Table of Contents

General Safety Information ......................................... 1 Warnings ...................................................................... 2 Graphical Symbols ........................................................ 2 Thrombolyzer Function Keys ......................................... 4 Introduction .................................................................. 6 Cap-piercing .................................................................. 7 The Measuring System................................................... 8 Ball Function .................................................................. 9 Unpacking the Thrombolyzer ...................................... 10 Location ...................................................................... 10 The Thrombolyzer XRC ................................................ 11 Overview of Functional Units ...................................... 12
1. Keypad 2. Rotors/Results Racks 3. Reagent Blocks 4. Wash Station 5. Dilutor 6. Cuvette Register 7. Result Distributor 8. Pipette Probe 9. Connection for Wash Water (IN) 10. Connection for Waste Water (OUT) 11. Predilution Block 12. Waste drawer 13. Illuminated guard bar for the entire working area 14. Power switch (Power) 15. Fuse 16. Mains cable connection 17. Connection to the water sensor (Sensor) 18. Connection to the PC (USB)  12 12 12 12 13 13 13 13 13 13 13 13 13 13 13 13 13 13

01018028 08-2007 V3

Preparations for Operation ......................................... 14

Turning on the device

14

The Screen ................................................................... 15

Menu window Test Status window Message window Status display Colour indicator in the message window

15 15 15 15 15 15

Preparation of the reagent block ............................... 16 The Cuvette Register .................................................... 17

Replacement Loading the Cuvette Register 17 17

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

Refilling the Washing Tank

17

The Waste Drawer ...................................................... 18 The Predilution ............................................................ 18 Checking Probe Position ............................................. 19 Prime Pumps ...............................................................20 Stand-by Mode............................................................20 Deactivating the Thrombolyzer ...................................20 The Main Menu Window.............................................. 21
Sample Prep. Reagent block STAT Run Display Calibration Q.C. Setup Run Control Reagent Database Hardware Result Test parameters Exit 21 21 21 21 21 21 21 21 21 21 21 21



01018028 08-2007 V3

Signs and Symbols ..................................................... 22 Sample Prep. ............................................................... 23

Preparation of the results Rotor Preparation Manual Data Entry Working with several rotors Adding samples during a running sample prep 23 23 24 25 25

Reagent Block ............................................................. 26

Reagent monitoring of the Thrombolyzer Refilling Reagent

26 27

STAT ............................................................................ 28
Inserting STAT measurements

28

Run Display ................................................................. 29 Calibration .................................................................. 30

Information in the Calibration Window Information in the chart Creating calibration curves with the option automatic Creating a new calibration curve with the option fully automatic Input of a calibration curve using keyboard (manual) 30 31 32 33 34

Q.C. setup ................................................................... 35

Details about working screen Displaying a Run Control Information in the chart

35 36 37

Run Control ................................................................. 38

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

38 38 39

Reagent Database....................................................... 40 Hardware ................................................................... 41

Status Window Test Position Probe Check Change Position Reagent Position Probe Clean Washing Position Syringe 41 41 42 42 44 44 44 44



01018028 08-2007 V3

Prime Pumps Clear Track LED Test LED Range Water Levels and Temperatures

45 45 45 45 45

Result .......................................................................... 46
Result Data Result search Transmit New Control Control Search Calibration Protocol Errors Error search Status Temporal data outuput limitation of the results Viewing a calibration curve from the database. Display a Q.C. chart from the result database Remove individual data record measurment values from the chart.

46 47 47 47 47 47 47 47 48 48 48 49 50 51

Test Parameter ............................................................ 52 Exit .............................................................................. 53 Special Functions ......................................................... 54 Maintenance and Care ................................................ 55
Daily Sample Preparation Weekly Care Maintenance Recommendation Bar Transport Check 55 55 56 56

Thrombolyzer Quick Reference Guide ........................ 57

Thrombolyzer in stand-by operation Place result rack/rotor with patient samples in the Thrombolyzer. Adding patient samples - Filling free positions in the sample plate Input of STAT patients Measuring Run Controls Run controls by means of sample prep Displaying a run control Generation of a calibration curve (example Fibrinogen with 4 bases) Compilation of a fully automatic calibration (example Fibrinogen) Checking the calibration (successfully measured) Printing Calibration Curves (example Fibrinogen)

57 57 57 58 58 58 58 59 59 59 60

V

01018028 08-2007 V3

Cycle of a measurement (using the example Fibrinogen) ............. 61

Preparations for the measurement Plasma dilution without cap-piercing Reagent pipetting Incubating Starting the measurement Measuring clotting Cuvette rack ejection and return transportation Calculating the measurement value Printing measurement, transmitting data to the EDP

61 61 61 61 61 62 62 62 62

Troubleshooting .......................................................... 63
Pipetting Station and Dilutor Fluid Sensor Dilutor Wash Station [EF55] Noisy

63 64 65 65 66

[EF] Error messages ..................................................... 67 Errors and failure ........................................................ 74 Accessories XRC ........................................................... 96 Recommended Spare Parts ......................................... 96 Consumable Material Starter Kit (reduced quantities) ............ 96 Optional Accessories ................................................... 97 Consumable Material .................................................. 97 XRC Technical Data ...................................................... 98
Scanner Dimensions Space Required Ambient Conditions Temperature regulations Specimen volume 98 98 98 98 98 98

Declaration of conformity ...........................................99

01018028 08-2007 V3

V

01018028 08-2007 V3

General Safety Information

All biological substances should be regarded as a potential source of infection! Wear gloves when handling blood, samples and objects contaminated by blood! DANGER ! Strictly follow the existing regulations pertaining to the handling and manipulation of reagents for laboratory use and blood samples!

IMPORTANT! This instrument may only be operated by trained specialists, who have been instructed and trained in procedures using In Vitro Diagnostics. They must be familiar with the instructions and able to work accordingly, to fully utilise the Thrombolyzers 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. 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. 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. Data processing equipment connected to the instrument, such as personal computers or printers, must conform to the EN 60950 or UL 1950, respectively. 
018028 08-2007 V3

ATTENTION!

ATTENTION!

ATTENTION!

Warnings
These instructions contain the information necessary for operating the Thrombolyzer. ATTENTION! It is strongly recommended that the user reads and understands these instructions thoroughly, in order to fully utilise the Thrombolyzers capacity!

Meaning of the warnings used in these instructions. DANGER! ATTENTION! This information is for your own safety. Information for optimum use of the Thrombolyzer.

Read and follow this information carefully before using the Thrombolyzer.

Graphical Symbols
Symbol Explanation
Direct current (DC) EC 47

Alternating current (AC) EC 47 Direct or alternating current EC 47

Earth conductor EC 47

Protective insulation protection class  EC 47

ON (mains switch) EC 47

OFF (mains switch) EC 47

018028 08-2007 V3

Graphical Symbols

Warning of a danger zone (Attention!) Observe documentation Black symbol on yellow background, ISO 3864

Warning of dangerous high voltage Black symbol on yellow background, ISO 3864

Warning of a hot surface Black symbol on yellow background, DIN EN 563

Warning of a biological hazard Black symbol on yellow background, 90/379/EEC

Warning of laser beam This symbol is situated next to the scanner window

Warning of hand injuries Black symbol on yellow background, DIN 4844-D-W027

Operation of the function keys and keyboard entries are explained in these instructions using the symbols of the relevant keys.

018028 08-2007 V3

Thrombolyzer Function Keys

Keypad Cursor keys Function move the cursor on a chosen menu common standard functions starts the processing pipetting process stop after the pipetting of a rack; wait for the message Arm ready. The autostart is avoided with an online EDP. restart everywhere, except delete the displayed messages. With error message, reac- Result tivate process, also via the keypad of the device. transmits the routine input to the host within the Sample Prep. menu of the selected sample plate same as p within the Sample Prep. menu of the selected sample plate within the Sample Prep. menu of the selected sample plate when on the Sample Prep. menu in an entry box within the Sample Prep. menu of the selected sample plate Sample Prep. menu STAT menu Sample Prep. menu - Result - Reagents - Calibration only on the Main menu Use

wxyz ^e m n

o m o p wp q wq

transmits all entries of a routines sample plate to the host (Caution: spaces are regarded as input) annotates a specimen with reactivate status and with sign. nput of new test identification code possible to reactivate all samples of a plasma rack with status and to mark them with the & character to delete one routine position (D - tests); if held down all subsequent positions can be deleted, even across multiple parameters! deletes the entire position occupancy of a selected sample plate (even when processed, with status ) moves the cursor through the Sample Prep. boxes to the beginning of the next sample plate moves within an entry box (beginning/end of the line) to choose a sub menu from within a Cursor box

bc* br* } dg k

* dependent on keyboard layout of the country 4

018028 08-2007 V3

Thrombolyzer Function Keys

] (square bracket right) to register a Quality Control in the d.-No. box of the routine for manual QC entry to move from the menu item Sample Prep. to the Test window, to enter a test for all positives of the selected sample plate see bc , but for deleting tests switch on Cap Piercing manually in the routine menu, select desired position with the cursor and the current data bank for this with F0 reactivates the printer reads the parameters for the calibration curve and displays the information in a new window. activates /deactivates cap piercing reactivates the host connection Mainmenu Result Sample Prep Mainmenu Sample Prep. menu - STAT menu - Sample Prep. menu

a9 bh bc s u bi u ks bp

018028 08-2007 V3

Introduction
The Thrombolyzer 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 (D) is either entered via bar code or keyboard. Names, numbers or consecutive numbers starting with any number can be entered. New Ds can be recorded at any time, even during the measurement. The Thrombolyzers sample throughput is.approx. 0 PTs/40 APTTs per hour. When using a cuvette register 40 tests can be analysed consecutively. Due to the micro method a measuring volume of only 0l is required. The required reagents can be placed in a refrigerated station with  positions for reagents and five positions for controls. You can integrate an emergency analysis into the running sample prep at any time. The Thrombolyzer will repeat measurements which are outside the tolerance automatically. Working with the Thrombolyzer 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.

018028 08-2007 V3

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 Thrombolyzer 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 a safe dosing without additional costs, even for the smallest volumes. Attention! For receptacles without protective caps, the cap piercing function must be switched off using the F8 key.

018028 08-2007 V3

The Measuring System

A cuvette bar holding four cuvettes is moved from the cuvette register to the pipetting position. There plasma and reagent is pipetted into the cuvettes. After being released the bar is moved to the incubation station, which can accommodate three bars simultaneously. After the incubation time has lapsed the bar is moved into the measuring block. The illustration above demonstrates the tilting technology. 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

Plasma Plasma

pipetting pipetting
transporting

incubating

Reagent Reagent

The ball rotates during the entire measuring time. When clotting sets in, the rotating ball causes the forming fibrin fibers to conglutinate. This effect enables the detection of minutest blood clots. After measuring the cuvette bar is ejected or, if there are still unused cuvettes in the bar, returned back to the pipetting station.

mixing

measuring

018028 08-2007 V3

Ball Function

. Normal plasma

with ball . Abnormal plasma without ball

. Abnormal plasma with low Fibrinogen contents

. Excellent reproducibility due to the gentle mixing of the sample. n the normal range the balls 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.. . n 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 gets very high. This leads to a positive detection of the beginning of clotting. . n case of low fibrinogen contents the forming fibrin from the results will bond to the ball. This bonding of the fibrin to the ball causes a quick brightening of the results with a large dynamic signal.

018028 08-2007 V3

Unpacking the Thrombolyzer

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 Thrombolyzer 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 rather 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 7C and C. Place the instrument in a position which allows unhindered access to the mains outlet at all times. Attention! Avoid the immediate vicinity of 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, depending on the model, is up to 1.80 m wide.

