Table of Contents Cont ents General Safet Safety y Informa Information tion ......... .................. .................. .................. .............. .....1 1 Warnings ......... .................. .................. ................. ................. .................. .................. ................. ........2 2 Graphical Symbols .................... ............................. .................. ................. ................. ........... 2 Thrombolyzer Function Ke Keys ys ......................... .................................. ................ .......4 4 Introduction Introduc tion ......... .................. .................. .................. .................. .................. ................. ............ ....6 6 Cap-pie Cap -piercing rcing ......... .................. .................. .................. .................. ................. ................. ............. ....7 7 The Measuring Sy System stem......... .................. .................. ................. ................. ................ .......8 8 Ball Function ........................ ................................. .................. ................. ................. ................ .......9 9 Unpacking the Thrombolyzer ............. ..................... ................. ................. ........ 10 Location ......... .................. .................. .................. .................. .................. ................. ................ ........ 10 The Thrombolyzer XRC ............... ........................ .................. .................. ............... ...... 11 Overview of Functional Functiona l Units ........................ ................................. .............. ..... 12 1. Keypa Keypad d 2. Rotors/Results Racks 3. Reagent Blocks 4. Wash Stat Station ion 5. Dilu Dilutor tor 6. Cuvette Register 7. Result Dist Distribu ributor tor 8. Pipette Probe 9. Connection for Wash Water (IN (IN)) 10. Connection for Waste Water (OUT) 11. Predil Predilutio utionn Bloc Blockk 12. Waste drawer 13. Illuminated guard bar for the entire working area 14. Power swit switch ch (Power) 15.. Fuse 15 16. Mains cable connectio connectionn 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
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Preparations Preparat ions for Operat Operation ion ........ ................. .................. .................. ............... ...... 14 Turning on the device
14
The Screen ........ ................. .................. ................. ................. .................. .................. ............... ...... 15 Menu wind window ow Test Status window Message window Status display Colour indicator in the message window
15 15 15 15 15 15
Preparation Preparat ion 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 Dra wer ........ ................. .................. .................. ................. ................. ........... .. 18 The Predilut Predilution ion ........................ ................................. .................. .................. .................. ......... 18 Checking Checki ng Probe Position ......... .................. .................. .................. .................. ......... 19 Prime Pumps ........ ................. .................. .................. .................. ................. ................. ........... ..20 20 Stand-by Stand -by Mode....... Mode................ ................. ................. .................. .................. .................. .........20 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
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Signs and Symbols ......... ................. ................. .................. .................. .................. .........22 22 Sample Prep. ............. ...................... ................. ................. .................. .................. ............... ......23 23 Preparation of the results Rotor Preparation Manual Data Entr Entryy Working with several rotors Adding samples during a running sample prep
23 23 24 25 25
Reagent Block ......... .................. .................. .................. .................. ................. ................ ........26 26 Reagent monitoring of the Thrombolyzer Refilling Reagent
26 27
STAT ........ ................. .................. .................. ................. ................. .................. .................. ............... ......28 28 Inserting STA STATT measurements
28
Run Display ......... .................. ................. ................. .................. .................. .................. ............ ...29 29 Calibration Calibra tion ........ ................. .................. .................. .................. .................. ................. ............. .....30 30 Informat ion in the Calibratio Information Calibrationn Window Information Informat ion in the char chartt Creating calibrat calibration ion cur curves ves with the option “automatic“ Creating a new calibratio calibrationn curve with the option “fully automatic“ Input of a calibrat calibration ion cur curve ve using keyboard (manual)
30 31 32 33 34
Q.C. setup ........ ................. .................. ................. ................. .................. .................. ............... ......35 35 Details about working screen Displaying a Run Control Information Informat ion in the char chartt
35 36 37
Run Control ......... .................. ................. ................. .................. .................. .................. ............ ... 38 Status window Details regarding the desktop Execution of Measurements as Run Control
38 38 39
Reagent Database ............ ..................... .................. ................. ................. ................. ........40 40 Hardware ......... .................. .................. .................. .................. .................. ................. ............. ..... 41 Status Window Test Positi Position on Probe Check Change Position Reagent Position Probe Clean Washing Position Syringe
41 41 42 42 44 44 44 44
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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)
V
57 57 57 58 58 58 58 59 59 59 60
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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
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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.
ATTENTION!
Intervention in and modification of the product, not explicitly approved by the equipment manufacturer, may result in loss of functional capability. The costs for necessary repairs are to be borne by the user.
ATTENTION!
The equipment manufacturer is not liable for any damage resulting from non-compliance of the specifications stated in these instructions, damage caused by handling of reagents and biological fluids, or other handling of the product which is not in line with these instructions.
ATTENTION!
Data processing equipment connected to the instrument, such as personal computers or printers, must conform to the EN 60950 or UL 1950, respectively.
018028 08-2007 V3
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 Thrombolyzer’s capacity!
Meaning of the warnings used in these instructions. DANGER!
This information is for your own safety.
ATTENTION!
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
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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.
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Thrombolyzer Function Keys Keypad
Function
Use
Cursor keys
wxyz move the cursor on a chosen menu ^e
common standard functions
m
starts the processing
n
pipetting process stop after the pipetting of a rack; wait for the message “Arm ready“. The autostart is avoided with an online EDP.
o m
restart
o
everywhere, except delete the displayed messages. With error message, reac- Result tivate process, also via the keypad of the device.
p
transmits the routine input to the host
within the Sample Prep. menu of the selected sample plate
wp
transmits all entries of a routine’s sample plate to the host (Caution: spaces are regarded as input)
same as p
q
annotates a specimen with reactivate status and with sign. nput of new test identification code possible
within the Sample Prep. menu of the selected sample plate
wq
to reactivate all samples of a plasma rack with status and to mark them with the “&” character
bc*
to delete one routine position (D - tests); if held down all subsequent positions can be deleted, even across multiple parameters!
when on the Sample Prep. menu in an entry box
br*
deletes the entire position occupancy of a selected sample plate (even when processed, with status ≡ )
within the Sample Prep. menu of the selected sample plate
}
moves the cursor through the Sample Prep. boxes to the beginning of the next sample plate
Sample Prep. menu STAT menu
dg
moves within an entry box (beginning/end of the line)
Sample Prep. menu
k
to choose a sub menu from within a “Cursor box”
- Result - Reagents - Calibration
only on the Main menu
≡
≡
within the Sample Prep. menu of the selected sample plate
* dependent on keyboard layout of the country 4
018028 08-2007 V3
Thrombolyzer Function Keys ] (square bracket right) a9
to register a Quality Control in the d.-No. box of the routine for manual QC entry
Sample Prep. menu - STAT menu
bh
to move from the menu item “Sample Prep.” to the Test window, to enter a test for all positives of the selected sample plate
- Sample Prep. menu
bc
see bc , but for deleting tests
s
switch on Cap Piercing manually
u
in the routine menu, select desired position with the cursor and the current data bank for this with F0
bi
reactivates the printer
Mainmenu
u
reads the parameters for the calibration curve and displays the information in a new window.
