACTIONS RESULTS

" Press the L key to reach Halogen Lamp  The following window is displayed:
Replacement, then confirm with the
 key Initializing...
 The Halogen Lamp Replacement menu
appears:

Lamp Replacement
Lamp Test
Return to Previous Menu
with the cursor on Lamp Replacement.

Lamp Replacement
See description in chapter Replacing Components, chapter 4.5.6.

Lamp Test

2Halogen Lamp Replacement menu displayed.

ACTIONS RESULTS

" Press the L key to Lamp Test, then  Halogen lamp test in process.
confirm with the  key
 At the end of this test, the following window
appears:

LAMP REPLACEMENT
The procedure was
successful
Space Bar to proceed...

" Press the Space Bar to proceed  The Halogen Lamp Replacement menu
appears.

Return to Previous Menu

2Halogen Lamp Replacement menu displayed.

ACTIONS RESULTS

" Press the L key to reach Return to  The Maintenance menu appears.
Previous Menu, then confirm with the
 key

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4.7.6.7 Dates of Recent Maintenance


This screen groups the dates and times of the recent maintenances for several parts of the STA
Compact®;
- Rinsing of needles No.1, No.2, No.3
- Replacement of needles No.1, No.2, No.3
- Replacement of the syringe (or of the Teflon tip)
- Replacement of suction tip
- Replacement of halogen lamp (not available on STA Compact< CT)
After each replacement or maintenance procedure, it is recommended to print this screen in order
to keep it in the maintenance log books used by the laboratory.

2Maintenance menu displayed

ACTIONS RESULTS

" Press the L key to reach Dates of Recent  The DATES OF RECENT MAINTENANCE
Maintenance then confirm with the  key screen appears (see Fig. 20 below).

" Press the keys Alt and Prtsc  Printout of the DATES OF RECENT
MAINTENANCE screen.

" Press the Esc key  The following window is displayed:

Do you want to return to the


previous menu
Y/N ?
Esc = Cancel

" Press the Y key  Home positions.


 The Maintenance menu appears.

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Fig. 20 - DATES OF RECENT MAINTENANCE Screen

4.7.6.8 Quit the Maintenance Menu

2Maintenance menu displayed

ACTIONS RESULTS

" Press the L key to reach Return to  Return to the User Maintenance menu.
Previous Menu, then confirm with the
 key

4.7.7 Photometry Graphics (not available on STA Compact< CT)


- In case of error on the colorimetry/immunology results, this program allows to provide
information used to help the Service Representative solve the problem
- This program enables to define new test settings for the colorimetry or immunology tests on the
STA Compact<

4.7.7.1 How to access the Photometry Graphics menu

2User Maintenance menu displayed

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ACTIONS RESULTS

" Press the L key to reach Photometry  The list of the last 99 files appears. The
Graphics, then confirm with the  key following keys are available:

 View
K,L Scroll
Esc Quit
Home Beginning of List
End End of List
 Previous page
 Following page

" Select the required file  The required graphics appear (see figure 21
below)
" Confirm with the  key

Fig. 21 - COLORIMETRY GRAPHICS (Example)

Legend:

1 Available functions:

Esc Back tot the User Maintenance menu.

F2 Point deletion or restoration, see 4.7.7.2.

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F3 Change in the display of the points.

In OD/Minute kinetic:
Full Calculus: all the points recorded during the test and not deleted are displayed in
yellow.
STA Calculus: only the points used to calculate the regression coefficient are displayed in
yellow.

In kinetic 2 points:
Full Calculus: T0, T1, the point before T0 and the point before T1 are displayed in red.
The other points are displayd in yellow.
STA Calculus: T0, T1, the point before T0, the point before T1, the point after T0, the
point after T1 and the recalculated points are displayed in red. The other points are
displayed in yellow.

The file is created when the sample is aspirated.


If no result has been given by the STA Compact®:
- no regression curve is displayed
- regression coefficient is zero
- OD value is zero
- measurement channel is zero

F4 Cursor movement change.


POINTS: the cursor can only go on the points recorded during the test
CURVE: the cursor can only go on the points of the regression curve

F5 Change in the graphic display.


Reduced scale: display of the graphic between measurement min. and measurement max.
Full scale: display of the graphic between DO min. and DO max.

F6 Screen print.

F7 Print out of the list of measurement values.


The pair of points [Time(sec); Optical Density (OD)] displayed in bold are those used by
the STA Compact® for the regression calculation.

F8 Modification of the window calculation limits.

F10 Display of another Patient File.

I Cursor movement.
J

+/- Modification of the step of the cursor movement.


Step: the number indicates the number of points between each cursor movement.

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2 Name of the screen: USER MAINTENANCE/COLORIMETRY GRAPHICS or IMMUNOLOGY


GRAPHICS, depending on the test

3 Date and Time of the results saving, name of the file, and channel used for measurement

4 Abbreviation of the test, type of method (OD/minute kinetics or kinetic 2 points), and file
Identification

5 Measurement points and regression curve:


• Point displayed in yellow: Point used for the regression calculation
• Point displayed in red: Point not used for the regression calculation

6 Reject criteria:

Kinetic OD/Minute:

Min OD
Recall of the linearity range of the measurement system.
Max OD

Slope Default value.

R Regression coefficient for the selected test as defined in the TEST SETUP
screens.

Kinetic 2 points:

Min OD
Recall of the linearity zone of the measurement system.
Max OD

7 Characteristics of the curve:

Kinetic OD/Minute:

OD Equation of the regression curve: a + b x Time


where a = intercept point and b =slope
R Regression coefficient

The equation of the regression curve (OD) and the regression coefficient (R) are calculated with
the yellow points included in the calculation window.
These values are updated at every addition/retrieval of one point in the window calculation or after
using the F3 key.

Kinetic 2 points:

'OD Optical density difference:


optical density at the the final time (T1) minus optical density at the initial time (T0)
T0 Initial Time
T1 Final Time

The calculation is updated when the limits of the calculation window are modified.

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8 Display of the intercept points of the cursor (OD and Time)

9 Calculation window

4.7.7.2 Eliminating or Restoring Points

2USER MAINTENANCE/COLORIMETRY GRAPHICS or IMMUNOLOGY GRAPHICS screen displayed.


POINTS mode (F4)
" With the J key, place the cursor on the yellow point which has to be eliminated or on the red
point which has to be restored.
" Press F2
 If the point belongs to the calculation window:
- regression is recalculated
- the new regression curve is displayed

4.7.7.3 STA Compact® Calculation

2USER MAINTENANCE/COLORIMETRY GRAPHICS or IMMUNOLOGY GRAPHICS screen displayed


(F3 STA Calculus displayed).

ACTIONS RESULTS

" Press the F3 key  All points used by the STA Compact< for the
regression calculation (patient result) appear
in yellow on the screen, points not used are
displayed in red.
 The regression curve appears.

4.7.7.4 Printing the curve

2USER MAINTENANCE/COLORIMETRY GRAPHICS or IMMUNOLOGY GRAPHICS screen displayed.

ACTIONS RESULTS

" Press the F6 key  The Photometry Graphics prints out.

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4.7.7.5 Printing the List of Measurement Values

2USER MAINTENANCE/COLORIMETRY GRAPHICS or IMMUNOLOGY GRAPHICS screen displayed

ACTIONS RESULTS

 Press the F7 key " The list of raw data for the required files
prints out.
" The pair of points [Time (sec); Optical
Density (OD)] displayed in bold are those
used by the STA Compact< for the
regression calculation (patient result).

4.7.7.6 Modifying the Calculation window

2USER MAINTENANCE/COLORIMETRY GRAPHICS or IMMUNOLOGY GRAPHICS screen displayed

ACTIONS RESULTS

" Press the F8 key  The following window is displayed:

File Name : COLMES XX.DAT


Initial Time : XX (seconds)
Final Time : XX (seconds)
XX: number of the calculation file.

" Change the final/initial time with the  The calculation window and the regression
numerical pad, then confirm with the curve are updated.
 key
Note: the initial time cannot be below 2.
" Press the F10 key to validate the
modifications

4.7.7.7 Loading Another Measurement File

2USER MAINTENANCE/COLORIMETRY GRAPHICS or IMMUNOLOGY GRAPHICS screen displayed

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ACTIONS RESULTS

" Press the F10 key  The list of the last 99 files appears. The
following keys are available:

 View
K,L Scroll
Esc Quit
Home Beginning of List
End End of List
 Previous page
 Following page

" Select the required file  The selected Photometry Graphics appears.
" Confirm with the  key

4.7.7.8 Quitting the Photometry Graphics Menu

2USER MAINTENANCE/COLORIMETRY GRAPHICS or IMMUNOLOGY GRAPHICS screen displayed

ACTIONS RESULTS

" Press the Esc key  The following window is displayed:

Do you want to return


to the previous menu
Y/N
Esc=Cancel

" Press the Y key  The User Maintenance menu appears.

4.7.8 Error History


This program allows the user to display the error messages of the day.

4.7.8.1 How to access the Error History Menu

2User Maintenance menu displayed

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ACTIONS RESULTS

" Press the L key to reach Error History  The ERROR HISTORY screen appears (see
" Confirm with the  key figure 22 below).

Fig. 22 - ERROR HISTORY Screen

4.7.8.2 Parameter Selection

2ERROR HISTORY screen displayed

ACTIONS RESULTS

" Press the F2 key  The sort criteria appear:

01: BACKGROUND TASK


02: CUVETTE FEED
03: RACK COMMUNICATION
04: MEASUREMENT BLOCK COMMUNICATION
05: SYSTEM HOST COMMUNICATION
06: MANAGEMENT OF ARM #1
07: MANAGEMENT OF ARM #2
08: START OF TEST
09: AXIS Z COMMUNICATION
10: MEASUREMENT MANAGEMENT
11: SYSTEM BOOT
49: STA COMPACT MAINTENANCE
51: SAMPLE LOADING
52: PRODUCT LOADING
53: LIQUID PRIMING

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ACTIONS RESULTS

" Enter the selection (2 numbers) then  The ERROR HISTORY screen appears.
confirm with the F10 key

" Press the L or K keys to display all the  The selected errors can be displayed.
selected error messages

4.7.8.3 Quitting the Error Message Menu

2ERROR HISTORY screen displayed.

ACTIONS RESULTS

" Press the Esc key  The following message is displayed:

Do you want to return


to the previous menu
Y/N ?
Esc = Cancel

" Press the Y key  Return to the User Maintenance menu.

4.7.9 Host Computer Communications


This program checks for the current communications between the STA Compact® and the host
computer. It recalls the communication parameters (see description chapter 10.2.3.2).

2User Maintenance menu displayed.

ACTIONS RESULTS

" Press the L key to reach Host Computer  The COMMUNICATIONS screen appears.
Communications, then confirm with the
 key

" Press the F1 key to run the test  The following message appears:

Test
In progress
 At the end of this test, the PASSED/FAILED
message appears at the left bottom of the
displayed screen

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ACTIONS RESULTS

" Check the connection between the STA


Compact® and the host computer in case of
problems, then rerun these tests

" Press the Esc key to Exit  The following window is displayed:

Do you want to return


to the previous menu
Y/N ?
Esc = Cancel

" Press the Y key  The User Maintenance menu appears.

4.7.10 Data Update


This program allows the user to update data using diskettes provided by Diagnostica Stago: new
software release, introduction of new reagents or new methods, ...
Refer to the notice provided with the diskettes to make the update.

To avoid computer viruses, do not use the diskettes provided by Diagostica Stago on any other
PC System.

4.7.11 Utilities

4.7.11.1 TDEX utilities (computerized exportation of patient files)


TDEX allows the user to save, on diskettes, patient results related to:
- results (name of the test, Id., average,...)
- associated calibrations (measurement, equation,...)
- information concerning the products used (designation, lot number...)

Patient data of a validated file: transfered even if the corresponding tube is not in the sample drawer.
Patient data of a file that is in error or to be validated: only transfered if the corresponding tube is in
the sample drawer.
The data are saved in a text file (.txt) that can be used with others application softwares (e.g: Excel).

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2User Maintenance menu displayed.

ACTIONS RESULTS

" Press the L key to reach Utilities Menu,  The following screen appears: (see Fig.20)
then confirm with the  key
1.TDEX
2. Saving Test Configurations disk updating
Your Choice [1,2]

To quit the UTILITIES menu:


" Press key 1 and, in the following screen,
press ESC.

" Press key 1  The following screen appears (see Fig.20)

Fig. 23 - TDEX UTILITIES Screen

ACTIONS RESULTS

" Enter the name of the files (8 characters  Creation of a file "xxxxxxxx.txt" which can
max.) then validate with the  key be used in other applications.
" Enter your comments, if necessary. It is
possible to enter 5 lines of comments which
can include up to 75 characters each
" Press the  key

" Insert the formated diskette in the reader

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ACTIONS RESULTS

" Press the F10 key to transfer the data  The folllowing window is displayed:

Transfer in progress
 Transfer of data from the diskette to hard
disk

" Press the ESC key to quit  The following window is displayed:

Do you want to return to the previous


menu
Y/N
Esc=Cancel

" Press the Y key

4.7.11.2 Update of the parameter backup diskettes


The UTILITIES menu allows to update parameter backup diskettes.
This operation must be realized under supervision of the local authorized Service Representative.

4.7.12 Return to the Main Menu

2User Maintenance menu displayed.

ACTIONS RESULTS

" Press the K key to return to the previous  Same results as described in chapter 3.1.
menu, then confirm with the  key

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Table of contents

5 Test Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

5.1 Description of Test Setup Parameters . . . . . . . . . . . . . . . . . 1


5.1.1 Methodology (page 1 of 3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
5.1.1.1 Test Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
5.1.1.2 Sample Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
5.1.1.3 Diluent Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
5.1.1.4 Reagent Definition (Ra, Rb, Rc, Rd ) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
5.1.1.5 Washing Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
5.1.1.6 Analysis Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
5.1.1.7 Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
5.1.1.8 Validation Section . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
5.1.1.9 Redilution Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
5.1.2 Calibration Part (Page 2 of 3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
5.1.2.1 Calibration mode Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
5.1.2.2 View Points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
5.1.2.3 Calibrator Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
5.1.2.4 Definition of Scales . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
5.1.2.5 Choice between Single/Duplicate for the Calibrators . . . . . . . . . . . . . . . . . . . . . . . . 19
5.1.2.6 Definition of Offset Corrector Plasma (not available on STA Compact®CT) . . . . . . 19
5.1.2.7 Calibration Control Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
5.1.3 Printout / Transmission of Results and Quality Control (Page 3 of 3) . 21
5.1.3.1 Printout / Transmission . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
5.1.3.2 Usual Value Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
5.1.3.3 Printout Limit Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
5.1.3.4 Quality Control Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
5.1.4 Dependent Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

5.2 Access to the Test Setup Parameters . . . . . . . . . . . . . . . . 26


5.2.1 Access to the Test Setup Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
5.2.2 Description of the TEST SETUP Screen . . . . . . . . . . . . . . . . . . . . . . . . 27
5.2.3 Access to the Screens of the Main Test Setup . . . . . . . . . . . . . . . . . . . 28
5.2.4 Access to the DEPENDENT TEST SETUP Screen . . . . . . . . . . . . . . . . . 29
5.2.4.1 Access to the DEPENDENT TEST SETUP Screen from the TEST SETUP Screen . . . . . 29
5.2.4.2 Access to the DEPENDENT TEST SETUP Screen from the Required Main Test Setup 29
5.2.5 Access to Setup Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

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5.3 Modifying a Setup Parameter . . . . . . . . . . . . . . . . . . . . . . . 31


5.3.1 Modification Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
5.3.2 Validation Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

5.4 Creation of a New Test . . . . . . . . . . . . . . . . . . . . . . . . . . . 34


5.4.1 Main Test Creation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
5.4.2 Dependent Test Creation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

5.5 Test Order on the TEST PANEL Screen . . . . . . . . . . . . . . . 35

5.6 Test Deletion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

5.7 Test Updating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

5.8 Calculated Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40


5.8.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
5.8.2 Description of the Definition Parameters for a Calculated Test . . . . . 41
5.8.3 Definition of Test [1] and Test [2] . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
5.8.4 Printout / Transmission Section . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
5.8.5 Definition of Calculation Formula . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

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Test Setup

5 Test Setup

Consult the warnings in chapter 1.4.

For each test, there are three screens of test setting parameters:
- Page 1 of 3 for methodology (see chapter 5.1.1)
- Page 2 of 3 for calibration (see chapter 5.1.2)
- Page 3 of 3 for printing, for transmitting results, and for quality control (see chapter 5.1.3)
For each dependent test, there is only one screen of test setting parameters (see chapter 5.1.4).

5.1 Description of Test Setup Parameters

5.1.1 Methodology (page 1 of 3)


Fig. 1 - Page 1 of the Test Setup

Legend:

1 List of possible functions:

PgDn Displays next page

F4 Access to dependent tests

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Esc Displays the EXIT OPTIONS window (see description chapter 5.3.2 l)

2 Date of latest modification (saved by the operator)

3 Test Identification

4 Sample parameter definition

5 Diluent parameter definition

6 Reagent parameter definition

7 Analysis definition

8 Result definition

9 Definition of the range of values for automatic confirmation of the results

10 Selection of the automatic redilution parameters

Note: The definitions of each parameter are described in the following pages.

5.1.1.1 Test Identification

Abbreviation Abbreviated name of test.


(8 characters)

Name Complete name of test (used for printout).


(25 characters)

Method Type of measurement method. The following choices are


available :
Clotting
Chromogenic (not available on STA Compact< CT):
- Kinetic 2 points
- Kinetic O.D/minute
Immunology (not available on STA Compact®CT):
- Kinetic 2 points
- Kinetic O.D/minute
Calculated Results (see chapter 5.8).

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Test Setup

5.1.1.2 Sample Definition

Volume Amount of final sample volume in microlitres (including dilution).


Possible choices:
from 25 —l to 200 —l by step of 5 —l.

RISK OF WRONG RESULTS


The total volume (sample +reagents) should be within the
following ranges :
- 150 —l to 400 —l for clotting tests
- 250 —l to 400 —l for photometric tests (not available on STA
Compact®CT).

Incu. Incubation time of plasma alone (from 0 sec. to 999 sec.).


0 = no incubation.

Dil. Dilution Ratio.


The following options are available :
1 /1 1/20 1/2 1/30
1/3 1/40 1/4 1/50
1/5 1/60 1/6 1/80
1/7 1/100 1/8 1/160
1/10 1/200 1/12 1/400 1/15

The 1/400 dilution is not possible for sample volumes under 50


Pl.

Reminder : 1 / 6
L L

Sample Volume Total Volume


(sample + diluent)

5.1.1.3 Diluent Definition

ID. Diluent’s identification.


(8 characters)

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Name Diluent’s name.


(6 to 15 characters)

Vial. Amount of initial diluent volume (in millilitres).


ml

Stab. Stability of diluent (in hours).


h Stability is checked after loading.

Min.Volume. Volume of remaining diluent at which the STA Compact® will


ml stop running tests.

5.1.1.4 Reagent Definition (Ra, Rb, Rc, Rd )

ID. Alphanumeric identification number of each reagent.


(8 characters)

Name Name of each reagent (Ra, Rb, Rc or Rd).


(6 to 15 characters)

Incu. Incubation time of each reagents (from 0 to 999 sec.).


sec. 0 : no incubation.
Minimum for incubaton time = 30 seconds
Depending on the time override authorized for incubation, the
following options can be used :
- P (critical incubation) : maximum allowable over-incubation
of 5 seconds;
- Nothing : maximum allowable over-incubation of 30 seconds.

Each override of incubation time will lead to the analysis to be


abandoned (cuvette disposed of into waste) and to the automatic
rerun of the test in question. This should therefore be reserved
for truly critical incubations.

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The selection of the incubation time for the sample (see chapter 5.1.1.2) as well as that for each
reagent must be defined in accordance with one of the following methods:

Incubation Methods

A Sample => Incubation 1 =>+ Rd

B Sample + Ra => Incubation 1 =>+ Rd

C Sample + Ra + Rb => Incubation 1 =>+ Rd

D Sample + Ra + Rb + Rc !Incubation 1 =>+ Rd

E Sample + Ra=> Incubation 1=> + Rb=> Incubation 2=>+ Rd

F Sample + Ra + Rb => Incubation 1=> + Rc => Incubation 2=>+ Rd

Vol. Reagent volume (in microlitres).


—l Possible choices:
from 25 Pl to 200 Pl by step of 5 Pl.

RISK OF WRONG RESULTS


The total volume (sample +reagents) should be within following
ranges:
- 150 Pl to 400 Pl for clotting tests;
- 250 Pl to 400 Pl for photometric tests (not available on STA
Compact®CT).

Vial. Initial reagent volume in the vial (in millilitres).


ml

Stab. Stability of each reagent (in hours).


h Stability is checked after loading.

Min.Volume Volume of remaining reagent at which the STA Compact® will


ml stop running tests.

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Washing ˆ Type of washing to be carried out before and/or after each


sampling of the reagent being used.
Before
• The following options are available :
No: no wash
Special: with a desorb solution (see below) + rinsing with
STA< - Cleaner Solution (washing solution)
After
• The following options are available :
Normal: with STA< - Cleaner Solution
Intensive: user-programmable from 10 to 25 pulses, by 1
pulse step
(STA< - Cleaner Solution)
Special: with a desorb solution (see below)+rinsing with
STA< - Cleaner Solution (washing solution)
ˆ Type of washing to be carried out after each sampling :
Normal: 5 pulses (STA< - Cleaner Solution)
Intensif: user-programmable from 10 to 25 pulses, by 1 pulse
step)
(STA< - Cleaner Solution)
Special: with a desorb solution (see below)+rinsing with
STA< - Cleaner Solution (washing solution)

5.1.1.5 Washing Definition

Fig. 2 - Pre and Post Washing Window

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Desorb Alphanumeric identification number of the desorb solution.


(8 characters)

Name Complete name of the desorb solution.


(6 to 15 characters)

Vial Initial desorb solution volume (in milliliters).


ml

Stability Stability of the desorb solution (in hours). Stability is checked


h after Desorb Solution loading.

Min. Volume Volume of remaining desorb solution at which the STA


ml Compact® will stop running tests.

5.1.1.6 Analysis Definition

The following parameters differ for each type of measurement.

Clotting

Min. Time Minimum time: inferior time limit for the analysis.
Below this limit, no result is given, “< V min.” is displayed
instead.

Max. Time Maximum time: superior time limit for the analysis.
Above this limit, no result is given, “> V max.” is displayed
instead.

Mean Time Estimated average clotting time of all patients. It is used by the
software to adjust the throughput and to avoid traffic problems in
the measurement zone.
In routine conditions the risk of traffic problems is rather low. On
the other hand, for a given test on large series of plasma with very
long clotting times (anti-vitamin K treatment for example), the
mean time must be increased to allow the STA Compact® to
slow down the throughput.

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Clot Type Nature of clot.


The following options are available :
Normal: PT type clot
Weak: Fibrinogen type clot

Kinetic 2-point Chromogenic or Immunologic (not available on STA Compact®CT)

First Point Time (in seconds) between the dispensing of the start reagent
and the first point of optical reading.

Second Point Time (in seconds) between the dispensing of the start reagent
and the second point of optical reading.

Kinetic O.D./min Chromogenic or Immunologic (not available on STA Compact®CT)

Linearity Min. Minimum value of linearity acceptable for each linear regression.

First Point Time (in seconds) between the dispensing of the start reagent
and the first point of optical reading.

Second Point Time (in seconds) between the dispensing of the start reagent
and the last point of optical reading.

Kinetic 2-point immunology with calibration mode: 2nd or 3rd order polynomial (not
available on STA Compact®CT)

In the special case of an immunological method in kinetic 2-point with calibration mode: 2nd or
3rd order polynomial, redilution level to use for out of range results.
Out of range results are defined as:
- 'O.D. obtained greater than 'O.D. obtained for the highest calibration point
- Or difference between the points of the initial plateau greater than 50 mO.D. (0.05 O.D.)

Redilution 1 Possible redilutions are :


1/1 1/20 1/2 1/30
1/3 1/40 1/4 1/50
1/5 1/60 1/6 1/80
1/7 1/100 1/8 1/160
1/10 1/200 1/12 1/400 1/15

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Redilution 2 Dose-Hook effect detection.


Note: The dose-Hook effect is only activated with
STAGO barcoded reagents. It cannot be manually
activated.
- If No Dose-Hook effect is detected: when the
measure is greater than the maximum O.D. Limit, “>
V max” is generated.
- If Dose-Hook effect is detected: even if the measure
is greater than the maximum O.D. limit, the test will
be rerun according to the redilution criteria. If the
dose-Hook effect still remains after the redilution 2, a
technical error (err ) will be generated.

The following parameters apply to all the read-out methods.

Rd Heating Type of heating for the start reagent.


The following options are available:
YES: start reagent preheated to 37°C in the pipetting head just
before dispensing.For incubation methods E and F (see
chapter 5.1.1.4),. the reagents Rb (method E) and Rc (method F)
are also preheated.
NO: no preheating

Stirring Type of stirring for the needle No.3 during dispensing of start
reagent (Rd) into the cuvette in measurement position.
The following options are available :
YES: stirring
NO: no stirring
Note: If intermediate reagents are dispensed before first
incubation, then the cuvette content is systematically stirred by a
lateral movement of needle No.2 in the cuvette.

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5.1.1.7 Results

Primary Unit Primary unit for result reporting.


The following options are available:
Raw: Seconds, ' O.D.a or O.D./mina
%: Percentage
Ratio: Ratio of time to reference time
g/l: Grams per liter
mg/dl: Milligrams per deciliter
ng/ml: Nanograms per milliliter
U/ml: Units per milliliter
IU/ml: International Units per milliliter
—g/ml: Micrograms per milliliter
INR: International Normalized Ratio
A.U.1: Arbitrary unit No.1
A.U.2: Arbitrary unit No.2
A.U.3: Arbitrary unit No.3

Corrector Systematic multiplying factor applied only on results given in


primary units for reporting results.
This factor is not applied on control results.

Single/Duplicate Type of determination, used for the samples, the calibration


controls and the quality controls.
The following two options are available:
Single determination
Duplicate determination
a.not available on STA Compact®CT

Please, see chapter 1.6.

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Precision Maximum permitted difference for a duplicate


determination.The deviation is expressed in percent
(relative deviation compared to the mean) and applies to
the raw data, that is to say to the clotting time or to the '
O.D. or O.D./min for colorimetry (not available on STA
Compact®CT) and immunology (not available on STA
Compact®CT).
M1 - M2
Precision = x 100
M

- M1, M2 : raw data


- M = (M1 + M2)/2
For immunological tests in kinetic 2-point (not available on
STA Compact®CT), the absolute deviation is used and it is
expressed in mO.D.
This parameter has to be defined even for single
determination because it is necessary for reruns (see
chapter 8.3.3 and 8.3.4).

5.1.1.8 Validation Section

Min. Max. Range of values given in the primary units of reported


results for which result validation is automatically
performed.

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5.1.1.9 Redilution Conditions


Definition of two other dilutions for the sample if it is outside the linearity range.

RISK OF WRONG RESULTS


Redilution conditions have to be used with great care since they are not always compatible with the
measurement principle.

Redilutions are forbidden for the following primary units :


- Raw (seconds, ' O.D.a or O.D./mina)
- Ratio
- INR

a.not available on STA Compact®CT

The rediluted result is given in the primary unit only (secondary units are not used in that case).
The result is displayed in blue in the test panel.

< "low limit" Low limit of the linearity zone in the primary unit for
reporting results.

> "high Limit" High limit of the linearity zone in the primary unit for
reporting results.

"Dil.1" < For the redilutions, the following options are available:
"Dil.2" > 1/1 1/20 1/2 1/30
1/3 1/40 1/4 1/50
1/5 1/60 1/6 1/80
1/7 1/100 1/8 1/160
1/10 1/200 1/12 1/400 1/15

Example 1:
For a regular methodology with a regular 1/20 dilution and a linearity up to 20—g/ml. If the dilution
above 20—g/ml is 1/40, the methodology must be set up as follows:
- Dil.1 1/1
- Dil.2 1/40, high limit 20
- save the methodology when quitting.

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Example 2:
For Fibrinogen, the linearity zone is given from 1.5 g/l to 9 g/l (150 to 900 mg/dl). For a regular 1/20
dilution, the following dilution conditions are defined:
- Dil.1 1/8, low limit 1.5
- Dil.2 1/40, high limit 9.0
- save the methodology when quitting.

It means that:
- For all results lower than 1.5 g/l, the assays will be automatically rerun with a 1/8 dilution
- For all results higher than 9.0 g/l, the assays will be automatically rerun with a 1/40 dilution
In both cases, the results will be given taking into account the dilution change, i.e.:
for a result > 9 g/l, result in primary units x 2.
for a result < 1.5 g/l, result in primary units x 8/20.

5.1.2 Calibration Part (Page 2 of 3)


The page 2 of Test Setup is different depending on the calibration mode selected.

Fig. 3 - Page 2 of Test Setup for graphic Mode

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Fig. 4 - Page 2 of Test Setup for Bar Coded Mode

Fig. 5 - Page 2 of Test for Raw Mode

Fig. 6 - Page 2 of Test Setup for Ratio Mode

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Legend:

1 Available functions :

PgDn Displays next page

PgUp Displays previous page

Esc Displays the EXIT OPTIONS window (see description chapter 5.3.2)

2 Abbreviation and complete name of test

3 Calibration mode definition

4 Calibrator definition or view point definition

5 Definition of calibration control

6 Definition of the scales

7 Choice between Single / Duplicate for the calibrators

8 Definition of offset corrector plasma parameters (not available on STA Compact®CT)

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5.1.2.1 Calibration mode Definition

Mode Choice of calibration mode.


There are seven options:
Bar code:
- Data transmitted by the assay value insert of STA products
reserved for Diagnostica Stago tests
Graphic:
- Graphic linear: linear regression on a minimum of 2 points (Y
= ax + b)
- Graphic 2nd order polynom.: polynomial regression of 2nd
order on a minimum of 4 points (Y = ax2 + bx + c)
- Graphic 3rd order polynom.: polynomial regression of 3rd order
on a minnimum of 6 points (Y = ax3 + bx2 + cx + d, reserved
to immunological tests)a
- Graphic hyperbolic: hyperbolic regression of a minimum of 5
points
[Y = a + b / (x - N)]
Note: depending on the selected scale, x or y may be
1
transformed into log x, log y,
y
Non graphic:
- Raw: Raw data (in the unit of measurement) : seconds, '
O.D1, or D.O./min1
- Ratio: Ratio to a reference
a.not available on STA Compact®CT

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5.1.2.2 View Points

These parameters are only available within bar coded calibration mode.

View Points Selected points (in primary units for reported results) which the
(8 maximum) user chooses to view on calibration screen (see chapter 7.2.1).

5.1.2.3 Calibrator Definition

These parameters are only available within graphic calibration modes (linear, 2nd order polynom,
3rd order polynom, or hyperbolic).

ID. Alphanumeric identification of the 8 calibrators.This may be


(8 characters) identical for the 8 calibrators. In this case, only the dilution ratios
change.

Key Only for the Diagnostica Stago products, allows to choose, in a list
corresponding to the order of the parameters printed on the bar
code labels, the test or the reagent concerned.

Name Complete name of each calibrator.


(6 to15 characters)

Dil. Choice of dilutions for each calibrator. There are the following
options:
1/1 1/20 1/2 1/30
1/3 1/40 1/4 1/50
1/5 1/60 1/6 1/80
1/7 1/100 1/8 1/160
1/10 1/200 1/12 1/400 1/15

Vial. Initial calibrator volume in each vial (in milliliters).


ml

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Stab. Stability of each calibrator (in hours).


h Stability is checked after loading.

Min.volume. Volume of remaining calibrator at which the STA Compact® will


ml not run another calibration.

For a calibration:
It is possible to use different calibrators or a single calibrator. In both cases, the dilution
corresponding to each calibration point must be specified.

Example 1: STA< - Hepanorm H (Cat. No. 00684)


The identifications and the names of the calibrators are different, the dilutions are
identical.

CALIBRATOR
DILUTION
ID. Name

12363 Hepanorm H0 1/1


12364 Hepanorm H3 1/1
12365 Hepanorm H6 1/1

Example 2: STA< - Unicalibrator (Cat. No. 00675)


The identifications and the names of the calibrators are the same but the dilutions are
different.

CALIBRATOR
DILUTION
ID. Name

12350 Unicalibrator 1/10


12350 Unicalibrator 1/20
12350 Unicalibrator 1/40
12350 Unicalibrator 1/80

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5.1.2.4 Definition of Scales

These parameters are only available for graphic calibration modes (linear, 2nd order polynom, 3rd
order polynom or hyperbolic) and bar coded calibration mode.

Measures Definition of scales along the measurement and concentration


Concentrations axes.There are the following options:
Linear
Inverse (only for the concentration axis)
Log

5.1.2.5 Choice between Single/Duplicate for the Calibrators

This parameter is only available for graphic calibration modes (linear, 2nd order polynom, 3rd order
polynom, or hyperbolic).

Single/Duplicate Type of determination applicable to all calibrators.There are two


possible options:
Single
Duplicate
In this case, each point is taken as an individual value.

5.1.2.6 Definition of Offset Corrector Plasma (not available on STA Compact®CT)

The parameters for “Offset corrector” apply only for chromogenic and immunological tests (only
for linear regression mode). This correction corrects for Y-intercept (the slope is maintained).

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ID. Alphanumeric identification of the plasma used for the offset


(8 characters) adjustment.

Key For Diagnostica Stago products only, allows to choose, in a list


corresponding to the order of parameters printed on the bar
code labels, the test or the reagent concerned.

Name Complete name of plasma used for the offset adjustment.


(6 to 15 chraacters)

Vial. Initial offset corrector plasma volume in each vial (in milliliters).
ml

Stab. Stability of plasma (in hours).


Stability is checked after loading.

Min. volume Volume of remaining offset corrector plasma at which the STA
ml Compact® stops running tests.

5.1.2.7 Calibration Control Definition

The following parameters apply to all measurement methods and to all calibration modes.

0 or 2 calibration validation controls can be defined. When 2 controls are used, they enable automatic
validation of the calibration (see chapter 7.3.1). They have to be defined for the bar coded tests and
when an offset corrector plasma is used.

ID. Alphanumeric identification of each control.


(8 characters)

Key Diagnostica Stago products only,allows to choose, in a list


corresponding to the order of parameters printed on the bar
code labels, the test or the reagent concerned.

Name Complete name of each control.


(6 to 15 characters)

Vial. Initial control volume (in millilitres).


ml

Stab. Stability of each control (in hours).


h Stability is checked after loading.

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Min. volume The volume of remaining control at which the STA Compact®
ml stops measurements.

5.1.3 Printout / Transmission of Results and Quality Control (Page 3 of 3)


Fig. 7 - Page 3 of Test Setup

Legend:

1 Available functions:

PgUp Displays previous page

Esc Displays the EXIT OPTIONS window (see description chapter 5.3.2)

2 Abbreviation and complete name of the test

3 Definition of parameters for Printout / Transmission

4 Definition of Usual Value range

5 Definition of Printout Limits

6 Definition of Quality Controls

5.1.3.1 Printout / Transmission

Unit Besides the primary units, three secondary units may be defined
and used for the printout and/or transmission.

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Main Reminder of the primary unit as selected in the result portion of


test setup on page 1 of 3.

Aux. 1 Definition of three secondary units.


Aux. 2
There are the following options:
Aux. 3
None (empty field, this secondary unit is not used)
Raw: Seconds, ' O.D.a (delta of the optical density), or O.D./
mina (optical density per minute)
%: percentage
Ratio: ratio of test time to reference time
g/l: grams per liter
mg/dl: milligrams per deciliter
ng/ml: nanograms per milliliter
U/ml: units per milliliter
IU/ml: International Units per milliliter
Eg/ml: micrograms per milliliter
A.U.: arbitrary unit No. 1
A.U.2: arbitrary unit No. 2
A.U.3: arbitrary unit No. 3
INR: International Normalized Ratio
Ref.: time of the reference plasma

Conver. Factor Conversion coefficient between the primary unit and the
secondary unit concerned, if applicable.

Print For the primary unit or for the secondary units, there are two
options for printing out:
YES: unit used
NO: unit not used

Transmission For transmission of primary or secondary units, the test number


Test Number corresponding to the host computer should be given if the unit is
used. If the unit is not used, the rank must be set to 0 (F1 key).
a.not available on STA Compact®CT

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5.1.3.2 Usual Value Definition

Min. Max. Definition of the normal value range as a function of the primary
unit in which the results are expressed.

5.1.3.3 Printout Limit Definition

Printout.Limits Range of acceptable values in primary units for reporting results.


min. Each out of range result is reported either as the minimum value
max. or as the maximum value (with an alarm code).

5.1.3.4 Quality Control Definition


One to three controls must be defined to be integrated in the quality control files: Level 1, Level 2
and Level 3.

ID. Alphanumeric identification for each of the three controls.


(8 characters)

Key For Diagnostica Stago products only,


allows to choose, in a list corresponding to the order of
parameters printed on the bar code labels, the test or the reagent
concerned.

Name Complete name of each of the three controls.


(6 to15 characters)

Period Definition of the period of each control (in hours).


Minimum: 1 hour
Maximum: 24 hours

Vial Initial control volume in the vial (in milliliters).


ml

Stab. Stability of each control (in hours)


h Stability is checked after loading

Min.volume Volume of remaining control at which the STA Compact® will not
ml run another quality control.

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5.1.4 Dependent Tests


From each main test, 8 dependent tests can be created which differ from the main test only with
respect to plasma dilution, corrector factor and transmission test number.
For measurement, all dependent tests use the same parameters as their main test except dilution.
For calculation of results, the dependent tests use the same calibrations as the main test and their
own corrector factor.
For transmission of results, the dependent tests use their own transmission test numbers.
For instance, dependent tests can be used for determination of factor levels at several dilutions.

Fig. 8 - DEPENDENT TESTS Screen

Legend:

1 Available function list:

 Access tozone 4 (see above) to create or modify a dependent test

Esc Displays the EXIT OPTIONS window (see description chapter 5.3.2)

2 Dependent test list

3 Reminder of some parameters of the main test

4 Definition of the parameters of the dependent test

Abbreviation Abbreviation of the dependent test.


