CardioChek User Guide - Stat
Contents
1. How to Clear Results Stored in Memory T Press either button to turn the device ON Wait for the display to read either INSTALL MEMO CHIP or INSERT STRIP Press Enter then press Next until UTILITY is displayed Press Enter Press Next until CLEAR MEMORY is displayed Press Enter Press Next until the display reads CLR YES Press Enter The display will read ERASE CLEARED and then CLEAR MEMORY To exit press Next until the display reads EXIT then press Enter Press Next until you return to RUN TEST 27 Vill CARE AND CLEANING ccn and Handling Handle the CardioChek PA device with care do not drop Do not store or operate the device in direct light such as sunlight spotlight under a lamp or by a window Do not expose the device or any of the supplies or accessories to high humidity extreme heat cold dust or dirt The device may be stored at a temperature of 68 80 F 20 27 C and 20 80 Relative Humidity RH Do not freeze If storage temperature is below 68 F 20 C allow the device to warm up to room temperature 68 F 20 C 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 Blood testing should be conducted in controlled room temperature conditions Optimal Operating Conditions 20 27 C 68 80 F Do not scratch or damage the surface of the check strip Pleas2. L or g L is desired press Next until the desired unit appears on the display screen 7 PressEnter to select the desired units The display will then read UNITS 8 Press Next until EXIT is displayed 9 Press Enter to return to USER SET 10 Press Next to return to RUN TEST UI m pa MM 15 Ill SETUP continued How to Set the Sound The CardioChek PA device sound has been preset to BEEP ON To turn the sound on or off please follow the steps listed below 1 IfRUNTEST is displayed go to Step 3 If the device is OFF press either button to turn the device ON Wait for the display to read INSTALL MEMO CHIP or INSERT STRIP Press Next The display will read RUN TEST Press Next until USER SET is displayed Press Enter then Next until SOUND is displayed Press Enter The display will read BEEP ON or BEEP OFF Press Next to select either BEEP OFF or BEEP ON Press Enter to accept the sound choice displayed Press Next until EXIT is displayed 9 Press Enter to return display to USER SET 10 Press Next to return to RUN TEST Introduction to the CardioChek PA and Printer System The CardioChek PA device with software version 2 20 and higher supports printing in two formats label or paper on the CardioChek PA Thermal Printer or Portable Printer To verify CardioChek PA test system software turn the device ON by pressing either button The software version will appear on the display How to Set Up th
3. concentration range has been established Controls are tested to check the performance of your test system CardioChek PA device MEMo Chip and test strips Use Quality Control materials provided by PTS Inc or commercially available Quality Control materials Currently PTS Inc has available PTS Panels Multi Chemistry Controls REF 721 PTS Panels HDL Controls REF 722 Refer to control package insert for control specifications Healthcare professionals should follow their facility s guidelines and policies regarding quality assurance and the use of Quality Control materials Quality Control materials should be run whenever a new lot of PTS Panels test strips are received 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 Section V QUALITY CONTROL TESTING To perform a control test you need CardioChek PA device PTS Panels test strips Quality Control materials Quality Control Instructions Quality Control Range Insert 19 V GUALITY CONTROL TESTING How To Run a uality Control Test 1 w Install the correct MEMo Chip for the lot of test strips that you are using Press either button to turn the device ON Press Next until the display reads UTILITY Press Enter Press Next until RUN CONTROL scrolls across the display Press Enter Insert the test strip into the device The CardioChek PA devi
4. or was removed before test was complete Insert same or new MEMo Chip properly Check test strip expiration date and make sure correct MEMo Chip is inserted Check date setting follow User Guide instructions Replace both batteries with new high quality AAA batteries The device will not run tests until batteries are replaced Test again with fresh test strip PRINT ERROR Print function has been Print result in MEMORY or test interrupted again Communication Cable was improperly connected Results will not print Printer cover is not closed properly Printer indicator light is red Labels paper were not loaded in the printer 31 Check all connections Reprint test results stored in memory Close printer cover correctly ensuring that the Printer indicator light is green Reprint test results stored in memory See CardioChek PA amp Printer System Setup Operating System Instruction Sheet packaged with thermal printer IX TROUBLESHOOTING continued PROBABLE Results are notas Test strips improperly Repeat test using a different expected stored vial of test strips Run controls confirm that results are in range Batteries are defective Change batteries The device was Make sure device was not ex improperly stored posed to high or low temperatures or humidity and repeat test Test strip insert Clean the test strip insert opening is dirty opening MEMo Chip a