Result
ks
activates /deactivates cap piercing
Sample Prep
bp
reactivates the host connection
Mainmenu
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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 Thrombolyzer’s sample throughput is.approx. 0 PT’s/40 APTT’s per hour. When using a cuvette register 40 tests can be analysed consecutively. Due to the micro method a measuring volume of only 0µl 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.
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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 t ransferred 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.
7
018028 08-2007 V3
The Measuring System
Plasma Plasma
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.
pipetting pipetting transporting
After the incubation time has lapsed the bar is moved into the measuring block. The illustration above demonstrates the tilting technology.
incubating
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.
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.
tipping
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
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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 ball’s rotation is stopped by the strong blood clot. Here the concentration of the blood clot has only little effect on the signal dynamics due to the rotation of the ball.. . 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.
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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 7°C 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
USB .0 interface
Throughput approx. 0 PT’s or 40 APTT’s
For continuous operation and emergency analyses
Cup Piercing 0 PT or 00 APTT‘s
Bar return
up to 40 samples with 4 parameters per hour
Open system for nearly all reagents
Test or patient oriented processing
Ready for immediate emergency analysis at any time
Automatic predilution
mmediate result display
Automatic repeated testing
QC programme
Automatic calibration curve calculation
PC can be used at any time (multitasking)
4 measuring channels
One Main menu for the entire sample prep
UV LED 400nm ∆ λ 0nm
Positive sample identification
Derived fibrinogen
Request of work lists from the host
Automatic level detection
Use of primary receptacles
Cuvette register for 40 tests
Sample and reagent reloading possible
rotor for primary receptacles
Refilling of the cuvettes possible at any time
Cooled reagent insertion for receptacles
Error monitoring during course of clotting
positions for the quality control
Error criteria output
Chronometric, chromogenic and immunological tests
Graphic display of the clotting process
Automatic reagent change
Unlimited database
Measuring system with process monitoring
Current display of sample status
Bidirectional interface
Automatic subsequent testing
018028 08-2007 V3
Overview of Functional Units
7
4
0 7
left side
front view
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 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:Thereisalsothealternativeofworkingwithseveralreagentblocks.
4. Wash Station To avoid contamination, the pipette is cleaned on the inside and outside. The washing cycle depends on the programme.
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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.
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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 Ü.
Note:
AfterthePChasbootedthesoftwarewillloadandtheThrombolyzer’s resultdistributormoves.
4
018028 08-2007 V3
The Screen 1
2
3
6 4 5
After turning the PC on the main screen, which is divided into six areas, will open.
1.
Menu window
Main menu for choosing the status windows required for the sample prep.
2.
Test
3.
Status window
4. 5. 6.
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 cursor’s position in the menu. Depending on the selected menu item, information is displayed or data can be edited.
Message window
System status display area (system and error messages).
Status display
of the function keys (time, date and software version).
Colour indicator in the message window
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.
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.
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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: “Insufficientamountofwaterinthereservoir”
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.
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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 probe’s 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 yet ready (Prime Pumps)“
After completion the message box reads: “XRC ready (Hardware)“
Exit the work field with ^. Note: “PrimePumps“isonlynecessaryifthesystemwasswitchedoffforseveralhours.In Stand-byoperationanautomaticshortrinsingtakesplaceevery30minutes.
Stand-b Standby 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 item’ item’ss 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
Display of the reagent block with reagent positions. positions. Replacement of of the reagent block when several several blocks are available.
STAT
For inserting STAT’s into the running sample prep. STAT’s are given priority in processing.
Run Display
Status display of the cuvette bars in the incubation / measuring block, as well as the results of the last three bars.
Calibration
Display and input of calibration curves cur ves and standard values.
Q.C. Setup
Display,, input and control of the QC limit values for every test. Display
Run Control
Entry of the controlling plasmas for the QC. Selection and start of the QC.
Reagent Database
Data display and data input of the reagents used.
Hardware
Maintenance and control menu for probe, syringe, bars, lamp, water level and temperatures.
Result
For searching the result database for measuring results, quality controls and system messages for viewing, printing and transmitting same to the host.
Test Te st parameters
Selection and control of the selected test parameters. Changes only via the maintenance menu.
Exit
The main menu must be exited before the PC is turned off.
018028 08-2007 V3
Signs and Symbols * Sample Prep Measurements *
Result is being processed
≡
Result has being processed
-
No more plasma has been found (blinking)
≡
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. D -number.
s
Status message i.e. sample prep in progress
n
STAT
c
cap piercing
m
manual data entry
Pos
stands for rotor #
- -
indicatess the position in the rotor indicate
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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 casing’s 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 scanner’s “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 !
incorrect !
The bar code is not vertical.
The bar code is not centred.
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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
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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
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Reagent Block When the cursor is on “Reagent Block” in the menu window, a diagram of the reagent block’s rack appears in the screen’s work field:
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.
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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 pipet ting needle stops immediately.
ATTENTION!Donotextractthereagentdrawerifthepipettingneedleiscurrently pipettingareagent.
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.
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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.
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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
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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 cur ve 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.
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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.
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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
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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:
Display test, for which quality check is conducted.
Plasma with Lot No.:
Plasma is adopted with name and lot number from the menu item “Run control“.
The chart for the limits of the condence 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:
Accesses the chart
Scale y min/Scale y max:
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.
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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 manufacturer’s instruction leaflet. The terms “high“ and “deep“
refer to the limits of the deviation from the desired value. Switch to the field “curve“ xz, e. A chart of the run control is configured. To return to the main menu, press ^ - x, depending on the position.
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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 È 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:
Names of control plasmas are entered here.
Lot No:
Lot number of control plasma is entered here.
Date:
Entry of the expiration date of the respective control.
Tests possible: Tests intended for the control plasma are entered here. Start test:
Tests for which a run control is to be started are entered here.
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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 probe’s position above the wash station’s red dot. Confirm test position with e. Attention!
The arm moves to the “test position”.
Adjust the probe’s position, if necessary. Select the menu item “Wash Station” e. Exit “Hardware” by pressing ^.
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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:
“Put the test receptacle on the wash station and press e“. (ME 63)
Attention!
The probe moves over the washing station then allots the solution into the test receptacle.
Message:
“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 probe’s 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.
false
right - Select “test position” yw. - Confirm with e. - Check the probe’s position.
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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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: “PrimePumps“isonlynecessaryifthesystemwasswitchedoffforseveralhours.In Stand-byoperationanautomaticshortrinsingtakesplaceevery30minutes.
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.
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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:
Test results for all patients incl. all reaction curves
Controls:
Contains data from measurements of “Q.C Set-up“.
