Diagon Coag2D User Manual Download Page 36 | Manualshive

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Diagon Coag2D User Manual Download Page 36

36

13. Quality Control

Figure 13.1 - QC Main Menu

Quality of measurements can only be ensured by systematic quality cont-

rol procedure. Results of the dedicated control material have to be mea-

sured and registered by the user. It is recommended to use QC material

delivered by Diagon or its distributors. The instrument software stores the

results of QC measurements, the measured data are able to be retrieved

and processed.

The QC menu is dedicated to measuring QC samples, and stores and

processes their results separately from patient results.

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Summary of Contents for Coag2D

Page 1: ...semi automated coagulometer User Manual Reference No 11000102EN Internal Reference No DIAB102AEN...

Page 2: ...ument applies to the latest software version listed and higher versions When a subsequent software version changes the information in this document a new electronic edition is released and supplied by...

Page 3: ...2 Specifications 17 6 Components of the Coag 2D 18 6 1 Structure of the Instrument 18 7 Installation of the Coag 2D 20 7 1 Installation Requirements 20 7 2 Connecting to the Electrical Network 20 7 3...

Page 4: ...es 37 13 2 Control Measurement 38 13 3 Processing Control Results 38 14 Maintenance of the Coag 2D 39 14 1 Cleaning the Measuring Unit 39 14 2 Cleaning the Screen 39 14 3 Cleaning the Housing 39 14 4...

Page 5: ...lotting time performing chromogenic and immunological assays on plasma specimens prepared from sodium citrate anticoagulated blood samples collected into standard sample tubes For the best Coag 2D exp...

Page 6: ...r spoken between the user and Diagon Ltd does not constitute as a confidential relationship Such information is considered non confidential which means Diagon Ltd may reproduce publish or use it witho...

Page 7: ...2 Package and Accessories Make sure all items listed are present in the package when unboxing Coag 2D analyzer 1 pc Power supply unit 1 pc Magnetic mixer 2 pcs set 1 set User Manual this document 1 p...

Page 8: ...able Symbols 3 2 Symbols on Accessories Serial Number Catalogue Number In Vitro Diagnostic Device CE Conformity Read the Manual Manufacturer information Requires specific disposal Single use only Non...

Page 9: ...9 3 3 Symbols on the Packaging Fragile Keep Dry Proper Storage Suitable Temperature Range Suitable Humidity Range...

Page 10: ...r the list of manufacturer approved consumables visit the official Diagon website www diagon com Compliance with this manual is also part of the conditions of intended use make sure to follow these in...

Page 11: ...in a room with good ventilation Make sure that there is no device that emits electromagnetic radiation or electronic interference in the proximity of the Coag 2D and avoid placing it near electronic w...

Page 12: ...ling blood samples as they are considered biohazardous The controls and the calibrator are considered potentially infectious Always take the necessary protective measures when using them The liquid an...

Page 13: ...sure the reagents do not come into contact with skin or soft tissue If the reagent comes into contact with your eyes rinse them with plenty of water and then seek medical aid Do not ingest reagents if...

Page 14: ...rinciple 5 1 1 Clotting Time Determination The blood plasma and the reagent are mixed in a plastic cuvette with the appropriate timing The cuvette is placed in the measurement position located in the...

Page 15: ...oftware of the instrument places a calibration curve on the input function points and based on the curve unknown concentration or percentage values can be determined based on the measured coagulation...

Page 16: ...function points and based on the curve unknown concentration values can be determined from the measured light intensity change The calibration curve points may be provided by the manufacturer of the r...

Page 17: ...aces a calibration curve on the input function points and based on the curve unknown relative concentration values can be determined from the measured light intensity change The points of the calibrat...

Page 18: ...block regulated to 37 C It has four pre heated cuvette positions two measure ment locations and two reagent positions for reagent vessels Reagent Positions There is a rotating magnetic field at the r...

Page 19: ...like other peripherals USB storage devices may be connected while the instrument is on however a 5 10 second waiting period is required before any action may be performed on them Slave USB connector f...

Page 20: ...y disconnected if necessary Do not place the instrument in direct sunlight 7 2 Connecting to the Electrical Network Connect the DC cable of the power unit to the socket on the rear of the device 7 3 T...

Page 21: ...nctional by tapping any button on screen The content displayed depends on the item selected To return to the main menu tap the Esc button Check whether the date and time displayed are correct In case...

Page 22: ...arameter turns orange To select a diffe rent parameter tap a different line To adjust the parameter values tap the pencil icon A virtual keyboard appears its button layout depends on the parameter sel...

Page 23: ...t stops the measure ment and the result will be marked with a T flag Lag Time During this time the software disregards any changes in the cuvette Reagent Nr Identifies the number of reagents Incubatio...

