Compact X: Instruction Manual

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Compact X

Instruction Manual

The Fully Automated Clotting Analyzer

Kommanditgesellschaft Behnk Elektronik GmbH & Co.


Hans-Böckler-Ring 27, D-22851 Norderstedt
Tel. +49 (0)40 524 10 91 Fax. +49 (0)40 524 10 94
E-Mail: [email protected] Web: www.behnk.de

BA_CX_en_Feb2011_V01_sc
Table of Contents
General Safety Information .......................................... 1

Graphic Symbols ........................................................... 2

Warnings....................................................................... 2

Compact X Function Keys................................................ 4

Introduction................................................................... 6

The Measuring System.................................................... 7

Ball Function................................................................... 8

Unpacking the Compact X.............................................. 9

Location......................................................................... 9

The Compact X............................................................. 10

Overview of functional units........................................ 12


1. Key field 12
2. Sample trays 12
3. Reagent block 12
4. Wash Station 12
5. Dilutor 12
6. Cuvette register 12
7. Sample distributor 12
8. Pipette probe 12
9. Connection for wash water 12
10. Connection for waste water 12
11. Predilution block 12
12. Illuminated guard bar for the entire working area 13
13. Power switch (Power) 13
14. Fuse 13
15. Mains cable connection 13
16. Connection to the PC (USB) 13
17. Connection to the water sensor 13
18. Host 13
19. EXT 13

 BA_CX_en_Feb2011_V01_sc
Preparations for Operation.......................................... 14
Turning on the device 14

The Screen.................................................................... 15
Menu window 15
Test 15
Status window 15
Message box 15
Status display 15
Colour indicator in the message window 15

Preparation of the reagent block................................. 16

The Cuvette Register..................................................... 17


Replacement 17
Loading the Cuvette Register 17

The Washing Tank........................................................ 17


Refilling the Washing Tank 17

Checking Probe Position .............................................. 18

Prime Pumps................................................................ 18

Stand-by Mode............................................................ 19

Turning the Compact X off............................................ 19

Taking the Compact X out of operation........................ 19

The Main Menu Window...............................................20


Sample Prep. 20
Reagent block 20
STAT 20
Run Display 20
Calibration 20
Q.C. Setup 20
Run Control 20
Reagent Database 20
Hardware 20
Test Parameter 20
Exit 20

Signs and Symbols....................................................... 21

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Sample Tray................................................................. 22

Data Entry ................................................................... 22


Working with several sample trays 22
Adding samples during a running sample prep. 23

Reagent Block.............................................................. 24
Level detection 24
Reagent monitoring of the Compact X 24
Refilling Reagents 25

STAT............................................................................. 26
Inserting STAT measurements 26

Run Display.................................................................. 27

Calibration................................................................... 28
Information in the Calibration Window 28
Information in the chart 30
Creating calibration curves with the option “Automatic“ 31
Creating a new calibration curve with the option “Fully automatic“ 32
Input of a calibration curve using keyboard (manual) 33

Q.C. setup.................................................................... 34
Details about working screen 34
Displaying a Run Control 35
Information in the chart 36

Run Control.................................................................. 37
Status window 37
Details regarding the desktop 37
Execution of Measurements as Run Control 38

Reagent Database........................................................ 39

Hardware....................................................................40
Status Window 40
Test Position 40
Adjust the probe’s position, if necessary. 40
Probe Check 41
Change Position 41
Reagent Position 42
Probe Clean 43
Probe Clean Manual 43
Cuvette Rack Adjust 44
Wash Position 44

III BA_CX_en_Feb2011_V01_sc
Syringe 44
Prime Pumps 45
LED Test 45
A/D Values 405nm / 620nm 46
Water Levels and Temperatures 46

Result........................................................................... 47
Result Data 47
Result search 48
Transmit New 48
Control 48
Control Search 48
Calibration 48
Protocol 48
Errors 48
Error search 49
Status 49
Time-based data output limitation of the results 49
Viewing a calibration curve from the database 50
Display a Q.C. chart from the result database 51
Remove individual data record measurement values from the chart 52

Test Parameter............................................................. 53

Exit............................................................................... 54

Special Functions.......................................................... 55

Maintenance and Care................................................. 56


Daily Sample Preparation 56
Weekly Care 56
Wash Solution Container 57
Cleaning 57
Incubator (Track) 57
Disposal 57
Maintenance Recommendation 57
Rack Transport Check 57

Compact X Quick Reference Guide .............................. 58


Compact X in stand-by operation 58
Place tray with patient samples in the Compact X. 58
Adding patient samples - Filling free positions in the sample plate 59
Input of STAT patients 59
Measuring Run Controls 59
Run controls by means of sample prep 59
Displaying a run control 60
Generation of a calibration curve 60
Checking the calibration (successfully measured) 61
Printing Calibration Curves (example Fibrinogen) 61

IV 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
Cycle of a measurement .............................................. 62
Preparations for the measurement 62
Reagent pipetting 62
Incubating 62
Starting the measurement 62
Measuring clotting 63
Cuvette rack ejection and return transportation 63
Calculating the measurement value 63
Printing measurement, transmitting data to the EDP 63

Troubleshooting...........................................................64
Pipetting Station and Dilutor 64
Fluid Sensor 65
Dilutor 66
Wash Station 66

Messages..................................................................... 67

Compact X incl. Accessories.......................................... 91

Consumables................................................................ 92

Recommended Spare Parts.......................................... 92

Optional Accessories.................................................... 92

Compact X - Specifications............................................ 93
Dimensions 93
Space required 93
Ambient conditions 93
Temperature specifications 93
Sample volume 93

Declaration of Conformity

 BA_CX_en_Feb2011_V01_sc
VI 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
General Safety Information
All biological substances should be regarded as a potential
source of infection!

Wear gloves when handling blood, samples and objects


contaminated by blood!

DANGER ! Strictly follow the existing regulations pertaining to the handling and
manipulation of reagents for laboratory use and blood samples!

IMPORTANT! This instrument may only be operated by trained specialists, who


have been instructed and trained in procedures using In Vitro
Diagnostics. They must be familiar with the instructions and able to
work accordingly, to fully utilise the Compact X capacities.

IMPORTANT! This product is an in vitro diagnostic medical device. It complies with


the requirements of the in vitro diagnostic (IVD) Directive 98/79/CE
and the requirements and limitations of the standards listed in the
declaration of conformity supplied with it. These limits are designed
to provide reasonable protection against harmful interference when
the equipment is operated in a residential, commercial or industrial
environment.
This equipment generates uses and can radiate radio frequency
energy, and, if not installed in accordance with the instruction
manual, may cause harmful interference to radio communications.
We recommend that you observe the different warnings inscribed on
the instrument itself and indicated in the documentation supplied.

ATTENTION! Follow all warnings and instructions affixed to the instrument or


stated in the instructions.

ATTENTION! Intervention in and modification of the product, not explicitly


approved by the equipment manufacturer, may result in loss of
functional capability. The costs for necessary repairs are to be borne
by the user.

ATTENTION! The equipment manufacturer is not liable for any damage resulting
from non-compliance of the specifications stated in these instructions,
damage caused by handling of reagents and biological fluids,
or other handling of the product which is not in line with these
instructions.

ATTENTION! Data processing equipment connected to the instrument, such as


personal computers or printers, must conform to the EN 60950 or
UL 601950, respectively.

 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
Warnings
These instructions contain the information necessary for operating the Compact X.

ATTENTION! It is strongly recommended that the user reads and understands these instructions
thoroughly, in order to fully utilise the Compact X capacity!

Meaning of the warnings used in these instructions:


DANGER! This information is for your own safety.

ATTENTION! Information for optimum use of the Compact X.

Read and follow this information carefully before using the Compact X.

Graphic Symbols
Symbol Explanation

Direct current (DC)

Alternating current (AC)

Direct or alternating current

Protected earth

Protective isolation protection class II

ON (mains switch)

OFF (mains switch)

Caution, observe documentation

Warning of dangerous high voltage

Warning of a hot surface

Warning of a biological hazard

Warning of hand injuries

 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
Graphic Symbols
Symbol Explanation

Warning of laser beam

Keep steel balls out of magnetic fields!


(Speakers, CRT Monitors, etc.)

Please refer to the Operation Manual

Returned goods and environmentally complaint disposal


This instrument is classified as a Category 8 product according to ElektroG
(medical products with the exception of implanted or infectious products).
This instrument does not fall under the RoHS Directive. As required by WEEE
2002/96/EG and ElektroG, we mark our instruments according to the following
symbol as designated by DIN EN 50419. This instrument is not allowed to
be disposed in normal waste. Please pay attention to and follow your local
provisions.
Please contact your instrument dealer for more information regarding the return
of used instruments.

 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
Compact X Function Keys
Keypad Function Use
Cursor keys

wxyz move the cursor on a chosen menu.

^e common standard functions.

m starts the processing. only on the “Main


Menu”

n pipetting process stop after the pipetting of a rack; wait


for the message “arm ready“. The autostart is avoided
with an online EDP.

o m restart.

o delete the displayed messages. With error message, reac- everywhere, except
tivate process, also via the keypad of the device. “Result”

p transmits the routine input to the host. within the “Sample


Prep.” menu of the
selected sample plate

jp transmits all entries of a routine’s sample plate to the host within the “Sample
��������
Caution! spaces are regarded as input Prep.”��������������
menu for all
samples

q annotates a specimen with reactivate status and with ≡. within the “Sample
��������
sign. Input of new test identification code possible. Prep.”�������������
menu of the
selected sample plate

jq to reactivate all samples of a plasma rack with status ≡. within the “Sample
��������
Prep.”�������������
menu of the
selected sample plate
to delete one routine position (ID - tests); if held down all when on the “Sample
��������
bc* subsequent positions can be deleted, Prep.”������������������
menu in an entry
even across multiple parameters! box

br* deletes the entire position occupancy of a selected within the “Sample
��������
sample plate (even when processed, with status ≡ ). Prep.”�������������
menu of the
selected sample plate

} moves the cursor through the “sample


����������������������������
prep.”��������������
boxes to the “Sample Prep.”������
menu
beginning of the next sample plate. “STAT” menu

dg moves within an entry box (beginning/end of the line). “Sample Prep.”�����


menu

* dependent on keyboard layout of the country

 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
Keypad Function Use
Cursor keys

k to select or page through a selection of choices. - “Result”


- “Reagents”
- “Calibration”
] square to register a quality control in the Id.-No. box of the - “Sample Prep.”
bracket routine for manual Q.C. entry. - “STAT menu”

bh press bhto assign a test to all detected samples. - �����������


“Main Menu”
Use wyto select approciate test and press e
bc see b�
h , but for detecting tests.
u in the “Sample Prep.”, select the desired position with the - “Sample Prep.”
cursor and the current database with u.

bi reactivates the printer. - “Main Menu”

u reads the parameters for the calibration curve and dis- - “Result”
plays the information in a new window.

bp reactivates the host connection. - “Main Menu”

 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
Introduction
The Compact X carries out a majority of sample preps for you and conducts chronometric and
chromogenic measurements fully automatically.

A patented procedure allows for simultaneous incubation of both sample and reagent in one cuvette.

Of course the primary receptacles can be placed directly in the sample rack from the centrifuge.

All necessary analyses for a patient are performed in one pass. The identification (ID) is either entered
via bar code or keyboard. Names, numbers or consecutive numbers starting with any number can be
entered. New IDs can be recorded at any time, even during the measurement.

The Compact X sample throughput is approximately 160 PT’s/140 APTT’s per hour. When the cuvette
register has been completely filled.
Due to the micro method a measuring volume of only 150µl is required. The required reagents can be
placed in a refrigerated station with 16 positions for reagents and 4 positions for controls.

You can integrate an emergency analysis into the running sample prep at any time. The Compact X will
automatically repeat measurements which are outside the tolerance.

Working with the Compact X is easy and requires only a few simple preparations:

- inserting the cuvette racks


- entering patient information
- inserting the primary receptacles
- inserting the reagent block
- and beginning operation

 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
The Measuring System
A cuvette rack holding four cuvettes is moved from
the cuvette register to the pipetting position. There
pipetting plasma and reagent are pipetted into the cuvettes.
After being released, the bar is moved to the
transporting
incubation station, which can accommodate three
incubating bars simultaneously.
Plasma
After the incubation time has lapsed, the bar is moved
into the measuring block. This illustration demonstrates
the tilting technology.

When the tilting starts, the ball is located in the upper


Reagent
part of the cuvette. When the tilting progresses, the
ball runs into the drops and transports them to the
bottom of the cuvette. The convergence of reagent
and plasma starts the measuring process.
tipping

The ball rotates during the entire measuring time.


When clotting sets in, the rotating ball causes the
forming fibrin fibres to bind. This effect enables the
detection of smallest blood clots. After measuring
mixing the cuvette rack is ejected or, if there are still unused
cuvettes in the rack, returned back to the pipetting
station.
measuring

 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
Ball Function

1. Normal plasma

with ball

2. Abnormal plasma
without ball

3. Abnormal plasma with


low Fibrinogen contents

1. Excellent reproducibility due to the gentle mixing of the sample. In the normal range
the ball’s rotation is stopped by the strong blood clot. Here the concentration of the
blood clot has only little effect on the signal dynamics due to the rotation of the ball.

2. In case of abnormal samples, the ball concentrates the blood clot in the optical path.
The dynamics of the clouding difference between the fluid and clotted sample are
very high. This leads to positive detection of the beginning of clotting.

3. In case of low fibrinogen contents, the forming fibrin bonds to the ball. This bonding
of the fibrin to the ball causes quick brightening of the sample with a large dynamic
signal.

 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
Unpacking the Compact X
Check the packaging for any signs of transport damage.

Attention! If the packaging or contents are damaged, make a complaint with the
forwarding company and notify the equipment manufacturer or your
dealer.
Assembly and installation should only be conducted by trained
specialists, your instrument supplier or a service engineer!

The Compact X is delivered with a set of standard accessories, the necessary software and various
components required for initial operation (also see Accessories). Hardware for the required EDP-system
is only optionally available.
Keep the original packaging for the purpose of possible future transport.

Attention! Direct or indirect damage to the instrument, caused by shipment in


improper packaging, is excluded from liability or warranty.

Location
Choose a location where the instrument is not subjected to direct sunlight, excess heat, humidity, dust
and vibrations.
The room temperature should be between 17°C and 28°C.

Place the instrument in a position which allows unhindered access to the mains outlet at all times.
Place the instrument on a firm, level table which has a depth of at least 60 cm and is up to 1.50 m wide.
The stability of the basis (table) should be adequate to support the instrument (50 kg).
The instrument can be lifted by the base plate at any position. 2 people should lift the instrument.

Choose the instrument location so that the instrument is protected from large temperature differences.
Direct sunlight, extremely bright lights, and radiators should be avoided.
The instrument must be located in a position where no water or fluids can enter the instrument.

