5.2.1 Thrombolyzer XRC - Instructions For Use

Thrombolyzer XRC
Instructions for use
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_XRC_en_Nov2011_V01_sc
Table of Contents
General Safety Information .......................................... 1
Graphic Symbols............................................................ 2
Warnings....................................................................... 2
Introduction................................................................... 6
Cap-piercing................................................................... 7
The Measuring System.................................................... 8
Ball Function................................................................... 9
Unpacking the XRC....................................................... 10
Location....................................................................... 10
The XRC........................................................................ 11
Overview of Functional Units....................................... 12

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

Preparations for Operation.......................................... 15
Turning on the device 15
The Screen.................................................................... 16
Menu window 16
Test 16
Status window 16
Message window 16
Status display 16
Preparation of the reagent block................................. 17
The Cuvette Register..................................................... 18

Replacement 18
Loading the Cuvette Register 18
The Washing Tank........................................................ 18

Refilling the Washing Tank 18
The Waste Drawer ....................................................... 19
The Predilution............................................................. 19
Checking Probe Position ..............................................20
Prime Pumps................................................................ 21
Stand-by Mode............................................................ 21
Turning the XRC off....................................................... 21
The Main Menu Window............................................... 22

Sample Prep. 22
Reagent block 22
STAT 22
Run Display 22
Calibration 22
Q.C. Setup 22
Run Control 22
Reagent Database 22
Hardware 22
Result 22
Test Parameter 22
Exit 22
II
Signs and Symbols....................................................... 23
Sample Prep................................................................. 24
Preparation of the samples 24
Rotor Preparation 24
Manual Data Entry 25
Working with several rotors 26
Adding samples during a running sample prep 26
Reagent Block.............................................................. 27
Reagent monitoring of the XRC 27
Refilling Reagents 28
STAT............................................................................. 29
Inserting STAT measurements 29
Run Display.................................................................. 30
Calibration................................................................... 31
Information in the Calibration Window 31
Information in the chart 32
Creating calibration curves with the option “automatic“ 33
Creating a new calibration curve with the option “fully automatic“ 34
Input of a calibration curve using keyboard (manual) 35
Q.C. setup.................................................................... 36
Details about working screen 36
Displaying a Run Control 37
Information in the chart 38
Run Control.................................................................. 39
Status window 39
Details regarding the desktop 39
Execution of Measurements as Run Control 40
Reagent Database........................................................ 41
Hardware.................................................................... 42
Status Window 42
Test Position 42
Adjust the probe’s position, if necessary. 42
Probe Check 43
Change Position 43
Reagent Position 44
Probe Clean Manual 45
Cuvette Rack Adjust 46
Wash Position 46
III
Syringe 46
Prime Pumps 47
LED Test 47
A/D Values 405nm and A/D Values 620nm 48
Water Levels and Temperatures 48
Result........................................................................... 49
List of patient data 49
Results search 50
Transmit New 50
Control 50
Control Search 50
Calibration 50
Protocol 50
Errors 50
Error search 51
Status 51
Time-based data output limitation of the results 51
Viewing a calibration curve from the database. 52
Display a Q.C. chart from the result database 53
Remove individual data record measurement values from the chart 54
Backup Param 55
Backup Database 55
Test Parameter............................................................. 56
Exit............................................................................... 56
Special Functions.......................................................... 57
Maintenance and Care................................................. 58

Daily Sample Preparation 58
Weekly Care 58
Incubator (Track) 59
Maintenance Recommendation 59
Rack Transport Check 59
XRC Quick Reference Guide ......................................... 60

XRC in stand-by operation 60
Place result rack/rotor with patient samples in the XRC. 60
Adding patient samples - Filling free positions in the sample plate 61
Measuring Run Controls 61
Run controls by means of sample prep 62
Displaying a run control 62
Generation of a calibration curve 62
Checking the calibration (successfully measured) 63
Printing Calibration Curves (example Fibrinogen) 63
IV
Cycle of a measurement ..............................................64
Preparations for the measurement 64
Plasma dilution without cap-piercing 64
Reagent pipetting 64
Incubating 64
Starting the measurement 64
Measuring clotting 65
Cuvette rack ejection and return transportation 65
Calculating the measurement value 65
Printing measurement, transmitting data to the EDP 65
Troubleshooting...........................................................66
Pipetting Station and Dilutor 66
Fluid Sensor 67
Dilutor 68
Wash Station 68
[EF55] Noisy 69
Messages..................................................................... 70
XRC incl. Accessories.................................................... 92
Consumables................................................................ 93
Recommended Spare Parts.......................................... 93
Optional Accessories.................................................... 93
XRC Specifications........................................................ 94
Scanner 94
Dimensions 94
Space required 94
Ambient Conditions 94
Temperature 94
Declaration of Conformity

VI
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
manipulat��
ion 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 XRC 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! If the equipment is used in a manor deviating from the specifications

of the manufacturer, the protection can be impaired or be without
function.
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.

