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pts Diagnostics CardioChek Plus, User Manual

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pts Diagnostics CardioChek Plus User Manual Download Page 49

 

 

 
 

XVI. EXPLANATION OF SYMBOLS

 

 

 

Symbols

 

 
 

 

Consult Instructions for Use

 

 

 
 

                              

 

 

Temperature Limitation 

              

      

 

 

In vitro diagnostic medical device 

    

 

                   

 

Serial Number 

 

                              

 

Manufacturer 

 
 

 

                      

Catalog Number 

 

 

 

Authorized Representative in the European Community 

 
 

 

This product fulfills the requirements of the European Directive

 

98/79 EC for in vitro diagnostic medical devices.

 

 

 
 
 

Product requires separate collection for electrical and electronic 
equipment per the WEEE Directive

 

 
 

                            

 

Federal Communications Commission

 

 
 
 

 
 
 
 
 
 
 

49

 

Summary of Contents for CardioChek Plus

Page 1: ...Professional Test System Portable Whole Blood Test System User Guide For Pro ess Us...

Page 2: ...ow to Set the Units 18 How to Set the Sound 19 How to Set the Wi Fi On or Off 20 How to Set Up the CardioChek Plus Professional Analyzer for Printing 21 Testing the Printer 22 How to Print Results Fro...

Page 3: ...II Wi Fi 37 Wireless Statement 37 Wireless Compatibility 37 Data Management 37 IX CARE AND CLEANING 38 Storage and Handling 38 Cleaning and Disinfection 38 X TROUBLESHOOTING 42 XI INTERPRETING RESULTS...

Page 4: ...uction other diseases involving lipid metabolism or various endocrine disorders Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mel...

Page 5: ...10 Direct 1 877 870 5610 Toll free inside the US 1 317 870 5608 Fax Email inforequest ptsdiagnostics com Website http www ptsdiagnostics com Important Safety Instructions Users should adhere to Standa...

Page 6: ...electrochemical biosensor technology to measure an enzymatic chemical reaction When a blood sample is applied to a reflectance test strip a chemical reaction occurs that produces a color change on th...

Page 7: ...The reflectance test strip is inserted here with the smooth side facing down MEMo Chip Port D The MEMo Chip port is located at the top of the analyzer USB Port E A port that allows communication with...

Page 8: ...for the test strip lot you are using The MEMo Chip Reads the test strip expiration date Tells the analyzer which test s to run Contains the calibration curve and the lot number for the specific test s...

Page 9: ...or the tip of the test strip for electrochemical tests As previously described the ensuing chemical reaction produces a color change or an electrical current which the analyzer measures and compares t...

Page 10: ...ic for glucose Other sugars or reducing substances such as ascorbic acid at normal blood concentrations have no significant effect on test results Acetaminophen Tylenol and dopamine may interfere caus...

Page 11: ...RE Studies were performed to test for substances that may interfere with these tests The results are below 1 PRESERVATIVES EDTA and heparin in venous blood collection tubes had no effect on the result...

Page 12: ...message is displayed replace the batteries with 4 new AA alkaline batteries of the same brand Do not use NiCad or rechargeable batteries Caution Improper installation of batteries can result in decre...

Page 13: ...Detailed information on the use of each menu follows Use the following buttons to navigate the menus Enter Button Press this button to turn on the analyzer or to accept the current menu choice Next Bu...

Page 14: ...III SETUP continued CardioChek Plus Analyzer Menus Note If the units are locked the UNITS screen does not appear 14...

Page 15: ...ed on you will be required to set the language date and time The language menu consists of the following choices English ENGLISH Spanish ESPA OL Italian ITALIANO German DEUTSCH French FRAN AIS Portugu...

Page 16: ...ERT STRIP if a current MEMo Chip is installed Note If RUN TEST is displayed go to Step 3 2 Press Enter The display will read RUN TEST 3 Press Next until SETTINGS is displayed 4 Press Enter then press...

Page 17: ...highlight the minutes Press Enter to accept the displayed minutes or press Next to advance the minutes Press Enter to select 11 The display will then highlight AM or PM Press Enter to accept the AM PM...

Page 18: ...ait for the display to read INSTALL MEMO CHIP or INSERT STRIP Note If RUN TEST is displayed go to Step 3 2 Press Enter The display will read RUN TEST 3 Press Next until SETTINGS is displayed 4 Press E...

Page 19: ...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 Next until SETTINGS is displayed 4 Press Enter then Next until SOUND is displa...

Page 20: ...Fi is displayed 5 Press Enter The display will highlight Wi Fi on 6 Press Enter to select Wi Fi on or press Next to highlight 7 Press Enter to accept the Wi Fi choice highlighted 8 Press Next until E...

Page 21: ...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 Next until SETTINGS is displayed 4 Press E...

Page 22: ...Print Results from Memory Note Up to 50 test results per chemistry and 10 control test results can be stored 1 If the analyzer is off press either button to turn on the analyzer Wait for the display t...

Page 23: ...play will read RUN TEST 3 Press Next until INFORMATION is displayed 4 Press Enter then TECHNICAL SUPPORT is displayed 5 Press Enter to display contact information 6 Press Enter then Next for ABOUT Car...

Page 24: ...verification be performed Daily If the analyzer has been dropped When a result is not consistent with expected results How to Use the Analyzer Check Strip 1 Turn on the analyzer by pressing either bu...