The mains voltage must coincide with the technical specifications of the instrument.
The mains circuit must have adequate fuse protection.
The instrument must be connected to a properly grounded outlet.
If in doubt about mains voltage or the circuit in general, contact a qualified electrician.

Attention! Avoid connection to circuits where other appliances consume large


amounts of current (for example centrifuges) or which turn on and off
frequently (for example refrigerator, water bath, etc.).
Avoid the immediate vicinity of radiators or devices which produce
large amounts of heat, etc.
Avoid direct draughts.

Do not connect other electrical appliances which may cause interference


with the circuit.
Do not set up the instrument near electrical appliances causing electric
interference (appliances bearing no CE label).

Ensure that other persons can not step on or trip over the power cord.
All connections to the instrument should be made with the instrument
turned OFF.

 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
The Compact X
Specifications

- Walk-away-system - USB 2.0 interface

- Throughput approx. 160 PT’s per hour - Continuous operation and emergency analyses

- Up to 40 samples with 4 parameters per hour - Rack return

- Patient oriented processing - Open system for nearly all reagents

- Automatic predilution - Ready for immediate emergency analysis at any


time
- Automatic repeat-testing
- Immediate result display
- Automatic calibration curve calculation
- Q.C. programme
- 4 measuring channels
- PC can be used at any time (multitasking)
- Two wave lengths
Red 620nm / blue 405nm - One main menu for the entire sample prep

- Derived fibrinogen - Request of work lists from the host

- Automatic level detection - Use of primary receptacles

- Cuvette register for 240 tests - Sample and reagent reloading possible

- 1 sample tray for 32 primary receptacles - Refilling of the cuvettes possible at any time

- Cooled reagent block for 16 receptacles - Error monitoring during the course of clotting

- 4 positions for the quality control - Error criteria output

- Chronometric, chromogenic and immunological - Graphic display of the clotting process


tests
- Current display of sample status
- Automatic reagent change
- Automatic subsequent testing
- Measuring system with process monitoring
- Extremly large database
- Bidirectional interface

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Overview of functional units

12

2 11 1 3 front view

19

18
9
13 16
14 10
15 17

side view

11 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
Overview of functional units
1. Key field
STOP The sampler stops immediately after this button is pressed.

ALARM OFF Messages are acknowledged by pressing the ALARM OFF button. This also removes the
message from the message box. ALARM OFF has the same function as <F4> on
the keyboard.

2. Sample trays
Hold the primary cups to place the patient samples in the CX.

3. Reagent block
Reagent blocks are loaded with reagents according to the schematic diagram on the Sample Prep.
menu. By placing the samples in the CX they are automatically cooled to approx. 16-22oC depending
on room temperature. When the block is in the CX, specific positions can be mixed. The control plasma‘
positions are also in the reagent block.
Note: As an option, it is possible to work with several reagent blocks.

4. Wash Station
To avoid contamination, the needle is cleaned on the inside and outside. The washing cycle depends on
which test is selected.

5. Dilutor
The dilutor controls fluid movement together with the sample distributor.

6. Cuvette register
The register holds 58 cuvette bars. It is easily exchanged.

7. Sample distributor
Distributes plasma and reagent according to the programmed test volume.

8. Pipette probe
Distributes samples and fluids depending on the selected program.

9. Connection for wash water


The wash water container is situated next to the instrument.

10. Connection for waste water


The waste water container is situated next to the instrument.

11. Predilution block


Predilution positions are available for precise measuring of high dilutions.

12 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
12. Illuminated guard bar for the entire working area
Illumination: white - stand-by and routine
flashing red - an error message has occurred

13. Power switch (Power)

14. Fuse
The fuses protect the instrument from damage.

15. Mains cable connection


Mains cable socket.

16. Connection to the PC (USB)


The USB interface is used to establish a connection with a PC.

17. Connection to the water sensor


The water sensor detects the water level in the washing tank

18. Host
The RS-232 interface is used to establish a connection to the LIS.

19. EXT
This interface is used to connect to the following analyzer from the Thrombolyzer series using the same
communication protocol.

13 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
Preparations for Operation
Prior to initial operation of the Compact X, the following requirements should be met:

- are all electrical connections established?


- are all tubes and sensors connected?
- are the probe and pipetting tube assembled?
- is the water tank filled?
- is the waste water tank emptied?
- is the cuvette register filled?
- are predilution cuvettes available?
- is the incubation station cover in place?

Turning on the device


If all conditions are fulfilled, switch on the Compact X first, then the monitor and then the PC.

Enter the password for the user ”routine“ into the registration console and confirm with Ü.

Note: After the PC has booted, the software will load and the Compact X sampler
moves.

14 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
The Screen

1 2 3

6
4
5

After turning the PC on the main screen, which is divided into six areas, will open.

1. Menu window
Main menu for choosing the status windows required for the sample prep.

2. Test
This column is faded out if it is not relevant for the current programme.

3. Status window
The status window is changed by the menu items in the main menu. The selection is
determined by the cursor’s position in the menu. Depending on the selected menu item,
information is displayed or data can be edited.

4. Message box
System status display area (system and error messages).

5. Status display
Status of the function keys (time, date and software version).

6. Colour indicator in the message window


The following situations are possible:
Green: sample rack is not being processed; it can be removed.
Red: sample prep will begin after patient results are identified.

On the left of the indicator, the samples which are already entered are indicated; on the right, the
selected reagent block (e.g. rb1) is displayed.

15 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
Preparation of the reagent block

The reagent block is an aluminium block with 16 positions for reagents and 4 con-
trol plasmas. The reagent block is designed as a module insert, so it can be loaded
outside the Compact X, or can be kept in the refrigerator during longer down times.

In order to load the reagent block, select the reagent block in the main menu. A
diagram of the reagent block can now be viewed on the desktop. The identification
codes of the tests to be used, the reagent identification code and the name of the
reagent are displayed in the individual positions. Load the reagent block according
to the diagram on the screen.There are two fixed positions outside of the reagent
block for standard liquids. These two liquids are “Clean” and “Dilution buffer”. The
term “Clean” represents a decontamination liquid for the probe.

The following preset identification codes are used for the reagent block:

RE = Reagent LA = Latex reagent


BU = Buffer BL = Bleach
DP = Deficiency plasma SU = Substrate
CC = Calcium chloride NP = Normal plasma
AC = Activator (blank) = not occupied

Place the reagent block into the intended position. In order to cool down the reagent to approx. 18°C,
push the module insert in as far as it goes (sensor controlled). “Mixed” indicates the positions which can
be mixed.

16 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
The Cuvette Register
Replacement
The cuvette register holds 60 cuvette racks.

The cuvette register can be replaced or reloaded at any


given time, even if only half-filled.
When the instrument is working, it must be stopped with n
before continuing. As soon as the sampler has stopped, the
register can be reloaded or replaced with a full one. Please
make sure the bar cover is returned to its original position.
Restart the instrument by pressing o/ALARM OFF.
.

Loading the Cuvette Register


In the package of cuvette racks, there is a leaflet included
which provides information on how to load the register.

The Washing Tank


The washing solution is stored in a receptacle which is situated outside
the Compact X. For the washing solution, de-ionized water or distilled
water may be used.
The water level is monitored by a sensor. If the water level is
insufficient, an alarm is sounded and the following message is
displayed in the message window:

“Distilled reservoir low level. Refill”

Refilling the Washing Tank


Remove the sensor from the washing tank and refill the washing solution. Replace the sensor and delete
the message in the message box by pressing o/ALARM OFF.

17 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
Checking Probe Position
Inspect the probe daily, this is important in order to guarantee a fault-free cycle of dosing of reagent
and specimen.

1. Test position

Select the menu item “Hardware“ by pressing yw, reconfirm


Probe: “Test Position” by pressing e. The probe should now
move exactly above the red test point on the washing station.

If necessary, align the probe manually, then choose “Test
Position” again.

Note: The arm moves to the “Home Position”.

2. Probe check

Select the menu item “Hardware“ by pressing e.


Confirm “Probe Check” with e.

Follow the instructions in the message window: “place the test receptacle in the wash station”, then
e.
Note: The probe positions itself over the washingstation and dispenses approximate
3ml into the test receptacle. Should the dosage be under the 2ml marker, please
contact the service department.

Follow the instructions in the message window: “please take the test receptacle from the washing
station, then press o“. Select the item “Washstation“ e. Exit the work field “Hardware“ with
^.

Prime Pumps
Select the menu item “Hardware“ / “Prime Pumps“. Confirm with e. The tubing system of the
Compact X fills with washing solution. The next message box reads:

“Compact X is not yet ready (Prime pumps)“

After completion, the message box reads:

“Compact X ready (Hardware)“

Exit the work field with ^.

Note:
“Prime Pumps“ is only necessary if the system was switched off for several hours. In
Stand-by mode, an automatic short rinsing takes place every 30 minutes.

18 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
Stand-by Mode
If no patients’ specimens are being processed, the Compact X automatically goes into stand-by mode.
In the stand-by mode, a short washing of the probe is carried out every 30 minutes.

Turning the Compact X off


Select “Exit“ in the menu using yw. Confirm by pressing etwice.

Note: The arm moves and a final washing process is conducted.

The operator interface changes to the login console.

Switch off the main switch Compact X.

Taking the Compact X out of operation


To take the Compact X out of operation see chapter “turning the Compact X off” and disconnect the
power cord. If the Compact X should be removed, please contact your service / distributor.

19 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
The Main Menu Window
In the “Main Menu” window, the various Compact X functions can be selected. Move the cursor with
yw to a menu item or enter the menu item’s first letter. When going to a different menu item, the
display of the status window changes accordingly. Pressing emoves the cursor to the corresponding
status window for editing. ^ brings you back to the menu to access a different menu item.


- Sample Prep.
Here the patients’ IDs and the desired tests can be entered.

- Reagent block
Display of the reagent block with reagent positions. Replacement of the reagent block when several
blocks are available.

- STAT
For inserting STAT’s into the running routine. STAT’s are given priority in processing.

- Run Display
Status display of the cuvette racks in the incubation / measuring block, as well as the results of the last
three racks.

- Calibration
Display and input of calibration curves and standard values.

- Q.C. Setup
Display, input and control of the “Q.C.” limit values for every test.

- Run Control
Entry of the controlling plasmas for the “Q.C” selection and start of the “Q.C.”

- Reagent Database
Data display and data input of the reagents used.

- Hardware
Maintenance and control menu for “Probe”, “Syringe”, “Racks”, “LED”, “Water level and Temperatures”.

- Result
For searching the result database for measuring results, quality controls and system messages for
viewing, printing and transmitting this information to the host.

- Test Parameter
Selection and control of the selected test parameters. Changes only via the maintenance menu.

- Exit
The main menu must be exited before the PC is turned off.

20 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
Signs and Symbols Sample Prep Measurements
* Sample is being processed

≡ Sample has being processed

- No more plasma has been found

≡ (red) Error message

► “STAT”

Manual input

These signs appear to the left of the ID-number.

s Status message i.e. ”Sample prep.” in progress

e “STAT”

m Manual data entry

Pos

1 Stands for tray No 1

1-32 Indicates the position in the sample tray

21 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
Sample Tray
Load the sample tray in numbering order.

Enter the patient data in the “ID No” column and the identification codes of the tests to be performed
in the “test” column. “Prep” indicates the sample tray number (1 or 2) and the position of the belonging
patient plasma in the sample tray (01 to 32).

Data Entry
The data can either be entered manually or with the optional hand scanner.

If the data is entered manually, and the instrument is connected to an EDP system, then the test must be
actively queried from the host by pressing p (for each patient) or jp (for all patients entered).

If the data is entered with the hand scanner, and the instrument is connected to an EDP system, then the
corresponding tests are received from the host for each patient entered.

If no EDP system is connected, then all tests must be entered manually.

Working with several sample trays


If there are many patient plasmas to be processed, you can facilitate the work by using multiple trays.
After loading and entry of the data for the first tray, it can then be started. While the Compact X is work-
ing, you can load the next tray.

Once all the tests for a tray are completed, the status display below on the right in the routine screen
changes from red to green. Now you can replace this tray with a new tray, scan or enter data and start.

22 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
Adding samples during a running sample prep.
You can add specimens at any time during the running sample prep by pressing n. Message
“stopped (arm is still working) wait for ‘ready’ – restart F4“ appears. The Compact X finishes pipet-
ting the current cuvette rack and interrupts its current routine. Wait until the message “stopped with F3
(arm ready: restart F4)“ appears. Pull back the tray, or take it out of the device and put in the new
specimens. Subsequently, push the tray back into the device, press the m button in order to read the
specimen and reactivate the interrupted routine with o. In case of connected EDP and already running
routine, you need not press m, because the readjusted specimens are automatically started.

Never reach under the protection guard in the pipetting zone while the
Compact X is in operation. In case of emergency, use the stop button to
immediately stop the movement of the arm.

Warning of a biological hazard.

23 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
Reagent Block
When the cursor is on “Reagent block” in the menu window, a diagram of the reagent block’s rack
appears in the screen’s work field.

In the reagent block, the reagent positions 1 to 12 are available for larger reagent bottles. Positions 13-16
are available for smaller reagent bottles. Positions 1and 3 are stirred.

5 = Positions in the reagent block


AC = Reagent identification code
Q2 = Test identification code
AT III = Reagent name
Mixed = Mix position 1, 3

Level detection
Display for the automatic liquid level control. The graphic level display shows the current liquid level for
each reagent.

Reagent monitoring of the Compact X


During the pipetting process, the Compact X monitors the reagent volume. If there is insufficient reagent
in the reagent block, this is reported in the message box “not enough reagent ... for further testing”.
If the reagent is used multiple times, then the positions are used one after another. If all reagent positions
are empty, then the message “Liquid XY not found” appears.

24 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
Refilling Reagents
When pressing n the message “stopped (arm is still working) wait for ‘ready’ – restart o/ALARM
OFF (sample prep.)” is displayed. The Compact X finishes pipetting the previously started cuvette rack
and interrupts its current routine. Wait until the message “stopped with n(arm ready: restart o/Alarm
Off.) sample prep.“ appears. Remove the reagent block from the device, and replenish the correspond-
ing reagent. Put the reagent block back into the device and start “Sample prep” with o/ALARM OFF.
After a reagent has been changed or refilled, the liquid level is automatically checked. This is done for
safety reasons.

Never reach under the protection guard in the pipetting zone while the
Compact X is in operation. In case of emergency, use the stop button
to immediately stop the movement of the arm. Always hold rotor or
reagent block at their handle.

Warning of a biological hazard.

Never place foreign objects, e.g. coins, under the reagent receptacles.

There is also the alternative of extracting the reagent block without using n in order to replace
reagents. In this case, the pipetting probe stops immediately.