Warnings
These instructions contain the information necessary for operating the XRC.
CAUTION! It is strongly recommended that the user reads and understands

these instructions, in order to fully utilize the XRC's capacity!
Meaning of the warnings used in these instructions.

DANGER! This information is for your own safety.
CAUTION! Information for optimum XRC use.
Read and follow this information before using the XRC.
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

Graphic Symbols
Symbol
Explanation
Warning of laser beam
Keep steel balls out of magnetic fields!

(Speakers, CRT Monitors, etc.) Keep steel balls out of magnetic fields!
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.

XRC 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 everywhere, except
delete the displayed messages. With error message, reac-
Result
tivate process, also via the keypad of the device.
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 Prep.
(Caution: spaces are regarded as input) menu for all samples
q within the Sample Prep.

annotates a specimen with reactivate status and with ≡
sign. Input of new test identification code possible 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 Prep.
sample plate (even when processed, with status ≡ ) 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

Keypad Function Use
Cursor keys
k to choose a sub menu from within a “Cursor box” - Result

- Reagents
- Calibration
] square to register a Quality Control in the Id.-No. box of the Sample Prep. menu
routine for manual QC entry - STAT menu
bh to move from the menu item “Sample Prep.” to the Test - Sample Prep. menu
window, to enter a test for all positives of the selected
sample plate
bc see bc , but for deleting tests
s Sample Prep. menu

switch on Cap Piercing manually for one sample
js activates /deactivates cap piercing for all samples Sample Prep.menu
u in the routine menu, select the desired position with the

cursor and the current database with F10
bi reactivates the printer Mainmenu
u reads the parameters for the calibration curve and dis- Result
plays the information in a new window.
bp reactivates the host connection Mainmenu

Introduction
The XRC 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 XRC sample throughput is approximately 160 PT’s/140 APTT’s per hour. When using a cuvette
register 240 tests can be analysed consecutively.
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 five positions for controls.
You can integrate an emergency analysis into the running sample prep at any time. The XRC will
automatically repeat measurements which are outside the tolerance.
Working with the XRC is easy and requires only a few simple preparations:
- inserting the cuvette rack,

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

Cap-piercing
Cap-piercing reduces the amount of work involved and
increases safety for the user when in contact with primary
receptacles
Excess as well as under pressure can dominate in a closed

test tube. This results in the recorded volumes not always
being accurate.
To guarantee the safe pipetting of specimens, the XRC has a specially

developed cell system in which additional intermediary chambers are
situated. Specimens taken from a closed system are temporarily stored
here. Then the plasma required for the measurement is transferred from
these intermediary chambers into the measuring cuvettes. This system
also guarantees safe pipetting without additional costs, even for the
smallest volumes.
Attention! For receptacles without protective caps, the cap-piercing function must
be switched off using the s key.
Attention! Use only primary containerswith clean plugs. No blood on the rubber
(in the recess) may be. Please clean if necessary!

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

moved into the measuring block. This illustration
demonstrates the tilting technology.
Reagent When the tilting starts, the ball is located in

the upper 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.
mixing After measuring the cuvette bar is ejected or, if

there are still unused cuvettes in the bar, returned
back to the pipetting station.
measuring

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.

Unpacking the XRC
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 XRC 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.
Attention! Avoid the immediate vicinity of water taps, baths, sinks, etc.
Avoid the immediate vicinity of centrifuges, washing machines or
dishwashers, etc.
Avoid the immediate vicinity of radiators or devices which produce
large amounts of heat, etc.
Avoid direct draughts.
Place the instrument on a firm, level table which has a depth of at least
60 cm and is up to 1.80 m wide.
DANGER! 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.
10
The XRC
Specifications
USB 2.0 interface
Walk-away-system
For continuous operation and emergency analyses
Throughput approx. 160 PT’s or 140 APTT’s
Rack return
Cup Piercing 120 PT or 100 APTT‘s
Open system for nearly all reagents
Up to 40 samples with 4 parameters per hour
Ready for immediate emergency analysis at any
Test or patient oriented processing time
Automatic predilution Immediate result display
Automatic repeat-testing Q.C. programme
Automatic calibration curve calculation PC can be used at any time (multitasking)
4 measuring channels One main menu for the entire sample prep
Two wave lengths Positive sample identification
Red 620nm / Blue 405nm Request of work lists from the host
Derived fibrinogen Use of primary receptacles
Automatic level detection Sample and reagent reloading possible
Cuvette register for 240 tests Refilling of the cuvettes possible at any time
1 rotor for 31 primary receptacles Error monitoring during the course of clotting
Cooled reagent block for 16 receptacles Error criteria output
5 positions for the quality control Graphic display of the clotting process
Chronometric, chromogenic and immunological Extremely large database

tests
Current display of sample status
Automatic reagent change
Automatic subsequent testing
Measuring system with process monitoring
Bidirectional interface
11
Overview of Functional Units
12
2 4 11 1 3 20
19
18
9
13 16
14 10
15
12
1. Key field
START The samples in the rotor are scanned after the START button is pressed. If a connection
to the host exists, the corresponding tests will be automatically registered. The “routine”
will then be started (no changings possible. F.e. CP off/on)
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. Rotor/Plasma rack
Hold the primary cups to place the patient samples in the XRC.
With removing the rotor, the scanner for the sample-ID is visible! Pay attention
to the warning: „DO NOT STARE INTO BEAM“!
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 XRC, they are automatically cooled to approx. 16-22oC depending
on room temperature. When the block is in the XRC, 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.
13
11. Predilution block
Predilution positions are available for precise measuring of high dilutions.
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)