(8 characters)

Name Complete name of the dependent test.


(25 characters)

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Dilution Choice of dilution for dependent test.There are the following


options:
1/1 1/20 1/2 1/30
1/3 1/40 1/4 1/50
1/5 1/60 1/6 1/80
1/7 1/100 1/8 1/160
1/10 1/200 1/12 1/400 1/15

Corrector Systematic multiplication factor for all reported results of


dependent tests (excluding raw data).

Units Reminder of the main and secondary units used for the
dependent test and the main test.

Transmission Test Num- For the use of primary or secondary units for transmission, the
ber transmission test numbers corresponding to the host computer
should be given if the unit is used. If the unit is not used, the rank
must be set to 0 (F1 key).

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5.2 Access to the Test Setup Parameters

5.2.1 Access to the Test Setup Menu

2TEST PANEL displayed.

ACTIONS RESULTS

" Press the Esc key  The Main Menu is displayed:

Status - Loading (...) - Halt


with the cursor positioned on Status.

" Press the E key  The following sub-menu is displayed:


" Or press theJkey 4 times, to move the
cursor to Setup, then press the  key Tests
Global Options
with the cursor on Tests.

" Press the key to open the Test Setup  The TEST SETUP screen is displayed with the
screen cursor on the first test.
 There is a yellow point in front of any
dependent test abbreviations.
 If the operator views a test setup and the
following message “Reading in process-
Modification not allowed- Space Bar:
washing window” is displayed at the
bottom of the screen, there are
measurements in progress.

" If the STA Compact® is in stand-by, you can  The TEST SETUP screen is displayed with the
create test setups. cursor on the first test.
To modify certain test setup parameters,  There is a yellow point in front of any
the following is also necessary: dependent test abbreviations.
- the concerned tests are not present in any
patient file of the working file
- no calibration, no quality control is in
progress for this parameter
- the access code is known
If not, you can only view them.
" Press the key to view or edit a test setup

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5.2.2 Description of the TEST SETUP Screen


Fig. 9 - TEST SETUP Screen

Legend:

1 Available function list:

 Access to the first TEST SETUP screen for the test on which the cursor is positioned

Esc Displays this window:

Displace Test
Delete Test
Update
Quit
For the options: Displace Test, Delete Test, Update, please see description in chapter 5.5, 5.6, and 5.7.

Please note: If measurements are in process, the available functions are:


Esc Return to TEST PANEL screen

 View a test setup

2 Title of the screen

3 Complete name corresponding to the cursor position. For each Dependent Test: name of the
main test it is derived from

4 Available test list. There is a yellow point in front of any dependent test abbreviation

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5.2.3 Access to the Screens of the Main Test Setup

2TEST SETUP screen displayed with the cursor on the first test (see chapter 5.2.1).

ACTIONS RESULTS

" Press the L or the J key  Cursor moving.

" Press the Lkey to the required main test  Cursor on the required test.
(without yellow point)

" Confirm the choice with the  key  Page 1 of 3 of the test setup displayed, with
the cursor on the first modifiable setup
parameter.

" Press the PgDn key  Page 2 of 3 of the test setup displayed with
the cursor on the first modifiable setup
parameter.

" Press the PgDn key  Page 3 of 3 of the test setup displayed, with
the cursor on the first modifiable setup
parameter.

" Press the PgUp key twice  Return to page 1 of 3 of the test setup.

" Press the Esc key  The EXIT OPTIONS window is displayed:

EXIT OPTIONS
Save before Quitting
Quit without Saving
Do not Quit

To exit without saving:  Confirmation of the exit without saving.


" Press the Q key  Return to the TEST SETUP screen.
" Or press the L key, then confirm with the
 key

To save:
" See the validation procedure in 5.3.2

In order to save changes, the user must know


the access code.

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If the Esc key is pressed by mistake, press it again in order to cancel the instruction to exit from the
setup screens.

5.2.4 Access to the DEPENDENT TEST SETUP Screen

5.2.4.1 Access to the DEPENDENT TEST SETUP Screen from the TEST SETUP Screen

NOTE There is a yellow point in front of any dependent test abbreviation

2TEST SETUP screen displayed, with the cursor on the first test (see chapter 5.2.1).

ACTIONS RESULTS

" Press the L or the J key to reach the  The cursor is on the required test.
required test (with a yellow point)

" Confirm the choice with the  key  The screen of the dependent test setup is
displayed with the cursor on the required
dependent test of the dependent test list
(see the description of this screen chapter
5.1.4).

 Confirm the choice with the  key  Cursor on the first modifiable parameter of
the dependent test setup.

5.2.4.2 Access to the DEPENDENT TEST SETUP Screen from the Required Main Test Setup

NOTE This access is available only from page 1 of 3 of the main test setup.

2Page 1 of 3 of the main test setup screen displayed

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ACTIONS RESULTS

" Press the F4 key  The DEPENDENT TESTS screen is displayed


with the cursor on the first dependent test
of the dependent test list (see the description
of this screen in chapter 5.1.4.).

" Press the L key to the required dependent  Cursor on the first modifiable parameter of
test, then confirm with the  key or just the dependent test setup.
confirm by pressing the  key

5.2.5 Access to Setup Parameters

2A setup screen is displayed, the cursor is on the first parameter.


Procedure for moving the cursor:

KEYS RESULTS

L  Moves cursor to next line.

K  Moves cursor to preceding line.

I, J  Moves cursor into entry field of parameter


concerned.

Tab  Moves cursor to the next modifiable


parameter.

Shift and Tab  Moves cursor to the previous modifiable


parameter.

 (Enter)  Moves cursor from one parameter to the


next.

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Test Setup

5.3 Modifying a Setup Parameter

Modifying certain parameters may have very important consequences:


- invalidation of calibration;
- deletion of quality controls.

This procedure is only possible if:


- the STA Compact® is in stand-by (no measurement in process);
- the operator knows the access code.
Morever, for some parameters, this procedure requires that none of the concerned tests are
present in the Patient files of the Working File.

Three kinds of fields:


ˆ Free entry fields:
No message is displayed at the bottom of the screen, data and cursor are displayed in blue.
ˆ Multiple-option field:
The message “Delete key to modify this field” is displayed at the bottom of the screen, data
and cursor are displayed in white.
ˆ Non modifiable fields:
Data are displayed in grey, no modification is possible.

5.3.1 Modification Procedure

Free entry field Enter the new information on the alphanumeric keyboard.
Confirm with the  key.

Multiple-option field There are two options:


- Two possible choices: The Delete key moves from one
option to another. Confirm the selection with the  key;
- Multiple possible choices: The Delete key allows to open
a selection window. Press the L or J key to move the cursor
to the required selection and validate with the  key.

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5.3.2 Validation Procedure

2One of the setup screens is displayed and all the modifications have been made.

ACTIONS RESULTS

" Press the Esc key  The following window is displayed :

EXIT OPTIONS
Save before Quitting
Quit without Saving
Do not Quit
with the cursor on Save before quitting.

" Press the  key to confirm  The software checks the consistency of (and
between) the different parameters.
 If an inconsistency is revealed [for instance,
total volume (sample + reagents) is higher
than 400 Pl]:
- the error window is displayed giving the
number of the setup page concerned by the
inconsistency and a description

ERROR - Page 1
Sample + Reagents volume
Out of range [150......400] Pl
Esc : Cancel this message
- the software displays automatically the
concerned setup page.

" Read carefully the displayed message, then  The cursor is automatically positioned on
press the Esc key the parameter to be modified.

" Proceed with the modification(s) then  The software checks the consistency once
press the Esc key once again again.
 If no inconsistency is revealed, the following
window is displayed:

Please enter
your access code:
€Validate Esc Quit

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ACTIONS RESULTS

" Enter your access code, then confirm with  The software checks if critical parameters
the  key have been modified (for example, incubation
times, reagent volumes).
If critical parameters have been modified:
 The following window warns the users of
the consequences of their modifications:

IMPORTANT CHANGES DETECTED


THE FOLLOWING ACTIONS WILL BE TAKEN:
Calibration ...
Quality Control ...
Please type YES to accept
Esc : Abort
with different statements depending on the
parameters modified:
- Calibration: invalidate (the user must rerun
the calibration of the test concerned)
- Quality Control: Delete (results of all the
Quality Control levels will be deleted)
If no critical parameter has been modified:
 The following message is displayed:

Saving ...
Please wait
- Test setup is saved
- Back to the TEST SETUP screen

" In case of modification of critical  Depending on modifications:


parameters, if the consequences are - Invalidation of calibration for test
accepted, type YES, then confirm with the concerned;
 key
- Deletion of Quality Control results for test
concerned.
 Then, test setup is saved.
 And return to the TEST SETUP screen.

" From the TEST SETUP screen, press the  A message advising the operator to proceed
Esc key then confirm with the  key with the saving of the test configurations is
displayed.

" Press the ESC key  Return to the TEST PANEL.

" Proceed with the saving of the test


configurations (see chapter 4.7.5)

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5.4 Creation of a New Test

This procedure is only possible if:


- the STA Compact® is in stand-by (no measurement in process),
- the operator knows the required access code.

NOTE For the description of the test setup parameters: see chapter 5.1

5.4.1 Main Test Creation


" Access the Test Setup menu (see chapter 5.2.1)
" Move the cursor with the End key to the empty space after the last test in the available test list
" Press the  key
" In the case of free entry fields: enter the new information for each parameter (see chapter 5.3.1)
" In the case of Multiple-Option fields, use the Delete key (see chapter 5.3.1)
" When the 3 pages of the test setup have been revised, validate the test setup (see chapter 5.3.2)

5.4.2 Dependent Test Creation


" Access the Test Setup menu (see chapter 5.2.1)
" Move the cursor to the main test from which the dependent test will come
" Press the  key
" Then, press the F4 key
" Move the cursor with the Lkey to the empty space after the last test of the dependent test list
" Press the  key
" In the case of free entry fields: enter the new information for each parameter (see chapter 5.3.1)
" In the case of Multiple-Option fields, use the Delete key (see chapter 5.3.1)

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" When all the parameters are defined, press the F10 key, then press the Esc key and the  key
(Save before Quitting), then enter your access code and confirm with the  key: return to the
Main Test
" Press the Esc key, then the Q key: return to the TEST SETUP screen

It is not necessary and even not recommended to save the main test since the system will reject this
request if there are still Patient files containing this main test in the Working File.

5.5 Test Order on the TEST PANEL Screen


Each laboratory can choose the position of the tests on the TEST PANEL screen and on the different
screens where tests are listed. This procedure is executed from the Test Setup menu.

This procedure is only possible if the STA Compact® is in stand-by (no measurement in process).

2The TEST SETUP screen is displayed, with the cursor on the first test (see chapter 5.2.1).

ACTIONS RESULTS

" Press the Esc key  The following window appears:

Displace Test
Delete Test
Update
Quit
with the cursor on Quit.

" Press the D key  The following window appears:


" Or move the cursor to Displace Test with
the L key, then confirm with the  key TEST DISPLACEMENT
€Select test to be moved
Esc : Quit
with the cursor on the first test.

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ACTIONS RESULTS

" Press the L key to the test which has to be  The following window appears:
moved then confirm by pressing the  key
Move cursor to the new position
 Insert
Esc Quit
with the yellow cursor on the test to be
moved.

" Press the Kor the L keys to move the  The test order is automatically reorganized.
yellow cursor to the required place, then
confirm with the key

" Same procedure as above to move the  The test order is automatically reorganized,
other tests, then exit this procedure by then return to the TEST SETUP screen.
pressing the Esc key

5.6 Test Deletion

This procedure is only possible:


- For the tests defined by the operator (the tests predefined by Diagnostica Stago are not erasable);
- If STA Compact® is in stand-by (no measurement in process);
- If none of the concerned tests are present in the Patient Files of the Working File;
- If the operator knows the access code.

If the deleted test is a main test, then all tests dependent from this test will be also deleted.

2The TEST SETUP screen is displayed, with the cursor on the first test of the list (see chapter 5.2.1).

ACTIONS RESULTS

" Press the L key to reach the test which has


to be deleted (main test or dependent test)

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ACTIONS RESULTS

" Press the Esc key  The following window appears:

Displace Test
Delete Test
Update
Quit
with the cursor on Quit

" Press the L key to Delete Test, then  The following window appears:
confirm with the  key
TEST DELETION
Abbrev. XXX
Name XXX
WARNING:
All dependent tests will be deleted if the
deleted test is a main test
Please type YES to confirm ...
Esc = Quit
with the yellow cursor positioned for the
confirmation.

" Type YES, then confirm with the key  The following window appears:

Please enter
your access code:
€Validate Esc Quit

" Type your access code, then confirm with  The following window appears :
the  Key
TEST DELETION
Abbrev. XXX
Name XXX
DELETING...
Please wait ...
 When the deletion is done:
Return to the TEST SETUP screen
automatically.

If you try to delete a test which is in process, the


following window appears:

TEST DELETION
Abbrev. XXX
Name XXX
Test used in Working File
CANNOT DELETE
Esc Cancel this message

" Press the Esc key to delete this last  The TEST SETUP screen appears.
message

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5.7 Test Updating

The procedure allows to update or create tests predefined by Diagnostica Stago. This procedure is
only possible if :
- the STA Compact® is in stand-by (no measurement in process);
- no test is present in the Patient Files of the Working File;
- the access code is known.

If tests have to be added, there should be enough empty positions, otherwise the operator will be
asked to delete the number of required tests.

The test update may have very important consequences:


- all dependent tests from an updated main test will be deleted;
- invalidation of calibration (depending on the modified parameters);
- deletion of quality controls (depending on the modified parameters).

2The TEST SETUP screen is displayed with the cursor on the first test of the test list (see chapter
5.2.1).

ACTIONS RESULTS

" Press the Esc key  The following window appears:

Displace Test
Delete Test
Update
Quit
with the cursor on Quit.

" Press the U key  The UPDATE TRACK RECORD screen


" Or move the cursor to Update, then appears with the following window:
confirm with the  key
OPTIONS
Update
Quit
with the cursor on Quit.
 The list of tests modified by previous
updates or creations appears in blue with
the modification dates.

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ACTIONS RESULTS

" Press the U key  The following window appears:


" Or move the cursor to Update, then
confirm with the  key Please enter
your access code
 Validate: Esc Quit

" Enter your access code then confirm with  The following window appears:
 key
Please insert the diskette
TESTS UPDATE
in the floppy drive
Confirm Esc Quit

If there are still Patient Files in the Working File,


the following window appears:

TEST UPDATING
WORKING FILE NOT EMPTY
Updating not completed
Erase Working File
Abort
with cursor positioned on Abort.
The Working File may be erased by pressing
the L and keys, then by confirming with
YES and 

" Insert the diskette in the floppy drive, then  The following window appears:
confirm with the  key
File reading
Please wait ... ...
 Then, the TEST UPDATING screen appears.
The list of tests which are going to be
updated or created is displayed in blue.
The number of tests to be added is also
displayed, as well as the number of positions
currently occupied, the number of available
positions.

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ACTIONS RESULTS

" Press the F10 key  The following window appears:

Test updating
Please wait ...
 On the TEST UPDATING screen, the test
display change from blue to yellow during
the updating.
 Then, the window changes into:

Update done
Esc Quit

" Press the Esc key  The UPDATE TRACK RECORD screen
appears. The tests previously updated or
created are displayed in blue, those
currently updated or created in yellow.
 The following window appears:

OPTIONS
Update
Quit
with the cursor positioned on Quit.

" Press the  key  Return to the TEST SETUP screen.

5.8 Calculated Tests

5.8.1 Introduction
The calculated tests are tests for which the result is a calculation expression using one of these
2 formulas:
(R1/R2) x k
or (R1-R2) x k
where:
R1, R2: Results not limited to the printout limits expressed as raw data (sec., 'O.D., O.D./min) for
test [1] and test [2] chosen by the operator.
k: Programmable coefficient.
Thus, one result can be given either as equal to a ratio between two tests or as equal to a difference.
The unit in which the result is given is implicit; i.e.: Ratio for a ratio calculation and raw data for a
difference calculation. The secondary units have not to be defined for calculated tests.
This type of calculation is authorized only when test [1] and test [2] are based on the same type of
measurement method: i.e.: clot-based, chromogenic (not available on STA Compact®CT) or
immunology (not available on STA Compact®CT).

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Calculated tests as well as dependent tests can not be used as test [1] or test [2].
Results from calculated tests are given only when those for test [1] and test [2] have as status “To
Confirm”, “Confirm”, “Dev.> tol.” or “V > V max.” (equivalent to T > T max.) (see description
of these statuses chapters 8.3.2 and 8.3.3).
Moreover, they can not be confirmed manually: their confirmation implicitly follows from those of
test [1] and test [2]. Results from calculated tests have as error code and as alarm code, the most
serious error code and the most serious alarm code among those assigned to test [1] and test [2].
Only alarm code H (result in primary unit limited to printout limit values) escapes this rule because
it directly applies to the values obtained for the calculated results (see below chapter 5.8.2).
Because of their particularity, calculated test can not be rerun, it exists neither calibration nor quality
control for this type of test and those can not have any dependent test.
The procedures to access, to modify and to create these tests are identical to those described for
the other types of test (see chapters 3.2, 5.3, 5.4).

5.8.2 Description of the Definition Parameters for a Calculated Test


Fig. 10 - Calculated Test Parameters

Legend:

1 ESC displays the EXIT OPTIONS window (see description chapter 5.3.2).

2 Test Identification Section (see description, chapter 5.1.1.1).

3 Definition of test [1] and test [2].

4 Definition of parameters for Printout / Transmission.

5 Definition of calculation formula.

6 Definition of the printout limits (see description chapter 5.1.3.3).

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5.8.3 Definition of Test [1] and Test [2]

Abbreviation Abbreviations for test [1] and test [2] to be selected in the list of
tests currently available on STA Compact®.
Reminder: Test [1] and test [2] must be of the same type: clot-
based, chromogenica or immunologicala.

Name Names of test [1] and test [2]. They are automatically displayed
after selection of the abbreviations.
a. not available on STA Compact®CT

5.8.4 Printout / Transmission Section

NOTE The unit is implicit with relation to the type of calculation selected, see chapter 5.8.1.

Printout Utilization of the unit for printout, two possible choices:


YES: Unit utilized;
NO: Unit not utilized.

Trans.: Test Number To be able to transmit the result of the calculated test, the
transmission test number corresponding to the host computer
has to be defined. If the test has not to be transmitted, rank has
to be set to 0 (F1 key).

5.8.5 Definition of Calculation Formula

Formula Choice between two types of formula:


(Result 1/ Result 2) x k
(Result 1 - Result 2) x k
Reminder: Result 1 and result 2 are expressed in raw data (sec.,
'O.D.a, O.D./min.a).

Constant k Coefficient programmable between 0.001 and 9999.999.


a.not available on STA Compact®CT

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Table of contents

6 Loading Products and Samples . . . . . . . . . . . . . . . . . 1

6.1 Generalities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

6.2 Access to the Loading Menu . . . . . . . . . . . . . . . . . . . . . . . . 3

6.3 Description of PRODUCT LOADING Screen . . . . . . . . . . . . . . . . . . . . . . 5

6.4 Description of the SAMPLE LOADING Screen . . . . . . . . . . . . 6

6.5 Identification and Loading of Reagents/Desorb Solutions


(Product Drawer) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
6.5.1 Bar Code Identification of Reagents/Desorb Solutions and Loading (Pro-
duct Drawer) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
6.5.2 Manual Identification of Reagents/Desorb Solutions and Loading (Product
Drawer) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

6.6 Identification and Loading of Controls/Calibrators (Product Drawer) 13


6.6.1 Bar Code Identification of Controls/Calibrators and Loading (Product
Drawer) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
6.6.2 Manual Identification of Controls/Calibrators and Loading
(Product Drawer) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

6.7 Identification and Loading of Diluents (Sample Drawer) . . 17


6.7.1 Description of the Entry Zone for a Diluent . . . . . . . . . . . . . . . . . . . . 17
6.7.2 Bar Code Identification of Diluents and Loading (Sample Drawer) . . . 17
6.7.3 Manual Identification of Diluents and Loading (Sample Drawer) . . . . . 18

6.8 Sample Identification and Loading (Sample Drawer) . . . . . 20


6.8.1 Introduction to Sample Identification and Test Selection . . . . . . . . . . 20
6.8.2 Definition of a Prefix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
6.8.3 Definition of a Test Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
6.8.3.1 Creating a Test Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

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6.8.3.2 Modifying a Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24


6.8.4 Sample Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
6.8.4.1 Generalities on Sample Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
6.8.4.2 Sample Type Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
6.8.5 MANUAL Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
6.8.5.1 Access to MANUAL Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
6.8.5.2 Selecting a Prefix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
6.8.5.3 Bar Code Identification of Samples and Tube Loading . . . . . . . . . . . . . . . . . . . . . . . . 28
6.8.5.4 Manual Identification of Samples and Tube Loading . . . . . . . . . . . . . . . . . . . . . . . . . . 28
6.8.5.5 Auto-incrementation of Sample Identification and Tube Loading . . . . . . . . . . . . . . . . 29
6.8.5.6 Individual Selection of Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
6.8.5.7 Selecting Tests by Profiles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
6.8.5.8 Teleloading Tests from Host Computer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
6.8.6 AUTOMATIC Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
6.8.6.1 Access the AUTO Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
6.8.6.2 Definitions of the Prefix and of the First Number for the AUTO Mode . .
33
6.8.6.3 Use of AUTO Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
6.8.7 Sample Loading with Automatic Display of the List of Tests . . . . . . . . 35

6.9 Modification on Loaded Products or Samples . . . . . . . . . . 36


6.9.1 Modification Procedure for the Product Drawer . . . . . . . . . . . . . . . . 36
6.9.2 Modification Procedure for the Sample Drawer . . . . . . . . . . . . . . . . . 37

6.10 Unloading of Samples or Products . . . . . . . . . . . . . . . . . . . 39


6.10.1 Unloading with Positive Identification . . . . . . . . . . . . . . . . . . . . . . . . . 39
6.10.2 Unloading without Positive Identification . . . . . . . . . . . . . . . . . . . . . . . 39

6.11 Loading without Positive Identification . . . . . . . . . . . . . . . 40


6.11.1 Sample Drawer Procedure . . . . . . . . . . . . . . . . . . . . . . . . 41
6.11.2 Product Drawer Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

6.12 Running Tests (Closing of Sample or Product Drawer) . . . 42

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Loading Products and Samples

6 Loading Products and Samples

6.1 Generalities
The samples and the products (controls, calibrators, diluents, reagents, desorb solutions) can be
loaded in the sample drawer or in the product drawer, see table below:

Loading is possible in:

Sample Drawer Product Drawer

Controls NO YES

Calibrators NO YES
Pour relecture / For proofreading 11/9/09

Diluents YES NO

Reagents NO YES

Desorb solutions NO YES

Samples YES NO

RISK OF INCORRECT RESULTS


Before any loading, the following points have to be checked:
- for reagents or any other product (controls, standards, diluents and desorb solutions), check
for foam on surface. If foam is present, eliminate it;
- for samples, use only tubes after centrifugation, check that there is enough plasma and that
there is no foam, no clot or no micro-clot that might interfere with the results.
For all loading and unloading operations, the proper precautions for handling biohazardous
materials should be observed in accordance with local existing regulations: for instance the use of
disposable gloves, of goggles and/or of a mask.

RISK OF INCORRECT RESULTS


For all loading operations, to avoid confusion, handle only one tube or vial at a time.

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RISK OF INCORRECT RESULTS


Carefully read the instructions of the package insert provided with each product (reagents,
controls, calibrators, dilution buffers, desorb solutions), and follow all the described procedures.

To comply with package inserts requests related to the intrinsic coagulation pathway
deficient plasmas (VIII, IX, XI, XII) as well as with those related to the reagent STA-
Staclot® Protein S, i.e.: “The factor assays of the patients samples follow the completion
of assay calibration and are performed within the time-frame that is compatible with the
stability of related factor in plasma”, the following procedure must be observed:
- before starting samples loading, block the required test (example: factor VIII), see procedure
chapter 8.7.3;
- run calibration for the required test (example: factor VIII);
- change to STAT (F12 key), any sample tube with the required test (example:
factor VIII) in its working list: whether, while loading (see procedure chapter 6.8.4) or while
processing Patient files (see procedure chapter 8);
as soon as calibration of the required test (example: factor VIII) is validated, unblock the test
(example: factor VIII) (see procedure chapter 8.7.3)

Pour relecture / For proofreading 11/9/09


RISK OF INCORRECT RESULTS
Products: Manual identification can lead to typing errors. It is used under complete responsibility of
the user.

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Loading Products and Samples

6.2 Access to the Loading Menu


2TEST PANEL screen displayed.

ACTIONS RESULTS

" Press the Esc key  The Main Menu is displayed:

Status Loading - (...) - Halt


with the cursor on Status.

" Press the L key (Loading)  The sub-menu is displayed:

Samples F1
Products F2
Cuvettes
Pour relecture / For proofreading 11/9/09

Washing Solution
with the cursor on Samples.

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Loading Products and Samples

ACTIONS RESULTS

" For the Sample Drawer, press the €key  2 possible cases:
" For the Reagent Drawer, press the P key - STA Compact® is pipetting in the selected
drawer or needs the drawer (mainly the
product drawer for the cuvettes still in
incubation); the message “X drawer:
Opening requested” appears at the
bottom of the TEST PANEL screen (X= the
number of the drawer).

In case the selected drawer is the product


drawer, the STA Compact® will stop pipetting
samples; it needs about 5 minutes to complete
the pending tests.
As soon as the STA Compact® can liberate the
selected drawer, a confirmation message is
displayed on the screen. The operator must

Pour relecture / For proofreading 11/9/09


confirm his request for opening. Thus, the
message “DRAWER OPENING” is displayed at the
bottom of the screen.

- STA Compact® can immediately open the


drawer, the message “DRAWER OPENING” is
displayed at the bottom of the TEST PANEL
screen.
 Drawer opens automatically.
 Bar code reader is switched on and beeps.
 The window: “Searching...” is displayed.
 For the sample drawer, the SAMPLE
LOADING screen is displayed (see description
chapter 6.4).
 For the product drawer, the PRODUCT
LOADING screen is displayed (see
chapter 6.3).

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Loading Products and Samples

RISK OF INJURY
In order to avoid any injury:
While a drawer is open, do not insert the hand or any object inside the STA Compact®.

Reminder If the liquid level detection management has been inhibited for one or several needles, a warning
message will be displayed upon opening of the related drawer (sample drawer for needle No.1,
reagent dawer for the 3 needles).
For the sample drawer, all tubes should be decanted and the operator must insure that
the plasma quantity is sufficient to perform the request assays.
For the product drawer, the theoretical bottle filling volumes as defined while loading shall be
consistent with the actual ones.

6.3
Pour relecture / For proofreading 11/9/09

Description of PRODUCT LOADING Screen

Fig. 1 - PRODUCT LOADING Screen

Legend:

1 Name of the screen, current Date and Time

2 Available keys:

Esc Returns to the TEST STATUS screen

K List/Change: this key accesses to these function keys:

 Allows product modifications (see chapter 6.9.1)


After the drawer is closed, nothing can be modified

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Del Allows removal of a product from the drawer

Esc Returns to the REAGENT LOADING

3 Identification number for each product. It is displayed in red when the stability is overdue, when
the minimum volume is reached or when a liquid level detection problem is detected.

4 Name of each product

5 Remaining volume of each product.It is displayed in red when the minimum volume is reached
or when a liquid level detection problem is detected

6 Stability for each product

7 Lot number of each product

8 Position of each product in the product drawer. The sign P is displayed at the right side of the
position for products transferred into the microcups.

9 Date and Time of the end of stability for each product. It concerns stability defined within the
Test Setup menu (see chapter 5.1). It is displayed in red when the given time is within the

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period: stability end minus 1h and stability end. It is replaced by the word Complete displayed
in red when the stability end is reached.

10 Upper zone = products already loaded

11 Entry zone for product to be loaded

12 Indication Normal Vol./Microvolume according to the selected choice (F8 key)

6.4 Description of the SAMPLE LOADING Screen


Fig. 2 - SAMPLE LOADING Screen: MANUAL Mode

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Fig. 3 - SAMPLE LOADING Screen: AUTO Mode

Legend:
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1 Name of the screen

2 Available keys:

Esc Options: this key opens the following windows:

For MANUAL Mode: For AUTO Mode:

Change profiles Change Profile


Change prefix Change Prefix/First Number
AUTO mode MANUAL Mode
Return to Loading Return to Loading
Quit Quit

Change profile(s): Creates or modifies Test Profiles (see description in chapter 6.8.3).
Change Prefix (MANUAL Mode) or Change Prefix/First Number (AUTO Mode):
- For Manual Mode, modifies the prefix selected by default (see chapter 6.8.5.2).
- For Auto Mode, modifies the prefix and the first number (see description in chapter 6.8.6.2).
Auto mode: Accesses the AUTO Mode.

Manual mode: Accesses the MANUAL mode.

Return to Loading: Returns to SAMPLE LOADING with the cursor on zone 11 of the sample
loading screen (see below).
Quit: Closes the sample drawer and displays the TEST STATUS screen.

K List/Change: This key allows access to the following function keys:

 Modifies several parameters; once the drawer is closed no more modification is possible

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Del Deletes a Patient tube or a diluent from the Sample Drawer

Esc Returns to the SAMPLE LOADING screen

3 Identification of the current mode (AUTO or MANUAL mode)

4 Selected prefix

5 Recall of the last six loadings

6 Identification (numeric or alphanumeric) of each sample or diluent. A colored code distinguishes


the different status:

White: Routine Sample


Yellow: STAT Sample;
Grey: Patient File without known working list (waiting for teleloading from the Host
Computer)
Green: Liquid Level Detection problem
Red: Patient File for which one or several tests have errors; or diluent with low volume
or overdue stability

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7 Position of each sample or diluent in the sample drawer. The sign P is displayed at the right of
the position of samples which have been transferred into microcontainers.

8 List of tests requested for each sample. For the diluents, name as defined within the TEST SETUP
screens (see chapter 5.1).

9 List of User defined profiles (MANUAL Mode)

10 Test selection list (MANUAL Mode)

11 Field for entering data concerning the sample which has to be loaded. In the ID field is displayed
the Normal tube or Microtube indication in blue for routine samples and in yellow for STAT
samples.

12 Selected parameters for AUTO Mode: test profile, prefix and first number

6.5 Identification and Loading of Reagents/Desorb Solutions


(Product Drawer)
For identification of reagents/desorb solutions, there are two options:
- Automatic identification using bar codes
- Manual identification using the keyboard

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RISK OF INCORRECT RESULTS


Expiration date and lot number are not managed by the analyzer for the following products:
STA<-OWREN KOLLER (TOK) buffer, STA< Desorb U solution, STA<-CaCl2 reagent.
The operator must therefore check the expiration date of these products before loading them in
the analyzer.
For these products, stability and volume only are managed by the analyzer.

In case of lot number change, the calibrations related to these reagents will no longer be valid.
When a stabilization period in STA Compact® analyzer is required for some reagents, it is essential
to block the tests using these reagents before loading them.
See the package inserts of each reagent kit and see blocking procedure chapter 8.7.3.
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6.5.1 Bar Code Identification of Reagents/Desorb Solutions and Loading (Product


Drawer)

2PRODUCT LOADING screen displayed with message “PRODUCT IDENTIFICATION (F8 = Normal
Vol./Microvolume)” at the bottom of the screen and Normal Vol. displayed (see description of
product LOADING SCREEN chapter 6.3).

ACTIONS RESULTS

" If the reagent/desorb solution is in its


original vial, skip the ACTIONS box below

" If the reagent has been transferred into a  The designation of Normal Vol. changes
microcup, press the F8 key into Microvolume (see description of
PRODUCT LOADING screen chapter 6.3).

" Scan the bar code label of the reagent/  Identification (ID), name (Name), volume
desorb solution vial across the bar code (Volume), stability (Stab.), and, if
reader necessary, lot number (Lot) of the reagent/
desorb solution are displayed.
" In case of failure of the Bar Code Reader,
proceed as indicated below (chapter 6.5.2)  The cursor is positioned on the Volume
field for correction if any.
 The message “INDICATE THE VOLUME
(in ml) - Esc = Correction” is displayed at
the bottom of the screen.

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ACTIONS RESULTS

" If it is necessary to modify the volume, type  The new volume is displayed.
the new value, then confirm with the   The cursor is positioned on the Stability
key field.
" Otherwise, confirm directly with the   The message “INDICATE THE STABILITY
key and skip to the RESULTS box below
(hours) - Esc = Correction” is displayed
at the bottom of the screen.

" Modify the stability if necessary, then  The volume and the stability are displayed.
confirm with the  key
 The message “LOAD THE LAST IDENTIFIED
" Otherwise, confirm directly with the  VIAL - Esc = correction” is displayed at the
key bottom of the screen.

" Position the vial in a position that  On the product drawer:


corresponds to its diameter. Reagents that The LED adjacent to the vial position lights
require mixing must be placed in a position up and the machine beeps: position and
with the vial position number circled. identification validated.
Note: If the vial is not properly positioned,  On the screen:
the operator will be informed by an error Automatic display of the position (Pos.).

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message.  If no lot change is detected, skip the two
You have to place the vial within 10 seconds, RESULTS boxes below.
otherwise the vial will have to be identified
 If a lot change is detected, the following
again.
window is displayed:

LOT NUMBER CHANGED


All related calibrations
will be definitively invalid
Accept (YES/NO) XXX

" If the Lot number change is accepted, enter  The following window is displayed:
YES then confirm with the key
Please scan the code sheet
in front of the reader

Esc: Quit

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ACTIONS RESULTS

" Scan the bar code sheet in front of the  For non-precalibrated reagent, skip to next
reader RESULTS box.

Note: In case of failure of the Bar Code  For precalibrated reagents, the two
reader, type the information printed below following windows appear one after another
the bar codes and confirm each line with if necessary:
the  key.
BAR CODE READING
End of Data Processing

BAR CODE READING


Data Read
A0 xxx
A1 xxx
A2 xxx
A3 xxx
N xxx
ISI xxx
Esc = Cancel this message
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" Press the Esc key  Data for this reagent/desorb solution
transferred to the top part of the screen (see
description on chapter 6.3).

" Follow the same procedure for the next vial


of reagent / desorb solution

6.5.2 Manual Identification of Reagents/Desorb Solutions and Loading (Product


Drawer)

2PRODUCT LOADING screen displayed with message “PRODUCT IDENTIFICATION (F8 = Normal
Vol./Microvolume)” at the bottom of the screen and Normal Vol. displayed (see description of
PRODUCT LOADING screen chapter 6.3).

ACTIONS RESULTS

" If the reagent/desorb solution is in its


original vial, skip the ACTIONS box below

" If the reagent has been transferred into a  The designation of Normal Vol. changes
microcup, press the F8 key into Microvolume (see description of
PRODUCT LOADING screen chapter 6.3).

" Enter the identification of the reagent/  The reagent/desorb solution identification is
desorb solution as defined in the Test displayed.
Setup on page 1 of 3 and confirm with the  The cursor is on the Name field.
 key

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ACTIONS RESULTS

" Type the name of the reagent/desorb  The name of the reagent/desorb solution is
solution as defined in the Test Setup page displayed.
1 of 3, then confirm with the  key
 The cursor is on the Volume field.
 The message “INDICATE THE VOLUME (in
ml) Esc = Correction” is displayed at the
bottom of the screen.

" Enter the reagent/desorb solution volume  The volume is displayed.


and confirm with the  key
 The cursor is on the Stab. field.
 The message " INDICATE THE STABILITY
(hours) - Esc = Correction" is displayed at
the bottom of the screen.

" Type the stability, then confirm with the  The stability is displayed.
 key  The cursor is on the Lot field.
 The message" INDICATE THE LOT NUMBER -
Esc = Correction" is displayed at the

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bottom of the screen.

" Enter the lot number if necessary and  For all reagents which are not from STA<
confirm with the  key line of Diagnostica Stago, the following
window is displayed:

REAGENT LOADING
Should the reagent be mixed?
Y = Yes N = No

" For a reagent which needs mixing, type Y  The message “LOAD THE LAST IDENTIFIED
VIAL - Esc = Correction” is displayed at
" For a reagent without mixing, type N
the bottom of the screen.

" Place the vial in a position corresponding to  On the product drawer:


its diameter. Reagents that require mixing The LED adjacent to the vial position lights
must be placed in a position with the vial up and the machine beeps:
position number circled. position and identification validated
Note: If the vial is not properly  On the screen:
positioned, the operator will be informed Automatic display of the position (Pos.).
by an error message.
 If no lot number change is detected, moves
You have to place the vial within 10 seconds, directly to the RESULTS box below.
otherwise the vial will have to be identified  If a lot number change is detected, the
again. following window is displayed:

LOT NUMBER CHANGED


All concerned calibrations will be definitively
invalid
Accept (YES/NO) XXX

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ACTIONS RESULTS

" If the lot number change is accepted, type  Data for this reagent/desorb solution
YES, then confirm with the  key transferred to the top part of the screen (see
description on chapter 6.3).

" Follow the same procedure for the next vial


of reagent/desorb solution

6.6 Identification and Loading of Controls/Calibrators (Product Drawer)

For identification of controls/calibrators there are two options:


- Automatic identification using bar codes
- Manual identification using the keyboard
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6.6.1 Bar Code Identification of Controls/Calibrators and Loading (Product


Drawer)

2PRODUCT LOADING screen displayed with message “PRODUCT IDENTIFICATION (F8 = Normal
Vol./Microvolume)” at the bottom of the screen and Normal Vol. displayed (see description of
PRODUCT LOADING screen chapter 6.3).

ACTIONS RESULTS

" If the control/calibrator is in its original vial,


skip the next ACTIONS box

" If the control/calibrator has been  The designation of Normal Vol. changes
transferred into a microcup, press the F8 into Microvolume (see description of
key PRODUCT LOADING screen chapter 6.3).

