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User Manual - Robonik India.in

1. 20 02 06 1567 20 02 06 1545 2 6 20 02 06 1595 2 PRINT Prints the Patient report with the patient name and identification number Note The patient s name and identification number PID can be entered up to six places DEL To delete the selected result M Mode yo Column A Absorbance F Fixed time K Kinetic E Endpoint D Differential R Ratio Version No 1 005A Effective Date Ma y 2012 Page 36 of 54 FOURCLOT Coagulation Analyser 8 6 Serial communication USER MANUAL The instrument is equipped with an RS232 serial port for PC configuration user computer interface A cable is available to link the instrument to PC RS232 DBS EiA TIA 574 Communication will only start when both ends detect the presence of an active terminal or device RS232 port settings in a windows Operating system PORT SETTINGS Bits per second Data Bits Parity None Stop Bits Flow control FOURCLOT 22 7 10 CLINIC NAME MAIN MENU 1 Test Operations 2 Technical Diagnosis 3 Utilities 4 Quality control 5 View Stored Results 6 Serial communication Version No 1 005A Effective Date Ma y 2012 SERIAL COMM 1 Result Page 37 of 54 Send Results FOURCLOT Coagulation Analyser USER MANUAL 9 Programming Modes PHOTOMETRIC 9 1 ABSORBANCE The instrument measures the Blank transmittance and the Sample transmittance subtracts them and calculates the sample absorbance
2. YES if you want to Run the Standards in Fixed Time mode Touch Concen in order to enter the number of concentrations Touch NO if you want to select Factor Name Mod KIN Pri 405 Sec 0 KF 1 000 Unit No Unt QC N Lag 0 Read 0 Bik N Normal N Std Y Factor 0 000 Limit Set Name Mod KIN Pri 405 Sec 0 KF 1 000 Unit No Unt QC N Lag 0 Read 0 Numeric Value 123 45 6 7890 Name Mode KIN Pri 630 Sec 0 KF 1 000 Unit mg dl QC N Lag 0 Read 0 Blk N Normal N Std N Factor 1 000 Normal Enter Normal Values_ Low 0 000 High 0 000 Numeric Value 123 4 5 6 78 9 0 Page 45 of 54 FOURCLOT Coagulation Analyser USER MANUAL Name Mode KIN Init OD 0 000 Pri 630 Sec 0 Max Delta 0 000 KF 1 000 Unit No_Unit QC N Lag 0 Read 0 Blk N Normal N Std N Factor 1 000 I gg CELIO Init OD 0 000 Init OD 1 000 Max Delta 0 000 Max Delta 0 000 Rgnt Linearity 0 000 Rgnt Linearity 0 000 Numeric Value Numeric Value 123456 123456 7890 7890 Init OD 1 000 Max Delta 1 500 Rgnt Linearity 0 000 Numeric Value 123456 7890 After entering all the parameters in KINETIC mode touch the SAVE option present on the screen Version No 1 005A Effective Date May 2012 Page 46 of 54 FOURCLOT Coagulation Analyser USER MANUAL gt Recalling Running Operating a pre
3. 19 characters Touch ENTR upon completion Touch CLR to clear a wrong entry Version No 1 005A Effective Date Ma y 2012 Page 33 of 54 FOURCLOT Coagulation Analyser 8 3 5 Lamp ON USER MANUAL It is a toggle to switch the lamp ON and OFF only in case of Photometric mode Whereas in Coagulation mode the LAMP is always in OFF condition Toggle any instruction that works first one way and then the other it turns something on the first time it is used and then turns it off the next time Step 1 Go to Utilities FOURCLOT CLINIC NAME MAIN MENU 1 Test Operations 2 ical pago 3 Utilities INIZI 4 Quality kontrol 5 View Stored Results 6 Serial communication 22 7 10 Step 2 Touch Lamp UTILITIES Version No ESC 1 Date 2 Password 3 Printer On Off ON 4 Enter Clinic Name 5 Lamp OFF 6 Stirrer OFF UTILITIES Version No ESC 1 Date 2 Password 3 Printer On Off ON 4 Enter Clinic Name 5 Lamp ON 6 Stirrer OFF Lamp is enabled To disable the lamp touch the Lamp option once again Toggle any instruction that works first one way and then the other it turns something on the first time it is used 8 3 6 Stirrer ON It is a toggle to switch the lamp ON and OFF and then turns it off the next time Step 1 Go to Utilities FOURCLOT CLINIC NAME MAIN MENU 1 Test Operations 22 7 10 2 Technical Dlagnosis 3 Utilities OS 4
4. Incub Time 0 Normal YES NO Enter Normal Values _ Low 0 000 High 0 000 Numeric Value 12345 6 7890 Name Mode TT Sample Avg 1 ESC Normal N QC N SAVE Incub Time 0 AO QCNormal Values _ QCNH 0 000 QCNL 0 000 QCAbnormal Values _ QCABH 0 000 Numeric Value 123 45 6 7890 Name Mode TT Sample Avg 1 ESC Normal N QC N SAVE A fann ian Version No 1 005A Effective Date Ma y 2012 Name Mode TT Sample Avg 1 Normal N QC N Incub Time 0 Numeric Value 1234556 7890 QCNormal Values _ QCNH 0 000 QCNL 0 000 QCAbnormal Values _ QCABH 0 000 QCABL 0 000 In this screen you can enter both QCNormal H L as well as QCAbnormal H L values Name Mode TT Sample Avg 1 Normal N Qc N Incub Time 0 Numeric Value This screen allows you to enter the Incubation time in seconds Page 20 of 54 USER MANUAL FOURCLOT Coagulation Analyser 4 FIB mode Name Mode FIB faoa Unit mg dl Normal N ESC QC N INCUb Time 0 SANE el Concen Sample Avg 1 Graph PT TO PT Y vs X Time vs LOGCONC Name Unit mg dl Normal N QC N Incub Time 0 Concen Sample Avg 1 Graph PT TO PT Mode FIB ESC SAVE Normal TO Seven QCNormal Values _ QCNH 0 000 QCNL 0 000 QCAbnormal Values _ QCABH 0 000 QCABL 0 000 Name Mode FIB Unit mg dl Normal N QC N
5. Incub Time 0 Sample Avg 1 Graph PT TO PT Y vs X Time vs LOGCONC Name Mode FIB Unit mg dl Normal N QC N _Incub Time 0 Concen Numeric Values 12 3 4 5 6 7890 Name Mode FIB Unit mg dl Normal N QC N Incub Time 0 ESC SAVE Concen Sample Avg 1 Graph PT TO PT Y vs X Time vs LOGCONC Note The UNIT in FIB mode is fixed Version No 1 005A Effective Date Ma y 2012 USER MANUAL Enter Normal Values _ Low 0 000 High 0 000 Numeric Value 123 45 6 7890 Enter the values of Normal in High Low range QCNormal Values_ QCNH 0 000 QCNL 0 000 QCAbnormal Values_ QCABH 0 000 Numeric Value 123456 7890 In this screen you can enter both QCNormal H L as well as QCAbnormal H L values No of Dil 6 Concen 0 000 0 000 0 000 0 000 0 000 0 000 Numeric Value Time Select Concen Enter the number of Dilution Here you can enter Max 6 Concen Min 2 Concen Graph Type PT TO PT Y vs X Time vs LOGCONC Scale LogTime vs CONC Time vs LOGCONC LogitTime vs Log CONC Time vs CONC LogTime vs Log CONC Type LINEAR PT TO PT Page 21 of 54 FOURCLOT Coagulation Analyser USER MANUAL Name Mode FIB Name Mode FIB Unit mg dl ESC Unit mg dl Normal N Normal N QC N Incub Time 0 SAVE QC N Incub Time 0 Concen Concen Sample Avg 1 Numeric Values Graph PT TO PT 12 3 4 5 6 Y vs X Time vs LOGCONC 78
6. Kg Approx Version No 1 005A Effective Date Ma y 2012 Page 9 of 54 FOURCLOT Coagulation Analyser USER MANUAL 4 PACKING TRANSPORT AND STORAGE 4 1 GENERAL WARNINGS Instrument has to be decontaminated before packing for transportation 4 2 PACKING Packaging is needed whenever the instrument is to be transported or shipped by courier or other means To pack the instrument follows the instructions below 1 Decontaminate the instrument as explained on decontamination chapter of this manual 2 Put the instrument into the original packaging box Instrument has to be properly protected by plastic protective material Put copy of safety clearance certificate copy of Safety clearance certificate is attached at the end of this manual 3 Mark the package with address instrument identification and warning labels 4 3 INSTRUMENT TRANSPORTATION The transportation of the instrument in unpacked condition must be limited within the room where it is used to avoid damage 4 4 STORAGE OF INSTRUMENT Before storing the instrument for a long period pack it carefully as described above and store indoors Relative humidity has to be less than 85 and temperature between 10 c and 60 C Version No 1 005A Effective Date May 2012 Page 10 of 54 FOURCLOT Coagulation Analyser USER MANUAL 5 INSTRUMENT DESCRIPTION 5 1 Touch Sensitive screen FOURCLOT provides a Touch sensitive LCD panel and a KEY