Turn the instrument on and off (not the PC)
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.
20. Waste drawer

Receptacle for processed cuvettes.
14
Preparations for Operation
Prior to initial operation of the XRC, the following requirements should be met:
- all electrical connections established

- all tubes and sensors connected
- probe and pipetting tube assembled
- water tank is filled
- waste water tank is emptied
- the cuvette register is filled
- predilution cuvettes are available
- incubation station correctly inserted
Turning on the device

If all conditions are fulfilled, switch on the XRC first, then the monitor and then the PC.
Enter the password for the user ”routine“ into the appropriate fields and confirm with e.
Note: After the login , the software will load and the XRC sampler moves.
15
The Screen
1
2 3
4 6
After turning the PC on the main screen, which is divided into six areas, will open.
All full screenshots and cropped screenshots in this manual display information intended for easier
understanding of the system and navigation of the various menu items. Some minor deviations to the
illustrated items may, however, exist.
1. Menu window
Main menu for choosing the status windows required for the sample prep.
2. Test
Shows possible tests. 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 window
System status display area (system and error messages).
5. Status display
6. Colour indicator in the message window
The following situations are possible:
Green: sample rack is not being processed; it can be removed.
Red (blinking): sample prep will begin after patient results are identified.
Yellow: LIS Communication is activated, Samples already started and “START”
button is pressed again (to scan additional patients).
On the left of the indicator, the samples which are already scanned are indicated; on the right, the
selected reagent block (e.g. rb1) is displayed.
16
Preparation of the reagent block
The reagent block is an aluminium block with 16 positions for reagents and 5 control plasmas. The rea-
gent block is designed as a module insert, so it can be loaded outside the XRC.
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 desk-
top. The identification codes of the tests to be used, the reagent identifica-
tion code and the name of the reagent are displayed in the individual
positions. Load the reagent block according to the diagram on the screen.
The position “CLEAN“ has a fixed position. 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). The text “Mixed” on the sreen indicates
the positions which can be mixed.
17
The Cuvette Register
Replacement
The cuvette register holds 60 cuvette bars.
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 or ALARM OFF.
Loading the Cuvette Register

In the package of cuvette bars, 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 XRC. For the washing solution, de-ionized water or distilled water
may be used. When using distilled water, it is recommended to add
(only) 5ml Clean solution per 1000cc water to the washing tank.
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

When the system is in “standby”, remove the sensor from the washing tank and refill the washing
solution. Replace the sensor and delete the message in the message window by pressing o or ALARM
OFF.
18
The Waste Drawer
The used cuvette bars are ejected into the waste drawer after
measuring. If the drawer is full, it ejects automatically and the message
“waste container nearly full“ appears. If the drawer is not emptied
now, the system will pipet another five cuvette bars and will then
interrupt the sample prep.
In order to empty the drawer, extract it completely, slightly lift the end
and take it out of the device. Dump the waste into an appropriate
container. Replace the plastic element of the drawer and push it back
into the device. After the message o/Alarm OFF has been acknowl-
edged, the device assumes operation.
The Predilution
2 inserts with 40 positions are available for the predilution. Place the inserts in the
designated positions. A required replacement of the predilution inserts is indicated in the
message box with the message:
“Predilution rack 1 is full ...“ or “Predilution rack 2 is full ...“. Press n and wait for
message “arm is standing“ before removing the insert. With o or ALARM OFF you will
delete the message and with f2 you restart the system.
ATTENTION! the rack position may not be left empty
The sampler check these position after o or ALARM OFF is pressed.
Never reach under the protection guard in the pipetting zone, while
the XRC is in operation. In case of emergency use the stop button to
immediately stop the movement of the arm.
19
Checking Probe Position
Inspect the needle daily, this is important in order to guarantee a fault-free cycle of dosing of reagent
and specimen.
Select the menu item “Hardware“ by pressing e.
1. Test Position
Confirm “Needle: Test Position” by pressing e. The needle should

now move exactly above the red test point on the washing station.