" Scan the bar code of the control/calibrator  Identification (ID), name (Name), volume
in front of the reader (i.e.: STA< - COAG (Volume), stability (Stab.), and lot number
CONT N) (Lot) of the control/calibrator are displayed.
" In case of failure of the bar code reader,  The cursor is positioned on the Volume
proceed as indicated below, chapter 6.6.2) field for correction if any.
 The message “INDICATE THE VOLUME (in
ml) - Esc = Correction” is displayed at the
bottom of the screen.

" If the volume has to be modified, enter the  The new volume is displayed.
new value, then confirm with the  key  The cursor is positioned on the Stability
" Otherwise directly confirm with the  key field.
and jump to the RESULTS box below
 The message “INDICATE THE STABILITY
(hours) - Esc = Correction” is displayed
at the bottom of the screen.

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ACTIONS RESULTS

" Modify if necessary the stability, then  The volume and the stability are displayed .
confirm with the  key  The message “LOAD THE LAST IDENTIFIED
" Otherwise confirm with the  key VIAL - ESC= Correction” is displayed at
the bottom of the screen.

" Load the vial in a position corresponding to  On the product drawer:


its diameter. The LED adjacent to the vial position lights
You have to place the vial within 10 seconds, up and the machine beeps: position and
otherwise the vial will have to be identified identification validated
again  On the screen:
Automatic display of the position (Pos.).
 If no change is detected, skip the two next
results boxes below.
 If a lot change is detected:
For a control, the following window is
displayed:

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LOT NUMBER CHANGED
For all concerned tests:
New ranges are needed
before controls can be run
Confirm (YES / NO) XXX
 For a calibrator, the following window
is displayed:

LOT NUMBER CHANGED


For all concerned tests:
The new concentration
must be entered when
running calibration
Confirm (YES / NO) XXX

" Enter YES then confirm with the  key  The following window is displayed:

Please pass the code sheet


in front of the reader

Esc: Quit

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ACTIONS RESULTS

" Scan the bar code sheet in front of the  At the end, the following window is
reader displayed:
" In case of failure of the bar code reading,
enter the data printed under the bar codes BAR CODE READING
and confirm with the  key at the end of Data Processing End
each line Esc: Cancel this message

" Press the Esc key  Data for this control/calibrator transferred
to the top part of the screen (see description
on chapter 6.3).

RISK OF INCORRECT RESULTS


For all the related tests, the values of calibrators
or control ranges will be properly dispatched in
the various screens on condition that the
primary unit chosen for the test is identical to
the primary unit used on the bar code sheet
(assay value insert) (except: Fibrinogen).
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" Follow the same procedure for the next vial


of control/calibrator

6.6.2 Manual Identification of Controls/Calibrators and Loading


(Product Drawer)

2PRODUCT LOADING screen displayed with message “PRODUCT IDENTIFICATION (F8 = Normal
Vol./Microvolume)” at the bottom of the screen and Normal Vol. displayed (see description of
PRODUCT LOADING screen chapter 6.3).

ACTIONS RESULTS

" If the control/calibrator is in its original vial,


skip the next ACTIONS box

" If the control/calibrator has been  The designation of Normal Vol. changes
transferred into a microcup, press the F8 into Microvolume (see description of
key PRODUCT LOADING screen chapter 6.3).

" Enter the alphanumeric identification of the  The identification of the control/calibrator is
control/calibrator as defined in the TEST displayed.
SETUP screens (including spaces), then
 The cursor is positioned on the Name field.
confirm with the  key,
The product chosen for this example is the
STA< - COAG CONT N.

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ACTIONS RESULTS

" Enter the product name: STA - COAG  The name of the control/calibrator is
CONT N (in this case) as it was defined in the displayed.
TEST SETUP screen (see chapter 5.1), then
 The cursor is on the Volume field.
confirm with the  key
 The message “INDICATE THE VOLUME (in
ml) Esc = Correction” is displayed at the
bottom of the screen.

" Enter the volume, then confirm with the  The volume is displayed.
 key
 The cursor is on the Stab. field.
 The message "INDICATE THE STABILITY
(hours) - Esc = Correction" is displayed at
the bottom of the screen.

" Enter the stability, then confirm with the   The stability is displayed.
key  The cursor is on the Lot field.
 The message "INDICATE THE LOT NUMBER -
Esc = Correction" is displayed at the

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bottom of the screen

" Enter the lot number indicated on the vial,  The message “LOAD THE LAST IDENTIFIED
then confirm with the  key TUBE - Esc = Repeat ident” is displayed at
the bottom of the screen.

" Load the vial in a position corresponding to  On the product drawer:


its diameter The LED adjacent to the vial position lights
You have to place the vial within 10 seconds, up and the machine beeps: position and
otherwise the vial will have to be identified identification validated.
again.
 On the screen:
Automatic display of the position (Pos.).
 If no lot change is detected, skip to the next
RESULTS box below.

 If a lot number change is detected:


• For a control, the following window is
displayed:

LOT NUMBER CHANGED


For all concerned tests:
New ranges are needed
before controls can be run
Confirm (YES / NO) XXX
• For a calibrator, the following window
is displayed:

LOT NUMBER CHANGED


For all concerned tests:
The new concentration
must be entered when
running calibration
Confirm (YES / NO) XXX

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ACTIONS RESULTS

" If the lot number change is accepted, enter  Data for this control/calibrator transferred
YES then confirm with the  key to the top part of the screen (see description
on chapter 6.3).

The values of the quality control ranges must be


modified in the related screens, otherwise, the
test will be blocked.

" Follow the same procedure for the next vial


of control/calibrator

6.7 Identification and Loading of Diluents (Sample Drawer)


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6.7.1 Description of the Entry Zone for a Diluent


Fig. 4 - Entry Zone for a Diluent

Legend:

1 Identification number for the diluent with indication of the sample type: Normal Tube or
Microtube

2 Position within drawer

3 Complete name of the diluent

4 Diluent volume

5 Diluent stability

6 Lot number of the diluent (if used)

6.7.2 Bar Code Identification of Diluents and Loading (Sample Drawer)

2SAMPLE LOADING screen displayed with MANUAL Mode or AUTO Mode (as described in
chapter 6.4).

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ACTIONS RESULTS

" Scan the bar code of the product in front of  The STA Compact® beeps and the following
the reader (i.e.: Owren - Koller Buffer) window is displayed:
" In case of failure of the bar code reader,
proceed as indicated below (chapter 6.7.3) Product detected
F1: Diluent
11361
F2: Sample
xxx C2: 6199B
xxx: Recall of the prefix if the latter has been
defined.

" Press the F1 key  The diluent name is displayed as well as the
volume and the stability.
 The cursor is positioned on the Volume box
(see description above chapter 6.7.1).

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" If the volume has to be modified, enter the  The new volume is displayed.
new value, then confirm with the  key

" Otherwise directly confirm with the  key  The cursor is positioned on the Stability
and jump to the RESULTS box below box (area 5, see description above
chapter 6.7.1).

" Modify if necessary the stability, then  The message “LOAD THE LAST IDENTIFIED
confirm with the  key TUBE - Esc = Repeat ident” is displayed in

" Otherwise confirm with the  key yellow at the bottom of the screen.

" Load the diluent vial in the reserved  On the sample drawer:
position (No. 8) or in any other position The LED adjacent to the product position
You have to place the vial within 10 seconds, lights up and the STA Compact® beeps =
otherwise the vial will have to be identified position and identification validated.
again.
 On the screen:
Automatic display of the position and data
transferred into the zone for samples
already loaded (see description of SAMPLE
LOADING screen chapter 6.4).

6.7.3 Manual Identification of Diluents and Loading (Sample Drawer)

2SAMPLE LOADING screen displayed with MANUAL Mode or AUTO Mode (as described in
chapter 6.4).

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ACTIONS RESULTS

" Enter the alphanumeric identification of the  The following window is displayed:
product as defined in the TEST SETUP
screens (including spaces), then confirm Product detected
with the  key, F1: Diluent
The product chosen for this example is the 11361
Owren - Koller Buffer. F2: Sample
11361

" Press the F1 key to confirm the product  The entry zone for diluent is displayed (see
type (F2 allows loading a sample whose description above chapter 6.7.1).
identity will be the same as that of a dilution  The cursor is positioned on the complete
buffer) name field (see description above
chapter 6.7.1).

" Enter the product name: Owren - Koller  The cursor is positioned on the Volume
(in this case) as it was defined in the TEST field (see description above chapter 6.7.1).
SETUP screen (see chapter 5.1), then
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confirm with the  key

" Enter the volume, then confirm with  The cursor is positioned on the Stability
the  key field (see description abov, chapter 6.7.1 of
this manual).

" Enter the stability, then confirm with  The message “LOAD THE LAST IDENTIFIED
the  key TUBE - Esc = Repeat ident” is displayed in
yellow at the bottom of the screen.

" Load the diluent vial in the reserved  On the sample drawer:
position (No. 8) or in any other position The LED adjacent to the position lights up
and the STA Compact® beeps = position
and identification validated.
 On the screen:
Automatic display of the position and data
transferred into the zone for samples
already loaded (see description of SAMPLE
LOADING screen chapter 6.4).

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6.8 Sample Identification and Loading (Sample Drawer)

6.8.1 Introduction to Sample Identification and Test Selection


ˆ Samples can be identified in a number of ways:
- Bar code identification with or without prefix
- Manual identification with or without prefix
- Automatic identification (with or without test selection)

RISK OF INCORRECT RESULTS


Samples: Manual identification can lead to typing errors. It is used under complete responsibility of
the user

Pour relecture / For proofreading 11/9/09


ˆ There are also several ways of selecting tests:
- Individual selection
- Selection by profile
- Tele-loading from Host computer
- Automatic display of the list of tests

The number of tests for each Patient File is limited to 12.

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All the combinations are possible, see below:

TEST Selection

Host Automa-
Individual Profile computer tic Dis-
teleloading play

Manual X X X X
with prefix

Sample Manual X X X X
without prefix

Identi- Bar codes with X X X X


fication prefix

Bar codes X X X X
without prefixes

The AUTO mode is dealt with separately because it incorporates the notions of prefix and test
Pour relecture / For proofreading 11/9/09

selection.
For the special case of the automatic display of the test list, see chapter 6.8.7.

6.8.2 Definition of a Prefix


A prefix can be defined regardless of whether identification is manual or by bar codes. It is also
possible whether for the MANUAL Mode or the AUTO Mode.
The prefix can serve to differentiate the different populations of samples according to criteria chosen
by the laboratory.
For example: POP for pre-operative, HEP for a patient treated with Heparin, AVK for a patient
treated with anti-vitamin K.

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6.8.3 Definition of a Test Profile


For the MANUAL Mode, up to 7 different test profiles can be defined, and these can be modified at
any time.
For the AUTO Mode, only one profile is used, which is called AUTO profile.

The number of tests per profile is limited to 6. Several profiles can be cumulated to the amount of
12 tests per Patient file (Manual Mode).

Fig. 5 - Profile Modification Screen

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Legend:

1 Name of the screen

2 List of profiles

3 Display zone for the list of available tests

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4 Available functions:

The  key (Modify) Leads to the following functions:

Insert/ Adds or deletes one or more tests for a selected profile


Remove

0 Teleloading Downloads tests from a central computer

F10 Save Validates the modification or creation of a profile

Esc Abandon Returns to the first profile of the list of profiles without saving the
modifications

The Esc key (Quit) Returns to the SAMPLE LOADING screen

6.8.3.1 Creating a Test Profile


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2SAMPLE LOADING screen displayed with MANUAL Mode or AUTO Mode (as described in chapter
6.4).

ACTIONS RESULTS

" Press the Esc key (Options)  For the MANUAL Mode, the following
window is displayed:

Change Profiles
Change Prefix
AUTO Mode
Return to Loading
Quit
 For the AUTO Mode, the following window is
displayed:

Change Profile
Change Prefix/First Number
MANUAL Mode
Return to Loading
Quit
 In both cases, the cursor is positioned on
Quit.

" Press the C key (Change Profile)  The PROFILE MODIFICATION screen appears
" Or move the cursor to Change Profile without the list of available tests (see
with the L key then confirm with the key description above).

" Move the cursor after the last profile using  The list of available tests appears with the
the Lkey, thenconfirm with the  key cursor on the first test.

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ACTIONS RESULTS

" Select the desired tests by moving the  The selected tests appear in the PROFILE
cursor keys L, J ,K, and I and confirm MODIFICATION screen (see above).
the choice of each test with the  key
 By teleloading is displayed in the PROFILE
" Or press the 0 key (Teleloading) MODIFICATION screen (see above).

" Save the new profile by pressing the  The new profile is validated.
F10 key

" Press the Esc key  Return to the SAMPLE LOADING screen.

6.8.3.2 Modifying a Profile

2SAMPLE LOADING screen displayed with MANUAL Mode or AUTO Mode (as described in
chapter 6.4).

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ACTIONS RESULTS

" Press the Esc key (Options)  The following window is displayed:

Change Profiles
Change Prefix
AUTO Mode
Return to Loading
Quit
 For the AUTO Mode, the following window is
displayed:

Change Profile
Change Prefix / First Number
MANUAL Mode
Return to Loading
Quit
 In both cases, the cursor is positioned on
Quit.

" Press the C key (Change Profile)  The PROFILE MODIFICATION screen appears
" Or move the cursor to Change Profile without the list of available tests (see
with the Lkey then confirm with the  key description above).

" Move the cursor to the desired profile using  The list of available tests appears with the
the L key, then confirm the choice with the cursor on the first test.
 key

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ACTIONS RESULTS

" Select the desired tests by moving the  The selected tests appear in the PROFILE
cursor using the cursor keys L, J, K and I MODIFICATION screen (see above).
and confirm the choice of each test with
 By teleloading is displayed in the PROFILE
the key
MODIFICATION screen (see above).
" or press the 0 key (Teleloading)

" Save the profile by pressing the F10 key  The profile is validated.

" Press the Esc key  Return to the SAMPLE LOADING screen.

6.8.4 Sample Type

6.8.4.1 Generalities on Sample Type


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Several sample categories can be distinguished:


- Normal samples: loaded in standard tubes with enough plasma to perform the requested non-
urgent tests
- STAT samples
- Samples transferred into microcontainers
Whether for the MANUAL Mode or for the AUTO Mode, the sample type has to be defined while
identifying the sample, by the F8 key for samples loaded in microcontainers or by the F12 key for
the STAT samples.
A STAT sample can be loaded in a microcontainer.

The STAT samples are identified in yellow. For the STAT sample processing, see description
chapter 6.12.

6.8.4.2 Sample Type Definition

2LOADING SAMPLE screen displayed in MANUAL Mode or in AUTO Mode (see description
chapter 6.4).

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ACTIONS RESULTS

" If the sample is normal (routine, not in a


microcontainer), proceed with its
identification (see below chapter 6.8.5
(MANUAL Mode) or chapter 6.8.6. (AUTO
Mode))

" If it is a STAT sample, press the F12 key  The designation of Normal tube changes
from blue to yellow (see description of
SAMPLE LOADING screen in chapter 6.4).

" If the sample has been transferred into a  The designation of Normal tube changes
microcontainer, press the F8 key into Microtube (see description of SAMPLE
LOADING screen in chapter 6.4).

" If the sample is a STAT sample which has  The designation of Microtube is displayed
been transferred into a microcontainer, in yellow (see description of SAMPLE
press both keys F8 and F12. LOADING screen in chapter 6.4).

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6.8.5 MANUAL Mode

6.8.5.1 Access to MANUAL Mode


This procedure is not necessary if MANUAL MODE is already displayed (see description of SAMPLE
LOADING screen, chapter 6.4).

2SAMPLE LOADING screen displayed with AUTO MODE (as described in chapter 6.4).

ACTIONS RESULTS

" Press the Esc key  The following window is displayed:

Change Profile
Change Prefix / First Number
MANUAL Mode
Return to Loading
Quit
with cursor on Quit.

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ACTIONS RESULTS

" Press the M key (MANUAL MODE).  Return to SAMPLE LOADING with the
" Or move the cursor to MANUAL Mode with indication: MANUAL MODE displayed (see
the L key then confirm with the  key description of SAMPLE LOADING screen
chapter 6.4).
 The message “SAMPLE IDENTIFICATION
(F12 = in priority F8 = Normal / Micro
Tube)” is displayed at the bottom of the
screen.

6.8.5.2 Selecting a Prefix

2SAMPLE LOADING screen with MANUAL Mode is displayed (as described in chapter 6.4) with the
message “SAMPLE IDENTIFICATION (F12 = in priority F8 = Normal/Micro Tube)” displayed
at the bottom of the screen.
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ACTIONS RESULTS

" Press the Esc key (Options)  The following window is displayed:

Change Profiles
Change Prefix
AUTO mode
Return to Loading
Quit
with the cursor on Quit.

" Move the cursor with the L key to Change  The following window is displayed:
prefix, then confirm with the  key
New Prefix
[ - ]  Save
Esc Abandon
with the cursor in the entry zone for the
prefix.

" To delete the current prefix, press the  Go to the last RESULTS box below.
= key until the prefix is completely erased,
then confirm with the  key

" To define a free prefix, type the free  Return to SAMPLE LOADING. The chosen
desired prefix then confirm with the  key prefix is displayed in the sample
identification area (see description of the
SAMPLE LOADING screen chapter 6.4).

 Any manual or bar code identification will


then be preceded by this prefix (see SAMPLE
LOADING screen)

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6.8.5.3 Bar Code Identification of Samples and Tube Loading

NOTE This identification can be done with or without prefix.

2SAMPLE LOADING screen with MANUAL Mode displayed and the cursor is in the sample entry
zone (as described in chapter 6.4).The sample type has been defined (see chapter 6.8.4.2).

ACTIONS RESULTS

" Scan the sample tube in front of the bar  The tube identification appears on the
code reader screen in the ID zone (see description of the
SAMPLE LOADING screen, chapter 6.4 ) and
the message “LOAD THE LAST IDENTIFIED
TUBE - Esc = Repeat ident” appears in

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yellow at the bottom of the screen.

" Place the sample tube in any position of the  On the sample drawer:
sample drawer The LED adjacent to the tube position lights
up and the machine beeps = position and
identification validated.

You have to place the tube within 10 seconds,  On the screen:


otherwise the tube will have to be identified Automatic display of the position within the
again. drawer (example A4) and the message
“INDICATE TESTS TO PERFORM - F10 =
VALIDATE” is displayed at the bottom of the
screen.

" Proceed to test selection (see below)

6.8.5.4 Manual Identification of Samples and Tube Loading

NOTE This identification can be done with or without prefix.

2SAMPLE LOADING screen with MANUAL Mode displayed and the cursor is in the sample entry
zone (as described in chapter 6.4).
The sample type has been defined (see chapter 6.8.4.2).

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ACTIONS RESULTS

" Enter the sample identification on the  The message “LOAD THE LAST IDENTIFIED
keyboard and confirm with the  key TUBE - Esc = Repeat ident” is displayed in
yellow at the bottom of the screen.

" Place the sample tube in any position of the  On the sample drawer:
sample drawer The LED adjacent to the tube position lights
up and the machine beeps = position and
identification validated.

You have to place the tube within 10 seconds,  On the screen:


otherwise the tube will have to be identified Automatic display of the position within the
again. drawer (example A4) and the message
“INDICATE TESTS TO PERFORM - F10 =
VALIDATE” displayed at the bottom of the
screen.

" Proceed to test selection (see below)


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6.8.5.5 Auto-incrementation of Sample Identification and Tube Loading


It is possible through the * key.
If it is used upon opening of drawer, the generated identification is 1.
If it is used during loading, the generated identification is that of the preceding patient file plus 1.

Example: Preceding File Generated Identification

SMITH SMITH 1

100 101

MAT100 MAT101

2SAMPLE LOADING screen with MANUAL Mode displayed and the cursor is in the sample entry
zone (as described in chapter 6.4).The sample type has been defined (see chapter 6.8.4.2).

ACTIONS RESULTS

" Press the * key  Generated identification = 1, if no


previously loaded tube.
 Generated Identification = previously
loaded file identification +1.

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ACTIONS RESULTS

" Confirm the generated identification with  The message “LOAD THE LAST IDENTIFIED
the  key TUBE - Esc = Repeat ident” appears in
yellow at the bottom of the screen.

" Place the sample tube in any position of the  On the sample drawer:
sample drawer The LED adjacent to the tube position lights
up and the machine beeps = position and
identification validated.

You have to place the tube within 10 seconds,  On the screen:


otherwise the tube will have to be identified Automatic display of the position within the
again. drawer (example A4) and the message
“INDICATE TESTS TO PERFORM - F10 =
VALIDATE” is displayed at the bottom of the
screen.

" Proceed to test selection (see below)

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6.8.5.6 Individual Selection of Test

2Tube in progress , already identified and loaded (see above). SAMPLE LOADING screen with
message “INDICATE TESTS TO PERFORM - F10 = VALIDATE” already displayed and cursor
positioned on the first test of the Selection zone (see description of the SAMPLE LOADING screen
chapter 6.4).

ACTIONS RESULTS

" Select the desired tests by moving the  The selected tests appear in the Test
cursor to them using the cursor keys L, K, Selection zone for the sample being loaded
I and J and confirm the choice of each (see description of the SAMPLE LOADING
test with the  key screen chapter 6.4).

" Save the test selection with the F10 key  Data for this sample are transferred into the
zone for samples already loaded (see
description of SAMPLE LOADING screen
chapter 6.4).

6.8.5.7 Selecting Tests by Profiles


Selecting Profiles by a Figure (1 to 7).

2Tube in progress , already identified and loaded (see above). SAMPLE LOADING screen with
message “INDICATE TESTS TO PERFORM - F10 = VALIDATE” already displayed and cursor
positioned on the first test of the Selection zone (see description of the SAMPLE LOADING screen
chapter 6.4).

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ACTIONS RESULTS

" Press on key (1 to 7) corresponding to  The selected test profiles appear in the Test
desired profile Selection zone for the sample being loaded
(see description of SAMPLE LOADING screen
chapter 6.4).

" Validate the sample with the F10 key  Data for this sample are transferred into the
Samples already loaded zone (see
description of SAMPLE LOADING screen,
chapter 6.4).

Selecting Profiles by Moving the Cursor.

2Tube in progress, already identified and loaded (see above). SAMPLE LOADING screen with
message “INDICATE TESTS TO PERFORM - F10 = VALIDATE” already displayed and cursor
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positioned on the first test of the Selection zone (see description of the SAMPLE LOADING screen
chapter 6.4).

ACTIONS RESULTS

" Press the I key  The cursor is positionned on the first profile
of the Recorded profiles area (see
description of the SAMPLE LOADING screen
chapter 6.4).

" Move the cursor to each selected profile  The selected test profiles appear in the Test
then save each profile with the  key Selection zone for the sample being loaded
(see description of SAMPLE LOADING screen
chapter 6.4).

" Save the sample with the F10 key  Data for this sample are transferred into the
Samples already loaded zone (see
description of SAMPLE LOADING screen
chapter 6.4).

6.8.5.8 Teleloading Tests from Host Computer


The BY TELELOADING option is chosen by means of a profile (see chapter 6.8.3).
The VERIFY PATIENT DATA option is defined within Global Options menu (see chapter 10.2.3.1).

2Tube already in progress identified and loaded (see above). SAMPLE LOADING screen with
message “INDICATE TESTS TO PERFORM - F10 = VALIDATE” already displayed and cursor
positioned on the first test of the Selection zone (see description of the SAMPLE LOADING screen
chapter 6.4).

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ACTIONS RESULTS

" Press the key (1 to 7) corresponding to the  BY TELELOADING is displayed in the Test
BY TELELOADING profile Selection zone for the sample being loaded
(see description of the SAMPLE LOADING
" Or press the I key, then the L key to
move the cursor to the BY TELELOADING screen chapter 6.4).
profile and confirm with the  key

" Confirm the sample with the F10 key  If the VERIFY PATIENT DATA option is set to
NO, data for this sample are transferred into
the samples already loaded zone (see
description of SAMPLE LOADING screen
chapter 6.4).
 If the VERIFY PATIENT DATA option is set to
YES, the following windows are displayed:

TELELOADING
Please wait

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Esc = Abandon

TELELOADED FILE
ID: XXX 1
Patient: XXX XXX
XXX 2 XXX
F10: Save Esc: Cancel
1 Patient File identification
2 Complementary Information (Name, First
name...) (see definitions chapter 10.2.3.3).

" If the data sent back by the Host Computer  Data for this sample are transferred into the
are correct, press the F10 key Samples already loaded zone (see
description of SAMPLE LOADING screen
chapter 6.4).

" If the data sent back by the Host Computer  The following window is displayed:
are not correct, press the Esc key
SAMPLE LOADING
MAINFRAME
Can you verify if the tube is removed
F10: Remove
 The LED near the tube blinks.

" Remove the tube and confirm with the


F10 key

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6.8.6 AUTOMATIC Mode


This mode allows fast loading of samples for which:
- The requested test profiles are identical
- The identification numbers are successive or by means of bar codes

6.8.6.1 Access the AUTO Mode


This procedure is not necessary if AUTO MODE is already displayed (see description of SAMPLE
LOADING screen, chapter 6.4).

2SAMPLE LOADING screen displayed with MANUAL MODE (as described in chapter 6.4).
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ACTIONS RESULTS

" Press the Esc key  The following window is displayed:

Change Profiles
Change Prefix
AUTO Mode
Return to Loading
Quit
with the cursor on Quit.

" Press the A key (AUTO Mode)  Return to SAMPLE LOADING screen with
" Or move the cursor to AUTO Mode with Auto Mode displayed (see description of
SAMPLE LOADING screen chapter 6.4 ).
the L key, then confirm with the  key
 The message: “ = FILE EDITING - (F12 =
in priority - F8 = Normal/Micro Tube)”
displayed at the bottom of the screen.

6.8.6.2 Definitions of the Prefix and of the First Number for the AUTO Mode

2SAMPLE LOADING screen displayed with AUTO Mode (as described in chapter 6.4) and Message “
=FILE EDITING (F12 = in priority F8 = Normal/Micro Tube)” displayed at the bottom of the
screen.

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ACTIONS RESULTS

" Press the Esc key (Options)  The following window is displayed:

Change Profile
Change Prefix / First Number
MANUAL Mode
Return to Loading
Quit
with the cursor positionned on Quit.

" Move the cursor to Change Prefix/First  The New Parameters window is displayed
Number with the L key, then confirm with with the cursor on the entry zone for the
the key prefix.

" To delete the current prefix, press the  Skip to RESULTS box below.
= key until the prefix is completely erased,
then confirm with the  key

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" To define a free prefix, type the free  The cursor is positioned on the entry zone
desired prefix, then confirm with the  key for the first number.

" Type the first number, then confirm with  Return to SAMPLE LOADING.
the F10 key
 The parameters defined for the AUTO Mode:
Profile, prefix and first number, are displayed
in the Parameters zone (see description of
the SAMPLE LOADING screen chapter 6.4).
 The identification of the first sample is
displayed in the ID zone for the sample
being loaded (see description of the SAMPLE
LOADING screen chapter 6.4).

6.8.6.3 Use of AUTO Mode

2SAMPLE LOADING screen displayed, with AUTO MODE and cursor positioned on the entry zone
for the sample (as described in chapter 6.4).
The sample type has been defined (see chapter 6.8.4.2).
The test profile has been defined (see chapter 6.8.3).
The prefix and the first number have been selected (see procedure chapter 6.8.6.2).

ACTIONS RESULTS

" Press the  key  The message “LOAD THE LAST IDENTIFIED
TUBE” is displayed in yellow at the bottom
" Or scan the sample tube in front of the bar
code reader of the screen.

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ACTIONS RESULTS

" Place the sample tube in any position of the  On the sample drawer:
drawer The LED adjacent to the tube position lights
up and the machine beeps = position and
identification validated.

You have to place the tube within 10 seconds,  On the screen:


otherwise the tube will have to be identified Data for this sample is transferred into the
again. Samples already loaded zone (see
description of the SAMPLE LOADING screen
chapter 6.4) with automatic display of the
position within the drawer (example A4),
the message “ = FILE EDITING (F12 = in
priority F8 = Normal Tube/Micro
Tube)” is displayed at the bottom of the
screen.

" Proceed to the next tube loading.


Note: at any time, the sample type can be
changed.
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6.8.7 Sample Loading with Automatic Display of the List of Tests


The automatic display of the list of tests is only possible for Patient files already known by the STA
Compact® because they have already been loaded, processed then removed.
This automatic display can occur for the MANUAL Mode as well as for the AUTO Mode.

Modifying the sample type or the list of tests will only be possible after loading of the sample tube
by means of the K key List/Change (see description chapter 6.9.2).

2SAMPLE LOADING screen displayed (MANUAL Mode or AUTO Mode), as described in chapter 6.4.

ACTIONS RESULTS

" Enter the sample identification on the  The list of tests is automatically displayed in
keyboard, then confirm with the  key the TEST SELECTION zone for the sample
being loaded (see description of the SAMPLE
" Or scan the sample tube in front of the bar
LOADING screen chapter 6.4).
code reader
 The message “LOAD THE LAST IDENTIFIED
TUBE - Esc = Repeat ident (ALREADY
EXISTS)” is displayed in yellow at the
bottom of the screen.

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ACTIONS RESULTS

" Place the sample tube in any position of the  On the sample drawer:
sample drawer The LED adjacent to the tube position lights
up and the machine beeps = position and
identification validated.

You have to place the tube within 10 seconds,  On the screen:


otherwise the tube will have to be again Data for this sample are transferred into the
identified. zone for samples already loaded (see
description of SAMPLE LOADING screen
chapter 6.4) with automatic display of the
position within the drawer (example A4).
 STA Compact® ready for loading of the next
sample.

6.9 Modification on Loaded Products or Samples

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6.9.1 Modification Procedure for the Product Drawer

This procedure is only possible for controls, calibrators, reagents or desorb solutions loaded during
the loading session in progress. The possible modifications concern:
- the volume;
- the stability;
- the indication Normal Vol./Microvolume

2PRODUCT LOADING screen displayed with message “PRODUCT IDENTIFICATION (F8 = Normal
Vol./Microvolume)” at the bottom of the screen and Normal Vol. displayed (see description of
PRODUCT LOADING screen chapter 6.3).

ACTIONS RESULTS

" Press the K key  The cursor is positioned on the last line of
the zone of products already loaded (see
description of the PRODUCT LOADING screen
chapter 6.3).

" Move the cursor on the required control/  Cursor positioned on the required control/
calibrator/reagent/desorb solution with the calibrator/reagent/desorb solution.
K key

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ACTIONS RESULTS

" Press the  key  All control/calibrator/reagent/desorb


solution information is displayed (see
description of the PRODUCT LOADING screen
chapter 6.3).
 The cursor is positioned in the Volume field.
 The message “INDICATE THE VOLUME
(in ml) - Esc = Cancel” is displayed at the
bottom of the screen.

" If it is necessary to modify the volume, type  The new volume is displayed.
the new value, then confirm with the  key
 The cursor is positioned in the Stability
" Otherwise, confirm directly with the  key field.
and jump to the RESULTS box below
 The message “INDICATE THE STABILITY
(hours) - Esc = Cancel” is displayed at the
bottom of the screen.

" Modify, if necessary, the stability, then  Volume and stability are displayed.
confirm with the  key
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 The cursor is positioned on the field


" Otherwise, confirm directly with the key indicating Normal Vol. or Microvolume.
 The message “ = MODIFY (F8 = Normal
Vol./Microvolume - Esc = Cancel” is
displayed at the bottom of the screen.

" Change, if necessary, the indication  Data for this control/calibrator/reagent/


Normal Vol./Microvolume with the F8 desorb solution transferred to the upper
key, then confirm with the  key part of the screen (see description of the
PRODUCT LOADING screen chapter 6.3).
" Otherwise, confirm modifications with the
 key

6.9.2 Modification Procedure for the Sample Drawer

This procedure is only possible for samples or diluents already loaded during a loading session.
For samples, the possible modifications are:
- the list of tests for Manual Mode;
- the indication Normal Tube/Microvolume (F8 key);
- the indication Normal/STAT (F12 key).

For diluents, the possible modifications are:


- the volume;
- the stability;
- the indication Normal Tube/Microvolume (F8 key).

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2SAMPLE LOADING screen displayed with MANUAL Mode or AUTO Mode (as described in
chapter 6.4).

ACTIONS RESULTS

" Press the K key  The cursor is positioned on the last line of
the zone for samples already loaded (see
description of SAMPLE LOADING screen
chapter 6.4).

" Move the cursor to the requested sample  Cursor positioned on the requested sample
or product or diluent.

" Press the  key  All data from this sample (diluent) are
displayed in the entry zone (see description of
SAMPLE LOADING screen chapter 6.4).

 The cursor is positioned on the indication:


(Normal tube) or (Microvolume) with
message “F12 = in priority -

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F8 = Normal/ Micro Tube” displayed at
the bottom of the screen.

" If necessary and depending on cases, press  The (Normal tube) indication changes to
the F8 key (Microvolume) or reversely.
" Or/and press the F12 key  The (Normal tube) or (Microvolume)
indication display changes from blue
(normal sample) to yellow (STAT sample).

" Then, press the  key  For samples, possibility to modify the list of
tests (see procedures chapters 6.8.5.6,
6.8.5.7 and 6.8.5.8).

For AUTO Mode, it is not possible to change the  For diluents, possibility to modify the
list of tests, automatic return to loading. volume and/or the stability (see procedures
chapter 6.7).

" For samples, validate the modifications by  Return to loading procedure: cursor
the F10 key positioned on the sample identification entry
zone.
" For diluents, validate the modifications by
the  key  Message “SAMPLE IDENTIFICATION
(F12 = in priority F8 = Normal/ Micro
Tube) displayed at the bottom of the screen.

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6.10 Unloading of Samples or Products

6.10.1 Unloading with Positive Identification

This procedure is only possible for samples or products (reagents, controls, calibrators, desorb
solutions or diluents) loaded with positive identification; i.e.: automatic acknowledgement of loading
position within drawer by STA Compact®.
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NOTE The LEDs adjacent to tubes (vials) are blinking:


- for samples whose related Patient files are complete;
- for products which have stability overdue or insufficient liquid.

2SAMPLE LOADING screen with MANUAL Mode or AUTO Mode displayed (as described in
chapter 6.4) or PRODUCT LOADING screen displayed (as described in chapter 6.3).

ACTIONS RESULTS

" Remove the tube (or vial)  The LED adjacent to the tube (vial) lights off.
 The identification of the tube (vial)
disappears from the list of already loaded
samples (products).

6.10.2 Unloading without Positive Identification

This unloading procedure is only possible for the products or samples of the open drawer.
This procedure is absolutely necessary for products or samples loaded without Positive
identification.

2SAMPLE LOADING screen with MANUAL Mode or AUTO Mode displayed (as described in

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chapter 6.4)
or PRODUCT LOADING screen displayed (as described in chapter 6.3).

ACTIONS RESULTS

" Press the K key (List/Change)  The cursor is positioned on the last line of
the zone for already performed loadings (see
description of SAMPLE LOADING screen
chapter 6.4 or description of PRODUCT
LOADING screen chapter 6.3).

" Move the cursor to the requested Patient  Cursor positioned on the requested patient
file or product with the K key file or product.

" Press the Delete key  For the sample drawer, the following
window is displayed:

SAMPLE LOADING
Are you sure you want to remove the
sample (product) from the drawer?

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Y=YES N=NO
 For the product drawer, the following
window is displayed:

PRODUCT LOADING
Are you sure you want to remove the
product from the drawer?
Y=YES N=NO

" Remove the tube (or vial), then press the  If the LED adjacent to the tube (vial) was lit,
Y key it goes off.
 The identification of the tube (vial)
disappears from the list of already loaded
samples (products).

6.11 Loading without Positive Identification


If the positive identification is no longer functional (totally or partly) on the sample drawer or on the
product drawer, the tube or vial position can be given manually (see procedure below).

RISK OF INCORRECT RESULTS


This procedure requires undivided attention from the operator who shall insure that the positions
they type, are consistent with the actual loadings.

For all tubes or vials loaded with this procedure, it is absolutely necessary to observe the
unloading procedure without positive identification (see chapter 6.10.2).

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6.11.1 Sample Drawer Procedure

2SAMPLE LOADING screen is displayed (with MANUAL Mode or AUTO Mode). Sample already
identified, tube ready to be loaded. Message “LOAD THE LAST IDENTIFIED TUBE - Esc = Repeat
ident” displayed at the bottom of the screen and cursor positioned in the “Pos.” box (see
description of the SAMPLE LOADING screen chapter 6.4).

ACTIONS RESULTS

" Load the sample tube (or the sample  The tube position is not displayed on the
adaptator) in any position of the sample screen.
drawer  On the sample drawer, the LED adjacent to
the tube does not light up.

" Enter the tube position on the keyboard by  Position (i.e.: G4) displayed on the screen.
typing first the letter indicated at the left
 The LED adjacent to the tube position lights
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side of the line occupied by the tube (i.e.:G),


up.
then type the number indicated at the
bottom right of the columm occupied by
the tube (i.e.: 4). For the position reserved
for diluent 8, enter directly the figure, then
confirm with the € key

 For MANUAL MODE, the message “INDICATE


TESTS TO PERFORM - F10 = VALIDATE” is
displayed at the bottom of the screen.
 For AUTO MODE, the message “ = FILE
EDITING (F12 = in priority F8 = Normal
/ Micro Tube)” is displayed at the bottom of
the screen.
 For diluents, automatic transfer of data to
the zone for already loaded samples (see
description of SAMPLE LOADING screen,
chapter 6.4).

" For MANUAL Mode, proceed to test


selection (see chapters 6.8.5.6 to 6.8.5.8)

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6.11.2 Product Drawer Procedure

2PRODUCT LOADING screen is displayed. Reagent, desorb solution, control or calibrator already
identified (Identification, Volume, Stability, Lot number) and vial ready to be loaded. Message
“LOAD THE LAST IDENTIFIED VIAL - Esc = Correction” displayed at the bottom of the screen
and cursor positioned in the “Pos.” Box.

ACTIONS RESULTS

" Place the vial in a position corresponding to  The vial position is not displayed on the
its diameter while considering the positions screen.
with or without mixing
 On the product drawer, the LED adjacent to
the vial does not light up.

