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FOURCLOT … Coagulation Analyser USER MANUAL FOUR CLOT Coagulation Analyser User Manual Version With Incubator 1.005A ROBONIK (INDIA) 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 protected] Website-www.robonik.in Version No. : 1.005A Effective Date: May 2012 Page 1 of 54 FOURCLOT … Coagulation Analyser TABLE OF CONTENTS USER MANUAL 1. GENERAL INFORMATION ................................................................................................... 4 1.1. Warranty Information:............................................................................................4 1.2. Technical Service: ..................................................................................................4 1.3. Disposal Instruction:..............................................................................................4 1.4. Contacts: ...................................................................................................................4 2. GENERAL SAFETY WARNINGS ........................................................................................ 5 2.1. Danger – warnings symbols: ...............................................................................5 2.2. Use of the Instrument: ...........................................................................................6 3. INTRODUCTION ..................................................................................................................... 7 3.1. DESCRIPTION ..........................................................................................................7 3.2. Special Features......................................................................................................7 3.3. Technical specification of FOUR CLOT:...........................................................8 4. PACKING, TRANSPORT AND STORAGE ....................................................................................10 4.1. GENERAL WARNINGS:.......................................................................................10 4.2. PACKING:................................................................................................................10 4.3. INSTRUMENT TRANSPORTATION :.................................................................10 4.4. STORAGE OF INSTRUMENT: ............................................................................10 5. INSTRUMENT DESCRIPTION ...........................................................................................11 5.1. Touch Sensitive screen .......................................................................................11 5.2. Perspective View...................................................................................................12 5.3. KEYPAD...................................................................................................................13 5.4. Printer.......................................................................................................................13 6. Installation and start-up instructions.............................................................................14 6.1. Placing the instrument ........................................................................................14 6.2. Power supply ..........................................................................................................14 6.3. Protective Grounding...........................................................................................14 6.4. Start up Instructions: ...........................................................................................14 7. PRECAUTIONS.....................................................................................................................15 8. MAIN MENU...........................................................................................................................16 8.1. TEST OPERATIONS: ............................................................................................16 A) Programming/ADDING a NEW TEST: ..................................................................16 B) Recalling a Saved TEST:..........................................................................................24 C) Running a Saved TEST (Operating the programmed Tests) ........................... D) List Tests: .....................................................................................................................28 8.2. TECHNICAL DIAGNOSIS:....................................................................................29 8.2.1. Clear Memory .............................................................................................................................. 29 8.2.2. Temperature Setting.................................................................................................................... 30 8.2.3. Lamp Amplitude .......................................................................................................................... 30 8.2.4. Printer Self Test........................................................................................................................... 31 8.3. UTILITIES SCREEN:..............................................................................................31 8.3.1 To ENTER/CHANGE Date and Time.............................................................................................. 31 8.3.2. Password Utility: ......................................................................................................................... 32 8.3.3. To disable or enable the Printer: ................................................................................................. 33 8.3.4. To Enter Clinic Name: ................................................................................................................. 33 8.3.5. Lamp: ON .................................................................................................................................... 