ATTENTION ! Do not extract the reagent block if the pipetting probe is currently
pipetting a reagent.

The software will allow this procedure within 30 seconds. In case the reagent block is not re-inserted
within the 30 second time limit, the bar currently being pipetted is discarded.

25 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
STAT
Inserting STAT measurements
Analyses for STAT patients can be performed at any time. STATS, including result printing, are
prioritised.

In the Compact X, the sequence is the same as in the menu option “Sample prep.“, only that you can
access the ID field using menu item “STAT“ e.
Now the specimen IDs read manually entered are STAT specimens and are processed with priority.
These specimen are marked with ►.
You can place STAT specimens in any free place in the tray.

End the data input ^ and start with m for manual input. The STAT specimens are inserted accord-
ing to the process described in chapter “adjusting specimen“. Processing and measuring of STATs in
“sample prep” processing have the highest priority.

26 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
Run Display
Status Display of Cuvette racks “being processed”
The menu item “Run Display” displays the status of eight cuvette racks. The display scrolls from bottom to top.

For each cuvette the following data is shown:

- The patient ID.


- Position of the specimen in the specimen stand.
- The tests (test) performed on the cuvette.
- Measured time in case of chronometric determination.
- Calculated measured value.
- A possible error flag.

Individual positions are displayed:

- “Results“ displays the measurement results described above.


- “Measurement block“ shows, which patient specimens are being currently measured.
- “Incub.1,2,3“ shows, which patient specimen is where in the incubation.
- “Pipetting“ shows, which patient specimen is being currently pipetted.

27 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
Calibration
In the “Calibration” menu values and times for your calibration are registered. There are three
alternatives of calculating a calibration curve: “Manual”, “Automatic” and “Fully automatic”.

1 3
2 4

6
7 5
8
9
10

11

Information in the Calibration Window


1) Test
The name of the previously selected test is automatically shown here.

2) Reagent
The reagent used is assumed from the “Reagent Database” entries.

3) Date
Current date and time is automatically entered for each value change in the chart.

4) Lot-No
This number is also transferred from the entries in the “Reagent Database“.

5) Pos. X 1 - X 4 and 29 - 32
In the “POS” column the plasma positions for automatic calibration curve calculation are shown. In the
example illustrated, “PT”, the second column shows the percentages. The type of calculation is set in
“Test Parameter” and automatically included in the chart. In the third column the corresponding times or
values of the activity, concentration are shown.

6) Min.Value and Max.Value


Min. and max. value specifies the limitation of the calibration curve. All the results outside this range are
not accepted and are marked with an error flag.

7) Automatic
The Compact X determines the values from calibration plasmas with different concentrations.

28 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
8) Fully Automatic
The Compact X calculates calibration curves using fully automatic plasma predilution.

9) Manual
Entering a calibration curve via the keyboard.

10) Curve
When the cursor is in the “Curve” box and e is pressed, the graphics screen opens and displays the
calibration curve.

11) Normal/ISI
Optional when calculating the INR value.

29 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
Information in the chart
There is a chart available for all parameters requiring a calibration curve. Use the following process in
the menu “Calibration curves“ in order to view the graph.
Test e. Select the test for the corresponding calibration curve yw. Confirm the test e.
On the desktop the cursor switches to “Automatic“. Press yw to change to “Curve“ e.
The chart is configured when confirming the curve.

First the details test, reagent, charge and date are displayed for the curve. Furthermore, the type of
scaling and the allocation type are specified.

ATTENTION ! The following parameters of the calibration curve display can only be
altered by the system administrator:

- LOG/LOG - LOG/LIN
- LIN/LOG - LIN/LIN

The form of scaling is set according to the reagents you use and the parameters before or during the
installation of the device. The same is applicable for the allocation types:

- Polynomial 3rd degree


- Linear regression
- Spline
- Linear interpolation (point to point)

Values of the curve are given e.g. in %, mg/dl, g/l, IU/ml on the X-axis of the curve. The Y-axis shows
the corresponding times. All calibration points must be within the “min. cal.“ and “max. cal. values“. No
values outside this range are calculated. The curve can be printed using i.

30 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
Creating calibration curves with the option “Automatic“
From menu option “Calibration“ again access the field “Test“ by pressing e. Press yw to se-
lect the test for which the calibration curve needs to be established e. The cursor is in the field
“Automatic“ e. A new menu appears and the entries of the previous column are deleted.
With e you can enter the first value for the desired dilution series. If you press e after entering
the value, the cursor goes to the next field of this column. All the calibration curve points are entered
^. The cursor switches to the field “Start“. Diluted plasmas are placed in the corresponding positions
in the specimen stand and started with e. Once the measured values are automatically entered in
the chart, the device shows the message “Compact X has completed calibration (see curve)“. Press
e to move the cursor to the field “Curve“. Now you can view the curve e. After leaving the
chart with ^ the cursor is in the field “Accept“, which has changed from “no“ to “yes“. If you want
to accept the new curve, press ^. If you want to view all old curves, change the field “Accept“ with
k from “yes“ to “no“.

Note: If you do not wish to alter the dilution series values of your calibration curve,
go directly to “start” to begin your measurements.

31 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
Creating a new calibration curve with the option “Fully automatic“
From menu item “Calibration“ press e to switch to the field “Test“. As earlier, select the test, for which
the calibration curve needs to be created e, press yw to go to the field “Fully automatic“ e.
A menu is opened. The cursor is in the field “Values“ e. Press w to move the cursor up to the item
“Reference“. Enter the desired concentration of your reference plasma e. With y go to the field
“Dilution“, position X1. With k you can select the first dilution. With y move down one position
and do the same to select the next dilution. Continue to proceed in this manner until you have entered
all the dilutions, which the Compact X should execute and measure, then press ^.

Dilution values are displayed in the right column. The message box specifies the positions in which the
dilution buffer, reference plasma and empty receptacles for dilutions must be placed.

32 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
Once you have brought calibrator, empty receptacles, buffer and all the reagents in the correct
positions, confirm with e, when the cursor is in the field “Start“. The Compact X starts pipetting the
dilutions and shows the message “Compact X is working (calibration)“. Once the calibration curve
is successfully measured, the message “Compact X has finished calibration (see curve)“ appears in
“Message“. Confirm from menu item “Calibration curves“ with e, the cursor switches to the field
“Curve“. Confirm again with e and you can view the graphic display of the calibration curve. Once
you leave the curve with eor ^, the cursor is in the field “Accept“. If you want to use the new
calibration curve, press e. If you want to use your old calibration curve, switch from “yes“ to “no“
with kand leave the work area with ^.

In case a calibration curve was measured incorrectly, move the cursor in the menu to “Calibration curves“
e. The cursor is in the work area “Calibration curves“ directly in the field “Values“. If you want to sup-
plement the missing value, press e. Go to the position of the missing value and enter the value. Once
you have entered the value, you will see the calibration curve and you can accept or reject it. If you do not
want to enter the missing value of the calibration curve, exit the work area “Calibration“ using ^. Your
old calibration curve remains unaltered.

Input of a calibration curve using keyboard (manual)


Select a test under “Calibration“, for which you want to enter the calibration and press e.
The cursor switches to “Automatic“, switch to the field “Manual“ ywe. The cursor switches to
“Values“ once you confirm with e , you can enter the values. If you want to use less entries for cali-
bration, overwrite the values of the previous entries with 0 (zero).

Once you have made all the alterations in the chart, you can alter the normal - ISI, min. and max. values
with yw. Normal and ISI value are optional and dependent on the test. The normal value is auto-
matically determined by the system during calibration. The ISI value can be found in the thromboplastin
instruction leaflet. Once you have completed all the entries, press ^.
The cursor switches to the field “Curve“ and with e you can view the new curve display. Again exit
the chart with ^, the cursor switches to the field “Accept“. If you want to use the new calibration
curve, press e. If you want to view your old calibration curve, switch from “yes“ to “no“ with k
and exit the work area with ^.
The calibrations of all tests are saved in the menu “Result” under “Calibration“.

33 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
Q.C. setup
On the “Q.C. setup” menu, the confidence values of the control plasmas are entered. A chart is
available for every control plasma measured so far.

Details about working screen

Test: Display test, for which quality check is conducted.

Plasma with Lot No.: Plasma is adopted with name and lot number from the menu item
“Run Control“.

The chart for the limits of the confidence interval desired value: low1 / high1; low2 / high2 changes
depending upon the selected test for measuring unit and values.

low1/high1 Form the 1S area


low2/high2 Form the 3S area

Values for the marginal values must be entered according to the instruction leaflet of the reagent
manufacturer.

Curve: Accesses the chart.

Scale y min/Scale y max: Setting for an optimum graphic display of Q.C. setup.
Scale y min must be either equivalent to or less than low2.
Scale y max must be either equivalent to or less than high2.

34 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
Displaying a Run Control
Select “Q.C. Setup“ in the menu by pressing yw and confirm with e.
Select the test, for which you want to view the “Q.C.Set-up” by pressing yw and confirm with e.
The cursor switches to the field “Curve“ of the first control plasma. If you want to view another control
plasma, press yw to switch to the next one. In order to view the chart, confirm with e.

With k the graphic display switches between all and only unmarked values.

If you want to change the limits of the confidence values in the chart, use yw to switch to the values
and enter the limit values from the reagent manufacturer’s instruction leaflet. The terms “high“ and “low“
refer to the limits of the deviation from the desired value.
Switch to the field “curve“xz, e. A chart of the run control is configured.

To return to the main menu, press ^ 2-3 times, depending on the position.

35 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
Information in the chart
High, Desired Value and Low
This information is taken from the entries in the chart.

Min and Max


“Min.” displays to lowest measuring value found, “max.” the highest value.

Mean
Displays the average value calculated in the chart.

SD
Specifies the calculation of standard deviation of the chart.

CV
Specifies the calculated variation coefficients of the chart.
The chart can be sent to the printer for printing by pressing i.
By pressing ^ three times you return to the blue menu field.

36 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
Run Control

Select “Run Control” on the Menu yw.

Status window
In the control plasma status window, you can specify the plasma to be used. The measurements for the
run control can also be started from this window.

Details regarding the desktop


Data of maximum five control plasmas can be entered in the chart. Each of the control spots corre-
sponds to a spot in the reagent block.

Plasma: Names of control plasmas are entered here.

Lot No: Lot number of control plasma is entered here.

Date: Entry of the expiration date of the respective control.

Tests possible: Tests intended for the control plasma are entered here.

Start test: Tests for which a run control is to be started are entered here.

37 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
Execution of Measurements as Run Control

Select “Run control“ in the menu by pressing yw, e. The cursor switches to “no“ of the first
position. Should the control plasma from the chart which is to be measured be in this position, change
the position from “no“ to “yes“ using k. If you want to measure more than one control, select the
required positions in “Reagent block“ by pressing xz. Switch the positions to “yes“ using k.
Exit the status window with ^.

“Compact X ready (Run control)” is displayed in the message window.

Check to make sure that all required control plasma and reagents are in their determined positions.
Press m to start the run control.

“Compact X is operating (run control)” is displayed in the message window.

When the analyses are completed the established results are transmitted to the result database and the
corresponding chart.

38 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
Reagent Database

Select “Reagent Database” in the menu window yw. The test screen will appear in the status
window.
Using “Reagent Database” e the entries in this menu item can be edited.
To move to a different column, press ywe. For each test displayed the following information can
be specified:

- Reagent name
- Lot number
- Expiration date of the reagent
- Comment

The information regarding reagent name and lot number are automatically entered in the item calibra-
tion curves.

39 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
Hardware
The menu item “Hardware” is a control and maintenance programme (also see chapter maintenance
and care).

Status Window
To start the programme, select “Hardware” yw and confirm with e. Use yw to move in the
status window, with e the desired action is conducted.

- Sample:
Test Position
Used for checking the probe’s position above the wash station’s
red dot. Confirm test position with e.

Attention! The arm moves to the “Test Position”.

Adjust the probe’s position, if necessary.


Select the menu item “Wash Position” e.

Exit “Hardware” by pressing ^.

40 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
Probe Check
Select “Hardware“ e.
Select “Sample“ e.
Select “Probe Check“ e.

Attention! The arm moves to the “Home Position”.

Follow the instructions in the message box.


Message: “Put the test receptacle on the wash station and press e“ .

Attention! The probe moves over the washing station and then pipettes the solution
into the test receptacle.

The lower section of the test container should be filled. The pipetting stream should be vertical and
should come out of the probe as a single stream. After this has been done, the tip of the probe should
be checked for any development of water drops. Water droplets on the tip of the probe are an
indication that the system might be leaky.

Message: “Please remove test receptacle from the wash station and press o“ .

Select the menu item “Wash Position” e.

Exit the “Sample” with ^.


Exit the “Hardware” with ^.

Change Position
- Remove the reagent block out of the Compact X.

- Remove the protective tube out of the guides on the casing.

- Push the protective tube back until the probe is exposed on the top.

- Remove the pipetting tube from the top of the probe.

Attention! When removing the tube, tightly hold on to the


probe’s black guide.

41 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
- Press the probe out and away from the notch in the guide.

- Press the silver locking cap upwards and then pull the probe up and
out.

- Insert the new probe the opposite way around.

Attention! When fitting the probe make sure it is


inserted as far as it goes.

right wrong

- Select “Test Position” yw, and confirm with e.


- Check the probe’s position
- Select “Wash Position” e. Exit “Hardware” by pressing ^.

Reagent Position
Confirm the “Reagent Position“ e. A list of reagent positions is displayed for selection. Enter the
position to be approached e. After a brief washing the arm moves to the corresponding position.
This serves the purpose of controlling individual positions in the reagent block. Exit the “Reagent
Position” with ^.
Select the “Wash Position“ by pressing yw, then press e and exit the work area with ^.

42 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
Probe Clean

In the menu “Hardware“ select the submenu “Probe Clean“ e. The probe exits the wash position,
please pay attention to the message box.
Pipette 1ml of 5% hypochloride in the washstation e.
The probe moves into the “Wash Position” and draws up the solution, allow this to work for approximate
15 - 30 min. e ^ .
Press w to change to “Prime Pumps“ e.

Probe Clean Manual


The probe should be cleaned manually if any droplets, on the shaft of the probe after pipetting, are
observed.

The probe must first reach its final position before any cleaning can be done.

Please be careful and avoid any injuries which could be caused by the tip of the probe.

Always wear protective gloves in order to protect yourself against contamination!

Warning! The probe should only be cleaned from top to bottom. Please pay
special attention to the instructions displayed in the message box!

43 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
Cuvette Rack Adjust

This is used to optimise the pipetting positions for the cuvette rack. Procedure: activate the
corresponding menu item.