0

018028 08-2007 V3

The Thrombolyzer XRC

Specifications Walk-away-system Throughput approx. 0 PTs or 40 APTTs Cup Piercing 0 PT or 00 APTTs up to 40 samples with 4 parameters per hour Test or patient oriented processing Automatic predilution Automatic repeated testing Automatic calibration curve calculation 4 measuring channels UV LED 400nm 0nm Derived fibrinogen Automatic level detection Cuvette register for 40 tests  rotor for  primary receptacles Cooled reagent insertion for  receptacles  positions for the quality control Chronometric, chromogenic and immunological tests Automatic reagent change Measuring system with process monitoring Bidirectional interface USB .0 interface For continuous operation and emergency analyses Bar return Open system for nearly all reagents Ready for immediate emergency analysis at any time mmediate result display QC programme PC can be used at any time (multitasking) One Main menu for the entire sample prep Positive sample identification Request of work lists from the host Use of primary receptacles Sample and reagent reloading possible Refilling of the cuvettes possible at any time Error monitoring during course of clotting Error criteria output Graphic display of the clotting process Unlimited database Current display of sample status Automatic subsequent testing



018028 08-2007 V3

Overview of Functional Units



  4   7 
left side front view

7 

 0  4    

1. Keypad
START The results in the rotor are scanned after the START key is pressed. f a connection to the computer exists, the corresponding tests will be automatically imported. Subsequently the sample preps will be started. STOP f the key is activated the result distributor will immediately stop. ALARM OFF Errors are acknowledged and deleted in the message box by pressing the ALARM OFF key. ALARM OFF has the same function as <F4> on the keyboard.

2. Rotors/Results Racks
Holds the primary receptacles in order to place the patient results in the Thrombolyzer.

3. Reagent Blocks
Reagent blocks are loaded with reagents according to the schematic in the main menu of the sample preps. By placing the them in the Thrombolyzer they are automatically cooled to approx. -C depending on room temperature. When the block is in the Thrombolyzer specific positions can be mixed. The positions of the control plasmas are also in the reagent block. Note: There is also the alternative of working with several reagent blocks.

4. Wash Station
To avoid contamination, the pipette is cleaned on the inside and outside. The washing cycle depends on the programme.



018028 08-2007 V3

5. Dilutor
t controls all fluid intake and dispensing by the results distributor.

6. Cuvette Register
The register holds  cuvette bars. t can easily be replaced with one hand movement.

7. Result Distributor
Distributes plasma and reagent according to the programmed test volume.

8. Pipette Probe
Scans the fluids and absorbs them depending on the programme.

9. Connection for Wash Water (IN)

The wash water container is situated next to the instrument.

10. Connection for Waste Water (OUT)

The waste water container is situated next to the instrument.

11. Predilution Block

Predilution positions are available for precise measurments with high dilution.

12. Waste drawer

Receptacle for processed cuvettes.

13. Illuminated guard bar for the entire working area

llumination: white flashing red - stand-by and sample prep - an error message has occurred

14. Power switch (Power)

The power switch switches the instrument on and off.

15. Fuse

The fuses protect the instrument from overloading.

16. Mains cable connection

Mains cable socket.

17. Connection to the water sensor (Sensor)

The water sensor controls the water level in the washing tank.

18. Connection to the PC (USB)



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

018028 08-2007 V3

Preparations for Operation

Prior to initial operation of the Thrombolyzer the following requirements should be met: - are all electrical connections established - are all tubes and sensors connected - are the probe and pipetting tube assembled - is the water tank filled - is the waste water tank emptied - is the cuvette register filled - are predilution cuvettes available - is the incubation station cover at hand

Turning on the device

f all conditions are fulfilled, switch on the Thrombolyzer first, then the monitor and then the PC. Enter the password for the user routine into the registration console and confirm with .

Note:

After the PC has booted the software will load and the Thrombolyzers result distributor moves.

4

018028 08-2007 V3

The Screen
1

6 4 5 After turning the PC on the main screen, which is divided into six areas, will open.

1. 2. 3.

Main menu for choosing the status windows required for the sample prep.

Menu window Test

This column is faded out if it is not relevant for the programme. The status window is changed by the menu items in the main menu. The selection is determined by the cursors position in the menu. Depending on the selected menu item, information is displayed or data can be edited. System status display area (system and error messages). of the function keys (time, date and software version). The following situations are possible: Green: results rack is not being processed, it can be removed. Red (blinking): sample prep will begin after patient results are identified.

Status window

4. 5. 6.

Message window Status display

Colour indicator in the message window

On the left of the indicator the results which are already scanned are indicated; on the right the selected reagent block (e.g. rb) is displayed.



018028 08-2007 V3

Preparation of the reagent block

The reagent block
The reagent block is an aluminium block with  positions for reagent and  control plasmas. The reagent block is designed as a module insert, so that it can be loaded outside the Thrombolyzer, or can be kept in the fridge during longer down times between operation n order to load the reagent block, select the reagent block in the main menu. The diagram of the reagent plate can now be viewed on the desktop. The identification codes of the tests to be used, the reagent identification code and the name of the reagent are displayed in the individual positions. Load the reagent plate according to the diagram on the screen. The position CLEAN has a fixed definition. The term Clean represents a decontamination liquid for the probe.

The following predetermined and definite identification codes are used for the reagent block: RE BU DP CC AC = = = = = Reagent Buffer Deficiency plasma Calcium chloride Activator LA = BL = SU = NP = (blank) = Latex reagent Bleach Substrate Normal plasma not occupied

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



018028 08-2007 V3

The Cuvette Register

Replacement
The cuvette register holds  ( units) cuvette bars. Each cuvette bar holds 4 cuvettes, so a maximum of  x 4 =  analyses are possible. The cuvette rack 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 to do so. As soon as the result distributor has stopped, the register can be replaced with a full one or rather reloaded. Please make sure that the bar cover is returned to its original postion. Restart the instrument by pressing o or ALARM OFF.

Loading the Cuvette Register

n 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 Thrombolyzer. For the washing solution de-ionized water or distilled water may be used. When using distilled water, it is recommended to add ml Clean solution per 000cc to the washing tank. The water level is monitored by a sensor. f the water level is insufficient, an alarm is sounded and the following message is displayed in the message window: Insufficient amount of water in the reservoir

Refilling the Washing Tank

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

7

018028 08-2007 V3

The Waste Drawer

The used cuvette bars are ejected into the waste drawer after measuring. f the drawer is full, it ejects automatically and the message waste container nearly full appears. f the drawer is not emptied now, the system will pipet another five cuvette bars and will then interrupt the sample prep. n 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 acknowledged, the device assumes operation.

The Predilution
 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  is full ... or Predilution rack  is full .... Press n and wait for message arm is standing before removing the insert.

Never reach under the protection guard in the pipetting zone, behind the plexiglas barrier, while the Thrombolyzer is in operation. In case of emergency use the stop button to immediately stop the movement of the arm. Warning of a biological hazard



018028 08-2007 V3

Checking Probe Position

nspect 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 yw, reconfirm needle: test position by pressing e . The needle should now move exactly to a position above the red test point on the washing station. Note: The arm moves to the test position. f necessary, align the probe by hand, then choose test position again. f the probes position is OK, select the probe test and then e. Note: The arm moves to the home position. Follow the instructions in the message window: place the test receptacle 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 washing station, then press o/ALARM OFF. Select the item Washing station e. Exit the work field Hardware with ^.



018028 08-2007 V3

Prime Pumps
Select the menu item Hardware / Prime Pumps. Confirm with e. The hose system of the Thrombolyzer 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.

Stand-by Mode
f no patients specimens are processed, the Thrombolyzer automatically goes into stand-by mode. n the stand-by mode, a short washing of the needle is carried out every 0 minutes.

Deactivating the Thrombolyzer

Select Exit in the menu using yw. Confirm by pressing e twice. Note: The arm moves and a final washing process is conducted. The operator interface changes to the log in console. You can now switch off the Thrombolyzer.

0

018028 08-2007 V3

The Main Menu Window

n the Menu window the various Thrombolyzer functions can be selected. Move the cursor with yw to a menu item or enter the menu items first letter. When going to a different menu item the display of the status window will change 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 Ds and the desired tests can be entered.

Reagent block STAT

Display of the reagent block with reagent positions. Replacement of the reagent block when several blocks are available. For inserting STATs into the running sample prep. STATs are given priority in processing.

Run Display Calibration Q.C. Setup

Status display of the cuvette bars in the incubation / measuring block, as well as the results of the last three bars. Display and input of calibration curves and standard values. Display, input and control of the QC limit values for every test.

Run Control

Entry of the controlling plasmas for the QC. Selection and start of the QC.

Reagent Database Hardware Result

Data display and data input of the reagents used. Maintenance and control menu for probe, syringe, bars, lamp, water level and temperatures. For searching the result database for measuring results, quality controls and system messages for viewing, printing and transmitting same to the host.

Test parameters Exit

Selection and control of the selected test parameters. Changes only via the maintenance menu. The main menu must be exited before the PC is turned off.



018028 08-2007 V3

Signs and Symbols * Sample Prep Measurements

* (blinking) <-> Result is being processed Result has being processed No more plasma has been found Error message Result 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 D-number.

s n c m Pos  -

Status message i.e. sample prep in progress STAT cap piercing manual data entry

stands for rotor # indicates the position in the rotor



018028 08-2007 V3

Sample Prep.
Preparation of the results
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. n 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 casings axel are repositioned according to the previously used rotor.

The rotor can be equipped outside the Thrombolyzer, e.g. directly on 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 Thrombolyzer, and press the start key.

ATTENTION! When attaching bar codes, you need to pay special attention, that they are placed in the scanners readable area. It is also important to uphold any specifications 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 ! The bar code is not vertical. 

incorrect ! The bar code is not centred.

018028 08-2007 V3

After scanning all bar codes with a connected EDP, the corresponding tests are sent for every patient, entered into the field tests and started. f, while scanning, the bar code is not recognised on a primary receptacle, the programme will display a corresponding error message.f no connection to the EDP exists, the XRC must be started via the keyboard. n case there is no EDP connection, XRC must be started using keyboard.

Go back to the menu with ^ and start the sample prep with m.

Manual Data Entry

Should the bar code not be available or legible, the data can be entered manually. f the system is linked to an EDP, the tests can be retrieved with % from the EDP after entering the D. Manual entry is then marked with the sign and this specimen can then not be read by the scanner. n case there is no EDP connection, the test must also be entered manually

4

018028 08-2007 V3

Working with several rotors

f there are many patient plasmas to be processed, you can facilitate the work by using several rotors. After loading and entry of the data for the first rotor, it can then be started. While the Thrombolyzer 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 rather enter data and start.

Adding samples during a running sample prep

You can adjust the specimen any time during the running sample prep n. Message stopped (arm is still working) wait for ready restart F4 appears. The Thrombolyzer finishes pipetting the commenced cuvette bar and interrupts its current sample prep. Wait until the message stopped with F (arm ready: restart F4) appears. Pull back the rotor up to the lock point (arrest point), or take it out of the device and put in the new specimen. Subsequently push the rotor back into the device, press the start button in order to read the specimen and start the interrupted sample prep with o. n case of connected EDP and already running sample prep, you need not press m, because the readjusted specimens are automatically started. Never reach under the protection guard in the pipetting zone, behind the plexiglas barrier, while the Thrombolyzer is in operation. In case of emergency use the stop button to immediately stop the movement of the arm.