7. MENU 1 Test Operations 2 Technical Diagno 3 Utilities 4 Quality control 5 View Stored Results 6 Serial communication ESC sis Version No 1 005A Effective Date Ma y 2012 UTILITIES Ver Version No ESC 1 Date 2 Password 3 Printer On Off ON 4 Enter Clinic Name 5 Lamp OFF 6 Stirrer OFF Date DD MM YY 27 12 06 Time Hrs 13 46 40 Min Sec To enter change the date and time touch on the shaded zones accordingly A numeric submenu screen will be displayed Enter the current date and time On completion Touch ESC to escape Page 31 of 54 FOURCLOT Coagulation Analyser 8 3 2 Password Utility FOURCLOT 22 7 10 CLINIC NAME MAIN MENU 1 Test Operations ESC 2 Technical Diagnosis 3 Utilities SAI A RA 5 View Stored Results 6 Serial communication PASSWORD UTILITY ADMIN A B l G J 0 R W Z 1 4 9 Q Y 3 To enable password Enter PASSWORD Touch ENTR on completion A message password enabled will be displayed at the bottom of the screen PASSWORD UTILITY 1 Enable Disable 2 Set Password 3 LOGIN 4 LOGOUT Version No 1 005A Effective Date Ma y 2012 USER MANUAL UTILITIES Ver Version No ESC 1 Date DE Password 3 Printer On Off ON 4 Enter Clinic Name 5 Lamp OFF 6 Stirrer OFF PASSWORD UTILITY 1 Enable Disable 2 Set Password 3 LOGIN 4 LOGOUT PASSWORD UTILITY USER A B l Q Y
8. Time 0 SAVE Concen Sample Avg 1 Y vs X Time vs LOGCONC Name Mode FA PT APTT QC N Incub Time 0 Concen Normal N Graph LINEAR Y vs X LogTime vs LogCONC Version No 1 005A Effective Date Ma y 2012 Enter Normal Values _ Low 0 000 High 0 000 Numeric Value 123 45 6 7890 Enter the values of Normal in High Low range Graph Type PT TO PT Y vs X Time vs LOGCONC Type Scale LINEAR LogTime vs CONC PTTOPT Time vs LOGCONC LogitTime vs Log CONC Time vs CONC LogTime vs Log CON Mode FA Incub Time 0 Numeric Value 123 45 6 7890 This screen allows you to enter the Incubation time in seconds Page 23 of 54 FOURCLOT Coagulation Analyser USER MANUAL B Recalling a Saved TEST The Programmed Saved Test can be recalled selected by List Tests When the unit is first turned on the screen is displayed as shown below Select Mode 1 Coagulation 2 Photometric Select Coagulation Main menu screen is displayed as shown below Main Menu screen FOURCLOT 19 7 10 CLINIC NAME TEST OPERATIONS MAIN MENU ESC 1 Add new test 1 Test Operations rio nono 2 List test 2 Technical Diagnosis 3 Run Std ctrl 3 Utilities 4 Run Sample 4 Quality control 5 Run QC 5 View Stored Results 6 Serial communication Select Test 1 TT 2 PT List test displays max of 10 Tests Page A List tests screen would look like the screen shown above Touch the test nam
9. all who come in contact with the instrument during shipping handling and servicing 11 3 General Considerations Any laboratory instrument that has been used for clinical analysis is considered a biohazard and should be decontaminated prior to handling Intact skin is generally considered an effective barrier against infectious Organisms however small abrasions and cuts may not be always be visible Prophylactic gloves must be worn when handling instruments that have not been decontaminated Gloved hands should be considered contaminated at all times and must be kept away from eyes mouth and nose at all times Mucous membranes are considered prime entry routes for infectious agents Wear eye protection and a surgical mask when there is a possibility of aerosols Eating and drinking while decontaminating instruments is not advisable 11 4 Procedure A solution of 5 Sodium Hypo Chlorite NaOCL solution Bleach is used Commercial bleach is 5 NaOCL household bleach is 3 NaOCL When using commercial bleach use a 10 1 mixture if using household bleach a 6 1 mixture is required This is a caustic solution It is important to wear gloves and eye protection when handling it Wipe down the carrier and all exposed surfaces of the unit with the bleach solution Remove the top shroud of the instrument and wipe down the top surface of the instrument base as well as the inside of the top shroud Reassemble the unit and discard the used g
10. and reagent cuvette Number of cuvette Holders incubation 0 Temperature 37 c Timer Programmable PT APTT TT Fibrinogen Factor assay Factor Il Analysis mode V VII IX X XI XI Results displayed in Seconds Ratio INR Concentration and Photometer 0 000 to 3 000 Absorbance Units A Photometric Accuracy 2 or 0 007 whichever is higher from 0 to 1 5 A 3 from 1 5 Ato 3 0 A lt 0 007 A nr Optical measurement Photodiode Filters Type of filter Narrow band Interference Wave Lengih 405 630 nm optional Light source Tungsten Halogen Analysis Mode Photometric mode Absorbance Kinetic End Point Fixed Time Version No 1 005A Effective Date Ma y 2012 Page 8 of 54 FOURCLOT Coagulation Analyser USER MANUAL Common Human Machine Interface TOUCH PANEL KEYPAD Display 5 Graphic LCD Negative Blue STN 32 KB Non Volatle RAM with Battery backup Storage Capacity Independent capacity of 250 open tests with 30 QC results Normal and Abnormal controls and More than 2500 patient results with PID for Coagulation and Photometer External interface Power Wattage 50 Watts Voltage 115 230 Volts 50 60 Hz Operating position On horizontal flat rigid and vibration free surface Operating conditions Temperature From 18 c to 35 c Relative humidity Up to 85 Storage conditions Temperature From 10 c to 60 c Relative humidity Up to 85 Weight Approx 5 4
11. environment it may cause radio interference in which case you may need to take measures to mitigate the interference 8 An advisory that the electromagnetic environment should be evaluated prior to operation of the device 9 Warning Do not use this device in close proximity to sources of strong electromagnetic radiation e g unshielded international RF sources as these may interfere with the proper operation Version No 1 005A Effective Date Ma y 2012 Page 6 of 54 FOURCLOT Coagulation Analyser USER MANUAL 3 INTRODUCTION 3 1 DESCRIPTION FOURCLOT is a programmable Coagulometer with a sophisticated on board software and user friendly touch screen lts versatile and unique software supports most of the calculation required for interpretation of results It is a reliable high precision machine It is intended for in vitro diagnostic use It has a user friendly program and capacity of storing the programmed analytical methods and the QC results It is intended for in vitro diagnostic use 3 2 Special Features Coagulation e Four independent programmable coagulation channels for faster throughput e Display on line results of all four channels simultaneously on single screen e Sample averaging up to 4 coagulation runs in PT APTT TT Fibrinogen e Designed to perform all routine tests such as PT APTT TT Fibrinogen Factor Il V VII IX X XI XII e Uniform mixing of Sample amp Reagent with magnetic st
