pts Diagnostics CardioCheck PA, User Manual

Page 1: ...User Guide For Professional Use PortableWhole BloodTest System Tes t Syste m ...

Page 2: ...on CardioChek PA System Intended Use 5 2 About the CardioChek PATest System 8 The CardioChek PATest System and Operating Principle 8 The MEMo Chip 10 PTS PanelsTest Strips 11 PTS Panels Lipid PanelTest Strips Limitations of the Procedure 12 PTS Panels GlucoseTest Strips Limitations of the Procedure 13 3 Setup 14 Battery Use and Replacement 14 How to Install Replace the Batteries 15 CardioChek PA A...

Page 3: ...onal healthcare settings This system should only be used with single use auto disabling lancing devices This system is for in vitro diagnostic use only Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders HDL lipoprotein measurements are used in the diagnosis and treatment of lipid dis...

Page 4: ...rocedures are followed Only auto disabling single use lancing devices should be used with this analyzer The CardioChek PA analyzer is fast portable and reliable This analyzer is a component of a test system that includes PTS Panels test strips The PTS Panels test strip box includes a MEMo Chipthat contains the assay calibration curve and other important information about the assay PTS Panels test ...

Page 5: ...he analyzer converts this color into a test result the darker the color the higher the analyte concentration The test result appears on the display screen A B D C E About the CardioChek PA Test System 2 Display Display shows test results messages time date and stored results Enter Button Press this button to turn on the analyzer or to accept the current menu choice Test Strip Slot The test strip s...

Page 6: ...he same lot number Lot X000 Cholesterol The MEMo Chip port is located at the top center of the analyzer The MEMo Chip is inserted into this port with the lot number facing down Push firmly but gently until the MEMo Chip is fully inserted Important Be careful not to bend the connector PTS PanelsTest Strips PTS Panels test strips are designed for specific analytes A test strip is inserted into the a...

Page 7: ...that test strip Only auto disabling single use lancing devices should be used with this analyzer PTS Panels GlucoseTest Strips Limitations of the Procedure 1 The analyzer should not be used to test critically ill patients 2 Blood samples from patients in shock patients with severe dehydration or patients in a hyperosmolar state with or without ketosis have not been tested It is not recommended to ...

Page 8: ... How to Install Replace the Batteries 1 Open the battery door on the back of the CardioChek PA analyzer by pressing and sliding it in the direction of the arrow toward the MEMo Chip port 2 Remove old batteries from the compartment and properly discard 3 Insert the new batteries into the battery compartment with the positive terminals correctly facing as marked on the inside compartment 4 Replace t...

Page 9: ... TRIG LIPIDS EXIT If the units are locked the UNITS screen does not appear Memory results will only be shown for chemistries that have been run CHECK STRIP RUN CONTROL CLEAR MEMORY EXIT UTILITY SETTINGS to select return to UTILITY return to CHECK STRIP to select PRINT SOUND SETTIME SET DATE UNITS EXIT return to SETTINGS return to PRINT ...

Page 10: ...nd hold down Enter for approximately 5 seconds during the analyzer power up stage until LANGUAGE is displayed 3 Press Enter Press Enter again to select English or press Next to scroll through the language choices 4 Press Enter to select the desired language that is displayed How to Set theTime 1 If the analyzer is off press either button to turn on the analyzer Wait for the display to read either ...

Page 11: ...ay UNITS the analyzer is locked in preset units The units cannot be changed if the system has been locked To confirm current configuration of the analyzer s units run a check strip in the RUN TEST mode and observe the units that are displayed If your analyzer s units have not been preset follow the steps listed below to change your units to mg dL mmol L or g L 1 If RUN TEST is displayed go to Step...

Page 12: ...on The software version will appear on the display How to Set Up the CardioChek PA for Printing For complete details refer to each printer s user guide Testing the Printer 1 If the analyzer is off press either button to turn on the analyzer Wait for the display to read INSTALL MEMO CHIP or INSERT STRIP Note If RUN TEST is displayed go to Step 3 2 Press Next The display will read RUN TEST 3 Press N...

Page 13: ...n the analyzer by pressing either button 2 When INSTALL MEMO CHIP or RUN TEST is displayed press Next until UTILITY is displayed Press Enter 3 Press Enter when CHECK STRIP is displayed 4 Hold the check strip at the base and insert the check strip ribbed side up into the test strip slot when INSERT STRIP is displayed 5 The analyzer should display PASSED If the display reads FAILED see the note at t...

