Service Manual - Frank`s Hospital Workshop
Contents
1. Human Gesellschaft f r Biochemica und Diagnostica mbH Max Planck Ring 21 e D 65205 Wiesbaden Germany Telefon 49 6122 9988 0 Telefax 49 6122 9988 100 eMail human human de Internet http www human de 01 2004 122. Activate the optic with the key Optic This screen appears only for a few seconds and switches automatically to next screen PT ACTIVE 000 the measurement starts automatically with the addition of reagent In case of problems press the key Optic to start PT gt gt gt gt 000 TiS See is running 0 023 Don t touch the cuvette during a run The value in the second line shows the optical density OD PT 12 8s 000 If a clot is found the result is displayed 1 1 04 00 and printed if printer is connected 00 if 25 value is set as zero Note Once started a faint beeping sound is followed by a scrolling arrow The current light absorbance OD can be read on the display Avoid contact with the cuvette while this message is shown A beeping sound will be heard again if a clot reaction was detected and the result will be displayed If a printer is attached the result will be also printed If the clot reaction takes more than the maximum reading time of 300 s the optic will stop and display which means no clot detected 4 7 Measurement Stop The measurement can be canceled at any time by pressing the key Optic again G i 4 8 Autostart The measurement will start automatically when the reagent is added if the optic is set to active For the some tests i e fibrinogen thrombin this feature does not work properly because the change in the signal is too small In this case inject the re
3. EU Power supply 90 264 Vac 12 Vdc US System board LCD display cpl Spacer M2 5 L12 Spacer M3 L9 for system board top Optic block cpl Temperature sensor cpl Cable RS232 Cable DC Input Cable ground Heating foil 5V 1W Casing cpl Type label Mounting plate Fastening angle Heating block Foil keyboard Reagent adapter da 23 4 di 16 0 Reagent adapter da 24 1 di 22 6 Spacer M3 L6 for system board bottom Spacer M2 5 L32 for display L12 L20 Fixation package Cardboard white Cardboard inlay User manual english Warranty card english Service manual english Position on drawing n a n a N n a n a n a n a 24 26 Service Manual HumaClot Junior 7 Human 9 TECHNICAL DRAWING 3D EXPLOSION 1 Casing cpl 2 Foil keyboard 3 Heating block 4 Optic block cpl 5 lt Receiver board 6 lt Transmitter board 8 LCD display cpl 9 Spacer M3 L9 10 Spacer M2 5 L20 11 Spacer M2 5 L12 12 Spacer M3 L6 18 Screw M2 5x8 19 Screw M2 5x6 20 Washer M2 5 21 Ejot screw 2 5x8 25 Screw M2 5x5 Service Manual HumaClot Junior 25 26 7 System board 13 Fastening angle 14 Heating foil 15 Mounting plate 16 Cable DC Input 17 Cable RS232 18 Screw M2 5x8 19 Screw M2 5x6 20 Washer M2 5 22 Ejot screw 2 5x6 23 Screw M3x6 24 Washer M3 26 Type label YEA ir Y 27 Temp sensor cpl 26 26 Service Manual HumaClot Junior
4. HumacClot Junior For specific test applications refer to sections in the user manual 4 1 Warm Up The first visible screen gives the operator the information of the installed software before changing to the warm up screen SOFTWARE C 5 14 Info screen u Software revision here Rev C 5 14 Red LED lights It takes approx 5 minutes for the instrument to eguilibrate to 37 C Green LED lights The HumacClot Junior is ready to operate active test stop watch During the warm up period no functions are available The hidden service menu can however be activated during the warm up period refer to section SERVICE The regular operator should not enter this menu 4 2 Test Selection Eight different tests can be performed on the HumaClot Junior PT PTT TT FIB FAC DD AT3 PC PT ooo Enter test selection with the key Test TEST PT Change active test with the cursor keys FIB ooo Confirm active test with the key Enter To alternate among the tests press key Test to activate test selection cursor keys to change and key Enter to confirm Service Manual HumacClot Junior 9 26 4 3 Stop Watch A stop watch function helps the operator to control the correct incubation times To start the stopwatch press the key Timer To stop and reset press the key Timer again 4 4 Calibration The specific parameters for the tests can be entered into the HumaClot Junior and stored Enter cal