" Enter directly on the keyboard the vial  On the screen, display of the position and
position, as indicated on its right side data for this reagent, desorb solution,

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(i.e.: 11). Then confirm with the  key control or calibrator automatically
transferred to the top part of the screen (see
description of the PRODUCT LOADING screen
chapter 6.3).

6.12 Running Tests (Closing of Sample or Product Drawer)

Running tests or stopping tests can also be performed from the Status menu (see description
chapter 10.1.5.1).

As soon as the running of tests is confirmed by the operator, the samples are processed as described
below:
- Pipetting of calibrators for all tests
- Pipetting of calibration controls for all tests
- Pipetting of quality controls for all tests
- Pipetting of STAT samples
- Pipetting of samples for all tests in chronological loading order

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2SAMPLE LOADING screen displayed with MANUAL Mode or AUTO Mode (see description
chapter 6.4); or PRODUCT LOADING screen displayed (see description chapter 6.3).

ACTIONS RESULTS

" Press the Esc key  For the sample drawer, one of the following
windows is displayed:
For MANUAL Mode:

Change Profiles
Change Prefix
AUTO Mode
Return to Loading
Quit

For AUTO Mode:

Change Profile
Pour relecture / For proofreading 11/9/09

Change Prefix/First Number


MANUAL Mode
Return to Loading
Quit

" In both cases, the cursor is positioned on


Quit.
" For the product drawer, the following
window is displayed:

Quit
YES
NO

with the cursor positioned on YES.

" Confirm with the key  The sample drawer (product drawer) closes
automatically.
 When all conditions are met (quality controls
or calibrations OK, no stability is overdue,
and no volume is insufficient) for all reagents
and products, the sample pipetting starts
again and the TEST STATUS screen is
displayed. The Esc key allows to return to
the TEST PANEL.
 If one of the conditions previously described
is not met, for one or several tests, the
sample pipetting is blocked and the TEST
STATUS screen is displayed with the
message “BLOCKED SAMPLE PIPETTING”
displayed in red at the bottom of the screen
(see description of TEST STATUS screen
chapter 10.1.3).

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Loading Products and Samples

ACTIONS RESULTS

" If sample pipetting has been blocked, press  The following window is displayed:
the Esc key
WARNING
New tests are delayed
Reactivate?
Y=YES N=NO

" To reactivate tests, press the Y key  The authorized sample pipetting starts again.
 Return to TEST PANEL.

In this case, only tests satisfying the following


conditions: products with correct calibration,
quality control, volume and stability, will be run.
The other tests will be blocked.

" To block tests, press the N key  Return to TEST PANEL.

" Following needs:

Pour relecture / For proofreading 11/9/09


- Load the requested products;
- Change the ranges of controls or
calibrators which are not from Diagnostica
STAGO.

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Table of contents

7 Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

7.1 Access to a Given Calibration . . . . . . . . . . . . . . . . . . . . . . . 1


7.1.1 Procedure to Access a given calibration . . . . . . . . . . . . . . . . . . . . . . . . 1
7.1.2 Description of the CALIBRATION Screen . . . . . . . . . . . . . . . . . . . . . . . . 2

7.2 Description of Calibration Screens . . . . . . . . . . . . . . . . . . . 3


7.2.1 Description of CALIBRATION Screens: Bar Coded Mode . . . . . . . . . . . 3
7.2.2 Description of CALIBRATION Screens: Raw Mode . . . . . . . . . . . . . . . . . 6
7.2.3 Description of CALIBRATION Screens: Ratio Mode . . . . . . . . . . . . . . . . 8
7.2.4 Description of Calibration Screens: Graphic Mode . . . . . . . . . . . . . . . . 9

7.3 Procedures to run and validate a Calibration . . . . . . . . . . . 14


7.3.1 General Principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
7.3.2 Loading Standards and Calibration Controls . . . . . . . . . . . . . . . . . . . . 15
7.3.3 Running and Validating Bar Coded Calibrations . . . . . . . . . . . . . . . . . . 16
7.3.4 Running and Validating Calibrations in Raw Mode . . . . . . . . . . . . . . . . 18
7.3.5 Running and Validating Calibrations in Ratio Mode . . . . . . . . . . . . . . . 19
7.3.5.1 Running and Validating Calibrations in Ratio Mode with Calibration Controls . . . . . . 19
7.3.5.2 Running and Validating Calibrations in Ratio Mode without Calibration Controls . . . 21
7.3.6 Running and Validating Calibrations in Graphic Mode . . . . . . . . . . . . . 22
7.3.6.1 Running and Validating Calibrations in Graphic Mode with Calibration Controls . . . 22
7.3.6.2 Running and Validating Calibrations in Graphic Mode without Calibration Controls. 24
7.3.7 Running Several Calibrations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

7.4 Procedures to Observe in Case of Calibration not Automatically


Confirmed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
7.4.1 Messages Displayed in Case of Calibration not Automatically Confirmed .
28
7.4.2 Description of CALIBRATION NOT CONFIRMED Windows . . . . . . . . . 29
7.4.2.1 Description of the CALIBRATION NOT CONFIRMED Window (out of Range Controls) 29
7.4.2.2 Description of the CALIBRATION NOT CONFIRMED Window (Absence of Controls) 30
7.4.3 Confirming out of Range Calibration Controls . . . . . . . . . . . . . . . . . . 30
7.4.4 Rerun Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
7.4.5 Manually Confirming a Calibration Curve . . . . . . . . . . . . . . . . . . . . . . 32

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7.4.6 Modifying then Confirming a Calibration Curve . . . . . . . . . . . . . . . . . 33


7.4.7 Restoring Previous Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
7.4.8 Rerun Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
7.4.9 Cancelling Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
7.4.9.1 Cancelling a "Not Confirmed" calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
7.4.9.2 Cancelling a calibration request . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

7.5 Other Possible Interventions on Confirmed Calibrations . 37


7.5.1 Modification of 100% Point . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
7.5.2 Modifying Offset (not available on STA Compact®CT) . . . . . . . . . . . . 39
7.5.3 Modifying Measures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
7.5.4 Printout of a Calibration Curve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
7.5.5 Modifying the ISI Value . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
7.5.6 Viewing the Information Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

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Calibration

7 Calibration

7.1 Access to a Given Calibration

7.1.1 Procedure to Access a given calibration

2TEST PANEL displayed.

ACTIONS RESULTATS

" Press the Esc key  The Main Menu is displayed:

Status Loading - (...) - Halt


with the cursor positioned on Status.

" Press the C key (Calib./Control)  The following sub-menu is displayed:


" Or press the J key to move the cursor to
Calib./Control then confirm with the Calibration
 key Quality Control
with the cursor on Calibration

" Press the key  The CALIBRATION screen is displayed (see


below chapter 7.1.2) with the cursor on the
first test of the list.

" Move the cursor to the test for which  The selected calibration screen is displayed
calibration is required using the cursor (see description below chapter 7.2).
keys L ,K , Jand confirm with the  key

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Calibration

7.1.2 Description of the CALIBRATION Screen


Fig. 1 - CALIBRATION Screen

Legend:

1 Title of the screen

2 Available keys:

 Accesses the calibration of the selected test

F1 Select Calibrations to Run: requests calibration run for the test on which the cursor
is positioned

F10 Run Selected Calibrations: runs the calibrations selected by the F1 key (see
chapter 7.3.7)

Esc Quit: returns to the TEST PANEL screen

3 List of test abbreviations. A colored square displayed at the left of the abbreviation indicates the
calibration current status (see point 5 below).

4 Complete name of the test on which the cursor is positioned

5 Color code identifies the status of each calibration:

White: Validated
Blue: To be validated
Yellow: In progress
Red: Not calibrated

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Calibration

7.2 Description of Calibration Screens

7.2.1 Description of CALIBRATION Screens: Bar Coded Mode

For this mode, there are two screens:


- a graphic screen;
- an information screen.

Fig. 2 - GRAPHIC CALIBRATION Screen - Bar Coded Mode

Legend:

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7 REFERENCE MANUAL
Calibration

1 Complete test name

2 Esc Options: this key opens the OPTIONS window:

OPTIONS
Information
Modify 100% Point - ISI
Print
Run Controls
Quit
Information: displays the second screen (Information screen) of the calibration.
Modify 100% Point - ISI: this option is only possible for clotting tests with % as the primary unit
and if the measurement scale is linear and the concentration scale is inverse.
It moves the calibration curve in a parallel direction to itself in such a way that the calibration passes
through the new point given in seconds and which corresponds to 100%.
It also allows access for ISI modification (International Sensitive Index) if INR (International
Normalized Ratio) has been chosen as the unit.
Print: (only possible if STA Compact< is in stand-by mode). Printout of the two calibration screens:
graphic and information.
Run Controls: modifies the calibration control ranges if those have been defined and runs them
(F10 key).
Quit: returns to CALIBRATION screen (test list).

3 Date and Time of calibration control validation

4 Calibration control results given in the primary unit:

- xxx: Waiting for calibration control results


- -----: Calibration controls are running
- Results displayed in white: Calibration control results are validated in normal conditions
- Results displayed in red Calibration control results are validated although those
and preceded by an asterisk: were out of range

5 ISI value (International Sensitive Index)


It is displayed only if INR (International Normalized Ratio) has been chosen as the unit

6 Value in seconds for the point corresponding to 100%. It is displayed only if it has been modified
and if the modification is possible, see above, point 2

7 Raw data values after interpolation from the calibration curve

8 View points as defined in the TEST SETUP screens (see chapter 5.1.2.2)

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Calibration

9 Graphic representation of the calibration curve

10 Equation of the calibration curve.

NOTE The parameters come from the bar code reading performed if a lot number change has been
detected during reagent loading (see chapter 6.5).

Fig. 3 - CALIBRATION INFORMATION Screen - Bar Coded Mode

11 Complete test name

12 Esc Quit: returns to the graphic calibration screen

13 Identification of the calibration mode

14 Identification number of each calibration control

15 Complete name of each calibration control

16 Lot number of each calibration control used for the calibration

17 Minimum and maximum values for each calibration control

18 Original range for each calibration control

19 Identification number of each reagent

20 Complete name of each reagent

21 Lot number of each reagent used for the calibration. An empty box means that the reagent has
no lot number

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Calibration

7.2.2 Description of CALIBRATION Screens: Raw Mode


Fig. 4 - CALIBRATION Screen: Raw Mode

Legend:

1 Complete name of the test

2 Esc Options: this key opens the following window:

Run Controls
Print
Quit
Run Controls: modifies the calibration control ranges if those have been defined and runs them
(F10 key).
Print: (only possible if STA Compact< is in stand-by mode). Printout of the calibration screen as
defined above
Quit: returns to CALIBRATION screen (test list)

3 Identification of the calibration mode

4 Date and Time of validation for the calibration controls if those are used. Otherwise, the box is
empty.

5 Calibration control results given in the primary unit:

- None: The calibration controls have not been defined


- xxx: Waiting for calibration control results
- -----: Calibration controls are running
- Results displayed in white: Calibration control results are validated in normal conditions
- Results displayed in red Calibration control results are validated although those were
and preceded by an asterisk out of range

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Calibration

If the calibration controls are used:


6 Identification number of each calibration control
7 Complete name of each calibration control
8 Lot number of each calibration control used for the calibration
9 Minimum and maximum values for each calibration control
10 Original ranges for each calibration control

11 Identification number of each reagent

12 Complete name of each reagent

13 Lot number of each reagent used for the calibration. An empty box means that the reagent has
no lot number

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Calibration

7.2.3 Description of CALIBRATION Screens: Ratio Mode


Fig. 5 - CALIBRATION Screen - Ratio Mode

Legend:

1 Complete test name

2 Esc Options: this key opens the following window:

Modify Reference Time / Range


Print
Quit
Modify Reference Time / Range: modifies the Reference Time, modifies the calibration control
ranges (if used) and runs the calibration controls (if used, F10 key).
Print: (only possible if STA Compact< is in stand-by mode). Printout of the calibration screen as
defined above.
Quit: returns to CALIBRATION screen (test list).

3 Identification of the calibration mode

4 Date and Time of validation for the calibration controls if those are used. Otherwise, the box is
empty

5 Reference Time Value as given by the operator

6 Calibration control results given in the primary unit:


- None: The calibration controls have not been defined
- xxx: Waiting for calibration control results
- -----: Calibration controls are running;
- Results displayed in white: Calibration control results are validated in normal conditions

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Calibration

- Results displayed in red Calibration control results are validated although those were
and preceded by an asterisk: out of range.

If calibration controls are used:


7 Identification number of each calibration control
8 Complete name of each calibration control
9 Lot number of each calibration control used for the calibration
10 Minimum and maximum values for each calibration control
11 Original ranges for each calibration control

12 Identification number of each reagent

13 Complete name of each reagent

14 Lot number of each reagent used for the calibration. An empty box means that the reagent has
no lot number.

15 ISI Value (International Sensitive Index), is only displayed if INR (International Normalized Ratio)
has been chosen as the unit.

7.2.4 Description of CALIBRATION Screens: Graphic Mode

For this mode, there are two screens:


- graphic screen;
- information screen.

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7 REFERENCE MANUAL
Calibration

Fig. 6 - GRAPHIC CALIBRATION Screen for a Clotting Test- Graphic Mode

Fig. 7 - GRAPHIC CALIBRATION Screen for a Photometric Test


(not available on STA Compact®CT) - Graphic Mode

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Calibration

Legend:

1 Complete test name

2 Esc Options: this key opens an OPTIONS window:

For clotting tests: For photometric tests


(not available on STA Compact®CT):

Options Options
Information Information
Modify 100 %. Point - ISI Modify Offset
Print Print
Calibrate Calibrate
Modify Raw Data Modify Raw Data
Quit Quit

Information: displays the second screen (INFORMATION screen) of the calibration.


Modify 100% Point - ISI: this option is only possible for clotting tests with % as primary unit and
if the measurement scale is linear and the concentration scale is inverse. It moves the calibration
curve in a parallel direction to itself in such a way that the calibration passes through the new point
given in seconds and which corresponds to 100%. It also gives access for ISI modification
(International Sensitive Index) if INR (International Normalized Ratio) has been chosen as the unit.
Modify Offset (not available on STA Compact®CT): modifies, if necessary, the parameters of
the information screen and runs the offset correction (1-point calibration) by the F10 key.
This option is only possible for photometric tests with linear graphic mode for which the offset
corrector and the calibration controls have been defined.
It moves the calibration curve in a parallel direction to itself in such a way that it passes through the
new point defined by the offset corrector plasma.
Print: (only possible if STA Compact< is in stand-by mode). Printout of the two calibration screens
graphic and information.
Calibrate: modifies, if necessary, the parameters of the information screen and runs the calibration
(F10 key).
Modify Raw Data: suppresses or modifies calibration points.
Quit: returns to CALIBRATION screen (test list).

3 Date and time of calibration validation

4 Calibration control results given in the primary unit:

- None The calibration controls have not been defined


- xxx: Waiting for calibration control results
- ----: Calibration controls are running
- Results displayed in white: Calibration control results are validated in normal conditions
- Results displayed in red Calibration control results are validated although those were
and preceded by an asterisk: out of range

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Calibration

5 ISI value (International Sensitive Index).


It is displayed only if INR (International Normalized Ratio) has been chosen as the unit

6 Value in seconds for the point corresponding to 100%. It is displayed only if it has been modified
and if the modification is possible, see above, point 2

7 Regression coefficient

8 Theoretical concentration of standards in the primary unit

9 For clotting tests: clotting time measured in seconds. For assays in photometry (not available on
STA Compact®CT): ' O.D. or O.D./min. An S is displayed at the left of the suppressed values
and an M at the left of the modified values

10 Value of standards after interpolation from the equation found for the calibration curve (in the
primary unit)

11 Graphic representation of the calibration curve

12 Equation of the calibration curve

13 Offset (not available on STA Compact®CT) : Value in 'O.D. or in O.D./min for the offset
corrector plasma if the latter has been run (see description of the Modifying Offset option
chapter 7.5.2)

Fig. 8 - CALIBRATION INFORMATION Screen for a Clotting Test - Graphic Mode

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Calibration

Fig. 9 - CALIBRATION INFORMATION Screen for a Photometric Test (not available on STA
Compact®CT) - Graphic Mode

Legend:

14 Complete test name

15 Esc Quit: returns to graphic calibration screen

16 Not applicable

17 Identification number of each standard

18 Complete name of each standard

19 Lot number of each standard used for the calibration

20 Dilution ratio for each standard, defined in the Test Setup menu (see chapter 5.1.2.3).

21 Concentration of each calibration point (primary unit)

If calibration controls are used:


22 Identification number of each calibration control
23 Complete name of each calibration control

24 Lot number of each calibration control used for the calibration

25 Minimum and maximum values for each calibration control

26 Original ranges for each calibration control

27 Identification number of each reagent

28 Complete name of each reagent

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Calibration

29 Lot number of each reagent used for the calibration. An empty box means that the reagent has
no lot number.

30 Identification number, complete name and lot number of the offset corrector plasma.
For clotting tests, this box is always empty.

7.3 Procedures to run and validate a Calibration

7.3.1 General Principles


Calibrations can be run:
- One by one from the calibration screen of each selected test (see chapters 7.3.3 to 7.3.6)
- Globally, from the CALIBRATION screen (test list), see chapter 7.3.7)

The calibrations can be run only if the sample pipetting has not been blocked either within the TEST
STATUS screen (see description chapter 10.1.3) or by the Stop Sample Pipetting function of the
Status sub-menu (see description chapter 10.1.5.1).
To block tests from the Global Modification menu does not block the calibrations (see description
chapter 8.7.3).

The calibrations can be performed according to seven different modes:

Mode Calibrate

Bar coded Run the 2 calibration controls.


The reading of the parameters is performed during the
reagent loading step (see chapter 6.5).
Only for some Diagnostica Stago
tests

Raw Run the 2 calibration controls if those have been defined in


the TEST SETUP screens.

Ratio Enter the Reference Time value.


Run the 2 calibration controls if those have been defined in
the TEST SETUP screens

Linear graphic Run standards.


Polynomial order 2 graphic Run the 2 calibration controls if those have been defined in
the TEST SETUP screens.
Polynomial order 3 graphic
Hyperbolic graphic

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Calibration

Use of calibration controls authorizes automatic validation of the calibrations. There must be 2 levels
of controls because a slope cannot be validated as fully reliable with only one level of controls.

NOTE The calibration modes as all the calibration parameters (standard definition, calibration control
definition, scales) are defined within the TEST SETUP screens (see chapter 5.1.2).

Standards are run in single or in duplicate according to the determination mode chosen within the
TEST SETUP screens (see description chapter 5.1.2).

When they are defined, the calibration controls are run in single or in duplicate according to the
determination mode chosen for the sample (see Test Setup menu chapter 5.1.1.7).
As soon as calibration control results are obtained, they are compared to the acceptance range; if
those are outside of the acceptance range, STA Compact< automatically reruns controls according
to principle described below:

First run Result(s) Automatic rerun


by STA Compact<

Control run in single Outside the defined range Rerun of control in duplicate

One of the 2 results is outside


Control run in duplicate Rerun of control in single
the defined range

If the calibration controls are confirmed as outside the acceptance range, the calibration will have to
be validated manually.
If the operator decides to accept out of range calibration controls, the results of these will be
displayed in red, preceded by an asterisk in the related CALIBRATION screen (see chapter 7.2).

If the same controls are used as calibration controls and as quality controls (same identification
numbers), then the calibration control results will be integrated in the quality control results and the
clock for the quality controls will be reset while running the calibration controls (see chapter 9.4.1).

If running has been requested for one or several calibrations or calibration controls, when existing
the CALIBRATION screen (test list), STA Compact< performs a consistency check and displays the
TEST STATUS screen.
If while running a calibration, some products necessary to perform the calibration are missing
(missing or on-board but with volume or stability not usable), then the calibration will not be run, the
missing products will be displayed in red in the TEST STATUS screen and the sample pipetting will be
blocked (see description chapter 10.1.3).

7.3.2 Loading Standards and Calibration Controls


The standards and the calibration controls are loaded in the product drawer (see description
chapter 6.6).
At each lot number change, the standard concentrations and/or the ranges of the calibration controls
for products from Diagnostica Stago are read out by means of the barcode sheets included within
each product box.

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7 REFERENCE MANUAL
Calibration

For all other products, the values have to be entered manually.

RISK OF WRONG RESULTS


For Diagnostica Stago’s STA< products, calibrator values and calibration control ranges are properly
entered in the related tests on condition that the primary unit chosen for this test is identical to that
defined on the assay value inserts included in each product box (except Fibrinogen, for g/l primary
unit, the values are properly dispatched even if they are given in mg/dl on the package insert).

7.3.3 Running and Validating Bar Coded Calibrations


The parameters of the calibration curve are read when scanning the barcode sheet for the related
reagent at each lot change. The calibration will have to be validated by two calibration controls which
will insure that your STA Compact< meets the criteria for the scanned lot.
After closing the product drawer with the calibration controls loaded, the calibration status for the
related test will change to “Running” in the TEST STATUS screen. The calibration controls are
automatically run by the STA Compact® if the calibration controls have been loaded and the operator
has not blocked the sample pipetting.
Otherwise, the calibration controls will be automatically run as soon as they will be loaded and on
condition that the operator has not blocked the sample pipetting.
If the results for the two calibration controls are within the expected ranges, the calibration will then
be automatically validated, the patient assays will start. The results of the two calibration controls are
displayed in the graph part of the related calibration screen, see description chapter 7.2.1).
If one or several calibration control results are outside the expected ranges, the operator will be
alerted by an error message and will be offered several possibilities (see below chapter 7.4).

At any time, the operator can request calibration controls, see below.

2Screen of a bar coded calibration displayed (see description in chapter 7.2.1).

ACTIONS RESULTATS

" Press the Esc key  The following window is displayed:

OPTIONS
Information
Modify 100% Point - ISI
Print
Run Controls
Quit
with cursor positioned on Quit.

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ACTIONS RESULTATS

" Press the R key (Run Controls)  The following window is displayed
" Or move the cursor to Run Controls with
the Kkey then confirm with the  key Please enter
your access code:
 Validate Esc Quit

" Type your access code then confirm with  The second screen (Information screen) is
the  key displayed (see description chapter 7.2.1).
 The cursor is positioned to modify, if
necessary, the minimum value of the range
of the first calibration control (see description
of this screen chapter 7.2.1).

" If necessary, modify each range value, then  Cursor positioned on the following range
confirm with the  key value.
" Otherwise, use the  key to move from a
range value to the other one

" When all range values are correct, press  Back on the selected calibration screen.
the F10 key
 The calibration controls are automatically
run by STA Compact< so long as the
consistency check does not lead to a
blocking of the sample pipetting.

" Press the Esc key  Back to CALIBRATION screen (test list).
 The colored square at the left of the
abbreviation for the selected test is
displayed in yellow (calibration in progress).
 If the calibration control results are within
the expected ranges:
- automatic calibration validation;
- the colored square at the left of the
abbreviation for the selected test is
displayed in white (confirmed calibration)
when the CALIBRATION screen (test list) is
visualized.
 if the calibration control results are not
within the expected ranges: an error
message is displayed (see chapter 7.4).

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7.3.4 Running and Validating Calibrations in Raw Mode

NOTE For raw mode, there exists no calibration; for a new lot, the only possible function is to validate the
reagent(s) of the method by running the 2 calibration controls if those have been defined.
If both calibration control results are within the expected ranges, the calibration is automatically
validated, patient assays may start.
If calibration control results are outside the expected ranges, the operator will be informed by an
error message and will be offered several possibilities (see chapter 7.4).
If calibration controls are not used, the calibration status is confirmed by default.

2Screen for a calibration in raw mode displayed (as described in chapter 7.2.2).

ACTIONS RESULTATS

" Press the Esc key  The following window is displayed:

Run Controls
Print
Quit
with cursor positioned on Quit.

" Press the R key (Run Controls)  The following window is displayed:
" Or move the cursor to Run Controls with
the L key, then confirm with the  key Please enter
your access code:
 Validate Esc Quit

" Type your access code then confirm with  The cursor is positioned to modify, if
the  key necessary, the minimum value of the range
of the first calibration control (see description
of the screen chapter 7.2.2).

" If necessary, modify each range value, then  The cursor is positioned on the following
confirm with the  key range value.
" Otherwise, use the  key to move from a
range value to the other one

" When all range values are correct, press  Back on the selected calibration screen.
the F10 key
 The calibration controls are automatically
run by STA Compact< so long as the
consistency check does not lead to a
blocking of the sample pipetting.

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Calibration

ACTIONS RESULTATS

" Press the Esc key  Return to the CALIBRATION screen (test
list).
 The colored square at the left of the
abbreviation of the selected test is displayed
in yellow (calibration in progress).
 If the calibration control results are within
the expected ranges:
- automatic calibration validation;
- the colored square at the left of the
abbreviation for the selected test is
displayed in white (confirmed calibration)
when the CALIBRATION screen (test list) is
visualized.
 If the calibration control results are not
within the expected ranges: an error
message is displayed (see chapter 7.4).

7.3.5 Running and Validating Calibrations in Ratio Mode

NOTE For Ratio Mode, calibrations mean entering the reference time, then validating the reagent(s) used
for the method by running the two calibration controls if they have been defined.
If both calibration control results are within the expected ranges, the calibration is automatically
validated, patient assays may start.
If calibration control results are outside the expected ranges, the operator will be informed by an
error message and will be offered several possibilities (see chapter 7.4).

7.3.5.1 Running and Validating Calibrations in Ratio Mode with Calibration Controls

2Screen of a calibration in Ratio Mode displayed (as described in chapter 7.2.3).

ACTIONS RESULTATS

" Press the Esc key  The following window is displayed:

Modify Reference Time / Range


Print
Quit
with cursor positioned on Quit.

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ACTIONS RESULTATS

" Press the M key (Modify Reference  The following window is displayed:
Time / Range)
" Or move the cursor to Modify Reference Please enter
Time / Range with the L key then confirm your access code:
with the  key  Validate Esc Quit

" Type your access code, then confirm with  The following window is displayed:
the  key
CALIBRATION CONTROL
F10 Run
Esc Quit
 The cursor is positioned to modify, if
necessary, the reference time (see
description of the screen chapter 7.2.3).

" If necessary, modify the value of the  The cursor is positioned to modify, if
reference time, then confirm with the necessary, the minimum value of the range
 key of the first calibration control (see description
of the screen chapter 7.2.3).
" Otherwise, confirm with the  key

" If necessary, modify each range value, then  The cursor is positioned on the following
confirm with the  key range value.
" Otherwise, use the  key to move from a  If INR unit has not been chosen, skip to last
range value to the other one but one ACTIONS box below.
 If INR unit has been chosen among the
secondary units, the cursor is positioned to
modify, if necessary, the ISI value (see
description chapter 7.2.3).

" If necessary, modify the ISI value, then  ISI value is displayed.
confirm with the  key

" When all modifications are performed,  Back on the selected calibration screen.
press the F10 key
 The calibration controls are automatically
run by the STA Compact< so long as the
consistency check does not lead to a
blocking of the sample pipetting.

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ACTIONS RESULTATS

" Press the Esc key  Return to CALIBRATION screen (test list).
 The colored square at the left of the
abbreviation for the selected test is
displayed in yellow (calibration in progress).
 If the calibration control results are within
the expected ranges:
- automatic calibration validation;
- the colored square at the left of the
abbreviation for the selected test is
displayed in white (confirmed calibration)
when the CALIBRATION screen (test list) is
visualized.
 If the calibration control results are not
within the expected ranges: an error
message is displayed (see chapter 7.4).

7.3.5.2 Running and Validating Calibrations in Ratio Mode without Calibration Controls

2Screen of a calibration in Ratio Mode displayed (as described in chapter 7.2.3).

ACTIONS RESULTATS

" Press the Esc key  The following window is displayed:

Modify Reference Time / Range


Print
Quit
with cursor positioned on Quit.

" Press the M key (Modify Reference  The following window is displayed:
Time / Range)
" Or move the cursor to Modify Reference Please enter
Time / Range with the Lkey then confirm your access code:
with the  key  Validate Esc Quit

" Type your access code, then confirm with  The following window is displayed:
the  key
REFERENCE TIME MODIFICATION
F10 Save
Esc Quit
 The cursor is positioned to modify, if
necessary, the reference time value (see
description of the screen chapter 7.2.3).

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ACTIONS RESULTATS

" If necessary, modify the reference time  If INR unit has not been chosen, skip the
value, then confirm with the  key ACTIONS cell below and move to the next

" Otherwise, confirm with the  key one.


 If INR unit has been chosen among the
secondary units, the cursor is positioned to
modify, if necessary, the ISI value (see
description chapter 7.2.3).

" If necessary, modify the ISI value, then  ISI value is displayed.
confirm with the  key

" When all modifications are performed,  Return to CALIBRATION screen (test list).
press the F10 key
 The colored square at left of the
abbreviation for the selected test is
displayed in white (confirmed calibration).

7.3.6 Running and Validating Calibrations in Graphic Mode

NOTE For graphic mode, calibration means running standards, then calibration controls if those have been
defined.
If both calibration control results are within the expected ranges, the calibration is automatically
validated, patient assays may start.
If calibration control results are outside the expected ranges, the operator will be informed by an
error message and will be offered several possibilities (see chapter 7.4).
If calibration controls are not used, the calibration validation will be done manually (see chapter 7.4).

7.3.6.1 Running and Validating Calibrations in Graphic Mode with Calibration Controls

2Screen of a calibration in graphic mode displayed (as described in chapter 7.2.4).

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ACTIONS RESULTATS

" Press the Esc key  For clotting tests, the following window is
displayed:

OPTIONS
Information
Modify 100% Point - ISI
Print
Calibrate
Modify Raw Data
Quit
 For photometric tests (not available on STA
Compact®CT), the following window is
displayed:

OPTIONS
Information
Modify Offset
Print
Calibrate
Modify Raw Data
Quit
 In both cases, the cursor is positioned on
Quit.

" Press the C key (Calibrate)  The following window is displayed:


" Or move the cursor to Calibrate with the
K key, then confirm with the key Please enter
your access code:
€Validate Esc Quit

" Type your access code, then confirm with  The second screen (INFORMATION screen)
the  key is displayed, (see description chapter 7.2.4).
 The cursor is positioned to modify, if
necessary, the concentration for the first
standard (see description of this screen
chapter 7.2.4).

" If necessary, modify the concentration of  For all standards having the same
the first standard, then confirm with the identification number, the concentrations
 key are automatically calculated and displayed.
" Otherwise, confirm with the  key  The cursor is positioned on the second
standard.

" If other standard concentrations have to be  For all standards having the same
modified, modify them, then confirm with identification number, the concentrations
the  key are automatically calculated and displayed.
 The cursor is positioned on the next
standard or on the minimum value of the
range of the first calibration control.

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ACTIONS RESULTATS

" Move the cursor to the minimum value of  The cursor is positioned on the next range
the range of the first calibration control, value.
modify, if necessary, each range value, then
confirm with the  key
" Otherwise, use the  key to move from a
range value to the other one

" When all parameters are set, confirm with  Back on the selected calibration screen.
the F10 key  The standards, then the calibration controls
are automatically run by the STA Compact<
so long as the consistency check does not
lead to a blocking of the sample pipetting.

" Press the Esc key  Back to CALIBRATION screen (test list).
 The colored square at the left of the
abbreviation for the selected test is
displayed in yellow (calibration in progress).
 If the calibration control results are within
the expected ranges:
- automatic calibration validation;
- the colored square at the left of the
abbreviation for the selected test is
displayed in white (confirmed calibration)
when the CALIBRATION screen (test list) is
visualized.
 If the calibration control results are not
within the expected ranges: an error
message is displayed (see chapter 7.4).

7.3.6.2 Running and Validating Calibrations in Graphic Mode without Calibration Controls.

2Screen of a calibration in graphic mode displayed (as described in chapter 7.2.4).

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ACTIONS RESULTATS

" Press the Esc key  For clotting tests, the following window is
displayed:

OPTIONS
Information
Modify 100% Point - ISI
Print
Calibrate
Modify Raw Data
Quit
 For photometric tests (not available on STA
Compact®CT), the following window is
displayed:

OPTIONS
Information
Modify Offset
Print
Calibrate
Modify Raw Data
Quit
 In both cases, the cursor is positioned on
Quit.

" Move the cursor to Calibrate with the  The following window is displayed:
n key, then confirm with the key
Please enter
your access code:
 Validate Esc Quit

" Type your access code, then confirm with  The second screen (INFORMATION screen)
the  key is displayed, (see description chapter 7.2.4).
 The cursor is positioned to modify, if
necessary, the concentration for the first
standard (see description of this screen
chapter 7.2.4).

" If necessary, modify the concentration of  For all standards having the same
the first standard, then confirm with the identification number, the concentrations
 key are automatically calculated and displayed.
" Otherwise, confirm with the  key  The cursor is positioned on the second
standard.

" If other concentrations have to be modified,  For all standards having the same
modify them, then confirm with the  key identification number, the concentrations
are automatically calculated and displayed.

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ACTIONS RESULTATS

" When all parameters are set, press the  Back on the selected calibration screen.
F10 key
 The standards are automatically run by the
STA Compact< so long as the consistency
check does not lead to a blocking of the
sample pipetting.

" Press the Esc key  Return to CALIBRATION screen (test list).
 The colored square at the left of the
abbreviation for the selected test is
displayed in yellow (calibration in progress).
 When the calibration is complete, an
information message is displayed.

" See chapter 7.4

7.3.7 Running Several Calibrations

This function is reserved to tests predefined by Diagnostica Stago because it implies that no
operator’s intervention is requested to modify standard concentrations and/or calibration control
concentrations. And this is only possible for the bar coded products (standards, controls) for which
the value transfer is automatically performed.

Calibration running requests are refused in the following conditions:


- raw mode without calibration controls;
- ratio mode without calibration controls or if the reference time has not been defined;
- calibration status is “in progress” or “to be validated”.

2CALIBRATION screen (test list) displayed (as described in chapter 7.1.2).

ACTIONS RESULTATS

" For each test whose calibration is  The letter S is displayed in grey at the left of
requested, move the cursor to its each test abbreviation for which the
abbreviation then press the F1 key calibration has been requested.
Note: To cancel a running request, press
the F1 key again.

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ACTIONS RESULTATS

" When all required calibrations are marked  The following window is displayed:
with the letter S, press the F10 key
Please enter
your access code:
 Validate Esc Quit

" Type your access code, then confirm with  On CALIBRATION screen (test list):
the  key
- the S letters disappear;
- the colored squares at the left of the
abbreviations for the selected tests are
displayed in yellow (calibration in progress).
 The standards and the calibration controls (if
necessary) are automatically run by the
STA Compact< so long as the consistency
check does not lead to a blocking of the
sample pipetting.

" Press the Esc key  The TEST STATUS screen is displayed (see
description chapter 10.1.3).
 If the calibration control results are within
the expected ranges:
- automatic calibration validation;
- the colored square at the left of the
abbreviation for the selected test is
displayed in white (confirmed calibration)
when the CALIBRATION screen (test list) is
visualized.
 If the calibration control results are not
within the expected ranges: an error
message is displayed (see chapter 7.4).
 If calibration controls are not used, please
see chapter 7.4.

7.4 Procedures to Observe in Case of Calibration not


Automatically Confirmed
There are two cases:
ˆ Calibration not confirmed because of out of range calibration controls
ˆ Calibration not confirmed due to absence of calibration controls

For calibrations with graphic mode, as long as the reagent lot numbers have not changed, the new
calibration curve is displayed in yellow and the previous one in grey. Raw data, curve equation and
regression coefficient are those of the new calibration curve.

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7.4.1 Messages Displayed in Case of Calibration not Automatically Confirmed


In both cases (see above), the operator is informed by a message:
ˆ Calibration controls out of range:

MEASURING MANAGEMENT
Error 05.06.06
CALIBRATION CONTROL
Control out of limit
for the test xxx
Esc=continue
xxx: Abbreviation of the related test.

ˆ Absence of control:

MEASURING MANAGEMENT
Error 05.06.10
CALIBRATION
Calibration is ready to be confirmed
for the test xxx
Esc=continue
xxx: Abbreviation of the related test.

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7.4.2 Description of CALIBRATION NOT CONFIRMED Windows


These windows are displayed while selecting a calibration whose status is to be confirmed (blue
square displayed at the left of the test abbreviation).

7.4.2.1 Description of the CALIBRATION NOT CONFIRMED Window (out of Range Controls)

Fig. 10 - CALIBRATION NOT CONFIRMED window (out of range controls)

Legend:

1 Calibration control identification numbers

2 Calibration control results. The primary unit is displayed


The out of range results are displayed in red

3 Recall of the minimum and maximum ranges for each calibration control

4 List of possible functions:

Confirm: validates out of range calibration controls (see chapter 7.4.3).


Rerun Controls: reruns calibration controls (see chapter 7.4.4).
Restore Previous Curve: returns to previous calibration if no lot change was detected (see
chapter 7.4.7).
Rerun Calibration: reruns calibration (see chapter 7.4.8) ;
Cancel the Calibration: cancels calibration in case of lot change (see chapter 7.4.9) ;
Postpone Decision: returns to CALIBRATION screen (test list).
The name of the functions are displayed in blue when available and in grey when unavailable.
The cursor is positioned on Postpone Decision.

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7.4.2.2 Description of the CALIBRATION NOT CONFIRMED Window (Absence of Controls)

CALIBRATION NOT CONFIRMED


Absence of Controls
Confirm
Modify then Confirm
Restore Previous Curve
Rerun
Cancel the Calibration
Postpone Decision

List of possible functions:


Confirm: manually validates the calibration (see chapter 7.4.5);
Modify then Confirm: modifies some raw data then manually validates the calibration (see
chapter 7.4.6).
Restore Previous Curve: returns to previous calibration if no lot change was detected (see
chaper 7.4.7);
Rerun Calibration: reruns calibration (see chapter 7.4.8);
Cancel the Calibration: cancels calibration in case of lot change (see chapter 7.4.9);
Postpone Decision: returns to CALIBRATION screen (test list).
The name of the functions are displayed in blue when available and in grey if not available.
The cursor is positioned on Postpone Decision.

7.4.3 Confirming out of Range Calibration Controls

This procedure is only possible if the operator knows the access code to accept out of range
controls (see chapter 1.5).