12. monochromatic mode It is possible to repeat the measure with a different wavelength Filter 2 secondary filter and consider the difference between the two measures Bichromatic mode PROGRAMMING ADDING a NEW TEST Name Mod ABS Pri 405 Sec 0 ABSORBANCE Mode screen before programming would look like the above screen Refer chapter11 for entering the test parameters On completion touch SAVE to save the programmed test i Mod ABS E Mode FIB 405 Sec 0 Filter 1 Filter 2 Select Filter Val O 630 405 Version No 1 005A Effective Date Ma y 2012 Page 38 of 54 FOURCLOT Coagulation Analyser USER MANUAL gt Recalling Running Operating a pre programmed test For example Name Test Name Mod ABS Pri 405 Sec 0 No_Unt To change values press EDIT Test Name ABS Test Name ABS Set temperature 37 00 Channel temperature 30 43 Close the Lid amp Press Run ESC to abort temperature Test Name ABS Test Name ABS Referencing Lag Time 5 Read Sample Test Name ABS Sr No 1 Result 0 705 Sample Readings Result 0 705 Remove Sample Cuvette After inserting the Cuvette in the Cuvette block in the photometric mode the sample get run by selecting RUN option Version No 1 005A Effective Date May 2012 Page 39 of 54 FOURCLOT Coagulation Analyser USER MANUAL 9 2 FIXED TIME Change in absorbance of sample is taken at programmed time inter
13. programmed test For example Name Mode KIN Pri 630 Sec 0 KF 1 000 Unit mg dl QC N Lag 0 Read 0 Bik N Normal N Std N Factor 1 000 Limit Set To change values press EDIT Test Name KIN Referencing Lag Time 5 Version No 1 005A Effective Date Ma y 2012 Test Name KIN Set temperature 37 00 Channel temperature 30 43 ESC to abort temperature y Test Name KIN Close the Lid amp Press Run Test Name KIN Factor 1 000 Read Sample Page 47 of 54 FOURCLOT Coagulation Analyser 9 4 END POINT USER MANUAL The instrument reads absorbance of the sample and calculates concentration using fed Factor or calculates the factor from concentration of the standard PROGRAMMING ADDING a NEW TEST Mode END Sec 0 Name Pri 630 KF 1 000 Unit mg dl Lag 0 QC N Read 0 Normal N Factor 1 000 Bik N Std N Limit Set END POINT Mode screen before programming would look like the above screen Lag 0 Bik N Std N Limit Set Read 0 Normal N Factor 1 000 Filter 1 Filter 2 Select Filter Val 0 630 405 Select the Primary amp Secondary filters Name Pri 630 ESC KF 1 000 ADD Unit mg dl QC N SAVE Lag 0 A A BIK N i Normal N Std N Factor 1 000 Mode END Sec 0 Limit Set i Mod END Sec 0 Name Pri 405 KF 1 000 Unit No Unt QC
14. required temperature is selected it y displays the cuvette temperature Set Incubation Temp Temperature 36 46 Ref UP 785 DOWN 8 2 3 Lamp Amplitude To check lamp amplitude of the filters FOURCLOT 22 7 10 CLINIC NAME TECHNICAL DIAGNOSIS ESC MAIN MENU 1 Clear Memory 1 Test Operations ESC 2 Printer Selftest 2 Technical Diagnosis 3 Set Temperature 3 Utilities 4 Lamp Amplitude 4 Quality control 5 View Stored Results 6 Serial communications Displays the Lamp Amplitude of all the filters Note The amplitude ideally should be in the range of 1500 to 2400 for all filters Version No 1 005A Effective Date Ma y 2012 Page 30 of 54 FOURCLOT Coagulation Analyser USER MANUAL 8 2 4 Printer Self Test Routine test to check printer When selected FOURCLOT CLINIC NAME MAIN MENU 1 Test Operations 2 Technical Diagnosis 3 Utilities 4 Quality control 5 View Stored Results 6 Serial communication 22 7 10 ESC 8 3 UTILITIES SCREEN UTILITIES TECHNICAL DIAGNOSIS 1 Clear Memory 2 Printer Selftest 3 Set Temperature 4 Lamp Amplitude If printer is ON and paper is properly inserted the analyzer prints the following two lines to check printing TECHNICAL DIAGNOSIS 1 Clear Memory Ver Version No ESC 3 Printer On Off ON gt 4 Enter Clinic Name gt 5 Lamp OFF 6 Stirrer OFF 8 3 1 To ENTER CHANGE Date and Time FOURCLOT 22 7 10 CLINIC NAME MAIN
15. the Incubation Time in seconds Page 18 of 54 USER MANUAL FOURCLOT Coagulation Analyser 2 APTT mode Name Made APTT cacao Sample Avg 1 ESC Norma N QC N SAVE Incub Tim 0 Name Mode APTT Sample Avg 1 ESC Normal N QC N SAVE Incub Time 0 Normal Me MES NO Enter Normal Values_ Low 0 000 High 0 000 Numeric Value 123 45 6 7890 Name Mode APTT Sample Avg 1 ESC Normal N Incub Time 0 QC Normal Values _ QCNH 0 000 QC NL 0 000 Mode APTT H P ENTR X CLR 2 0 Name Mode APTT Sample Avg 1 Normal N QC N Incub Time 0 Numeric Value 123 45 6 7890 QC Normal Values _ QCNH 0 000 QCNL 0 000 QC Abnormal Values _ QCABH 0 000 QCABL 0 000 USER MANUAL QC Abnormal Values _ In this screen you can enter both QC QCABH 0 000 Normal H L as well as QC Abnormal H L values Numeric Value 123 45 6 7890 Name Mode APTT Name Mode APTT Sample Avg 1 ESC Sample Avg 1 Normal N Normal N Qc N SAVE Qc N Incub TiMe Oo ciacacianioninncan conca corran raro be cub Time 0 Numeric Value This screen allows you to enter the Incubation time in seconds Version No 1 005A Effective Date May 2012 Page 19 of 54 FOURCLOT Coagulation Analyser 3 TT mode Name Mode TT nua Sample Avg i ESC Normal N QC N SAVE IncubiTim 0 Name Mode TT Sample Avg 1 ESC Normal N QC N SAVE
16. the instrument Parts that are inherently subject to deterioration are excluded from the warranty In case of defects due to misuse of the instrument any travel and man hour expenses will be charged extra 1 2 Technical Service ROBONIK is always accessible to the customers for any kind of information about installation use maintenance etc When asking for service please refer to this manual and report the data reported on the identification label serial number Only qualified technicians are entitled to fix the instrument the user as described in this manual should carry out ordinary maintenance ROBONIK technical service or an authorized service center with specialized technicians with suitable instrumentation and original spare parts only are always available for extraordinary maintenance repair under a yearly maintenance contract or on specific demand 1 3 Disposal Instruction In case of removal or disposal of instrument following instructions need to be followed 1 Do not dispose in municipal waste follow local regulations for instrument disposal 2 Plastic parts Electronic PCBs and components can be recycled so return back the instrument to manufacturer 1 4 Contacts MANUFACTURER ROBONIK INDIA PVT LTD A 374 TTC MIDC Industrial Area MAHAPE NAVI MUMBAI 400710 INDIA el 91 22 67829700 Fax 91 22 67829701 Email sales robonikindia com Website www robonik in Version No 1 005A
17. 0 After entering all the parameters in FIXTIME mode touch the SAVE option present on the screen Version No 1 005A Effective Date May 2012 Page 42 of 54 FOURCLOT Coagulation Analyser gt Recalling Running Operating a pre programmed test For example Running screen of FIXED TIME mode when Factor 1 Name Mode FIX Pri 630 Sec 0 KF 1 000 Unit No Unit QC N Lag 0 Read 0 Blk N Normal N Std N Factor 1 000 Limit Set To change values press EDIT Test Name FIX Test Name FIX ESC PID RUN RUNQC Set temperature 37 00 Channel temperature 30 43 ESC to abort temperature Close the Lid amp Press Run Test Name FIX Test Name FIX Referencing Lag Time 5 Read Sample Test Name FIX Factor 1 000 ESC Sr No 1 PID Init OD 0 710 0 710 RUN Delta 0 001 RunQC Result 0 001 Umo L Sample Readings Result 0 001 Umo L Remove Sample Cuvette Version No 1 005A Effective Date May 2012 Page 43 of 54 USER MANUAL FOURCLOT Coagulation Analyser USER MANUAL 9 3 KINETIC Multiple readings are taken at set temperature at regular intervals and change in absorbance per minute is calculated Concentration is calculated from the factor fed by the user or by using standard PROGRAMMING ADDING a NEW TEST Name Mode KIN Pri 630 Sec 0 KF 1 000 Unit mg dl QC N Lag 0 Read 0 Bik N Normal N Std N Factor 1 000 Limit Set KINETIC Mod