A cuvette rack is transported to the pipetting position. The pipetting sensor searches for the reference
point on the rack and automatically corrects the probe’s Z - position. Use the cursor keys to optimise the
positioning of the X and Y axes. Press ^ to finish the procedure. The arm then drives to its “Home
Position”, and the rack returns to the wait position.

Wash Position
The “Wash Position” must always be selected in order to be able to exit the work area “Hardware“ (exit
with ^).

Syringe
“Syringe“ is a maintenance programme for the extraction of dosing syringes and filling
prime pumps.
Select “Syringe“ yw in the operating area “Change Position“ e. The syringe moves a
few steps down. You can now uninstall the syringe:

- Unscrew the knurled screw (2) in the dilutor (approximately 2 rotations).


- Unscrew and remove the syringe from the top connection (1).
- The new syringe is inserted in the reverse order (first on top at the connection, then at the
bottom on the dilutor).

Please ensure that the syringe is tightly fitted on the connection as well as
at the bottom on the dilutor.

Select “Start Position“ e. Now the syringe moves back to its initial position.
Select “Prime Pumps“ e. “Compact X is not yet ready (Prime Pumps)“ appears in the message
box. Wait until the message “Compact X ready (Hardware)“ appears and exit the work area with
^.

44 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
Prime Pumps
Select the menu item “Hardware“ / “Prime Pumps“. Confirm with e. The tubing system of the
Compact X fills with washing solution. The next message box reads:

“Compact X is not yet ready (Prime


Pumps)“

After completion the message box reads:

“Compact X ready (Hardware)“

Exit the work field with ^.

Note: “Prime Pumps“ is only necessary if the system was switched off for several
hours. In Stand-by operation, an automatic short rinsing takes place every 30 minutes.

- LEDs:

LED Test
By confirming with e, the light intensity of the measuring system is checked. At the end of the test, the
message “LED is OK” appears in the message box.

If an error message appears in the message box, please clean the measuring block.

45 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
A/D Values 405nm / 620nm
Select “Hardware” and choose “LEDs” e.

Upon selecting this menu item, a window opens which displays the A/D values of the four measuring
channels. Please clean the measuring block if one or more channels are outside the displayed range.

Water Levels and Temperatures


Water reservoir status and the temperatures are displayed in a chart. If the water level is not shown to
be OK, refill the water reservoir as described in chapter “the washing tank”. If one of the temperatures
is not OK, the Compact X stops the measurement routine.

46 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
Result
In the menu option “Result“ you can view and edit all saved messages and measurement values. In case
the cursor is on “Result” in the menu, press e and the screen changes to database selection.

Results: Test results for all patients incl. all reaction curves.

Controls: Contains data from measurements of “Q.C. Set-up“.

Calibration curves: Contains all the executed calibration curves.

Protocol: Contains the work log of the previous measurements.

Messages: List of generated error messages.

Status: Number of specimens, Q.C.’s and error messages.

Result Data
If the item “Result” of the database is confirmed with e, the display changes to the list of patient
data. The patient measured last is displayed at the bottom. You can scroll with yw through the
patient data. You can select the following functions: “Print“ and “Send“.

i Selected data set is sent to the printer for printing.


p Selected data set is sent to the central computer.
j yw Select several data sets for printing or sending.

47 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
Results
Confirm a new ID number with e, the corresponding index card for that patient is displayed.

e The details of the detected tests are displayed.


e The reaction curve of the selected tests are displayed.
e The reaction curve are displayed over the whole screen.
i Print curve characteristics.
^ Exit curve.
2x^ Exit index card.

Result search
When opening the option “Result search“ under “Result“ by pressing e, an input field is opened.
The system will search for an alpha-numeric combination, which may take place at any place in the
“ID.-no.“ (observe upper and lower case letters).

Transmit New
Here only analyses which were not yet sent to the central computer on the current day are displayed.
Sending is started with p.

Control
Move the cursor to the working area “Result“ on “Control“ and confirm with e.
All quality checks available in the database are displayed. After selection of a control with yw and
eall results are displayed for this Q.C. Continue to proceed as in the patient‘s database. With t
you have the opportunity of entering a comment for this control.

Control Search
Control search see “Results Search”.

Calibration
Move the cursor to the work area on “Calibration“ and confirm with e. All calibrations of this
system are displayed with test name, test abbreviation, type of calibration, status, date and time. Select
a standard curve with yw and with e all results are displayed for this calibration. With t you
have the opportunity of entering a comment for this standard curve.

Protocol
Under the item “Protocol“ you can view all measurements from the last 30 days. All individual values
and averages with all possible information are displayed. Additionally after selecting with yw and
e, a chart with the reaction characteristics of the measurement is displayed.

Errors
Upon pressing e a display appears which gives information regarding the number of patient plas-
mas measured up until now, the number of checks conducted and the number of registered messages.
48 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
Error search
Full text search of the entered errors.
For this search, corresponding search
criterion can be entered in the search
field.

Status
Shows an overview of all entries in the
database.

- “Patients”
- “Controls”
- “Error Messages”
- “Strips”
- “Cuvettes”

Time-based data output limitation of the results


You will need to enter exact data outside of these limits in order to recall information from the database.

Results 90 days
Control 750 days
Calibration 750 days
Error Messages 180 days
Protocol 90 days

49 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
Viewing a calibration curve from the database
Select ”Calibration”. Confirm with e.

Select a data record by using yw


and then press the u key.

Confirm with e.

50 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
Display a Q.C. chart from the result database
Select ”Control”. Confirm with e.

Select a data record by using yw.


Confirm with e.

Press u to display the chart. The chart


includes all measuring values contained
in the data record.

51 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
Remove individual data record measurement values from the chart
Mark all data records which are to be
deactivated with k. A ”-” symbol will
appear in front of each deactivated data
record.

After pressing u, only the valid values


will be indicated in the curve.

Press k to display only the valid


values in the curve.

52 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
Test Parameter

The individual parameters for the selected tests are displayed in this working area. It is possible to tell
the system if you would like the selected test done in single or double determination.
All of the other parameters can only be changed if you have the appropriate access rights.

53 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
Exit
If you would like to stop working with the Compact X, select “Exit“ in the menu.

Confirm 2 times with e.

ATTENTION! The arm moves and a final washing cycle is conducted.

The user interface to the login console. Press aS and confirm with e.

The PC switches off automatically.

Now switch off the Compact X.

54 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
Special Functions
Altering Data

The following functions are available to alter or delete data in the “Sample Prep.” menu:

a) When the cursor is in the status window the following key combinations are enabled:

- Bring cursor into position 1 b {.


- Scroll to the ID field {}.

Move the cursor to the desired test input with yw. Select the desired line area with xz and edit it.
If you wish to delete the entire line including ID.-no. and tests, press bc.

Attention! The line will be deleted without any further requirement for
confirmation.

b) When the cursor is in the main menu’s item “Sample Prep.”:

- To delete a test for all patients bc.


- The cursor moves to the box “test” , select the test which is to be deleted yw.
- Confirm the deletion with e.
- To add a test for all patients bh.
- Select the test to be added in the box “test” yw.
- e adds and confirms.

After starting sample prep, all data can be viewed with {}, but no longer altered.

55 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
Maintenance and Care
Daily Sample Preparation
Probe
In the menu “Hardware“/”Sampler”:
Select sub menu “Test Position“ and check the probe as described in “Probe
Check”. If the probe or their tip is visibly damaged (bent or deformed), please
exchange the probe (please refer to chapter “hardware”).
Visible signs of wear and tear on the coating of the probe are normal and do not
negatively influence the proper functioning of the probe.

Tube system Select the sub menu “Prime Pumps” in the menu ”Hardware“. Check the general
sequence and check whether air bubbles are present in the system. Check the
canister fill level and refill if necessary.

Weekly Care
Probe Cleaning - In the menu “Hardware“ / “Sampler”, select the sub menu “Probe Clean“ e.
The probe moves out of the washstation. Please pay attention to the
message box.
- Pipette 1 ml of 5% hypochloride into the wash station e.
The probe moves into the wash position and draws up the solution, allow this
to take effect for approximate15 - 30 min. e ^.
- Press w to switch to “Prime Pumps“ e.
- When done, the sub menu “Probe Check” should be selected. Please follow the
appropriate steps as described in the “Hardware” section.
- Check how firmly the syringe is mounted: both top and bottom.
- Check for condensation beneath the teflon tip.

If there is condensation present, then this is a sign that the syringe may be leaky.
The syringe should then be replaced.

Cleaning the Measuring Block

Moisten the top of the cleaning spatula with 300 µl NaCl 0.9%/Clean. First clean
the upper, then the lower part of the measuring block through the ejection slot.
Afterwards dry with the clean /dry side of the cleaning spatula. The cleaning
spatula can be used several times. However, it is recommended to frequently use a
fresh cleaning spatula, especially when a gray colouring is clearly visible.

If you remove the protection cover, don‘t put your fingers in or around the measuring
block!

56 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
Wash Solution Container
Empty and clean the water storage canisters mechanically (by means of a bottle brush) and refill.
Then access the menu and sub menu “prime pumps“ repeatedly.

Cleaning
For cleaning the Compact X take a lint - free cloth which is moistened with water.

Incubator (Track)
Wipe with a lint free cloth which is moistened with NaCl 0.9%.

Disposal
The waste water should be disposed according to local regulation.
If the used racks are disposed, strictly follow the existing regulations pertaining to the handling and
manipulation of reagents for labotratory use and blood samples.

Maintenance Recommendation
We recommend changing the probe and syringe after 20.000 tests. An alternative to this is a yearly
inspection by an authorised technician.

Rack Transport Check


During every restart, any racks remaining in the pipetting position will be ejected. In the event of failure,
please check if all racks has been ejected.

57 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
Compact X Quick Reference Guide
Compact X in stand-by operation
Preparation

Cuvette register Check, and if necessary refill.


Water tank Check, and if necessary refill.
Waste water canister Check, and empty if necessary.

Menu yw “Hardware” e “Test Position” ereference point OK.


“Sampler” e Follow the instructions at the message box.
“Probe Check” edosage flow OK.

“Wash Position” e^ basic position


of the probe.

“Prime Pumps” eafter completion exit with ^.

Dissolve the reagents according to the manufacturer’s specifications, and place in the reagent block.

Menu yw “Reagent Block” Display of the reagent

Place tray with patient samples in the Compact X.


Menu yw “Sample Prep.” e Manual input of the patient‘s data. Exit operating area
with ^. “Starting of measurements.

Menu yw “Run Display” “Run Display” of the measurement results, or protocol
of the printer.

58 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
Adding patient samples - Filling free positions in the sample
plate
Menu yw n Stops the pipetting process. Wait for the message:
“Stopped with F3 (arm ready: restart F4)“ before
adding patient samples.

Menu yw Menu yw “Sample Prep.” eManual input of the


“Sample Prep.”
patient‘s data. Exit operating area with ^m.

Menu o / ALARM OFF Start the interrupted “Sample Prep.”

Menu m Add the new samples to the “Sample Prep.”


Menu yw “Run Display” Run display of the measurement results or protocol of
the printer.

Input of STAT patients


Menu yw n Stops the pipetting process. Wait for the message:
“Stopped with F3 (arm ready: restart F4“) before
adding patient samples.

Menu yw STAT e Arrange the samples in the free positions of the tray.
Or manual input of the patient‘s data. Exit operating
area with ^.

Menu o / ALARM OFF Start the interrupted “Sample Prep.”

Menu m Assumption of the new samples in the “Sample Prep.”

Menu yw “Run Display” Run display of the measurement results or protocol of


the printer.

Measuring Run Controls


Menu yw “Run Control” e With {} and k (yes/no) switch the control
which is to be measured to “yes“ then e. Enter
desired test abbreviations for the control plasmas
under “tests selected“ with ^. Press m to start run
control.

Run controls by means of sample prep


Menu yw “Sample Prep.” e Enter special character ] and the name of the control,
as defined in the run control. Afterwards enter the tests
as already done with the patients.

59 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
Displaying a run control
Menu yw “Q.C. set-up” e Select test for the run control yw and confirm e.
“Run control” Select “curve“ of the control plasma yw
Curve then e in order to display chart or switch to
“values“ with yw and e in order to change the
areas.
Chart Output of the curve or print with i.
Chart Exit the curve with ^.
“Run Control” Exit with 3 x ^.

Generation of a calibration curve


(Example: automatic Fibrinogen calibration curve using 4 reference
points)
Menu yw “Reagent Database” e For Fibrinogen enter the reagent, the new load number
and the expiration date.

Menu yw “Calibration” e Select test “FIB” e.

“Calibration” Select fully automatic yw then e.

Values e Switch to reference using w . Enter the Fibrinogen


concentration from the package insert into the
reference, then press e.

Dilution Select X1 with k 3:1, then e. In X2, X3, X4


enter the dilutor in the same way 2:1, 1:1, and 1:2 e,
after the last entry press e. The cursor is located on
start “values“.
The calculated values are automatically entered in the
chart. The dilutor chart only has to be entered for the first
calibration. For all other calibrations of this test the dilutors
are assumed.

Message: “Follow the instructions in the message
box”.

The Compact X begins with the calibration curve for the Fibrinogen.

60 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
Checking the calibration (successfully measured)
Message “Compact X has finished calibration. See curve“

Menu yw “Calibration” e
The cursor is located on “curve“. If not, press yw to
move it there. View the curve by pressing e and
confirm it with e.
Accept: “YES“ - if you would like to use the new
calibration curve, confirm with e.
If you want to use the old calibration curve, press
k to switch from accept: “YES” to accept “NO”.
“Calibration” Exit the work area with e.

Printing Calibration Curves (example Fibrinogen)


Menu yw “Calibration” e Select test and confirm e.

“Automatic” yw Switch to the box “Curve“, then press e.



For displaying the curve Press i to print the curve.

To display the curve Exit the curve with ^.


.

61 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
Cycle of a measurement (using the example Fibrinogen )
Preparations for the measurement
- System check.
- Probe in “Test Position”.
- Check level in the water solution container.
- Place clean and reagents in the reagent block for analysis.
- Position sample receptacle.
- Enter ID number
- Enter test identification code.

Place sample receptacle into the tray (bar code aligned). Enter the ID number manually via the
keyboard in the corresponding position.

- Enter test identification code in the “Test” field.


- Exit the “Sample Prep.” window with ^.
- Start measuring with m.

The instrument status changes from “ready” to “working”. The status display above the message window
changes from green to red, in the message window “system working” is displayed. The sample being
processed is marked with a * on the left of the ID number. A cuvette rack is moved forward from the
holding position to the pipetting position, the sampler starts the pipetting process with the pipette volume
specified in the volume chart for plasma dilution and reagents.