Calibration curves: Contains all the executed calibration curves. Protocol:
Contains the work log of the previous measurements
Messages:
List of generated error messages.
Status:
Number of specimens, 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. Conrm a new D number with e, the corresponding index card of the patient is displayed.
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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
i
^ 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 patient‘s database. With t you have the opportunity of entering a comment for this control.
Control Search Control search see results search.
Calibration Move the cursor to the work area on “calibration“ and confirm with e. All calibrations of this system are displayed with test name, test abbreviation, type of calibration, 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 e
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 nal 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.
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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 menu’s item “sample prep.”: - To delete a test for all patients bc. - The cursor moves to the “test” box , select the test which is to be deleted yw. - Confirm the deletion with e. - To add a test for all patients bh. - Select the test to be added in the “test” box yw. - e adds and confirms. After starting sample prep, all data can be viewed with {}, but no longer altered.
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Maintenance and Care Daily Sample Preparation Probe
In the menu “hardware“:
Tube system
Select the submenu “prime pumps” in the menu ”hardware“. Check
Select “probe / test position“ in the submenu and check (see checking the probe).
the general sequence and check whether air bubbles are present in the metering system. Check the canister fill level , if necessary empty or refill .
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 È. 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 00µl 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.%.
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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 station’s 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
check and if necessary refill check and if necessary refill check and empty if necessary check and empty if necessary
Menu yw
test position e
reference point OK
Probe test e
dosage flow OK
hardware e
Washing position e ^ basic position of the probe Prime pumps e
after completion exit with ^
Dissolve the reagents according to the manufacturer’s 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
Start key
Patient‘s data is scanned and the tests transferred by
sample prep e
Manual input of the patient‘s data. Exit operating area with ^. Starting of measurements.
Menu yw
run display
Run display of the measurement results, or protocol of the printer.
Adding patient samples - Filling free positions in the sample plate Menu yw
n
nterrupt running sample prep, insert specimens.
Menu yw
Start key
Patient‘s data is scanned, and the tests are transmitted by the host and started. Or menu yw sample prep eManual input of the patient‘s data. Exit operating area with ^m.
Menu
o / ALARM OFF
Start the interrupted sample prep.
Menu Menu yw
m
Add the new samples to the sample prep Run display of the measurement results or protocol of the printer.
run display
*When a sample prep is running, autostart is effected (only with host) 7
018028 08-2007 V3
Input of STAT patients Menu yw
n
Stops the pipetting process. Wait for the message “arm ready”
Menu yw
STAT e
Arrange the samples in the free positions of the rotor. Patient‘s data is scanned and the tests transferred by the host. Or manual input of the patient‘s data. Exit operating area with ^.
Menu
o /ALARM OFF
Start the interrupted sample prep.
Menu
m
assumption of the new samples in the sample prep.
Menu yw
run display
Run display of the measurement results or protocol of the printer.
Measuring Run Controls Menu yw
run control e
With {} and k (yes/no) switch the control which is to be measured to “yes“ then e. Enter desired test abbreviations for the control plasmas under “tests 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 ^.
018028 08-2007 V3
Generation of a calibration curve (example Fibrinogen with 4 bases) Compilation of a fully automatic calibration (example Fibrinogen)
Menu yw
reagent database e
For Fibrinogen enter the reagent, the new load number and the expiration date.
Menu yw
calibration e
Select test “FB” e.
Calibration
Select fully automatic yw then e.
Values e
Switch to reference using w . Enter the Fibrinogen concentration from the package insert into the reference, then press e.
Dilution
Select 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.
Checking the calibration (successfully measured) Menu yw
Message
“XRC has finished calibration. See curve“
Calibration e
The cursor is located on “curve“, if not, press yw to move it there. View the curve by pressing e and confirm it with e. Accept: “YES“ - if you would like to use the new calibration curve, confirm with e. f you want to use the old calibration curve, press k to switch from accept: “YES” to accept “NO”.
Calibration
Exit the work area with e.
018028 08-2007 V3
Printing Calibration Curves (example Fibrinogen) Menu yw
.
Calibration e
Select test and confirm e.
Automatic yw
Switch to the box “curve“, then press e
For displaying the curve
Press i to print the curve.
To display the curve
Exit the curve with ^.
0
018028 08-2007 V3
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 µl of buffer solution in the reagent plug-in unit, moves to the specimen receptacle and in addition takes up µl of plasma, then it moves to the cuvette bar in the pipetting position and delivers 0 µl of this volume through the upper opening of the cell rack (first the µl of plasma taken up last, then 4 µl 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 40µl kaolin, then 0µl Fibrinogen reagent and dispenses this volume in the cuvette bar through the lower opening of the same cuvette (0µl of the last taken up fibrinogen reagent and 0µl 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 optic’s measuring amplifiers time to adjust to the cuvettes and then star ts 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 device’s 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
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.
Calculating the measurement value
The Fibrinogen test is calculated by means of a calibration of measuring time in concentrat concentration. ion. For this purpose the registered seconds seconds measurement is converted by a calibration calibration for example into 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 µl Clean, water is pumped into the washing position, the needle measures 0 µl of Clean into the washing postion, detects the mixture volume, immerges and takes up 00 µl for the final cleaning process.
Printing measurement, transmitting data to the EDP
All data, such as patient’s D, raw values and results are printed with date and time and are transmitted to the EDP, provided provided that these devices are installed. Furthermore Furt hermore 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
Cause/Source
Action
Probe misses correct pipetting positons
Probe be bent nt dur urin ingg pip pipet ettiting ng
Pres esss but butto tonn of of Thr Throm ombo boly lyze zerr, select “Exit”, wait min., 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/do up/down wn 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 Movement t he pipetting arm was prevented by force. The arm forward/back guide bars = “Y”-axis “Y”-ax is and up/down = “Z”-axis have run dry (very rare) or become dirty, causing stiff-ness.
018028 08-2007 V3
Fluid Sensor E r r or
Cause / Source
Action
The probe sensor is not detecting liquid
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
Check that probe is assembled correctly, check that the cable’s cable’s 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 cable’s cable’s 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.
The pipette probe remains above the sample / reagent and starts to continuously move up and down.
WARNING!
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 correctly.. Sensor Sen sor sett setting ing is inc incorr orrect ect..
- 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. correctly. Undertake Underta ke sen sensor sor sett setting ing as des descri cribed bed 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
Cause/Source
Action
Probe is dripping during the pipetting process.
The tube to the dilutor is kinked, resulting in a contraction and reduced uid ow.
Replace tube.
Tube has worked loose at the dilutor’s compression tting.
Pull tube from the guide to the compression tting, then retighten the tting and run it properly. (f only the tting is tightened, any possible tension on the tube could cause the tting to loosen again. Therefore dismounting and reinstallation are necessary after the tting has been retightened!
Tube not completely lled with uid.