5. am z OH a a z Ne a KS a 4 ua 4 gt A po am gt m s ew s ew w a ri a ri e A d emm JA z a ra m o u zu m P a D um um EE a D m a 4 m nm m D R ml F aa z S q 2 a Seel Ss F a Pd We m m KSE z A wa e mi ERA 1 JO On Off Optic start d A fn O 4 Cursor up Cursor down JE go a Nun tt Timer Stopwatch Enter Ci gt m Test Menu B so gt Service Mailfunction Ready to use O 2 Optic channel Figure The Front panel 6 26 Service Manual HumaClot Junior Ss Human 3 INSTALLATION No special precautions are necessary when starting up the HumaClot Junior However the following is recommended e Place on a level surface in an area free from excessive temperature fluctuations Avoid vibration during measurement e Protect the instrument from direct sunlight moisture and dust H Check that the voltage and frequency data on the identification plate of the instrument agree with the local power rating before starting the instrument for the first time The instrument is connected to the power supply by the mains cable supplied If obvious damage has occurred during shipping do not use Contact your local distributor for replacement or repair 3 1 Equipment Standard delivery package e 1Pc HumacClot Junior e 1Pc Power supply e 25Pcs Sin
6. will not transmit hepatitis AIDS or other infectious diseases appropriate precautions should be taken by the instrument operator In case of plasma spilled on the instrument clean with a paper towel soaked in 10 bleach The HumaClot Junior is manufactured for HUMAN GmbH Company Address HUMAN GmbH Max Planck Ring 21 D 65205 Wiesbaden Germany Contact Phone 49 0 6122 9988 0 Fax 49 0 6122 9988 100 or 99 e Mail human human de Internet http www human de Service Manual HumacClot Junior 3 26 1 REVISIONS 1 1 1 2 Software Rev Modification Remark C 5 14 Test adaptations First release For PC AT3 DD Service Manual Document Rev Reference Software Remark C 5 14 First edition 4 26 Service Manual HumacClot Junior Ss Human 2 INSTRUMENT VIEWS Prewarm Figure Front view HumacClot Junior 12 Vdg 1A Human GmbH H Max Planck Ring 21 MA 65205 Wiesbaden ke Germany RS232C Made in Germany Figure Rear view Interface for printer DC Input 12V 1A or data transmission Sub D9 pole Pin 2 data send Pin 3 data receive Pin 5 ground Service Manual HumaClot Junior 5 26 DI f A 0000 a 0000 HumaClot Junior gt gt vo K 4 Q Pod Pd Pod 4 a wm f a x m S Se m z m a D A D Y a H Mah H DH H ma BR a ee m 4 yi a da JZ
7. Service Manual HumaClot Junior CONTENTS 1 REVISIONS 1 1 Software 1 2 Service Manual Document 2 INSTRUMENT VIEWS 3 INSTALLATION 3 1 Eguipment 3 2 Technical Data 3 3 Safety Standard Approvals 4 OPERATION INSTRUCTION 4 1 Warm Up 4 2 Test Selection 4 3 Stop Watch 4 4 Calibration 4 5 Default Test Values 4 6 Measurement 4 7 Measurement Stop 4 8 Autostart 5 SERVICE 5 1 Service Functions 5 2 Total Default Values 5 3 Temperature Adjustment 5 4 Optic Adjustment 5 4 1 OD Correction 5 4 2 COAG CORRECTION 5 4 3 OPTIC CHECK 5 4 4 Interface RS232 6 TROUBLESHOOTING GUIDE 7 DISASSEMBLY ASSEMBLY 7 1 Disassembling the Instrument 7 2 Assembling the Instrument 8 SPARE PARTS 9 TECHNICAL DRAWING 3D EXPLOSION O O WOANN OP E FA RO RO RPO NO NM a A AP AP HP A A AP AP AP Aa Aa sch sch Aa CO A Go OO OO Oo d d OO OO A 0 Ga MM MA O OO CO This page left blank 2 26 Service Manual HumacClot Junior 7 Human Warning Please read this service manual in its entirety prior to servicing the HumaClot Junior In order to ensure a high level of performance all warnings and references to technical safety in this service manual must be followed Repairs to the instrument may only be carried out by trained personnel and replacement parts must comply with instrument specifications The HumaClot Junior is intended for use with human plasma As there is no known test that can offer complete assurance that product derived from human blood