If necessary, align the probe by hand.
Leave the menu with ^.
2. Probe check
Confirm “Probe Check” with e.
Note: The arm moves to the “Home Position”

Follow the instructions in the message window: “place the test cup in the wash station”, then e
Note: The probe positions itself over the wash station and dispenses approx. 3ml
into the test receptacle. Should the dosage be under the 2ml marker, please contact
the service department.
“Please take the test receptacle from the wash station, then press o/ALARM OFF“. Select the item
“Wash Position“ e. Exit the work field “Hardware“ with ^.
20
Prime Pumps
Select the menu item “Hardware“ / “Prime Pumps“. Confirm with e. The tubing system of the XRC
fills with washing solution. The next message box reads:
“XRC is not yet ready (Prime Pumps)“
After completion, the message box reads:
“XRC ready (Hardware)“
Exit the work field with ^.
Stand-by Mode
If no patients’ specimens are being processed, the XRC automatically goes into stand-by mode. In the
stand-by mode, a short washing of the needle is carried out every 30 minutes.
Turning the XRC 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.
You can now switch off the XRC.
21
The Main Menu Window
In the “Menu” window, the various XRC 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 sample prep. 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 bars.
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, bars, lamp, 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.
22
Signs and Symbols * Sample Prep Measurements
* Sample is being processed
≡ Sample has being processed
- No more plasma has been found
≡ (red) Error message
<-> Sample interchanged
► STAT
↓ Bar code not readable
∩ Processing of the specimen with cap piercing
Manual input
↑ Occupied position with non-readable bar code
* These signs appear to the left of the ID-number.
s Status message i.e. “sample prep” in progress
n STAT
c Cap piercing
m Manual data entry
Id-Number Id-Number of the patient (barcode number)
Prep1 Stands for rotor #1
1-31 Indicates the position in the rotor

Tests Tests to be measured
23
Sample Prep.
Preparation of the samples
Rotor Preparation
By turning the central knob in the middle of the rotor, the rotor can be
individually set for all common primary receptacles. After this step has
been completed, the rotor plate is secured from below with a self-locking
nut. In order to do so, you will need to lift the rotor from the rotor-casing.
Note: When purchasing a new rotor,

please pay attention that the possible
existing adjusting rings on the casing’s
axel are repositioned according to the
previously used rotor.
Attention! Use only primary contain-

erswith clean plugs. No blood on the
rubber (in the recess) may be. Please
clean if necessary!
The rotor can be equipped outside the XRC, e.g. directly by the centrifuge. When inserting the primary
receptacles, position them in a manner so that the internal scanner can read their bar codes. Push the
rotor as far as it goes into the intake of the XRC, and press the “Start“ key.
ATTENTION! When attaching bar codes, you need to pay special attention that they
are placed in the scanner’s “readable” area. It is also important to uphold any speci-
fications which were made by the manufacturer of the primary receptacle when
positioning the bar code on the test tube.. The bar code must be properly positioned
on the primary receptacle: vertically and centred. The minimum distance to the cover
plate and base of the rotor is 4 mm.
correct ! incorrect ! incorrect !
The bar code is not

The bar code is not vertical. centred.
24
After scanning all bar codes (with a connected EDP), the corresponding tests are received from the host
for every patient entered into the field “tests“ and started. If, while scanning, the bar code is not recog-
nised on a primary receptacle, the programme will display a corresponding error message. If no con-
nection to the EDP exists, the XRC must be started via the keyboard. Go back to the menu with ^and
start “Sample Prep” with m.
Manual Data Entry

Should the bar code not be available or legible, the data can be entered manually. If the system is
linked to an EDP, the tests can be retrieved with % from the EDP after entering the ID. Manual entry is
then marked with the sign and this specimen can then not be read by the scanner. In case there is no
EDP connection, the test must also be entered manually.
25
Working with several rotors
If there are many patient plasmas to be processed, you can facilitate the work by using multiple rotors.
After loading and entry of the data for the first rotor, it can then be started. While the XRC is working,
you can load the next rotor.
Once all the tests for a rotor are completed, the status display below on the right in the routine screen
changes from red to green. Now you can replace this rotor with a new rotor, scan or enter data and
start.
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 XRC finishes pipetting the current cuvette
bar and interrupts its current routine. Wait until the message “stopped with F3 (arm ready: restart F4)“
appears. Pull back the rotor to the lock point (arrest point), or take it out of the device and put in the
new specimens. Subsequently, push the rotor back into the device, press the “Start“ button in order to
read the specimen and reactivate the interrupted sample prep with o. In case of connected EDP and
already running sample prep, you need not press m, because the readjusted specimens are automati-
cally started.
Never reach under the protection guard in the pipetting zone while
the XRC is in operation. In case of emergency, use the stop button to
immediately stop the movement of the arm.
26
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 11 are available for larger reagent bottles. Positions 12-16
are available for smaller reagent bottles. Positions 1, 3 and 5 are stirred. Position 7 is exclusively reserved
for dilution buffers.
16 = Positions in the reagent block

RE = Reagent identification code
A = Test identification code
Quick = Reagent name
Mixed = Mix position 1, 3, 5
Reagent monitoring of the XRC