Perform “Prime Pumps”.
Syringe of the dilutor leaky or not correctly fastened.
Check syringe and/or fastening (note sealing washer at the seat’s 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 station’s rinse cycle is software controlled by the probe sensor. Error
Cause/Source
Action
”Wash station overow”.
Waste water drain tube squeezed.
Check tube path outside of the instrument (possibly also a blocked drain port, e.g. after transport of the instrument).
Waste water tank without vent opening.
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
AC pipett. time out
4
Chromo. curve not OK
0
Strip pipett. time out
4
Chromo linear < 0.4
07
Plasma not found sc
4
Chromo polynom < 0.
0
Not enough plasma sc
44
No signal (derived)
0
Cup removed
4
Chromo result > .0
0
Plasma not found
4
Meas value > meas
Reagent not found
47
Meas value > meas
Pipet stop time out
4
Value < single min
Plasma rack left time out
4
Value > single max
Reagent rack time out
0
Duplicat. error
Pre. posi. not free
Sample too dark
7
Predilution position not found
MP not OK
Barcode not readable
MP not OK
Barcode wrong
4
Cal. CV value not OK
0
Ball bear. missing
Noisy
Mixing motor defect
- : Unoccupied
Curve not o.k.
Result not OK
No clot
0
Result < calib. range
4
Start not OK (channel , or 4)
Result > calib. range
Start not OK at ch.
Result < 0.0
Threshold sign. out
Result < Q.C. minimum
7
gnored („Trace“)
4
Result > Q.C. maximum
Sign. at thresh.slow
Result < lower limit
Sign. at thresh.fast
Result > upper limit
0
LEDs too dim
7
Overflow Result >
LEDs too bright
Same results: verify
Chan.xx out of range <
-70 : Unoccupied
Chan.xx out of range >
7
Meas. mix mot.slow
4
Chan.x < mean
7
Meas. pos. not up
Chan.x > mean
7
Meas. pos. not down
7
018028 08-2007 V3
Flag Brief text on
Meaning
EF05 AC pipett. time out
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.
EF06 Strip pipett. timeout
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.
EF07 Plasma not found sc
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.
EF08 Not enough plasma sc
After delivery of the specimen from the closed tube into the intermediary chamber of the cuvette rack, not enough liquid could be found.
EF09 Cup removed
Test tube was again removed after the first reading.
EF10
Plasma not found
Not enough plasma in the primary receptacle. Dosing needle is not correctly mounted or probe adjustment is incorrect.
EF11
Reagent not found
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.
EF12
Pipet stop time out
The emergency stop in the device was pressed for longer than minute. The device interrupted the sequence.
EF13
Plasma rack time out
The rotor was missing for longer than minute. The device interrupted the sequence.
EF15 Reagent rack time out
The reagent block was missing for longer than minute. The device interrupted the sequence.
EF16 Pre. posi. not free
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.
018028 08-2007 V3
Flag Brief text on printer*
Meaning
EF17 Predilution sample not found
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.
EF18
Barcode not readable
The bar code on the tube is illegible.
EF19
ncorrect bar code
The bar code on the tube is no longer correct. The tube should be replaced.
EF20
No. of balls not OK
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.
EF21
Mixing motor defect
The drive motor for the agitator under the measuring block is blocked.
EF22
Curve not OK
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.
EF23
No clot
There was no clotting detected within the measuring time /measuring time .
EF24
Start not OK (channel , or 4)
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.
EF25
Start channel not OK
like with EF4, but with the st channel, specific features of this error: The complete rack is rejected.
EF26
Threshold sign. out
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.
018028 08-2007 V3
Meaning
Flag Brief text on printer* EF27
gnored (“trace”)
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.
EF28
Double threshold slow
Only for PT with the fibrinogen calculated. The progression of the clotting signal was too slow (possibly very high fibrinogen).
EF29
Double threshold fast
Only for PT with the fibrinogen calculated. The progression of the clotting signal was too fast (possibly low fibrinogen).
EF30
LED’s too dim
The measuring channels do not receive enough light and have perhaps become soiled. Clean measuring block with cleaning rod.
EF31
LED’s too bright
The measuring channels are receiving too much light. Liquid may have gotten into the measuring chamber. Clean measuring block with cleaning rods.
EF32
Chan. xx out of range<
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.
EF33
Chan. xx out of range>
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.
EF34
Chan. x < mean
The A/D value of an individual channel has deviated too far below the default value (A/D - Values = 0).
EF35
Chan. x > mean
The A/D value of an individual channel has deviated too far above the default value (A/D - Values = 0).
EF41
Chromo. curve not OK
Reaction progress cannot be defined (elucidation rather than clouding). Check measurement system using hardware/lamp test
70
018028 08-2007 V3
Flag Brief text on
Meaning
EF42
Chromo linear < 0.4
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.
EF43
Chromo pol. < 0.
“chro-pol” = increase measurement with polynom. The CV calculated over the measured values is < 0.. Reagent, sample or test adaptation not OK.
EF44
No signal (derived)
The reaction signal was too low or non-existant. Reaction occured too late, possibly after expiration of the measuring time period.
EF45
Chromo Result > .0
Reaction ist too large.
EF46
Meas value> meas
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).
EF47 Meas value> meas
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).
EF48
Value < single min
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.
EF49
Value > single max
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
EF50
Duplicat. error CV
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).
EF51
Sample too dark
The sample has too much clouding. The sample is too lipaemic, hemolytic or icteric. 7
018028 08-2007 V3
Meaning
Flag Brief text on printer* EF52
MP not OK.
Only derived Fibrinogen: The signal at the start of the reaction ist not OK. Check “times“ Max.
EF53
MP not OK.
Only derived Fibrinogen: The signal at the end of the reaction ist not OK. Check “times“ Max.
EF54
Cal. CV result not OK
The measured values of a calibration point are too different (only with 4 measurements per calibration point).
EF55
Noisy
see chapter “Troubleshooting”, page
EF59
Repeat. dupl. error
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. EF60
Result < calib. range
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.
EF61
Result > calib. range
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.
EF62
Result < 0.0
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.
EF63
Value < Q.C. minimum
The result of the run control is below the programmed confidence interval.
EF64
Value > Q.C. minimum
The result of the run control is above the programmed confidence interval.
EF65
Value < lower limit
The result is below the programmed standard range.
EF66
Value > upper limit
The result is above the programmed standard range.
EF67
Overflow Result >
Calculation overrun. Change the calculation type or entries under calibration.
EF68
Same results: verify
The message can be displayed when four of the same measuring values result in one cuvette rack.
EF71
Meas. mix mot. slow
The revolution of the mixer unit under the measuring block is too low. 7
018028 08-2007 V3
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.
EF73
Sens/meas. block bottom F.
as in EF7 but with measuring position
* Printing of the error text only when protocol print is activated!