34 8.3.6. Stirrer: ON ................................................................................................................................... 34 Version No. : 1.005A Effective Date: May 2012 Page 2 of 54 FOURCLOT … Coagulation Analyser USER MANUAL 8.4. QUALITY CONTROL:............................................................................................35 8.5. View Stored Results/ Print Patient Report:....................................................36 8.6. Serial communication:.........................................................................................37 9. Programming Modes (PHOTOMETRIC).........................................................................38 9.1. ABSORBANCE.......................................................................................................38 9.2. FIXED TIME.............................................................................................................40 9.3. KINETIC....................................................................................................................44 9.4. END POINT..............................................................................................................48 10. Trouble Shooting: .............................................................................................................52 11. Decontamination ...............................................................................................................53 11.1. Decontamination Procedure ............................................................................53 11.2. Purpose of Decontamination ...........................................................................53 11.3. General Considerations ....................................................................................53 11.4. Procedure..............................................................................................................53 12. SAFETY CLEARANCE CERTIFICATE.........................................................................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 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 Tel: +91-22-67829700, Fax: +91-22-67829701 Email: [email protected] Website: www.robonik.in Version No. : 1.005A 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. General Symbols Symbol for “Manufacturer” Symbol for “ IN VITRO DIAGNOSTIC MEDICAL DEVICE” Version No. : 1.005A Effective Date: May 2012 Page 5 of 54 FOURCLOT … Coagulation Analyser USER MANUAL 2.2. Use of the Instrument: The 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. In a domestic 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: May 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. Its 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 • • • • • • • • • • • Four independent programmable coagulation channels for faster throughput. Display on line results of all four channels simultaneously on single screen. Sample averaging up to 4 coagulation runs in PT, APTT, TT, Fibrinogen. Designed to perform all routine tests such as PT, APTT, TT, Fibrinogen, Factor II, V, VII, IX, X, XI, XII. Uniform mixing of Sample & Reagent with magnetic stirrer. Reporting of results in second, INR, Ratio and %, Automatic sensing of sample/reagent dispensing to start the measurement Incubation for 24 positions for samples and reagent. Built in printer and option to connect external 80 column printer. Low reagent/sample volume for testing Multipoint Calibration curve with user entered standard dilution %, in FIB and Factor Assay Photometer • • • Independent channel for Photometric assays Multipoint calibration curve with max.7 calibrators for Photometric assays. Chromgenic assays antithrombin III (AT-III), protein C (PC), protein S (PS), D-dimer. Common Features • • • • • • • • • • • Effective temperature regulation system. Robust system with built in stabilizer. 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: Measuring System Photometric Optical measurement Photodiode Measurement Volume 150 µl Sample & reagent mixing With magnetic stirrer Dry block incubator Number of cuvette Holders 24 positions for sample and reagent cuvette incubation. Temperature 37 c Timer Programmable 0 Light source LED/Laser Analysis mode PT, APTT, TT, Fibrinogen, Factor assay (Factor II, V, VII, IX, X, XI, XII). Results displayed in Seconds, Ratio, INR, Concentration and % Photometer: Linear measurement range Photometric Accuracy Drift Photometric Linearity Optical measurement Filters Type of filter Wave Length Light source Warm up Time Analysis Mode Version No. : 1.005A Effective Date: May 2012 0.000 to 3.000 Absorbance Units (A). ± 2% or 0.007 whichever is higher, from 0 to 1.5 A ± 3% from 1.5 A to 3.0 A <0.007 A/hr 2.2 A Photodiode Narrow band Interference 405, 630 nm (optional) Tungsten Halogen 90 Sec Photometric mode Absorbance Kinetic End Point Fixed Time Page 8 of 54 FOURCLOT … Coagulation Analyser USER MANUAL Common: Human Machine Interface Display TOUCH PANEL / KEYPAD 5” Graphic LCD, Negative Blue, STN Printer Built – in thermal printer, 20 column Memory 32 KB Non Volatile 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 RS232 Power Wattage 50 Watts Voltage 115 – 230 Volts ± 50 / 60 Hz. Operating position On horizontal flat, rigid and vibration free surface Operating conditions 0 0 Temperature From + 18 c to 35 c Relative humidity Up to 85 % Storage conditions 0 0 Temperature From -10 c to 60 c Relative humidity Up to 85 % Enclosure ABS Fire retardant Size (cms) 34.5 X 30 X 14.7 (l x b x h) Weight (Approx) 5.4 Kg (Approx.) Version No. : 1.005A Effective Date: May 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 -10ºc and -60ºC. 