Warning of a biological hazard



018028 08-2007 V3

Reagent Block
When the cursor is on Reagent Block in the menu window, a diagram of the reagent blocks rack appears in the screens work field:

n the reagent block, the reagent positions  to  are available for larger reagent areas. Positions - are available for smaller reagent areas. Positions ,  and  are stirred. Position 7 is exclusively reserved for dilution buffers.  RE A Quick = = = = Position in reagent block Reagent identification code Test identification code Reagent name

Reagent monitoring of the Thrombolyzer

During the pipetting process, the Thrombolyzer evaluates the reagent volume. f there is insufficient reagent in the reagent block, this is reported in the message box not enough reagent ... for further testing . n case this reagent is positioned several times, the Thrombolyzer evaluates these positions, whether there is still a reagent available. n case all the positions for a reagent are empty, the message reagent X (pos. X) not found appears.



018028 08-2007 V3

Refilling Reagent
When pressing n the message stopped (arm is still working) wait for ready restart o (sample prep.) is displayed. The Thrombolyzer finishes pipetting the previously started cuvette bar 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 corresponding reagent. Close the cover and push the reagent block back into the device and start the sample prep with o/ALARM OFF

Never reach under the protection guard in the pipetting zone, behind the plexiglas barrier, while the Thrombolyzer 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. n 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 0 seconds. n case the reagent drawer is not reinserted within the 0 second time limit, the bar currently being pipetted is discarded.

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

n the Thrombolyzer the sequence is the same as in the menu option sample prep., only that you can access the D field using menu item STAT e. Now the specimen Ds 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 according to the process described in chapter adjusting specimen. Processing and measuring of STATs in sample prep processing have the highest priority.



018028 08-2007 V3

Run Display
Status Display of Cuvette Bars Being Processed
The menu item run display displays the status of eight cuvette bars. The display scrolls from bottom to top.

For each cuvette the following data is shown: - the patient D. - 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 ndividual positions are displayed: Results displays the measurement results described above. Measurement block shows, which patient specimens are being currently measured. ncub.,, shows, which patient specimen is where in the incubation. Pipetting shows, which patient specimen is being currently pipetted.



018028 08-2007 V3

Calibration
n 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.

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 n the POS column the plasma positions for automatic calibration curve calculation are shown. n 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. n 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.

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7) Automatic The Thrombolyzer determines the values from calibration plasmas with different concentrations. 8) Fully Automatic The Thrombolyzer 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 will open and display the calibration curve. 11) Normal/ISI Optional when calculating the NR 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 curves in order to view the graph. Test e. Select the test for the corresponding calibration curve yw. Confirm the test e. On the desktop the cursor switches to automatic. Press yw to change to curve. 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 - LN/LOG - LOG/LN - LN/LN



018028 08-2007 V3

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 rd degree Linear regression Spline Linear interpolation (point to point) Values of the curve are given e.g. in %, mg/dl, g/l, U/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 PRNT

Creating calibration curves with the option automatic

From menu option calibration again access the field test by pressing e. Press yw to select 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. f 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. f you want to accept the new curve, press ^. f 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.



018028 08-2007 V3

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 X. 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 Thrombolyzer 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.



018028 08-2007 V3

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 Thrombolyzer starts pipeting the dilutions and shows the message Thrombolyzer is working (calibration). Once the calibration curve is successfully measured, the message Thrombolyzer 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. f you want to use the new calibration curve, press e. f you want to view your old calibration curve, switch from yes to no with K and leave the work area with ^. n 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. f you want to supplement 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. f 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. f you want to use less entries for calibration, overwrite the values of the previous entrieswith 0 (zero).

Once you have made all the alterations in the chart, you can alter the normal-S, min. and max. values with yw. Normal and S value are optional and dependent on the test. The normal value is automatically determined by the system during calibration. The S 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. f you want to use the new calibration curve, press e. f 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 option database under calibration curves. 4
018028 08-2007 V3

Q.C. setup
On the Q. C. setup menu the confidence intervals of the control plasmas are entered. A chart is available for every control plasma measured so far.

Details about working screen

Test: Plasma with Lot No.: Display test, for which quality check is conducted. 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/deep / high/ deep/ high changes depending upon the selected test for measuring unit and values. deep/high deep/high form the S area form the S area

Values for the marginal values must be entered according to the instruction leaflet of the reagent manufacturer. Curve: Scale y min/Scale y max: Accesses the chart Setting for an optimum graphic display of Q.C. set-up. Scale y min must be either equivalent to or less than deep. Scale y max must be either equivalent to or less than high.



018028 08-2007 V3

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. f you want to view another control plasma, press yw to switch to the next one. n order to view the chart, confirm with e. With k the graphic display switches between all and only unmarked values. f you want to change the limits of the confidence interval in the chart, use yw to switch to the values and enter the limit values from the reagent manufacturers instruction leaflet. The terms high and deep refer to the limits of the deviation from the desired value. Switch to the field curvexz, e. A chart of the run control is configured. To return to the main menu, press ^ - x, depending on the position.



018028 08-2007 V3

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. Average 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.

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Run Control
Select Run Control on the Menu yw.

Status window
n the control plasma status window you can specify the plasma to be used. The measurments 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 corresponds to a spot in the reagent block. Plasma: Lot No: Date: Names of control plasmas are entered here. Lot number of control plasma is entered here. Entry of the expiration date of the respective control.

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



018028 08-2007 V3

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 meaured be in this position, change the position from no to yes using k. f 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. n the start tests box enter the parameters the controls are to be determined for. Exit the status window with ^. Thrombolyzer 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. Thrombolyzer 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.



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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 calibration curves.

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Hardware
The menu item hardware is a control and maintenance programme (also see chapter maintenance).

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.

Test Position
Used for checking the probes position above the wash stations red dot. Confirm test position with e. Attention! The arm moves to the test position.

Adjust the probes position, if necessary. Select the menu item Wash Station e. Exit Hardware by pressing ^.

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Probe Check
Select hardware e Select probe check e Attention! The arm moves to the home position.

Follow the instructions in the message window. Message: Attention! Message: Put the test receptacle on the wash station and press e. (ME 63) The probe moves over the washing station then allots the solution into the test receptacle. Please remove test receptacle from the wash station and press o. (ME 68)

Select the menu item wash position e Exit the hardware with ^

Change Position
Remove the reagent block out of the Thrombolyzer. - Remove the protective hose out of the guides on the housing

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

- Remove the pipetting tube from the top of the probe. Attention! When removing the hose, tightly hold on to the probes black guide

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- 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 - Select test position yw. - Confirm with e. - Check the probes position.

false

Select wash position e. Exit hardware by pressing ^.

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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 ^.

Probe Clean
n the menu hardware select the submenu probe clean e. The probe exits the washing position, please pay attention to the message box. Pipet  ml of % hypochloride in the washing postion e. The probe moves into the washing position and draws up the solution, allow this to work for approx.  - 0 min. e ^ . Press w to change to Prime Pumps e.

Washing 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 () in the dilutor (approximately  rotations). Unscrew and remove the syringe from the top connection (). 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 w start position e. Now the syringe moves back to its initial position. Select prime pumps y & e. Thrombolyzer is not yet ready (prime pumps) appears in the message box. Wait until the message Thrombolyzer ready (hardware) appears and exit the work area with ^.

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018028 08-2007 V3

Prime Pumps
Select the menu item Hardware / Prime Pumps. Confirm with e. The hose system of the Thrombolyzer 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.

Clear Track
This menu item is only used in the event of a mechanical fault of the transport system. When started by pressing e, all cuvette bars presently in the pipetting position and the incubation positions are ejected. The Thrombolyzer independently repeats the measurements, which were not processed by the cleared track. The cleared track can also be activated during the progressing sample prep, after the system has been stopped with n.

LED Test
By confirming with e , the measuring system is checked for light intensity. At the end of the test, the message LED is OK appears in the message box. f an error message appears in the message box, please clean the measuring block

LED Range
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 of the displayed range .

Water Levels and Temperatures

Water reservoir status and the temperatures are displayed in a chart. f the water level is not shown to be OK, refill the water reservoir as described in chapter washing tank. f one of the temperatures is not OK, the Thrombolyzer stops the sample prep.

4

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Result
n the menu option result you can view and edit all saved messages and measurement values. n case the cursor is on result in the menu, press e and the screen changes to database selection.

Results: Controls:

Test results for all patients incl. all reaction curves Contains data from measurements of Q.C Set-up.

Calibration curves: Contains all the executed calibration curves. Protocol: Messages: Status: Contains the work log of the previous measurements List of generated error messages. Number of specimens, QCs and error messages

Result Data
f the item result data 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 backwards with yw through the patient data. You can select the following functions: print and send.

i p j yw

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

Should a database location of a specimen not be created only for one entry in the sample prep, enter a & before the specimen D in sample prep when entering the D number. The entry in the database can then be made over several days. The new results will be added. f an & is not entered, a new database position is created for each patient plasma. Confirm a new D number with e, the corresponding index card of the patient is displayed.

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018028 08-2007 V3

The conducted tests with measurement values, results and any possible error flags are displayed. To view possibly existing individual data, press e Display of the cuvette position, in which this test was measured for the patient.

e e

^ x^

the curve characteristics are displayed. the curve characteristics are displayed over the whole working area. Print curve characteristics exit curve. exit index card

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

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

Control
Move the cursor to the working area result on control and confirm with e. All quality checks available in the database are displayed. After selection of a control with yw and eall results are displayed for this QC. Continue to proceed as in the patients 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, state, 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 of the last 0 days. All individual values and averages with all possible information are displayed. Additionally after selecting with yw and e, a chart with the reaction characteristics of the measurement is displayed.

Errors

Upon pressing e a display appears which gives information regarding the number of patient plasmas measured up until now, the number of checks conducted and the number of registered messages.

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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. - Specimens - Controls - Errors

Temporal data outuput limitation of the results

Results Control Calibration Error Messages Protocol 0 days 70 days 70 days 0 days 0 days

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Viewing a calibration curve from the database.

Select calibration curve. Confirm with

Select a data record by using yw and then press the u key.

Confirm with e

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Display a Q.C. chart from the result database

Select controls. Confirm with e

Select a data record by using yw. Confirm with e

Press the u key to display the chart. The chart includes all measuring values contained in the data record

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Remove individual data record measurment values from the chart.

Mark all data records which are to be deactivated with k . A - symbol will appear in front of each deactivated data record. After pressing u only the valid values will be indicated in the curve.

Press k to display only the valid values in the curve.



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Test Parameter
The work area under menu option test parameters is merely an information interface and cannot be altered. Alterations are only possible in the maintenance programme.



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Exit
f you would like to stop working with the Thrombolyzer, select Exit from yw in the menu. Confirm  times with e ATTENTION! The arm moves and a final washing process is conducted. The user interface to the log in console. Press aS and confirm with e The PC switches off automatically.. Now switch off the Thrombolyzer.



018028 08-2007 V3

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  b {. - Scroll to the D field {}. Move the cursor to the desired test input with yw. Select the desired line area with xz and edit it f you wish to delete the entire line including D.-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 menus 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.

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018028 08-2007 V3

Maintenance and Care

Daily Sample Preparation
Probe In the menu hardware: Select probe / test position in the submenu and check (see checking the probe). Select the submenu prime pumps in the menu hardware. Check the general sequence and check whether air bubbles are present in the metering system. Check the canister fill level , if necessary empty or refill .

Tube system

Weekly Care
Probe Cleaning In the menu Hardware select the submenu probe clean e. The probe moves out of the washing position. Please pay attention to the message box. Pipett  ml of % hypochloride into the washing position e. The probe moves into the washing position and draws up the solution, allow this to take effect for approx. - 0 min. e . Press w to switch to prime pumps e.

Cleaning the Measuring Block

Open the service cover on the right side of the XRC.Moisten the top of the cleaning spatula with 00l NaCl 0.%/Clean. First clean the upper, then the lower part of the measuring block through the ejection slot. Afterwards dry with the clean or rather 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.

correct

incorrect

Wash Solution Container

Empty and clean the water storage canisters mechanically (by means of a bottle brush) and refill. Then access the menu and submenu prime pumps repeatedly.