7
018028 08-2007 V3
Errors and failure
Errormessages,EPrange:(m-e-errp.txt) EPerrorsarestatuserrors Liquid X is missing
EP01
Control plasma X not found
EP02
Plasma X not found
EP03
No enough of liquid X (low level)
EP04
Reagent X e.g “RE A (position 5)” not found
EP05
Too many tests have been selected
EP06
no reagent e.g. “RE D”.Plasma rack e.g. (2) not started
EP07
Mixing speed for meas. block too slow (actual
EP08
Interface X not OK
EP10
Measuring chanel X too dark
EP11
Measuring chanel X too bright
EP12
Measuring chanel %s too dark (difference to mean)
EP13
Measuring chanel %s too bright (difference to mean)
EP14
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. 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 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. The reagent in position X will only suffice for the cuvette rack which has just been started. 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. Service: message from applications area Service: message from applications area
The speed of the mixing motor in the measuring block is below the nominal speed. Please call service to clean the mixing motor. Service: technical error The specified measuring channel is too dark (chromogene tests). Please clean the measuring block. The specified measuring channel is too bright (chromogene tests). Please clean the measuring block. The booster may be set incorrectly. Please call service. The specified measuring channel is deviating too much from the other measuring channels in the dark range (chromogene tests). Please clean the measuring block. The specified measuring channel is deviating too much from the other measuring channels in the bright range (chromogene tests). Please clean the measuring block.
74
018028 08-2007 V3
Test code e.g. “X3” not selected
EP15
File X not found. Press F4
EP16
File X not saved. Press F4
EP17
Predilution rack X is full. Please replace it!
EP23
Calibration, e.g. “Test A” is not OK
EP28
Version of the task not OK
EP29
Read Error in file X. Press F4.
EP30
Volume table for test (e.g. “B”) is not OK
EP31
Predilution plasma in cuvette X not found
EP32
Cuvette X for predilution not available
EP33
Database
EP35
Follow-up test e.g. “X3” not selected
EP39
Derived test e.g. “X3” not selected
EP40
Test parameters of the derived test e.g. “X4” not OK
EP41
Detection type of the derived test e.g. “X4” not OK
EP42
Test parameters for test e.g. “F” are not OK
EP43
Predilution not possible (volume chart for test e.g. “F”)
EP44
Service: message from applications area Service: technical error Service: technical error
The last cuvettes were used in the predilution rack. Please replace the predilution rack, so that the next predilution can be pipetted without delay. 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“). Call service. Call service. Call service.
Placement of the predilution cuvette was forgotten. Please place predilution cuvettes in the device..
Timely replacment of the predilution cuvettes for devices with predilution was forgotten. Please place unused predilution cuvettes in the device. (For position, see EP) Call service. Service: error from applications area Service: error from applications area Service: error from applications area Service: error from applications area Call service.
Service: error from applications area
7
018028 08-2007 V3
Test parameters of follow-up test e.g. “F” not OK
EP45
Rotor X (pos. Y) blocked, check, then F4
EP46
Rotor X (pos. Y) not existent or start pos. not OK
EP47
Timer for reagent e.g.” RE A” in “pos. 5” expired in reagent block 5)
EP48
Fatal ERROR on Rotor Scanner X! Please Quit!
EP49
File “...” cannot be found. Please exit the system !
EP50
Barcode in prep. Xs not readable (1st time)
EP51
Wrong barcode in prep.X (1st time)
EP52
Transport of strip backwards not OK
EP54
Error in file X. Press F4 and check parameters! Error in file X press the o /ALARM OFF and check the parameters.
EP56
Measuring channel X too dark (LEDs off)
EP57
Measuring channel X too bright (LEDs off)
EP58
Plasma X not found
EP59
Plasma X not found (level X, Xµl missing)
EP60
Communication with Sampler not OK. Please exit the software
EP61
Service: error from applications area
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.. The rotor does not function properly during the sample prep. Please check whether the rotor can be turned by of hand or is blocked. The expiration date for the reagent has run out, the reagent must be renewed. Call service. Call service.
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. 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. 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!!
The LED test determined that a measuring channel is too dark with a switched off lamp. Please call service. 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. The patient‘s plasma could not be found. The patient‘s plasma could not be found. The amount in the mixing chamber is too low. Call service. Communication with the specimen distributor was interrupted. The device must be shut down and restarted. 7
018028 08-2007 V3
Device ID mismatch. Please quit
EP62
X with incorrect hardware version. Please exit!
EP63
X with incorrect software version. Please exit!
EP64
No communication. Please restart the system
EP65
Bar code in prep. X not readable
EP66
Wrong bar code in pos. X
EP67
Attention: check results and sample in rotor pos. X !
EP68
File X not found. Please exit the system and call service
EP73
Error in file X. Please exit the system and call service
EP74
The software does not match the hardware. The hardware does not match the current software
The software does not match the current hardware.
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. Check the bar code in pos. X. f necessary, repeat Check the bar code in pos. X. f necessary, repeat Check the specimen, check measurements for plausibility. f necessary, repeat. Please call service Please call service
Errormessages,ERrange:(m-e-err.txt) ERerrorsarestatusandfailureerrors Printer not ready
ER01
No communication. Please restart the system
ER02
Wash position overflow Press o /ALARM OFF. f the error appears again, please exit. The error
ER03
No water transport to the wash position (F4) Press o /ALARM OFF. f the error appears again, please exit!. The error
ER04
Probe Cleaner not found
ER05
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. 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.
suggests a defective waste water pump or a blocked waste water filter. Call service.
suggests a defective feed water pump, a blocked feed water filter or a defective feed water valve. Call service. No hypochloride was filled in the wash position for the probe cleaning function (prime pumps). Please add the hypochloride.
77
018028 08-2007 V3
Probe is wet before driving down
ER07
Cuvette holder empty (sensor not OK) 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
ER08
Check cuvette position at pipetting station Once you have pressed o / ALARM OFF, check the position of the rack in the
ER09
Not enough water in the reservoir.
ER10
Temperature out of range (pipetting area)
ER11
Temperature out of range (incubation area)
ER12
Temperature out of range (measuring block)
ER13
Check that the probe and metering hose are fitted tightly or e.g. check for loss of liquid
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.
pipetting area. f the error reoccurs, call service.