18. 3 PASSWORD UTILITY USER To Login enable user enter the name In this example its DAVID Page 32 of 54 FOURCLOT Coagulation Analyser USER MANUAL 8 3 3 To disable or enable the Printer It is a toggle to disable or enable the printer Toggle Any instruction that works first one way and then the other it turns something on the first time it is used and then turns it off the next time Step 1 Go to Utilities Step 2 Select Printer On Off to enable FOURCLOT 22 7 10 UTILITIES Ver Version No CLINIC NAME MAIN MENU 1 Date 1 Test Operations 2 Password 2 Technical Diagnosis 3 Printer On Off OFF 3 Utilities IO E 4 Enter Clinic Name 4 Quality control 5 Lamp OFF i 5 View Stored Results 6 Stirrer OFF 6 Serial communication UTILITIES Ver Version No 1 Date 2 Password 3 Printer On Off ON 4 Enter Clinic Name 5 Lamp OFF 6 Stirrer OFF Step 3 Pinter is enabled To disable the printer select Printer On Off 8 3 4 To Enter Clinic Name Step 1 Go to Utilities FOURCLOT 22 7 10 CLINIC NAME MAIN MENU 1 Test Operations 2 Technical Diagnosis 4 Quality control 5 View Stored Results 6 Serial communication Step 2 Touch Enter Clinic Name UTILITIES Ver Version No 1 Date 2 Password 3 Printer On Off ON 4 Enter Clinic Name 5 Lamp OFF 6 Stirrer OFF UTILITIES Version No CLINIC Cc K Enter Clinic Name Max Up to
19. 4 FOURCLOT Coagulation Analyser USER MANUAL 8 2 TECHNICAL DIAGNOSIS TECHNICAL DIAGNOSIS Ref 8 2 1 Clear Memory Ref 8 2 2 2 Printer Self test Ref 8 2 3 3 Set Temperature Ref 8 2 4 4 Lamp Amplitude 8 2 1 Clear Memory To clear memory Tests and results are stored separately TECHNICAL DIAGNOSIS ESC TECHNICAL DIAGNOSIS 1 Clear Memory 1 Clear Memory 2 Printer Selftest 2 Printer Selftest 3 Set Temperature 3 Set Temperature 4 Lamp Amplitude 4 Lamp Amplitude Clear Results Clearing memory Clears all the stored Results only TECHNICAL DIAGNOSIS ESC 1 Clear Memory 2 Printer Selftest 3 Set Temperature 4 Lamp Amplitude Clearing memory Clears all the stored tests Clear Tests Records Warning If you select YES option then all the Test Results and Test Records will get deleted Version No 1 005A Effective Date May 2012 Page 29 of 54 FOURCLOT Coagulation Analyser USER MANUAL 8 2 2 Temperature Setting To verify the set temperature FOURCLOT 22 7 10 CLINIC NAME TECHNICAL DIAGNOSIS ESC MAIN MENU 1 Clear Memory 1 Test Operations ESC 2 Printer Self Test 2 Technical Diagnosis 3 Set Temperature 3 Utilities 4 Lamp Amplitude 4 Quality control 5 View Stored Results 6 Serial Communication Set Channel Temp Temperature Setting Temperature 36 86 1 Set Channel Temp 2 Set Incubation Temp Ref UP 785 DOWN When the
20. 9 0 This screen allows you to enter the Incubation time in seconds his MODO Ai ri Mode FIB ESC 5 FA mode Incub Time 0 SAVE G O Normal N Ww Graph LINEAR Y vs X LogTime vs LogCONC Mode FA Incub Time 0 SAVE Normal N Graph LINEAR Y vs X LogTime vs LogCONC FA_VIII FA_IX FA_XI FA XII Name Mode FA PT FA_V APTT QC N Incub Time 0 Concen Normal N Graph LINEAR Y vs X LogTime vs LogCONC QC N Incub Time 0 Concen Normal N Graph LINEAR Y vs X LogTime vs LogCONC Version No 1 005A Effective Date May 2012 Page 22 of 54 FOURCLOT Coagulation Analyser USER MANUAL Name Mode FA PT ESC APTT FA_XI QC N Incub Time 0 SAVE do Concen Normal N Graph LINEAR Y vs X LogTime vs LogCONC No of Dil 6 Concen Time 0 000 0 000 0 000 0 000 0 000 0 000 Numeric Value 123456 7890 QCNormal Values_ QCNH 0 000 QCNL 0 000 QCAbnormal Values _ QCABH 0 000 QCABL 0 000 QCNormal Values _ QCNH 0 000 QCNL 0 000 QCAbnormal Values _ QCABH 0 000 Numeric Value 12345 6 7890 Select Concen Enter the number of Dilution hIS soroan yoo canicate balli QC Norma Here you can enter Max 6 Concen Min 4 Concen H L as well as QC Abnormal H L values Name Mode FA PT FA_V APTT QC N Incub Time 0 Concen Normal N Graph LINEAR Normal Name Mode FIB Unit mg dl ESC Normal N QC N _ Incub
21. Con2 50 Con3 Con4 Con5 Cone Con7 Numeric Value 123 4 5 6 7890 Here you have to enter the number of standards after which you can enter it s concentration Version No 1 005A Effective Date May 2012 Page 49 of 54 FOURCLOT Coagulation Analyser Name Mode END Pri 630 Sec 0 KF 1 000 Unit mg dl QC N Lag 0 Read 0 Bik N Std N Factor 1 000 Limit Set Name Mode END Pri 630 Sec 0 KF 1 000 Unit No Unit QC N Lag 0 Read 0 Bik N Normal N Std N Factor 1 000 Limit Set Init OD 0 000 Max Delta 0 000 Rgnt Linearity 0 000 Init OD 1 000 Max Delta 1 500 Rgnt Linearity 0 000 Numeric Value USER MANUAL Name Mode END Pri 630 Sec 0 KF 1 000 Unit mg dl QC N Lag 0 Read 0 Bik N Normal N Std N Factor 1 000 Normal Enter Normal Values _ Low 0 000 High 0 000 Numeric Value 123 4 5 6 7890 Init OD 1 000 Max Delta 0 000 Rgnt Linearity 0 000 Numeric Value 123 45 6 7890 Init OD 0 000 Max Delta 0 000 Rgnt Linearity 0 000 Numeric Value 123456 7890 Enter Reagent Linearity in the Numeric screen Touch ENTR upon completion Touch CLR to clear a wrong entry After entering all the parameters in ENDPOINT mode touch the SAVE option present on the screen Version No 1 005A Effective Date May 2012 Page 50 of 54 FOURCLOT Coagulation Analyser USER MANUAL gt Recalli
22. Effective Date May 2012 Page 4 of 54 FOURCLOT Coagulation Analyser USER MANUAL 2 GENERAL SAFETY WARNINGS 2 1 Danger warnings symbols The following symbols are used to inform the user of the safety rules This symbol indicates generic danger It means that serious damage can occur to the operator if described precautions are not observed This symbol indicates HIGH ELECTRIC VOLTAGE It is dangerous to touch any part having this label Only qualified operators can access these components after unplugging the instrument from the Supply This symbol indicates that the instrument involves the handling of samples which can be infected urine or human serum In this condition infection or contamination might occur Pay attention to the general safety warnings when in presence of such biological substances Use Protective clothes gloves and glasses This symbol in the user manual indicates that damages to the instrument or erroneous results could occur if the given warnings are not followed This symbol indicates a portion which is particularly important and should be studied carefully This symbol indicates a Protective Earth or Ground terminal OYS PEE General Symbols pl Symbol for Manufacturer IVD Symbol for IN VITRO DIAGNOSTIC MEDICAL DEVICE E Version No 1 005A Effective Date May 2012 Page 5 of 54 FOURCLOT Coagulation Analyser USER MANUAL 2 2 Use of the Instrument T
23. FOURCLOT Coagulation Analyser USER MANUAL FOUR CLOT Coagulation Analyser User Manual Version With Incubator 1 005A 2030NIC ROBONI K INDI A PVT LTD Plot No A 374 TTC MIDC Industrial Area Mahape Navi Mumbai 400 710 INDIA Tel 91 22 67829700 Fax 91 22 67829701 Email sales robonikindia com Website www robonik in Version No 1 005A Effective Date May 2012 Page 1 of 54 FOURCLOT Coagulation Analyser USER MANUAL TABLE OF CONTENTS 1 GENERAL INFORMATION escociniocicinianiiin icons iii 4 1 1 Warrahiy Informationi lea la 4 t 2 Fechnical Service costlliaoia a 4 1 93 Disposal INSITUCHONE Sai 4 TA COMAS A liste ine ata cha a ala 4 2 GENERAL SAFETY WARNINGS iii 5 2 1 Danger warnings symbolS ii 5 2 2 USC O METAS TUNE Wi a ees Scan a a 6 3 INERODUGTION urna 7 3 1 DESCRIPTION ln ile ii ei al 7 3 2 Sp cial AA 7 3 3 Technical specification of FOUR CLOT 8 4 PACKING TRANSPORT AND STORAGE sscessseessssessessessenseseseeneeseeneesnesaneneeaneneeseenaeseenensesees 10 4 1 GENERAL WARNINGS nono rn nro rana nono 10 4 2 PACKING osc se caret cat eee ta 10 4 3 INSTRUMENT TRANSPORTATION t li 10 4 4 STORAGE OF INSTRUMENT li 10 5 INSTRUMENT DESCRIPTION eaten 11 5 1 Touch Sensitive screen ii