Incubator (Track)

Wipe with a lint-free cloth which is moistened with NaCl 0.%.



018028 08-2007 V3

Maintenance Recommendation
We recommend annual service by a qualified technician or after 0.000 tests at the latest.

Bar Transport Check

During every restart, any bars remaining in the pipetting position (window in the incubation stations cover) will be ejected. n the event of failure, please check if all bars have been ejected (see clear track in the hardware chapter).



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Thrombolyzer Quick Reference Guide

Thrombolyzer in stand-by operation
Preparation Bar stock Water tank Waste water canister Waste drawer Menu yw hardware e check and if necessary refill check and if necessary refill check and empty if necessary check and empty if necessary test position e Probe test e reference point OK dosage flow OK

Washing position e ^ basic position of the probe Prime pumps e after completion exit with ^

Dissolve the reagents according to the manufacturers regulations and place in the reagent block. Menu yw reagent block Display of the reagent

Place result rack/rotor with patient samples in the Thrombolyzer.

Menu yw the host* or Menu yw Menu yw Start key sample prep e run display Patients data is scanned and the tests transferred by Manual input of the patients data. Exit operating area with ^. Starting of measurements. Run display of the measurement results, or protocol of the printer.

Adding patient samples - Filling free positions in the sample plate

Menu yw Menu yw

n
Start key

nterrupt running sample prep, insert specimens. Patients data is scanned, and the tests are transmitted by the host and started. Or menu yw sample prep eManual input of the patients data. Exit operating area with ^m. Start the interrupted sample prep. Add the new samples to the sample prep Run display of the measurement results or protocol of the printer.

Menu Menu Menu yw

o / ALARM OFF
run display

*When a sample prep is running, autostart is effected (only with host) 7

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Input of STAT patients

Menu yw Menu yw

n
STAT e

Stops the pipetting process. Wait for the message arm ready Arrange the samples in the free positions of the rotor. Patients data is scanned and the tests transferred by the host. Or manual input of the patients data. Exit operating area with ^. Start the interrupted sample prep. assumption of the new samples in the sample prep. Run display of the measurement results or protocol of the printer.

Menu Menu Menu yw

o/ALARM OFF m
run display

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.

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



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Generation of a calibration curve (example Fibrinogen with 4 bases)

Compilation of a fully automatic calibration (example Fibrinogen) Menu yw Menu yw reagent database e calibration e Calibration Values e For Fibrinogen enter the reagent, the new load number and the expiration date. Select test FB e. Select fully automatic yw then e. Switch to reference using w . Enter the Fibrinogen concentration from the package insert into the reference, then press e. Select X with k 0:0, then e. n X to X enter the dilutor in the same way 0:0, 0:0, and 0:0 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 Thrombolyzer begins with the calibration curve for the Fibrinogen.

Dilution

Checking the calibration (successfully measured)

Message Menu yw Calibration e XRC has finished calibration. See curve 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. f you want to use the old calibration curve, press k to switch from accept: YES to accept NO. Exit the work area with e.

Calibration



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Printing Calibration Curves (example Fibrinogen)

Menu yw Calibration e Automatic yw For displaying the curve . To display the curve Select test and confirm e. Switch to the box curve, then press e Press i to print the curve. Exit the curve with ^.

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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 D.-no. - Enter test identification code. Place sample receptacle into the rotor (bar code aligned). Press the start key in order to enter the D 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 D number. A cuvette bar is moved forward from the holding position to the pipetting position, the result distributor 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 70 l of buffer solution in the reagent plug-in unit, moves to the specimen receptacle and in addition takes up  l of plasma, then it moves to the cuvette bar in the pipetting position and delivers 0 l of this volume through the upper opening of the cell rack (first the l of plasma taken up last, then 4 l of buffer; this corresponds to 0:0 plasma dilution). n the washing position, the needle releases the surplus buffer amount into the waste and is cleaned.

Reagent pipetting

n the reagent block the probe takes up 40l kaolin, then 0l Fibrinogen reagent and dispenses this volume in the cuvette bar through the lower opening of the same cuvette (0l of the last taken up fibrinogen reagent and 0l kaolin taken up first). n 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 7 C.

Incubating

For incubating the cuvette bar is moved by the cuvette transport, according to the time setting on incubation (normally 0 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 0 seconds, giving the optics measuring amplifiers time to adjust to the cuvettes and then starts the measurement (clotting = measuring time aquisition) by tilting the cuvette bar. This merges the drops until now separated; the stirring device below the measuring block is turned on and the ball in each cuvette is agitated by the stirring devices rotating magnets, causing the reaction volume to be mixed homogeneously.



018028 08-2007 V3

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. n addition, the measuring thresholds are applied above and below this measuring signal. f clotting occurs the optical density changes and the measuring signal will cross one of these two thresholds. n this moment, the measuring time is registered. With the 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 sphere.

Cuvette rack ejection and return transportation Calculating the measurement value

f 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. 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 D 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 00 l Clean, water is pumped into the washing position, the needle measures 0 l of Clean into the washing postion, detects the mixture volume, immerges and takes up 00 l for the final cleaning process.

Printing measurement, transmitting data to the EDP

All data, such as patients D, 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.



018028 08-2007 V3

Troubleshooting
Pipetting Station and Dilutor
Fault Probe misses correct pipetting positons Cause/Source Probe bent during pipetting Action Press <Stop> button of Thrombolyzer, select Exit, wait  min., then turn PC + Thrombolyzer off. Check test position after restarting, adjust if necessary. With the Thrombolyzer turned off, manually check left/right/forward/back shaft guides, with probe in upper position, for smoothness of operation. Then check the up/down shaft as well. f movement is stiff, clean shafts with spirit and apply a light coat of lubricant. After another manual check turn the Thrombolyzer 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 correctly positioned in the sample rotor; the probe made contact with the cup when moving sideways Test position not checked before 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.



018028 08-2007 V3

Fluid Sensor
Error The probe sensor is not detecting liquid Cause / Source The pipette probe is not secured correctly. The sensor cable is not connected correctly or the cable is defective. The pipette probe is not secured correctly. The sensor cable is not connected correctly or the cable is defective.Sensor setting is incorrect. PipPosition Ref not OK Action Check that probe is assembled correctly, check that the cables plug connections are secure and check the cable for damage. The cable must be replaced if it is damaged in any way. Check that probe is assembled correctly, check that the cables plug connections are secure and check the cable for damage. The cable must be replaced if it is damaged in any way.f the error is still present, then undertake sensor setting as described below. WARNING! - Press the Stop button - Press the adjustment button on the pipette arm - Press the Stop button - Restart thrombolyzer using the o / ALARM OFF button Check that probe is assembled correctly.

The pipette probe remains above the sample / reagent and starts to continuously move up and down.

The probe position above the cuvette is too high. The probe sensor is not detecting liquid or only very large volumes.

Cause / sources of error: The pipette probe is not secured correctly. Sensor setting is incorrect.

Undertake sensor setting as described below. WARNING! - Press the Stop button - Press the adjustment button on the pipette arm - Press the Stop button - Restart thrombolyzer using the o / ALARM OFF button

4

018028 08-2007 V3

Dilutor
Error Probe is dripping during the pipetting process. Cause/Source The tube to the dilutor is kinked, resulting in a contraction and reduced fluid flow. Action

Replace tube.

Tube has worked loose at the dilutors compression fitting.

Pull tube from the guide to the compression fitting, then retighten the fitting and run it properly. (f only the fitting is tightened, any possible tension on the tube could cause the fitting to loosen again. Therefore dismounting and reinstallation are necessary after the fitting has been retightened! Perform Prime Pumps.

Tube not completely filled with fluid. Syringe of the dilutor leaky or not correctly fastened.

Check syringe and/or fastening (note sealing washer at the seats top).

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  times.

Wash Station
General: The wash stations rinse cycle is software controlled by the probe sensor. Error Wash station overflow. Cause/Source Waste water drain tube squeezed. Waste water tank without vent opening.  Action Check tube path outside of the instrument (possibly also a blocked drain port, e.g. after transport of the instrument). Provide vent opening.

018028 08-2007 V3

[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 cappiercing.

EF  flags the measuring value without overwriting it. With an EDP (host) connection: the data is not automatically sent to the host. A warning message (EP) is displayed in the message box. t is recommended to recheck the result. f any doubts remain, repeat the measurement.

Example picture: (the vertical line shows the point in the reaction cycle marked noisy)



018028 08-2007 V3

[EF] Error messages

0 0 07 0 0 0      7   0    4   7   0    4  AC pipett. time out Strip pipett. time out Plasma not found sc Not enough plasma sc Cup removed Plasma not found Reagent not found Pipet stop time out Plasma rack left time out Reagent rack time out Pre. posi. not free Predilution position not found Barcode not readable Barcode wrong Ball bear. missing Mixing motor defect Curve not o.k. No clot Start not OK (channel ,  or 4) Start not OK at ch. Threshold sign. out gnored (Trace) Sign. at thresh.slow Sign. at thresh.fast LEDs too dim LEDs too bright Chan.xx out of range < Chan.xx out of range > Chan.x < mean Chan.x > mean 4 4 4 44 4 4 47 4 4 0    4  Chromo. curve not OK Chromo linear < 0.4 Chromo polynom < 0. No signal (derived) Chromo result > .0 Meas value > meas  Meas value > meas  Value < single min Value > single max Duplicat. error Sample too dark MP not OK MP not OK Cal. CV value not OK Noisy

- : Unoccupied  0    4   7  Result not OK Result < calib. range Result > calib. range Result < 0.0 Result < Q.C. minimum Result > Q.C. maximum Result < lower limit Result > upper limit Overflow Result >  Same results: verify

-70 : Unoccupied 7 7 7 Meas. mix mot.slow Meas. pos. not up Meas. pos. not down

7

018028 08-2007 V3

Flag Brief text on

EF05 AC pipett. time out

Meaning
A time out has occurred (i.e., no more AC reagent, or the reagent drawer has been removed) during the pipetting process using the D-Dimer AC reagent. f the delay is too long, the measurements will be flagged with EF 0. The measurement will be repeated (pipetted and measured) in a new cuvette rack. A time out occurred during the pipetting process of a cuvette rack (i.e., no more reagent, or the reagent drawer has been removed) during the pipetting process. f the delay is too long, the measurements will be flagged with EF 0. The measurement will be repeated (pipetted and measured) in a new cuvette rack. After delivery of the specimen from the closed tube into the intermediary chamber of the cuvette rack, it could not be found. Check needle sensor. After delivery of the specimen from the closed tube into the intermediary chamber of the cuvette rack, not enough liquid could be found. Test tube was again removed after the first reading. Not enough plasma in the primary receptacle. Dosing needle is not correctly mounted or probe adjustment is incorrect. Not enough reagent in the receptacle for detection. Note: If a missing reagent is not replaced within 2 min. the sequence will be interrupted and the tests are continued which do not require this reagent. The emergency stop in the device was pressed for longer than  minute. The device interrupted the sequence. The rotor was missing for longer than  minute. The device interrupted the sequence. The reagent block was missing for longer than  minute. The device interrupted the sequence. All cuvettes for predilution are being used. The message was not responded to within  minutes. Place new cuvette racks in predilution and work can be continue.