Page 14: ...l and federal regulations Important Check the expiration date printed on the control bottles Do not use control solutions that have expired For performing a quality control test see the instructions below To perform a control test you need CardioChek PA analyzer PTS Panels test strips Quality control materials Quality control instructions Quality control range card Quality ControlTesting 5 How to ...

Page 15: ...low for convenient collection 3 Clean the site with an alcohol wipe 4 Apply gentle pressure to the finger with lancet and stick the finger left or right of center 5 Gently apply pressure squeeze and release to the finger to produce a large drop of blood Note Avoid milking the finger This may cause tissue fluid dilution or hemolysis and affect the accuracy of results 6 Use cotton or gauze to wipe a...

Page 16: ...peat this step until you return to RUN TEST Memory 7 Quick Reference How to Run aTest 1 Press either button to turn the analyzer on 2 Remove the MEMo Chip from the box of test strips 3 Insert the MEMo Chip in the port at the top of the analyzer with the lot code number facing down 4 When INSERT STRIP is displayed remove a test strip from the vial and immediately replace the cap 5 Insert the strip ...

Page 17: ...C and 20 80 Relative Humidity RH Do not freeze If storage temperature is below 68ºF 20ºC allow the device to warm to room temperature 68ºF 20ºC before using If the device has been stored under excessive conditions allow at least 30 minutes at room temperature for the device to equilibrate to these temperatures Do not scratch or damage the surface of the check strip Please read the test strip packa...

Page 18: ...zer Do not use bleach peroxide or window cleaners on this analyzer If you have any questions or need to know where to purchase the disinfectant wipes call PTS Diagnostics Customer Service at 1 877 870 5610 US or 1 317 870 5610 There are a large number of distributors of this disinfectant If you cannot obtain from the distributor who supplies your other supplies please contact us for assistance The...

Page 19: ...before use After disinfection user s gloves should be removed and hands should be thoroughly washed with soap and water before proceeding to the next patient The CardioChek PA analyzer has been validated for 11 001 cleaning and disinfection cycles Please obtain a new analyzer after cleaning and disinfecting the analyzer 11 001 times or once the lifetime of the analyzer 3 years has been reached whi...

Page 20: ...nmentandtestafter analyzerreachespropertemperature HIGHTEMP Analyzerisaboveacceptable operatingtemperature Movetoacceptableenvironmentandtestafter analyzerreachespropertemperature INSTALLMEMOCHIP MEMoChipisnotproperlyinserted orisdefective InsertsameornewMEMoChipproperly Troubleshooting 9 Message or Issue Probable Cause What to Do EXPIRED LOT Test strips are expired wrong MEMo Chip is inserted or ...

Page 21: ...will not be calculated on samples with triglycerides of 400 mg dL 4 52 mmol L or greater Interpreting Results 10 See Measuring Range section of each test strip package insert for the measuring range for that specific test strip CLIA Information 11 General CLIA Information US Only Please read before testing 1 CLIA waived Each laboratory or testing site using the PTS Panels test strips MUST have a C...

Page 22: ...trips Please read the instructions package insert included with the test strips for information specific to each chemistry Optional CardioChek PTS Connect Printer Power Supply For complete details refer to each printer s user guide Specifications 12 Help For assistance with the CardioChek PA test system please contact PTS Diagnostics Customer Service M F 6 a m 9 p m US EST or your local authorized...

Page 23: ...installed or operation not in accordance with the user guide damaged by accident or neglect or if any parts are improperly installed or replaced by the user Note Removing or loosening screws from the back of the analyzer voids all warranties There are no user serviceable parts inside the case Warranty 14 Explanation of Symbols 15 Symbols Consult instructions for use Temperature limitation Invitro ...

Page 24: ...tact Information 43 Date Setting 20 Help 43 Interpreting Results 40 Language Setting 18 MEMo Chip 10 Memory 31 Quick Reference How to Run aTest 30 Quality Control 26 Shut Down 18 Sound Setting 22 Specifications 42 Symbols 45 Testing Blood 28 Time Setting 19 TroubleshootingTable 38 Units Setting 21 Warranty 44 Index 16 ...

Page 25: ...ems Inc All other trademarks and product names are the property of their respective owners Copyright 2018 PolymerTechnology Systems Inc PS 002461 EN Rev 4 01 18 PolymerTechnology Systems Inc 7736 Zionsville Road Indianapolis IN 46268 USA Direct 1 317 870 5610 Toll free inside the US 1 877 870 5610 Fax 1 317 870 5608 Email customerservice ptsdiagnostics com Website ptsdiagnostics com MDSS GmbH Schi...