8. agent quickly and with more force into cuvette and or press the key optic again 12 26 Service Manual HumaClot Junior 7 Human 5 SERVICE WARNING Please read this section in its entirety prior to operating on the HumaClot Junior In order to ensure accurate and reliable performance of the instrument only authorised personnel should perform any service functions on the HumaClot Junior instrument 5 1 Service Functions To enter the hidden service submenu press key Timer and key Enter simultaneously WAIT FOR 37 C key Timer Enter LOAD DEFAULT NO The following service procedures can be performed on the HumaClot Junior Reset to default values Temperature adjustment OD correction Coag correction Optic check Set RS232 Use the cursor keys to change and the key Enter to confirm Incorrect adjustments will influence the measurement significantly Before changing anything be aware of the conseguences Service Manual HumacClot Junior 13 26 Total Default Values The HumacClot Junior can store test and system parameter permanent on board Calibration PT Calibration PTT Calibration PT Calibration FIB Calibration FAC Calibration DD Calibration AT3 Calibration PC Temperature OD Correction PT OD Correction FIB OD Correction FAC OD Correction PTT OD Correction DD OD Correction TT OD Correction AT3 OD Correction PC Coag Correction PT Coag Co
9. by entering COAG CORRECTION 110 Factor 1 10 COAG CORRECTION PT 100 16 26 Service Manual HumacClot Junior Ss Human 5 4 3 OPTIC CHECK The OPTIC CHECK is recommend if problems with measurements arise Remove the cuvette from optic OPTIC CHECK mw 11323 014 The HumacClot Junior has adjusted this optic value mw to 11323 at an amplification amp of level 14 Control range ensure that no cuvette is placed in the optic mw 10000 13000 amp 10 18 Press key menu to repeat the optic check or the up down keys to change the amplification 5 4 4 Interface RS232 The interface can used in two ways Print Mode gt Results are printed Debug Mode gt Reaction curve can be portrayed on aPC DATA gt RS232 NO NO gt Print Mode YES gt Debug Mode The interface port is set to 2400 Baud 8 Bits 1 Stop No parity Protocol M1 tab NR tab TEST tab SEC tab mOD tab tab INR tab Unit LF Example of a results printout run 01 run 02 run 03 run 04 Service Manual HumacClot Junior 17 26 6 TROUBLESHOOTING GUIDE Note Always verify instrument performance by testing appropriate control samples System Error Message Interpretation and corrective action Optic Failure The HumaClot Junior is not operating in accordance with its optical specifications This can happen if there is not sufficient light i e with very turbid reagents or lipemic samples Change to HUMAN r
10. e of 37 0 C is displayed on the HumaClot Junior Check and correct the system temperature if not eguivalent to the external thermometer Use the Up Down keys to increase or decrease of temperature Service Manual HumaClot Junior 15 26 5 4 Optic Adjustment 5 4 1 OD Correction OD CORRECTION PT 100 The optical density measured by the instrument can be corrected by a factor for each test Therefore it is possible to adapt other reagents OD Correction 100 gt optical density 1 00 gt no effect OD Correction 120 gt optical density 1 20 OD CORRECTION below 100 will cause longer clotting times reduce sensitivity of the method more results will showas s OD CORRECTION above 100 will cause shorter clotting times increase sensitivity of the method which can cause wrong results short time results WARNING OD CORRECTION should be within 50 150 special OD CORRECTION for fibrinogen test Run a 300 mg dL calibrator The result should be close to 10 s If it is above below 10 s in decrease the OD CORRECTION slightly 5 4 2 COAG CORRECTION With the COAG CORRECTION the instrument can correct the result for better correlation to other systems or reagents Example On another instrument a plasma sample measures with PT 12 1 seconds on the HumaClot Junior the result is 11 0 seconds To get equal results the result has to be corrected by factor of 1 10 10 This can be done