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 KEYPAD 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 Normal: N MNPT: 0.000 %dilution: Sample Avg: 4 QC: N Incub. Time: 0 ESC SAVE 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. • 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. • 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 Touch Screen Incubator Keypad Photometric Cuvette chamber Coagulation Cuvette chamber Rear View: SMPS Fan Contrast POT ON / OFF Switch External Printer (Optional ) RS232 port Version No. : 1.005A Effective Date: May 2012 Cooling Fan R-RED Page 12 of 54 SMPS FOURCLOT … Coagulation Analyser USER MANUAL 5.3. KEYPAD 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. 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.) ü 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 Version No. : 1.005A Effective Date: May 2012 After inserting the paper Page 13 of 54 FOURCLOT … Coagulation Analyser USER MANUAL B) External Printer (Optional) Switch off the analyzer before connecting 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 18ºC and 35 ºC 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 the following screen FOURCLOT ROBONIK (INDIA) PVT. LTD. Plot No. A-374, TTC, MIDC Industrial Area, Mahape Navi Mumbai– 400 710 Tel: +91-22-67829700, Fax: +91-22-67829701 Web:- www.robonik.india.in Email:- [email protected] Select Mode 1. Coagulation 2. Photometric FOURCLOT TOUCH CLINIC NAME MAIN MENU 1. Test Operations 2. Technical Diagnosis 3. Utilities 4. Quality control 5. View Stored Results 6. 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 20/7/10 ESC FOURCLOT … Coagulation Analyser USER MANUAL 1) 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) 2) Once initialization is over, a lamp located within the instrument will glow. This lamp requires 90 seconds for stabilization. 3) After the instrument completes the above steps, a TEST MENU SCREEN / MAIN MENU Screen appears. 4) The instrument is now in IDLE mode, and ready for use. 7. PRECAUTIONS v Keep the place dry and clean. v Check all the grounding wires properly. v Repeat the readings, if Absorbance is more than 2.0 A. v Use original Packing for transportation. v Use clean Cuvettes. Check the blank absorbance of the cuvette at regular intervals. v Check the temperature of cuvette block at regular intervals. v Check the linearity of the instrument at regular intervals using standards. v Do not take any reading when the lid is open. v Incubate the cuvettes at set temperature for at least 10 minutes before using. v Incubate the reagents at set temperature for at least 10 minutes before using. v 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) Programming/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. ü 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 TEST OPERATIONS 1. Add New Test 2. List Test 3. Run Std / Cntr 4. Run sample 5. Run QC ESC Select Menu “Test Operations” ESC Select Menu “Add New Test” Select Test Mode 1) PT 2) APTT 3) TT 4) FIB 5) FA ESC 1 0 1 0 0 On Select Test Mode screen all the test modes along with the no. of test entered are displayed Select test mode in which test is to be entered Coagulation consists of five different modes. They are as follows1. 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 USER MANUAL 1. PT mode Name: 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 Normal: N MNPT: 0.000 % DILUTION: N Sample Avg:4 QC: N Incub. Time: 0 Mode: PT ESC SAVE ESC SAVE A I Q Y 3 B C J K R S Z , 4 5 D E L M T U - + 6 7 F N V _ 8 G O W 1 9 Enter Normal Values_ Name: Mode: PT ISI index: 0.000 Normal: N MNPT: 0.000 % DILUTION: N Sample Avg:4 QC: N Incub. Time: 0 Normalize: N Ctrl. Time: N SAVE Low: 0.000 High: 0.000 Numeric Value: 1 2 3 4 5 6 7 8 9 0 . Numeric Values: 1 2 3 4 5 6 7 8 9 0 . ENTR CLR ENTR CLR Select “Normalize” if you want to run the standards in PT mode. Normalize: N Ctrl. Time: N Numeric Values: 1 2 3 4 5 6 7 8 9 0 . ENTR CLR Name: Mode: PT ISI index: 0.000 Normal: N MNPT: 0.000 % DILUTION: N Numeric Value: 1 2 3 4 5 6 ENTR 7 8 9 0 . CLR Name: Mode: PT ISI index: 0.000 ESC Normal: N MNPT: 0.000 SAVE % DILUTION: N Sample Avg:4 QC: N Normal YES NO ESC H P X 2 0 ENTR CLR Select “Ctrl. Time” if you directly want to run the samples in PT mode. Version No. : 1.005A Effective Date: May 2012 Page 17 of 54 FOURCLOT … Coagulation Analyser Name: Mode: PT ISI index: 0.000 Normal: N MNPT: 0.000 % DILUTION: N Sample Avg: 4 QC: N Incub. Time: 0 ESC SAVE No. of Dil: 2 Concen Time 0.000 0.000 0.000 0.000 Numeric Value: 1 2 3 4 5 6 7 8 9 0 . ENTR CLR ESC SAVE Name: Mode: PT ISI index: 0.000 Normal: N MNPT: 0.000 % DILUTION: N Numeric Values: 1 2 3 4 5 6 ENTR 7 8 9 0 . CLR 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 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 % DILUTION ESC SAVE YES NO No. of Dil: 2 Concen Time 0.000 0.000 0.000 0.000 In this screen you have to enter the concentration value & the time related to it. Name: Mode: PT ISI index: 0.000 Normal: N MNPT: 0.000 % DILUTION: N Sample Avg: 4 QC: N Incub. Time: 0 USER MANUAL ESC SAVE Numeric Value: 1 2 3 4 5 6 7 8 9 0 . ENTR CLR 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 ESC QCNormal Values_ QCNH: 0.000 QCNL: 0.000 QCAbnormal Values_ QCABH: 0.000 Numeric Value: 1 2 3 4 5 6 7 8 9 0 . ENTR CLR 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: 1 2 3 4 5 6 ENTR 7 8 9 0 . CLR From this screen you can enter the Incubation Time in seconds. Version No. : 1.005A Effective Date: May 2012 Page 18 of 54 FOURCLOT … Coagulation Analyser USER MANUAL 2. APTT mode Name: Mode: APTT Sample Avg: 1 ESC Normal: N QC: N SAVE Incub. Time: 0 Name: Mode: APTT Sample Avg: 1 ESC Normal: N QC: N SAVE Incub. Time: 0 Normal YES NO Name: A I Q Y 3 B C J K R S Z , 4 5 Mode: APTT D E L M T U - + 6 7 F N V _ 8 G O W 1 9 H P X 2 0 ENTR CLR Name: Mode: APTT Sample Avg: 1 Normal: N QC: N Incub. Time: 0 Numeric Value: 1 2 3 4 5 6 7 8 9 0 . ENTR CLR Enter Normal Values_ Low: 0.000 High: 0.000 Numeric Value: 1 2 3 4 5 6 7 8 9 0 . ENTR CLR Name: Mode: APTT Sample Avg: 1 ESC Normal: N QC: N SAVE Incub. Time: 0 QC Normal Values_ QCNH: 0.000 QC NL: 0.000 QC Abnormal Values_ QCABH: 0.000 Numeric Value: 1 2 3 4 5 6 7 8 9 0 . QC Normal Values_ QCNH: 0.000 QCNL: 0.000 QC Abnormal Values_ QCABH: 0.000 QCABL: 0.000 ESC In this screen you can enter both QC Normal (H /L) as well as QC Abnormal (H /L) values. ENTR CLR Name: Mode: APTT Sample Avg: 1 ESC Normal: N QC: N SAVE Incub. Time: 0 Name: Mode: APTT Sample Avg: 1 Normal: N QC: N Incub. Time: 0 Numeric Value: 1 2 3 4 5 6 7 8 9 0 . ENTR CLR 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 USER MANUAL 3. TT mode Name: Mode: TT Sample Avg: 1 Normal: N QC: N Incub. Time: 0 Name: Mode: TT Sample Avg: 1 Normal: N QC: N Incub. Time: 0 Normal Name: Mode: TT ESC SAVE ESC SAVE A I Q Y 3 B C J K R S Z , 4 5 D E F L M N T U V - + _ 6 7 8 G O W 1 9 ENTR CLR Name: Mode: TT Sample Avg: 1 Normal: N QC: N Incub. Time: 0 Numeric Value: 1 2 3 4 5 6 7 8 9 0 . YES NO H P X 2 0 ENTR CLR Enter Normal Values_ Low: 0.000 High: 0.000 Numeric Value: 1 2 3 4 5 6 7 8 9 0 . ENTR CLR Name: Mode: TT Sample Avg: 1 Normal: N QC: N Incub. Time: 0 ESC SAVE QCNormal Values_ QCNH: 0.000 QCNL: 0.000 QCAbnormal Values_ QCABH: 0.000 Numeric Value: 1 2 3 4 5 6 7 8 9 0 . QCNormal Values_ QCNH: 0.000 QCNL: 0.000 QCAbnormal Values_ QCABH: 0.000 QCABL: 0.000 ESC In this screen you can enter both QCNormal (H /L) as well as QCAbnormal (H /L) values. ENTR CLR Name: Mode: TT Sample Avg: 1 Normal: N QC: N Incub. Time: 0 ESC SAVE Name: Mode: TT Sample Avg: 1 Normal: N QC: N Incub. Time: 0 Numeric Value: 1 2 3 4 5 6 7 8 9 0 . ENTR CLR This screen allows you to enter the Incubation time in seconds. Version No. : 1.005A Effective Date: May 2012 Page 20 of 54 FOURCLOT … Coagulation Analyser USER MANUAL 4. FIB mode Name: Mode: FIB Unit: mg/dl ESC Normal: N QC: N Incub. Time: 0 SAVE Concen Sample Avg: 1 Graph: PT TO PT Y vs X: Time vs LOGCONC Name: Name: Mode: FIB Unit: mg/dl Normal: N QC: N Incub. Time: 0 Concen Sample Avg: 1 Graph: PT TO PT Normal Enter Normal Values_ A I Q Y 3 B C J K R S Z , 4 5 Mode: FIB D L T 6 E F M N U V + _ 7 8 G O W 1 9 H P X 2 0 ENTR CLR ESC SAVE YES NO Low: 0.000 High: 0.000 Numeric Value: 1 2 3 4 5 6 7 8 9 0 . ENTR CLR Enter the values of Normal in High / Low range QCNormal Values_ QCNH: 0.000 QCNL: 0.000 QCAbnormal Values_ QCABH: 0.000 QCABL: 0.000 ESC QCNormal Values_ QCNH: 0.000 QCNL: 0.000 QCAbnormal Values_ QCABH: 0.000 Numeric Value: 1 2 3 4 5 6 7 8 9 0 . Name: Mode: FIB Unit: mg/dl ESC Normal: N QC: N Incub. Time: 0 SAVE Concen 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: 1 2 3 4 5 6 7 8 9 0 . Name: Mode: FIB Unit: mg/dl Normal: N QC: N Incub. Time: 0 Concen Sample Avg: 1 Graph: PT TO PT Y vs X: Time vs LOGCONC ENTR CLR ESC SAVE In this screen you can enter both QCNormal (H /L) as well as QCAbnormal (H /L) values. No. of Dil: 6 Concen Time 0.000 0.000 0.000 0.000 0.000 0.000 Numeric Value: 1 2 3 4 5 6 7 8 9 0 . ENTR CLR 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 Type LINEAR PT TO PT (Note: The UNIT in FIB mode is fixed) Version No. : 1.005A Effective Date: May 2012 ENTR CLR Page 21 of 54 ESC Scale LogTime vs CONC Time vs LOGCONC LogitTime vs Log CONC Time vs CONC LogTime vs Log CONC FOURCLOT … Coagulation Analyser Name: Mode: FIB Unit: mg/dl ESC Normal: N QC: N Incub. Time: 0 SAVE Concen Sample Avg: 1 Graph: PT TO PT Y vs X: Time vs LOGCONC USER MANUAL Name: Mode: FIB Unit: mg/dl Normal: N QC: N Incub. Time: 0 Concen Numeric Values: 1 2 3 4 5 6 7 8 9 0 . ENTR CLR This screen allows you to enter the Incubation time in seconds. 5. FA mode Name: Mode: FA PT: ESC APTT: QC: N Incub. Time: 0 SAVE Concen Normal: N Graph: LINEAR Y vs X: LogTime vs LogCONC Name: Name: Mode: FA PT: ESC APTT: QC: N Incub. Time: 0 SAVE Concen Normal: N Graph: LINEAR Y vs X: LogTime vs LogCONC FA_II FA_V FA_VII FA_X FA_VIII FA_IX FA_XI FA_XII Name: Mode: FA PT: FA_V ESC APTT: QC: N Incub. Time: 0 SAVE Concen Normal: N Graph: LINEAR Y vs X: LogTime vs LogCONC A I Q Y 3 B C J K R S Z , 4 5 Mode: FIB D E F L M N T U V - + _ 6 7 8 Name: Mode: FA PT: ESC APTT: FA_XI QC: N Incub. Time: 0 SAVE Concen Normal: N Graph: LINEAR Y vs X: LogTime vs LogCONC Version No. : 1.005A Effective Date: May 2012 Page 22 of 54 G O W 1 9 H P X 2 0 ENTR CLR FOURCLOT … Coagulation Analyser Name: Mode: FA PT: ESC APTT: FA_XI QC: N Incub. Time: 0 SAVE 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: 1 2 3 4 5 6 7 8 9 0 . USER MANUAL QCNormal Values_ QCNH: 0.000 QCNL: 0.000 QCAbnormal Values_ QCABH: 0.000 QCABL: 0.000 ESC QCNormal Values_ QCNH: 0.000 QCNL: 0.000 QCAbnormal Values_ QCABH: 0.000 Numeric Value: 1 2 3 4 5 6 7 8 9 0 . ENTR CLR Select “Concen”. Enter the number of Dilution. Here you can enter Max 6 Concen, Min 4 Concen Name: Mode: FA PT: FA_V APTT: QC: N Incub. Time: 0 Concen Normal: N Graph: LINEAR Normal ENTR CLR In this screen you can enter both QC Normal (H /L) as well as QC Abnormal (H /L) values. Enter Normal Values_ ESC SAVE YES NO Low: 0.000 High: 0.000 A Numeric Value: 1 2 3 4 5 6 7 8 9 0 . ENTR CLR Enter the values of Normal in High / Low range Name: Mode: FIB Unit: mg/dl ESC Normal: N QC: N Incub. Time: 0 SAVE Concen Sample Avg: 1 Graph: PT TO PT Y vs X: Time vs LOGCONC Graph Type: PT TO PT Y vs X: Time vs LOGCONC Name: Mode: FA PT: ESC APTT: QC: N Incub. Time: 0 SAVE Concen Normal: N Graph: LINEAR Y vs X: LogTime vs LogCONC Name: Mode: FA PT: APTT: QC: N Incub. Time: 0 Concen Type LINEAR PT TO PT ESC Scale LogTime vs CONC Time vs LOGCONC LogitTime vs Log CONC Time vs CONC LogTime vs Log CON Numeric Value: 1 2 3 4 5 6 7 8 9 0 . ESC SAVE ENTR CLR This screen allows you to enter the Incubation time in seconds. Version No. : 1.005A Effective Date: May 2012 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 CLINIC NAME MAIN MENU 1. Test Operations 2. Technical Diagnosis 3. Utilities 4. Quality control 5. View Stored Results 6. Serial communication 19/7/10 TEST OPERATIONS 1. Add new test 2. List test 3. Run Std / ctrl 4. Run Sample 5. Run QC ESC Select Test 1. TT 2. PT ESC ESC MENU SEL PRNT NXT PREV DEL 2. PT List test displays max. of 10 Tests/ Page . A “List tests” screen would look like the screen shown above. Touch the test name 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 Mode: PT ESC PRNT EDIT 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 programmed 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 belowSelect Test Operations Main Menu screen To run the STD of FIB / FA or Normalization Controls of PT. Step1: Select Menu TEST OPERATIONS. 