NOTE If for a given test, the calibration controls are confirmed while out of range, then results of these
controls will be displayed in red with an asterisk in the related CALIBRATION screen (see chapter
7.2).
In the CALIBRATION NOT CONFIRMED window (out of Range Controls), the out of range controls
are displayed in red with an asterik and the ranges of each control are displayed (see description
chapter 7.4.2.1).

2The screen of the selected calibration is displayed with the CALIBRATION NOT CONFIRMED
window (out of Range Controls), cursor is positionned on Postpone Decision (see description
chapter 7.4.2.1).

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ACTIONS RESULTATS

" Move the cursor to Confirm with the  The following window is displayed:
L key, then confirm with the  key
Please enter
your access code:
 Validate Esc Quit

" Type your access code, then confirm with  The selected CALIBRATION screen is
the  key updated for the date, the time, the
calibration control results.
 Out of range calibration control results are
displayed in red with an asterisk.

" Press the Esc key then confirm with the  Return to CALIBRATION screen (test list).
 key
 The colored square at the left of the test
abbreviation is displayed in white (confirmed
calibration).

7.4.4 Rerun Controls

NOTE This function is possible only if calibration controls have been defined.

2The screen of the selected calibration is displayed with the CALIBRATION NOT CONFIRMED
window (out of Range Controls), the cursor is positioned on Postpone Decision (see
description chapter 7.4.2.1).

ACTIONS RESULTATS

" If necessary, reload products (reagents,  The following window is displayed:


standards, diluents, controls)
" Move the cursor to Rerun Controls with Please enter
the L, then confirm with the  key your access code:
 Validate Esc Quit

" Type your access code, then confirm with  The CALIBRATION CONTROL RUNNING
the  key window appears.
 Controls are rerun by STA Compact< so
long as the consistency check does not lead
to a blocking of the sample pipetting.

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ACTIONS RESULTATS

" Press the Esc key  Return to CALIBRATION screen (test list).
 The colored square at the left of the test
abbreviation is displayed in yellow
(calibration in progress).

" Press the Esc key  The TEST STATUS screen is displayed (see
description chapter 10.1.3).

7.4.5 Manually Confirming a Calibration Curve

This procedure is possible only if the calibration controls were not used.

2Screen of the selected calibration displayed with the CALIBRATION NOT CONFIRMED window
(Absence of Controls), the cursor is positioned on Postpone Decision (see description
chapter 7.4.2.2).

ACTIONS RESULTATS

" Move the cursor to Confirm with the  The following window is displayed:
L key, then confirm with the  key
Please enter
your access code:
Validate Esc Quit

" Type your access code, then confirm with  The CALIBRATION NOT CONFIRMED
the  key (Absence of Controls) window disappears.

" Press the Esc key then confirm with the  Return to CALIBRATION screen (test list).
 key
 The colored square at the left of the test
abbreviation is displayed in white (confirmed
calibration).

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7.4.6 Modifying then Confirming a Calibration Curve

This procedure is possible only if the operator knows the access code to critical functions (see
chapter 1.5).

NOTE This procedure is possible only if the calibration controls were not used.

2The screen of the selected calibration is displayed with the CALIBRATION NOT CONFIRMED
window (Absence of Controls), the cursor is on Postpone Decision (see description
chapter 7.4.2.2).

ACTIONS RESULTATS

" Move the cursor to Modify/Validate with  The following window is displayed:
the K key, then confirm with the  key
CORRECTION
DEL DELETE
Ins RESTORE
F10 CONFIRM
ESC QUIT

 The cursor is positioned on the first


calibration data point.

" To delete values:  A yellow S is displayed at the left of the


Move the cursor to the value(s) to be deleted value(s).
deleted with the L key, then press the  The deleted value is displayed in grey.
Delete key

Depending on the regression type, a minimum


number of calibration points should remain:
2 for linear regression;
4 for polynomial 2nd order regression;
5 for hyperbolic regression;
6 for polynomial 3rd order regression.

Note: A value can be restored with the


Insert key.

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ACTIONS RESULTATS

" To modify values:  The modified value(s) are displayed.


Move the cursor to the value(s) to be
modified with the L key, then proceed to
the modification(s) and confirm with the
 key

" When all modifications are done, press the  The following window appears:
F10 key
Please enter
your access code:
 Validate Esc Quit

" Type your access code then confirm with  The new calibration is recalculated then the
the  key following are displayed: the new calibration
curve, the new equation and the new
regression coefficient.
 A yellow S is displayed near the deleted
value(s) and a yellow M near the modified
value(s).
 Deleted values are still displayed in grey.

" Press the Esc key then the key  Return to CALIBRATION screen (test list).
 The colored square at the left of the test
abbreviation is displayed in white (confirmed
calibration).

7.4.7 Restoring Previous Calibration

This procedure is possible only if the operator knows the access code to critical functions (see
chapter 1.5).

NOTE This procedure is only possible for calibration curves performed with the same reagent lot numbers
as previously used.

2Screen of the selected calibration displayed with the CALIBRATION NOT CONFIRMED window
(Out of Range Controls or Absence of Controls), the cursor is on Postpone Decision.

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ACTIONS RESULTATS

" Move the cursor to Restore Previous  The following window is displayed:
Curve with the K key, then confirm with
the  key Please enter
your access code:
Validate Esc Quit

" Type your access code, then confirm with  The CALIBRATION NOT CONFIRMED
the  key window disappears.
 The screen of the selected calibration is
displayed again with the previous calibration
and all associated parameters (equation,
regression coefficient, measured values,
interpolated concentrations).

7.4.8 Rerun Calibration

This option is not available for bar coded calibrations.

2Screen of the selected calibration displayed with the CALIBRATION NOT CONFIRMED window
(Out of Range Controls or Absence of Controls), the cursor is positioned on Postpone
Decision.

ACTIONS RESULTATS

" If necessary, load products (reagents,  The following window is displayed:


controls, calibrators, diluents)
" Move the cursor to Rerun Calibration Please enter
with the K key, then confirm with the  key your access code
 Validate Esc Quit

" Type your access code, then confirm with  The CALIBRATION RUNNING window
the  key appears.
 The standards (and the calibration controls if
those are used) are rerun by STA Compact<
so long as the consistency check does not
lead to a blocking of the sample pipetting.

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ACTIONS RESULTATS

" Press the Esc key  Return to CALIBRATION screen (test list).
 The colored square at the left of the test
abbreviation is displayed in yellow
(calibration in progress).

" Press the Esc key  The TEST STATUS screen is displayed (see
description chapter 10.1.3).

7.4.9 Cancelling Calibration

7.4.9.1 Cancelling a "Not Confirmed" calibration

This option is only available if the calibration has been run with new reagent lot numbers.

2Screen of the selected calibration displayed with the CALIBRATION NOT CONFIRMED window
(out of Range Controls or Absence of Controls), the cursor is positioned on Postpone
Decision.

ACTIONS RESULTATS

" Move the cursor to Cancel the  The CALIBRATION NOT CONFIRMED
Calibration with the K key, then confirm window disappears.
with the  key
 The calibration curve disappears.
 A red square is displayed before the
abbreviation of the test with calibration
status: not calibrated.

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7.4.9.2 Cancelling a calibration request

RISK OF WRONG RESULTS


Do not cancel a calibration that is in progress.
Only cancel a calibration if it has not yet been launched or if it is finished.
When cancelling an existing calibration, it is mandatory to rerun the calibration controls and make
sure that the ISI value is the correct one without further cancellation.

2Calibration request confirmed by pressing key F10.


When a calibration has been run, it is possible to cancel it by pressing key F3. The calibration is
affected the following way:
 The values displayed in the information screen (see chapter 7.5.6) correspond to the last entered
threshold values (typed in or read by the barcode reader during the lot change).
 The calibration status remains the same.
 The calibration control status is "not done".

7.5 Other Possible Interventions on Confirmed Calibrations

7.5.1 Modification of 100% Point

This procedure is only possible if the operator knows the access code allowing critical functions (see
chapter 1.5).

NOTE This option is only possible for clotting tests with % as primary unit and if the measurement scale
is linear and the concentration scale is inverse.
After the 100% point is entered, a parallel curve is displayed that passes through the new 100%
point..

2Screen of the selected calibration displayed with the OPTIONS window (cursor positioned on
Quit).

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ACTIONS RESULTATS

" Move the cursor to Modify 100% Point -  The following window is displayed:
ISI with the K key, then confirm with the
 key Please enter
your access code:
 Validate Esc Quit

" Type your access code, then confirm with  The following window is displayed:
the  key
MODIFICATION
F10 Save
Esc Quit
 The cursor is positioned on the entry field
for:
• The ISI value if INR has been chosen as an
auxiliary unit [see description of the
CALIBRATION screen (bar coded mode)
chapter 7.2.1 and of the CALIBRATION
screen (graphic mode), chapter 7.2.4].
• Modifying the 100 % point [see description
of the CALIBRATION screen (bar coded
mode) chapter 7.2.1 and of the
CALIBRATION screen (graphic mode),
chapter 7.2.4].
In this last case, skip the ACTIONS box below.

" Move the cursor with the L key  The cursor is positioned on the entry field
for:
• Modifying the 100 % point [see description
of the CALIBRATION screen (bar coded
mode) chapter 7.2.1 and of the
CALIBRATION screen (graphic mode )
chapter 7.2.4].

" Type in seconds the time corresponding to  The screen of the selected calibration is
the 100 % of the lab, then confirm with the displayed with previous calibration drawn in
 key stippled yellow and the new one in yellow.
 In the curve equation, the slope is kept and
the Y intercept is recalculated.
 The interpolated concentrations are
recalculated.

" Save the modificatons with the F10 key  If calibration controls are defined, they are
automatically run by STA Compact<so long
as the consistency check does not lead to a
blocking of the sample pipetting.

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ACTIONS RESULTATS

" Press the Esc key  Return to CALIBRATION screen (test list).
 If calibration controls are defined, the
colored square at left of the abbreviation of
the selected test is displayed in yellow
(calibration in progress).
 If calibration controls are not defined, the
colored square at left of the abbreviation of
the selected test is displayed in white
(confirmed calibration).

" Press the Esc key  If calibration controls are defined, the TEST
STATUS screen is displayed (see description
chapter 10.1.3).
 If calibration controls are not defined, return
to TEST PANEL.

7.5.2 Modifying Offset (not available on STA Compact®CT)

NOTE This function is only possible for photometric (chromogenic or immunological) tests with linear
graphic mode and if the offset corrector and the calibration controls have been defined. It moves
the calibration curve in parallel direction to itself in such a way that it passes through the new points
defined by the offset corrector plasma.

2CALIBRATION screen displayed for a photometric test with the OPTIONS window (cursor
positioned on Quit).

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ACTIONS RESULTATS

" Move the cursor to Modify Offset with the  The following window is displayed:
L key, then confirm with the  key
Please enter your
access code:
 Validate Esc Quit

" Type your access code, then confirm with  A screen similar to the information screen is
the  key displayed (see description chapter 7.2.4) with
information on the offset corrector plasma
instead of information on the standards.
 The cursor is positioned to modify, if
necessary, the concentration of the offset
corrrector plasma.

" If necessary, modify the concentration of  The cursor is positioned on the minimum
the offset corrector plasma then confirm value of the range of the first calibration
with the  key control.

" If necessary, modify each range value, then  The cursor is positioned on the following
confirm with the  key range value.

" When all parameters are set, press the  Back on the selected calibration screen.
F10 key  The offset corrector plasma and the
calibration controls are automatically run by
STA Compact< so long as the consistency
check does not lead to a blocking of the
sample pipetting.

" Press the Esc key  Return to CALIBRATION screen (test list).
 The colored square at the left of the
abbreviation for the selected test is
displayed in yellow (calibration in progress).

" Press the Esc key  The TEST STATUS screen is displayed (see
description chapter 10.1.3).

After confirmation of the calibration:


- the new curve is displayed in yellow;
- the previous curve is displayed in stippled yellow;
- the interpolated concentrations are recalculated;
- the reading corresponding to the offset corrector plasma is displayed near Offset (see description
chapter 7.2.4) (not available on STA Compact®CT).

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Calibration

7.5.3 Modifying Measures

This procedure is possible only if the operator knows the access code to critical functions (see
chapter 1.5).

NOTE This procedure is also possible on calibrations whose status is to be confirmed (see procedure
chapter 7.4.6).

2CALIBRATION screen displayed with OPTIONS window (cursor positioned on Quit).

ACTIONS RESULTATS

" Move the cursor to Modify Raw Data  The following window is displayed:
with the K key, then confirm with the
 key Please enter
your access code:
 Validate Esc Quit

" Type your access code, then confirm with  The following window is displayed:
the  key
CORRECTION
DEL DELETE
Ins RESTORE
F10 CONFIRM
ESC QUIT

The cursor is positioned on the first


calibration point.

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ACTIONS RESULTATS

" To delete values:  A yellow S is displayed at the left of the


Move the cursor to the value(s) to be deleted value(s).
deleted with the L key, then press the  Deleted values are displayed in grey.
Delete key

Depending on the regression type, a minimum


number of calibration points should remain:
- 2 for linear regression;
- 4 for polynomial 2nd order regressiona;
- 5 for hyperbolic regressiona;
- 6 for polynomial 3rd order regression.

Otherwise, the curve will disappear.


Note: A value can be restored with the
Insert key.

" To modify values:  The modified value(s) are displayed.


Move the cursor to the value(s) to be
modified with the Lkey, then proceed to
the modification(s) and confirm with the
 key

" When all modifications are done, validate  The new calibration is recalculated then the
with F10 key following are displayed: the new calibration
curve, the new equation, and the new
regression coefficient.
 A yellow S is still displayed near deleted
value(s) and a yellow M appears near
modified value(s)
 Deleted value(s) are still displayed in grey.

" Press the Esc key, then the  key  Return to CALIBRATION screen (test list).
 If calibration controls are defined, they are
automatically run by STA Compact< so long
as the consistency check does not lead to a
blocking of the sample pipetting.

" Press the Esc key  If calibration controls are defined, the TEST
STATUS screen is displayed (see description
chapter 10.1.3).
 If calibration controls are not defined, return
to TEST PANEL.
a. not available on STA Compact®CT

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7.5.4 Printout of a Calibration Curve

This function is possible only if the STA Compact< is in stand-by mode (no measurements in
progress) and if all printouts of patient files previously generated have been performed.

NOTE Depending on the calibration mode, one or two calibration screens are printed (for details, see
calibration screen descriptions chapter 7.2.1 to 7.2.4).

2Screen of selected calibration displayed with OPTIONS window (cursor on Quit).

ACTIONS RESULTATS

" Press the P key (Print).  The following window is displayed:


" Or move the cursor to Print with the
K key, then confirm with the  key PRINTOUT
EXECUTE
Printer Test
Form Feed
Quit
with cursor positioned on EXECUTE.

" Press the  key (Execute)  The “PRINTING” indication is displayed at


the bottom of the screen.
 Depending on the calibration mode, one or
two pages are printed (as described in
chapters 7.2.1 to 7.2.4).
 An asterisk is printed at the left of each out
of range calibration control result.

" When the printout is complete, press the  The Printout window disappears.
Esc key
 Back to the selected calibration screen.

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7.5.5 Modifying the ISI Value

The ISI value for the Prothrombin must be the ISI value indicated on the insert of the STA
product.
it is imperative that the user check the ISI value before leaving the menu if there has been
a lot change, a software update, or any major change.
An incorrect ISI value can lead to inaccurate INR (International Normalization Ratio)
results.

This procedure is only available if the operator knows the access code to critical functions, (see
chapter 1.5).
The ISI (International Sensitivity Index) value is modified differently depending on the calibration
mode:
- for ratio modes, it can be accessed through the Modify reference time function (see description
in chapter 7.3.5),
- for graphic and bar coded modes, see procedure below.

2Screen of the selected calibration displayed with the OPTIONS window (cursor on Quit).

ACTIONS RESULTATS

" Move the cursor to Modify100% Point -  The following window is displayed:
ISI with the L key, then confirm with the
 key Please enter
your access code:
 Validate Esc Quit

" Type your access code, then confirm with  The following window is displayed:
the  key
MODIFICATION
F10 Save
Esc Quit
 The cursor is positioned on the entry field
for the ISI value (see description of the
CALIBRATION screen (bar coded mode),
chapter 7.2.1 and of the CALIBRATION
screen (graphic mode), chapter 7.2.4.

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ACTIONS RESULTATS

" Type the new ISI value, then confirm with  The new ISI value is displayed near ISI
the F10 key Coefficient (see description of the
CALIBRATION screen (bar coded mode),
chapter 7.2.1 and of the CALIBRATION screen
(graphic mode), chapter 7.2.4).

7.5.6 Viewing the Information Screen

NOTE This function is available only when there are two screens to define a calibration: bar coded mode
or graphic mode (linear, hyperbolic, polynomial 2nd order or polynomial 3rd order).

2Screen of selected calibration displayed with the OPTIONS window, cursor is positioned on Quit.

ACTIONS RESULTATS

" Move the cursor to Information with the  The Information screen is displayed (see
L key, then confirm with the  key description of this screen in chapters 7.2.1 and
7.2.4).

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Table of contents

8 Patient File Management . . . . . . . . . . . . . . . . . . . . . 1

8.1 Generalities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

8.2 Confirmation / Printout / Transmission Menu . . . . . . . . . . . 1


8.2.1 Access to the Confirmation / Printout / Transmission Menu . . . . . . . . . 1
8.2.2 Description of the CONFIRMATION/PRINTOUT Screen . . . . . . . . . . . . . 2
8.2.3 To Select Files (CONFIRMATION/PRINTOUT Screen) . . . . . . . . . . . . . . 3
8.2.3.1 Access to the FILE SELECTION Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
8.2.3.2 Description of the FILE SELECTION Window (CONFIRMATION/PRINTOUT Screen) . . 4
8.2.3.3 Change the Selection (CONFIRMATION / PRINTOUT Screen) . . . . . . . . . . . . . . . . . . . . 5
8.2.4 To Quit the CONFIRMATION/PRINTOUT Screen . . . . . . . . . . . . . . . . . . 6

8.3 Processing of a Patient File of the Working File . . . . . . . . . . 6


8.3.1 Access to a Given File . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
8.3.2 Description of the FILE PROCESSING Screen for the Working File . . . . 7
8.3.3 Description of the Possible Functions in the File Processing Screen . . 10
8.3.4 Procedure to Process a Patient File . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
8.3.5 Adding Complementary Information (Demoagraphic Parameters) . . . 12
8.3.6 Adding a Non-Standard Note . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
8.3.7 Using a Standard Note . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
8.3.8 Creating or Modifying Standard Notes . . . . . . . . . . . . . . . . . . . . . . . . 13

8.4 Transmitting Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14


8.4.1 Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
8.4.2 Generalities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
8.4.3 On-Line Transmission . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
8.4.4 Batch Uploading of Patient Files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
8.4.4.1 Accessing the FILE TRANSMISSION Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
8.4.4.2 Description of the FILE TRANSMISSION Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
8.4.4.3 Running a Transmission of Patient Files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

8.5 Patient File Printout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17


8.5.1 Generalities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

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8.5.2 Accessing the PRINTOUT Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18


8.5.3 Description of the PRINTOUT Window . . . . . . . . . . . . . . . . . . . . . . . . 18
8.5.4 On-Line Printout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
8.5.5 Printout of a Patient File Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
8.5.6 Printout Examples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

8.6 Deleting Patient Files from the Working File . . . . . . . . . . . 23


8.6.1 Access the FILE DELETION Window . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
8.6.2 Description of the FILE DELETION Window . . . . . . . . . . . . . . . . . . . . . 24
8.6.3 Procedure of Deletion of the Patient Files from the Working File . . . 25
8.6.4 Procedure to Delete the Entire Working File . . . . . . . . . . . . . . . . . . . 26

8.7 File Modification Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28


8.7.1 Access the FILE MODIFICATION Screen . . . . . . . . . . . . . . . . . . . . . . . . 28
8.7.2 Description of the FILE MODIFICATION Screen . . . . . . . . . . . . . . . . . . 28
8.7.3 Blocking or Unblocking Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
8.7.4 Rerunning or Deleting Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

8.8 Customer Printout of Validated Files . . . . . . . . . . . . . . . . . 32


8.8.1 Generalities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
8.8.2 Access to CUSTOMER PRINTOUT OF VALIDATED FILES Screen . . . . . . 33
8.8.3 Description of the CUSTOMER PRINTOUT OF VALIDATED FILES Screen . .
34
8.8.4 To Define the Customer Printout Parameters . . . . . . . . . . . . . . . . . . 35
8.8.4.1 Customer Printout Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
8.8.4.2 Access to PRINTOUT CONFIGURATION Screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
8.8.4.3 PRINTOUT CONFIGURATION Screen, page 1 (Customer Printout Menu) . . . . . . . . . 37
8.8.4.4 PRINTOUT CONFIGURATION Screen, page 2 (Customer Printout Menu) . . . . . . . . . 39
8.8.4.5 Modification of the Customer Printout Definition Parameters . . . . . . . . . . . . . . . . . 40
8.8.5 To Select Files for the Customer Printout . . . . . . . . . . . . . . . . . . . . . . 40
8.8.5.1 Access to the FILE SELECTION Window (Customer Printout) . . . . . . . . . . . . . . . . . . 40
8.8.5.2 Description of the FILE SELECTION Window (Customer Printout) . . . . . . . . . . . . . . 41
8.8.5.3 Change the Selection (Customer Printout) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
8.8.6 Printout of a File Selection (Customer Printout) . . . . . . . . . . . . . . . . . 43

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8.9 Download of Working Lists . . . . . . . . . . . . . . . . . . . . . . . . 44

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Patient File Management

8 Patient File Management

8.1 Generalities
STA Compact® manages one file containing 600 Patient Files: the Working File.
As soon as a Patient file is created, it is stored in the Working File whether the corresponding sample
tube is loaded or not in the sample drawer.
On the Patient files with the corresponding sample tubes loaded in the sample drawer, the following
operations are possible:
- Confirmation of tests or files
- File printout
- File transmission to a host computer
- Deletion of tests within Patient files
- Rerun of tests
- Insertion of tests in files
- Change a file from non-urgent to STAT and vice versa
- Deletion of a file selection
- Addition of complementary information (name, first name, ... ) on the files

All these operations can be performed directly from the TEST PANEL screen by positioning the cursor
on the desired file or from the Files menu, CONFIRMATION/PRINTOUT screen.
Tests may also be blocked, unblocked, deleted or rerun as a global action (see chapter 8.7).

8.2 Confirmation / Printout / Transmission Menu

NOTE This menu allows access to the Patient files of the Working file

8.2.1 Access to the Confirmation / Printout / Transmission Menu

2TEST PANEL screen displayed.

ACTIONS RESULTS

" Press the Esc key  The Main Menu is displayed:

Status Loading Files (...) - Halt


with the cursor on Status.

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ACTIONS RESULTS

" Press the F key (Files)  The Files menu is displayed:

Confirmation/Printout/Transmission
Delete Patient Files
Customer Printout
with the cursor on Confirmation /
Printout/Transmission.

" Pressthe key  The CONFIRMATION / PRINTOUT screen is


displayed with the list of selected files (see
description, chapter 8.2.2).

8.2.2 Description of the CONFIRMATION/PRINTOUT Screen


Fig. 1 - CONFIRMATION/PRINTOUT screen

Legend:

1 Available keys:

 Processes the file on which the cursor is positioned (see chapter 8.3)

F6 Prints out a selected patient file

Esc Options, this key opens the following window:

Change file selection


Transmit
Print
Quit
Change File Selection: selects a group of Patient files with filtering if necessary (see chapter 8.2.3)

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Transmit: transmits the file selection (see chapter 8.4.4)


Print: prints out the file selection (see chapter 8.5.5)
Quit: returns to the TEST PANEL

2 Complementary information (name, first name ... see description chapter 10.2.3.3), concerning
the file on which the cursor is positioned

3 Recall of color code signification as well as the number of files corresponding to each category
for the entire Working File

4 Selected File List:

- Two letters (T and P) confirm if the transmission (T) or the printout (P) have been done. The two
letters may not appear at all (no transmission done nor printout) or simultaneously (file
transmitted and printed out)
- A colored square provides the status of each file:
Blue: Confirmed file
White: Complete file
Red: Complete file with error
Yellow: Incomplete file (including non loaded tubes and loaded tubes not yet run)

8.2.3 To Select Files (CONFIRMATION/PRINTOUT Screen)

8.2.3.1 Access to the FILE SELECTION Window

2CONFIRMATION/PRINTOUT screen displayed (see chapter 8.2.1).

ACTIONS RESULTS

" Press the Esc key (Options)  The following sub-menu is displayed:

Change File Selection


Transmit
Print
Quit
with the cursor on Quit.

" Press the C key (Change File Selection)  The FILE SELECTION window is displayed
(see description chapter 8.2.3.2) with cursor
" Or move the cursor to Change File
positioned in area 1.
Selection with the L key then confirm
with the  key

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8.2.3.2 Description of the FILE SELECTION Window (CONFIRMATION/PRINTOUT Screen)

Fig. 2 - FILE SELECTION Window

Legend:

1 Identification of the first file of the file selection

2 Identification of the last file of the file selection

3 Available functions:

F1 “Beginning of List” displays the first file of the chronological file listing in the Working File

F2 “End of List” displays the last file of the chronological file listing in the Working File

F3 Selects the files with the cursor in the displayed list

F10 Executes and displays the selection

Esc Returns to the CONFIRMATION/PRINTOUT screen

KL Moves the cursor to the different parameters

4 Filtering prefix identification

5 Category of the required files, the  key allows display or deletion of the colored square
corresponding to the category of the required file. This functions allows a better filtering.

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8.2.3.3 Change the Selection (CONFIRMATION / PRINTOUT Screen)

2FILE SELECTION window displayed (see description on chapter 8.2.3.2).

ACTIONS RESULTS

 Type the identification of the first file of the  The identification of the first file of the list is
desired selection then confirm with the displayed in area 1 or “Beginning of List” is
 key displayed in area 1 and the cursor is
 Or press the F1 key to display “Beginning positioned in area 2 (see description of the
of List” (corresponding to the first file (the FILE SELECTION window chapter 8.2.3.2).
oldest) of the Working File)
 Or press the F3 key to select the files with
the cursor. In this case, use the moving
cursor keys to move it to the required file,
then confirm with the  key

It is impossible to use F1/F2 keys with the


F3 key.

" Type the identification of the last file of the  The identification of the last file of the list is
desired selection then confirm with the displayed in area 2 or “End of List” is
 key displayed in area 2 and the cursor is
" Or press the F2 key to display “End of positioned in area 4 (see description of the
List” (corresponding to the last file (most FILE SELECTION window chapter 8.2.3.2).
recent file) of the Working File)
" To select the last file with the cursor, use
the moving cursor keys to move it to the
required file, then confirm with the  key

It is impossible to use F1/F2 keys with the


F3 key.

" To filter: type the prefix identification, then  Filtering prefix identification displayed in the
confirm with the  key (If the cursor is not area 4 (if defined) with the cursor
positioned in area 4, move it with the positioned in area 5 (see description of the
L key FILE SELECTION window, chapter 8.2.3.2 ).
" Or type the first number(s) or letter(s) of
the patient files identification, then confirm
with the  key
" Or leave the area empty (no prefix
definition) and confirm with the  key

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ACTIONS RESULTS

" To improve the filtering, use the  key to  The colored square appears near the type of
display a colored square near the type of desired files.
desired files. If the square is already
displayed, move the cursor with the L key

" If a type of file is not desired, use the  key  The colored square disappears.
to remove the colored square

" When all the parameters of the desired  The new selection is displayed on the
selection are set, press the F10 key CONFIRMATION/PRINTOUT screen (see
description chapter 8.2.2).

8.2.4 To Quit the CONFIRMATION/PRINTOUT Screen

2CONFIRMATION/PRINTOUT screen displayed (see chapter 8.2.1).

ACTIONS RESULTS

" Press the Esc key (Options)  The following sub-menu is displayed:

Change File Selection


Transmit
Print
Quit
with the cursor positioned on Quit.

" Confirm with the  key  If no test has been added in patient files, back
on the TEST PANEL screen.
 If tests have been added or rerun in patient
files, TEST STATUS screen is displayed (see
chapter 10.1.3).

8.3 Processing of a Patient File of the Working File

8.3.1 Access to a Given File


There are two options:
- From TEST PANEL
- From the CONFIRMATION/PRINTOUT screen on condition that the desired test is present in the
list of selected files, otherwise a new file selection will have to be performed (see chapter 8.2.3)

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2- TEST PANEL screen displayed or


- CONFIRMATION/PRINTOUT screen displayed with the list of selected files (see chapter 8.2.1).

ACTIONS RESULTS

" Move the cursor to the desired file with the  The cursor is positioned on the desired file.
K and J keys

" Confirm with thekey  The screen FILE PROCESSING for the
Working File is displayed (see description
below).

8.3.2 Description of the FILE PROCESSING Screen for the Working File
Fig. 3 - FILE PROCESSING screen
(from CONFIRMATION/PRINTOUT screen)

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Fig. 4 - FILE PROCESSING screen


(from TEST PANEL)

Legend:

1 Recall of the chosen filtering

2 Recall of the validation limits, for the test on which the cursor is positioned

3 Raw data (time or O.D.1/min. or ' O.D.1) and final results in primary units for each
determination and for the mean, for the test on which the cursor is positioned.
In case of duplicate determination, STA Compact® compares the difference between the two
results by means of the PRECISION parameter defined within the page 1 of 3 of the TEST SETUP
screens (see description chapter 5.1.1.7).
If the calculated difference is greater than the defined one, STA Compact® automatically reruns
a third test, compares the three results and keeps the best result pair.

4 Available functions (see description below chapter 8.3.3)

5 File status:

ˆ On the left of the line:


Confirm: all the tests of the file are done and confirmed
Complete: all the tests of the file are done but some of them have to be confirmed
Complete/Error: all the tests of the file are done but some of them have an error
Incomplete: some tests or all tests on the file have to be done, the file has no test (file with
teleloading), or file without tube

ˆ On the center of the line:


STAT is displayed for the STAT samples
1. not available on STA Compact®CT

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Patient File Management

ˆ On the right of the line:


Transmit: the file has been transmitted
Printed: the file has been printed
Transmit/Printed: the file has been transmitted and printed out

6 File Identification:

ˆ On the left of the first line:


Identification number with color codes allowing to distinguish the different status (identical to
those used on the TEST PANEL):
White: Routine sample (tube loaded or not)
Yellow: STAT sample (tube loaded or not)
Grey: File for which a tube has been loaded but the list of tests is unknown (waiting
for teleloading from the host computer)
Green: A liquid level detection error has been detected
Red: An error has been detected on one or several tests

ˆ On the right of the first line:


- For Patient files with loaded tube: position of the sample in the sample drawer
- For Patient files without tube: empty area

ˆ On the second line:


Complementary information (name, first name, ... ) see description of the Global Options sub-
menu (chapter 10.2.3.3).
This information can either be transmitted by the host computer or defined by moving the cursor
to this area (see procedure chapter 8.3.5).

7 Test list of the file. An asterisk appears on the left for tests with alarm(s) (see point 12 hereafter).

8 For each test, mean of the result, in the primary unit

9 For each test, mean of the result, in the first secondary unit

10 For each test, mean of the result, in the second secondary unit

11 For each test, status of the result:


- Blocked
- Erased
- Waiting
- In process
- To confirm
- Tech. err. (technical error)
- Value > Max. (equivalent to > V max. displayed on the TEST PANEL, see description chapter 3.2)
- Value < Min. (equivalent to < V min. displayed on the TEST PANEL, see description chapter 3.2)
- Dev. > tol. (deviation > precision, only for double determination)
- Linearity (<regression coefficient, for colorimetry and immunology, not available on STA
Compact®CT)
- QNS (quantity of plasma not sufficient)
- Rerun
- Confirmed

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For each test, the areas 7, 8, 9, 10, and 11 are displayed with a specific color depending on the
results status:
Blue: Confirmed
White: To be confirmed
Black: Waiting;
Grey: Rerun
Red: Error

12 For the test on which the cursor is positioned, type of alarm code if necessary:

A Result validated with Time > Max. Time


B Not used
C Quality controls out of range detected by STA Compact® or not done
D Quality controls out of range but validated by the operator
E Liquid Level Detection for needle # 3 not controlled (see chapter 10.1.2.1)
F Liquid Level Detection for needle # 2 not controlled (see chapter 10.1.2.1)
G Liquid Level Detection for needle # 1 (samples) not controlled (see chapter 10.1.2.1)
H Result in primary unit limited to printout limit values (see chapter 5.1.3.3)
I Result obtained after redilution (this redilution is defined in TEST SETUP screens, see
chapter 5.1.1.9)
J Result rerun by the operator
K Temperature of product drawer out of range
L Preventive maintenance not done for the syringe

The alarms are classified by priority order (from A to L). The first one appears totally, the other ones
are represented by alphabetical codes and can be viewed by pressing the * key.

13 Adds or selects a note among the standard ones by pressing the F9 key (see procedure in
chapters 8.3.6 to 8.3.8).

8.3.3 Description of the Possible Functions in the File Processing Screen


PgUp Page Up: the previous file is displayed, Page Down: the next file is displayed
PgDn

Esc List: Returns to the CONFIRMATION/PRINTOUT screen (not available from TEST PANEL)

Esc Quit: Returns to TEST PANEL if no tests have been inserted or rerun; otherwise displays the
TEST STATUS screen if one or several tests have been inserted or rerun (see description of this
screen chapter 10.1.3), not available from CONFIRMATION/PRINTOUT screen

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F1 Confirm File - All results with status To confirm are changed to status Confirm; upon
saving (F10 key), if all result status are Confirm, then the file status is changed to Confirm

F2 Accept Test - The test status on which the cursor is positioned is changed to Confirm if its
original status allows it: To confirm or Dev. > tol. or Value > max. (when it is equivalent to
time > T max.)

F3 Rerun Test - The test on which the cursor is positioned will be rerun. Its status is changed to
rerun.
For duplicate determination, the tests are rerun in duplicate. The current results have to be
printed out because they will disappear.
For single determination, the previous value is stored and a new single determination is run. The
parameter PRECISION defined on the first page of the TEST SETUP screens (see description
chapter 5.1.1.7), is used to compare both results. If the difference is greater than the defined
one, the STA Compact® automatically reruns the test a third time, compares the three results
and keeps the best pair of results.

- When returning to the TEST PANEL, the STA Compact® automatically displays the TEST STATUS
screen (see chapter 10.1.3).
- Test rerun is also possible in File Modification screen (see chapter 8.7).

F4 Delete Test - The test on which the cursor is positioned will be deleted. Its status is changed
to erased.

Note:
Test deleting can also be done in File Modification screen (see chapter 8.7).

F5 Insert Test - Accesses a TEST SELECTION window; move the cursor to the required test and
confirm with the  key. This is only possible for tests which are not already selected.

When returning to the TEST PANEL, the STA Compact® automatically displays the TEST STATUS
screen (see chapter 10.1.3).

F6 Print - The displayed patient file is printed

F10 Save - Records all the modifications applied to the displayed patient file

F11 Save + Transmit - Records all the modifications applied to the displayed patient file and
transmits the file (for more details on transmission see chapter 8.4)

F12 STAT/NORMAL - Changes a non-urgent file to a STAT file or vice versa

KL Moves cursor

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8.3.4 Procedure to Process a Patient File


- Access to Patient file either from TEST PANEL or from CONFIRMATION/PRINTOUT screen (see
chapter 8.3.1).
- Use the different possible commands (see description, in chapters 8.3.3 and 8.3.5 to 8.3.8).

8.3.5 Adding Complementary Information (Demoagraphic Parameters)

NOTE Only the complementary information (demographic parameters) as defined in the Global Options
menu can be added (see chapter 10.2.3.3).

2A FILE PROCESSING screen is displayed.

ACTIONS RESULTS

" With the first test in the list highlighted, use  The cursor is positioned on the first area
the K key to move the cursor to area 6, (see available for complementary information
description chapter 8.3.2) (see description chapter 8.3.2).

" Type the desired information then confirm  The cursor moves to the following area.
with the J key

" When all complementary information is  The cursor moves back to the first test of
defined, confirm with the  key the test list (see description chapter 8.3.2).

8.3.6 Adding a Non-Standard Note

2A FILE PROCESSING screen displayed.

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ACTIONS RESULTS

" With the last test in the list highlighted, use " The cursor is positioned in the “Note” area
the L key to move the cursor to the “Note” (see chapter 8.3.2).
area (see chapter 8.3.2 ) " The message “Optional notes - F9: using
standard notes” is displayed at the bottom
of the screen.

" Type the required note with the keyboard " Cursor is positioned back on the last test of
then confirm with the  key the list of the tests of the patient file.

8.3.7 Using a Standard Note

2A FILE PROCESSING screen displayed, with the cursor in the “Note” area (see description
chapter 8.3.2) and the message “Optional notes - F9 = using standard notes” is displayed at
the bottom of the screen.

ACTIONS RESULTS

" Press the F9 key  The list of standard notes is displayed.

" Move the cursor to the desired note with  The list of standard notes disappears and the
the L key then confirm with the  key chosen note is displayed in the “Note” zone
(see description chapter 8.3.2).

" Press the key  Cursor is positioned back on the last test of
the list of the tests of the patient file.

8.3.8 Creating or Modifying Standard Notes

2A FILE PROCESSING screen displayed, with the cursor in the “Note” field (see description
chapter 8.3.2) and the message “Optional notes - F9 = using standard notes” is displayed at
the bottom of the screen.

ACTIONS RESULTS

" Press the F9 key  The list of standard notes is displayed.

" Move the cursor with the L key to a free  The cursor is positioned in the desired field.
field to create a standard note or to an
existing note to modify it

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ACTIONS RESULTS

" Press the F2 key, type the required text,  The new (or modified) note is now included
then confirm with the  key in the list of standard notes.

" Press the Esc key  Back to the FILE PROCESSING screen.

8.4 Transmitting Results

8.4.1 Conventions
All the results are transmitted according to an ASTM protocol. For more information, see document
“User Interface RS 232-C STA Compact< ASTM”, Cat. No. 28062.
All results are transmitted with two codes. The first one defines the result status (see description
chapter 8.3.2, point 11), and the second one the type of alarm if necessary (see description chapter
8.3.2, point 12).