Reagent pipetting
In the reagent block, the probe takes up 40µl Kaolin, then 20µl Fibrinogen reagent and dispenses
this volume in the cuvette rack through the lower opening of the same cuvette (20µl of the fibrinogen
reagent taken up last and 20µl Kaolin taken up first). In the wash position the probe is then cleaned.
Since the fibrinogen reagent is very agressive additional cleaning is conducted with Clean solution,
followed by another rinse cycle. With this there are two separately positioned drops in the cuvette at the
pipetting position which are now incubated to 37°C.

Incubating
For incubating, the cuvette bar is moved by the cuvette transport system, according to the time setting
on “Incubation” (normally 180 seconds), through the three incubation stages before reaching the
measuring block.

Starting the measurement


The software recognises the rack arriving at the measuring block and waits for an “alignment period”
of 10 seconds; giving the optic’s measuring amplifiers time to adjust to the cuvettes before starting the
measurement (clotting = measuring time aquisition) by tilting the cuvette rack.
This merges the drops which were previously separated; the stirring device below the measuring block is
turned on and the ball in each cuvette is agitated by the stirring device’s rotating magnets, causing the
reaction volume to be mixed homogeneously.

62 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
Measuring clotting
After tilting the cuvettes (that is after both reaction liquids have merged together) the electric signal
produced by the optical measuring channel is actively traced. In addition, the “measuring thresholds”
are applied above and below this measuring signal.
If clotting occurs, the optical density changes and the measuring signal will cross one of these two
thresholds, in this moment the measuring time is registered.
With Fibrinogen, it is typical that the optical density decreases when clotting starts (more light reaches
the photoelectric cell). This effect originates from the fact that the Kaolin from the clot produced is pulled
out by the rotating ball.

Cuvette rack ejection and return transportation


If the measuring time is registered, the cuvette rack is ejected either into the waste, or if there are
cuvettes which have not yet been used, transported back to the pipetting station.

Calculating the measurement value


The Fibrinogen test is calculated by means of a calibration of measuring time in concentration. For this
purpose the registered seconds measurement is converted by a calibration for example into g\l.

The measured specimen is marked with ≡ left of the ID number. The device status changes from
“operating” to “ready” and the display status above the message box changes from red to green.
The probe moves into the clean position and takes up 100 µl Clean, water is pumped into the washing
position, the probe measures 50 µl of Clean into the washing postion, detects the mixture volume,
immerges and takes up 300 µl for the final cleaning process.

Printing measurement, transmitting data to the EDP


All data, such as patient’s ID, raw values and results are printed with date and time and are transmitted
to the EDP, provided that these devices are installed. Furthermore this data is saved with the reaction
curves in the device and is available any time.

63 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
Troubleshooting
Pipetting Station and Dilutor
Fault Cause/Source Action

Probe misses Probe bent during pipetting. Press <Stop> button of Compact X, select
correct pipetting “exit”, wait 1 min., then turn PC + CX off.
positons. Check test position after restarting, adjust if
necessary. With the CX turned off, manually
check left/right/forward/back shaft guides,
with probe in upper position, for smoothness
of operation. After another manual check
turn the CX on and check the test position.

A primary cup was not cor-


rectly positioned in the sample
tray; the probe made contact
with the cup when moving
sideways.

Test position not checked be-


fore the routine was started.

Test position not check after


probe replacement.

Movement of the pipetting arm


was prevented by force.

64 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
Fluid Sensor
Error Cause / Source Action

The probe sensor is not The pipette probe is Check that probe is assembled correctly,
detecting liquid. not secured correctly. check that the cable’s plug connections are
The sensor cable is not secure and check the cable for damage. The
connected correctly or the cable must be replaced if it is damaged in
cable is defective. any way.

The pipette probe The pipette probe is Check that probe is assembled correctly,
remains above the not secured correctly. check that the cable’s plug connections are
sample / reagent and The sensor cable is not secure and check the cable for damage.
starts to continuously connected correctly or the The cable must be replaced if it is damaged
move up and down. cable is defective. Sensor in any way.If the error is still present, then
setting is incorrect. undertake sensor setting as described below.
WARNING!
- Press the “Stop” button.
- Press the adjustment button on the pipette
arm.
- Press the “Stop” button.
- Restart the CX using the o button.
The probe position Cause / sources of error: Check that probe is assembled correctly.
above the cuvette is too The pipette probe is not
high. secured correctly.
The probe sensor is not Sensor setting is incorrect. Undertake sensor setting as described below.
detecting liquid or only WARNING!
very large volumes. - Press the “Stop” button.
- Press the adjustment button on the pipette arm
- Press the “Stop” button.
- Restart CX using the o button.

65 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
Dilutor
Error Cause/Source Action

Probe is dripping The tube to the dilutor Replace tube.


during the pipetting is kinked, resulting in a
process. contraction and reduced
fluid flow.

Tube has worked loose Pull tube from the guide to the compression
at the dilutor’s compres- fitting, then retighten the fitting and run it
sion fitting. properly. (If only the fitting is tightened, any
possible tension on the tube could cause the
fitting to loosen again. Therefore dismount-
ing and reinstallation are necessary after the
fitting has been retightened!

Tube not completely Perform “Prime Pumps”.


filled with fluid.

Syringe of the dilutor Check syringe and/or fastening (note sealing


leaky or not correctly washer at the seat’s top).
fastened.

Note:
Following any service to the dilutor / tubing / probe system the following checks must be performed on
the “hardware” menu:

“Test Position” - “Probe Check” - “Prime Pumps”, and strongly recommended:


a series test, e.g. with Fibrinogen, using the same sample 16 times.

Wash Station
General:
The wash station’s rinse cycle is software controlled by the probe sensor.

Error Cause/Source Action

”Wash station over- Waste water drain Check tube path outside of the instrument
flow”. tube squeezed. (possibly also a blocked drain port, e.g. after
transport of the instrument).

Waste water tank Provide vent opening.


without vent opening.

66 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
Messages
If you are not able to resolve the errors or problems after consulting the error list and
corresponding descriptions, or if you do not have the necessary access rights, please contact your
authorised service technician.

EF05 - AC pipetting timeout


A time out has occurred (e.g., no more AC reagent, or the reagent drawer has been removed) during
the pipetting process using the D-Dimer “AC” reagent. If the delay is too long, the measurements will be
flagged with EF05. The measurement will be repeated (pipetted and measured) in a new cuvette rack.

EF06 - Strip pipett. timeout


A time out occurred during the pipetting process of a cuvette rack (e.g., no more reagent, or the
reagent drawer has been removed) during the pipetting process. If the delay is too long, the
measurements will be flagged with EF06. The measurement will be repeated (pipetted and measured)
in a new cuvette rack.

EF07- Plasma not found sc


After delivery of the specimen from the closed tube into the intermediary chamber of the cuvette rack,
the specimen could not be found. Needle sensor check.

EF08 - Not enough plasma sc


After delivery of the specimen from the closed tube into the intermediary chamber of the cuvette rack,
not enough liquid could be found.

EF09 - Cup removed


Test tube was removed after the initial detection.

EF10 - Plasma not found


Not enough plasma in the primary vessel. Pipetting needle is not correctly mounted or probe
adjustment is not correct.

EF11 - Reagent not found


Not enough reagent for detection in the vessel.

Note: If a missing reagent is not replaced within 2 min., the sequence is interrupted
and the tests, which do not require this reagent, continue.

EF12 - Pipett. stop time out


The emergency stop in the device was pressed for longer than 1 minute. The device interrupted the
sequence.

EF13 - Plasma rack timeout


The rotor was missing for longer than 1 minute. The device interrupted the sequence.

EF15 - Reag. rack time out


The reagent block was missing for longer than 1 minute. The device interrupted the sequence.

EF16 - Pre. posi. not free


All cuvettes for predilution have been used. This message has not been responded to within 2 minutes.
Replace with new predilution cuvette racks so work can continue.

EF17 - Pre. plas.not found


An item / series of cuvettes is missing in predilution. The metering system has assigned predilution to a
free item. Consequence: abort program, clean predilution block, fit new cuvettes, then restart.

67 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
EF18 - Barcode not readable
The bar code on the tube is not readable. Check the quality of the barcode.

EF19 - Barcode wrong


The bar code on the tube is not correct. The tube should be exchanged. Check the quality of the bar
code.

EF20 - Ball bear. missing


A ball is missing in one / several cuvette/s of a rack. Automatic repetition of all tests if a ball is missing
when defined as single determination.

EF21 - Mixing motor defect


The drive motor for the magnetic stirrer, under the measuring block, is blocked.

EF22 - Check Curve


Possible with types of detection:
pn/check, cpol, and apol 405nm.
1) Clot: the signal is compared with a special standard. The flag is produced if a variance occurs.
2) Chromogen: No large reaction flaws may occur.
3) Immunological: same as chromogen and while crossing the measuring range.

EF23 - No clot
There was no coagulation detected within the measuring time 1/measuring time 2. Check the reagents;
check the pipetting system.

EF24 - Start not OK


An expected optical change did not occur in the tilting process. This can occur spontaneously, without
further causes. The pipetting system might not operate perfectly. Possible with channels 2-4.

EF25 - Start not OK ch.1


Same as EF24, but with the 1st channel. Specific feature of this error: The complete rack is rejected.
Check cuvette transport.

EF26 - Threshold sign. out


Safety supervision with coagulation tests. At the instant of the “Start“- time, the measuring signal is still
outside the measuring thresholds. The measurement values are ignored and the system repeats the
measurements. Possible causes can be too small measuring volumes or a premature reaction of the
specimen.

EF27 - Ignored ”Trace”


Safety supervision with coagulation tests. For this test, only a flawless coagulation signal measuring with
the input “trace“ in the test parameters is accepted. Ignored measurements are repeated automatically
without this safety supervision, but in double determination. Controls are always evaluated without this
safety supervision.

EF28 - Sign. at thresh.slow


Only for PT with calculated fibrinogen. The progression of the clotting signal was too slow (possibly
very low fibrinogen).

EF29 - Sign. at thresh. fast


Only for PT with calculated fibrinogen. The progression of the clotting signal was too fast (possibly very
high fibrinogen).

EF30 - LED too dim The measuring channels do not receive enough light, and perhaps they have
become soiled. Clean the measuring block with a clean stick; check optics.

68 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
EF31 - LED too bright
The measuring channels receive too much light. Liquid may have gotten into the measuring chamber.
Clean measuring block with a clean stick; check optics.

EF32 - Ch. x out of range <


The measuring channels receive too little light signal. Clean the measuring block with a clean stick.
A measuring channel in the measuring block is heavily soiled. Perhaps the rack has not been completely
ejected and blocks this channel in the LED test.

EF33 - Ch. x out of range >


One measuring channel is receiving too much light signal. Too much liquid was put onto the sponge
of the clean stick when cleaning the measuring block. Solution: let the liquid in the measuring block
evaporate.

EF34 - Chan. x < mean


The value of an individual channel deviates too far below the mean value.

EF35 - Chan. x > mean


The value of an individual channel deviates too far above the mean value.

EF41 - Chromo curve not OK


Reaction progress cannot be defined (elucidation rather than clouding). Check the measurement system
using hardware/LED test.

EF42 - Chromo linear < 0.94


Status only possible in tests with “chro-lin” recording of measured values. “chro-lin” = increase
measurement with lin. regression. The “CV” calculated over the 5 measured values is < 0.94. Reagent,
sample or test adaptation not OK.

EF43 - Chromo polynom < 0.95


“chro-pol” = increase measurement with polynom. The “CV” calculated over the 5 measured values is
< 0.95. Reagent, sample or test adaptation is not OK.

EF44 - No signal (derived)


The reaction signal was too low or non-existent. Reaction occurred too late; possibly after the measuring
time period had ended.

EF45 - Chromo result > 3.0


Reaction is too large.

EF46 - Value > meas. Time 1


The measurement time for a test is greater than the measurement time 1 programmed for this test. This is
possible if several tests with different measurement times are being measured in one rack (e.g. PT of 60
seconds + PTT of 180 seconds).

EF47 - Value > meas. Time 2


The measurement time for a test is greater than the measurement time 2 programmed for this test. This is
possible if several tests with different measurement times are being measured in one rack (e.g. PT of 60
seconds + PTT of 180 seconds).

EF48 - Value < single min


The measured value was recorded below the programmed “min entry”. Possible during clotting and
chromogenic tests. Only possible during tests done in single determination. Test is repeated.

69 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
EF49 - Value > single max
The measured value was recorded above the programmed “max entry”. Possible during clotting and
chromogenic tests. Only possible during tests done in single determination. Test is repeated.

EF50 - Duplicat. error


The two measured values of duplicate cases are outside tolerance. Sample is very non-homogeneous
(especially during PTT, thrombin time). Sample has clotted in advance. Pipetting system is not OK
(condition of syringe/probe).

EF51 - Sample very dark


The sample is too cloudy. The sample is too lipaemic, hemolytic or icteric.

EF52 - Meas. point 1 not OK


Only derived Fibrinogen: The signal at the start of the reaction is not OK. Check “times“ max 1.

EF53 - Meas. point 2 not OK


Only derived Fibrinogen: The signal at the end of the reaction is not OK. Check “times“ max 2.

EF54 - Cal. CV value not OK


The measured values of a standard point are too different (only with 4 measurements per standard
point).

EF55 - Noisy
Detection of an irregular (noisy) reaction path during a coagulation test:
The following items could cause this problem:
1) Micro-clot
2) A piece of the rubber (or cap material) is in the cuvette (when working with “cap-piercing”).
EF 55 flags the measuring value without overwriting it. With an EDP (Host) connection: The data is
not automatically sent to the host. A warning message (EP68) is displayed in the message box. It is
recommended to re-check the result. If any doubts remain, repeat the measurement.

EF59 - Repeat. dupl. error


Flag is only possible in duplicate cases once a test has been repeated. Two different flags are then
produced: analyse the sample again.

EF60 - Result < calib.range


The measured value cannot be converted into a result, because it is below the calibration curve limit.
Change “min and/or max” calibration curve limits.

EF61 - Result > calib.range


The measured value cannot be converted into a result, because it is above the calibration curve limit.
Change “min and/or max” calibration curve limits.

EF62 - Result < 0.0


The measured value is in the negative area of the calibration curve. Only possible with chromogenic
tests. Sample, reagent and/or test adaptation is not OK. Check pipetting system and probe sensor.

EF63 - Value < Q.C. min.


The result of the quality check lies below the programmed confidence range.

EF64 - Value > Q.C. max.


The result of the quality check lies above the programmed confidence range.

EF65 - Value < lower limit


The result lies below the programmed normal range.

70 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
EF66 - Value > upper limit
The result lies above the programmed normal range.

EF67 - Overflow res. > 9999


Calculation overrun. Change the calculation type or entries under calibration curve.

EF68 - Same results: verify


The message can be displayed when four same measuring values in one cuvette rack occur. Check if
the same sample is used.

EF71 - Mb Mixing Motor slow


The speed of the mixer unit under the measuring block is too low.