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 ESC Step 2: Select Run Std / Ctrl. TEST OPERATIONS 1. Add new test 2. List test 3. Run Std / ctrl 4. Run Sample 5. Run QC ESC After selecting Run Std / Ctrl menu, screen is displayed to check the channel temperature. Initially if the channel temperature is 30.43°C then this screen is displayed till Channel temperature attend 37°C. To abort Temperature, Select ESC ESC MENU SEL PRNT NXT PREV DEL Select test 1. PT 2. APTT 3. TT 4. FIB 5. FA 4. FIB FIB Std Res FIB CH-1 Dilut: Incub. Time: 10.25 ESC Run CH-2 Dilut: Incub. Time: 10.15 ESC Run CH-3 Dilut: Incub. Time: 10.09 ESC Run CH-4 Dilut: Incub. Time: 10.20 ESC ESC Run ESC Set temperature :37.00 Channel temperature:30.43 ESC to abort temperature After reaching the temperature or selecting ESC, test mode screen is displayed as shown aside. Select the test mode of which the standard is to be run After selecting the particular test, it displays the RUN screen. On selecting the RUN option, it will run the Incubation time if and only if you select Incub. Time in test parameter. Again select RUN option in order to run the standard for the required test. A Version No. : 1.005A Effective Date: May 2012 Page 25 of 54 FOURCLOT … Coagulation Analyser USER MANUAL A ESC Run FIB Std Res CH-1 Dilut: Add Sample: CH-2 Dilut: Load Cuv + Rgt ESC Run CH-2 Dilut: Add Sample: ESC Run CH-3 Dilut: Load Cuv + Rgt ESC Run CH-3 Dilut: Add Sample: ESC Run CH-4 Dilut: Load Cuv + Rgt ESC ESC Run CH-4 Dilut: Add Sample: ESC ESC Run FIB Std Res CH-1 Dilut: Load Cuv + Rgt FIB FIB ESC Run 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 FIB 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 CLINIC NAME MAIN MENU 1. Test Operations 2. Technical Diagnosis 3. Utilities 4. Quality control 5. View Stored Results 6. Serial communication 19/7/10 ESC Step 2: Select Run Sample. TEST OPERATIONS 1. Add new test 2. List test 3. Run Std / ctrl 4. Run Sample 5. Run QC ESC A 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. A ESC Initially if the channel temperature is 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 ESC to abort temperature After attending the temperature or Selecting ESC, Program Channels screen is displayed as shown . Select the channel in which you want to run the sample. Program Channels Test Name Mode CH-1= CH-2= CH-3= CH-4= MENU ESC RUN PRNT On selecting the channel it will display “Select Test” screen through which we can select the tests whose samples we want to run. Suppose 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 Test Name 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 MENU ESC RUN PRNT 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 Select Test 1 TT 2 PT 3 PT_1 4 FIB 5 FA ESC MENU SEL PRNT NXT PREV DEL “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. “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 “ Main Menu screen 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 Select Test 1 TT 2 PT 3 PT_1 4 FIB 5 FA ESC ESC MENU SEL PRNT NXT PREV DEL TEST OPERATIONS 1. Add New Test 2. List Tests 3. Run STD/ Control 4. Run Sample 5. Run QC Select Test 1 TT 2 PT 3 PT_1 4 FIB 5 FA 1 TT Touch “SEL” to operate the test. (The selected test is displayed at the bottom of the screen) Version No. : 1.005A Effective Date: May 2012 Touch “TT” to select the test. Page 28 of 54 ESC ESC MENU SEL PRNT NXT PREV DEL FOURCLOT … Coagulation Analyser USER MANUAL 8.2. TECHNICAL DIAGNOSIS: Ref. Ref. Ref. Ref. 8.2.1 8.2.2 8.2.3 8.2.4 TECHNICAL DIAGNOSIS 1 Clear Memory 2 Printer Self test 3 Set Temperature 4 Lamp Amplitude ESC 8.2.1. Clear Memory To clear memory. Tests and results are stored separately. TECHNICAL DIAGNOSIS 1 Clear Memory 2 Printer Selftest 3 Set Temperature 4 Lamp Amplitude ESC TECHNICAL DIAGNOSIS 1 Clear Memory 2 Printer Selftest 3 Set Temperature 4 Lamp Amplitude Clear Results ? ESC YES NO “Clearing memory …” [Clears all the stored Results only] TECHNICAL DIAGNOSIS 1 Clear Memory 2 Printer Selftest 3 Set Temperature 4 Lamp Amplitude ESC Clear Tests Records? YES NO “Clearing memory ….” [Clears all the stored tests] 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 MAIN MENU 1. Test Operations ESC 2. Technical Diagnosis 3. Utilities 4. Quality control 5. View Stored Results 6. Serial Communication TECHNICAL DIAGNOSIS 1 Clear Memory 2 Printer Self Test 3 Set Temperature 4 Lamp Amplitude ESC Set Channel Temp. ESC Temperature=36.86 Temperature Setting 1 Set Channel Temp. 2 Set Incubation Temp. ESC Ref UP. 785 DOWN. 6. Serial communications When the required temperature is selected, it displays the cuvette temperature. Set Incubation Temp. ESC 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 MAIN MENU 1. Test Operations ESC 2. Technical Diagnosis 3. Utilities 4. Quality control 5. View Stored Results 6. Serial communications TECHNICAL DIAGNOSIS 1 Clear Memory 2 Printer Selftest 3 Set Temperature 4 Lamp Amplitude ESC 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: May 2012 Page 30 of 54 FOURCLOT … Coagulation Analyser USER MANUAL 8.2.4. Printer Self Test Routine test to check printer. When selected, FOURCLOT 22/7/10 CLINIC NAME MAIN MENU 1. Test Operations ESC 2. Technical Diagnosis 3. Utilities 4. Quality control 5. View Stored Results 6. Serial communication TECHNICAL DIAGNOSIS 1 Clear Memory 2 Printer Selftest 3 Set Temperature 4 Lamp Amplitude ESC If printer is ON, and paper is properly inserted, the analyzer prints the following two lines to check printing. TECHNICAL DIAGNOSIS 1 Clear Memory 8.3. UTILITIES SCREEN: UTILITIES 8.3.1. 