EF06 Strip pipett. timeout

EF07

Plasma not found sc

EF08 Not enough plasma sc

EF09 Cup removed EF10 Plasma not found

EF11

Reagent not found

EF12

Pipet stop time out

EF13

Plasma rack time out

EF15 Reagent rack time out EF16 Pre. posi. not free



018028 08-2007 V3

Flag Brief text on printer*

EF17 Predilution sample not found

Meaning
An item / series of cuvettes is missing in predilution. The metering system has assigned predilution to an unoccupied position. Consequence: abort programme, clean predilution block, fit new cuvettes, then restart. The bar code on the tube is illegible. The bar code on the tube is no longer correct. The tube should be replaced. A ball is missing in one / several cuvette/s of a rack. Automatic repetition of all tests if a ball is missing in the case of individual determination. The drive motor for the agitator under the measuring block is blocked. Possible for detection types: pn/check, c-pol, and a-pol 40 nm. ) Clotting: the signal is compared with a special standard. The flag is produced if a variance occurs. ) Chromogen: No large reaction flaws may occur. ) mmunological: How chromogen and when exceeding the measuring range. There was no clotting detected within the measuring time /measuring time . An expected optical alteration did not occur during the tilting process. Can develop spontaneously, without any further causes. The dosing system does not operate appropriately. Possibly with channel -4. like with EF4, but with the st channel, specific features of this error: The complete rack is rejected. Safety monitoring during clotting tests. At the moment of starting time, the measuring signal is still outside the measuring thresholds This state leads to disregarding of the measurement value and to repetition. Possible causes can be measuring volumes which are too small or a prereaction of the specimen.

EF18 EF19 EF20

Barcode not readable ncorrect bar code No. of balls not OK

EF21 EF22

Mixing motor defect Curve not OK

EF23 EF24

No clot Start not OK (channel , or 4)

EF25

Start channel  not OK

EF26

Threshold sign. out



018028 08-2007 V3

Flag Brief text on printer*

EF27 gnored (trace)

Meaning
Safety monitoring during clotting tests. For this test, only a flawless clotting signal measuring with the input Trace in the test parameters is accepted. gnored measurements are repeated automatically without this safety monitoring, but in double regulation. Run controls are always evaluated without this safety monitoring. Only for PT with the fibrinogen calculated. The progression of the clotting signal was too slow (possibly very high fibrinogen). Only for PT with the fibrinogen calculated. The progression of the clotting signal was too fast (possibly low fibrinogen). The measuring channels do not receive enough light and have perhaps become soiled. Clean measuring block with cleaning rod. The measuring channels are receiving too much light. Liquid may have gotten into the measuring chamber. Clean measuring block with cleaning rods. The measuring channels are not receiving enough light signals. (AD - Value < 00) Clean measuring block with cleaning rods. A measuring channel in the measuring block is heavily soiled. Perhaps the rack has not been completely ejected and is blocking this channel during the lamp test.  measuring channel is receiving too many light signals. (AD - value > 00) refer to . Comment: too much liquid applied to the sponge of the cleaning rod when cleaning the measuring block. Rectification: leave liquid in measuring block to evaporate. The A/D value of an individual channel has deviated too far below the default value (A/D - Values = 0). The A/D value of an individual channel has deviated too far above the default value (A/D - Values = 0). Reaction progress cannot be defined (elucidation rather than clouding). Check measurement system using hardware/lamp test

EF28

Double threshold slow

EF29

Double threshold fast

EF30

LEDs too dim

EF31

LEDs too bright

EF32

Chan. xx out of range<

EF33

Chan. xx out of range>

EF34

Chan. x < mean

EF35

Chan. x > mean

EF41

Chromo. curve not OK

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018028 08-2007 V3

Flag Brief text on

EF42 Chromo linear < 0.4

Meaning
Status only possible in tests with chro-lin recording of measured values. chro-lin = increase measurement with lin. regression. The CV calculated over the  measured values is < 0.4. Reagent, sample or test adaptation not OK. chropol = increase measurement with polynom. The CV calculated over the  measured values is < 0.. Reagent, sample or test adaptation not OK. chro-pol = increase measurement with polynom. The CV calculated over the  measured values is < 0.. Reagent, sample or test adaptation not OK. The reaction signal was too low or non-existant. Reaction occured too late, possibly after expiration of the measuring time period. Reaction ist too large. The measurement time for a test is greater than the measurement time  programmed for this test. This is possible if several tests with different measurement times are being measured in one rack. (e.g. PT of 0 seconds + PTT of 0 seconds). The measurement time for a test is greater than the measurement time  programmed for this test. This is possible if several tests with different measurement times are being measured in one rack (e.g. PT of 0 seconds + PTT of 0 seconds). The measured value was recorded below the programmed MN entry. Possible during clotting and chromogene tests. Only possible during cases of individual determination, test is repeated. The measured value was recorded above the programmed Max entry. Possible during clotting and chromogene tests. Only possible during cases of individual determination, test is repeated The two measured values of duplicate cases are outside the tolerance. Sample is very nonhomogeneous (especially during PTT, thrombin time). Sample has clotted in advance. Metering system is not OK (condition of syringe/probe). The sample has too much clouding. The sample is too lipaemic, hemolytic or icteric. 7
018028 08-2007 V3

EF43

Chromo pol. < 0.

EF44

No signal (derived)

EF45 EF46

Chromo Result > .0 Meas value> meas 

EF47

Meas value> meas 

EF48

Value < single min

EF49

Value > single max

EF50

Duplicat. error CV

EF51

Sample too dark

Flag Brief text on printer*

EF52 EF53 EF54 MP not OK. MP not OK. Cal. CV result not OK

Meaning
Only derived Fibrinogen: The signal at the start of the reaction ist not OK. Check times Max. Only derived Fibrinogen: The signal at the end of the reaction ist not OK. Check times Max. The measured values of a calibration point are too different (only with 4 measurements per calibration point). see chapter Troubleshooting, page  Flag only possible in duplicate cases once a test has been repeated.  different flags were produced: - Set protocol printing in Print menu to YES. - Analyse sample again. The measured value cannot be converted into a result because it is below the calibration curve limit. Change MN and / or MAX calibration curve limits. The measured value cannot be converted into a result because it is above the calibration curve limit. Change MN and/or MAX calibration curve limits. The measured value is in the negative area of the calibration curve. Only possible with chromogene tests. Sample, reagent and/or test adaptation not OK. Check metering system and/or probe sensor. The result of the run control is below the programmed confidence interval. The result of the run control is above the programmed confidence interval. The result is below the programmed standard range. The result is above the programmed standard range. Calculation overrun. Change the calculation type or entries under calibration. The message can be displayed when four of the same measuring values result in one cuvette rack. The revolution of the mixer unit under the measuring block is too low. 7
018028 08-2007 V3

EF55 EF59

Noisy Repeat. dupl. error

EF60

Result < calib. range

EF61

Result > calib. range

EF62

Result < 0.0

EF63 EF64 EF65 EF66 EF67 EF68 EF71

Value < Q.C. minimum Value > Q.C. minimum Value < lower limit Value > upper limit Overflow Result >  Same results: verify Meas. mix mot. slow

EF72

Sensor/meas. block top F.

The measuring rack is not in move-in position Upwards. Tilt rack is restricted when swinging. Tilt motor is not working correctly. Sensor does not recognise the corresponding position. as in EF7 but with measuring position

EF73

Sens/meas. block bottom F.

* Printing of the error text only when protocol print is activated!

7

018028 08-2007 V3

Errors and failure

Error messages, EP range: (m-e-errp.txt) EP errors are status errors Liquid X is missing The reagent for test X has not been defined in the reagent block menu item. The Thrombolyzer cannot conduct the test. ncorrect reagent block selected. Control plasma X not found There is no control plasma or too little control plasma in the specified position in the Q.C. set-up menu item. Please add plasma. Plasma X not found Plasma X has not been placed in the sample preparation system or the liquid level is so low that the thrombolyzer cannot detect it. The Thrombolyzer moves to the next sample to continue working from that point. The result which is not found is marked in the print-out and result menu item by EF0. No enough of liquid X (low level) The reagent in position X will only suffice for the cuvette rack which has just been started. Reagent X e.g RE A (position 5) not found All defined spaces for reagent X are below the low level. The Thrombolyzer cannot continue to work. Please provide the reagent needed at the corresponding position in the reagent block. Too many tests have been selected Service: message from applications area no reagent e.g. RE D.Plasma rack e.g. (2) not started Service: message from applications area Mixing speed for meas. block too slow (actual <nominal), The speed of the mixing motor in the measuring block is below the nominal speed. Please call service to clean the mixing motor. Interface X not OK Service: technical error Measuring chanel X too dark The specified measuring channel is too dark (chromogene tests). Please clean the measuring block. Measuring chanel X too bright The specified measuring channel is too bright (chromogene tests). Please clean the measuring block. The booster may be set incorrectly. Please call service. Measuring chanel %s too dark (difference to mean) The specified measuring channel is deviating too much from the other measuring channels in the dark range (chromogene tests). Please clean the measuring block. Measuring chanel %s too bright (difference to mean) The specified measuring channel is deviating too much from the other measuring channels in the bright range (chromogene tests). Please clean the measuring block. EP01

EP02

EP03

EP04 EP05

EP06 EP07 EP08

EP10 EP11

EP12

EP13

EP14

74

018028 08-2007 V3

Test code e.g. X3 not selected Service: message from applications area File X not found. Press F4 Service: technical error File X not saved. Press F4 Service: technical error Predilution rack X is full. Please replace it! The last cuvettes were used in the predilution rack. Please replace the predilution rack, so that the next predilution can be pipetted without delay. Calibration, e.g. Test A is not OK An attempt was made to start a sample prep with . The calibration for test A is not OK. The current calibration for this test must be validated.(menu calibration). Version of the task not OK Call service. Read Error in file X. Press F4. Call service. Volume table for test (e.g. B) is not OK Call service. Predilution plasma in cuvette X not found Placement of the predilution cuvette was forgotten. Please place predilution cuvettes in the device.. Cuvette X for predilution not available Timely replacment of the predilution cuvettes for devices with predilution was forgotten. Please place unused predilution cuvettes in the device. (For position, see EP) Database Call service. Follow-up test e.g. X3 not selected Service: error from applications area Derived test e.g. X3 not selected Service: error from applications area Test parameters of the derived test e.g. X4 not OK Service: error from applications area Detection type of the derived test e.g. X4 not OK Service: error from applications area Test parameters for test e.g. F are not OK Call service. Predilution not possible (volume chart for test e.g. F) Service: error from applications area 7

EP15 EP16 EP17 EP23

EP28

EP29 EP30 EP31 EP32

EP33

EP35 EP39 EP40 EP41 EP42 EP43 EP44

018028 08-2007 V3

Test parameters of follow-up test e.g. F not OK Service: error from applications area Rotor X (pos. Y) blocked, check, then F4 Rotor blocked during the sample prep. Please check whether the rotor can be turned by hand or whether the rotor is blocked due to foreign objects.. Rotor X (pos. Y) not existent or start pos. not OK The rotor does not function properly during the sample prep. Please check whether the rotor can be turned by of hand or is blocked. Timer for reagent e.g. RE A in pos. 5 expired in reagent block 5) The expiration date for the reagent has run out, the reagent must be renewed. Fatal ERROR on Rotor Scanner X! Please Quit! Call service. File ... cannot be found. Please exit the system! Call service. Barcode in prep. Xs not readable (1st time) The first scanning attempt for the sample in rotor X, pos. XX during the sample prep has failed. This error is not displayed on the screen but instead saved in the error result database for service purposes. Wrong barcode in prep.X (1st time) The first scanning attempt of the specimen in the rotor during the sample prep has failed. This error is not displayed on the screen but instead saved in the error result database for service purposes. Transport of strip backwards not OK An error has occurred during transport of a cuvette rack from a measuring block back to the pipetting position. Exit the main menu and follow the instructions in the warning window once the software has been restarted!! Error in file X. Press F4 and check parameters! Error in file X press the o/ALARM OFF and check the parameters. Measuring channel X too dark (LEDs off) The LED test determined that a measuring channel is too dark with a switched off lamp. Please call service. Measuring channel X too bright (LEDs off) The LED test determined that a measuring channel is too bright with a switched off lamp. Please make sure that there is no direct sunlight present otherwise, call service. Plasma X not found The patients plasma could not be found. Plasma X not found (level X, Xl missing) The patients plasma could not be found. The amount in the mixing chamber is too low. Call service. Communication with Sampler not OK. Please exit the software Communication with the specimen distributor was interrupted. The device must be shut down and restarted. 7