EF72 - Mb pos. not up


The measuring rack is not in move-in position “upwards“. Tilt rack is restricted by swinging. Tilt motor is
not working correctly. Sensor does not recognise the correct position.

EF73 - Mb pos. not down


see EF72

01 - [st] System is not yet ready, ejecting strips


Normal status message once the routine software has been started. “ready” appears after about 40
seconds.

02 - [st] System is not yet ready


This message indicates that the system cannot be started yet. You must wait for the cuvette rack to eject
after the system has been restarted.

03 - [st] System is working


The system is working. Details are also provided for the area in which it is working.

04 - [st] System ready


The routine can be started.

05 - [st] System ready (F3, for start press first F4)


n is activated. Press o to restart.
06 - [st] System stopped with error, restart with F4
Check the incident before you press o; call service if necessary.

07 - [st] Stopped with F3 (arm ready: restart F4)


The system has been stopped using n and can be restarted using o.

08 - [st] Stopped (arm is still working) wait for “ready”


You have pressed n to stop the routine process after pipetting the current rack to e.g. scan in new
samples. Press o to restart the routine.

09 - [st] Wait for scanning (arm is still working)


You have pressed the scan button to undertake a scanning process after pipetting the current rack.
Scanning process is started automatically after pipetting the current rack.

10 - [st] Scanning in progress


Wait until the scanning process is complete.

71 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
11 - [st] (Sample prep.)
Status message in (....): This process is started once m is pressed.

12 - [st] (Calibration)
Status message in (....): This process is started once m is pressed.

13 - [st] (Run Control)


Status message in (....): This process is started once m is pressed.

14 - [st] (Hardware)
Status message in (....): Always exit the hardware so the needle is in the wash station.

15 - [st] (Prime pumps)


Status message in (....): currently underway.

16 - [st] (Probe clean) press <ENTER> to continue


Press e to end cleaning of the needle (recommended interval of 10 - 20 minutes).

17 - [st] > X minutes


Gives the prospective rest time in minutes for the currently started specimens.

18 - [st, er] Distilled reservoir level low - refill


There is not enough water in the wash tank. You can only start the machine once you have topped up
the water. If there is ready sufficient water, the sensor may be defective.

19 - [st, er] Temperature out of range (pipetting station)


The warm-up phase can last up to one hour depending on the environmental temperature/conditions.

20 - [st, er] Temperature out of range (incubation station)


The warm-up phase can last up to one hour depending on the environmental temperature/conditions.

21 - [st, er] Temperature out of range (measuring station)


The warm-up phase can last up to one hour depending on the environmental temperature/conditions.

22 - [st, er] Temperature out of range (reagent station)


Service message: in case reagent cooling fails. Check environmental temperature.

23 - [st, er] Plasma block in working station not present


The plasma rack or rotor is not in the system during routine.

24 - [st, er] Reagent block X not present


During the routine, the reagent insert is not in the device.

25 - [st, er] Plasma rack not present (arm stopped)


The plasma rack is missing or is not completely inserted.

26 - [st] Reagent block not present (arm stopped)


The reagent block is missing or is not completely inserted.

27 - [st] Pipetting stop is active


The pipetting process has been stopped using the stop button on the system.
You have to press the stop button again to restart the process.
1) Only press the stop button if the pipetting process is to be stopped immediately.
2) Only briefly press the stop button to e.g. replace a reagent!
Caution: delays caused by the stop button being pressed for too long (>1 minute) may have an impact
on the measurement results!

72 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
28 - [st, er] Waste container not present
Please insert an empty waste container into the device.

29 - [st, er] Waste container nearly full


The container for the waste is almost full and must be emptied at the next opportunity.

30 - [st, er] Waste container full


The container for the waste is full and must be emptied.

31 - [st, er] Place pre.buf.: pos. 7, plasma: c1, cups: X


This message appears if the fully automatic calibration is to be started. Place the reference plasma in
the reagent block in the “control 1” position, corresponding empty containers (e.g. Hitachi cups) in the
specified positions X (e.g. X2..X4) in the rotor or plasma rack.

32 - [st] Place plasma in %s, cups in %s


Place the reference plasma in the reagent block in the “X” position, corresponding empty container
(e.g. Hitachi cups) in the specified positions in the plasma rack.

33 - [st] Place predil buffer at pos.7 and press <ENTER>


No predilution buffer at pos. 7. Please place predilution buffer at position 7.

34- [st] Calibration finished. Failed!


The calibration curve produced is incorrect and must be repeated. Check the calibration process.

35 - [st] System has finished calibration. See curve


The system has completed the measurements for automatic calibration, for fully automatic calibration or
for recalibration. Enter the “calibration” menu item and look at the curve.

36 - [st] Host offline


Data transfer to the Host (EDV, LIS) is not possible at the moment. Reactivate with bp.
Check system parameter settings via maintenance.

37 - [st] Printer offline


Reactivate with bi. Check system parameter settings via maintenance. Check via icon
“configure printer”.

38 - [er] System parameter not OK


Only maintenance: The system parameters are not in order. Please check, e.g. device for host

39- [er] Barcode parameter not OK


Only maintenance: The bar code parameters are not in order. Please check.

40 - [er] Reagent block parameter not OK


Only maintenance: The reagent block parameters are not in order. Please check.

41 - [er] Same barcodes not readable, see Sample Prep.


Some barcodes are not readable. Check in the menu Sample Prep. which tubes were not read.

42- [me] Test X not defined for control plasma Y


A quality check is integrated in the normal routine. The test selected is not defined for this check.

43 - [me] Lot-no. X not found.


Message from reagent database. Lot-No. X scanned with hand scanner does not exist.

73 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
44 - [me] Control plasma X is defined twice
Two control plasmas have the same name. Please change one of the two names. You cannot exit the
program item until you have changed the names.

Caution: even blank characters are recognized as names for control plasma!

45 - [me] Up volume is too great (max. X)


Wrong volume: maximum X. Check test setting in maintenance.

46 - [me] Down volume for X pos. is too great (max. X)


Wrong volume: maximum X. Check test setting in maintenance.

47 - [me] Down volume for cuvette is too great (max. X, Single / Double)
Wrong volume: maximum X. Check test setting in maintenance.

48 - [me] Please enter test for definition of liquid


Volume setting without test. Check test setting in maintenance.

49 - [me] Dilution Volume Setting X not defined


Volume setting for dilution X (e.g. 1:4) not defined. Copy files “dilu-*” from param_default to param or
reinstall software.

50 - [me] Derived test X is not possible


Check test setting in maintenance.

51 - [me, er] Derived test X is not selected


Check test setting in maintenance.

52 - [me] Block X in working station is not yet ready


The plasma rack was removed from the system before processing was completed. Reinsert the plasma
rack.

53 - [me, er] Definition of parameter for derived test X not OK


Check via test setting in maintenance. Check main test and derived test.

54 - [me] Rack X is full, no free prep-positions


Sample prep: rack is full, scan of new samples is not possible.

55- [me] X value is too small (min. Y)


The calibration value X is too small. It must be greater than Y.

56 - [me] X value is too great (max. Y)


The calibration value X is too great. It must be less than Y.

57 - [me] X column: value is too small (min. Y)


Calibration table: the value for column X is too small. Please enter a higher value.

58 - [me] X column: value is too great (max. Y)


Calibration table: the value for column X is too great. Please enter a smaller value.

59 - [me] Reference value must be greater X


The start value in the fully automatic production of calibration curves must be greater than X.

60 - [me] ISI < min. ISI value (min. X)


The ISI value entered in the “calibration curves” menu item for manual and automatic production of
calibration curves is less than the value specified. Please correct your entry.

74 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
61 - [me] ISI > max. ISI value (max. X)
The ISI value entered in the “Calibration Curves” menu item for manual and automatic production of
calibration curves is greater than the value specified. Please correct your entry.

62 - [me] Value is too small (min. X)


A value is too small (incubation, measurement time 1, measurement time 2, calibration). Change the
value.

63 - [me] Value is too great (max. X)


A value is too great (incubation, measurement time 1, measurement time 2, calibration). Change the
value. Service: message from applications sector.

64 - (me, er)Too many tests selected (max X)


In sample prep too many tests are selected for one sample. Delete one or more tests.

65 - [me] Reagent block not defined (max X)


Select a reagent block with the correct number.

66 - [me] This value must be empty: end of table is X value


When making manual entries into the calibration table, another value below the limit value (0) has been
entered. Please delete the value entered or change the line containing the limit value.

67 - (me, er) Test X is not selected


Check test setting and reagent block in maintenance.

68 - [me] Serial pipetting not possible


Check test setting in maintenance.

69 - [me] Add 1ml of 5% bleach in wash stn. + ENTER for start


When selecting the “Probe Clean” menu item in “Hardware”, the wash station must be filled with bleach
before the second cleaning stage. Please fill with bleach and press e.

70 - [me] Value not ok (X)


Check test setting in maintenance.

71 - [me] For predilution please pipette the buffer first


Check test setting in maintenance.

72 - [me] Volume setting for predilution is not ok (X lines)


Check test setting in maintenance.

73 - [me] Up volume of X must be greater 0


Check test setting in maintenance.

74 - Down volume of X must be 0


Check test setting in maintenance.

75 - [me] Wash or clean in predil. X line not possible (must be empty)


Check test setting in maintenance.

76 - [me] Only normal pipetting possible


Check test setting in maintenance.

77 - [me] Incubation in predilution pipetting not possible (must be 0)


Check test setting in maintenance.

75 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
78 - [me] For predilution, please pipette plasma in predil cuv.
Check test setting in maintenance.

79 - [me] Down vol. for predil cuv. is too small (min. X)


Check test setting in maintenance.

80 - [me] Down vol. for predil cuv. is too great (max. X)


Check test setting in maintenance.

81 - [me] Down volume > up volume (X) not possible


Check test setting in maintenance.

82 - [me] X. line: please pipett predil. plasma in cuvette


Check test setting in maintenance.

83 - [me] Down volume of X must be greater 0


Check test setting in maintenance.

84 - [me] Up volume of pr. plasma too great (X)


Check test setting in maintenance.

85 - [me] Pipetting of predilution not possible


Check test setting in maintenance.

86 - [me] Chromogenic coagulation X not possible


Check test setting in maintenance.

87 - [me] Following test X is not possible


Check test setting in maintenance.

88 - [me, er] Following test X is not selected


Check test setting in maintenance.

89 - [me] No test found with reagent X


Menu “Run Control”.

90 - [me] Please read values for reagent X


Menu “Run Control”..

91 - [me] Rotor X is not in working station (Y)


Before scanning the tubes in the sample preparation, rotor X is missing in the device (errorcode Y).
Please put the rotor in the corresponding position.

92 - [me] Rotor X home not ok(Y)


The rotor X “Home Position” is not reached before the samples are scanned (errorcode Y). Please check
whether the rotor is meshing correctly with the toothed gear or whether the bar code in the “home
position” is dirty.

93 - [me] No patients in rotor X (Y)


When scanning the samples, no samples were found in rotor X (errorcode Y). Please check if the
barcodes on the small plasma tubes are aligned correctly.

94 - [me] Patient barcode in prep. X is not ok (Y)


Sample X was scanned in previous scan. The actual scan process of sample X ends with an error
(errorcode Y).

76 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
95 - [me] Rotor: parameter error X
Start software with protocol. Check via adjusting rotor.

96 - [me] Test X not possible: has self depending tests


Calibration: test X can not depend on another test, because test X is main test. Check test setting in
maintenance.

97 - [me] Test X is depending on test Y


Calibration: test X is depending on test Y, additional dependency on another test is not possible. Check
test setting in maintenance.

98 - [me] Calibration not possible: depending on test X


The test does not have its own calibration curve, because it is linked to the calibration curve of another
test. Change tests.

99 - [me] Test X depending on test Y not possible


Test X can not depend on test Y, because it is the same test. Check test setting in maintenance.

100 - [me] Depending tests for calculation type X not possible


Dependency tests are not allowed for the requested calculation type. Check test setting in maintenance.

101 - [me] Pipetting liquid X into position Y not possible


Liquid X can not be pipetted into destination position Y. Check test setting in maintenance.

102 - [me, er] Coagulation type of derived test X not ok


Only some coagulation types are allowed for derived tests. Check test setting in maintenance.

103 - [me] Too many records selected (max. X)


The maximum amount of data possible for printing or sending has been exceeded (maximum X).

104 - [me] Wash sequence needed


After every pipetting of a reagent or specimen, a washing cycle must follow.

105 - [me] Wash sequence X in last line of table not possible (must be without ‚C‘)
Check test setting in maintenance.

106 - [me] Please put X mm cup on the wash station and press <ENTER>
Serves as a daily check of the needle (see daily routine).

107 - [me] Sample in prep. X not found


After acquiring the specimen and during the pipetting, it was detected that the sample tube at position X
was removed (Reflector foil was detected).

108 - [me] Dilution X not possible: volume setting of plasma without dilution
Fully automatic calibration: dilutions 4:1, 3:1, 2:1 not possible. Requires plasma dilution in volume
setting. Check plasma pipetting in volume table or use other dilutions.

109 - [me] USB stick could not be mounted


The USB stick can not be recognized by the system. Remove the USB stick and insert it again.

110 - [me] No test on USB stick found


No test was found on the USB stick that could be copied to the system.

111 - [me] Device not ok (X)


Accessing linux device X (e.g. USB stick) not possible. Check device names in profile.local.

77 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
112 - [me] Error from script X
Internal error from copy script. Check device names in profile.local. Reinstall software.

113 - [me] No USB stick found (Y)


No USB stick found.

114 - [me] Too many USB sticks found (Y)


Too many USB sticks (count Y) found. Remove all USB sticks and external disks from PC and try again.

115 - [me] X position difference too large


“Hardware/Cuvette Rack Adjust”: the tolerance of position X differences is too large. Check via
adjusting/sampler positions.

116 - [me] X column: not all values ascending


The values entered in the column X (left/right) of the calibration table must be entered in ascending
order to be able to manually produce calibration curves. Please correct this value.

117 - [me] X column: two values are equal


Two equal values have been entered in the column X (left/right) of the calibration table in order to
manually produce calibration curves. The values must be different. Please correct this value.

118 - [me] X column: not all values descending


The values entered in the column X (left/right) of the calibration table must be entered in descending
order to be able to manually produce calibration curves. Please correct this value.

119 - [me] Key permitted only in main-menu (press ESC)


The key just pressed is not permitted in the current menu. Press the ˆ key to go back until you reach
the main menu. You can then re-select the key you pressed previously.

120 - [me] Test not available


A test for which there are no abbreviations has been entered in the “Sample Prep” menu item. The
letters A-N and X1, X2, etc. are intended for change tests. This message will appear if you enter a “P”
for example.