8.3.2. 8.3.3. 8.3.4. 8.3.5. 8.3.6. Ver (Version No) 1 Date 2 Password 3 Printer On/ Off: ON 4 Enter Clinic Name 5 Lamp: OFF 6 Stirrer: OFF ESC 8.3.1. To ENTER/CHANGE Date and Time FOURCLOT 22/7/10 CLINIC NAME MAIN MENU 1. Test Operations ESC 2. Technical Diagnosis 3. Utilities 4. Quality control 5. View Stored Results 6. Serial communication 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 ESC 27 / 12 / 06 Time: Hrs : Min : Sec 13 : 46 : 40 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. Version No. : 1.005A Effective Date: May 2012 Page 31 of 54 FOURCLOT … Coagulation Analyser USER MANUAL 8.3.2. Password Utility: FOURCLOT CLINIC NAME 22/7/10 ESC PASSWORD UTILITY J K ESC 1. Enable / Disable E F G H L M N O P U V W X ENTR CLR Q R S T 1. Date 2. Password 3. Printer On/ Off: ON 4. Enter Clinic Name 5. Lamp: OFF 6. Stirrer: OFF PASSWORD UTILITY ADMIN 0000000 I Ver (Version No) ESC MAIN MENU 1. Test Operations 2. Technical Diagnosis 3. Utilities 4. Quality control 5. View Stored Results 6. Serial communication A B C D UTILITIES Y Z , - + - 1 2 3 4 5 6 7 8 9 0 2. Set Password 3. LOGIN 4. LOGOUT To enable password, Enter “PASSWORD” PASSWORD UTILITY Touch ENTR on completion USER 0000000 (A message” password enabled “will be displayed at the bottom of the screen) A B C D I J K E F G H L M N O P V W X ENTR CLR Q R S T U Y Z , - + - 1 2 3 4 5 6 7 8 9 0 To create user, enter required user name For example “DAVID” Touch ENTR on completion PASSWORD UTILITY 1. Enable / Disable 2. Set Password 3. LOGIN 4. LOGOUT ESC PASSWORD UTILITY USER 0000000 A B C D I J K E F G H L M N O P V W X ENTR CLR Q R S T U Y Z , - + - 1 2 3 4 5 6 7 8 9 0 To Login/ enable user, enter the name. In this example its “DAVID” Version No. : 1.005A Effective Date: May 2012 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 CLINIC NAME MAIN MENU 1. Test Operations ESC 2. Technical Diagnosis 3. Utilities 4. Quality control 5. View Stored Results 6. Serial communication UTILITIES Ver (Version No) ESC 1. Date 2. Password 3. Printer On/Off: OFF 4. Enter Clinic Name 5. Lamp: OFF 6. Stirrer: OFF UTILITIES Ver (Version No) ESC 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” Step 2: Touch “Enter Clinic Name” 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 UTILITIES Ver (Version No) ESC ESC 1. Date 2. Password 3. Printer On/Off: ON 4. Enter Clinic Name 5. Lamp: OFF 6. Stirrer: OFF UTILITIES (Version No) CLINICUU UUU UUU A B C D E F G H I J K L M N O P Q R S T U V W X Y Z , - + - 1 2 3 4 5 6 7 8 9 0 ENTR CLR Enter Clinic Name (Max. Up to 19 characters) Touch “ENTR”, upon completion. Touch “CLR”, to clear a wrong entry. Version No. : 1.005A Effective Date: May 2012 Page 33 of 54 FOURCLOT … Coagulation Analyser USER MANUAL 8.3.5. Lamp: ON 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 22/7/10 CLINIC NAME MAIN MENU 1. Test Operations ESC 2. Technical Diagnosis 3. Utilities 4. Quality control 5. View Stored Results 6. Serial communication 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. 8.3.6. Stirrer: ON It is a toggle to switch the lamp ON and OFF. (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 22/7/10 CLINIC NAME MAIN MENU 1. Test Operations ESC 2. Technical Diagnosis 3. Utilities 4. Quality control 5. View Stored Results 6. Serial communication 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 Stirrer is enabled. To disable the Stirrer touch the Stirrer option once again. Version No. : 1.005A Effective Date: May 2012 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 less the precision of the method. For example: 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 Select test 1 PT 6 PT_N1 2 APTT 7 FIB_2 3 TT_1 8 APTT_2 4 FIB 9 TT_2 5 FA 10 PT_N2 QC NORMAL ESC ESC MENU SEL PRNT NXT PREV DEL YES NO Version No. : 1.005A Effective Date: May 2012 Select test 1 PT 2 APTT 3 TT_1 4 FIB 5 FA 6 PT_N1 7 FIB_2 8 APTT_2 9 TT_2 10 PT_N2 ESC ESC MENU SEL PRNT NXT PREV DEL 1 PT (Touch “NO” for QC Abnormal) (Touch “YES” for QC Normal) QC Normal Test Name: PT H: 5.000 L: 2.000 No. Date Result 1. 20/02/06 1555.2 2. 20/02/06 1678 3. 20/02/06 1457.3 4. 20/02/06 1567 5. 20/02/06 154 QC 1. Levy Jennings. 2. Standard Deviation. QC ABNORMAL Test Name: PT H: 4.000 L: 1.000 No. Date Result 1. 20/02/06 1555.2 2. 20/02/06 1678.6 3. 20/02/06 1457.3 4. 20/02/06 1567.4 5. 20/02/06 1545.2 ESC NXT PREV PLOT PRNT Page 35 of 54 ESC NXT PREV PLOT PRNT 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 PT P 2.454 TT T 66.59 FIB F 272.6 Units sec sec ESC NEXT PREV DEL ID 101 27 PAT ID A B C I J K Q R S Y Z , 3 4 5 D L T 6 E M U + 7 F N V 8 G O W 1 9 H P X 2 0 ENTR CLR PRINT PID Enter Patient’s identification number. Test Name: H: No. Date 1. 20/02/06 2. 20/02/06 3. 20/02/06 4. 20/02/06 5. 20/02/06 6. 20/02/06 CREATNINE L: Result 1555.2 1678 1457.3 1567 1545.2 1595.2 Enter Patient’s Name: ESC NEXT PREV PLOT PRINT PAT ID A B C I J K Q R S Y Z , 3 4 5 D L T 6 E M U + 7 F N V 8 G O W 1 9 H P X 2 0 ENTR CLR “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 (2ND Column): A-Absorbance, F-Fixed time, K-Kinetic, E- Endpoint, D-Differential, R-Ratio Version No. : 1.005A Effective Date: May 2012 Page 36 of 54 FOURCLOT … Coagulation Analyser USER MANUAL 8.6. Serial communication: 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 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 : 9600 : 8 : None : 1 : None FOURCLOT 22/7/10 CLINIC NAME MAIN MENU 1. Test Operations ESC 2. Technical Diagnosis 3. Utilities 4. Quality control 5. View Stored Results 6. Serial communication Version No. : 1.005A Effective Date: May 2012 SERIAL COMM. ESC 1. Result Page 37 of 54 Send Results YES NO 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 (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: Pri. : 405 Mod: ABS Sec: 0 ESC ADD SAVE 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 Name: Pri. : 405 Mod: ABS Sec: 0 Filter 1 : Filter 2 : Name: ESC ADD SAVE A I Q