Page 25: ...hek Plus professional analyzer test strip slot where the check strip is inserted into the analyzer See Section IX Care and Cleaning 2 Inspect the check strip to make sure it is not dirty or damaged Us...

Page 26: ...stics com for control specifications Healthcare professionals should follow their facility s guidelines and policies regarding quality assurance and the use of quality control materials Quality contro...

Page 27: ...Results Are Not in Range IMPORTANT Patient tests should not be performed until control results are within range 1 Ensure test strip slot area is clean 2 Make sure neither the test strips nor the contr...

Page 28: ...l Results Are Not in Range IMPORTANT Patient tests should not be performed until control results are within range 1 Ensure test strip port area is clean 2 Make sure neither the test strips nor the con...

Page 29: ...or capillary blood collector Gauze or cotton balls Alcohol wipe optional This analyzer requires whole blood for testing Do not operate the analyzer in direct light Reference the Section IX Care and Cl...

Page 30: ...y the first drop of blood with gauze and use the second blood drop for testing The blood drop should be hanging down from the finger to make it easier to collect the sample with a pipet or capillary b...

Page 31: ...idelines Biosafety in Microbiological and Biomedical Laboratories BMBL found at http www cdc gov biosafety publications bmbl5 Protection of Laboratory Workers From Occupationally Acquired Infections A...

Page 32: ...test strip and discard 9 The analyzer automatically shuts down after three minutes of idle time with no test strip inserted How to Run an Electrochemical Test 1 Insert the MEMo Chip that matches the l...

Page 33: ...ance test strip into the designated test strip slot 7 The reflectance icon and electrochemical icon will display together 8 For the electrochemical test 1 Obtain a drop of blood using a lancet per the...

Page 34: ...5 7 times to mix completely Immediately collect sample with glass capillary tube and dispense correct volume as specified in test strip instructions for use package insert onto test strip 3 Excessive...

Page 35: ...until MEMORY is displayed 3 Press Enter CHEM is displayed 4 Press Enter then Next to select the desired chemistry Note Until the chemistry has been run at least once the test name is not displayed 5 P...

Page 36: ...the display to read either INSTALL MEMO CHIP or INSERT STRIP 2 Press Enter then press Next until UTILITY is displayed Press Enter 3 Press Next until CLEAR MEMORY is displayed Press Enter to clear mem...

Page 37: ...the equipment into an outlet on a circuit different from that to which the receiver is connected Consult the dealer or an experienced radio TV technician for help Wireless Compatibility See Section II...

Page 38: ...check strip Please read the test strip package insert for storage and handling information that applies to each test strip Cleaning and Disinfection Cleaning and disinfection of devices that come in...

Page 39: ...e or window cleaners on this analyzer If you have any questions or need to know where to purchase the disinfectant wipes call PTS Customer Service at 1 877 870 5610 US or 1 317 870 5610 There are a la...

Page 40: ...is clean when held at different angles If it is not repeat Step 4 Following cleaning and disinfection inspect the analyzer for the following signs of deterioration These include Scratching on optical...

Page 41: ...ime of the analyzer 5 years has been reached whichever comes rst References 1 FDA Public Health Notification Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne P...

Page 42: ...ide away from windows and away from direct lamp light MEMO CHIP ERROR MEMo Chip is defective Use another MEMo Chip from the same lot TEST ERROR Insufficient sample has been added to test strip Test ag...

Page 43: ...Test again with a new test strip PRINT ERROR Print function has been interrupted Print result in MEMORY or test again Results will not print Communication Cable was improperly connected Printer cover...

Page 44: ...alue Result is above the measuring range of the test Repeat the test Run controls and confirm that controls are in range Display reads _ _ _ _ or N A Result is not available due to a missing value fro...

Page 45: ...form CMS 116 2 Before you start testing carefully read all instructions including quality control Failure to follow instructions including quality control instructions will result in high complexity r...

Page 46: ...C Humidity Range Between 20 and 80 RH Dimensions Width 3 2 in 8 13 cm Length 6 0 in 15 24 cm Height 1 5 in 3 8 cm Weight without batteries 5 5 oz 156 g PTS Panels Test Strips Please read the instructi...

Page 47: ...Service M F 8 a m 5 p m US EST or your local authorized CardioChek dealer Polymer Technology Systems Inc 7736 Zionsville Road Indianapolis IN 46268 USA 1 317 870 5610 Direct 1 877 870 5610 Toll free...

Page 48: ...n of the warranty registration card to PTS Inc If the analyzer becomes inoperative during this time PTS Inc will replace the analyzer with equivalent analyzer at its option at no cost to the purchaser...

Page 49: ...er Manufacturer Catalog Number Authorized Representative in the European Community This product fulfills the requirements of the European Directive 98 79 EC for in vitro diagnostic medical devices Pro...

Page 50: ...eaning 38 CLIA Information 45 Contact Information 47 Date Setting 16 Help 47 Interpreting Results 44 Language Setting 15 Memory 35 Quality Control 26 Shut Down 15 Sound Setting 19 Specifications 46 Sy...

Page 51: ...an Patent No 267323 South African Patent Nos 2004 4929 and 2006 06561 EP Patent No 0750739 DE FR GB IT Other patents pending Polymer Technology Systems Inc 7736 Zionsville Road Indianapolis IN 46268 U...

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