EP45 EP46

EP47

EP48 EP49 EP50 EP51

EP52

EP54

EP56 EP57

EP58

EP59 EP60

EP61

018028 08-2007 V3

Device ID mismatch. Please quit The software does not match the hardware. X with incorrect hardware version. Please exit! The hardware does not match the current software X with incorrect software version. Please exit! The software does not match the current hardware. No communication. Please restart the system This error can be caused by the following: The connection between the Thrombolyzer and the PC is missing or is defective. The Thrombolyzer is not switched on. Bar code in prep. X not readable Check the bar code in pos. X. f necessary, repeat Wrong bar code in pos. X Check the bar code in pos. X. f necessary, repeat Attention: check results and sample in rotor pos. X ! Check the specimen, check measurements for plausibility. f necessary, repeat. File X not found. Please exit the system and call service Please call service Error in file X. Please exit the system and call service Please call service Error messages, ER range: (m-e-err.txt) ER errors are status and failure errors Printer not ready Check status of printer. Caution: if the sample prep is conducted for a longer period of time without the printer being ready, errors in the process may occur. No communication. Please restart the system This error can be caused by the following: the link between the Thrombolyzer and PC is missing or defective. The Thrombolyzer is not switched on. Wash position overflow Press o/ALARM OFF. f the error appears again, please exit. The error suggests a defective waste water pump or a blocked waste water filter. Call service. No water transport to the wash position (F4) Press o/ALARM OFF. f the error appears again, please exit!. The error suggests a defective feed water pump, a blocked feed water filter or a defective feed water valve. Call service. Probe Cleaner not found No hypochloride was filled in the wash position for the probe cleaning function (prime pumps). Please add the hypochloride.

EP62 EP63 EP64 EP65

EP66 EP67 EP68 EP73 EP74

ER01

ER02

ER03

ER04

ER05

77

018028 08-2007 V3

Probe is wet before driving down Check that the probe and metering hose are fitted tightly or e.g. check for loss of liquid

ER07

Cuvette holder empty (sensor not OK) ER08 1) Normal condition: there are no more cuvette racks in the cuvette register. Refill with cuvette racks and press o/ALARM OFF. f o/ALARM OFF is pressed and the cuvette racks have not been refilled, it will take around 0 seconds for the error to reappear. 2) Error condition: check whether any racks are jammed or whether e.g. there are any balls under the cuvette register and eliminate the error accordingly. Once this error has reappeared, please wait at least 0 seconds before pressing o/ALARM OFF again and thereby eliminating the error. Check cuvette position at pipetting station Once you have pressed o / ALARM OFF, check the position of the rack in the pipetting area. f the error reoccurs, call service. Not enough water in the reservoir. The Thrombolyzers wash fluid must be refilled. The error is deleted once o / ALARM OFF has been pressed. f the error reappears despite the wash fluid being refilled, please call service. Temperature out of range (pipetting area) The temperature in this area is not OK. f the environmental temperature is within the specified range, please call service. Attention! The warming up phase can take up to  hour dependent on the environmental temperature. Temperature out of range (incubation area) The temperature in this area is not OK. f the environmental temperature is in the specified range, please call service. Attention! The warming up phase can take up to  hour dependent on the environmental temperature. Temperature out of range (measuring block) The temperature in this area is not OK. f the environmental temperature is in the specified range, please call service. Attention! The warming up phase can take up to 1 hour dependent on the environmental temperature. Calibration curve failed The process of automatically producing a calibration curve could not be completed successfully. A reason for this could be that the specimen has not clotted. f you have printed a protocol , you can view the individual values of duplicate cases. Otherwise the values can be viewed in the run display. Enter the values manually in the calibration or repeat the process of automatically producing a calibration curve. Please check the dilution of your plasmas. ncorrectly diluted plasma may also cause the production of the calibration curve to fail. Could not find calibration parameter file Service: technical error LEDs too dark The LEDs are too dark or the measuring block is dirty. Clean the measuring block LEDs too bright The LEDs are too bright. Call service ER09

ER10

ER11

ER12

ER13

ER14

ER16 ER18 ER19

7

018028 08-2007 V3

LEDs OK The LEDs are OK. The error appears once the lamp has been checked in the hardware menu LED test Lamp will faile soon Call service Predilution buffer not found Buffer liquid for a fully automatic calibration during predilution is missing. Plasma rack is not present There is no specimen insert available. Please place the specimen insert into the Thrombolyzer. Measuring block not up The measuring block is not moving all the way into the entry position (horizontally). Problems should be expected when entering the measuring block (rack jamming). Measuring block not down The measuring block does not move completely into the measuring position (vertically). Problems with rack ejection should be expected (rack jamming in the waste drawer). Position error (x/y) (1st time) This is an error indicating that a rectifiable arm error has occurred. ATTENTION: arm x/y position not OK Press o / ALARM OFF. The arm must now move into its HOME position and then approach the correct position. Should this error occur frequently, call service. Position error (z) (1st time) This is an error indicating that a rectifiable arm error has occurred. ATTENTION: arm z position not OK Press o / ALARM OFF. The arm must now move into its HOME position and then approach the correct position. Should this error occur frequently, call service. Cuvette rack empty, please refill ) There are no more cuvette racks in the cuvette register. Please refill with cuvette racks and press o / ALARM OFF. f you have pressed F4 without refilling the cuvette rack, it will take around 0 seconds for the error to reappear. ) Error condition: (Error reappears although the cuvette racks have been refilled) Check whether any racks are jammed or whether e.g. there are any balls under the cuvette register and eliminate the error accordingly. Attention: once the error has reappeared, please wait at least 10 seconds before pressing o / ALARM OFF and thereby eliminating the error. Otherwise a process error may develop!

ER20

ER21 ER22 ER23

ER28

ER29

ER35 ER36

ER37 ER38

ER39

7

018028 08-2007 V3

ER 40 to ER 46: All the following errors require the sample prep software to be exited 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 so, remove them manually if necessary!! Please check the transport channel for foreign objects. Cuvette transport error M2 (pipet pos.) An error has occurred in the pipette position during rack transport. Cuvette transport error (1st incub.pos.) An error has occurred in the incubation  position during rack transport. Cuvette transport error (2nd incub.pos.) An error has occurred in the incubation  position during rack transport. Cuvette transport error (3rd incub.pos.) An error has occurred in the incubation  position during rack transport. Cuvette transport error M6 (measuring block entrance) An error has occurred in the incubation  in measuring block position during rack transport. Please check rack ejection on the measuring block. Cuvette feeder measuring block error (< 2 sec.) There was probably already rack in the measuring block, when the rack was transported to the measuring block. Remove this rack and please check the transport channel. Close the sample prep and restart the Thrombolyzer. Cuvette jam M7 in measuring block (press F4 + mech. help) When ejecting a rack out of the measuring block, the rack jams. Press o / ALARM OFF and pull on the rack. No plasma rack in working position Please check whether the specimen rack is pushed in as far as it goes. Probe cleaner not found The container for the probe cleaner solution is empty. Please refill the container and put it in the respective position. Calibration plasma not found One of the items (X-X4, -) of the calibration menu item does not contain any plasma or only insufficient plasma. Not enough probe cleaner (low level) The Thrombolyzer reports that the probe cleaner is nearly empty. Please refill the probe cleaner. Not enough bleach (low level) nsufficient amount of cleaning agent (ml) was only pipetted into the wash position to clean the probe. L.I.S communication error There is a fault in the link to the host computer. The Thrombolyzer cannot transmit its results automatically. Once the sample prep has been exited, you can highlight the data measured in the transmit new menu item and transmit it to the host computer. 0 ER40 ER41 ER42 ER43 ER44

ER45

ER46

ER49 ER50

ER51

ER52

ER53

ER54

018028 08-2007 V3

ER 55 to ER 57: All the following errors require the sample prep software to be exited 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 so, remove them manually if necessary!! Please check the transport channel for foreign objects. Cuvette position error (rt.sen.): stop testing The rack has not reached the correct pipette position. Please exit the sample prep immediately. Cuvette position error (lft.sen.): stop testing The rack has not reached the correct pipette position. Please exit the sample prep immediately. Cuvette position error (meas.blck>16.): stop testing No rack has arrived in the measuring block within the time specified. Please exit the sample prep immediately. Software version mismatch. Please exit the software. Call service. Liquid level sensing error The probe sensor is not stable. Please check that the probe is fitted correctly and / or call service. Database memory error, no more patients can be stored. Call service and / or delete the database section Balls missing from cuvette The ball sensor has not detected a ball in the cuvette. The test is repeated. No communication (block) ! Please < exit > This error may be caused by the following: the link between the Thrombolyzer and PC is missing or defective. The Thrombolyzer is not switched on. LEDs fail Call service. LEDs unstable Call service. LEDs fail. Please exit Call service. LEDs unstable. Please exit Call service. Left rotor offline Call service. Incubation type not OK. Please quit! Call service. ER55

ER56

ER57

ER59 ER60

ER61 ER62 ER65

ER66 ER67 ER68 ER69 ER70 ER72



018028 08-2007 V3

Measuring block: no strip arrived! An interruption has occurred when transporting the rack within the incubation area and the rack has not reached the measuring block. Possible errors: rack is jammed in the incubation or a transport motor in the incubation has a defect. Measuring block: motor defective ! 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 however, there was o optical change (dark) on channel 4. Possible errors: rack is jammed in the incubation or the transport motor measuring block is defective. Possible error: direct sunlight on the measuring block output! Measuring block: LED 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 however, there optical signal (bright) on channel 4 required for correct positioning was missing. Strip backwards in waitnot arrived Transport was interrupted when transporting the rack back into its waiting position. The rack did not reach the waiting position. Possible errors: defective transport motor in incubation. Transport of strips not OK. Please quit The previous four errors lead to this error if o / ALARM OFF is pressed. Exit the programme and restart it. The program has to be restarted as the result of a transport of bars not OK error. Please exit the error and then, once started a red warning window appears in the working area of the programme. Follow the instructions provided in this warning window and restart the sample prep.. Warning! Observe the following in the warning window: A: Always wait until the Thrombolyzer ready message appears in the message box. B: Correctly enter the password and confirm by pressing e. Transport of strips not OK. Please quit The password was entered incorrectly in the red warning window or not confirmed by pressing e. Transport of strips not OK: accepted f the red warning window has been correctly confirmed, this error only appears in the results.f the red window reappears after several restarts, call service. System parameter not OK The set system parameters are not OK. Please check. Bar code parameter not OK The set bar code parameters are not OK. Please check Reagent block parameter not OK The set reagent parameters are not OK. Please check. Needle sensor unstable (1st time) The probe sensor could not calibrate itself during the first attempt to search for liquids. A second attempt is conducted automatically.