The Thrombolyzer’s 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. 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. 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. 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
ER14
Could not find calibration parameter file
ER16
LEDs too dark
ER18
LEDs too bright
ER19
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. Service: technical error
The LEDs are too dark or the measuring block is dirty. Clean the measuring block The LEDs are too bright. Call service
7
018028 08-2007 V3
LEDs OK
ER20
Lamp will faile soon
ER21
Predilution buffer not found
ER22
Plasma rack is not present
ER23
Measuring block not up
ER28
Measuring block not down
ER29
Position error (x/y) (1st time)
ER35
ATTENTION: arm x/y position not OK Press o / ALARM OFF. The arm must now move into its “HOME position” and then
ER36
Position error (z) (1st time)
ER37
ATTENTION: arm z position not OK Press o / ALARM OFF. The arm must now move into its “HOME position” and then
ER38
Cuvette rack empty, please refill
ER39
The LEDs are OK. The error appears once the lamp has been checked in the “hardware“ menu “LED test“ Call service
Buffer liquid for a fully automatic calibration during predilution is missing. There is no specimen insert available. Please place the specimen insert into the Thrombolyzer. 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). 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). This is an error indicating that a rectifiable arm error has occurred.
approach the correct position. Should this error occur frequently, call service. This is an error indicating that a rectifiable arm error has occurred.
approach the correct position. Should this error occur frequently, call service.
) 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!
7
018028 08-2007 V3
ER 40 to ER 46: All the following errors require the sample prep software to be exited and rest arted! 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.)
ER40
Cuvette transport error (1st incub.pos.)
ER41
Cuvette transport error (2nd incub.pos.)
ER42
Cuvette transport error (3rd incub.pos.)
ER43
Cuvette transport error M6 (measuring block entrance)
ER44
Cuvette feeder measuring block error (< 2 sec.)
ER45
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
ER46
No plasma rack in working position
ER49
Probe cleaner not found
ER50
Calibration plasma not found
ER51
Not enough probe cleaner (low level)
ER52
Not enough bleach (low level)
ER53
L.I.S communication error
ER54
An error has occurred in the pipette position during rack transport. An error has occurred in the “incubation ” position during rack transport. An error has occurred in the “incubation ” position during rack transport. An error has occurred in the “incubation ” position during rack transport. An error has occurred in the “incubation in measuring block ” position during rack transport. Please check rack ejection on the measuring block. 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.
and pull on the rack.
Please check whether the specimen rack is pushed in as far as it goes. The container for the probe cleaner solution is empty. Please refill the container and put it in the respective position. One of the items (X-X4, -) of the “calibration” menu item does not contain any plasma or only insufficient plasma. The Thrombolyzer reports that the probe cleaner is nearly empty. Please refill the probe cleaner. nsufficient amount of cleaning agent (ml) was only pipetted into the wash position to clean the probe. 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
018028 08-2007 V3
ER 55 to ER 57: All the following errors require the sample prep software to be exited and rest arted ! 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
ER55
Cuvette position error (lft.sen.): stop testing
ER56
Cuvette position error (meas.blck>16.): stop testing
ER57
Software version mismatch. Please exit the software.
ER59
Liquid level sensing error
ER60
Database memory error, no more patients can be stored.
ER61
Balls missing from cuvette
ER62
No communication (block) ! Please < exit >
ER65
LEDs fail
ER66
LEDs unstable
ER67
LEDs fail. Please exit
ER68
LEDs unstable. Please exit
ER69
Left rotor offline
ER70
Incubation type not OK. Please quit!
ER72
The rack has not reached the correct pipette position. Please exit the sample prep immediately. The rack has not reached the correct pipette position. Please exit the sample prep immediately. No rack has arrived in the measuring block within the time specified. Please exit the sample prep immediately. Call service.
The probe sensor is not stable. Please check that the probe is fitted correctly and / or call service. Call service and / or delete the database section
The ball sensor has not detected a ball in the cuvette. The test is repeated. This error may be caused by the following: the link bet ween the Thrombolyzer and PC is missing or defective. The Thrombolyzer is not switched on. Call service. Call service. Call service. Call service. Call service. Call service.
018028 08-2007 V3
Measuring block: no strip arrived!
ER74
Measuring block: motor defective !
ER75
Measuring block: LED fail
ER76
Strip backwards in waitnot arrived
ER77
Transport of strips not OK. Please quit The previous four errors lead to this error if o / ALARM OFF is pressed. Exit the
ER78
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. 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! 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. 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.
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
ER79
Transport of strips not OK: accepted
ER80
System parameter not OK
ER81
Bar code parameter not OK
ER82
Reagent block parameter not OK
ER83
Needle sensor unstable (1st time)
ER84
The password was entered incorrectly in the red warning window or not confirmed by pressing e. 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. The set system parameters are not OK. Please check. The set bar code parameters are not OK. Please check The set reagent parameters are not OK. Please check. The probe sensor could not calibrate itself during the first attempt to search for liquids. A second attempt is conducted automatically.
018028 08-2007 V3
Needle sensor unstable, please check
ER86
Dilutor error. Please quit!
ER87
Unexpected RESET! Please restart the system
ER88
Waste container nearly full
ER89
Waste container full
ER90
Waste container not present
ER91
Reagent block not present
ER92
Same barcodes not readable, see Sample prep.
ER93
Measuring block not up. Please quit
ER94
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. 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. The device has conducted an unexpected reset and must be restarted The waste box for the cuvettes is almost full and must be emptied at the next opportunity. The container for the cuvette waste is full and must be emptied. The device interrupts operation Please insert empty waste container intp the device Please insert the reagent block into the device Several bar codes are illegible. Check in the sample prep menu which tubes were not legible. Exit the sample prep and restart the Thrombolyzer. Errormessages,MPrange:(m-e-msgp.txt) EPerrorsarestatuserrorsregardingtestsystemparameters Test X not defined for control plasma
MP01
Lot-no. e.g. “1234” not found.
MP04
Control plasma X is defined twice
MP06
No control plasma is specified for this test. Error from the results (search function)
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
MP07
Service: error from applications area
018028 08-2007 V3
Down volume for high pos. too high (max.. )
MP08
Down volume for low pos. too high (max.. )
MP09
Down volume for cuvette too high (max.. single)
MP10
Down volume for cuvette too high (max.. double)
MP11
Please also enter tests for the definition of liquids
MP12
Dilution programme not entered
MP13
Derived test e.g. “G” is not possible
MP14
Derived test e.g. “G” is not selected
MP15
Block X in working station is not yet ready
MP16
Definition of derived test e.g. “G” not o.k.
MP17
Min. value is too small (min. ...)
MP20
Min. value is too great (max. ...)
MP21
Max. value is too small (min. ...)
MP22
Max. value is too great (max. ...)
MP23
Right column: value is too small (min...)
MP24
Left column: value is too small (min...)
MP25
Right column: value is too great (max...)
MP26
Service: error from applications area
Service: error from applications area Service: error from applications area Service: error from applications area Service: error from applications area Service: error from applications area Service: error from applications area Service: error from applications area
The specimen rack was removed from the system before processing was completed. Reposition this block. Service: error from applications area
The minimum calibration value is too small. t must be greater than 0.0. The minimum calibration value is too great. t must be less than 0000. The minimum calibration value is too small. t must be greater than the minimum value. The maximum calibration value is too great. t must be less than 0000. The value for calculations in the “Calibration” menu item is too small. Please enter a higher value. 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. The value in the right column of the chart for the calibration is too great.