121 - [me] Menu entrance not permitted, check calibration data via Manual, Curve
Selecting of “Calibration, Curve” not possible. Create Calibration via “Calibration/ Manual / Curve”.

122 - [me] LED test not possible


The LED’s cannot be tested during the current routine. Press n and wait until the current pipetting
process is complete. You can then test the LED’s in the “Hardware” menu.

123 - [me, er] Mixing ball(s) from cuvette is missing


There is a ball missing in the cuvette rack. The test is repeated automatically.

124 - [me] Probe is not in wash position


When exiting “hardware”, the needle must first be moved into the wash position. Before exiting
“Hardware”, you should, therefore, first select the “Wash Station” item. Only then should you exit
“Hardware” using the ˆ key.

125 - [me] Prime pumps and probe clean not possible


The “Prime Pumps” menu item cannot be activated while the system is processing the routine. Please
wait until the system has completed the routine and then restart “Prime Pumps”.

126 - [me] Hardware test not possible


The programs of the “Hardware” menu item cannot be selected during the current routine. Press n and
wait until the current pipetting process is complete. You can then rhun the “Hardware” programs.

78 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
127 - [me] Volume table for single test is empty
Check test setting in maintenance.

128 - [me] Position 7 for buffers only


Check reagent block setting in maintenance.

129 - [me] Control-plasma not defined


A quality check is integrated in the normal routine. This message is displayed if the control plasma has
not been defined. Change the name if you have incorrectly typed it, or delete the request.

130 - [me] Values are not OK


The Q.C. limits in the check values for high, average and low are not correct, e.g. the average value is
less than the value for low.

131- [me] No Curve for this calculation type


Calibration: this calculation type works without calibration curve.

132 - [me] Clear track not finished


The “Hardware” menu item cannot be exited if the process of ejecting the rack has not been completed.

133 - [me] In the first three lines must be a right value


When manually producing the calibration curve, the values for the first three calibration points must be
entered in the calibration table. Please enter the missing values.

134 - [me] In the first two lines must be a right value


When manually producing the calibration curve, the values for the first two calibration points must be
entered in the calibration table (chromogenic tests). Please enter the missing values.

135 - [me] Normal < min. calibration value


The normal time entered in the calibration table to manually and automatically produce calibration
curves is too low. Please correct your entry.

136 - [me] Normal > max. calibration value


The normal time entered in the calibration table to manually and automatically produce calibration
curves is too high. Please correct your entry.

137 - [me] Only one standard print possible


Maintenance: Both types of standard print have been selected from the “Print” menu. Please select just
one type of standard print.

138 - [me] Press <ENTER> to end the probe clean


The “Probe clean” menu item in “Hardware” must be quit after a sufficient cleaning time by pressing
e.
139 - [me] Volume table for duplicate test is empty
Check test setting in maintenance.

140 - [me] Please read first control plasma


This message appears when scanning control plasma data using a hand-held scanner.

141 - [me] Please read first name of reagent


This message appears when scanning reagent data using a hand-held scanner.

142 - [me] Please scan <END> for next line


This message appears when scanning reagent data using a hand-held scanner.

79 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
143 - [me] Lot number missing
This message appears when scanning reagent data using a hand-held scanner

144 - [me] To register the patients please press <F3> first


During the routine, you can place new samples in the rotor once the current rack has been fully
pipetted.

145 - [me] SCAN permitted only in main- or plasma-prep menu


The scan keys on the system are only permitted in the main or routine menu.

146 - [me] LIS communication error (already in work, or ready)


The host computer sends tests for a sample. The actual sample has been processed or is just processing.
Reactivate sample with q or wait until sample processing is finished.

147 - [me] Calculation type only duplicate test possible


Calculation type rat 1:2 needs duplicate testing. Check test setting via maintenance.

148 - [me] Please put test cup on the washstation and press <ENTER>
Message from “Hardware/Probe Check.”

149 - [me] Please press <ENTER> for end of probe check


The needle check is hereby ended.

150 - [me] Probe check is not finished


Press o; follow the instructions in the message box.

151 - [me] Please remove test cup from washstation and press <F4>
Now, take the container off the wash station to check the volume and press o.

152 - [me] Please wait


Please wait until the process has been completed.

153 - [me] Error: Copy not ok


An error occurred during copying from or to USB stick.

154 - [me] First unit is not ok


The conversion unit for this test is not OK. Check test setting via maintenance.

155 - [me] Success


Message appears after copying successfully.

156 - [me] Second parameter must be empty


Check test setting in maintenance.

157 - [me] Second parameter can be NorISI, CurISI or empty


Check test setting in maintenance.

158 - [me] Second unit is not ok


Check test setting in maintenance.

159 - [me] Second print format is not OK


Check test setting in maintenance.

160 - [me] Second unit must be empty


Check test setting in maintenance.

80 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
161 - [me] Second print format must be empty
Check test setting in maintenance.

162 - [me] LIS is switched off in system parameters


When sending to the EDP with p it is ascertained that the communication is turned off.

163 - [me] Printer is switched off in system parameters


When attempting to print, it was ascertained that the printer is switched off in the system parameters.

164 - [me] Please wait: copying


Message during copying data.

165 - [me] ‚CurISI‘ can not be first parameter


Check test setting in maintenance.

166 - [me] Attention: you are working without checksum


Check system parameter setting in maintenance. Ensure that a checksum on the host connection is not
necessary.

167 - [me] Error: Thrombolyzer device and host device equal not possible
Check system parameter setting in maintenance. Use different devices for system and host.

168 - [me] Attention: probe drives to manual clean position, don‘t grab into work area!
“Hardware/Probe Clean manually”: be careful!

169 - [me] Attention: wipe probe with alcohol only from top to bottom!
“Hardware/Probe clean manually”.

170 - [er] Liquid X Y is missing


The reagent X for test Y has not been defined in the “reagent block” menu item. The system cannot
undertake the test. Possible error cause: incorrect reagent station selected.

171 - [er] Control plasma X not found


There is no control plasma or too little control plasma at the specified position. Please add plasma.

172 - [er] Plasma X not found


Plasma X has not been placed in the sample preparation system or the liquid level is so low that the
system cannot detect it. The system passes to the next sample to continue working from this point. The
sample not found is identified by EF10.

173 - [er] Not enough of liquid X Y (Z) (low level)


The reagent X for test Y in position Z will only suffice for the cuvette rack which has just been started,
e.g. RE A (12).

174 - [er] Liquid X Y not found


All defined spaces of reagent X for test Y are below the “low level”. The system cannot continue work.
Please provide the reagent needed at the corresponding positions in the reagent block., e.g. RE A.
(Message will not appear in the error database)

175 - [er] No patient data in block X and X


No new patient data was recorded after “Scan”

176 - [er] Interface X not ok. Please exit!


PC interface not accessible. Check name of system device and name of host device via maintenance.
E.g. ttyS1 selected, but doesn‘t exist.

81 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
177 - [er] Measuring channel x too dark
The specified measuring channel is too dark. Please clean the measuring block. Check via “Adjusting/
Optics”.

178 - [er] Measuring channel x too bright


The specified measuring channel is too bright (chromogenic tests). Please clean the measuring block.
Check via “Adjusting/Optics”.

179 - [er] Measuring channel x too dark (difference to mean)


The specified measuring channel deviates too much from the other measuring channels in the dark
range (chromogenic tests). Please clean the measuring block. Check via “Adjusting/Optics”.

180 - [er] Measuring channel x too bright (difference to mean)


The specified measuring channel deviates too much from the other measuring channels in the bright
range (chromogenic tests). Please clean the measuring block. Check via “Adjusting/Optics”.

181 - [er] File X not found. Press F4


Missing parameter file X (e.g. sys-par.txt): restore it or recreate it.

182 - [er] File X not saved. Press F4


Parameter file X (e.g. sys-par.txt) could not be written: check access rights via file manager.

183- [er] No patient data in block X


Only tests or only ID numbers were entered in sample prep. Enter the missing ID numbers or tests.

184 - [er] Place plasma block X in working station and press F2


This message appears when changing from one plasma rack to another.

185 - [er] Predilution rack X is full. Please change it.


The last cuvettes were used in the predilution rack. Please change the predilution rack, so the next
predilution can be pipetted without delay.

186- [er] Calibration for test X is not OK, verify via Calibration, Manual, Curve
An attempt was made to start a routine with m. The standard curve for test X is not OK. The current
standard curve for this test must be validated.

187- [er] Version of X task not OK.


Not all parts of the software are of the same version: logout, login, reinstall software.

188 - [er] Read error in file X. Press F4. Call Service


Some missing fields in parameter file (e.g. sys-par.txt). Check settings in maintenance or reinstall the
parameters.

189 - [er] Volume table for test X is not OK


Some wrong fields in parameter file for test X (e.g. test-par-00.txt). Check settings in maintenance.

190 - [er] Predilution plasma in cuvette X not found


When using stations with predilution, the operator has forgotten to position the predilution cuvettes.
Please place predilution cuvettes in the station. Check needle sensor via adjusting.

191 - [er] Cuvette X for predilution not free


When using stations with predilution, the operator has forgotten to change the predilution cuvettes in
time. Please place unused predilution cuvettes in the station at position X.

192 - [er] Definition of parameter for test X is not OK


Check via test setting in maintenance. Check all fields of test X.

82 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
193- [er] Definition of parameter of following test X not OK
Check via test setting in maintenance. Check main test and following test.

194 - [er] Rotor X overload (prep. X)


Rotor blocked while routinely driving to position X. Please check whether the rotor can be turned by
hand or whether the rotor is being hampered from turning by foreign bodies.

195 - [er] Rotor X timeout (prep. X)


During the routine, the rotor does not run correctly (driving to position X). Please check whether the
rotor can be turned by hand, or if it is blocked.

196 - [er] Timer for liquid X Y expires (prep. Z)


The usage date of reagent X for test Y at position Z has expired. The reagent must be renewed.

197 - [er] ERROR on rotor scanner (X). Please exit!


Initialize rotor via adjusting. (errorcode X).

198 - [er] File X not found. Please exit the system!


Missing parameter file (e.g. barc-par.txt): restore it or recreate it.

199 - [er] Barcode in prep. X not readable (1st time)


The first scanning attempt for the sample pos. X during the routine was not successful. This message is
not displayed on screen, but it is saved in the error database instead for service purposes.

200 - [er] Wrong barcode in prep. X (1st time)


The first scanning attempt of a sample in the rotor during the routine was not successful. This message is
not displayed on screen, but it is saved in the error database instead for service purposes.

201 - [er] Rotor error:waiting of rotor X, answer from rotor X. Please exit!

202 - [er] Transport of strip backwards not ok (X Y)


An error has occurred when transporting a cuvette rack from the measuring block back to the pipetting
position. Quit the main menu and follow the instructions in the warning window once the software has
been restarted. (position X, errorcode Y). Check cuvette transport via “Adjusting”.

203 - [er] Error in file X. Press F4 and check parameters!


Format error in file X (e.g. sys-par.txt). Press o and check the appropriate parameters via maintenance.

204 - [er] Measuring channel X too dark (LEDs off)

205 - [er] Measuring channel X too bright (LEDs off)

206 - [er] Plasma X not found (sc Y)


The patient‘s plasma X could not be found in cuvette strip (secondary cup Y). Cap piercing. Check
needle sensor via “Adjusting”.

207 - [er] Plasma X not found (level Y, Zµl missing)


The patient‘s plasma X could not be found in cuvette strip (secondary cup Y). The amount in the mixing
chamber (secondary cup) is too low. Check arm position, check needle sensor, check the pipetting
system.

208 - [er] Communication with SAMPLER not ok (X). Please exit the software
The communication with the specimen distributor was disturbed. The device must be shut down and then
restarted. (errorcode X).

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209 - [er] X device ID mismatch (Y). Please Exit!
The sof tware does not match the hardware. (errorcode X, Y).

210 - [er] X with wrong hardware version. Please QUIT


The hardware does not match the current software. (subcontroller X). Update hardware.

211 - [er] X with wrong software version. Please Exit!


The software does not match the required software version. (subcontroller X). Update subcontroller via
“Adjusting”.

212 - [er] No communication (X). Please restart the system


This message can be caused by the following: The connection between the system and the PC is missing
or defective. The system is not switched on. Some connections inside the system are not OK. Check
cables (subcontroller X).

213 - [er] Barcode in prep. X not readable


During pipetting: bar code in pos. X not readable. Sample is flagged. Check the sample position in the
rotor; check the quality of the bar code.

214 - [er] Wrong barcode in prep. X


During pipetting: bar code in pos. X not readable. Sample is flagged. Check the sample position in
rotor; check the quality of the bar code.

215 - [er] Attention: check results and sample in rotor prep. X!


Check the specimen and measurement values; check for plausibility. If necessary, repeat.

216 - [er] Unexpected RESET from X! Please restart the system


Communication with subcontroller X failed. Check power supply, cables and fuses.

217 - [er] Unexpected ANSWER from X (Y)! Please restart the system
Communication with subcontroller X failed with errorcode Y.

218 - [er] Unexpected EVENT from X (Y)! Please restart the system
Communication with subcontroller X failed with errorcode Y.

219 - [er] Unexpected BOOTLOADER message from X (Y)! Please Quit!


Communication with subcontroller X failed (message Y). Update firmware of subcontroller X via
adjusting.

220 - [er] File X not found. Please quit the system and call service
Missing parameter file X (e.g. sampler-par.txt): restore it or recreate it.

221 - [er] Error in file X. Please quit the system and call service
Error in parameter file (e.g. sampler-par.txt): restore it or recreate it.
Error in parameter file (e.g. interfaces.txt): check connection, logout, login.

222 - [er] Position error z (1st time) in X


A sampler error on z axis occurred, which could be corrected. (position X, e.g. reag 1).

223 - [er] ATTENTION: arm z position not ok in X


A sampler error occurred, which could not be corrected automatically (position X, e.g. reag 1). Press
o. The arm must now move to its “Home Position” and then drive to the correct position. Should this
error occur frequently, check via adjusting sensors.

84 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
224 - [er] Rotor position error (X) (1st time)
A rotor positioning error occurred, which could be corrected (position X).

225 - [er] Rotor position error (X). Press F4


A rotor positioning error occurred, which could not be corrected automatically (position X). Press o.
The rotor must now move to its “Home Position” and then drive to the correct position. Should this error
occur frequently, check via adjusting rotor.

226 - [er] Rotor reflector foil not found (X). Please check, press F4, SCAN
A rotor positioning error occurred during initializing/scanning procedure. Check position of reflector
foil. Press o. The rotor must now move to its “Home Position”. Should this error occur frequently, check
via adjusting rotor.

227 - [er] Error on Baseboard (X). Please QUIT


An error on the baseboard (power supply etc.) occurred. Check power supply, cables and fuses.