24. IB mode 2 Run Sample When the unit is first turned on the screen is displayed as shown below Select Mode 1 Coagulation 2 Photometric Select Coagulation main menu screen is displayed as shown below Select Test Operation Main Menu screen To run the Sample of added test Step 1 Select menu TEST OPERATIONS FOURCLOT 19 7 10 CLINIC NAME MAIN MENU essssansenieg ESC 1 Test Operations i 2 Technical Diagnosis 3 Utilities 4 Quality control 5 View Stored Results 6 Serial communication Step 2 Select Run Sample TEST OPERATIONS 1 Add new test 2 List test 3 Run Std ctrl 4 Run Sample tea a arar y 5 Run QC Version No 1 005A Effective Date May 2012 Page 26 of 54 FOURCLOT Coagulation Analyser USER MANUAL After selecting Run sample menu screen is displayed to check the channel temperature Initially if the channel temperature is 30 43 C then this screen is displayed till Sip i SE 37 C To abort Set temperature 37 00 emperature Select Channel temperature 30 43 ESC to abort temperature y Program Channels MENU Test Name Mode ESC After attending the temperature or Selecting CH 1 RUN ESC Program Channels screen is displayed CH 2 PRNT as shown Select the channel in which you CH 3 want to run the sample CH 4 On selecting the channel it will display Select Test screen through which we can select the tests whose samples we want to run Sup
25. N Read 0 Normal N Factor 0 000 Lag 0 Bik N Std N Blank Touch YES if you want to select Blank Version No 1 005A Effective Date May 2012 Mode END G O W Name Pri 630 KF 1 000 Unit No Unit QC N Lag 0 Read 0 Numeric Value 123 45 6 Mode END Sec 0 MIL mEq L Umo L mg dl Set Times __ Lag Time 0 Read Time 0 Numeric Value 123 4 5 6 78 9 0 Page 48 of 54 FOURCLOT Coagulation Analyser USER MANUAL Name Mode END QCNormal Values _ Pri 630 Sec 0 QCNH 0 000 KF 1 000 QCNL 0 000 Unit mg dl QCAbnormal Values _ Lag 0 QCABH 0 000 Blk N H Std N Numeric Value Limit Set 123456 7890 Name Mod END Name Mod END Pri 405 Sec 0 Pri 405 Sec 0 KF 1 000 KF 1 000 Unit No Unt QC N Unit No Unt QC N Lag 0 Read 0 Lag 0 Read 0 BIk N Normal N BIk N Normal N Std N Factor 0 000 Std Y Factor 0 000 shoe Standard Limit Set Name Mod END Touch NO if you want to select Factor Pri 405 Sec 0 KF 1 000 Name Mod END Pri 340 Sec 0 Unit No Unt QC N KF 1 000 Lag 0 Read 0 i z N BIk N Normal N dn on Sua Std Y Concen 10 1 EA EE 1 Numeric Value 123456 7890 Touch YES if you want to Run the Standards in Fixed Time mode Touch Concen in order to enter the number of concentrations Std Num 0 Coni 25
26. PAD for easy user interface The Menus are displayed the text of the parameter forms the TOUCH ZONE Touch screen Layout For Example In PT Mode Name Mode PT ISI index 1 000 ESC Normal N MNPT 0 000 SAVE dilution Sample Avg 4 QC N Incub Time 0 Above is the generic representation of a Test Screen The Highlighted zones are TOUCH ZONES which are active On touching the Touch Zone of a parameter a sub menu menu is displayed or the requested action is carried out and rest of the Touch Zone is deactivated For Example To activate the selection e To enter the ISI Index touch any point in the shaded area ISI Index on the LCD screen On proper selection the analyser responds with blinking of the parameter text and also the TOUCH ZONE and a submenu is displayed e To enter Test Name Touching the Name touch zone provides a alphanumeric screen Enter the Test name by touching the Touch zone of that variable The selected value blinks and is displayed next to the parameter Selection Indicator Selected onscreen item is shown in a shaded background When the screen first displays the default selection is shown Pressing a selection either highlights that item or activates it Version No 1 005A Effective Date May 2012 Page 11 of 54 FOURCLOT Coagulation Analyser USER MANUAL 5 2 Perspective View Front View Printer Incubator Photometric Cuvette chamb
27. Quality control 5 View Stored Results 6 Serial communication Stirrer is enabled To disable the Stirrer touch the Stirrer option once again Version No 1 005A Effective Date Ma y 2012 Step 2 Touch Lamp UTILITIES Version No ESC 1 Date 2 Password 3 Printer On Off ON 4 Enter Clinic Name 5 Lamp OFF 6 Stirrer OFF UTILITIES Version No ESC 1 Date 2 Password 3 Printer On Off ON 4 Enter Clinic Name 5 Lamp OFF 6 Stirrer OFF Page 34 of 54 FOURCLOT Coagulation Analyser USER MANUAL 8 4 QUALITY CONTROL Quality Control is a process that checks an instrument or testing site to make sure it is reporting accurate results on patients The reproducibility of a result from a testing site or instrument should fall within a certain range Control solutions of known values are often times used for checking quality control An institution may choose how often control solutions are run depending on the accrediting body and test complexity the analyte falls under Levy Jennings charts are often used identify problems with QC results A levy Jennings chart is a graph that quality control data is plotted on to give a visual indication whether a laboratory test is working well SD Standard Deviation A measure of variability representing an average distance of the data from the mean The greater the standard deviation the greater the difference between the individual determinations and the les
28. SAVE ie DILUTION N Sample Avg 4 QC N Incub Time 0 No of Dil 2 Concen Time 0 000 0 000 0 000 0 000 Numeric Value 123 45 6 7890 In this screen you have to enter the concentration value amp the time related to it Mode PT Name ISI index 0 000 Normal N MNPT 0 000 DILUTION N Sample Avg 4 ESC SAVE Name Mode PT ISI index 0 000 Normal N MNPT 0 000 DILUTION N Sample Avg 4 QC N DILUTION No of Dil 2 Concen 0 000 0 000 Time 0 000 0 000 Numeric Value 123 45 6 7890 Enter the Number of Dilutions Here Min number of dilution 2 and Max number of dilution 6 QCNormal Values _ QCNH 0 000 QCNL 0 000 QCAbnormal Values _ QCABH 0 000 QCABL 0 000 Incub Time 0 Name Mode PT ISI index 0 000 Normal N MNPT 0 000 DILUTION N Numeric Values 12345 6 7890 From this screen you can enter the Sample Avg values Max Samp Avg 4 Name Mode PT ISI index 0 000 Normal N MNPT 0 000 DILUTION N ESC SAVE Sample Avg 4 QC N MA Version No 1 005A Effective Date Ma y 2012 QCNormal Values _ QCNH 0 000 QCNL 0 000 QCAbnormal Values _ QCABH 0 000 Numeric Value 123 45 6 7890 In this screen you can enter both QCNormal H L as well as QCAbnormal H L values Name Mode PT ISI index 0 000 Normal N MNPT 0 000 DILUTION N Numeric Values 123456 7890 From this screen you can enter
29. Unit No Unt Lag 0 BIk N Std Y QC N Read 0 Normal N Factor 0 000 QC N Read 0 Normal N Concen Touch YES if you want to Run the Standards in Fixed Time mode Touch Concen in order to enter the number of concentrations Std Num 0 Con1 25 Con2 50 Con3 Con4 Con5 Touch NO if you want to select Factor Mod FIX Sec 0 Name Pri 405 KF 1 000 Unit No Unt Lag 0 BIk N Std N Limit Set Cone Con7 QC N Read 0 Normal N Numeric Value Factor 0 000 1234556 789 0 Here you have to enter the number of standards after which you can enter it s concentration Mod FIX Sec 0 Name Pri 405 KF 1 000 Unit No Unt Lag 0 Numeric Value 123 45 6 7890 Qc N Read 0 Version No 1 005A Effective Date May 2012 Page 41 of 54 FOURCLOT Co Name Mode FIX Pri 630 Sec 0 KF 1 000 Unit No _ Unit QC N Lag 0 Read 0 Bik N Normal N Std N Factor 1 000 Limit Set A Init OD 0 000 Max Delta 0 000 Rgnt Linearity 0 000 Numeric Value 1234556 7890 Min Init OD 0 Max Init OD 4 H agulation Analyser USER MANUAL E E 4nit OD 0 000 Max Delta 0 000 Rgnt Linearity 0 000 Init OD 1 000 Max Delta 0 000 Rgnt Linearity 0 000 Numeric Value 123 45 6 7890 Init OD 1 000 Max Delta 1 500 Rgnt Linearity 0 000 Numeric Value 123 45 6 789