During the pipetting process, the XRC 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. Display for the automatic liquid level
control. The graphic level display shows the current liquid level for each reagent.
27
Refilling Reagents
When pressing n the message “stopped (arm is still working) wait for ‘ready’ – restart o (sample
prep.)” is displayed. The XRC finishes pipetting the previously started cuvette rack and interrupts its
current sample prep. Wait until the message “stopped with n (arm ready: restart o) (sample prep.)“
appears. Remove the reagent block from the device, open reagent cover and replenish the correspond-
ing reagent. Close the cover and push the reagent block back into the device and start the 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 XRC 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 drawer without using n in order to
replace reagents. In this case, the pipetting needle stops immediately.
ATTENTION ! Do not extract the reagent drawer if the pipetting needle is currently
pipetting a reagent.
The software will allow this procedure within 30 seconds. In case the reagent drawer is not re-inserted
within the 30 second time limit, the bar currently being pipetted is discarded.
28
STAT
Inserting STAT measurements
Analyses for STAT patients can be performed at any time. STATS, including result printing, are
prioritised.
In the XRC, 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 via “START“ or 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 rotor.
End the data input ^ and start with m for manual input. Upon entering with the START key on the
device and automatic test request, the system automatically starts. The STAT specimens are inserted ac-
cording to the process described in chapter “adjusting specimen“. Processing and measuring of STATs
in sample prep processing have the highest priority.
29
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.
- the optical density in case of chromogenic 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.
30
Calibration
In the “Calibration” menu values and times for your calibration are registered. There are three
alternatives of calculating a calibration curve: manually, automatically and fully automatically.
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 8
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 or optical density (for chromogenic analyses) 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 XRC determines the values from calibration plasmas with different concentrations.
31
8) Fully Automatic
The XRC 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 ^ is pressed, the graphics screen opens and displays the
calibration curve.
11) Normal/ISI
Optional when calculating the INR value.
Information in the chart

There is a chart available for all parameters requiring a calibration curve. Use the following process in
the menu “Calibration“ 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“.
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
32
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
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 “XRC 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.
33
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 XRC 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.
34
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 XRC starts pipetting the dilutions
and shows the message “XRC is working (calibration)“. Once the calibration curve is successfully
measured, the message “XRC 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 view your old calibration curve, switch from “Yes“ to “No“ with K and 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“.
35
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.
36
Displaying a Run Control
Select “QC 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 kthe 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.
37
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.
38
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.
Tests selected: Test to be measured are entered here.
Start: Tests for which a run control is to be started are entered here.
Quality controls which can be measured are started for the selected tests. With k
you can change between „Yes“/„No “. Only in the main menu you can start with m.
39
Execution of Measurements as Run Control
Select “Run Control“ in the menu by pressing xz, 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.
In the “Start Tests” box, enter the parameters the controls are to be determined for.
Exit the status window with ^.
“XRC 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”.
“XRC 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.
40
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.
41
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 Station” e.
Exit “Hardware” by pressing ^.
42
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 window:
Message: “Put the test cup on the wash station and press e“.
Attention! The probe moves over the washing station and then pipettes the solution
into the test cup.
The lower section of the test container should be filled. The pipetting stream should be vertical and
should come out of the needle as a single stream. After this has been done, the tip of the needle
should be checked for any development of water drops. Water droplets on the tip of the needle are an
indication that the system might be leaky.
Message: “Please remove test cup from the wash station and press o“.
Select the menu item “Wash Position” e

Exit the “Hardware” with ^
Change Position
Remove the reagent block out of the XRC.
- 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.
43
- 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 ^.
44
Probe Clean
In the menu “Hardware“ select the submenu “Probe Clean“ e. The probe exits the washing position,
please pay attention to the message box.
“add 1 ml of 5% bleach in wash station + ENTER for Start“.
The probe moves into the washing position and draws up the solution, allow this to work for approx.
15 - 30 min. e ^ . Press w to change to “Prime Pumps“ e.
Probe Clean Manual

The needle should be cleaned manually if any droplets, on the shaft of the needle after pipetting, are
observed. To clean the needle more easily, you can remove the rotor before you select: “Probe Clean
Manual”
The needle 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 needle.
Always wear protective gloves in order to protect yourself against contamination!
Warning! The needle should only be cleaned from top to bottom.

Please pay special attention to the instructions displayed in the
message box!
45
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 needle’s Z-position. Use the cursor keys to optimise the
positioning of the X and Y axes (needle should be centered). Press ^ to finish the procedure. The
arm then drives to its home position, and the rack returns to the wait position.
Wash Position
The washing 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 “Switch 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. “XRC is not yet ready (Prime Pumps)“ appears in the message box. Wait
until the message “XRC ready (Hardware)“ appears and exit the work area with ^.
46
Prime Pumps
Select the menu item “Hardware“ / “Prime pumps“. Confirm with e. The tubing system of the XRC
fills with washing solution. The next message box reads:
“XRC is not yet ready (Prime Pumps)“
After completion the message box reads:
“XRC 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.
47
A/D Values 405nm and A/D Values 620nm
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 “Washing tank”. If one of the temperatures is
not OK, the XRC stops the routine. A + / - shows the direction of the wrong temperature.
48
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.
Control Contains all data from measurements of “Q.C. Set-up“.
Calibration Contains all the executed calibration curves.
Protocol Contains the work log of the previous measurements.
Errors List of generated error messages.
Status Number of specimens, Q.C.’s and error messages.
Backup Create a backup on a USB stick.
List of patient data