ER74

ER75

ER76

ER77

ER78

ER79

ER80

ER81 ER82 ER83 ER84



018028 08-2007 V3

Needle sensor unstable, please check During the second calibration, the probe sensor is still not in the working area and cannot detect any liquid. Possible causes: - The probe is not fitted correctly - The sensor cable is defective or not fitted correctly f other malfunctions arise: call service. Dilutor error. Please quit! The dilutor cannot guide the syringe correctly. Therefore the encoder created an error message. The main menu must be exited and restarted. Possible causes: - Only use the original diluter syringe greased with silicon!! - Mechanical or electric malfunction f other malfunctions arise: call service. Unexpected RESET! Please restart the system The device has conducted an unexpected reset and must be restarted Waste container nearly full The waste box for the cuvettes is almost full and must be emptied at the next opportunity. Waste container full The container for the cuvette waste is full and must be emptied. The device interrupts operation Waste container not present Please insert empty waste container intp the device Reagent block not present Please insert the reagent block into the device Same barcodes not readable, see Sample prep. Several bar codes are illegible. Check in the sample prep menu which tubes were not legible. Measuring block not up. Please quit Exit the sample prep and restart the Thrombolyzer. Error messages, MP range: (m-e-msgp.txt) EP errors are status errors regarding test system parameters Test X not defined for control plasma No control plasma is specified for this test. Lot-no. e.g. 1234 not found. Error from the results (search function) Control plasma X is defined twice Two control plasmas have the same name. Please change one of the two names. You cannot exit the programme item until you have changed the names. Attention: even space characters are recognised as names for control plasma! Up volume is too great Service: error from applications area 

ER86

ER87

ER88 ER89 ER90

ER91 ER92 ER93

ER94

MP01 MP04 MP06

MP07

018028 08-2007 V3

Down volume for high pos. too high (max.. ) Service: error from applications area Down volume for low pos. too high (max.. ) Service: error from applications area Down volume for cuvette too high (max.. single) Service: error from applications area Down volume for cuvette too high (max.. double) Service: error from applications area Please also enter tests for the definition of liquids Service: error from applications area Dilution programme not entered Service: error from applications area Derived test e.g. G is not possible Service: error from applications area Derived test e.g. G is not selected Service: error from applications area Block X in working station is not yet ready The specimen rack was removed from the system before processing was completed. Reposition this block. Definition of derived test e.g. G not o.k. Service: error from applications area Min. value is too small (min. ...) The minimum calibration value is too small. t must be greater than 0.0. Min. value is too great (max. ...) The minimum calibration value is too great. t must be less than 0000. Max. value is too small (min. ...) The minimum calibration value is too small. t must be greater than the minimum value. Max. value is too great (max. ...) The maximum calibration value is too great. t must be less than 0000. Right column: value is too small (min...) The value for calculations in the Calibration menu item is too small. Please enter a higher value. Left column: value is too small (min...) n the Calibration menu item for manual and automatic production of calibrations, a value in the column for the measured values (%, mg/dl, etc.) is too low. Please correct this value. Right column: value is too great (max...) The value in the right column of the chart for the calibration is too great.

MP08 MP09 MP10 MP11 MP12 MP13 MP14 MP15 MP16

MP17 MP20 MP21 MP22 MP23 MP24

MP25

MP26

4

018028 08-2007 V3

Left column: value is too great (max...) The value in the left column of the chart for the calibration is too great. Reference value must be greater than x The start value in the fully automatic production of the calibration must be greater than x. ISI < Min. ISI value (min...) The S value entered in the Calibration menu item for manual and automatic production of the calibration is less than the value specified. Please correct your entry. ISI > Max. ISI value (max...) The S value entered in the Calibration menu item for manual and automatic production of the calibration is greater than the value specified. Please correct your entry. Value is too small (min...) A value is too small (incubation, measurement time , measurement time , calibration). Alter the value. Value is too great (min...) A value is too great (incubation, measurement time , measurement time , calibration). Alter the value. Service: error from applications area Too many tests selected (max 11...) Service: error from applications area Reagent block not defined Select the correct reagent block for the tests entered. This value must be empty: end of table is x value When making manual entries into the calibration chart calibration, another value below the limit value (0) was entered. Please delete the value entered or alter the line containing the limit value. Test is not selected Service: error from applications area Serial pipetting not possible Service: error from applications area Add 1ml bleach in wash stn. than ENTER When selecting the probe clean menu item in prime pumps, the wash position must be filled with hypochloride before the second cleaning stage is conducted.. Please fill with hypochloride and press e. Value not OK Service: error from applications area For predilution, please pipet the buffer first Service: error from applications area Pip table for predilution is not OK Service: error from applications area

MP27 MP28

MP29

MP30

MP31

MP32

MP33 MP34 MP35

MP36 MP38 MP39

MP40 MP41 MP42



018028 08-2007 V3

Up volume of (x) must be greater than 0 Service: error from applications area Down volume of (x) must be 0 Service: error from applications area Washing or cleaning in predilution line not possible Service: error from applications area Only normal pipetting possible Service: error from applications area Incubation in predilution pipetting not possible Service: erroro from applications area For predilution plasma pipet predil cuv. Service: error from applications area Down vol. for predil cuv. is too small Service: error from applications area Down vol. for predil cuv. is too great Service: error from applications area Down volume > receptacle volume not possible Service: error from applications area (X) line: pipet predil. plasma in cuv. Service: error from applications area Down volume of (x) must be greater than 0 Service: error from applications area Down volume of predil. plasma too great Service: error from applications area Pipetting of predilution not possible Service: error from applications area Chromogenic coagulation not possible (X) Service: error from applications area Follow-up test (X) is not possible Service: error from applications area Follow-up test (X) is not selected Service: error from applications area No test found with reagent name (X) Service: error from applications area Please first read limits for reagent (X) Service: error from applications area

MP43 MP44 MP45 MP46 MP47 MP48 MP49 MP50 MP51 MP52 MP53 MP54 MP55 MP56 MP57 MP58 MP60 MP61



018028 08-2007 V3

Rotor x is not in the working station Before scanning the tubes in the test preparation, rotor X is missing in the device. Please put the rotor in the corresponding position. Rotor x home not ok The rotors Home position is not reached before the test tubes in the sample preparation are scanned. Please check whether the rotor is meshing correctly with the toothed gear or whether the bar code in the Home position is dirty. No patients in rotor x When scanning the test tubes in sample preparations, no specimens were found in the specified rotor. Please check whether the bar codes of the plasma tibes are aligned correctly. Patient barcode in prep. X is not ok The scanner finds a different bar code to pipette the specimens than when the one recorded from the bar code (scan) Barcode in prep.X not readable During pipetting, the bar code at the specified position cannot be read. The remaining tests for this sample are not conducted. Wrong barcode in prep. X During pipetting, the bar code at the specified position does not match the one found during plasma preparations. The remaining tests for this sample are not conducted. Rotor: parameter error (X) Call service Test x not possible: has self depending Tests Service: error from applications area Test (X) is already assigned to test (X) Service: error from applications area Calibration not possible: is assigned to test e.g. D. The test does not have its own calibration because it is linked to a different calibration in the test parameters. Test X depending from Test X not possible Service: error from applications area Assigned tests for calculation (X) not possible Service: error from applications area Pipetting liquid X in position (X) not possible Service: error from applications area Coagulation type of derived Test X not OK Service: error from applications area Too many records selected (max.%s) The possible amount of data possible for printing or transmitting was exceeded

MP62

MP63

MP64

MP65

MP66

MP67

MP68 MP70 MP71 MP72

MP73 MP74 MP75 MP76

MP77

7

018028 08-2007 V3

Wash sequence needed After every pipetting of a reagent or specimen, a washing cycle must follow Wash sequence X in last line of chart not possible (only without C) Service: error from applications area Place X mm reagent receptacle on the wash position and press <ENTER> Serves as a daily check of the needle (see daily sample prep) Sample in prep. X not found After acquiring the specimen and during the pipetting, it was detected that a test tube was removed (Reflector foil was detected). Barcodes not readable, see Sample Prep. This error is displayed when during the registering neither the reflector foil nor a bar code was recognised (Position is occupied but the bar code cannot be read) USB stick could not be mounted The USB stick used cannot be recognised by the system. No tests found on USB stick No tests were found on the disc which could be copied to the system. Error messages, ME range: (m-e-msg.txt) ME errors are varied errors Key permitted only in main-menu (press ESC) The key just pressed is not admissible in the current menu. Press the ^ key to go back until you reach the main menu. You can now reselect the key you previously pressed .

MP78 MP79 MP80 MP81

MP82

MP84 MP85

ME02

Test not available ME03 A test for which there is no abbreviations has been entered in the sample prep menu item. The letters A-N and X, X, etc. are intended for test parameters. This error will appear if you enter a P for example. Menu entrance not permitted An incorrect password was entered for the menu item. The Thrombolyzer has three password levels which grant access to different menu items. Calibration not possible The calibration cannot be altered while the Thrombolyzer is processing the sample prep. Wait until the Thrombolyzer has finished its work. Now the calibration for a test can be altered. ME04

ME06

LED test not possible ME07 The LEDs cannot be tested during the running sample prep. Press n and wait until the running pipetting process is completed. You can then test the LEDs in the hardware menu. mixing ball is missing There is a ball missing in the cuvette rack. The test is repeated automatically. Test not selected When submitting entries during plasma preparations, a test was entered which is not available in the test menu. ME12 ME13



018028 08-2007 V3

Probe is not in wash position When exiting hardware, the probe must first be moved into the wash position. Before exiting hardware, you should therefore first access the wash station item. Only then should you exit hardware using the ^ key. Syringe is not in the start position Before exiting hardware, the syringe must first be moved to the home position after replacing it. Access the home position item. You can now exit hardware using the ^ key. Too many tests selected Service: error from applications area Prime pumps and probe clean not yet possible The prime pumps menu item cannot be activated while the Thrombolyzer is processing the sample prep. Please wait until the Thrombolyzer has completed the sample prep and then restart prime pumps. Hardware.. test not yet possible The programmes of the hardware menu item cannot be accessed during the running sample prep. Press n and wait until the current pipetting process is completed. You can then run the hardware programmes. Volume chart for single test is empty Service: error from applications area Position 7 can only be occupied with buffers Service: error from applications area LED test not finished yet The hardware menu item cannot be exited if the programme for the LED test has not yet been completed. Please wait until this is the case. Control plasma not defined A run control is integrated in the normal sample prep. This error is displayed if the control plasma has not been defined. Alter the name if you have, for example, made a typing error or delete the request. Test not defined for this control plasma A run control is integrated in the normal sample prep. The selected test is not defined for this Q.C.. Values are not OK The limits in the Q.C. set-up for high, average and low are incorrec, e.g. the average value is less than the value for low. No Curve for this calculation type Response curves cannot be illustrated during the measurement. Wait until the measurement is completed. Clear track not yet finished The hardware menu item cannot be exited if the programme for ejecting the rack has not yet been completed.

ME14

ME15

ME18 ME20

ME21

ME23 ME25 ME26

ME27

ME28

ME29

ME30

ME31



018028 08-2007 V3

In the first three lines must be a right value When producing the calibration manually, the values for the first three calibration points must be entered in the calibration menu item. Please enter the missing values. In the first two lines must be a right value When producing the calibration manually, the values for the first two calibration points must be entered in the calibration (chromogene tests) menu item. Please enter the missing values. Right column: value > max. calibration value Too great a value has been entered in the column for the measurement times in the Calibration menu item for producing calibration manually. Please correct this value. Right column: value < min. calibration value Too low a value has been entered in the column for the measurement times in the calibration menu item for producing calibration manually. Please correct your entry. Right column: not all values ascending The values entered in the column for measurement times in the calibration menu item must be entered in increasing order for producing calibration manually. Please correct this value. Right column: two values are equal Two equal values were entered in the column for measurement times in the calibration menu item for producing calibration manually. The values for the measurement times must be different. Please correct this value. Right column: not all values descending The values entered in the column for measurement times in the calibration menu item must be entered in decreasing order for producing calibration manually. Please correct this value. Left column: not all values ascending The values entered for measured values in the calibration menu item for producing calibration manually and automatically must be entered in increasing or decreasing order. Please correct your entry. Left column: two values are equal Two equal values were entered in the column for measured values in the Calibration menu item for producing calibration manually and automically. Please correct your entry. Left column: not all values descending The values entered for measured values in the calibration menu item for producing calibration manually and automatically must be entered in increasing or decreasing order. Please correct your entry. Normal < min. calibration value The normal time entered in the calibration menu item producing calibration manually and automatically is too low. Please correct your entry.