8.4.2 Generalities
According to the conventions defined above, there are three options for transmitting results:
- On-line Transmission: results are sent test by test as soon as they are obtained (see description
below chapter 8.4.3).
- Uploading File by File with the F11 key from different FILE PROCESSING screens, access by the
CONFIRMATION/PRINTOUT screen or by the TEST PANEL screen (see chapter 8.3.3);

- Batch uploading (see description below chapter 8.4.4).

To check the transmission, see chapter 4.

8.4.3 On-Line Transmission


When the On-line transmission is enabled, the results are sent test by test as soon as they are
obtained according to the conventions defined in chapter 8.4.1.
Procedure to enable the On-line transmission:
2TEST PANEL screen displayed.

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ACTIONS RESULTS

" Press the Esc key  The Main Menu is displayed:

Status Loading Files (...) - Halt


with the cursor on Status.

" Press the  key  The Status menu is displayed:

System
Tests
Products
Stop Sample Pipetting NO
On-Line Transmission NO
On-Line Printout NO
with the cursor on System.

" Move the cursor to On-Line  The option On-Line Transmission No


Transmission No with the L key then changes to On-Line Transmission Yes.
confirm with the  key

8.4.4 Batch Uploading of Patient Files


This procedure allows transmission of patient files of a given selection to the host computer.
It is first necessary to proceed to a file selection: see chapter 8.2.3.

8.4.4.1 Accessing the FILE TRANSMISSION Window


Access this window by the Files menu from the CONFIRMATION/PRINTOUT screen (see access in
chapter 8.2.1).
2CONFIRMATION/PRINTOUT screen displayed

ACTIONS RESULTS

" Press the Esc key (Options)  The following window is displayed:

Change File Selection


Transmit
Print
Quit
with the cursor positioned on Quit

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ACTIONS RESULTS

" Press the T key (Transmit)  The FILE TRANSMISSION window is


" Or move the cursor to Transmit with the displayed (see description below).
L key, then confirm with the  key

8.4.4.2 Description of the FILE TRANSMISSION Window

Fig. 5 - FILE TRANSMISSION window

Legend:

1 Allows to choose between:

- Transmits only files never transmitted (option displayed by default)


- Transmits all files, including those already transmitted

2 Identification of the Patient file currently transmitted

3 Number of Patient files remaining to transmit

4 Available functions:

F10 Runs the Patient file transmission (or starts it again if it was stopped)

Esc Returns to list of selected files or stops the transmission

8.4.4.3 Running a Transmission of Patient Files

2FILE TRANSMISSION window displayed (see chapter 8.4.4.1).

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ACTIONS RESULTS

" To include patient files which have been  The identification of the patient files being
already transmitted: transmitted are displayed near Processed
press the Y key, then confirm with the File (see the FILE TRANSMISSION window)
F10 key; otherwise, press the F10 key and the number of files remaining to
transmit near Rest (see description above
chapter 8.4.4.2).
 The message “TRANSMITTING” then
“TRANSMISSION COMPLETE” are displayed
above Processed File (see description above
chapter 8.4.4.2).

" To stop the current transmission:  The message “TRANS. INTERRUPTED” is


press the Esc key displayed above Processed File (see
description, chapter 8.4.4.2).
 The F10 key restarts the transmission.
 The Esc key returns to the list of selected
files.

" When the transmission is done:  Returns to the list of selected files.
press the Esc key  The letter T is displayed in front of the
identification of each file actually
transmitted.

8.5 Patient File Printout

8.5.1 Generalities
There are three options for printing out patient files:
On-Line Printout: the patient files are printed file by file as soon as they are completed (see
description, chapter 8.5.4)
Printout of an individual file by means of the F6 key:
- Directly from the CONFIRMATION/PRINTOUT screen for the file corresponding to the position of
the cursor (see chapter 8.2.2)
- Or from the FILE PROCESSING screens accessible either from the CONFIRMATION/PRINTOUT
screen or from the TEST PANEL screen (see chapter 8.3.3)
Printout of a selection of files (see chapter 8.5.5)
For all these cases, the printout parameters are defined from the PRINTOUT window accessible as
soon as the Print option is selected (see chapters 8.5.2 to 8.5.4).
To check the printer parameters or the printer connection, see chapter 4.
In addition, patient file printout can also be custom-built (see description chapter 8.8.).

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8.5.2 Accessing the PRINTOUT Window


This window is accessible within the Files menu from the CONFIRMATION/PRINTOUT screen (see
access chapter 8.2.1).

2CONFIRMATION / PRINTOUT screen displayed.

ACTIONS RESULTS

" Press the Esc key (Options)  The following window is displayed:

Change File Selection


Transmit
Print
Quit
with the cursor positioned on Quit.

" Press the P key (Print)  The PRINTOUT window is displayed, see
" Or move the cursor to Print by pressing description below.
the L key, then confirm with the  key

8.5.3 Description of the PRINTOUT Window


Fig. 6 - PRINTOUT Window

Legend:

1 Prints only the unprinted files from a selection of Patient files (see procedure in chapter 8.5.5)

2 Prints all the selected files (see chapter 8.5.5)

3 Defines the printout parameters (see hereafter)

4 Returns to the list of selected files or interrupts the printout in progress

5 Printout parameters

Three parameters allow definition of the printout (area 5 of the PRINTOUT window):

Mode: all files or single file

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- all files: the patient files are printed one after the other in a table, the lab name is printed on top
of each page.
- single file: only one file per printed page, the lab name is printed for each file.
Quality: standard or presentation
- standard: allows a rapid printout, unable to print certain special character forms
- presentation: allows a better printout quality but is slower
Page Length: defined in line quantity without taking into account the real length of paper
To avoid frequent cuts in files, apply the following principle :
- 1 inch = 6 lines
- 11" paper = 66 lines in a real page
- To print 2 patient files per page = set Page Length to 22 lines
- To print 3 patient files per page = set Page Length to 33 lines
If a printed file is divided:
- The message “Continued: next page” is printed on the lower right corner of the first part.
- The complete patient file identification (including the complementary information) is recalled on
top of the second part.
- The message “CONTINUED” is printed right under the patient file identification for the second
part.

NOTE The lab name is defined within the Global Options menu (see chapter 10.2.2.2).

Defining the printout parameters:

2PRINTOUT window displayed with cursor positioned on Quit (see chapter 8.5.2).
²

ACTIONS RESULTS

" Press the P key (Printer Setup)  The following window is displayed
" Or move the cursor to Printer Setup by
pressing the L key twice, then confirm with
the  key

with the cursor positioned on all files or on


Single file.

" To modify a given parameter: move the  For “Mode” parameter, definition changes
cursor on it with the L key then, confirm from all files to single file or inversely.
with the key.
 For “Quality” parameter, definition changes
from standard to presentation or
inversely.
 For “Page Length” parameter, the cursor is
positioned on the number of lines (see
description of the printout parameters in
chapter 8.5.4).

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ACTIONS RESULTS

" Type with the keyboard the number of  The parameters are displayed.
desired lines then confirm with the  key

" When all the printout parameters are set,  Back on PRINTOUT window.
press the Esc key

8.5.4 On-Line Printout


When On-Line Printout is enabled, the patient files are printed as soon as all the tests of the file are
completed even if results have errors or alarms.
Printing is performed according to the printer parameters defined from the PRINTOUT window (see
description chapter 8.5.2 and 8.5.3).

Procedure to enable the On-line printout:

2TEST PANEL displayed.

ACTIONS RESULTS

" Press the Esc key (menu) " The Main Menu is displayed:

Status Loading Files (...) - Halt


with the cursor on Status.

" Press the  key  The Status menu is displayed:

System
Tests
Products
Stop Sample Pipetting NO
On-Line Transmission NO
On-Line Printout NO
with the cursor on System.

" Move the cursor to On-Line Printout No  The option On-Line Printout No
with the L key, then confirm with the changes to On-Line Printout Yes.
 key

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8.5.5 Printout of a Patient File Selection

If the On-Line Printout has been chosen, this option is available only if the STA Compact® is in stand-
by mode (no measurement in progress) and if all the printouts previously scheduled have been done.
If the On-Line Printout has not been chosen, this option is always available.

With this procedure, all patient files of a given selection are printed; it is first necessary to proceed
to file patient selection (see chapter 8.2.3).
2PRINTOUT window displayed (see procedure chapter 8.5.2) with the cursor positioned on Quit.

ACTIONS RESULTS

" Change the printout parameters if  A window is displayed in the upper left
necessary (see chapter 8.5.3) corner of the screen. This window indicates
the identification of the file being processed
" Depending on the required patient files:
as well as the number of files remaining to
- All the files not yet printed, print.
press the Lkey Unprinted Files) then
 At the same time, the file printout starts.
confirm with the key
- All the selected files:
press the L key to All Files, then confirm
with the  key

" To stop the current printout, press the  The files already processed are being
Esc key printed.
 Then, the printout stops.

" When all files are printed  Automatic return to the list of selected files.
 The letter P is printed in front of the
identification of each file actually printed

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8.5.6 Printout Examples


Fig. 7 - Printout of a Patient File - Single File mode - Presentation quality

Fig. 8 - Printout of a Patient File - All Files mode - Standard quality

Legend:

1 Name of the lab, as defined within the Global Options menu (see chapter 10.2.2.2)

2 Date and time of the printout

3 Patient file identification including, if necessary, the complementary information (name, first
name, etc.); on the second line, the standard notes if necessary

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4 Complete name of the test; it is preceded by an asterisk (*) if the test is concerned by one or
several alarms

5 Result in primary unit

6 Result in the first secondary unit if necessary

7 Result in the second secondary unit if necessary

8 Result in the third secondary unit if necessary


Note :
Areas 5, 6, 7 and 8 are empty if the result can not be validated.

9 Result status:
- Blocked
- Waiting
- In process
- To confirm
- Error (corresponds to the following results:
technical error, Value > Max., Value < Min., Dev. > tol, linearity, plasma quantity not sufficient)
- Confirm, the result is validated

10 Usual values for each test as defined within the Test Setup menu (see chapter 5.1.3.2).

11 List of alarms presented by test (see definition point 12 of chapter 8.3.2).

12 Page Number - In “Single File” mode, the page number starts at 1 with each File printout

8.6 Deleting Patient Files from the Working File

This option is only accessible if the STA Compact® is in stand-by mode (no measurement in
progress) and if the printouts previously scheduled have been done.
When the Working File is full (more than 600 records), the operator is requested to delete the
oldest file whose sample tube has been removed.

The Patient files deleted by this procedure are permanently lost.

NOTE The option Delete Files from the Working File is also available when switching on the STA
Compact® (see procedure chapter 3.1.4). But in this case, no selection is possible.

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8.6.1 Access the FILE DELETION Window

2TEST PANEL screen displayed.

ACTIONS RESULTS

" Press the Esc key  The Main Menu is displayed:

Status Loading Files (...) - Halt


with the cursor on Status.

" Press the F key (Files)  The following sub-menu is displayed:

Confirmation/Printout/Transmission
Delete Patient Files
Customer Printout
with the cursor positioned on
Confirmation/Printout/Transmission.

" Press the D key (Delete Patient Files)  The FILE DELETION window is displayed (see
description below chapter 8.6.2).
" Or move the cursor to Delete Patient
Files with the L key then confirm with the
 key

8.6.2 Description of the FILE DELETION Window


Fig. 9 - FILE DELETION Window

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Legend:

1 Identification of the first file of the selection

2 Identification of the last file of the selection

3 Prefix identification

4 Category of the required files identified by a colored square:


Blue: Confirmed file (Yes/No)
White: Complete file (Yes/No)
Red: Complete file with error (Yes/No)
Yellow: Incomplete file (Yes/No)
By default, all the options are set to Yes (colored square is displayed).

5 Available functions:

F3 Selects the files with the cursor in the displayed list

F4 Deletes the entire Working File

F10 Displays the list of selected files then deletes the selection

LK Moves the cursor to different parameters

Esc Returns to TEST PANEL screen

6 List of selectable files (selection procedure in progress) or list of selected files (selection
procedure done)

8.6.3 Procedure of Deletion of the Patient Files from the Working File

2FILE DELETION window displayed (see chapter 8.6.1).

ACTIONS RESULTS

" Press the F3 key  The message “Please select the First File” is
displayed.
 All the available patient files of the Working
File are displayed (see above FILE DELETION
window description chapter 8.6.2).

" Use the moving cursor keys to move it to  The message “Please select the Last File” is
the required file, then confirm with the displayed.
 key  Identification of the first file is recalled.

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ACTIONS RESULTS

" Use the moving cursor keys to move it to  The FILE DELETION window is displayed
the required file, then confirm with the with the cursor positioned near Prefix and
 key the identifications of the first selected file
and of the last selected file displayed (see
description of the FILE DELETION window
chapter 8.6.2).

" Type the prefix identification then confirm  The prefix identification is displayed and the
with the  key cursor is positioned on area 4 (see
" Or type the first number(s) or letter(s) of description of the FILE DELETION window
the required patient file identifications, then chapter 8.6.2).
confirm with the  key
" Or leave this area empty (no prefix
identification) and confirm with the  key

" If a type of file is not desired, use the L key  The colored square disappears.
to move the cursor to it, then confirm with
the  key to remove the colored square

" When all the parameters of the desired  The following window appears furtively:
selection are set, press the F10 key
Research in progress
Please, wait.
 The list of selected files is displayed (see
description of the FILE DELETION window
chapter 8.6.2).
 The message “Please, type YES to confirm”
is displayed.

" Type the letters: YES and confirm the file  The patient files are deleted from zone 6
deletion with the  key (see description of the FILE DELETION window
chapter 8.6.2).

" Press the Esc key  Return to TEST PANEL screen.

8.6.4 Procedure to Delete the Entire Working File

2FILE DELETION window displayed (see chapter 8.6.1).

ACTIONS RESULTS

" Press the F4 key  All the available patient files of the Working
File are displayed(see above FILE DELETION
window description, chapter 8.6.2).
 The message “Please, type YES to confirm”
is displayed.

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ACTIONS RESULTS

" Type the letters: YES and confirm the  All files of the Working File are deleted from
deletion with the  key zone 6 (see description of the FILE DELETION
window, chapter 8.6.2).

" Press the Esc key  Return to TEST PANEL screen.

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8.7 File Modification Menu


This menu allows to block or to unblock tests, to rerun or to delete tests for a given selection.

8.7.1 Access the FILE MODIFICATION Screen

2TEST PANEL displayed.

ACTIONS RESULTS

" Press the / key (Options) of the keypad  The following window is displayed:
(right side of the keyboard)
Help
File Modification
Quit
with the cursor positioned on Quit.

" Press the F key (file modification)  The FILE MODIFICATION screen is displayed
" Or move the cursor to File Modification (see description below chapter 8.7.2).
with the L key, then confirm with the  key

8.7.2 Description of the FILE MODIFICATION Screen


Fig. 10 - FILE MODIFICATION Screen

Legend:

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1 F1 Change: opens the following window which allows to choose the type of file
modification to apply:

Block
Unblock
Rerun
Delete
Block: Blocks tests in pending status:
Unblock: Unblocks blocked tests;
Rerun: Reruns tests for the selected files;
Delete: Deletes tests for the selected files.
Note: There is only one type of modification possible at one time.

2 Identification of the type of modification chosen; the first letter of the name of the modification
is displayed in yellow

3 F2 Selects the patient files on which the file modification will be applied (see procedure below
chapter 8.7.4). This function is not available when the chosen file modifications are Block or
Unblock.

4 Identification of the first file of the selection

5 Identification of the last file of the selection

6 Available functions:

 Applies the chosen file modification (or cancels it) for the test corresponding
to the position of the cursor

F10 Executes the chosen file modification

Esc Returns to the TEST PANEL screen

7 Complete name of the test corresponding to the position of the cursor

8 List of the abbreviations of the available tests. The letter B (Blocked) is displayed in grey at the
left of the tests currently blocked. When chosing the application of the file modification, a letter
is displayed in yellow at the left of the selected tests:

B for block
U for unblock
R for rerun
D for delete
Note: The “BLOCKED SAMPLE PIPETTING” message is displayed in white on a red background at the
bottom of the screen when the sample pipetting is blocked whether:
- Voluntarily by the operator (Stop Sample Pipetting function, see description in chapter 10.1.5.1)
- Or automatically by the STA Compact® after the consistency check; if the required assays cannot
be done

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8.7.3 Blocking or Unblocking Tests

The Block or Unblock options concern the tests of any patient files present in the Working File and
the quality control automatic (periodic) running function. It does not concern the calibrations nor
the calibration controls. Consequently, the file selection is not available.
Block is only possible for pending tests and Unblock for blocked tests.
Indeed, the operator can force any quality control running for a blocked test by using the Run
function of the Quality Control menu (see chapter 9.3).
After unblocking tests, while returning to the TEST PANEL, the STA Compact® automatically
displays the TEST STATUS screen (see description chapter 10.1.3).

2FILE MODIFICATION screen displayed (see procedure chapter 8.7.1).

ACTIONS RESULTS

" Press the F1 key  The following window is displayed:

Block
Unblock
Rerun
Delete
with the cursor positioned on Block

" To block, press the  key  Block is displayed in the ACTION area (see
" To unblock, press the U key (Unblock) or description of the FILE MODIFICATION screen
move the cursor to Unblock with the chapter 8.7.2).
L key, then confirm with the  key  Unblock is displayed in the ACTION area
(see description of the FILE MODIFICATION
screen chapter 8.7.2).
 The cursor is positioned on the first test (see
description of the FILE MODIFICATION screen
chapter 8.7.2).

" Use the moving cursor keys to move it to  A letter is displayed in yellow at the left of
each related test then select each test with the selected test; B for Block or U for
the  key Unblock.

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ACTIONS RESULTS

" When all parameters are set, press the  The file modification is applied.
F10 key  For the Block function, the TEST PANEL is
displayed:
The message Block appears in red replacing
requests for the tests concerned by the
Block option.
 For the Unblock function, the TEST STATUS
screen is displayed (see description
chapter 10.1.3).

8.7.4 Rerunning or Deleting Tests

NOTE For duplicate determination, the tests are rerun in duplicate. The current results have to be
printed out because they will disappear.
For single determination, the previous value is stored and a new single determination is run. The
PRECISION parameter defined on the first page of the TEST SETUP screens (see description
chapter 5.1.1.7) is used to compare both results. If the difference is greater than the defined one,
the STA Compact® automatically reruns the test a third time, compares the three results and keeps
the best pair of results.

After chosing to rerun tests, while returning to the TEST PANEL, the STA Compact® automatically
displays the TEST STATUS screen (see description chapter 10.1.3).

2FILE MODIFICATION screen displayed (see procedure chapter 8.7.1).

ACTIONS RESULTS

" Press the F1 key  The following window is displayed:

Block
Unblock
R erun
Delete
with the cursor positioned on Block.

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ACTIONS RESULTS

" To rerun tests, press the R key (Rerun) or  Rerun is displayed in the ACTION area (see
move the cursor to Rerun with the L key, description of the FILE MODIFICATION screen
then confirm with the  key chapter 8.7.2).
" To delete tests, press the D key (Delete)  Delete is displayed in the ACTION area (see
or move the cursor to Delete with the L description of the FILE MODIFICATION screen
key, then confirm with the  key chapter 8.7.2).

 Press the F2 key  The TEST PANEL is displayed.


 The message “Please select the First File”
is displayed.

" Use the moving cursor keys to move it to  The message “Please select the Last File” is
the required file then confirm with the displayed.
 key
 The identification of the first selected file is
recalled.

 Use the moving cursor keys to move it to  The FILE MODIFICATION screen is displayed
the required file then confirm with the with the cursor positioned on the first test of
 key the list of available tests and the
identifications of the first selected file and of
the last selected file are displayed (see
description of the FILE MODIFICATION screen
chapter 8.7.2).

" Use the moving cursor keys to move it to  A letter is displayed in yellow at the left of
each related test, then confirm with the each selected test: R for Rerun, D for
 key Delete.

" Press the F10 key  The file modification is applied.


 For the Rerun function, the TEST STATUS
screen is displayed (see description
chapter 10.1.3).
 For the Delete function, the TEST PANEL is
displayed, the results are wiped out (see
description of TEST PANEL chapter 3.2).

8.8 Customer Printout of Validated Files

8.8.1 Generalities
This menu gives the opportunity to print the Patient Files according to each laboratory specific needs.
All the confirmed Patient Files present in the Working File are available for this printout.

NOTE A confirmed or validated Patient File is a Patient File for which all tests are done and confirmed

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The location and the type of information related to the Patient Files (Patient ID, test name, results)
are fixed ; only the headings or the additional remarks are defined by each laboratory.
Only one file is printed per page.

RISK OF WRONG RESULTS


If you use of this menu, the results will be printed out without any alarm messages. For that reason,
an important part of the information which may affect the results are missing. Diagnostica Stago
denies all responsibilities as for the use of this menu.

For customer printout of Patient Files:


" The printout parameters must be defined, see chapter 8.8.4
" The Patient Files to be printed must be selected, see chapter 8.8.5
" The printout must then be run, see chapter 8.8.6

8.8.2 Access to CUSTOMER PRINTOUT OF VALIDATED FILES Screen

This access is only possible if STA Compact® is in stand-by (no measurement in progress).

2TEST PANEL displayed.

ACTIONS RESULTS

" Press the Esc key  The Main Menu is displayed:

Status Loading Files (...) - Halt


with the cursor on Status.

" Press the F key (Files)  The Files menu is displayed:

Confirmation/Printout/Transmission
Delete Patient Files
Customer Printout
with the cursor on Confirmation/
Printout/Transmission.

" Move the cursor to Customer Printout  The CUSTOMER PRINTOUT OF VALIDATED
with the K key, then confirm with the FILES screen is displayed (see description
 key chapter 8.8.3).

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8.8.3 Description of the CUSTOMER PRINTOUT OF VALIDATED FILES Screen


Fig. 11 - CUSTOMER PRINTOUT OF VALIDATED FILES Screen

Legend:

1 Available functions:

F6 Prints out the confirmed Patient File on which the cursor is positioned

Esc Options, this key opens the following window:

Change File Selection


Print Unprinted Files
Print all Files
Printout Configuration
Quit
Change File Selection: selects a group of Patient files (see chapter 8.8.5)
Print Unprinted Files: prints only the unprinted files from a selection of Patient files
(see chapter 8.8.6)
Print all Files: prints all the selected files (see chapter 8.8.6)
Printout Configuration: defines the printout parameters (see description chapter 8.8.4)
Quit: returns to the TEST PANEL

2 Complementary information (name, first name ... see description chapter 10.2.3.3) for the file
on which the cursor is positioned

3 Selected File List. The letter (P) shows that the file has already been printed by means of the
CUSTOMER PRINTOUT OF VALIDATED FILES screen

4 Warning Message

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8.8.4 To Define the Customer Printout Parameters

8.8.4.1 Customer Printout Format

Fig. 12 - Customer Printout Format

To determine the length of the Patient File, the Customer Printout menu uses the Page Length
parameter defined within the Files menu (PRINTOUT window, CONFIRMATION/PRINTOUT screen)
on condition that this parameter is at least greater than 54 (see chapter 8.5).

Legend:

1 Data defined by the laboratory (Titles, data, name, notes ...); for these data definitions, see
chapters 8.8.4.3 and 8.8.4.4)

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2 Patient File Identification (16 characters max.), Field No.1 as defined within the Global Options
menu, see chapter 10.2.3.3

3 Contents of fields No.2 and No.3 as defined within the Global Options menu, see chapter
10.2.3.3, (16 characters and 12 characters max.).
The field No.2 content is printed in upper case character; the first character of the field No.3
content is printed in upper case character, the remaining in lower case character

4 Contents of field No.4 as defined within the Global Options menu, see chapter 10.2.3.3
(6 characters max.)

5 Content of field No.5 as defined within the Global Options menu, see chapter 10.2.3.3
(4 characters max.)

6 Printout Date; the used format is defined within the Global Options menu, see chapter 10.2.3.4

7 Test complete name as defined within the Test Setup menu (see chapter 5.1.1.1)
The result table can contain an entire file, i.e.: 12 tests

8 Result in primary unit

9 Result in first secondary unit

10 Result in second secondary unit

11 Result in third secondary unit

Note: Results for secondary units can be printed only if YES has been selected for the printout
within the TEST SETUP screens, see chapter 5.1.3.1.

Note: The fields 8, 9, 10 and 11 are replaced by the message “Out of Range” if the result
has been confirmed even though its status was “Time > Max Time”, see chapter 8.3.3.

12 Usual values for each test as defined with the TEST SETUP screens, see chapter 5.1.3.1

13 Standard note as defined within the FILE PROCESSING screens, see chapters 8.3.6 to 8.3.8

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8.8.4.2 Access to PRINTOUT CONFIGURATION Screens

2CUSTOMER PRINTOUT OF VALIDATED FILES screen displayed, see chapter 8.8.2.

ACTIONS RESULTS

" Press the Esc key  The following sub-menu is displayed:

Change File Selection


Print Unprinted Files
Print all Files
Printout Configuration
Quit
with the cursor on Quit.

" Move the cursor to Printout  The first screen of PRINTOUT


Configuration with the K key, then CONFIGURATION is displayed (see chapter
confirm with the  key 8.8.4.3).

8.8.4.3 PRINTOUT CONFIGURATION Screen, page 1 (Customer Printout Menu)

Fig. 13 - PRINTOUT CONFIGURATION Screen


Page 1 of 2

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For the customer printout format, see chapter 8.8.4.1.

Legend:

1 Available functions:

ESC Returns to the CUSTOMER PRINTOUT OF VALIDATED FILES screen

PgDn Displays the second PRINTOUT CONFIGURATION screen

LK Moves the cursor to the following line (Lkey) or to the preceding line (K key)

F10 Saves the printout parameters

2 Definition of the 2 main titles:


2 lines of 48 characters
If one of the two titles contains more than 35 characters, then the 2 main titles are printed in
enlarged, bold and condensed format, otherwise (d35), they are printed in enlarged and bold
format

Note: The first main title is a mandatory acquisition field

3 Definition of 4 secondary titles:


4 lines of 60 normal characters; the non-defined titles are printed out as blank lines

4 Definition of 5 general data names:


5 lines of 25 characters printed in normal format; the general data names have to be defined
according to their respective contents, see description chapter 8.8.4.1.

Note: General data names No.1, No.2 and No.5 are mandatory acquisition fields.

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8.8.4.4 PRINTOUT CONFIGURATION Screen, page 2 (Customer Printout Menu)

Fig. 14 - PRINTOUT CONFIGURATION Screen


Page 2 of 2

For the customer printout format, see chapter 8.8.4.1.

Legend:

1 Available functions:

ESC Returns to the CUSTOMER PRINTOUT OF VALIDATED FILES screen

PgUp Displays the first PRINTOUT CONFIGURATION screen

LK Moves the cursor to the following line (Lkey) or to the preceding line (K key)

F10 Saves the printout parameters

2 Definition of the titles for the result table:


3 lines of 16 characters printed in condensed and bold format.
These titles have to be defined according to the respective content of each column (see
chapter 8.8.4.1)

Note: The 3 result titles are obligatory acquisition fields.

3 Constant remark:
2 lines of 60 characters printed on one line in condensed format

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4 Definition of the optional note name:


1 line of 16 characters (See definition, point 13 of chapter 8.8.4.1)

5 Definition of the 2 final titles:


2 lines of 40 characters printed in bold, enlarged and condensed format

8.8.4.5 Modification of the Customer Printout Definition Parameters

2PRINTOUT CONFIGURATION screen displayed, see access chapter 8.8.4.2).

ACTIONS RESULTS

" Move the cursor to the requested  The cursor is positioned on the requested
parameter with the L key parameter.

" Enter the new information on the  The new information is displayed.
alphanumeric keyboard, then confirm with
 The cursor moves to the next data.
the  key

" When all information is entered, press the  Customer printout definition parameters
F10 key are saved.
 Back to the CUSTOMER PRINTOUT OF
VALIDATED FILES screen.

8.8.5 To Select Files for the Customer Printout

8.8.5.1 Access to the FILE SELECTION Window (Customer Printout)

2CUSTOMER PRINTOUT OF VALIDATED FILES screen displayed (see chapter 8.8.2.).

ACTIONS RESULTS

" Press the Esc key  The following sub-menu is displayed:

Change File Selection


Print Unprinted Files
Print all Files
Printout Configuration
Quit
with the cursor on Quit.

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ACTIONS RESULTS

" Press the C key (Change File Selection)  The FILE SELECTION window is displayed
" Or move the cursor to change File (see description, chapter 8.8.5.2).
Selection with the L key, then confirm
with the  key

8.8.5.2 Description of the FILE SELECTION Window (Customer Printout)

Fig. 15 - FILE SELECTION Window (Customer Printout)

Legend:

1 Identification of the first file of the file selection

2 Identification of the last file of the file selection

3 Available functions:

F1 “Beginning of List” displays the first file of the confirmed files listing in chronological
order in the Working File

F2 “End of List” displays the last file of the confirmed files listing in chronological order in
the Working File

F3 “By cursor” selects the files with the cursor in the available files

F10 Executes the selection and displays it

ESC Returns to the CUSTOMER PRINTOUT OF VALIDATED FILES screen

KL Moves the cursor to the different parameters

4 Filtering prefix identification

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8.8.5.3 Change the Selection (Customer Printout)

2FILE SELECTION window displayed from CUSTOMER PRINTOUT OF VALIDATED FILES screen, (see
description on chapter 8.8.5.1).

ACTIONS RESULTS

" Type the identification of the first file of the  The identification of the first file of the list is
desired selection then confirm with the displayed in area 1 or “Start ” is displayed in
 key area 1 and the cursor is positioned in area 2,
" Or press the F1 key to display “Start” see description of the FILE SELECTION window
(corresponding to the first confirmed file (the chapter 8.8.5.2 .
oldest) of the Working File)
" Or press the F3 key to select the files with
the cursor. In this case, use the moving
cursor keys to move it to the required file,
then confirm with the  key

It is impossible to use F1/F2 keys with the


F3 key.

" Type the identification of the last file of the  The identification of the last file of the list is
desired selection then confirm with the displayed in area 2 or “End of File” is
 key displayed in area 2 and the cursor is
" Or press the F2 key to display positioned in area 4, see description of the
“End of File”(corresponding to the last FILE SELECTION window chapter 8.8.5.2.
confirmed file (the latest) of the Working File)
" To select the last file with the cursor, use
the moving cursor keys to move it to the
required file, then confirm with the  key.

It is impossible to use F1/F2 keys with the


F3 key.

" To filter: type the prefix identification, then  Filtering prefix identification displayed in the
confirm with the  key area 4 (if defined), see description of the
FILE SELECTION window chapter 8.8.5.2.
" Or type the first number(s) or letter(s) of
the patient files identification, then confirm
with the  key
" Or leave the area empty (no prefix
definition) and confirm with the  key

" When all the parameters of the desired  The new selection is displayed on the
selection are set, press the F10 key CUSTOMER PRINTOUT OF VALIDATED FILES
screen, see description chapter 8.8.3.

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8.8.6 Printout of a File Selection (Customer Printout)

2CUSTOMER PRINTOUT OF VALIDATED FILES screen displayed, see access chapter 8.8.2.

ACTIONS RESULTS

" Press the Esc key  The following sub-menu is displayed:

Change File Selection


Print Unprinted Files
Print all Files
Printout Configuration
Quit
with the cursor on Quit.

" Depending on the required Patient files:  A window is displayed in the upper left
corner of the screen. This window indicates
- All the files not yet printed,
the identification of the file being processed
move the cursor to Print Unprinted
as well as the number of files remaining to
Files with the Lkey, then confirm with
print.
the key
 At the same time, the file printout starts.
- All the selected files:
move the cursor to Print all Files withthe
K key, then confirm with the  key

" To stop the current printout, press the  The files already processed are being
Esc key printed.
 Then, the printout stops.

" When all files are printed  Automatic return to the list of selected files.
 The letter P is printed in front of the
identification of each file actually printed.

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8.9 Download of Working Lists


Purpose: To request once again to the host computer the working list for all the patient tubes
already loaded which have not received it during the loading step. Indeed, if the Patient File
identification is not known by the host computer while loading the tube, the STA Compact® receives
no answer. Without this function, the only way to perform once again the working list request is to
unload the tubes and load them again one by one.

2TEST PANEL displayed.

ACTIONS RESULTS

" Press the F11 key  The following window is displayed:

Downloading
File: xxxx
ESC = Abort
xxxx = identification of the Patient File being
downloaded.
 The Patient File working lists are received.

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Table of contents

9 Quality Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

9.1 Generalities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

9.2 Access to Quality Control Results . . . . . . . . . . . . . . . . . . . . 2

9.3 Description of the QUALITY CONTROL Screens . . . . . . . . . 3


9.3.1 Decription of the QUALITY CONTROL Screen (Test List) . . . . . . . . . . . 3
9.3.2 Description of a QUALITY CONTROL RESULT Screen (Graphic Form) . 4
9.3.3 Description of a QUALITY CONTROL RESULT Screen (Tabular Form) . 7

9.4 Procedures to Run and to Confirm Quality Controls . . . . . 9


9.4.1 Main Principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
9.4.2 Loading Quality Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
9.4.3 Changing the Range of Acceptable Results for Quality Controls . . . . . 11
9.4.4 Running One Level of Quality Control . . . . . . . . . . . . . . . . . . . . . . . . . 13
9.4.5 Simplified Running for Quality Controls . . . . . . . . . . . . . . . . . . . . . . . . 14

9.5 Procedures to Observe for out of Range Quality Controls 15


9.5.1 Alarm Code and Alarm Message Displayed for out of Range Quality Con-
trols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
9.5.2 Description of the CONTROL OUT OF RANGE window . . . . . . . . . . . . 15
9.5.3 Accepting out of Range Quality Controls . . . . . . . . . . . . . . . . . . . . . . . 16
9.5.4 Rerunning out of Range Quality Controls . . . . . . . . . . . . . . . . . . . . . . 17

9.6 Other Available Operations on Quality Controls . . . . . . . 17


9.6.1 Cancelling a Running Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
9.6.2 Deleting Today’s Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
9.6.3 Deleting all the Quality controls Results . . . . . . . . . . . . . . . . . . . . . . . 19
9.6.4 Printing Quality Control Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
9.6.4.1 Printing Quality Control Results as Graphic Form . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
9.6.4.2 Printing Quality Control Results as Tabular Form . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
9.6.5 Transmitting Today’s Quality Control Results . . . . . . . . . . . . . . . . . . . 22

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9 Quality Control

9.1 Generalities
For each test, at least one quality control has to be run daily if at least one patient results is requested
for this test.

RISK OF WRONG RESULTS


If the result of a quality control does not meet the norms, all the results since the last correct quality
control with a validated status should be called into question.

Up to three quality controls can be defined for each test within the TEST SETUP screens (see
chapter 5.1.3.4).
Quality controls are loaded in the product drawer and are automatically run by STA Compact® (see
details, chapter 9.4).
In the Quality Control sub-menu, the quality control results are treated on 3 zones:
- CONTROLS FOR TODAY zone
- CUM DAILY zone
- CUM MONTHLY zone
(See description of these zones in chapter 9.3.2 and 9.3.3).
In these zones, up to 2 lot numbers can be stored.

When controls from a new lot are loaded, values of the oldest lot are automatically deleted, the
preceding lot changes into the old lot and the new lot into the current lot.

The treatment of the quality controls is based on the Levey-Jennings statistical model:

i=n

¦ xi
Mean : m = i-------------
=1 - xi = result in primary unit
n

Standard deviation : Coefficient of variation in % :

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n varies depending on the treatment zone:

Zone n

CONTROL FOR TODAY 1 to 24

CUM DAILY 1 to 31

CUM MONTHLY 1 to 12

9.2 Access to Quality Control Results


2TEST PANEL screen displayed.

ACTIONS RESULTATS

" Press the Esc key  The Main Menu is displayed:

Status Loading- (...) - Halt


with cursor positioned on Status.

" Press the C key (Calib./Control)  The sub-menu is displayed:

Calibration
Quallity Control
with cursor on Calibration.

" Press the L key to Quality Control, then  The QUALITY CONTROL screen is displayed
confirm with the  key (see description chapter 9.3.1).
 The cursor is positioned on the first test of
the list.

" Press the L or J keys to move the cursor  Results of quality control for the first control
to the selected test, then confirm with the displayed in graphic form (see description
 key chapter 9.3.2 ).

" Press the F3 key  Results of quality control for the next control
displayed in graphic form (see description
Note: If only one quality control level has
chapter 9.3.2).
been defined; with F3, the same level is
displayed. For 2 or 3 levels, with F3, the
different levels are looped.

" Press the F2 key  Return to the results of the preceding


control in graphic form (see description
chapter 9.3.2).

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ACTIONS RESULTATS

" Press the F1 key  Results of quality control for the control
selected displayed in tabular form (see
description chapter 9.3.3).

" From the screen of quality control results in  Return to QUALITY CONTROL screen (test
graphic form, press the Esc key, then list).
confirm with the  key

" Press the Esc key  Return to TEST PANEL screen.

9.3 Description of the QUALITY CONTROL Screens

9.3.1 Decription of the QUALITY CONTROL Screen (Test List)


Fig. 1 - QUALITY CONTROL Screen (Test List)

Legend:

1 Available keys:

 Views the quality control results of the selected test


F1 Select Controls to Run: requests running of all quality control levels for the test on
which the cursor is positioned
F10 Run Selected Controls: runs quality controls requested by F1 option (see procedure of
simplified run chapter 9.4.5)
Esc Returns to TEST PANEL screen

2 Name of this screen

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3 List of test abbrevations. A colored square displayed at the left of the abbreviation indicates the
quality control current status (see point 5 below)

4 Complete name of the test on which the cursor is positioned

5 Color codes identifies the status of each quality control:

White: Validated
Blue: To be validated
Yellow: In progress
Red: Not done

9.3.2 Description of a QUALITY CONTROL RESULT Screen (Graphic Form)


Fig. 2 - QUALITY CONTROL RESULT Screen
(Graphic Form)

Legend:

1 Available keys:

F1 Views the results in tabular form.