If the item “Results” 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.
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.
49
Results
Confirm a new ID number with e, the corresponding index card for that patient is displayed.
e The curve characteristics are displayed.
e The curve characteristics are displayed over the whole working area.
i Print curve characteristics.
^ Exit curve.
2x^ Exit index card.
Results search
When opening the option “Results Search“ under “Result“ by pressing e, the input field “Search” is
activated. 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
and marked. With wyou can select single patients (w+jyou can select several patients).
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
All error messages are chronologically specified here.
50
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.Upon pressing e a
display appears which gives information
regarding the number of patient plasmas
measured up until now, the number of
checks conducted and the number of
registered messages.
- 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
51
Viewing a calibration curve from the database.
Select ”Calibration Curve”. Confirm with
e.
Select a data record by using yw and
then press the u key.
Confirm with e.
52
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.
53
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, you will see the chart,

all values will be indicated in the curve.
Press k to display only the valid values

in the curve.
54
Backup Param
These functions are used to make parameter back-ups
When backup is selected, all system relevant settings and test parameters are saved on a USB stick.
Make sure to always have a current backup of your parameters!
Connect a USB stick (provided USB stick) to the PC and select “Backup Parameter”.
The message “Sucess” appears after finish.
Backup database
These functions are used to make database backup. When selecting this function become secured all
patients/control results without reaction curves and error messages on a USB stick.
These functions are used to make database backup. When selecting this function become secured all
patients/control results without reaction curves and error messages on a USB stick. Connect a USB
stick (USB provided stick) with the PC and select them for “Backup data base”. The message “Success”
appears after the completion.
55
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.
Exit
If you would like to stop working with the XRC, select “Exit“ from ywin 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 XRC.
56
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 “Test” box , 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 “Test” box yw.
- e adds and confirms.
After starting sample prep, all data can be viewed with {}, but no longer altered.
57
Maintenance and Care
Daily Sample Preparation
Probe In the menu “Hardware“:
Select “Test Position/ Probe check“ in the sub menu and check (see checking the
probe). If the needle or needle tip is visibly damaged (bent or deformed), then the
needle needs to be changed (please refer to the “Hardware” section).
If cap piercing is being used, then the needle should be checked for visual residue
and deposits. If any are present, the sub-menu “Probe Clean Manual” should be
activated and carried out (please refer to the “Hardware” section). Visible signs
of wear and tear on the coating of the needle are normal and do not negatively
influence the proper functioning of the needle.

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. If necessary, empty or refill.
Weekly Care
Probe Cleaning In the menu “Hardware“, select the sub menu “Probe Clean“ e.
The probe moves out of the washing position. Please pay attention to the
message box.
Pipette 1 ml of 5% ISE Clean into the washing position e.
The probe moves into the washing position and draws up the solution, allow this to
take effect for approx.15 - 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
Open the service cover on the right side of the XRC. 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.
right wrong
58
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.
Incubator (Track)
Wipe with a lint - free cloth which is moistened with NaCl 0.9%.
Maintenance Recommendation
We recommend changing the needle 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 bars remaining in the pipetting position (window in the incubation station’s
cover) will be ejected. In the event of failure, please check if all bars have been ejected (see “Clear
Track” in the “Hardware” chapter).
Attention! For receptacles without protective caps, the cap piercing function must
be switched off using the s key.
59
XRC Quick Reference Guide
Attention! For receptacles without protective caps, the cap piercing function must
be switched off using the F8 key.
XRC in stand-by operation

Preparation
“Rack stock” check and if necessary refill

“Water tank” check and if necessary refill
“Waste water canister” check and empty if necessary
“Waste drawer” check and empty if necessary
“Predilution cuvettes” check and if necessary refill
Menu yw “Hardware” e “Test Position” e reference point OK
“Probe Check” e dosage flow OK
“Wash Position” e ^ basic position

of the probe
“Prime Pumps” e after 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 result rack/rotor with patient samples in the XRC.

Menu yw Start key Patient data is scanned and the tests to be run are
received from the host. The system starts automatically.
or
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.
60
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 Start key

Patient‘s data is scanned, and the tests are transmitted
by the host and started. Or menu yw sample prep
eManual input of the 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 rotor.
Patient‘s data is scanned and the tests transferred by
the host. Or manual input of the patient‘s data. Exit
operating area with ^.

Menu o/ALARM OFF Start the interrupted routine.
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 Start“ with ^. Press m to start “Run
Control”.
61
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.
Displaying a run control
Menu yw “QC 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.
“Curve” Output of the curve or print with i.
“Curve” 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 03:01, then e. In X2 to X5

enter the dilutor in the same way 02:01, 01:01, and
01:02 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 XRC begins with the calibration curve for the Fibrinogen.
62
Checking the calibration (successfully measured)
Message “XRC 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 ^.