ME33

ME34

ME35

ME36

ME37

ME38

ME39

ME40

ME41

ME42

ME43

0

018028 08-2007 V3

Normal > max. calibration value The normal time entered in the calibration menu item for producing calibration manually and automatically is too high. Please correct your entry. Only one standard print possible Both types of standard print have been selected from the print menu. Please select just one type of standard print. Press <ENTER> to end the probe clean The probe clean menu item in prime pumps must be exited after a sufficient cleaning time by pressing ^. Min. one test must be selected Service: error from applications area Volume chart for double testing is empty Service: error from applications area Please read first control plasma Service: error appears when scanning in control plasma data using a hand-held scanner Please read first name of reagent Service: error appears when scanning in reagent data using a hand-held scanner Please scan <END> for next line Service: error appears when scanning in reagent data using a hand-held scanner Lot number missing Service: error appears when scanning in reagent data using a hand-held scanner To register the patients please press <F3> first During the sample prep,you can place new specimens in the rotor once the current rack has been fully pipetted. Start permitted only in main- or plasma-prep menu The START keys are only permitted in the main or sample prep menu. LIS communication error (already in work, or READY The host computer has requested tests for a specimen. However the speciment on which the cursor is situated has already been processed. For this type of calculation only double testing possible Service: error from applications area Exit probe check The probe check test is hereby concluded. Probe check is not concluded Press o/ALARM OFF, follow the instructions in the message box. Please remove container from wash position and press F4 Now take the 0 mm container off the wash position to check the volume (see MS) and press o/ALARM OFF. 

ME44

ME46

ME50

ME51 ME52 ME55

ME56 ME57 ME58 ME59

ME60 ME61

ME62 ME64 ME65 ME66

018028 08-2007 V3

Please wait Please wait until the process is completed. Error: Copy not OK An error occurred during copying from or onto disk First unit is not OK The conversion unit for this test is not OK. Alter to define calculation type. Success Message appears after successful copying. Second parameter must be empty Service: error from applications area Second parameter must be NorISI, CurISI or empty Service: error from applications area Second unit is not OK Service: error from applications area Second print format is not OK Service: error from applications area Second unit must be empty Service: error from applications area Second print format must be empty Service: error from applications area EDP is switched off in system parameters When tranmitting to the EDP with x, it is was determined that the communication is switched off. Printer not ready The printer is turned off or offline. Not the right Password The entered password is incorrect (upper and lower case sensitive). Printer is switched off in system parameters When attempting to print, it was determined that the printer is not switched on in the system parameters. Please wait: copying Message when copying data. CurISI cannot be first parameter Service: error from applications area Error: Thrombolyzer device and host device equal not possible Service: error from applications area

ME69 ME71 ME72 ME73 ME74 ME75 ME76 ME77 ME78 ME79 ME80

ME81 ME82 ME85

ME86 ME89 ME94



018028 08-2007 V3

Errors, ST range: (m-e-zust.txt) ST errors are status errors XRC is not yet ready This error indicates that the Thrombolyzer cannot yet be started. You must wait for the cuvette rack to eject after the Thrombolyzer has been restarted. XRC ready The sample prep can be started. XRC is in operation The Thrombolyzer is in operation. Details are also provided of the area in which it is working. XRC stopped due to error, restart with F4 Check the occurence before you press o/ALARM OFF, call service if necessary. XRC has completed calibration (see curve). TheThrombolyzer has completed the measurements for automatic calibration. Enter the calibration menu item and view the curve. F3 activated ARM STILL WORKING! restart: F4 You have pressed > to stop the sample prep process after pipetting the current rack to scan in new specimens for example. Then press o/ALARM OFF to restart the sample prep. Automatic calibration error! The produced calibration is incorrect and must be repeated. Check the calibration process. EMERGENCY STOP (STOP key on the device) IS ACTIVATED! The pipetting process has been stopped using the stop key on the left side of the device. You have to press the stop key again to restart the process. ) Only press the stop key if the pipetting process is to be stopped immediately. ) Only briefly press the stop key to e.g. replace a reagent! Attention: delays caused by pressing the stop key too long (>1 minute), can influence the results of the measurement! Wait for START/SCAN (ARM STILL WORKING) The Thrombolyzer is not connected to the EDP: you have pressed the scan key to conduct a scanning process after pipetting the current rack. (Sample prep) Status message in (....): This process is started once is pressed. (Calibration) Status message in (....): This process is started once is pressed. (Control) Status message in (....): This process is started once is pressed. (Hardware) Status message in (....): Always exit the hardware so that the probe is in the wash position.  ST01

ST02 ST03

ST04 ST05

ST06

ST07

ST08

ST09

ST10 ST11 ST12 ST13

018028 08-2007 V3

(Prime pumps) Status message in (....): presently running. (Probe clean) exit = ESC Press ^ to exit probe cleaning (recommended waiting period of 0-0 minutes) Distilled reservoir level low - refill There is not enough water in the reservoir. You can only start the device once you have refilled the water. f there is already sufficient water, the sensor may be defective. Temperature in pipetting station not ok The temperature in the pipetting area is not OK. This error appears if the station has been switched on during the heating up phase. f this errpr appears during operation, it indicates overheating. Please switch off the station and leave it to cool down. f this action doesnt help, please call service. Temperature in incubation station not ok The temperature in the incubation station is not OK. This error appears if the station has been switched on during the heating up phase. f this error appears during operation, it indicates overheating. Please switch off the station and leave it to cool down. f this action doesnt help, please call service. Temperature in measuring station not ok The temperature in the measuring block is not OK. This error appears if the station has been switched on during the heating up phase. f this error appears during operation, it indicates overheating. Please switch off the station and leave it to cool down. f this action doesnt help, please call service. Rack at position e.g. Inc3 not OK A problem has developed while transporting the cuvette rack into the incubation. Exit the software and follow the instructions provided in the warning window after restarting. Plasma bloc in working station not present After pressing m, the plasma rack or rotor is not in the device. Reagent block not present After m or during the sample prep, the reagent insert is not in the device Temperature in reagent station not ok Service error should reagent cooling fail.

ST14 ST15 ST16

ST17

ST18

ST19

ST20

ST21 ST24 ST25

Stopped with F3 (arm ready: restart F4 ST26 The Thrombolyzer has been stopped using n and can be restarted using o/ALARM OFF Buffer in pos. 7, plasma in C1, receptacles in (e.g.) X1-X4 ST27 This error appears if the fully automatic process for producing calibration is to be started. Place the reference plasma in the reagent block in the control  position, corresponding empty receptacles (e.g. Hitachi receptacles) in the specified positions in the rotor or plasma rack. Plasma in C1, receptacles. in (e.g.) X1-X4 Place the reference plasma in the reagent block in the control  position, corresponding empty receptacles (e.g. Hitachi receptacles) in the specified positions in the plasma rack. Plasma rack not present (arm stopped) The plasma rack is missing or is not inserted all the way. 4 ST29

ST32
018028 08-2007 V3

Reagent block not present (arm stopped) The reagent block is missing or is not inserted all the way. Scanning in progress Wait until the scanning process is completed. XRC is not yet ready, ejecting racks Normal status message once the sample prep software has been started. After approx. 40 sec. ready appears > X minutes ndicates the anticipated rest time in minutes for the currently started specimens. Host offline Data transfer to the EDP is not possible at the moment. Printer offline Printing not possible, printer switched off. Waste container nearly full The container for the cuvette waste is almost full and must be emptied during the next stand-by. Waste container full The container for the cuvette waste is full and must be emptied. Waste container not in the device Please insert an emptied waste container into the device. XRC ready - F3 for start > is activated. Press o/ALARM OFF for restart

ST33 ST34 ST35

ST36 ST37 ST38 ST39

ST40 ST41 ST42



018028 08-2007 V3

Accessories XRC
Order-no. Qty. 0-04 00-0 00-40 0-0 70-0 0-0 0-0 0-00 0-40 0-4 0-0 0-4 0- 40-4 0-00 04- -00 -400 -00 7-0 -00 40- - 0-0                4         Description x x x x x x x x x x x x x x x x x x x x x x x x XRC nstruction Manual Software Software CD Knoppix Linux Rotor No.  XRC Wash solution container,  liters Cuvette register Cuvette holding-down clamp Reagent block Adapter 0/.mm , reagent block Adapter 0/mm , reagent block Adapter 0/7mm , reagent block Adapter /0mm , reagent block Cover, incubation unit, XRC Probe CP cpl. Clean rod Predilution rod XRC Cable USB m Cable Cleaning Solution Container Power cord Sensor, Clean solution container Tube, mm ( meters) Pipetting tube Meshed tubing black  cm Fast washing control tank

Recommended Spare Parts

40-4 400-0 40- 0-00 -00 70-0 -7 Probe Syringe Hamilton Pipetting tube Cleaning sticks Tube, mm Clean solution container,  liters Adapter, rotor, pack of 0

Consumable Material Starter Kit (reduced quantities)

04-0 04- 00- 00- 00- 00-0 00-0 0-00  4 0 0 0 0   x x x x x x x x Cuvette bars CP Predilution sticks XRC Cuvettes Hitachi Reagent receptacles, 0mm Reagent receptacles, mm Reagent receptacles, mm Stirring sticks, magnetic Blister insert for waste drawer



018028 08-2007 V3

Optional Accessories
Cat. No. 0-0 0-0 0-0 0-0 0-0 0- Description Desktop PC Keyboard Mouse (USB)  TFT Monitor Printer Laser Printer

Consumable Material
04-0 04- 00- 00- 00- 00-0 00-0 00-0 00-40 Cuvette bars CP Predilution sticks Cuvettes Hitachi Reagent receptacles 0mm Reagent receptacles mm Reagent receptacles mm Stirring sticks, magnetic Clean, 00ml Kaolin g/l, 00ml

7

018028 08-2007 V3

XRC Technical Data

Protection class: Working voltage: Supply frequency Power input: Fuses:  ~ VAC 47~ Hz 0VA  x 0mm,T .A UL / EC 7

Scanner
according to EN 0-:4 + Al:00 + A:00: according to UL: CFR 040.0 Laser Class  Laser Class  with packing 0.0cm x .0cm x 0.0cm ,0 kg

Dimensions
W x H x D: Weight:

w/o packing 7.0cm x 7.0cm x .0cm ,0 kg

Space Required
W x H x D: 00cm x 70cm x 0cm

Ambient Conditions
Operating temperature: Storage temperature: rel. humidity: Maximum heat output: Sound ntensity: Overvoltage category: Contamination level: Environment of application: +7C - +C +0C - +40C 0% - 0% 0W dB(A)  according to EN 00 - :00  ndoor use in residential areas, commercial dwellings and light industrial environments

Temperature regulations
ncubation: Measuring block: Reagent cooling: 40.C 0.C * .0C 0.C * .0C - .0C

* Corresponds to a temperature in the cuvette of 37.0C 0.8C after a 3minute waiting period and a filling volume of 220l.

Specimen volume
(plasma + reagent)

minimum 0l/maximum 0l



018028 08-2007 V3

Declaration of conformity



018028 08-2007 V3