11. eagent Avoid extreme samples there is too intense light i e direct sunlight Protect against sunlight LED is burned out Replace device Measurement does not start automatically The change in the signal is too small This can happen with very clear reagents ie fibrinogen thrombin Try to pipette forcefully and quickly or start measurement by pressing the key OPTIC after adding the reagent Measurement starts incorrectly Signal noise and temperature drift can start the measurement incorrectly Stop the measurement and activate the optic shortly before starting Red Service LED is on Electrical power is not sufficient Use original power supply Charge battery pack if used Green Ready LED is off Temperature is out of range Wait a few minutes If the error persists contact technical service Temperature not correct Adjust the temperature s No Clot Detect Always repeat the sample to verify the result Possible reasons include the following Clotting time is longer than 300 secs Clotting time is shorter than 8 secs Incorrect reagent Fibrinogen level of sample is below 100 mg dL i e sample dilutions Air bubbles Debris in cuvette Sample improperly collected OD Correction is set to zero Clotting time too short Always repeat the sample to verify the result Possible reasons include the following Incorrect reagent Air bubbles Debris in cu
12. gle cuvettes e 5Pcs Reagent tubes 22 5 mm e 5Pcs Reagent tubes with cap 16 0 mm e 1Pc Reagent adaptor Ga 23 4 Gi 16 0 mm e 1Pc Reagent adaptor Ga 24 1 Gi 22 6 mm e 1Pc Operating manual e 1Pc Warranty card Consumables Human REF Product Content 18690 Single cuvette 500 19120 Pipette 5 uL 50 uL 1 19130 Pipette 20 uL 200 uL 1 19910 20 Pipette tips 2 200 uL 1 000 Service Manual HumacClot Junior 7 26 3 2 Technical Data Dimensions LxBxH Weight Ambient Temperature Power Supply Device Interface Optic Cell Keyboard Display Incubation block 205 x 150 x 75 cm 0 51 kg without power supply 18 23 C Input 90 264 V Output 12 V 1 0A Micro controller board 14 Bit ADC on chip controlling of LCD RS232 keyboard charging temperature optic Serial 2400 baud 8 bits 1 stop no parity used in print or debug mode Photometer with pulsed 400 nm LED Variable pulse modulation Variable detector amplification Linear range 0 001 1 000 OD Foil keyboard with 8 keys and 2 LED s 2 lines x 16 characters liguid crystal 1 measuring 8 sample 2 reagent wells warmed to 37 C 3 3 Safety Standard Approvals Manufacturer fulfills EN ISO 9001 2000 and EN ISO 13485 11 2000 8 26 Service Manual HumacClot Junior Ss Human 4 OPERATION INSTRUCTION This section provides general instructions necessary for the user to achieve maximal use and benefit from the
13. ibration with the key Menu E Change parameter with the cursor keys Confirm with Enter PT PT 100 Change parameter 100 value Normal value 12 0 with the cursor keys Confirm with Enter PT PT 50 Change parameter 50 value 16 7 with the cursor keys PT PT 25 Change parameter 25 value 25 0 with the cursor keys 0 0 s no calculation to activity active test is PT 000 calibrated Remark The input of values is done by pressing the up down keys first in steps of 10 and then with change of direction in steps of 1 10 26 Service Manual HumacClot Junior 4 5 Default Test Values PT PTT TT FIB FAC DD AT PC D ee 12 8s 2 50 16 7 s 3 25 25 0 s Normal 30 0 s Normal 15 0 s 1 300 mg dL 12 0 s 2 150 mg dL 23 0 s 3 75 mg dL 36 0 s 1 100 32 5s 2 10 60 0 s 3 5 70 0 s 1 1600 ng ml lt 150 mE 2 200 ng ml 30 mE 3 0 ng ml 0 mE 1 100 400 mE 2 50 800mE 3 1 1100 mE 1 100 62 mE 2 50 23mE 3 1 3mE 7 Human Service Manual HumacClot Junior 11 26 4 6 Measurement Reconstitute reagent according to the reagent description and pre warm if required in the reagent positions of the instruments Insert the cuvettes in the incubation area 6 positions and pipette the required volume of plasma into the cuvettes To start ameasurement place the specific cuvette in the Optic position