.
63
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.-no.
- Enter test identification code.
Place sample receptacle into the rotor (bar code aligned). Press the start key in order to enter the ID
number or enter manually via the keyboard in the corresponding position.
- Enter test identification code in the “Test” box.

- 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.
Plasma dilution without cap-piercing

The needle accepts 170 µl of buffer solution from the reagent unit, moves to the specimen receptacle
and takes up an additional 5 µl of plasma. Then it moves to the cuvette rack in the pipetting position and
delivers 150 µl of this volume through the upper opening of the cuvette (first the 5µl of plasma taken up
last, then 145 µl of buffer; this corresponds to 01:30 plasma dilution). In the wash position, the needle
releases the surplus buffer amount into the waste and is cleaned.
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 rack 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 bar 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 bar.
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.
64
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 position.
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 needle moves into the clean position and takes up 100 µl Clean, water is pumped into the washing
position, the needle 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.
65
Troubleshooting
Pipetting Station and Dilutor
Fault Cause/Source Action
Probe misses Probe bent during pipetting. Press <Stop> button of XRC, select “Exit”,
correct pipetting wait 1 min., then turn PC + XRC off. Check
positons. test position after restarting, adjust if neces-
sary. With the XRC 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 XRC on and check the test position.
Probe inadvertently bent by

operator interference during
the routine, e.g. replacing
a reagent without using the
“Stop” button, by the operators
hand.
A primary cup was not cor-

rectly positioned in the sample
rotor; 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.
The arm forward/back guide

bars = “Y”-axis and up/down
= “Z”-axis have run dry (very
rare) or become dirty, causing
stiff-ness.
66
Fluid Sensor
Error Cause / Source Action
The probe sensor is not The pipette probe is not Check that probe is assembled correctly,
detecting liquid. secured correctly.The sensor check that the cable’s plug connections are
cable is not connected secure and check the cable for damage. The
correctly or the cable is cable must be replaced if it is damaged in
defective. any way.
The pipette probe The pipette probe is not Check that probe is assembled correctly,
remains above the secured correctly.The sensor check that the cable’s plug connections are
sample / reagent and cable is not connected secure and check the cable for damage.
starts to continuously correctly or the cable is The cable must be replaced if it is damaged
move up and down. defective.Sensor setting is in any way.If the error is still present, then
incorrect. undertake sensor setting as described below.
PipPosition Ref not OK. WARNING!
- Press the Stop button.
- Press the adjustment button on the pipette
arm.
- Restart XRC using the o/ALARM OFF
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
- Restart XRC using the o/ALARM
OFF button.
67
Dilutor
Error Cause/Source Action
The tube to the dilutor

Probe is dripping
is kinked, resulting in a
during the pipetting Replace tube.
contraction and reduced
process.
fluid flow.
Pull tube from the guide to the compression

fitting, then retighten the fitting and run it
Tube has worked loose properly. (If only the fitting is tightened, any
at the dilutor’s compres- possible tension on the tube could cause the
sion fitting. 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.
68
[EF55] Noisy
Description:
Detection of an irregular (noisy) reaction cylce during a clotting test.
Causes for this could be:
- Micro-clot
- 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 is
displayed in the message box.
It is recommended to recheck the result. If any doubts remain, repeat the measurement.
Example picture: (the vertical line shows the point in the reaction cycle marked “noisy“)
69
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.
70
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
barcode.
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.
71
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.
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.
72
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.
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.
73
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.
11 - [st] (Sample prep.)

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

74
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)

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

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!
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.
75
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.
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)

76
47 - [me] Down volume for cuvette is too great (max. X, Single / Double)
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

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.
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.
77
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

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)

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

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

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

74 - Down volume of X must be 0

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

76 - [me] Only normal pipetting possible

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

78 - [me] For predilution, please pipette plasma in predil cuv.

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

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

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

78
82 - [me] X. line: please pipett predil. plasma in cuvette
83 - [me] Down volume of X must be greater 0

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

85 - [me] Pipetting of predilution not possible

86 - [me] Chromogenic coagulation X not possible

87 - [me] Following test X is not possible

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

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).
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.
79
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‘)
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.
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.
80
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.
127 - [me] Volume table for single test is empty

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.
81
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
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.
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.
82
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

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

158 - [me] Second unit is not ok

159 - [me] Second print format is not OK

160 - [me] Second unit must be empty

161 - [me] Second print format must be empty

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

83
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.
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”.
84
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.
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).
85
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).
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.
86
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.
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).
87
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.
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”.
88
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!
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.)