Y 3 B C J K R S Z , 4 5 ESC Select Filter Val : 0 630 405 Version No. : 1.005A Effective Date: May 2012 Page 38 of 54 Mode: FIB D E F L M N T U V - + _ 6 7 8 G O W 1 9 H P X 2 0 ENTR CLR FOURCLOT … Coagulation Analyser USER MANUAL Ø Recalling /Running (Operating ) a pre-programmed test For example: Name: Test Name, Mod: ABS Pri. : 405 , Sec.:0 ESC PRNT EDIT RUN QCR No_Unt To change values press EDIT Test Name: ABS ESC PID RUN RUN QC Set temperature: 37.00 Channel temperature: 30.43 Test Name: ABS ESC PID RUN RunQC Close the Lid & Press Run ESC to abort temperature Test Name: ABS Test Name: ABS ESC PID RUN RunQC ESC PID RUN RunQC . Referencing......... Lag Time: 5 Read Sample Test Name: ABS Sr. No. : 1 Result: 0.705 ESC PID RUN RunQC 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 interval 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 Blk: N, Normal: N Std: N, Factor: 0.000 Limit Set: ESC PRNT EDIT RUN QCR 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 memory. Name: Mod: FIX Pri. : 405 , Sec.: 0 KF: 1.000 Unit: No – Unt QC: N Lag: 0 , Read: 0 Blk: N, Normal: N Std: N, Factor: 0.000 Limit Set: Filter 1 : Filter 2 : Select Filter Val : 0 630 405 Version No. : 1.005A Effective Date: May 2012 Name: ESC PRNT EDIT RUN QCR ESC A I Q Y 3 B C J K R S Z , 4 5 Mode: FIX D E L M T U - + 6 7 F N V _ 8 G O W 1 9 Name: Mode: FIX Pri: 630 ,Sec: 0 KF: 1.000 Unit: No_Unit QC: N Lag: 0 ,Read: 0 Numeric Value: 1 2 3 4 5 6 7 8 9 0 . Page 40 of 54 H P X 2 0 ENTR CLR ENTR CLR FOURCLOT … Coagulation Analyser 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: ESC ADD SAVE Set Times_ Lag Time: 0 Read Time: 0 Numeric Value: 1 2 3 4 5 6 7 8 9 0 . ESC CLR USER MANUAL UNITS_ _ No_Unt U/ L mU/ ml MIL U/ml mEq/ L mmo/ L Umo/ L nmo/ L % g/ l mg/ dl Ug/ dl g/ dl Ug/ ml Name: Mod: FIX Pri. : 405 , Sec.: 0 KF: 1.000 Unit: No – Unt QC: N Lag: 0 , Read: 0 Blk : N, Normal: N Std: N, Factor: 0.000 Blank: YES NO Touch “YES”, if you want to select Blank. Name: Mod: FIX Pri. : 405 , Sec.: 0 KF: 1.000 Unit: No – Unt QC: N Lag: 0 , Read: 0 Blk: N, Normal: N Std: N, Factor: 0.000 Standard YES NO Name: Mod: FIX Pri. : 405 , Sec.: 0 KF: 1.000 Unit: No – Unt QC: N Lag: 0 , Read: 0 Blk: N, Normal: N Std: Y, 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: Con6: Con7: Del1: Del2: Del3: Del4: Del5: Del6: Del7: Numeric Value: 1 2 3 4 5 6 7 8 9 0 . ENTR CLR (Touch “NO” if you want to select “Factor”) Name: Mod: FIX Pri. : 405 , Sec.: 0 KF: 1.000 Unit: No – Unt QC: N Lag: 0 , Read: 0 Blk: N, Normal: N Std: N, Factor: 0.000 Limit Set: Here you have to enter the number of standards, after which you can enter it’s concentration. Name: Mod: FIX Pri. : 405 , Sec. : 0 KF: 1.000 Unit: No – Unt QC: N Lag: 0 , Read: 0 Numeric Value: 1 2 3 4 5 6 ENTR 7 8 9 0 . CLR Version No. : 1.005A Effective Date: May 2012 Page 41 of 54 FOURCLOT … Coagulation Analyser 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: USER MANUAL Init. OD: 0.000 Max Delta: 0.000 Rgnt. Linearity: 0.000 ESC ADD SAVE Init. OD: 0.000 Max Delta: 0.000 Rgnt. Linearity: 0.000 ESC Init. OD: 1.000 Max Delta: 0.000 Rgnt. Linearity: 0.000 Numeric Value: 1 2 3 4 5 6 7 8 9 0 . Numeric Value: 1 2 3 4 5 6 7 8 9 0 . ENTR CLR ENTR CLR Min Init. OD= 0, Max Init. OD= 4 Init. OD: 1.000 Max Delta: 1.500 Rgnt. Linearity: 0.000 Numeric Value: 1 2 3 4 5 6 7 8 9 0 . ENTR CLR 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 USER MANUAL Ø 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 ESC PRNT EDIT RUN QCR ESC PID RUN RUN QC Test Name: FIX ESC PID RUN RUNQC Set temperature: 37.00 Channel temperature: 30.43 Close the Lid & Press Run ESC to abort temperature Test Name: FIX Test Name: FIX ESC PID RUN RunQC Referencing......... Lag Time: 5 ESC PID RUN RunQC Read Sample Insert sample Cuvette & select Run Test Name: FIX Factor: 1.000 Sr. No. : 1 Init. OD: 0.710 0.710 Delta: 0.001 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 ESC PID RUN RunQC 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: Pri: 630 KF: 1.000 Unit: mg/ dl Lag: 0 Blk: N Std: N Limit Set: Mode: KIN ,Sec: 0 QC: N ,Read: 0 Normal: N Factor: 1.000 ESC ADD SAVE KINETIC Mode screen before programming would look like the above screen Name: Pri: 630 KF: 1.000 Unit: mg/ dl Lag: 0 Blk: N Std: N Limit Set: Mode: KIN ,Sec: 0 QC: N ,Read: 0 Normal: N Factor: 1.000 Filter 1 : Filter 2 : Name: ESC ADD SAVE ESC Select Filter Val : 0 630 405 A I Q Y 3 B C J K R S Z , 4 5 Mode: KIN D E F L M N T U V - + _ 6 7 8 G H O P W X 1 2 9 0 Name: Mode: FIX Pri: 630 ,Sec: 0 KF: 1.000 Unit: No_Unit QC: N Lag: 0 ,Read: 0 Numeric Value: 1 2 3 4 5 6 7 8 9 0 . ENTR CLR ENTR CLR Select the Primary & Secondary filters. Name: Pri: 630 KF: 1.000 Unit: mg/ dl Lag: 0 Blk: N Std: N Limit Set: Mode: KIN ,Sec: 0 QC: N ,Read: 0 Normal: N Factor: 1.000 ESC ADD SAVE Set Times_ Lag Time: 0 Read Time: 0 Numeric Value: 1 2 3 4 5 6 7 8 9 0 . ESC CLR UNITS_ _ No_Unt U/ L mU/ ml MIL U/ml mEq/ L mmo/ L Umo/ L nmo/ L % g/ l mg/ dl Ug/ dl g/ dl Ug/ ml Name: Mod: KIN Pri. : 405 , Sec.: 0 KF: 1.000 Unit: No – Unt QC: N Lag: 0 , Read: 0 Blk : N, Normal: N Std: N, Factor: 0.000 Blank: YES NO 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 Blk: N, Normal: N Std: N, Factor: 0.000 Standard YES NO USER MANUAL Name: Mod: KIN Pri. : 405 , Sec.: 0 KF: 1.000 Unit: No – Unt QC: N Lag: 0 , Read: 0 Blk: N, Normal: N Std: Y, 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: Con6: Con7: D/ M1: D/ M2: D/ M3: D/ M4: D/ M5: D/ M6: D/ M7: Numeric Value: 1 2 3 4 5 6 7 8 9 0 . (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 Blk : N, Normal: N Std: Y, Factor: 0.000 Limit Set: ENTR CLR Here you have to enter the number of standards, after which you can enter it’s concentration. Name: Mod: KIN Pri. : 405 , Sec.: 0 KF: 1.000 Unit: No – Unt QC: N Lag: 0 , Read: 0 Numeric Value: 1 2 3 4 5 6 ENTR 7 8 9 0 . CLR Name: Pri: 630 KF: 1.000 Unit: mg/ dl Lag: 0 Blk: N Std: N Limit Set: Mode: KIN ,Sec: 0 QC: N ,Read: 0 Normal: N Factor: 1.000 