14. lug the cable j B a AAANAAAAAAAAAA RU Grounding connections Service Manual HumaCblot Junior 21 26 DC Input RS232 Microcontroller System board Keyboard connection Microcontroller Ground Battery DC Input Optic block connections RS232 TTL 22 26 Service Manual HumaClot Junior Ss Human 7 2 Assembling the Instrument e Assembling of the instrument is the reverseof disassembly e Carefully put together the components fixing tightening them firmly e After complete assembly of all components connect the external power supply and switch on the instrument e Run basic function tests checking dialogue e Simulate measurement without reagent Start the optic and stop after approx 15 seconds with a pencil inserted into the optic channel This will stop the measurement and show the virtual result e f the system board heating components or microcontroller has been changed a temperature check should be done before the final QC Quality Control procedure Service Manual HumacClot Junior 23 26 8 SPARE PARTS Human REF 18681 1 18681 2 18681 3 18681 4 18681 5 18681 6 18681 7 18681 8 18681 9 18681 10 18681 11 18681 12 18681 13 18681 14 18681 15 18681 16 18681 17 18681 18 18681 19 18681 20 18681 21 18681 22 18681 23 18681 24 18681 25 18680 1 18680 4 18680 2 Product description Power supply 90 264 Vac 12 Vdc
15. rrection FIB Coag Correction FAC Coag Correction PTT Coag Correction DD Optic check mw RS 232 Print Results ISI 1 10 1 100 Normal 12 8 s 2 50 sz 16 7 s 3 25 lt 25 0 s Normal 30 0 s Normal 15 0 s 1 300 mg dL lt 12 0 s 2 150 mg dL 23 0s 3 75 mg dL lt 36 0 s 1 100 32 5 s 2 10 lt 60 0 s 3 5 70 0s 1 1600 ng ml 150 mE 2 200 ng ml 30 mE 3 0 ng ml OmE 1 100 400 mE 2 50 800 mE 3 1 1100 mE 1 100 62mE 2 50 23mE 3 1 z 3 mE C 370 9040 100 100 100 100 100 100 100 100 100 100 100 100 100 mw approx 11500 range from 10xxx to 13xxx Integration time approx 013 from 011 to 020 Data gt RS232 NO Service Manual HumacClot Junior 7 Human 5 3 Temperature Adjustment The incubation block of the HumaClot Junior should maintain a temperature of 37 2 C When the green LED is on fill a reagent tube with 1 ml water and place it in a reagent position Place a digital thermometer in the reagent tube and allow to warm up for approx 10 min before reading the temperature SET TEMPERATURE C 371 9085 Example The current temperature is 37 1 C and the digital target value is 9085 Compare the temperature displayed by the system and the thermometer If the temperature is different adjust the temperature on the HumaClot Junior by pressing the Up Down cursor keys Wait until a stable temperatur
16. vette Sample improperly collected Optic is incorrectly adjusted Action Use recommended materials Decrease OD Correction slightly Increase OD Range 18 26 Service Manual HumacClot Junior 7 Human System Error Message Interpretation and corrective action Clotting time too long Always repeat the sample to verify the result Possible reasons includes the following Incorrect reagent Air bubbles Debris in cuvette Low fibrinogen level Sample improperly collected Optic is incorrectly adjusted Action Use recommended materials Increase OD Correction slightly Decrease OD Range Service Manual HumacClot Junior 19 26 7 DISASSEMBLY ASSEMBLY Tools required Phillips screwdriver medium small 7 1 Disassembling the Instrument HumacClot Junior 12 Vdy1a a Human GmbH a Max Planck Ring 21 G Wiesbaden ermany RS232C Made in Germany 18680 HC 1052 a Remove the two EJOT screws M2 5x8 with screwdriver on the rear of the instrument b Move upper part towards the front against the base c The parts are now separated d d e f d d d Remove the four EJOT screws with the screwdriver e Remove the M3x6 screw with the ground cable f Unplug the keyboard cable from system board connector g Lift up the complete inner assembly from the top case 20 26 Service Manual HumaClot Junior 7 Human h Remove the four screws from the display and unp
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