30. ck the temperature of cuvette block at regular intervals Check the linearity of the instrument at regular intervals using standards Do not take any reading when the lid is open Incubate the cuvettes at set temperature for at least 10 minutes before using Incubate the reagents at set temperature for at least 10 minutes before using Do not use any sharp objects on the Touch Screen Always use the STYLUS provided to operate the touch panel Version No 1 005A Effective Date May 2012 Page 15 of 54 FOURCLOT Coagulation Analyser USER MANUAL 8 MAIN MENU 8 1 TEST OPERATIONS A Progra mming ADDING a NEW TEST When the unit is first turned on Mode selection screen is displayed Select Mode 1 Coagulation 2 Photometric To add and Run coagulation test select 1 Coagulation Main Menu Screen appears on the display Y Main Menu screen Main Menu screen consist of Menus as shown below FOURCLOT 19 7 10 CLINIC NAME MAIN MENU 1 Test Operations 2 Technical Diagnosis 3 Utilities 4 Quality control 5 View Stored Results 6 Serial communication Test Operations screen Select Menu Test Operations TEST OPERATIONS 1 Add New Test 2 List Test 3 Run Std Cntr 4 Run sample 5 Run QC Select Menu Add New Test Select Test Mode 1 PT 2 APTT 3 TT 4 FIB 5 FA On Select Test Mode screen all the test modes along with the no of test entered are displayed Select
31. e screen before programming would look like the above screen Name Mode KIN Lag 0 Bik N Std N Limit Set Filter 1 Name Mode FIX Filter 2 Pri 630 Sec 0 KF 1 000 Select Filter Val Unit No Unit QC N 0 630 405 Lag 0 Read 0 Numeric Value 123 45 6 7890 Name Mode KIN UNITS Pri 630 Sec 0 ESC No Unt U L KF 1 000 ADD mU ml MIL QC N SAVE U ml mEq L Read 0 mmo L Umo L Bik N Normal N i nmo L Std N Factor 1 000 g l mg dl Limit Set Ug dl g dl Ug mi Set Times_ Name Mod KIN Pri 405 Sec 0 Lag Time 0 KF 1 000 Read Time 0 Unit No Unt QC N Lag 0 Read 0 Numeric Value Bik N Normal N 1234556 Std N Factor 0 000 7890 Blank Touch YES if you want to select Blank Version No 1 005A Effective Date May 2012 Page 44 of 54 FOURCLOT Coagulation Analyser Name Mod KIN Pri 405 Sec 0 KF 1 000 Unit No Unt QC N Lag 0 Read 0 BIk N Normal N Std N Factor 0 000 Standard Std Num 0 Cont 25 Con2 50 Con3 Con4 Con5 Cone Con7 Numeric Value 123 4 5 6 78 9 0 Name Mode KIN Pri 630 Sec 0 KF 1 000 Unit mg dl QC N Lag 0 Read 0 Bik N Std N Factor 1 000 Limit Set Version No 1 005A Effective Date Ma y 2012 USER MANUAL Name Mod KIN Pri 405 Sec 0 KF 1 000 Unit No Unt QC N Lag 0 Read 0 BIk N Normal N Std Y Concen Touch
32. e to select the test Suppose we have selected the test in PT mode then it will display the screen of PT mode In this screen you can Edit the test parameters Name PT ISI index 9 000 Normal Y MNPT 0 000 dilution Sample Avg 4 QC Y Incub Time 10 Similarly you can Edit the test parameters in APTT TT FIB FA mode by recalling the particular test C Running a Saved TEST Operating the progra mmed Tests 1 Run Std Ctrl 2 Run Sample Version No 1 005A Effective Date May 2012 Page 24 of 54 FOURCLOT Coagulation Analyser USER MANUAL 1 Run Std Ctrl In case of test with standard control without running the standard control the test sample can not be run a To run the control of PT test When the unit is first turned on the screen is displayed as shown below Select Mode 1 Coagulation 2 Photometric Select Coagulation Main menu screen is displayed as shown below Select Test Operations Main Menu screen To run the STD of FIB FA or Normalization Controls of PT Step1 Select Menu TEST OPERATIONS Step 2 Select Run Std Ctrl FOURCLOT 19 7 10 CLINIC NAME TEST OPERATIONS MAIN MENU 1 Add new test 1 Test Operations 2 List test 2 Technical Diagnosis 3 Run Std Ctrl coo coo conronconcnocorcnncon cono omar 3 Utilities 4 Run Sample i 4 Quality control 5 Run QC 5 View Stored Results 6 Serial communication After selecting Run Std Ctrl menu screen is displayed to c
33. er Coagulation Cuvette chamber Rear View SMPS Fan Contrast POT ON OFF Switch 0000000000000D000 Q Q a D o o a o Q o o o a o 9 o 9 Q a o o o g Q a DO 9 o a 8 o e 00000000000000000 External Printer Optional Cooling Fan SMPS RS232 port Version No 1 005A Effective Date May 2012 Page 12 of 54 FOURCLOT Coagulation Analyser USER MANUAL 5 3 KEYPAD FOURCLOT Coaguie on Analyser 5 4 Printer A Internal Printer Thermal Printer FOURCLOT comes with a built in 20 column Thermal Printer User has to take proper care to handle this delicate instrument o TIPS FOR CAREFUL USAGE OF PRINTER 1 Do not pull the paper when loaded 2 Lift the paper lever carefully and load the paper 3 Keep the instrument clean and dust free FOURCLOT gives line feed automatically wherever it is necessary for clear reading like a While powering on b In between character lines Note User may operate the instrument by disabling the printer from the utilities menu v How to insert the paper Insert the thermal paper roll by placing the sensitive side facing down The sensitive paper side is recognizable by its smoother face Before inserting the paper After inserting the paper Version No 1 005A Effective Date May 2012 Page 13 of 54 FOURCLOT Coagulation Analyser USER MANUAL B External Printer Optional Switch off the analyzer before connec
34. he following screen FOURCLOT FOURCLOT TOUCH 20 7 10 Select Mode CLINIC NAME ROBONIK INDIA PVT LTD 1 Coagulation MAIN MENU Plot No A 374 TTC 2 Photometric 1 Test Operations ESC MIDC Industrial Area Mahape 2 Technical Diagnosis Navi Mumbai 400 710 3 Utilities Tel 91 22 67829700 4 Quality control Fax 91 22 67829701 Web www robonik india in A n Vaia ra Email sales robonikindia com serial communication User can select the option to run coagulation test or photometric test Version No 1 005A Effective Date May 2012 Page 14 of 54 FOURCLOT Coagulation Analyser USER MANUAL E e amp es If a printer is enabled Model Name Version Number Clinic name Serial Number Current time and date will be printed Note If a printer is not enabled Disable printer message is displayed Touch YES to disable or NO to proceed Refer for Printer settings Once initialization is over a lamp located within the instrument will glow This lamp requires 90 seconds for stabilization After the instrument completes the above steps a TEST MENU SCREEN MAIN MENU Screen appears The instrument is now in IDLE mode and ready for use PRECAUTIONS Keep the place dry and clean Check all the grounding wires properly Repeat the readings if Absorbance is more than 2 0 A Use original Packing for transportation Use clean Cuvettes Check the blank absorbance of the cuvette at regular intervals Che