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F2/F3 Accesses the other levels; the results are always displayed in graphic form.
Esc Options; this key opens the following window:

Print
Run
Cancel
Change Range
Delete All Results
Return to Result List

Print: prints the graphic screen


Run: runs quality control for the displayed level
Cancel: cancels quality control (status: «in progress») for the displayed level
Change range: changes the range of acceptable results
Delete All Results: purges all the displayed values
Return to Result List: returns to the QUALITY CONTROL screen (test list)

When an option is not available, its name is displayed in grey instead of blue

2 Level indication: 1, 2 or 3

3 Complete name of the test

4 Primary unit to express results

5 Control identification number

6 Complete name of the control

7 Curent lot number of the control

8 CUM DAILY: zone to display the last 31 means of daily controls.

The points do not necessarily correspond to consecutive days, they come from several months.
The day corresponding to each mean is displayed at the bottom of the CUM DAILY zone.

Adding a new point is made from the right side of the existing points; shifting those points to the
left when there are more than 31 values. In this case, visualization of the first point is lost.

The means of the daily controls are displayed according to the following color codes:

+++(green): Daily control means obtained during preceding months which are within
the range of acceptable results

+++(red): Daily control means obtained during preceding months which are outside
of the range of acceptable results

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xxx (yellow): Daily control means for the current month which are within the range of
acceptable results

xxx (red): Daily control means for the current month which are outside of the range
of acceptable results

' red): Results out of scale

When the range of acceptable results is changed, the colors of the various points are reviewed
according to the range of acceptable results (see description chapter 9.4.3).

9 CONTROL FOR TODAY zone:


Zone to display the quality control results for a 24-hour period. From the day change, as soon
as a quality control is confirmed (manually or automatically), this zone is automatically emptied
and the point corresponding to the mean of the last 24-hour period is displayed in the
CUM DAILY zone.
In the CONTROLS FOR TODAY zone, points are added to the right of the existing ones.

Points of this zone are displayed according to those color codes:


o (Blue): Result within the range of acceptable results for the quality control
o (Red): Result outside of the range of the acceptable results for the quality control
'(Red): Result out of scale

10 Green vertical bar indicating a lot change (up to 2 lots are shown)

11 Range of acceptable results for the quality control. It is represented by white dotted lines which
are displayed in the 3 zones: CONTROLS FOR TODAY/CUM DAILY/CUM MONTHLY.

12 Mean of range of acceptable results for the quality control. It is represented by a white solid line
which is displayed in the 3 zones: CONTROLS FOR TODAY/CUM DAILY/CUM MONTHLY.

13 Mean ± 2 K (V = standard deviation) for quality control results of the CUM DAILY zone. It is
represented by yellow dotted lines.

14 Mean of quality control results of the CUM DAILY zone, it is represented by a solid yellow line.

15 Glossary explaining the meanings of the color codes displayed on the screen.

16 CUM MONTHLY zone:


Zone to display the monthly means for the quality control results. For each calendar month, the
mean ±2 Kis shown: mean by a solid yellow line, mean +2 Kand mean -2 K by dotted lines.
Out of scale values are displayed with a red . The month number is displayed at the bottom of
the CUM MONTHLY zone.

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9.3.3 Description of a QUALITY CONTROL RESULT Screen (Tabular Form)


Fig. 3 - QUALITY CONTROL RESULT Screen
(Tabular Form)

Legend:

1 Available keys:

Esc Back to Graph: returns to graphic form for quality control results of the selected level
F4 Suppress current Controls: suppresses one or several results from the CURRENT
CONTROLS zone
F6 Print: prints results as tabular form
F11 Transmit Current Controls: Transmits all today’s quality control results to the Host
computer
2 Level indication: 1, 2 or 3

3 Complete name of the test

4 Primary unit to express results

5 Control identification number

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6 Complete name of the control

7 Current lot number of the control

CURRENT CONTROLS zone:


8 Zone to display the results of today’s quality controls

The following indications appear:


- The result in primary units (Res.)
- The hour (Time) at which the quality control has been run

They are displayed:


- In dark blue for values obtained with the old lot
- In light blue for values obtained with the current lot
- In red when the values are out of the range of acceptable results

9 Day when the controls have been run

10 Range of acceptable results for the current lot of the quality control in the primary unit

11 Mean (Mean), Standard Deviation (K) and coefficient of variation (CV) for the results of the
today quality controls

DAILY MEANS zone:


12 Zone to display the last 31 daily means

The following indications appear:


- The day (D)
- The daily mean (Mean)
They are displayed:
- In dark blue for the old lot
- In light blue for the current lot
- In red for daily means which are outside of the range of acceptable results

13 Mean (Mean), Standard Deviation (K) and coefficient of variation (CV) for the daily means from
the old lot (displayed in dark blue).

14 Mean (Mean), Standard Deviation (K) and coefficient of variation (CV) for the daily means from
the current lot (displayed in light blue).

MONTHLY MEANS zone:


15 Zone to display the last 12 monthly means.

The following indications appear:


- The month (M)
- The monthly mean (Mean)
- The monthly Standard Deviation (V)
- The monthly coefficient of variation (cv)

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Quality Control

They are displayed:


- In dark blue for the old lot
- In light blue for the current lot
- In red when the monthly means are outside of the range of acceptable results

For the month corresponding to the lot change, the displayed mean corresponds to that with the
more representative points.

9.4 Procedures to Run and to Confirm Quality Controls

9.4.1 Main Principles


The quality controls for a related test are automatically run by the STA Compact® as soon as the STA
Compact® has to perform an analysis of this test and that the time elapsed since the last control run
is greater than the period defined within the TEST SETUP screens (see chapter 5.1.3.4). This period
cannot exceed 24 hours. Quality controls can also be run on operator’s request from these 2
screens:
- QUALITY CONTROL screen (test list). In this case, all quality control levels of the selected test are
run (simplified run, see description chapter 9.4.5).
- Screen for quality control results for a selected level. In this case, only the selected level is run.

Running controls on request is possible only if the sample pipetting has not been blocked either from
the TEST STATUS screen ( see description chapter 10.1.3) or by the Stop Sample pipetting
function of the Status sub-menu (see description chapter 10.1.5.1).
To block tests by means of the FILE MODIFICATION screen blocks the quality control automatic
(periodic) running function but not a running decided by the operator (see description chapter 8.7.3).

Quality controls are run in single or in duplicate depending on the determination type chosen for the
sample (see description chapter 5.1.1.7 ).

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As soon as quality control results are obtained, they are compared to the range of acceptable results,
if they are outside of the range, the STA Compact®automatically reruns the controls according to
the principle below:

Automatic Rerun
First run Result(s)
by STA Compact®

Control run in single Outside of the defined range Control rerun in duplicate

Control run in duplicate 1 of the 2 results outside of Control rerun in single


the defined range

If the quality control is confirmed as outside of the range of acceptable results, all the patient results
for the related test will be given with an alarm code: «Quality Control: out of range or not done»;
they will be displayed in light red on the TEST PANEL screen.
If the operator decides to accept quality control results declared as out of range, all patient results
for the related test will be given with an alarm code: «Quality Control: overridden».
If quality control has been run or rerun, when returning to the TEST PANEL screen, STA Compact®
performs a consistency check and displays the TEST STATUS screen (see description, chapter 10.1.3).
If upon running quality controls (automatically or on request), those are not present in the drawer
(not present or present but with volume or stability not usable) and if the time elapsed since the last
quality control run is less than 24 hours, then STA Compact® does not perform the control. It
proceeds with the assays for the related test and all patient results for the related test are given with
the alarm code: «Quality Control: out of range or not done». In the same case, with an elapsed
time greater than 24 hours, the sample pipetting for the related test is blocked.
If the control lot number has changed or if the quality control results have been reset, the sample
pipetting for the related test will start again only when the products necessary to perform the first
controls will have been loaded. In the same way, the sample pipetting for the related test will be
blocked as long as the range values have not been defined.

Reminder When the same controls are used (same identification Numbers) as calibration controls and as
quality controls, the results of the calibration controls are added into the results for quality controls
and the time at which the calibration controls have been run resets the clock for the quality
controls.

If the On-line Transmission option is enabled (see description chapter 10.1.5.2), then all quality
control results will be sent with their error codes as soon as the measurements are obtained.

No alarm codes will be sent for quality controls.

For description of the error and alarm codes, see chapter 8.3.2. Each quality control result will be
sent with the run date and time. If the On-Line Transmission is not enabled , all today’s confirmed
quality control results can be sent from the quality control result table, see chapter 9.6.5.

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9.4.2 Loading Quality Controls


The quality controls are loaded in the product drawer (see description, chapter 6.6). At each lot
number change, the values for the range of acceptable results for the Diagnostica Stago controls are
scanned in by means of the barcode sheets inserted in each control box. For the other controls, these
values have to be manually entered.

Reminder For Diagnostica Stago controls, the values for the range of acceptable results are properly entered
for the related tests, on condition that for those, the primary unit chosen is identical to that defined
on the package inserts of each control box (except Fibrinogen, for g/l primary unit, values are
properly entered even if on the package insert, they are given in mg/dl).

9.4.3 Changing the Range of Acceptable Results for Quality Controls

This procedure is possible only if:


- the selected control is not running, its status is «to be validated» or «not done» because of missing
products;
- the operator knows the access code to critical functions, (see chapter 1.5).

For controls which are not from Diagnostica Stago, the range of acceptable results has to be
absolutely defined at each lot change so that controls can be run.

For controls from Diagnostica Stago, the range of acceptable results can only be reduced, it cannot
be in any case increased.

2QUALITY CONTROL RESULTS screen (graphic form) displayed for the selected level (see access
chapter 9.2).

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ACTIONS RESULTATS

" Press the Esc key  The following window is displayed:

Print
Run
Cancel
Change Range
Delete All Results
Return to Result List
with the cursor positioned on Return to
Return List

" Move the cursor to Change Range with  The following window is displayed:
the K key, then confirm with the  key.
Range Modification
New values 1 xxx - xxx % 3
(Original Values 2 xxx - xxx)
F10 Save Esc Abort
with cursor positioned on the Entry zone for
new values.
1 Entry zone for the new range values in
primary unit

2 For controls from Diagnostica Stago, range


values as scanned in from the bar code
sheet.

3 Primary unit is recalled.

" Type the new range values, confirm with  The Range Modification window
the  key then save the new values with disapears.
the F10 key
 The following window is displayed:

Please enter
your access code:
 Validate Esc: Quit

" Type your access code, then confirm with  The screen for quality control results is
the  key displayed with the new range of acceptable
results.
 In the 2 zones: CONTROLS FOR TODAY and
CUM DAILY, all points outside of the new
range are displayed in red.

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9.4.4 Running One Level of Quality Control

Running is impossible:
- if control is already running or if its status is «to be validated»;
- if the calibration for the selected test is not validated;
- if products necessary to perform the control are not present;
- if the values for the range of acceptable results have not been defined (see chapter 9.4.3).

2Screen of quality control results (graphic form) displayed for the selected level (see access
chapter 9.2).

ACTIONS RESULTATS

" Press the Esc key  The following window appears:

Print
Run
Cancel
Change Range
Delete All Results
Return to Result List
with the cursor positioned on Return to
Result List

" Move the cursor to Run with the L key,  The following window is displayed
then confirm with the  key
Please enter
your access code:
 Validate Esc: Quit

" Type your access code, then confirm with  STA Compact® runs the quality control level
the  key as long as the consistency check does not
lead to a blocking of the sample pipetting.

" Press the Esc key then confirm with the  Return to QUALITY CONTROL screen (test
 key list).

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9.4.5 Simplified Running for Quality Controls

Running is impossible:
- for tests with one control already running or already with status «to be validated»;
- if the calibration for the selected test is not validated;
- if products necessary to run the quality controls are not present, (see chapter 9.4.1).
- for test with undefined range of acceptable results of quality controls (see chapter 9.4.3).

2QUALITY CONTROL screen (test list) displayed (see access chapter 9.2).

ACTIONS RESULTATS

" To select a test for quality controls to be run  If running is possible (all the necessary
on, move the cursor on its abbreviation, products are loaded and the control ranges
then press the F1 key have been defined), the letter S is displayed
at the left of each test abbreviation for which
Note: To cancel a selection, press the F1
controls have been selected.
key again.
 If running is impossible, STA Compact®
beeps and the letter S is not displayed.

" When all the requested controls are  The following window is displayed:
selected, press the F10 key
Please enter
your access code:
 Validate Esc Quit

" Type your access code, then confirm with  The letters S at the left of the abbreviations
the  key disappear.
 Controls are run by STA Compact® as long
as the consistency check does not lead to a
blocking of the sample pipetting.
 The colored squares at the left of the
abbreviations for the selected tests are
displayed in yellow.

" Press the Esc key  The TEST PANEL screen is displayed (see
description chapter 10.1.3).

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9.5 Procedures to Observe for out of Range Quality Controls

9.5.1 Alarm Code and Alarm Message Displayed for out of Range Quality Controls
When a quality control result is outside of the range of acceptable results (out of range), the operator
is informed by the following message:

MEASURING MANAGEMENT
Error 05.06.09
QUALITY CONTROL
Control out of limits
for the test xxx
Esc = continue
xxx = Test Abbreviation
For the related test, all patient results are given with an alarm code: «Quality Control: out of range
or not done» and on the TEST PANEL screen, all results are displayed in light red.

9.5.2 Description of the CONTROL OUT OF RANGE window


This window is displayed when looking at a Quality control results screen while a result is out of
range.

Fig. 4 - CONTROL OUT OF RANGE Window

Legend:

1 Test abbreviation

2 Quality control identification number

3 Results obtained for the quality control (in the primary unit)

4 Recall of the range of acceptable results for the quality control (in primary unit)

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5 Recall of the mean for the CUM DAILY zone

6 Recall of the mean for the CUM MONTHLY zone

7 Available functions:

Accept: accepts an out of range quality control (see description chapter 9.5.3)
Rerun: reruns the quality control (see description chapter 9.5.4)
Postpone Decision: returns to QUALITY CONTROL screen (test list)

9.5.3 Accepting out of Range Quality Controls

This procedure is only possible if the operator knows the access code which allows to accept out
of range controls (see chapter 1.5).

Reminder If the operator accepts quality control results out of range, all patient results for the related test will
be given with the alarm code: «Quality Control: overridden».

In the CONTROL OUT OF RANGE window, out of range results are displayed in red and the range of
acceptable results is displayed (see description chapter 9.5.2).

2Screen of quality control results displayed with with the CONTROL OUT OF RANGE window,
cursor positioned on Postpone Decision.

ACTIONS RESULTATS

" Press the A key (Accept)  The CONTROL OUT OF RANGE window
disappears.
" Or move the cursor to Accept with the
L key then confirm with the  key  The following window is displayed:

Please enter
your access code:
 Validate Esc Quit

" Type your access code, then confirm with  Depending on the value of the out of range
the  key result, a red o or a red '(out of scale) is
displayed in the CONTROLS FOR TODAY
zone.

" Press the Esc key, then the  key  Return to QUALITY CONTROL screen (test
list).

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9.5.4 Rerunning out of Range Quality Controls

Reminder When the STA Compact® declares a quality control as out of range, the control has already been
run 3 times.
If a control result is out of the range of acceptable results, for a single determination, control is rerun
in duplicate and for a duplicate determination, it is rerun in single (see description chapter 9.4.1).

In the CONTROL OUT OF RANGE window, out of range results are displayed in red and the range of
acceptable results is displayed (see description chapter 9.5.2).

2Screen of quality control results displayed with the CONTROL OUT OF RANGE WINDOW, cursor
positioned on Postpone Decision.

ACTIONS RESULTATS

" Press the R key (Rerun)  The following window is displayed:


" Or move the cursor to Rerun with the
L key, then confirm with the  key Please enter
your access code:
 Validate Esc Quit

" Type your access code, then confirm with  STA Compact®reruns the quality control so
the  key long as the consistency check does not lead
to a blocking of the sample pipetting.
 Return to the quality control results of the
selected control level.

9.6 Other Available Operations on Quality Controls

9.6.1 Cancelling a Running Control

This function is not available if the control status is «confirmed», «to be validated» or «not done». It
is only possible for running controls (yellow square at the left of the test abbreviation).

2Screen of quality control results displayed (graphic form) for a selected level (see access
chapter 9.2).

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ACTIONS RESULTATS

" Press the Esc key  The following window appears:

Print
Run
Cancel
Change Range
Delete All Results
Return to Result List
with the cursor positioned on Return to
Result List.

" Move the cursor to Cancel with K key,  The quality control running for the selected
then confirm with the  key level is cancelled.

" Press the Esc key  Return to QUALITY CONTROL screen (test
list).
 The colored square at the left of the
abbreviation for the selected test is
displayed in red (not done).

" Press the Esc key  Return to TEST PANEL

9.6.2 Deleting Today’s Controls

This procedure is possible only if the operator knows the access code to critical functions, (see
chapter 1.5). It concerns only quality control results of the controls for today zone (see description
of this zone chapter 9.3.2, point 9).

2Screen of quality control results displayed (graphic form) for a selected level (see access
chapter 9.2).

ACTIONS RESULTATS

" Press the F1 key  The quality control results of the selected
level are displayed as tabular form.

" Press the F4 key  The following window is displayed:

Please enter
your access code:
 Validate Esc Quit

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ACTIONS RESULTATS

" Type your access code, then confirm with  The following window is displayed:
the  key
Current Controls Suppression
DEL Suppress
INS Restore
F10 Save
Esc Abandon
The cursor is positioned on the first result of
the CURRENT CONTROLS zone

" For each result to be deleted, move the  Each result which has to be deleted is
cursor to it with the L key, then press the displayed in grey.
Delete key

" Press the F10 key  the Current Controls Suppression


window disappears.
Note: As long as the F10 key has not been
selected, results can be restored by the  In the CURRENT CONTROLS zone, the
Insert key. selected results disappear.
 Mean, V and cv are updated.

" Press the Esc key  Return to the quality control results as
graphic form.

9.6.3 Deleting all the Quality controls Results

This operation deletes all the quality control results for the selected level.

For this operation, the operator must know the access code to critical functions (see chapter 1.5).

This function is not available if the control status is «in progress» or «to be validated».

2Quality control results screen displayed (graphic form) for a selected level (see access
chapter 9.2).

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ACTIONS RESULTATS

" Press the Esc key  The following window is displayed:

Print
Run
Cancel
Change Range
Delete All Results
Return to Result List
with the cursor positioned on Return to
Result List

" Press the D key (Delete All Results)  The following window is displayed:
" Or move the cursor to Delete All Results
with the K key, then confirm with the Please enter
 key your access code:
 Validate Esc Quit

" Type your access code then confirm with  The following window is displayed:
the  key
DELETE ALL CONTROL RESULTS
accept (YES/NO) xxxx ?

" Type YES then confirm with the  key  All quality control results of the selected
level are detected.

" Press the Esc key, then confirm with the  Return to QUALITY CONTROL screen (test
 key list).

9.6.4 Printing Quality Control Results

9.6.4.1 Printing Quality Control Results as Graphic Form

This operation is possible only if the STA Compact® is in stand-by mode (no measurement in
progress) and if all printouts previously generated have been performed.

2Screen of quality control results displayed (graphic form) for a selected level (see access
chapter 9.2).

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Quality Control

ACTIONS RESULTATS

" Press the Esc key  The following window is displayed:

Print
Run
Cancel
Change Range
Delete All Results
Return to Result List
with the cursor positioned on Return to
Result List

" Press the P key (Print)  The Printout following is displayed:


" Or move the cursor to Print with the
L key, then confirm with the  key PRINTOUT
EXECUTE
Printer Test
Form Feed
Quit
with cursor positioned on EXECUTE

" Press the  key (EXECUTE)  The «PRINTING...» indication is displayed at


the bottom of the screen.
 The quality control results are printed as
graphic form for the selected level.

" When the «PRINTING...» indication  The PRINTOUT window disappears.


disappears, press the Esc key
 Return to the screen of quality control
results for the selected level (graphic form).

9.6.4.2 Printing Quality Control Results as Tabular Form

This operation is possible only if the STA Compact® is in stand-by mode (no measurement in
progress) and if all printouts previously generated have been performed.

2Screen of quality control results displayed (graphic form) for a selected level (see access,
chapter 9.2).

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ACTIONS RESULTATS

" Press the F1 key  The quality control results of the selected
level are displayed as tabular form.

" Press the F6 key  The following window is displayed:

PRINTOUT
EXECUTE
Printer Test
Form Feed
Quit
with cursor positioned on EXECUTE

" Press the  key (EXECUTE).  The «PRINTING...» indication is displayed at


the bottom of the screen.
 The quality control results are printed as
tabular form for the selected level.

" When the «PRINTING...» indication  The PRINTOUT window disappears.


disappears, press the Esc key
 Return to the table of quality control results
for the selected level.

" Press the Esc key  Return to the screen of quality control
results as graphic form.

9.6.5 Transmitting Today’s Quality Control Results

2Screen of quality control results displayed (graphic form) for a selected level (see access
chapter 9.2).

ACTIONS RESULTATS

" Press the F1 key  The quality control results of the selected
level are displayed as tabular form.

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Quality Control

ACTIONS RESULTATS

" Press the F11 key  The two following windows are displayed:

TRANSMITTING

then,

TRANSMISSION COMPLETED
Esc= Clear this message
 All today’s quality control results for the
selected level are transmitted to the Host
computer with their rspective running date
and time.

" Press the Esc key  Return to the table of quality control results
for the selected level.

" Press the Esc key  Return to the screen of quality control
results as graphic form.

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Table of contents

10 STATUS and GLOBAL OPTIONS Screens . . . . . . . . . 1

10.1 STATUS Screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1


10.1.1 Access to the STATUS Screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
10.1.2 SYSTEM STATUS Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
10.1.2.1 Description of SYSTEM STATUS Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
10.1.2.2 Modifying the Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
10.1.2.3 Modifying the Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
10.1.2.4 Modifying the Level Detection Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
10.1.3 Description of TEST STATUS Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
10.1.4 Description of PRODUCT STATUS Screen . . . . . . . . . . . . . . . . . . . . . . 11
10.1.5 Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
10.1.5.1 Stop Sample Pipetting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
10.1.5.2 On-Line Transmission (YES/NO) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
10.1.5.3 On-Line Printout (YES/NO) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

10.2 GLOBAL OPTIONS Screens . . . . . . . . . . . . . . . . . . . . . . . . . 13


10.2.1 Access to the GLOBAL OPTIONS Screens . . . . . . . . . . . . . . . . . . . . . . . 14
10.2.2 GLOBAL OPTIONS Screen, page 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
10.2.2.1 Description of the GLOBAL OPTIONS Screen, page 1 . . . . . . . . . . . . . . . . . . . . . . . . . 15
10.2.2.2 Printout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
10.2.2.3 Access Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
10.2.2.4 Bar Code Reading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
10.2.2.5 Miscellaneous . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
10.2.2.6 Arbitrary Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
10.2.3 GLOBAL OPTIONS Screen, page 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
10.2.3.1 Description of the GLOBAL OPTIONS Screen, page 2 . . . . . . . . . . . . . . . . . . . . . . . . . 18
10.2.3.2 Communications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
10.2.3.3 File Acquisition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
10.2.3.4 Miscellaneous . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
10.2.4 Modification of a Global Option Parameter . . . . . . . . . . . . . . . . . . . . . 20
10.2.4.1 Generalities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
10.2.4.2 Modification Procedure for a Free Entry Field . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
10.2.4.3 Modification Procedure for a Multiple-Option Field . . . . . . . . . . . . . . . . . . . . . . . . . 21
10.2.4.4 Modification of the Time Display Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
10.2.4.5 Modification of the Date Display Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
10.2.5 Saving Parameters from GLOBAL OPTIONS Screens . . . . . . . . . . . . . . 24

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Table of contents

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STATUS and GLOBAL OPTIONS Screens

10 STATUS and GLOBAL OPTIONS Screens

10.1 STATUS Screens


The STATUS screens allow to display on a single screen all the information concerning one of the
following:
- The system.
- The tests.
- The products: reagents, diluents, desorb solutions, controls and calibrators.

10.1.1 Access to the STATUS SCREENS


2TEST PANEL screen displayed.

ACTIONS RESULTS

" Press the Esc key  The Main Menu is displayed:

Status Loading (...) - Halt


with the cursor on Status.

" Press the  key (Status)  The Status menu is displayed:

System
Tests
Products
Stop Sample Pipetting YES
On-Line Transmission YES
On-Line Printout YES
with the cursor on System.

" Then press one of the following keys for  The SYSTEM STATUS screen is displayed.
the screen required:
 The TEST STATUS screen is displayed.
"  (System)
 The PRODUCT STATUS screen is displayed.
" T (Test)
" P (Product)

" Refer to chapter 10.1.5. to modify the


following options:
Stop Sample Pipetting, On-Line
Transmission, On-Line Printout.

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STATUS and GLOBAL OPTIONS Screens

To exit from the STATUS screens, press the Esc key and the TEST PANEL screen will be displayed
again.

10.1.2 SYSTEM STATUS Screen

10.1.2.1 Description of SYSTEM STATUS Screen

Fig. 1 - SYSTEM STATUS Screen

Legend:

1 Esc Options
The Esc key opens the following window:

Change Date
Change Time
Level Detection Management
Quit

Change Date: see chapter 10.1.2.2


Change Time: see chapter 10.1.2.3
Level Detection Management: changes the option from managed to not managed and vice
versa, see below the description of these two options in point 5
Quit: returns to the TEST PANEL screen

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STATUS and GLOBAL OPTIONS Screens

2 Date and time

3 Name of the screen

4 Temperatures measured by the STA Compact®.

Needle No.3, measurement block: the temperature must be within 36.5°C to 37.5°C.

Otherwise : - the temperature is displayed in red


- the STA Compact® stops the measurements

Product drawer: the temperature must be within 15°C to 19°C.

Otherwise : - the temperature is displayed in red


- each result is printed with the following warning message:
“Product drawer: Temperature out of limit”

5 Level detection option for each needle: No.1 (samples), No.2 and No.3.

Not managed (displayed in red):


- The level detection works but the software does not warn the operator that the liquids are not
detected.
- The level detection does not work. The STA Compact® works without level detection (the
probe goes to the bottom of the tube or the vial).
In both cases, each result is printed with a warning message to the operator that the level detection
is not managed.

Managed (displayed in black):


- The software warns the operator with error messages for all level detection problems.

The operator can change the options of the level detection from managed to not managed (and
vice versa), see chapter 10.1.2.4.

6 Number of functioning hours of STA Compact® since the last service call.

7 Number of functioning hours of STA Compact® since the STA Compact® installation.

8 Number of remaining cuvettes (displayed in black).


When 20 cuvettes or less remain, this number is displayed in red.

9 Quantity of STA<-Cleaner Solution remaining (displayed in black).


When 50 milliliters or less remain, this number is displayed in red.

10 Availability before the next maintenance (expressed in %).

When the availability reaches 0, a message warns the operator. If the maintenance is not done, the
number becomes negative and is displayed in red.
When the value of the field Syringe is 0:
- Each result is given with an alarm indicating that the maintenance has not been done.
- The Syringe Teflon tip must be replaced.

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When the value of the field Light source (not available on STA Compact®CT) is 0:
- The results have no specific alarm because the light intensity level is always controlled.
- It is advised to change the Halogen lamp as a preventive measure.
11 No piercing kit. If a cap piercing kit is installed, please refer to the corresponding notice.

12 Version of the STA Compact® software.

10.1.2.2 Modifying the Date

2SYSTEM STATUS screen, with .

ACTIONS RESULTS

" Press the Esc key (Options)  The following window is displayed:

Change Date
Change Time
Level Detection Management
Quit
with the cursor on Quit.

" Press the L key (Change Date), then  The TYPE NEW DATE window is displayed:
confirm with the  key
TYPE NEW DATE
Format mm*dd*yyyy
 The separator key (*) and the date display
format are defined at the page 2 of the
GLOBAL OPTIONS screens, see description
chapter 10.2.3.4.

" Type the new date with respect to the  The date is updated.
displayed format and separator then
 The following window is displayed:
confirm with the  key.
For this exampletype the month
(2 characters), the displayed separator, the Change Date
day (2 characters), the displayed separator, Change Time
the year (4 characters), then confirm with Level Detection Management
the  key. Quit
with the cursor on Quit

10.1.2.3 Modifying the Time

2SYSTEM STATUS screen displayed.

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ACTIONS RESULTS

" Press the Esc key (Options)  The following window is displayed:

Change Date
Change Time
Level Detection Management
Quit
with the cursor on Quit.

" Press the K key (Change Time), then  The TYPE NEW TIME window is displayed:
confirm with the  key
TYPE NEW TIME
Format hh*mm*ss
The separator key (*) and the date display
format are defined at the page 2 of 2 of the
GLOBAL OPTIONS screens, see description
chapter 10.2.3.4.

 Type the new time with respect to the  The time is updated.
displayed format and separator then  The following window is displayed:
confirm with the key.
For this example: type the hour
(2 characters), the displayed separator, the Change Date
minutes (2 characters), the displayed Change Time
separator, the seconds (2 characters), then Level Detection Management
confirm with the  key. Quit
with the cursor on Quit.

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10.1.2.4 Modifying the Level Detection Management

2SYSTEM STATUS screen displayed, level detection option: managed.

ACTIONS RESULTS

" Press the Esc key (Options)  The following window is displayed:

Change Date
Change Time
Level Detection Management
Quit
with the cursor on Quit.

" Press the K key (Level Detection  The LEVEL DETECTION MANAGEMENT
Management) then confirm with the window is displayed:
 key
LEVEL DETECTION MANAGEMENT
Needle No.1
Needle No.2 Controlled/Not Ctrl.
Needle No.3 Esc Quit

with the cursor on Needle No.1.

" Press the  key to suppress level detection  The following warning window is displayed:
for needle No.1 (samples)
WARNING:
Needle No.1 Level Detection
Management
INHIBITION OF CONTROL REQUESTED
You must DECANT ALL THE TUBES in the
sample drawer
All results will be flagged
Cancel CONFIRM

with the cursor on CANCEL.

" Press the J key to CONFIRM and validate  The message “not managed” appears.
with the  key
 The software does not warn the operator
" Decant all the tubes in the sample drawer when liquids are not detected. All the results
are flagged with an alarm code.

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ACTIONS RESULTS

" Press the L key to Needle No.2, then  The following warning window is displayed:
confirm with the  key to suppress level
detection for needle No.2 WARNING:
Needle No.2 Level Detection
Management
INHIBITION OF CONTROL REQUESTED
All results will be flagged
CANCEL CONFIRM

with the cursor on CANCEL.

" Press the J key to CONFIRM  Then press the  key to validate.
 The software does not warn the operator
when liquids are not detected. All the results
are flagged with an alarm code.

" Press the L key to Needle No.3, then  The following window is displayed:
confirm with the  key to suppress level
detection for needle No.3 WARNING:
Needle No.3 Level Detection Management
INHIBITION OF CONTROL REQUESTED
All results will be flagged
CANCEL CONFIRM

with the cursor on cancel.

" Press the J key to CONFIRM, then press  The message “not managed” appears.
the  key to validate  The software does not warn the operator
when liquids are not detected. All the results
are flagged with an alarm code.

In order to inform the operator that level detection has been supressed for a needle, a warning
message is displayed upon opening of the sample drawer or upon opening of the product drawer.

To reactivate level detection: follow the above procedure.

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10.1.3 Description of TEST STATUS Screen

NOTE This screen corresponds to a consistency check between the workload for STA Compact®
(number of tests to perform except the blocked ones) and the needs to complete this task:
- Products (cuvettes, washing solution, controls, calibrators, diluents, reagents, ...)
- Validated calibrations
- And validated quality controls

It is displayed:
- Upon request from the Status menu
- During closing of the drawers (sample and product), see chapter 6.12
- When tests are inserted in the Patient Files from the FILE PROCESSING screens (Confirmation /
Printout / Transmission menu or TEST PANEL), see description chapter 8.3
- When rerunning tests (see chapters 8.3 and 8.7.4)
- When running calibrations, see chapter 7.3.1
- When running quality controls, see chapter 9.4.1
If after the consistency check, one of the needs to complete the workload is not met, then all the
sample pipetting (sample plasma, controls and calibrators) will be blocked and the “BLOCKED SAMPLE
PIPETTING” message will be displayed in white on a red background at the bottom of the screen.

In this case, the operator can reactivate the sample pipetting for the tests which meet all the
conditions (correct calibration, quality control, volume and stability for all requested products) by
pressing the ESC key and then the Y key.
Otherwise, if after the consistency check, all conditions are met, then the sample pipetting continues
or starts again, the ESC key returns directly to the TEST PANEL screen.
This screen is updated every 5 minutes.

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Fig. 2 - TEST STATUS Screen

Legend:

1 F6 Prints the data related to this screen


Esc Returns to the TEST PANEL screen, whether:

- Directly if the “BLOCKED SAMPLE PIPETTING” message is not displayed at the bottom of the
screen
- Or after a confirmation window if the “BLOCKED SAMPLE PIPETTING” message is displayed at the
bottom of the screen (see description chapter 6.12)

2 Date and Time

3 Name of the screen

4 For the cuvettes and the washing solution (STA< - Cleaner Solution), quantity currently available

5 For the cuvettes and the washing solution (STA< - Cleaner Solution), quantity theoretically
remaining once all the assays have been performed.
When the values are positive (surplus), they are displayed in grey. When the values are
negative (quantity not sufficient to perform all the assays), they are displayed in red.

6 Total number of tests (including the blocked tests) that the STA Compact® has to run without
taking into account calibrations and controls

7 Number of pending tests

8 Estimated end of work (hour and minutes) for the required tests, if all necessary products
(reagents, diluents, controls, Desorb Solutions, or calibrators) have been loaded and if their
stability is not expired. The estimated end of work is updated every 5 minutes, according to the
loading of the products.

For each product (reagents, diluents, Desorb Solutions, controls, or calibrators):


9 Alphanumeric identification of the product.
The symbol ( ) indicates that the product stability may end before the end of the tests.

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10 Name of the product.

11 Indication of the positioning zone of the products: D1 (sample drawer for the diluents) or D2
(product drawer for all the other products). When there are more than one vial for the same
product, the volumes of the vials are added and only the addition will be displayed with the recall
of the positioning zone

12 Margin: usable quantity theoretically remaining once all the assays have been performed.
The margin includes all the vials of the given product that are in the drawer.
A positive value indicates a surplus, it is displayed in grey
A negative value indicates missing products, it is displayed in red. These products must be
reloaded to allow the STA Compact® to finish all the tests.

In case of negative values, the zones: 9 (identification) and 10 (name), are also displayed in red.

The products are sorted by priority order:


- Products with negative margin (and eventually with stability problem)
- Products with risk of stability overdue
- Other Products
When the TEST STATUS screen is displayed, the cursor is positioned on the first product. The
keys L andK move the cursor from one product to the other one and so view all of them.

For each type of test:


13 Abbreviation of the test.

14 Calibration status:
- Not done
- Running
- Confirm (to be confirmed)
- Control out (control out of range)
- Validated

15 Quality control status:


- Running
- Out of range
- Validated
- Not done

When the test STATUS SCREEN is displayed, the cursor is positioned on the first product.
The J key moves the cursor to the test status area, then the L and K keys move the cursor from
one test to the other one.

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16 The “BLOCKED SAMPLE PIPETTING” message is displayed in white on a red background at the
bottom of the screen when the sample pipetting is blocked whether:
- Voluntarily by the operator (Stop Sample Pipetting function, see description in chapter 10.1.5.1)
- Or automatically by the STA Compact® after the consistency check; if the required assays cannot
be done

10.1.4 Description of PRODUCT STATUS Screen


The Product Status screen provides information concerning cuvettes and products (reagents,
diluents, desorb solutions, controls or calibrators) on board.

Fig. 3 - PRODUCT STATUS Screen

Legend:

1 Esc Returns to the TEST PANEL


Space bar: Display of the roll lot number and of the number of remaining cuvettes

2 Date and Time

3 Name of the screen

4 Alphanumeric identification of the product as defined in the TEST SETUP screens (see chapter
5.1), normally displayed in blue; it will be displayed in red in case of insufficient volume, liquid
level detection problem or expired stability.

5 Name of the product as defined in the TEST SETUP screens (see chapter 5.1).

6 Position of the product.


D1 = sample drawer, D2 = product drawer.

7 Lot number of the product.


This field remains empty when the product lot number is not managed.

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8 Current total volume of the product.


The STA Compact® takes as starting point the volume of the vial after reconstitution as specified
within the TEST SETUP screens (see chapter 5.1). Yet, this volume can be modified when loading
the product (see chapters 6.5, 6.6 and 6.7).

Subsequently, after each sample has been taken, the vial volume is decreased by the sample
volume as specified in the TEST SETUP screens (see chapter 5.1).
When the volume reaches the Min. Volume specified in the TEST SETUP screens (see
chapter 5.1), then the Min. Volume value is displayed in red as well as the alphanumeric
identification of the product.
If, compared to the theoretical decrease in volume, the STA Compact® does not detect the
liquid level, then the displayed volume is 0 in red; the alphanumeric identification of the required
product is displayed in red too, and the product is not useable.

9 Theoretical stability end for each product specified with the month, the day and the time.

To calculate this value, the STA Compact® uses the stability (t) specified in the TEST SETUP
screens (see chapter 5.1). This stability can be edited during the loading step (see chapters 6.5,
6.6 and 6.7).

From the loading of each product (t) the STA Compact® does the following sum:

t0 + t = T T = displayed stability end.

The displayed color of the stability end and the alphanumeric identification depends on the
following parameters :

Current Date and Time Alphanumeric Stability End (T)


Identification of Product

Up to T - (1 hour) Blue Blue

From [ T - (1 hour ) ] to T Blue Red

After T Red Finished is displayed in red

10.1.5 Options
The Status menu enables the management of the 3 following options:
- Pipetting stop, see chapter 10.1.5.1.
- On-line transmission of the results, see chapter 10.1.5.2.
- Automatic printout of each patient file when all the related tests are done, see chapter 10.1.5.3.