Page 24: ...etween the preparation of the reaction mixture and the endpoint of the reaction Reagent Nr Identifies the number of reagents Incubation Time Sets the time period between adding the sample and adding t...

Page 25: ...lable Options Language English Polish Ukrainian French Spanish Italian Date Time Date Time Settings Sound On Off Printer On Off Export Import settings In order to prevent data loss data can be exporte...

Page 26: ...rument see section 6 1 Note it is recommended to perform this action before upgrading the instrument software as all settings will be erased by resetting the instru ment 9 2 Error Messages The error f...

Page 27: ...when dispensing samples the tip has to be replaced between each sample to prevent carryover Only use reagents controls calibrators and consumables that are manufactured accordingly with measurement r...

Page 28: ...surement win dows are displayed FIgure 10 1 Measurement windows To start the measurement tap the upper part above the line of either measurement windows Figure 10 2 Entering sample ID A virtual keyboa...

Page 29: ...he required action from the user The system always displays the next required action in the status row After entering sample ID the first action is Add Cuvette Depending on the test setup of the actua...

Page 30: ...nnel s Zero green Add Sample 4 Sample added according to the pro tocol described in the appendix Incubation time oran ge Incubating 5 Incubation time is over sound signal Incubation time oran ge Add R...

Page 31: ...rcode contains three lines consisting of 16 alphanumeric characters The software can only correctly interpret the barcode system used by Diagon In case control material is entered and there is a range...

Page 32: ...code in this menu item the barcode can be entered either by typing it in manually or by using the barcode reader which is connected to the USB port The data can be set and validated by tapping the tic...

Page 33: ...percentage values the right column contains the OD min values These values of the calib ration curve can be recorded by measuring specific calibrators 11 4 Producing a Dilution Series The reagent man...

Page 34: ...ata of 1000 patients in the format shown in Figure 12 1 Tap the Result button to access this menu Figure 12 1 Results Menu The test results are displayed in chronological order To move back and forth...

Page 35: ...en The test selected will be highlighted with an orange background The original results calculated values measurement channel number the possible error codes and whether or not a particular test has b...

Page 36: ...rial have to be mea sured and registered by the user It is recommended to use QC material delivered by Diagon or its distributors The instrument software stores the results of QC measurements the meas...

Page 37: ...ch is located on the top of the screen Target values may be set for four different tests per control material QC data may be entered manually based on the QC data sheet provided or by reading them in...

Page 38: ...identical to a regular mea surement procedure except when entering the ID previously defined QC materials may be chosen The results are stored in the QC result databa se which is accessible from QC m...

Page 39: ...h cotton buds soaked in water mixed with a washing agent Leave the unit to dry in heated position for at least ten minutes after clea ning and before starting measurements 14 2 Cleaning the Screen Cle...

Page 40: ...f measurement Check with standard PT assay and nor mal sample Occurs with all assays Frozen software Switch off and restart Repeated freezing Temperature regulation failure Switch off Call service 14...

Page 41: ...oes not start in time because the incubation time is too long O Incubation was overheated If the thermostatic block is too warm E Expired lot The reagent used has expired R Barcode type error If the r...

Page 42: ...37 C Dia FIB at room temperature Dia TT at room temperature Sample pre paration Plasma control 1 10 dilution with Dia Imi dazol Sample dosing 50 l plas ma control 50 l plas ma control 50 l Dia PTT 10...

Page 43: ...Sample preparation Plasma control 1 20 dilution with Dia ATIII FIIa Diluent Sample dosing 20 l plasma control 115 l Dia Ddi Buffer 50 l prepared sample 50 l Dia ATIII FIIa Incubation 2 minutes 2 minu...

Page 44: ...or ASCII 124 1 Time HH MM 5 Separator ASCII 124 1 Measuring type TTTTT Note 1 5 Separator ASCII 124 1 Raw result 1 C ssss s Note 2 8 Separator ASCII 124 1 Raw result 2 C ssss s Note 2 8 Separator ASCI...

Page 45: ...number and secundum will be equal Raw result 1 Raw result Note 3 The result is gFEU ml in case of DDIMER in case of ATIII Note 4 The Error code is the 3 digit decimal format of the error byte The bit...

Page 46: ...46 e g Expired lot and the Curve error in same time 01001000 hex 48h the error code is 072...

Page 47: ...removing and reformatting the pendrive to a FAT32 file system Copy the update files back onto pendrive and attempt the update again 7 When firmware update is finished you need to press the Reboot butt...

Page 48: ...48 13 Answer Yes when the instrument prompts so 14 Switch the coagulometer off when the process is finished 15 The instrument software is now up to date and ready to use from the next restart...

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