35. he instrument has to be used for the designed purposes under specified conditions following proper procedures and safety rules by qualified personnel THIS MANUAL CONTAINS INSTRUCTIONS FOR OPERATION BY QUALIFIED PERSONNEL 1 A qualified user has to make sure that environmental condition is suitable the installation is correct the use and maintenance are proper according to the general safety rules as well as to the particular precautions described in the manual However he is not entitled to repair the instrument 2 A qualified technician is entitled to maintain and fix the instrument according to the instructions given using the original spare parts Maintain room temperature and Humidity as specified in the manual 3 The instrument has to be used as described in this manual If it is not use the protection provided by the instrument may be impaired 4 Alterations to the instrument are prohibited The user is liable for any improper modification to the instrument and for the deriving consequences 5 Should the instrument need extraordinary maintenance contact MANUFACTURER service or authorized service center Specialized technicians who will be able to repair the instrument using original spare parts will carry out the maintenance 6 This IVD equipment complies with the emission and immunity requirements as per IEC61326 series 7 Warning This equipment has been designed and tested to CISPER11 Class A Ina domestic
36. heck the channel temperature Initially if the channel temperature is nir 30 43 C then this screen is displayed till Channel temperature attend 37 C To abort Temperature Select ESC Set temperature 37 00 Channel temperature 30 43 Select test 1 PT ESC to abort temperature 2 APTT 3 TT 4 FIB After reaching the temperature or selecting 5 FA ESC test mode screen is displayed as shown aside Select the test mode of which the 4 FIB standard is to be run FIB Std Res FIB CH 1 Dilut Incub Time 10 25 CH 2 Dilut After selecting the particular test it Incub Time 10 15 displays the RUN screen On selecting the RUN option it will run CH 3 Dilut Incub Time 10 09 the Incubation time if and only if you select Incub Time in test parameter CH 4 Dilut Again select RUN option in order to Incub Time 10 20 run the standard for the required test ESC Version No 1 005A Effective Date May 2012 Page 25 of 54 FOURCLOT Coagulation Analyser USER MANUAL FIB Std Res FIB FIB Std Res FIB CH 1 Dilut CH 1 Dilut Load Cuv Rgt Add Sample CH 2 Dilut CH 2 Dilut Load Cuv Rgt Add Sample CH 3 Dilut CH 3 Dilut Load Cuv Rgt Add Sample CH 4 Dilut CH 4 Dilut Load Cuv Rgt Add Sample ESC ESC After loading Cuv Rgt it will run the standards in FIB mode Thus you can get the standard values for the test saved in FIB mode After running the standards you have to run the samples in F
37. i 11 5 2 Perspective View conio 12 5 3 KEYPAD lt del ilaria 13 DAPHNE A a oe elo 13 6 Installation and start up iINStructions rrriiii eine 14 6 1 Placing the instrument iii 14 6 2 Power Supply nile anali 14 6 3 Protective Groundind Lille id 14 6 4 Slam UD INSTITUCION nihil iaia 14 T PRECAUTION Sii ia 15 8 MAIN ME NU rar arara aaan taasen a iia 16 8 1 TEST OPERATIONS a aenea ri lei ANE 16 A Programming ADDING a NEWTESTi 16 B Recalling a Saved TESTi i 24 C Running a Saved TEST Operating the programmed Tests D Ut ESIS o RE E EN 28 8 2 TECHNICAL DIAGNOSIS 00030 na 29 8 2 1 Clear MOM ny io alii ai LAI ee eee 29 8 2 2 Temperature Setting ii A ee a co 30 3 23 Lamp AMplitude oa ei ee ed ee as 30 9 2 4 Printer Self Test roerne ia or Real 31 8 3 UTILITIES SCREEN a a e 31 8 3 1 To ENTER CHANGE Date and TiMEe 31 8 3 2 Password Utility Socio in eee Ae eee 32 8 3 3 To disable or enable the Printer eee 33 8 3 4 To Enter Clinic Nam iiaa aan a aa dea 33 8 3 5 Lampi 0ONx e aL LOR Ea ele AA aa 34 8 3 6 Stirrer ON EEE TA EE RAR ana 34 Version No 1 005A Effective Date Ma y 2012 Page 2 of 54 FOURCLOT Coagulation Analyser USER MANUAL 8 4 QUALITY CON TROLS occ ii iti 35 8 5 View Stored Results Print Pat
38. ient Reporti i 36 8 6 Serial communicatioNi cc nana corn nc cnn nn aran nc anna 37 9 Programming Modes PHOTOMETRIC ssscsecsssesseeseessseeneeneeeeneeseeeeeenseeneeneseeneennees 38 DT ABSORBANCE unitat lat 38 9 2 FIXED TIME LIL AS TEA RA O as a ee 40 Lo RE EE FOIE LG ae a A AS cia 44 JALENDO PONE iii i in clelia cia 48 10 Trouble Shooting aaa 52 Ii Decontaminatio Ns iia anal 53 11 1 Decontamination Procedure ii 53 11 2 Purpose of Decontamination iii 53 11 3 General Considerations i 53 A Procedure pile n T EEA 53 12 SAFETY CLEARANCE CERTIFICATE o ccoocccccncnncconnnccnnnonanannonanonannanonanaronanaronanarananaranana 54 Version No 1 005A Effective Date May 2012 Page 3 of 54 FOURCLOT Coagulation Analyser USER MANUAL 1 GENERAL INFORMATION 1 1 Warranty Information Each Instrument is completely tested and guaranteed for twelve months from delivery The warranty applies to all the mechanical and electrical parts It is valid only for proper installation use and maintenance in compliance with the instructions given in this manual ROBONIK will at its discretion repair or replace parts which may be found defective in the warranty period The warranty does not include any responsibility for direct or indirect personal and material damages caused by improper use or maintenance of
39. irrer e Reporting of results in second INR Ratio and e Automatic sensing of sample reagent dispensing to start the measurement e Incubation for 24 positions for samples and reagent e Built in printer and option to connect external 80 column printer e Low reagent sample volume for testing e Multipoint Calibration curve with user entered standard dilution in FIB and Factor Assay Photometer e Independent channel for Photometric assays e Multipoint calibration curve with max 7 calibrators for Photometric assays e Chromgenic assays antithrombin III AT III protein C PC protein S PS D dimer Common Features e Effective temperature regulation system e Robust system with built in stabilizer e Latest technology with battery back up for 250 tests with QC and more than 2500 results independent memory for Coagulation and Photometric mode Alpha numeric Patients ID entry Combine report printing for coagulation and photometer test with unique patient ID Robust in built 20 column thermal printer with 384 stationary heads Unique circuitry for long lamp life Human machine interface Touchpad Keypad Built in Incubator Quality Control with Levy Jennings and standard deviation graphs Access to test by touch of key Version No 1 005A Effective Date May 2012 Page 7 of 54 FOURCLOT Coagulation Analyser USER MANUAL 3 3 Technical specification of FOUR CLOT Coagulation Dry block incubator 24 positions for sample
40. loves and towels Version No 1 005A Effective Date May 2012 Page 53 of 54 FOURCLOT Coagulation Analyser USER MANUAL 12 SAFETY CLEARANCE CERTIFICATE Please complete all information requests on this form prior to returning the instrument to the manufacturer or your local distributor for servicing repairs or return Thank you for your co operation Customer Contact Address_ Position Dept Tel Country Fax Post Code Model No __ Serial No Accessories Returned Date of Purchase if known Complaint Has the equipment been exposed to any of the following delete as applicable a Blood body fluids pathological specimens YES NO If YES please specify b Other Biohazard YES NO if YES Please specify Version No 1 005A Effective Date May 2012 Page 54 of 54