" Select the option using the keys K L


" Press  to change (YES or NO)

10.1.5.1 Stop Sample Pipetting

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This option is automatically set to YES by the STA Compact® if after inserting new assays to run
(sample tubes, controls or calibrations), one of the following conditions is not satisfied:
- Sufficient volume
- No risk of stability overdue
- Calibration done and validated
- Quality control done

The operator may then decide to unblock some tests (see chapter 10.1.3) by changing the option to
NO.
The operator may also use this option to stop the sample pipetting by changing the option from NO
to YES. In this case, all sample pipetting (including calibrators and controls) is blocked. However, STA
Compact® finishes the assays in progress for all the cuvettes still on the incubation plate.

10.1.5.2 On-Line Transmission (YES/NO)


When YES is chosen for this option, the results are sent one by one to the host computer as soon
as they are obtained, with respect to the conventions described in chapter 9.4.1.

10.1.5.3 On-Line Printout (YES/NO)


When YES is chosen for this option, the Patient Files are automatically printed as soon as all tests of
the Patient File have been run.

If YES is chosen for this option, the other printouts (printout of a file selection...) can be performed
only according to special conditions.

10.2 GLOBAL OPTIONS Screens


These screens are used to define the parameters specific to the laboratory: address, access, codes,
type of information to be entered into patient files, communication parameters and miscellaneous.

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10.2.1 Access to the GLOBAL OPTIONS Screens

This access is possible only if:


- the STA Compact® is in stand-by mode (no measurements in progress);
- the operator knows the related access code.

2TEST PANEL displayed.

ACTIONS RESULTS

" Press the Esc key  The Main Menu is displayed:

Status Loading (...) - Halt


with the cursor on Status.

" Press the E key (Setup)  The Setup menu is displayed:


" Or press the J key to reach Setup, then
confirm with the  key Tests
Global Options
with the cursor on Tests.

" Press the G key (Global Options)  The following window appears:
" Or Press the L key to reach Global
Options, then confirm with the  key Please enter
your access code:
 : Validate Esc: Quit

" Type your access code, then confirm with  The first screen of GLOBAL OPTIONS
the  key appears (see description below).

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10.2.2 GLOBAL OPTIONS Screen, page 1

10.2.2.1 Description of the GLOBAL OPTIONS Screen, page 1

Fig. 4 - GLOBAL OPTIONS Screen, Page 1 of 2

Legend:

1 Esc Opens the EXIT OPTIONS window (see description, chapter 10.2.5)
PgDn Displays the second page of GLOBAL OPTIONS.

2 Date of last saving of the GLOBAL OPTIONS screens.

3 Name of the screen.

4 Printout parameters (see chapter 10.2.2.2).

5 Definition of the access codes (see chapter 10.2.2.3).

6 Reading parameters of the bar code reader (see chapter 10.2.2.4).

7 Miscellaneous section (see chapter 10.2.2.5).

8 Definition of the arbitrary units (see chapter 10.2.2.6).

10.2.2.2 Printout
Content of the 2 lines of the printout headings. These 2 lines usually identify the laboratory.

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Title 1 Content of the heading first line (34 characters max.).


(34 characters)

Titl e 2 Content of the heading second line (34 characters max.).


(34 characters)

10.2.2.3 Access Codes


The following functions may have a restricted access:
- Test Setup: Modification of test setups, creation or deletion of test setups, updating test setups
- Calibration, Calibration Control,Quality Control:
Run + Confirm: Running of calibrations and quality controls, manual validation of calibrations
Run + Confirm + Forced Confirmation: Running of calibrations and quality controls, manual
validation of calibrations, acceptance of results out of range for calibration controls and quality
controls (in case of predefined limits), access to critical functions : change ranges for controls,
deletion of control values, etc.
- Access to this program: Access to the GLOBAL OPTIONS screens
" For each of these functions, define a 3 letter max. access code.

Before defining these codes, please read carefully chapter 1.5.

10.2.2.4 Bar Code Reading


If the laboratory uses bar code identification for the patient samples, it may happen that it only needs
to read part of the bar code digits. In this case, it is possible to define which digits can be deleted.

Non significant Digit (s) Leading / Ending Number of digits to delete on the left and/or on
the right (1 character)

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10.2.2.5 Miscellaneous

Default Desorb Alphanumeric identification of the Desorb


(8 characters) Solution to use by default at each STA
Compact® startup.

Audible Alarm YES: audible alarm generated during the error


messages
NO: without audible alarm during the error
messages

10.2.2.6 Arbitrary Units


The laboratory can create up to 3 additional units.

Name Unit name (5 characters max.).

Decimal Definition of the number of characters after the


decimal point (1,2 or 3).

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10.2.3 GLOBAL OPTIONS Screen, page 2

10.2.3.1 Description of the GLOBAL OPTIONS Screen, page 2

Fig. 5 - GLOBAL OPTIONS Screen, Page 2 of 2

Legend:

1 Esc Opens the EXIT OPTIONS window, see chapter 10.2.5


PgUP Displays the first GLOBAL OPTIONS screen

2 Name of the screen

3 Communication parameters (see chapter 10.2.3.2)

4 File acquisition parameters (see chapter 10.2.3.3)

5 Definition of the time and date display format (see chapter 10.2.3.4)

10.2.3.2 Communications
The following parameters are used to define the characteristics necessary for a central computer
connection (ASTM Protocol):

Station Number (0...99) Allows host computer to identify the STA Compact® (2
characters).

Baud Rates Transmission speed:


Bauds 300, 600, 1200, 2400, 4800 or 9600 Bauds.

Parity Type of parity: none, even or odd.

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Number of Data Bits Options: 7 or 8.

Number of Stop Bits Options: 1 or 2.

Number of On Error Retries Number of times the STA Compact® sends each frame
after receiving a NACK message. For consistency with
standard E1381-91, this number is set to 6.

Verify Patient Data YES: The first four fields to identify a patient file are sent
by the host computer at the same time as the work list.
These fields can be checked during sample loading (see
File Acquisition chapter 10.2.3.3).
NO: The first four fields to identify a patient file are sent
by the host computer at the same time as the work list.
These fields can not be checked during sample loading
(see File Acquisition chapter 10.2.3.3).

Send Sequence Number Chose YES to send to the host computer the sequence
number the laboratory gives to each file.

10.2.3.3 File Acquisition

1 to 5 items may be used to define each patient file.


The name of each item may have up to 12 characters.
Item No1 (ID) cannot be modified.
Each patient file is always located by its identification (16 alphanumeric characters maximum).
The laboratory may define the items 2 to 5 in order to provide further information. These
information may be the last name, first name, department, physician etc.
Only the defined fields can be used.
The number of authorized characters for each item field is different. This number is indicated in
column Format. The characters may be alphanumerical or numerical. This can be chosen in the field
ID type.

10.2.3.4 Miscellaneous

Time Format Options for the display:


0 - 24h format (17:35:24)
0 - 12h format (05:35:24 p)
The abbreviations (letters) and the separator
may be changed (example: hh: mm: ss).
Possible options for the separator:
/ : - . ,

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Date Format Options for the display:


Day - month - year format
Month - day - year format
Year - month - day format
The abbreviations (letters) and the separator
may be changed (example: dd/mm/yyyy).
Options for the separator:
/ : - . ,

10.2.4 Modification of a Global Option Parameter

10.2.4.1 Generalities

This procedure is possible only if:


- the STA Compact® is in stand-by mode (no measurements in progress)
- the operator knows the access code to the GLOBAL OPTIONS screens

Modification of certain parameters may have very important consequences on:


- the reading of the bar codes used for the sample tubes
- the transmission of results to the host computer.

Parameters displayed in blue or in white can be modified.


Parameters displayed in grey cannot be modified.

With the cursor positioned on the parameter to modify, two options:


Free entry field: no message is displayed at the bottom of the screen, the data and the cursor are
displayed in blue
Multiple-option field: the message “Key DEL = Modification” is displayed at the bottom of the
screen. The data and the cursor are displayed in white.
The Delete key displays the possible options one after the other or in a window (Time format, Date
format, type of printer), see modification procedure below, chapters 10.2.4.3 to 10.2.4.5.

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10.2.4.2 Modification Procedure for a Free Entry Field

2GLOBAL OPTIONS screen displayed (page 1 or page 2), the cursor is positioned on data displayed
in blue.

ACTIONS RESULTS

" Enter the new information on the  New data are displayed.
alphanumeric keyboard, then confirm with  The cursor moves to the next data field.
the  key

10.2.4.3 Modification Procedure for a Multiple-Option Field

2GLOBAL OPTIONS screen displayed (page 1or 2), the cursor is positioned on a white parameter
and the message “Key DEL = Modification” is displayed at the bottom the screen.

ACTIONS RESULTS

" Press the Delete key  The options appear.

" When the selected option is highlighted,  The selected option is displayed.
press the  key
 The cursor moves to the next parameter.

10.2.4.4 Modification of the Time Display Format

2GLOBAL OPTIONS screen, page 2 of 2 displayed. Cursor next to Time Format.


ACTIONS RESULTS

" Press the Delete key  The TIME FORMAT window appears:

TIME FORMAT
Separator
17:35:24
05:35:24 p
International Time
17 H 35 M 24 S
with the cursor on Separator.
Display of the separator key (:) according to
the last choice.

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ACTIONS RESULTS

Selecting the Separator Key

" Press the  key  The available separator keys are displayed in
the following window:

/ : - . ,

" Move the cursor to the required separator  The TIME FORMAT window is displayed with
key the chosen separator key.
" Confirm with the  key

Selecting the Time Display Format

" Press the L key to the required display The TIME ABBREVIATION window is
format. displayed with the cursor on the first letter
of the chosen format.
" Confirm with the  key

Change the abbreviations if necessary:  The TIME FORMAT window appears:


" Type the chosen abbreviation
TIME FORMAT
" Press the  key
Separator
17:35:24
05:35:24 p
International Time
17 H 35 M 24 S

" Press the Esc key  The display is updated. Page 2 of the GLOBAL
OPTIONS screen is displayed.

To modify the time, refer to 10.1.2.3.

10.2.4.5 Modification of the Date Display Format

2GLOBAL OPTIONS screen, page 2 of 2 displayed. Cursor next to Time Format.

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ACTIONS RESULTS

" Press the Delete key  The DATE FORMAT window appears:

DATE FORMAT
Separator
06/08/1993
1993/08/06
08/06/1993
For Year = 1993
Month = 8
Day = 6
with the cursor on Separator.
Display of the separator key (:) according to
the last choice.

Selecting the Separator Key

" Press the  key  The available separator keys are displayed in
the following window:

/ : - . ,

" Move the cursor to the required separator  The DATE FORMAT window is displayed with
key the chosen separator key.
" Confirm with the  key

Selecting the Date Display Format

" Press the L key to the required date display  The DATE ABBREVIATION window is
format displayed with the cursor on the first letter
of the selected format.
" Confirm with the  key
(j or d= day, m = month, a or y = year)

Change the abbreviations if necessary:  The DATE FORMAT window appears:


" Type the chosen abbreviation
DATE FORMAT
" Press the  key
Separator
06/08/1993
1993/08/06
08/06/1993
For Year = 1993
Month = 8
Day = 6

" Press the Esc key  The display is updated. Page 2 of the GLOBAL
OPTIONS screen is displayed.

To modify the date, refer to 10.1.2.2.

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10.2.5 Saving Parameters from GLOBAL OPTIONS Screens

2GLOBAL OPTIONS screen (Page 1 or 2) displayed.

ACTIONS RESULTS

" Press the Esc key  The EXIT OPTIONS window is displayed:

EXIT OPTIONS
Saving before quitting
Quit without saving
Do not quit
with the cursor on Save before quitting.

" Press the  key  The modifications are saved.


 Display ot the STA Compact® logo and
check of several parameters.
If a problem is found, an error message is
displayed.
 Back on the TEST PANEL.

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Table of contents

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

11.1 Displayed messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1


11.1.1 Error messages with error number . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
11.1.2 Blocking error messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
11.1.3 Message : Optical module lamp, the level is too low . . . . . . . . . . . . . . . 8

11.2 Problems relating to the cuvettes . . . . . . . . . . . . . . . . . . . . 8

11.3 Problems with Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10


11.3.1 List of Points to Be Checked . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
11.3.2 Typical Problems with Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

11.4 Problems Related to the Test Execution . . . . . . . . . . . . . . 13

11.5 Other Problems Found . . . . . . . . . . . . . . . . . . . . . . . . . . . 14


11.5.1 Power-on Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
11.5.2 Problems regarding screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

11.6 Problems regarding tube reading . . . . . . . . . . . . . . . . . . . . 15

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Troubleshooting

11 Troubleshooting

11.1 Displayed messages


Error messages with an error number, see chapter 11.1.1.
Blocking error messages, see chapter 11.1.2.

An Emergency Stop can be performed by pressing ALT - F10. This will access the USER
MAINTENANCE menu.
Tests that are were in process prior to the emergency stop will be rerun when the analyzer restarts.

The power off procedure of the STA Compact® is described in chapter 3.6.2.

11.1.1 Error messages with error number


Description:

Management of Arm #2 ) Type of problem

Error 07.30.30 ) Error number

Removal ) Cause of error


Missing Cuvette. )

Esc = Continue ) Solution

Follow the instructions given by the STA Compact® and if the problem persists, call your local
authorized Service Representative

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Non-exhaustive list of error messages:

Error Number Item(s) concerned Procedure


Beginning with:

01 Washing Solution " Replace the bottle of STA<-Cleaner


Solution, see chapter 3.5
" If the problem persists, call your local
authorized Service Representative

01 Vacuum Reservoir " Proceed with the cleaning of the


washing wells, see chapter 4.2.4
" If the problem persists, call your local
authorized Service Representative

01 Incubation " Check the Peltier reservoir, see


product drawer chapter 4.2.7
" If the problem persists, call your local
authorized Service Representative

01 Cleaner Solution " Check that the closing of the switch


Reservoir detecting the presence of the bottle is
Check presence heard when it is replaced, see
chapter 3.5
" If the problem persists, call your local
authorized Service Representative

01 Used Liquid Container " Check that the closing of the switch
Check presence detecting the presence of the bottle is
heard when it is replaced, see
chapter 3.5
" If the problem persists, call your local
authorized Service Representative

01 Used Liquid Container " Check the liquid level in the bottle of
Check maximum allowed used liquid, replace if necessary, see
volume chapter 3.5
" If the problem persists, call your local
authorized Service Representative

01 Cuvette Disposal Drawer " Check that the cuvette disposal drawer
Check presence is pushed fully home
" If the problem persists, call your local
authorized Service Representative

02 Cuvette Missing " Replace the roll of cuvettes, see


chapter 3.3
" If the problem persists, call your local
authorized Service Representative

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Troubleshooting

Error Number Item(s) concerned Procedure


Beginning with:

02 Loading Station " See chapter 11.2


Measuring Station
Shuttle missing

03 Rack Communication Follow the instructions:


" Press the Esc key
" Or Press ALT - F10 to perform an
emergency stop
" Switch the STA Compact®off
" Switch the STA Compact® on again
" If the problem persists, call your local
authorized Service Representative

04 Measurement Block Follow the instructions:


Communication
" Press the Esc key
" Or Press ALT - F10 to perform an
emergency stop
" Switch the STA Compact®off
" Switch the STA Compact® on again
" If the problem persists, call your local
authorized Service Representative

05 System Host Follow the instructions:


Communication " Press the Esc key
" If an accession or test transmission
number is not recognized by the host
computer, check the numbers on the
STA Compact® and the host computer
" In case of file error, restart the
transmissions from the STA Compact®,
see chapter 8.4
" If the problem persists, call your local
authorized Service Representative

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Error Number Item(s) concerned Procedure


Beginning with:

06 Management of Follow the instructions, depending on the


Arm # 1: error messages:
Movement P
" Press the Esc key
X
Y " Or Press the ALT+ F10 keys
Z1
" Switch off the STA Compact®
Z2
Z3 " Move manually the related axis of the
pipetting head:
Uncompleted X (left-right movement),
movement Y (front-rear movement),
Z1 (needle#1 up-down),
Impossible Z2 (needle#2 up-down),
mouvement Z3 (needle # 3 up-down)
" Switch the STA Compact® on again
" If the problem persists, call your local
authorized Service Representative

06 Management of Arm #1 Follow the instructions, depending on the


(Pipetting Head) error messages:
The needle must be
" Press the Esc key
bended
Check the needle No.X " Or Press the ALT+ F10 keys
" Switch the STA Compact® off
" Switch the STA Compact® on again
" If the problem persists, call your local
authorized Service Representative

06 Management of Arm #1 Follow the instructions:


(Pipetting Head) " Press the Esc key
No. Level Detection
" Check the liquid level in the vial or in the
tube of plasma
" Replace if necessary the vial or the tube
of plasma
" Make sure that level detections are
managed, see chapter 10.1.2.1
" If the problem persists, call your local
authorized Service Representative

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Troubleshooting

Error Number Item(s) concerned Procedure


Beginning with:

07 Management of Arm#2 Follow the instructions, depending on the


(Suction Head). error messages:
" Press the Esc key
Movement Y " Or Press the ALT+ F10 keys
Movement Z
" Switch the STA Compact®off
Impossible " Move manually the related axis on the
movements suction head:
Y (front-rear movement),
Uncompleted Z (up-down)
movements
" Switch the STA Compact® on again
" If the problem persists, call your local
authorized Service Representative

07 Management of Arm#2 Follow the instructions, depending on the


(Suction Head) error messages:
" Press the Esc key
The suction vacuum is not
operating correctly " Or Press the ALT+ F10 keys
" Proceed with the suction tip cleaning
(see chapter 4.2.8) or if necessary with
replacement of the sucton tip (see
chapter 4.5.4)
" If the problem persists, call your local
authorized Service Representative

07 Management of Arm#2 " See chapter 11.2


(Suction Head)

Cuvette Missing

08 Start of test Follow the instructions:


Problem reading file " Press ALT- F10
Test.dat
Calib.dat " Switch the STA Compact® off
Cq.dat
" Switch the STA Compact® on again
" If the problem persists, call your local
authorized Service Representative

08 Start of test Follow the instructions:


Product Missing " Press the Esc key
" Load the missing products

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Error Number Item(s) concerned Procedure


Beginning with:

09 Axis Z Communication Follow the instructions:


" Press the Esc key
" Or Press simultaneously the
ALT+ F10 keys
" Switch the STA Compact®off
" Switch the STA Compact® on again
" If the problem persists, call your local
authorized Service Representative

10 Measurement Follow the instructions:


Management " Press the Esc key
Incorrect channel " Or Press simultaneously the
ALT+ F10 keys
Motor too slow
" Switch the STA Compact®off
Incorrect conversion " Switch the STA Compact® on again
" If the problem persists, call your local
authorized Service Representative

10 Measurement Follow the instructions:


Management " Press the Esc key
11 System Boot " Run the lamp test of the User
Optical module Maintenance, see chapter 4.7.6.6.
lamp does not work " If the error message remains, replace
the lamp, see chapter 4.5.5
Optical module
lamp, level is too low " If the problem persists, call your local
authorized Service Representative

10 Measurement Follow the instructions:


Management " Press the Esc key
11 System Boot " Clean or replace if necessary the air
filter of the optical module (see
Optical module respectively chapter 4.2.1 and 4.4)
temperature is too high " If the problem persists, call your local
authorized Service Representative

11 System Boot Follow the instructions:


" Press the Esc key
Software Versions
" Or Press ALT- F10
RAM/ROM state
" Switch the STA Compact®off
Chronometry Calibration, " Switch the STA Compact® on again
" If the problem persists, call your local
Chromogemic
authorized Service Representative
Calibration

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Troubleshooting

Error Number Item(s) concerned Procedure


Beginning with:

49 MAINTENANCE Follow the instructions:


" Press the Esc key
" Or Press ALT- F10
" Switch the STA Compact®off
" Switch the STA Compact® on again
" If the problem persists, call your local
authorized Service Representative

51 SAMPLE LOADING Follow the instructions:


" Remove what is blocking the opening
Sample Drawer (or the closing) of the drawer
Jammed
" Press the  key
" If the problem persists, call your local
authorized Service Representative

52 PRODUCT LOADING, Follow the instructions:


" Remove what is blocking the opening
Product Drawer (or the closing) of the drawer
Jammed
" Press the  key
" If the problem persists, call your local
authorized Service Representative

11.1.2 Blocking error messages


Type 1: «Run time error...” appears in a window
or: “Disk error...” appears anywhere on the screen
or: “Fatal error...” appears anywhere on the screen

Type 2: “HFXX error...” appears in yellow at the bottom of the screen


“HSXX error...” is displayed in black on a grey background
Procedure if a type 1 or type 2 message appears:
" Write the error number
" Press the Alt and PrtSc key to print out the screen
" Switch the STA Compact®off
" Switch the STA Compact® on again
" If the problem persists, call your local authorized Service Representative and forward the
information of the screen print out

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Troubleshooting

11.1.3 Message : Optical module lamp, the level is too low


(not available on STA Compact®CT)
Description:

Optical module lamp,


the level is too low

Esc = Cancel this window

Procedure:
" Press the Esc key to close the message
" Replace the lamp (see chapter 4.5.3)

The photometric tests will resume only if the lamp has been replaced.

11.2 Problems relating to the cuvettes


ˆ Example 1:

MANAGEMENT OF ARM #2
Error 07.30.30
REMOVAL
Missing cuvette
Esc=Continue
" Press the Esc key to delete the error message.

When the STA Compact® goes to standby mode (no more measurement in progress), the following
message is displayed:

Start of test
Error 08.20.00
CUVETTE ERROR
At least one cuvette is still on
the measuring block
How do you want
to remove it?
F1=Automatic F2=Manual

Possible functions:

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Troubleshooting

F1: Arm No. 2 (Suction Head) tries again to pick up the cuvette.

In case of defective suction tip or defective cuvette, this operation is impossible and may lead to
jammed situations.

F2: The operator can open the transparent panel and manually remove the cuvette which cannot
be automatically picked up (with usual precautions to biohazardous material).

Close the transparent panel after this procedure to continue testing.

Likely cause(s) Possible solution(s)

 Suction tip defective " Clean the suction tip (see procedure
chapter 4.2.8)
" Replace it if necessary (see procedure
chapter 4.5.4)

 Cuvette in poor condition, for example: " Replace the roll of cuvettes
broken wings.

 Bead present in a measurement or " Access the User Maintenance menu (see
incubation well, causing the cuvette to be chapter 4.7.1)
wrongly positioned
" Remove the transparent panel
" Remove the bead

 Suction head incorrectly positioned on the " Call your local authorized Service
cuvette. Representative

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Troubleshooting

ˆ Example 2: “Shuttle missing - loading station”

Likely cause(s) Possible solution(s)

 Cuvetttes jammed in loading system. " Press the Esc key


" Switch the STA Compact®off
(see chapter 3.7)
" Pull the cuvette roll drawer
" If the cuvette roll drawer cannot be
opened, remove the bottle of the
STA< -Cleaner Solution, remove the bottle
of used liquid, remove the bottle support
in order to access the cuvette loading
system
" Remove the cuvettes by unwinding the
take-up reel
" Use a thin screwdriver or pliers to remove
all the cuvettes from the loading system

RISK OF INJURY
In order to avoid risks of injuries by the
pneumatic jack:
- Do not use fingers.
- Use a tool to remove the cuvettes jammed
in the loading system.

" Remove all cuvette debris


" Replace all items
" Switch the STA Compact® on again
" If the problem persists, call your local
authorized Service Representative

 Shuttle detection switch faulty " Call your local authorized Service
Representative

11.3 Problems with Results

11.3.1 List of Points to Be Checked


If a problem is found in the results, the following points should be checked:
1 Check that mechanical and robotic items are operating satisfactorily

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Troubleshooting

2 Check the rinsing volumes: run the function Rinsing Pump of User Maintenance menu (see
chapter 4.7.2)

3 Run a quality control and compare the result with the previous results

4 Check the samples for:


- Poor centrifugation
- Insufficient volume
- Presence of clots or micro-clots
- Presence of bubbles, etc.

5 Verify the test setting: in the Test Setup menu, check the configuration of the test(s) causing a
problem and compare with the test settings recommended by Diagnostica Stago.

6 Check the reagents:


- Reagent or reagents incorrectly reconstituted, etc.
=> In this case, load a new vial of reagent.

7 Run a quality control for a major test and compare the result to the previous results

8 Check the other routine tests run on the same sample

9 Check that the appropriate weekly, monthly and quarterly maintenance has been carried
out

11.3.2 Typical Problems with Results


The examples shown below are expressed in clotting time and refer to 3 mixed routine tests
(patient by patient).

PT PTT Fibri- Likely Possible Solution(s)


(Time) (Time) nogene Cause(s)
(Time)

OK Short OK  1st: " Check the rinsing of needle No.2 (see


or Needle No.2 procedure chapter 4.7.2.2)
long Incorrect
" Pass the stylet through the needle No.2
pipetting
to unblock it (see procedure chapter
4.2.4)
" Pass the stylet through the needle No.3
to unblock it (see procedure chapter
 2nd: 4.2.4)
Contamination " Check the suction in washing well No.3
of needle No.3 (see procedure for cleaning washing wells
in chapter 4.2.4)
" Call your local authorized Service
Representative

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Troubleshooting

PT PTT Fibri- Likely Possible Solution(s)


(Time) (Time) nogene Cause(s)
(Time)

Short Short OK  Contamination " Pass the mandrel through the needle
of needle No.3 No.3 to unblock it (see procedure
chapter 4.2.4)
" Check the suction in washing well No.3
(see procedure for cleaning washing wells
in chapter 4.2.4)
" Replace the vial of STA<- DESORB U.
" Call your local authorized Service
 STA< Desorb Representative
U contamined

OK OK Long  Sample " Check the rinsing of needle No.1 (see


incorrectly procedure chapter 4.7.2.2)
pipetted " Pass the mandrel through needle No.1
(dilution) to unblock it (see procedure chapter
4.2.4)
" Call your local authorized Service
Representative

Short Short Short  Needle No.3 " Check the rinsing of needle No.3 (see
or or or incorrect procedure chapter 4.7.2.2)
long long long pipetting " Pass the mandrel through needle No.3
to unblock it (see procedure chapter
4.2.4)
" Replace the Teflon tip of the syringe:
(see procedure in chapter 4.3)
" Call your local authorized Service
Representative

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Troubleshooting

11.4 Problems Related to the Test Execution

Problem Type Likely Cause(s) Possible Solution(s)

For a selected test, analyses  Test has been blocked by Unblock the test (see
are not run. means of the File procedure chapter 8.7.3)
Modification menu (see
" View the TEST STATUS
chapter 8.7.3).
screen: the missing
Block is displayed in red on
products are displayed in
the TEST PANEL instead of
red (see chapter 10.1.3)
the result for this test.
" Load the missing products
 Products are missing to run if necessary
the test.
" View the TEST STATUS
 For this test, the calibration
screen, the calibration
is not confirmed.
status for the selected test
 For the selected test, no is not: Validated (see
quality control has been description chapter 10.1.3)
run for more than
" Run the calibration of the
24 hours.
selected test
" View the TEST STATUS
screen, the quality control
status for the selected test
is not: Validated (see
description chapter 10.1.3)
" Run a quality control for
each selected test

None of the assays is run.  The sample pipettings have " Load if necessary the
been blocked whether by missing products (see the
the Stop Sample list in the TEST STATUS
Pipetting function of the screen)
Status sub-menu (see
" Run the missing
description chapter
calibrations (see the list in
10.1.5.1) or from the TEST
the TEST STATUS screen)
STATUS screen (see
description chapter 6.12). " Run the missing controls
(see the list in the TEST
STATUS screen)

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11.5 Other Problems Found

11.5.1 Power-on Problems


Problems Observed Likely Causes Possible Solutions

No response from keyboard  The power cord is not " Connect the power cord
and STA Compact® does not connected. correctly
start.
 The wall socket is not " Plug the STA Compact®
active. in elsewhere

 The main fuses have " Replace the main fuses


blown. (see chapter 4.5.6)

 The analyzer is defective. " Call your local authorized


Service Representative

11.5.2 Problems regarding screen


Likely causes:
- A strong electromagnetic field may be interfering with the screen functioning.
If problems, call your local authorized Service Representative.

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Troubleshooting

11.6 Problems regarding tube reading


 Existing labels must be completely covered when applying new labels.
 Do not use damaged labels
 Tubes must be clean before attaching lables to them.
 The bar codes must conform to the following criteria:
:

Legend:

1 White zone = 15 mm

2 55 mm max.

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REFERENCE MANUAL A
Safety appendix

A Safety appendix
A copy of the Material Safety data Sheet for the coolant (Frigoporteur T1) used in the STA Compact®
is attached.

Formulation of the Frigoporteur T1 coolant may use a pink dye or a blue dye.
The solutions are compatible and may be mixed.

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A REFERENCE MANUAL
Safety appendix

A-2
0931033L - July 2009
PROFROID I n d u s t r i e s S. A. S
Z.I. des Paluds 178, rue du Fauge 13782 AUBAGNE Cedex
tél : +33 4 42 18 05 00 - FAX : +33 4 42 18 05 07

IN CASE OF EMERGENCY: Poison Center Paris +33 1 40 05 48 48

SAFETY DATA SHEET

Presentation and writing rule according to 2001/58/EC directive


to apply 1999/45/EC directive.

FRIGOPORTEUR T1

1/ Identification of the material substance preparation


. Main function:
Antifreeze

2/ Composition/information on ingredients
. Substance contributing to danger
Monoethylenglycol(CAS107.21.1) :Xn R22 -content 20-40%.weight by weight
Methanol (CAS-67.56.1) F and T :R 11- 23/24/25;R39/23/24/25 content 2.5-5%weight by weight
. Substances classified as "dangerous" -

3/ Hazards identification
Preparation classified as dangerous according to 1999/45/EC Directive,

Kit hazard classification: Hazardous substance (labelling)


Non-dangerous goods (transport) Xn

Labelling information:
Hazard Symbol : Xn-harmful
Risk phrases: R20/21/22: Harmful by inhalation, in contact with skin and if swallowed.
R68/20/21/22: Harmful: possible risk of irreversible effects through inhalation,
in contact with skin and if swallowed.
Safety phrase: S36/37: Wear suitable protective clothing and gloves.

KEEP AWAY FROM C H I L D R E N !

FRIGOPORTEUR T1 p 1/4 Version 1.3 updated November 07, 2006


4/ First-Aid Measures
In case of doubt, or if symptom persists always call a physician,
DON'T GIVE ANYTHING TO INGEST TO AN UNCONSCIOUS PERSON

In case of ingestion or inhalation:

If the victim is unconscious, move him to a lateral safety position.

.In case of contact with eyes:


Wash eyes immediately with copious quantities of water for at least 15 minutes while maintaining
eyelids open. If irritation persists or in case of visual disturbance, please consult an ophtalmologist.
.In case of contact with skin:
Remove contaminated clothing. Wash copiously with water and soap
for at least 15 minutes.
If skin lesion is observed or if the contamination area is large, consult a physician.
.In case of excessive inhalation:
Allow individual to rest in fresh air and consult a physician.
.In case of ingestion:
Consult a physician.

5/ Fire-fighting Measures
. Fire or explosion hazard: liquid with flash point over 55° C
. Fire-fighting equipment:
- recommended: CARBON DIOXYDE (CO2) or POWDER
- do not use: DIRECT WATER SPRAY
. Protective measures while fire-fighting:
Use autonomous breathing equipement and wear protective clothing
. Other recommandations: In case of fire, do not breathe the emitted fumes.

6/ Accidental release Measures


Wear appropriate personal protective equipment as specified in section 8.

. To protect the environment: Avoid direct discharge.


. Method for cleaning: use sand or a universal agglomerating product (cf. point 13).

7/ Handling and Storage


Keep this product in its original container, tightly capped, in a cool and ventilated area.

FRIGOPORTEUR T1 p 2/4 Version 1.3 updated November 07, 2006


8/ Exposure controls/Personal protection

Watertight glasses Breathing mask ‰


Watertight gloves ‰ work in a well ventilated area

Protective clothing ‰
Hygienic measures : Do not eat, drink or smoke when you use this product
Wash hands thoroughly when finished
Biological limit values: not available.
Engineering controls: not available.
Australian exposure standards: not available.

9/ Physical and chemical properties

aspect Limpid liquid specific gravity (at 20°C) 1.03 (+/- 0.03)
colour Pink .
odor characteristic water solubility miscible

Boiling Point >100°c pH 7.95-8.15


freezing point -17°c

10/ Stability and reactivity

Product must be used outside or in a ventilated area and kept away from fire.

Incompatibility: keep product away from heavy acids and oxidizing agents

11/ Toxicological information


Overexposure can develop moderate ocular irritation
contact with eyes
contact with skin Long or repeated exposure can develop skin irritation

Under normal conditions of use, the product is not irritating to the respiratory tract
inhalation

Accidental ingestion of small amounts of the product can develop


ingestion
transitory hepatic-gastric problems

12/ Ecological information

. Degradation: this biodegradable product is destined to be treated in a water


purification plant
. Ecotoxicity and bioaccumulation:
This product is not toxic for aquatic organisms.

FRIGOPORTEUR T1 p 3/4 Version 1.3 updated November 07, 2006


13/ Disposal Considerations
. Avoid direct spills in a natural environment
. Dispose of packaging according to the regulations in force
. Incinerate in an authorized installation

14/ Transport information


by road or rail
by sea
by air NOT REGULATED
n° O.N.U

15/ Regulation information


Classification and label according to 1999/45/EC directive
Hazard Symbol: Xn - harmful
Risk phrases: R20/21/22, R68/20/21/22
Safety phrase: S36/37

Text for R- and S- phrases: see section 3.

Additional Australian regulatory information:


SUSDP: not relevant
AICS: not relevant.

16/ Other information


Contains Bitrex which can cause vomiting if ingested

This sheet completes the technical instructions but does not replace them
and does not give guaranteed or insurance data on the product properties.
This information is given according to our technical knowledge on the product
for the indicated date.
User's attention is drawn on the possible risks incurred
when a product is used for purposes other than those for which it has been designed.
This sheet does not, in any case, prevent the user from knowing
and following the whole regulatory texts related to his activity.
It is the user's responsability to determine the suitability of this information and to ensure that all
appropriate safety precautions are respected. We accept no responsability for indirect damages.

Modifications: general revising.

FRIGOPORTEUR T1 p 4/4 Version 1.3 updated November 07, 2006


REFERENCE MANUAL
Index

A
Access codes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-16
Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-23, 5-41
Audible alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-17
List of alarms associated to results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-10
alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-41
ASTM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-22, 10-18
Communication parameters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-18
Communication protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-14
Connexion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-22
Host computer communications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-88
Automatic identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8, 6-13, 6-20
Bar code identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9, 6-13
Automatic rerun . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-15, 9-10
Average. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7

B
Bar code
Problems regarding bar code reading . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-15
Bar code test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-62

C
Calculated Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-40
Calibrator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-17, 5-18, 5-19, 6-1, 6-13, 6-15
Clot. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Colorimetry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-18, 2-20, 2-21
Cum
Cum daily . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5
Cum monthly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6
Cuvette disposal bag. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15
Cuvette disposal bag replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-14
Cuvette rolls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-21
Cuvettes
Number of cuvettes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-21
CV (Coefficient of variation). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1

D
Dates
Date format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-20

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Dates of recent maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-79


Modifying the date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-4
Modifying the system date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Decontamination
Decontamination procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-55
Decontamination solution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Dependent Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-34
Determination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10, 5-19
Duplicate determination. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-8, 8-11, 8-31
Single determination. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-11, 8-31
Dilution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3, 5-17, 5-25
Drawer
Product drawer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-16
Drawers
Cleaning drawers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8
Sample drawer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15

E
Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4, 3-9, 3-17, 11-1, 11-7
Error history . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-86
Error messages
Description of an error window. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1
Error messsages
Problems regarding tube reading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-15

F
Fuses
Location of the fuses. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-50, 4-51
Replacement of the fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-49, 4-51

G
Global options. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-13

I
Immunology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-18, 2-20, 2-21
Incubation-measurement zone. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14
INR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10, 5-12, 5-22, 7-4, 7-11, 7-44

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ISI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4, 7-4, 7-11, 7-44

L
Level detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14, 10-6
Loading
Generalities. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
Loading the roll of cuvettes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8
Loading the Washing Solution Bottle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-16
Product loading. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5, 6-8, 6-13
Sample loading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6, 6-17, 6-20

M
Main Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-34
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
Preventive maintenance schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
Management
Level detection management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2, 10-6
Liquid level detection management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
Product management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-20
Sample management. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-20
Manual Identification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11, 6-15, 6-18, 6-28
Manual identification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8, 6-13, 6-20

N
Note . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-12, 8-13

O
Offset corrector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-19
Optical density . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4

P
Patient files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Customer printout of validated files. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-32
Routine mannagement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6

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Sense of color codes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3


sense of color codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-9
Standard note . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-12, 8-13
Standard notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-13
Photometric . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
Photometry. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4, 2-21
Photometry Graphics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-80

Q
QNS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8, 8-9
Quality Control
Description of the quality control screens . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
Level of quality control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-13
Range of acceptable results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-11

R
Redilution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8, 5-12
Reference time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-8, 7-14, 7-19
Restoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-34
Results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10, 5-41
Choice of unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-17
Graphic display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-65
Results display. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
Results status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-10
Transmission of results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-21
Roll . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8, 3-13
Running control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-9, 9-17

S
Samples. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-39
Saving
Saving parameters from global options . . . . . . . . . . . . . . . . . . . . . . . . . . 10-24
Screens
Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1, 10-13
Shut down
Extended shut down. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-22
Routine shut down . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21
Standard deviation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
Stirring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4, 5-9

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T
TDEX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-90
Test
Teleloading tests from host computer . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-31
Test panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
Test Setup
Dependent test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-29, 5-34
Main test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-28, 5-34
Methodology. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Test setup parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-26
Time
Modifying the system time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Modiying the time. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-4
Time format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-19
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1

U
Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-21, 5-25
Arbitrary unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-17
Primary unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10
Unloading of products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-39
Unloading of samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-39
Urgent
Loading a STAT sample . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1, 8-9, 8-11

V
Validation section . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11

W
Warnings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2, 1-3, 1-5
Working File . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1, 8-6, 8-23, 8-25, 8-26
Working List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-44

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