ESC ADD SAVE Name: Pri: 630 KF: 1.000 Unit: mg/ dl Lag: 0 Blk: N Std: N Normal Mode: KIN ,Sec: 0 ESC ADD SAVE QC: N ,Read: 0 Normal: N Factor: 1.000 YES NO Enter Normal Values_ Low: 0.000 High: 0.000 Numeric Value: 1 2 3 4 5 6 7 8 9 0 . Version No. : 1.005A Effective Date: May 2012 Page 45 of 54 ENTR CLR FOURCLOT … Coagulation Analyser Name: Mode: KIN 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: USER MANUAL Init. OD: 0.000 Max Delta: 0.000 Rgnt. Linearity: 0.000 ESC ADD SAVE Init. OD: 0.000 Max Delta: 0.000 Rgnt. Linearity: 0.000 ESC Init. OD: 1.000 Max Delta: 0.000 Rgnt. Linearity: 0.000 Numeric Value: 1 2 3 4 5 6 7 8 9 0 . Numeric Value: 1 2 3 4 5 6 7 8 9 0 . ENTR CLR ENTR CLR Init. OD: 1.000 Max Delta: 1.500 Rgnt. Linearity: 0.000 Numeric Value: 1 2 3 4 5 6 7 8 9 0 . ENTR CLR 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 Ø Recalling /Running (Operating ) a pre-programmed test For example: 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 Limit Set: To change values press EDIT Test Name: KIN ESC PRNT EDIT RUN QCR ESC PID RUN RUN QC Set temperature: 37.00 Channel temperature: 30.43 ESC to abort temperature Test Name: KIN Test Name: KIN ESC PID RUN RunQC ESC PID RUN RUNQC Referencing......... Lag Time: 5 Close the Lid & Press Run Test Name: KIN Factor: 1.000 Read Sample Version No. : 1.005A Effective Date: May 2012 Page 47 of 54 ESC PID RUN RunQC FOURCLOT … Coagulation Analyser USER MANUAL 9.4. END POINT 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 Name: Mode: END 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 Limit Set: ESC ADD SAVE END POINT Mode screen before programming would look like the above screen Name: Mode: END 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 Limit Set: Filter 1 : Filter 2 : Name: ESC ADD SAVE ESC Select Filter Val : 0 630 405 A I Q Y 3 B C J K R S Z , 4 5 Mode: END D E F L M N T U V - + _ 6 7 8 G O W 1 9 H P X 2 0 ENTR CLR Name: Mode: END Pri: 630 ,Sec: 0 KF: 1.000 Unit: No_Unit QC: N Lag: 0 ,Read: 0 Numeric Value: 1 2 3 4 5 6 ENTR 7 8 9 0 . CLR Select the Primary & Secondary filters. Name: Pri: 630 KF: 1.000 Unit: mg/ dl Lag: 0 Blk: N Std: N Limit Set: Mode: END ,Sec: 0 QC: N ,Read: 0 Normal: N Factor: 1.000 Name: Mod: END Pri. : 405 , Sec.: 0 KF: 1.000 Unit: No – Unt QC: N Lag: 0 , Read: 0 Blk : N, Normal: N Std: N, Factor: 0.000 Blank: ESC ADD SAVE UNITS_ _ No_Unt U/ L mU/ ml MIL U/ml mEq/ L mmo/ L Umo/ L nmo/ L % g/ l mg/ dl Ug/ dl g/ dl Ug/ ml Set Times_ Lag Time: 0 Read Time: 0 YES NO Numeric Value: 1 2 3 4 5 6 7 8 9 0 . Touch “YES”, if you want to select Blank. Version No. : 1.005A Effective Date: May 2012 Page 48 of 54 ESC CLR FOURCLOT … Coagulation Analyser Name: Pri: 630 KF: 1.000 Unit: mg/ dl Lag: 0 Blk: N Std: N Limit Set: Mode: END ,Sec: 0 QC: N ,Read: 0 Normal: N Factor: 1.000 Name: Mod: END Pri. : 405 , Sec.: 0 KF: 1.000 Unit: No – Unt QC: N Lag: 0 , Read: 0 Blk: N, Normal: N Std: N, Factor: 0.000 Standard USER MANUAL QCNormal Values_ QCNH: 0.000 QCNL: 0.000 QCAbnormal Values_ QCABH: 0.000 ESC ADD SAVE Numeric Value: 1 2 3 4 5 6 7 8 9 0 . ENTR CLR Name: Mod: END Pri. : 405 , Sec.: 0 KF: 1.000 Unit: No – Unt QC: N Lag: 0 , Read: 0 Blk: N, Normal: N Std: Y, Factor: 0.000 Limit Set: YES NO Touch “NO” if you want to select “Factor” Name: Mod: END Pri. : 405 , Sec.: 0 KF: 1.000 Unit: No – Unt QC: N Lag: 0 , Read: 0 Blk: N, Normal: N Std: Y, Concen: Name: Mod: END Pri. : 340 , Sec.: 0 KF: 1.000 Unit: No – Unt QC: N Lag: 0 , Read: 0 Numeric Value: 1 2 3 4 5 6 ENTR 7 8 9 0 . CLR 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: Con6: Con7: Numeric Value: 1 2 3 4 5 6 7 8 9 0 . Ab1: Ab2: Ab3: Ab4: Ab5: Ab6: Ab7: ENTR CLR 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: Pri: 630 KF: 1.000 Unit: mg/ dl Lag: 0 Blk: N Std: N Limit Set: Mode: END ,Sec: 0 ESC ADD SAVE QC: N ,Read: 0 Normal: N Factor: 1.000 Name: Mode: END 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: Init. OD: 0.000 Max Delta: 0.000 Rgnt. Linearity: 0.000 USER MANUAL Name: Pri: 630 KF: 1.000 Unit: mg/ dl Lag: 0 Blk: N Std: N Normal Mode: END ,Sec: 0 QC: N ,Read: 0 Normal: N Factor: 1.000 Enter Normal Values_ ESC ADD SAVE Low: 0.000 High: 0.000 Numeric Value: 1 2 3 4 5 6 7 8 9 0 . ESC ENTR CLR Init. OD: 1.000 Max Delta: 0.000 Rgnt. Linearity: 0.000 Numeric Value: 1 2 3 4 5 6 7 8 9 0 . ENTR CLR 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: 1 2 3 4 5 6 7 8 9 0 . YES NO ENTR CLR Numeric Value: 1 2 3 4 5 6 7 8 9 0 . ENTR CLR 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 Ø Recalling /Running (Operating) a pre-programmed test . For example: Name: ABC Mode: END Pri: 630 ,Sec: 0 KF: 2.000 Unit: mg/ dl QC: Y Lag: 0 ,Read: 0 Blk: N Normal: Y Std: N Factor: 1.000 Limit Set: To change values press EDIT Test Name: END ESC PRINT EDIT RUN QCR Set temperature: 37.00 Channel temperature: 30.43 ESC to abort temperature Test Name: END Test Name: END ESC PID RUN RunQC Referencing......... Lag Time: 5 Close the Lid & Press Run Test Name: END Factor: 1.000 ESC PID RUN RunQC Read Sample Version No. : 1.005A Effective Date: May 2012 ESC PID RUN RUN QC Page 51 of 54 ESC PID RUN RUNQC FOURCLOT … Coagulation Analyser USER MANUAL 10. Trouble Shooting: MESSAGES CAUSE /CORRECTIVE ACTION Remove Cuvette This error will come in coagulation mode while referencing. Remove the cuvette. Invalid Assay In Multi standard mode if standard are not proper then this error will appear. Check the calibrators and rerun the test. Memory Full If Number of saved tests exceeds the memory 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 outlines the method of decontaminating the instrument before packaging and shipment. 11.2. Purpose of Decontamination Decontamination minimizes the risk to 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 gloves 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 If YES, please specify *YES/NO b) Other Biohazard if YES, Please specify *YES/NO Version No. : 1.005A Effective Date: May 2012 Page 54 of 54