4
018028 08-2007 V3
Left column: value is too great (max...)
MP27
Reference value must be greater than x
MP28
ISI < Min. ISI value (min...)
MP29
ISI > Max. ISI value (max...)
MP30
Value is too small (min...)
MP31
Value is too great (min...)
MP32
Too many tests selected (max 11...)
MP33
Reagent block not defined
MP34
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.
MP35
Test is not selected
MP36
Serial pipetting not possible
MP38
Add 1ml bleach in wash stn. than ENTER
MP39
Value not OK
MP40
For predilution, please pipet the buffer first
MP41
Pip table for predilution is not OK
MP42
The value in the left column of the chart for the calibration is too great. The start value in the fully automatic production of the calibration must be greater than x. 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. 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. A value is too small (incubation, measurement time , measurement time , calibration). Alter the value. A value is too great (incubation, measurement time , measurement time , calibration). Alter the value. Service: error from applications area Service: error from applications area
Select the correct reagent block for the tests entered.
Service: error from applications area Service: error from applications area 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. Service: error from applications area Service: error from applications area Service: error from applications area
018028 08-2007 V3
Up volume of (x) must be greater than 0
MP43
Down volume of (x) must be 0
MP44
Washing or cleaning in predilution line not possible
MP45
Only normal pipetting possible
MP46
Incubation in predilution pipetting not possible
MP47
For predilution plasma pipet predil cuv.
MP48
Down vol. for predil cuv. is too small
MP49
Down vol. for predil cuv. is too great
MP50
Down volume > receptacle volume not possible
MP51
(X) line: pipet predil. plasma in cuv.
MP52
Down volume of (x) must be greater than 0
MP53
Down volume of predil. plasma too great
MP54
Pipetting of predilution not possible
MP55
Chromogenic coagulation not possible (X)
MP56
Follow-up test (X) is not possible
MP57
Follow-up test (X) is not selected
MP58
No test found with reagent name (X)
MP60
Please first read limits for reagent (X)
MP61
Service: error from applications area Service: error from applications area Service: error from applications area Service: error from applications area
Service: erroro from applications area Service: error from applications area Service: error from applications area Service: error from applications area Service: error from applications area Service: error from applications area Service: error from applications area Service: error from applications area Service: error from applications area Service: error from applications area Service: error from applications area Service: error from applications area Service: error from applications area Service: error from applications area
018028 08-2007 V3
Rotor x is not in the working station
MP62
Rotor x home not ok
MP63
No patients in rotor x
MP64
Patient barcode in prep. X is not ok
MP65
Barcode in prep.X not readable
MP66
Wrong barcode in prep. X
MP67
Rotor: parameter error (X)
MP68
Test x not possible: has self depending Tests
MP70
Test (X) is already assigned to test (X)
MP71
Calibration not possible: is assigned to test e.g. “D”.
MP72
Test X depending from Test ‘X’ not possible
MP73
Assigned tests for calculation (X) not possible
MP74
Pipetting liquid “X” in position (X) not possible
MP75
Coagulation type of derived Test X not OK
MP76
Before scanning the tubes in the test preparation, rotor X is missing in the device. Please put the rotor in the corresponding position. The rotor’s “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. 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. The scanner finds a different bar code to pipette the specimens than when the one recorded from the bar code (scan) During pipetting, the bar code at the specified position cannot be read. The remaining tests for this sample are not conducted. 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. Call service
Service: error from applications area Service: error from applications area
The test does not have its own calibration because it is linked to a different calibration in the test parameters. Service: error from applications area Service: error from applications area Service: error from applications area Service: error from applications area
Too many records selected (max.%s)
The possible amount of data possible for printing or transmitting was exceeded
7
MP77
018028 08-2007 V3
Wash sequence needed
MP78
Wash sequence X in last line of chart not possible (only without ‚C‘)
MP79
Place X mm reagent receptacle on the wash position and press
MP80
Sample in prep. X not found
MP81
Barcodes not readable, see Sample Prep.
MP82
USB stick could not be mounted
MP84
No tests found on USB stick
MP85
After every pipetting of a reagent or specimen, a washing cycle must follow Service: error from applications area
Serves as a daily check of the needle (see daily sample prep)
After acquiring the specimen and during the pipetting, it was detected that a test tube was removed (Reflector foil was detected). This error is displayed when during the registering neither the reector foil nor a bar code was recognised (Position is occupied but the bar code cannot be read) The USB stick used cannot be recognised by the system. No tests were found on the disc which could be copied to the system. Errormessages,MErange:(m-e-msg.txt) MEerrorsarevariederrors Key permitted only in main-menu (press ESC)
ME02
Test not available
ME03
Menu entrance not permitted
ME04
Calibration not possible
ME06
LED test not possible
ME07
mixing ball is missing
ME12
Test not selected
ME13
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 . 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. An incorrect password was entered for the menu item. The Thrombolyzer has three password levels which grant access to different menu items. The calibration cannot be altered while the Thrombolyzer is processing the s ample prep. Wait until the Thrombolyzer has finished its work. Now the calibration for a test can be altered. 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. There is a ball missing in the cuvette rack. The test is repeated automatically. When submitting entries during plasma preparations, a test was entered which is not available in the test menu.
018028 08-2007 V3
Probe is not in wash position
ME14
Syringe is not in the start position
ME15
Too many tests selected
ME18
Prime pumps and probe clean not yet possible
ME20
Hardware.. test not yet possible
ME21
Volume chart for single test is empty
ME23
Position 7 can only be occupied with buffers
ME25
LED test not nished yet
ME26
Control plasma not defined
ME27
Test not defined for this control plasma
ME28
Values are not OK
ME29
No Curve for this calculation type
ME30
Clear track not yet finished The “hardware” menu item cannot be exited if the programme for ejecting the rack has not yet been completed.
ME31
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. 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. Service: error from applications area 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”. 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. Service: error from applications area Service: error from applications area
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. 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. A run control is integrated in the normal sample prep. The selected test is not defined for this Q.C.. 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. Response curves cannot be illustrated during the measurement. Wait until the measurement is completed.
018028 08-2007 V3
In the first three lines must be a right value
ME33
In the first two lines must be a right value
ME34
Right column: value > max. calibration value
ME35
Right column: value < min. calibration value
ME36
Right column: not all values ascending
ME37
Right column: two values are equal
ME38
Right column: not all values descending
ME39
Left column: not all values ascending
ME40
Left column: two values are equal
ME41
Left column: not all values descending
ME42
Normal < min. calibration value
ME43
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. 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. 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. 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. 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. 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. 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. 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. 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. 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. The normal time entered in the “calibration” menu item producing calibration manually and automatically is too low. Please correct your entry.