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

“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”.
89
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”.
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.
90
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.
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.
91
018-028 XRC incl. Accessories
Cat.-No. Qty. Description
018-108 1 Rotor CP No.1 for XRC
055-200 1 Clean stick
055-350 1 Wash contol cup
060-254 1 Software Debian
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
401-946 2 Needle CP kpl.
660-200 1 Reagent block
660-220 1 Adapter 30/17mm, reagent block
660-603 1 Cuvette register
660-606 1 Cuvette holding down clamp
660-811 1 Cover, incubation unit
670-602 1 Washing tank 5l
671-601 1 Sensor Clean solution container
690-410 2 Adaptor 30/22,5mm, reagent block
690-411 2 Adaptor 30/26mm, reagent block
690-418 1 Adaptor 33/30mm, reagent block
960-049 1 Instruction Manual XRC
Reduced quantities:
050-610 10 Reagent containers 25mm

050-810 3 Stirring sticks, magnetic 12mm
054-520 2 Cuvette bars CP (1 Magazin)
054-522 4 Predilution bar B
055-111 20 Cuvettes Hitachi
055-300 1 Inserts for waste drawer
361-200 1 Tube 5mm (2m)
92
Consumables
Cat.-No. Description
050-111 Cuvettes Hitachi a´ 250 pcs.
050-610 Reagent containers ø 25mm á 100 pcs
050-611 Reagent containers ø 30mm á 100 pcs.
050-618 Reagent containers ø 16mm á 100 pcs.
050-710 Lids for 050-610 ø 25mm á 25 pcs.
050-711 Lids for 050-611 ø 30mm á 25 pcs.
050-810 Magnetic stirrers 12mm á 10 pcs.
050-940 Kaolin Suspension 3g/l / 100ml
050-950 CLEAN Solution 500m
054-520 Cuvette racks for Cap Piercing á 2.320 samples
054-522 Pre-dilution bars á 25 pcs. for 1000 tests.
055-200 Clean stick
055-300 Inserts for waste drawer á 10
691-727 Adaptor Eppendorf
691-729 Adaptor for CP -Rotor á 10pcs.
Recommended Spare Parts

361-200 Tube 5mm, 5m
400-106 Syringe Hamilton 0,5 ml
401-926 Pipetting tube XRC
401-946 Probe
670-602 Washing tank 5l
Optional Accessories
018-112 Desktop PC Debian
018-058 TFT Monitor
018-059 Keyboard
018-088 Mouse (USB)
019-082 Barcode scanner (USB)
93
XRC - Specifications
Protection class: I
Working voltage: 100 to 240 VAC
Supply frequency: 50 to 60 Hz
Power Input: 150VA
Fuses: T 3.15A
Scanner

According to EN 60825-I:2007: Laser Class II
Maximum output: 1 ,8mW
Puls duration: 120 µs
Wavelenght: 650 - 690nm
Dimensions
w/o packing with packing
W x H x D: 73.0 x 37.0 x 55.0 cm 90.0 x 62.0 cm x 80.0 cm
Weight: 38,0 kg 51,0 kg
Space required
W x H x D: 100cm x 70cm x80cm
Ambient conditions
Operating temperature: +17°C to +32°C
Storage temperature: +10°C to +40°C
Relative humidity: 10% to 80%
Maximum heat output: 140W
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
94
95

5.2.1 Thrombolyzer XRC - Instructions For Use

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5.2.1 Thrombolyzer XRC - Instructions For Use

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Thrombolyzer XRC

Instructions for use

The Fully Automated Clotting Analyzer

Kommanditgesellschaft Behnk Elektronik GmbH & Co.

The Measuring System.................................................... 8

Unpacking the XRC....................................................... 10

Overview of Functional Units....................................... 12

Preparation of the reagent block................................. 17

The Cuvette Register..................................................... 18

The Washing Tank........................................................ 18

The Waste Drawer ....................................................... 19

Checking Probe Position ..............................................20

Turning the XRC off....................................................... 21

The Main Menu Window............................................... 22

Maintenance and Care................................................. 58

XRC Quick Reference Guide ......................................... 60

XRC incl. Accessories.................................................... 92

Recommended Spare Parts.......................................... 93

Wear gloves when handling blood, samples and objects

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

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

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

ATTENTION! If the equipment is used in a manor deviating from the specifications

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

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

CAUTION! It is strongly recommended that the user reads and understands

Meaning of the warnings used in these instructions.

CAUTION! Information for optimum XRC use.

Read and follow this information before using the XRC.

Direct current (DC)

Alternating current (AC)

Direct or alternating current

Protective isolation protection class II

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

Warning of laser beam

Keep steel balls out of magnetic fields!

Please refer to the Operation Manual

Returned goods and environmentally complaint disposal

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

q within the Sample Prep.

* dependent on keyboard layout of the country

k to choose a sub menu from within a “Cursor box” - Result

bc see bc , but for deleting tests

s Sample Prep. menu

js activates /deactivates cap piercing for all samples Sample Prep.menu

u in the routine menu, select the desired position with the

bi reactivates the printer Mainmenu

bp reactivates the host connection Mainmenu

- inserting the cuvette rack,

Excess as well as under pressure can dominate in a closed

To guarantee the safe pipetting of specimens, the XRC has a specially