228 - [er] Position error x/y (1st time) in X


A sampler error on x/y axis occurred, which could be corrected. (position X, e.g. reag 1).

229 - [er] ATTENTION: arm x/y position not OK


A sampler error on x/y axis occurred, which could not be corrected automatically. (position X, e.g. reag
1). Press o. The arm must now move to its “Home Position” and then drive to the correct position. Should
this error occur frequently, check via adjusting sensors.

230 - [er] Printer not ready


Check status of printer. Check connection. Reactivate printer with bi.

231 - [er] No communication. Please restart the system.


This message may be caused by the following: the link between the system and PC is missing or
defective. The system is not switched on.

232 - [er] Wash station overflow X


Press o. If the message appears again, please abort. The message suggests a defective waste water
pump or a blocked waste water filter.

233 - [er] No water in wash station X


Press o. If the message appears again, please abort. The message suggests a defective fresh water
pump, a blocked fresh water filter or a defective fresh water valve.

234 - [er] Probe Cleaner not found


No bleach has been filled in the wash station for the probe cleaning function (prime pumps). Please
add the bleach.

235 - [er] Water pressuer too low: call service

236 - [er] Cuvette holder empty (sensor not OK)


1) Normal status: there are no more cuvette racks in the cuvette register. Refill with cuvette racks and
press o. If o is pressed and the cuvette racks have not been refilled, it will take around 20 seconds
for the message to reappear.
2) Error status: check whether any racks have jammed or whether there are any balls under the cuvette
register and rectify the error accordingly. Once this message has reappeared, please wait at least
10 seconds before pressing o again thereby rectifying the error. Check the sensors and motors via
adjusting.

85 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
237 - [er] Check cuvette position at pipetting station
Once you have pressed o, check the position of the rack in the pipetting station. If the error re occurs,
check the sensors and motors via “Adjusting”.

238 - [er] Calibration curve failed


The process of automatically producing a calibration curve could not be completed successfully.
One reason for this could be that the sample has not clotted. If you have allowed a protocol to be
printed, you can view the individual values of duplicate cases. Otherwise, the values can be read
off the “process check”. Enter the values manually in the calibration curve or repeat the process of
automatically producing a calibration curve. Please check the dilution of your plasma. Incorrectly
diluted plasma may also result in failure to produce the calibration curve.

239 - [er] Chromogenic tests not possible


Message from applications sector.

240 - [er] LEDs too dark


The LEDs are too dark or the measuring block is dirty. Clean the measuring block; check optics via
“Adjusting”.

241 - [er] LEDs too bright


The LEDs are too bright. Check optics via “Adjusting”.

242 - [er] LEDs OK


The LEDs are OK. The message appears once the lamp has been checked in the “Hardware“ menu
“LED Test“.

243 - [er] LEDs will fail soon (call service)


Check via “Adjusting” / “Optics”; clean measuring block.

244 - [er] Predilution buffer not found


There is no buffer liquid detected during predilution for fully automatic calibration.

245 - [er] Measuring block not up


The measuring block has not moved all the way to the entry position (horizontal). Problems should be
expected when moving the measuring block to its horizontal position (e.g. rack jam).

246 - [er] Measuring block not down


The measuring block does not move completely into the measuring position (vertically). Problems with
the rack ejection should be taken into consideration (e.g. rack clamp in the waste drawer).

247 - [er] Cuvette rack empty, please refill


1) There are no more cuvette racks in the cuvette register. Please refill with cuvette racks and press
o. If you have pressed o but not first refilled the cuvette rack, it will take around 20 seconds for the
message to reappear.
2) Error status: Message reappears although the cuvette racks has been refilled. Check whether any
racks have jammed or whether there are any balls under the cuvette register and rectify the error
accordingly.
Caution: once the message has reappeared, please wait at least 10 seconds before
pressing o again thereby rectifying the error. Otherwise, a process fault may arise!

86 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
248 to ER 254:
All the following messages require the routine software to be quit and restarted!
After the restart, ensure that there are no more racks in the transport channel up to the point of
rack ejection on the measuring block. If this is the case, remove them manually if required!! Please
check the transport channel for foreign bodies.

248 - [er] Cuvette transport error (pipette pos.)


An error has occurred at the pipetting position during rack transport. Check motors via “Adjusting”.

249 - [er] Cuvette transport error (1st incub.pos.)


An error has occurred at the “Incubation 1” position during rack transport. Check motors via
“Adjusting”.

250 - [er] Cuvette transport error (2nd incub.pos.)


An error has occurred at the “Incubation 2” position during rack transport. Check motors via
“Adjusting”.

251 - [er] Cuvette transport error (3rd incub.pos.)


An error has occurred at the “Incubation 3” position during rack transport. Check motors via
“Adjusting”.

252 - [er] Cuvette transport error (meas. block)


An error has occurred at the “measuring block” position during rack transport. Please check rack
ejection on the measuring block. Check motors via “Adjusting”.

253 - [er] Cuvette transport error (< 2 )


When transporting the rack into the measuring block, it is possible that there was a rack in the
measuring block. Remove this rack, and please check the transport channel. Quit the routine and restart
the system. Check motors via “Adjusting”.

254 - [er] Cuvette jam in measuring block (press F4)


This occurs when a rack sticks/jams during ejection out of the measuring block. Press o and remove
the rack. Check motors via “Adjusting”.

255 - [er] Calibration plasma not found


One of the items (X1-X8, c1) in the “Calibration” menu item contains no plasma or insufficient plasma.

256- [er] Not enough probe cleaner (low level)


The system reports that the probe cleaner is nearly empty. Please top up the probe cleaner.

257- [er] L.I.S communication error


There is some error in the link to the host computer. The system cannot transmit its results automatically.
Once the routine has been quit, you can highlight the data measured in the “Result” menu item and
transmit it to the host computer. Reactivate LIS communication with bp.

258 to ER 259:
All the following messages require the routine software to be quit and restarted !
After the restart, ensure that there are no more racks in the transport channel up to the point of
rack ejection on the measuring block. If this is the case, remove them manually if required!! Please
check the transport channel for foreign bodies.

258 - [er] Cuvette position error (rt.sen. / lft.sen.): stop testing


The rack has not reached the pipetting position correctly. Please quit the routine immediately. Check
sensors, motors and the magnetic lifter via “Adjusting”.

87 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
259 - [er] Cuvette position error (meas.blck>16): stop testing
No rack has arrived in the measuring block within the time specified. Please quit the routine
immediately. Check sensors, motors and the magnetic lifter via “Adjusting”.

260 - [er] Software version mismatch, Please exit the software.


Not all parts of the software are of the same version: logout, login, reinstall software.

261 - [er] Liquid level sensing error


The needle sensor is not stable. Please check if the needle is mounted correctly and check sensor via
“Adjusting”.

262 - [er] Database memory error. No more patients can be stored


Restart database, restore database or delete database.

263 - [er] LEDs fail

264 - [er] LEDs unstable

265 - [er] LEDs fail. Please exit!


Replace the photometer LED or call service.

266 - [er] LEDs unstable. Please exit!

267 - [er] X rotor not defined

268 - [er] Incubation type not OK. Please QUIT!


Check connection of incubation. Check version of incubation.

269 - [er] Measuring block: no strip arrived


An interruption has occurred while transporting the rack within the incubation, and the rack has not
reached the measuring block. Possible errors: rack has jammed in the incubation or a transport motor in
the incubation is defective.

270 - [er] Measuring block: motor defect


The rack did not reach its measurement position within the measuring block. The rack was detected by
the flow sensor of the transport motor in the measuring block, but there was no optical change (dark)
at channel 4. Possible errors: rack has jammed in the incubation or the transport motor in the measuring
block is defective. Possible error: direct sunlight on the measuring block!

271 - [er] Measuring block: LEDs fail


The rack did not reach its measurement position within the measuring block. The rack was detected by
the flow sensor of the transport motor in the measuring block but there was no optical signal (bright) at
channel 4 for correct positioning.

272 - [er] Strip backwards wait position not arrived


Transport was interrupted when transporting the rack back into its wait position. The rack did not reach
the wait position. Possible errors: defective transport motor in the incubation.

273 - [er] Transport of strips not OK. Please exit


The previous four error messages lead to this message if o is pressed. Quit the program and restart
it. The program has to be restarted as a result of this message. A red warning window appears in the
working area of the program once it has restarted. Follow the instructions provided in this warning
window, and then restart the routine.
Warning! Note the following in the warning window:
A: Always wait until the “system ready” message appears in the message box.
B: Correctly enter the password and confirm by pressing e.

88 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
274 - [er] Transport of strips not OK: accepted
If the red warning window has been correctly confirmed, this message only appears in the database. If
the red window reappears after several restarts, check transport motors via “Adjusting”.

275 - [er] Needle sensor unstable (1st time)


The needle sensor could not calibrate itself when first searching for liquids. A second attempt is
undertaken automatically.

276- [er] Needle sensor unstable, please check


During the second calibration, the needle sensor is still not in the working area and cannot detect any
liquid. Possible causes:
- The needle is not mounted correctly
- The sensor cable is defective or not mounted correctly
If other functional errors arise: check sensor via “Adjusting”.

277 - [er] ATTENTION: dilutor position not ok. Please exit!


The dilutor cannot correctly guide the syringe. The encoder has, therefore, created an error message.
The main menu must be quit and restarted.
Possible causes:
- Only use the original dilutor syringe greased with silicon!!
- Mechanical or electrical malfunction
If other functional errors arise: check sensor via “Adjusting”.

278 - [er] Measuring block not up. Please QUIT


Quit the routine and restart the system. Check the measuring module, waste container and cuvette
ejection.

[279 ]%s: unknown EVENT from %s! (%s)

[280 ] %s: unknown ANSWER from %s! (%s)

[281] %s: wrong ANSWER received! (%s)

[282] %s: undefined ANSWER received! (%s)

[283] %s: command ANSWER missing! (%s)

[284] %s: wrong EVENT received ! (%s)

[285] %s: undefined EVENT received! (%s)

[286] %s: command EVENT missing! (%s)

[287] %s: too many EVENTs! (%s)

[288] %s: unexpected end of command received!(%s)

[289] %s: end of command not received!(%s)

[290] %s: busy error! (%s)

[291] %s: encoder%s error at STOP! (%s)

[292] %s: encoder%s positioning error! (%s)

89 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
[293] %s: encoder error%s was not in home! (%s)

[294] %s: encoder positioning error%s not in home! (%s)

[295] %s: encoder error timeout at driving%s! (%s)

[296] %s: error at needle tuning! (%s)

[297] %s: error finger found! (%s)

[298] %s: unknown error! (%s)

[299] ANSWER from %s: parameter error in command %s! (%s)

[300] ANSWER from %s: unknown command %s! (%s)

[301] %s: all floors are free! (%s)

[302] %s: all floors are occupied! (%s)

[303] %s: no strip in floor%s! (%s)

[304] %s: driving to floor%s! (%s)

[305] %s: motor timeout! (%s)

[306] %s: motor overload! (%s)

[307] Waste open! (%s)

[308] Waste closed! (%s)

[309] %s with wrong device mode (%s). Please Exit!

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018 - 016 Compact X incl. Accessories
Accessories consist of:
Cat.-No. Qty. Description
055-200 1 Clean Sticks
055-350 1 Fast washing control tank
060-254 1 Software Debian
060-255 1 Software Compact X
352-400 1 Cable washing tank
352-800 1 Cable USB 1m
353-001 1 Power cord
361-211 1 Meshed tubing black 65 cm
401-926 1 Pipetting tube
401-950 1 Probe 250mm cpl.
501-423 1 Casing strip ejection cap cpl.
660-603 1 Cuvette register
660-606 1 Cuvette holding down clamp
660-424 1 Cover, incubation unit, Compact
670-602 1 Washing tank 5l
671-601 1 Sensor for Washing tank 5l cpl.
690-450 1 Reagent rack
690-407 1 Sample rack
690-418 1 Adapter 30/33 mm, reagent block
960-053 1 Instruction Manual Compact

Reduced quantities:
050-610 10 Reagent containers 25mm
050-611 10 Reagent containers 30mm
050-618 10 Reagent containers 16mm
050-810 3 Stirring sticks, magnetic 12mm
054-420 2 Packs of cuvette racks
050-111 20 Cuvettes Hitachi
361-200 1 Tube 5mm (2m)
050-280 20 Cuvettes for predilution

91 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
Consumables
Cat.-No. Description
050-111 Cuvettes Hitachi a´ 250 pcs.
050-610 Reagent receptacles 25mm a´100 pcs.
050-611 Reagent receptacles 30mm a´100 pcs.
050-618 Reagent receptacles 16mm a´ 100 pcs.
050-810 Stirring sticks, magnetic 12 mm a’ 10 pcs.
050-940 Kaolin 3g /l 100ml
050-950 Clean 500 ml
054-420 Cuvette racks a´ 2.320
055-200 Clean Sticks
691-243 Sample rack adaptor a 10-32
050-280 Cuvettes for predilution for 800 tests
050-710 Lids for 050-610 25mm á 25 pcs.
050-711 Lids for 050-611 30mm á 25 pcs.

Recommended Spare Parts


361-200 Tube 5mm
400-106 Syringe Hamilton
401-926 Pipetting tube
401-950 Probe

Optional Accessories
018-058 TFT Monitor
018-069 Keyboard
018-088 Mouse
012-225 Laserprinter
019-082 Barcodescanner USB
018-112 Desktop PC (Debian)

92 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
Compact X - Specifications
Protection class: I
Working voltage: 100 to 240 VAC ± 10%
Supply frequency: 50 to 60 Hz
Power Input: 100VA
Fuses: 5 x 20mm, T 2.0A UL / IEC 127


Dimensions
w/o packing with packing
W x H x D: 56.0 x 55.0 x 38.0 cm 80.0 x 80.0 cm x 65.0 cm
Weight: 27.5 kg 40.0 kg

Space required
W x H x D: 100cm x 70cm x80cm

Ambient conditions
Operating temperature: +17°C to +28°C
Storage temperature: +10°C to +40°C
Relative humidity: 50% to 80%
Altitude: not for use over 2000 m.
Maximum heat output: 80W
Sound intensity: 65 dB (A)
Overvoltage category: II according to EN 61010 -1:2001
Pollution degree: 2
Usage environment: Indoor use in residential areas, commercial dwellings and light
industrial environments.

Temperature specifications
Incubation: 40.5°C ±0.8°C *
Measuring block: 38.0°C ±0.8°C*
Reagent cooling: 16.0°C to 22.0°C
* Corresponds to a temperature in the cuvette of 37.0oC ±0.8°C after 3 minute waiting period and a filling volume of 220µl.


Sample volume
(plasma + reagent): minimum 150µl /maximum 260µl

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94 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc
95 011BABjdkjkajelajdBA_CX_en_Feb2011_V01_sc

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