0
018028 08-2007 V3
Normal > max. calibration value
ME44
Only one standard print possible
ME46
Press to end the probe clean
ME50
Min. one test must be selected
ME51
Volume chart for double testing is empty
ME52
Please read first control plasma
ME55
Please read first name of reagent
ME56
Please scan for next line
ME57
Lot number missing
ME58
To register the patients please press first
ME59
Start permitted only in main- or plasma-prep menu
ME60
LIS communication error (already in work, or READY
ME61
For this type of calculation only double testing possible
ME62
Exit probe check
ME64
Probe check is not concluded Press o /ALARM OFF, follow the instructions in the message box.
ME65
Please remove container from wash position and press F4
ME66
The normal time entered in the “calibration” menu item for producing calibration manually and automatically is too high. Please correct your entry. Both types of standard print have been selected from the “print” menu. Please select just one type of standard print. The “probe clean” menu item in “prime pumps” must be exited after a sufficient cleaning time by pressing ^. Service: error from applications area Service: error from applications area
Service: error appears when scanning in control plasma data using a hand-held scanner Service: error appears when scanning in reagent data using a hand-held scanner Service: error appears when scanning in reagent data using a hand-held scanner Service: error appears when scanning in reagent data using a hand-held scanner During the sample prep,you can place new specimens in the rotor once the current rack has been fully pipetted. The START keys are only permitted in the main or sample prep menu. The host computer has requested tests for a specimen. However the speciment on which the cursor is situated has already been processed. Service: error from applications area
The probe check test is hereby concluded.
Now take the 0 mm container off the wash position to check the volume (see MS) and press o /ALARM OFF.
018028 08-2007 V3
Please wait
ME69
Error: Copy not OK
ME71
First unit is not OK
ME72
Success
ME73
Second parameter must be empty
ME74
Second parameter must be NorISI, CurISI or empty
ME75
Second unit is not OK
ME76
Second print format is not OK
ME77
Second unit must be empty
ME78
Second print format must be empty
ME79
EDP is switched off in system parameters
ME80
Printer not ready
ME81
Not the right Password
ME82
Printer is switched off in system parameters
ME85
Please wait: copying
ME86
‚CurISI‘cannotbefirstparameter
ME89
Error: Thrombolyzer device and host device equal not possible
ME94
Please wait until the process is completed. An error occurred during copying from or onto disk The conversion unit for this test is not OK. Alter to “define calculation type“. Message appears after successful copying. Service: error from applications area Service: error from applications area Service: error from applications area Service: error from applications area Service: error from applications area Service: error from applications area
When tranmitting to the EDP with x, it is was determined that the communication is switched off. The printer is turned off or offline. The entered password is incorrect (upper and lower case sensitive). When attempting to print, it was determined that the printer is not switched on in the system parameters. Message when copying data. Service: error from applications area Service: error from applications area
018028 08-2007 V3
Errors,STrange:(m-e-zust.txt) STerrorsarestatuserrors XRC is not yet ready
ST01
XRC ready
ST02
XRC is in operation
ST03
XRC stopped due to error, restart with F4 Check the occurence before you press o /ALARM OFF, call service if necessary.
ST04
XRC has completed calibration (see curve).
ST05
F3 activated – ARM STILL WORKING! – restart: F4
ST06
Automatic calibration error! The produced calibration is incorrect and must be repeated. Check the calibration process.
ST07
EMERGENCY STOP (“STOP key” on the device) IS ACTIVATED!
ST08
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. The sample prep can be started. The Thrombolyzer is in operation. Details are also provided of the area in which it is working.
TheThrombolyzer has completed the measurements for automatic calibration. Enter the “calibration” menu item and view the curve. 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.
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 inuence the results of the measurement! Wait for START/SCAN (ARM STILL WORKING)
ST09
(Sample prep)
ST10
(Calibration)
ST11
(Control)
ST12
(Hardware)
ST13
The Thrombolyzer is not connected to the EDP: you have pressed the scan key to conduct a scanning process after pipetting the current rack. Status message in (....): This process is started once “ is pressed. Status message in (....): This process is started once “ is pressed. Status message in (....): This process is started once “ is pressed. Status message in (....): Always exit the hardware so that the probe is in the wash position.
018028 08-2007 V3
(Prime pumps)
ST14
(Probe clean) exit = ESC Press ^ to exit probe cleaning (recommended waiting period of 0-0 minutes)
ST15
Distilled reservoir level low - refill
ST16
Temperature in pipetting station not ok
ST17
Temperature in incubation station not ok
ST18
Temperature in measuring station not ok
ST19
Rack at position e.g. “Inc3” not OK
ST20
Plasma bloc in working station not present After pressing m, the plasma rack or rotor is not in the device.
ST21
Reagent block not present After m or during the sample prep, the reagent insert is not in the device
ST24
Temperature in reagent station not ok
ST25
Status message in (....): presently running.
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. The temperature in the pipetting area is not OK. This error appears if t he 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 doesn’t help, please call service. 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 doesn’t help, please call service. 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 doesn’t help, please call service. 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.
Service error should reagent cooling fail.
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
Plasma in C1, receptacles. in (e.g.) “X1-X4”
ST29
Plasma rack not present (arm stopped)
ST32
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. 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. The plasma rack is missing or is not inserted all the way. 4
018028 08-2007 V3
Reagent block not present (arm stopped)
ST33
Scanning in progress
ST34
XRC is not yet ready, ejecting racks
ST35
> X minutes
ST36
Host ofine
ST37
Printer ofine
ST38
Waste container nearly full
ST39
Waste container full
ST40
Waste container not in the device
ST41
XRC ready - F3 for start > is activated. Press o /ALARM OFF for restart
ST42
The reagent block is missing or is not inserted all the way. Wait until the scanning process is completed. Normal status message once the sample prep soft ware has been started. After approx. 40 sec. “ready” appears ndicates the anticipated rest time in minutes for the currently started specimens. Data transfer to the EDP is not possible at the moment. Printing not possible, printer switched off. The container for the cuvette waste is almost full and must be emptied during the next stand-by. The container for the cuvette waste is full and must be emptied. Please insert an emptied waste container into the device.
018028 08-2007 V3
Accessories XRC Order-no. Qty.
Description
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
x x x x x x x x x x x x x x x x x x x x x x x x
4
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.
Description
0-0 0-0 0-0 0-0 0-0 0-
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
Cuvett e 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
Dimensions W x H x D: Weight:
w/o packing 7.0cm x 7.0cm x .0cm ,0 kg
Laser Class Laser Class with packing 0.0cm x .0cm x 0.0cm ,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:
+7°C - +°C +0°C - +40°C 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 * .0°C ± 0.°C * .0°C - .0°C
* Corresponds to a temperature in the cuvette of 37.0°C ± 0.8°C after a 3minute waiting period and a filling volume of 220µl.
Specimen volume (plasma + reagent)
minimum 0µl/maximum 0µl
018028 08-2007 V3