41. ng Running Operating a pre programmed test For example Name ABC Mode END Test Name END Pri 630 Sec 0 KF 2 000 Unit mg dl QC Y Lag 0 Read 0 Bik N Normal Y Set temperature 37 00 Std N Factor 1 000 Channel temperature 30 43 Limit Set To change values press EDIT ESC to abort temperature Test Name END Test Name END Referencing Lag Time 5 Close the Lid amp Press Run Test Name END Factor 1 000 Read Sample Version No 1 005A Effective Date May 2012 Page 51 of 54 FOURCLOT Coagulation Analyser USER MANUAL 10 Trouble Shooting MESSAGES CAUSE CORRECTIVE ACTION This error will come in coagulation mode while referencing Remove the cuvette Remove Cuvette In Multi standard mode if standard are not Invalid Assay proper then this error will appear Check the calibrators and rerun the test If Number of saved tests exceeds the memory Memory Full limit then delete the unwanted tests and save the test Version No 1 005A Effective Date May 2012 Page 52 of 54 FOURCLOT Coagulation Analyser USER MANUAL 11 Decontamination 11 1 Decontamination Procedure If the instrument is to be shipped after being exposed to potentially hazardous material it should be decontaminated The following procedure autlines the method of decontaminating the instrument before packaging and shipment 11 2 Purpose of Decontamination Decontamination minimizes the risk to
42. pose we have selected test in PT mode whose Sample AVG is 4 then it will assign the samples in all the four channels Program Channels TestName Mode CH 1 PT P CH 2 PT P CH 3 PT P CH 4 PT P Version No 1 005A Effective Date May 2012 Page 27 of 54 FOURCLOT Coagulation Analyser USER MANUAL D List Tests List Test screen Displays max of 10 Tests Page A List tests screen would look like the screen shown below ESC To escape User can select a saved test by first touching the required TEST NAME on the screen and then touch the SEL option to carry out further operation on the test Select Test 1 TT 2PT 3PT_1 DEL Deletes the selected test If the number of tests is more than 10 NEXT and PREV can be used for browsing through the list pages PRINT For printing the LIST TESTS 4 FIB 5 FA Main Menu screen FOURCLOT 22 7 10 CLINIC NAME TEST OPERATIONS MAIN MENU 1 Add New Test 1 Test Operations 2 List Tests 2 Technical Diagnosis 3 Run STD Control 3 Utilities 4 Run Sample 4 Quality control 5 Run QC 5 View Stored Results 6 Serial communication Select Test 4 TT Select Test 2 PT 1 TT se ae 4 FIB a 4 FIB di 5 FA 1TT Touch SEL to operate the test The selected test is displayed at the bottom Touch TT to select the test of the screen Version No 1 005A Effective Date May 2012 Page 28 of 5
43. s the precision of the method For example FOURCLOT 22 7 10 CLINIC NAME ac ESC MAIN MENU 1 Levy Jennings 1 Test Operations 2 Standard Deviation 2 Technical Diagnosis 3 Utilities 4 Quality control 5 View Stored Results 6 Serial communication Select test Select test 1PT 1PT 6 PT_N1 2 APTT 2 APTT 7 FIB_2 3TT_1 3TT_1 8 APTT_2 4 FIB 4 FIB 9TT_2 5 FA 5 FA 10 PT_N2 QC NORMAL 1PT Touch YES for QC Normal Touch NO for QC Abnormal QC Normal QC ABNORMAL Test Name PT Test Name PT H 5 000 L 2 000 i H 4 000 L 1 000 No Date Result No Date Result 20 02 06 1555 2 1 20 02 06 1555 2 20 02 06 1678 2 20 02 06 1678 6 3 20 02 06 1457 3 20 02 06 1457 3 20 02 06 1567 4 20 02 06 1567 4 Version No 1 005A Effective Date May 2012 Page 35 of 54 FOURCLOT Coagulation Analyser USER MANUAL 8 5 View Stored Results Print Patient Report Displays the latest 10 stored tests results The system can store 2500 results in its database The moment a sample is RUN the result is stored in the system database The variables stored in the database are as follows MODEL NAME CURRENT DATE Date of Testing Name M Result Units ID PT P 2 454 sec 101 TT T 66 59 sec 27 FIB F 272 6 ESC NEXT PREV DEL PRINT PID Enter Patient s identification number Test Name CREATNINE Enter Patient s Name H L No Date Result 20 02 06 1555 2 20 02 06 1678 20 02 06 1457 3
44. test mode in which test is to be entered Coagulation consists of five different modes They are as follows 1 PT mode 2 APTT mode 3 TT mode 4 FIB mode 5 FA mode Let us see how to create a New Test in each mode Version No 1 005A Effective Date May 2012 Page 16 of 54 FOURCLOT Coagulation Analyser 1 PT mode Name Mode PT ISI index 0 000 ESC Normal N MNPT 0 000 SAVE DILUTION N Sample Avg 4 QC N Incub Time 0 Name Mode PT ISI index 0 000 Normal N__ MNPT 0 000 DILUTION N Sample Avg 4 QC N Incub Time 0 Name Mode PT ISI index 0 000 ESC Normal N MNPT 0 000 SAVE DILUTION N Sample Avg 4 QC N Normal Name Mode PT ISI index 0 000 Normal N DILUTION N Sample Avg 4 QC N Incub Time 0 Normalize N Ctrl Time N Numeric Values 123456 7890 Select Ctrl Time if you directly want to run the samples in PT mode Version No 1 005A Effective Date Ma y 2012 USER MANUAL Name Mode PT ISl index 0 000 Normal N MNPT 0 000 DILUTION N Numeric Value 1234556 7890 Enter Normal Values _ Low 0 000 High 0 000 Numeric Value 123 45 6 7890 Normalize N Ctrl Time N Numeric Values 123456 ENTR 7890 CLR Select Normalize if you want to run the standards in PT mode Page 17 of 54 FOURCLOT Coagulation Analyser Name Mode PT ISI index 0 000 Normal N ESC A
45. ting the printer Disconnect the small cable from the external printer port Ref Diagram in 5 3 provided on the rear of analyzer User can then connect the external printer using the standard communication cable to external printer port Note If an external printer is connected then the internal printer is disabled 6 Installation and start up instructions While installing and setting up the instrument the safety warnings and general precautions described in section 7 must be observed 6 1 Placing the instrument Place the instrument on a flat working surface or bench top capable of supporting the weight of the instrument A clearance of at least 3 inches around the instrument is required to assure optimal ventilation Room temperature should be between 18 C and 35 C with a relative humidity below 85 Protect it from direct sunshine and maintain the instrument in a clean relatively dust free environment to ensure maximum performance 6 2 Power supply Once the instrument has been placed plug it into a power source by using the locally available approved plug in cable Power cord should be CE CSA and UL marked Voltage 115 230 Volts 10 60 50 Hz 6 3 Protective Grounding Warning Make sure that electrical power source is properly grounded 6 4 Start up Instructions 1 Switch on the instrument 2 The instrument initializes all the parameters internally and carries out a power on self test and then displays t
46. val and concentration is calculated either from the factor fed by the user or using standard PROGRAMMING ADDING a NEW TEST Name Mod FIX Pri 405 Sec 0 KF 1 000 Unit No Unt QC N Lag 0 Read 0 Bik N Normal N Std N Factor 0 000 Limit Set FIXED TIME Mode screen before programming would look like the above screen Refer chapter11 for entering the test parameters On completion touch SAVE to save the programmed test in Prnnnnnnnnnnnnanas A A TO Mode FIX ENT E PRNT L Unit No Unt QC N EDIT Lag 0 BIk N Normal N Std N Factor 0 000 Limit Set Filter 1 Mode FIX Filter 2 i sec 0 Select Filter Val Unit No Unit QC N 0 630 405 Lag 0 Read 0 Numeric Value 123456 7890 Version No 1 005A Effective Date May 2012 Page 40 of 54 FOURCLOT Coagulation Analyser Mode FIX Sec 0 Name Pri 630 KF 1 000 Unit No Unit QC N Lag 0 BIK N Std N Limit Set Factor 1 000 Set Times_ Laa Time 0 Read Time 0 Numeric Value 123456 7890 USER MANUAL Mod FIX Sec 0 Name Pri 405 KF 1 000 Unit No Unt Lag 0 Bik N Std N Blank QC N Read 0 Normal N Factor 0 000 Touch YES if you want to select Blank Mod FIX Sec 0 Name Pri 405 KF 1 000 Unit No Unt Lag 0 BIk N Std N Standard Mod FIX Sec 0 Name Pri 405 KF 1 000

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