5. Cardio Chek ZPA Brand Analyzers Portable Whole Blood Test System User Guide e eo pn a For Professional Use TABLE OF CONTENTS Mk Vere Te vie EE i KE 4 Il Introduction to the CardioChek PA Test System 5 CardioChek PA device MEMo Chip PTS Panels test strips MES RR EE EO 9 Installing Batteries CardioChek PA System Menus How to Turn Device Off Setting Language Setting Time Setting Date Setting Units Setting Sound Setup for Print IV Checking the System eee Gee Gee GER GER GER ee ee ee 18 Check Strip Ouality Control V Quality Control Testing seke gesek gesek gesek eek eek eek ee 20 Running a Control Test ML RUNNING a TEST EE ER ER ee GR ee ER 22 Blood Testing Testing Supplies Ouick Reference IE MEMO EE RENS ANNE AE ARENA MRNA UMRDS 26 Recalling Results Clearing Memory VIll Gare aim leaning is rette cried ee 28 Storage and Handling Cleaning Instructions IX Troubleshooting eese teen gee eek 30 X Interpreting Results e ee Gee eek eek ee tentent tonne 33 XI CLIA Information ese rE eek ee ees 34 XII Specifications Rte reete e ERE 35 XIII Contact Information eese tenen Geek Rea Re ee 36 Help XIV ENE GO N RO EE ONA 37 XV Explanation of Symbols eese gesek ese ee Gee 38 Re ARE EEN OE DO NE N 39 Il INTRODUCTION The C
6. ardioChek PA device from Polymer Technology Systems Inc PTS Inc is intended for in vitro diagnostic use using whole blood samples This point of care POC test system is designed for professional use The CardioChek PA test system has an optional printer and the CardioChek Link software solution to assist in data reporting The CardioChek PA device is fast portable and reliable This device is a component of a test system that includes PTS Panels test strips The PTS Panels test strip box includes a MEMO Chip that contains the assay calibration curve and other important information about the assay PTS Panels test strips are sold separately and are available as single and multiple analyte test strips This test system uses reflectance photometry technology An enzymatic reaction on the test strip produces a color change that is detected by the device after whole blood is applied This User Guide includes all the information that you need to run POC assays using the CardioChek PA test system Before you begin testing please read this entire User Guide and the package inserts which are included with the PTS Panels test strips Please remember to return the enclosed warranty card to PTS Inc to ensure that you receive product updates and other important information For questions or additional assistance with your CardioChek PA test system please contact PTS Inc Hours 8 00 a m to 8 00 p m USA Eastern Time using the f
7. ber code on the test strip vial MEMo Chip and device display must match If the expiration date in the MEMo Chip has expired the device will display EXPIRED LOT If your MEMo Chip is lost or missing please call PTS Inc Customer Service for a replacement 7 Il INTRODUCTION TO THE CARDIOCHEK PA TEST SYSTEM continued The MEMo Chip port is located at the top center of the device The MEMo Chip is inserted into this port with the finger notch facing up Push firmly but gently until the MEMo Chip is fully inserted Important Be careful not to bend the connector Test Strip Test strips are designed for specific analytes A test strip is inserted into the device then blood is applied to the blood application window As previously described the ensuing chemical reaction produces a color change which the device measures and compares to the calibration curve stored in the MEMo Chip The device converts this color reading into a test result displayed on the screen Each PTS Panels test strip box contains a package insert that provides instructions for use and information specific for each test Please read the instructions completely before testing Blood Application Window Example of a PTS Panels test strip am sk as MM aa EN ad ae io Ill SETUP Battery Use and Replacement The CardioChek PA device requires two 2 AAA 1 5 volt high quality alkaline batteries When to Re
8. ce will display APPLY SAMPLE This indicates the system is ready for a sample control to be applied Immediately replace the vial cap making sure the test strip vial is closed tightly Remove cap from the Quality Control material and turn bottle upside down CONTROL MUST BE APPLIED TO TEST STRIP WITHIN 10 SECONDS OF REMOVING THE TEST STRIP FROM THE VIAL Hold bottle directly over and perpendicular to the blood application window on the test strip Squeeze bottle so a small drop of control solution is formed Allow the drop of control solution to fall onto the application window of the test strip Do not allow the tip of the bottle to touch the test strip 10 Replace cap on the Quality Control material 20 m I fah V GUALITY CONTROL TESTING continued How To Run a Quality Control Test continued 11 During testing CONTROL is displayed Results will be displayed within about one to two minutes 12 Compare control results to the values on the Quality Control Range Insert included with control materials 13 The control result s will also be stored in the device s memory 14 To exit the control testing menu press Enter twice RUN CONTROL will be displayed 15 Press Next until EXIT is displayed Press Enter 16 Press Next until RUN TEST is displayed If Quality Control Results are Not in Range 1 Ensure test strip insert opening area is clean 2 Make sure neither the test strips nor the controls a
9. d of the center See picture below CORRECT WAY TO STICK THE FINGER 4 To geta drop of blood gently apply pressure to the finger starting at the end of the finger closest to the hand and moving towards the tip Wipe away 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 capillary pipet or plastic blood collector 5 Follow the specific instructions found in the test strip package insert for each test for sample application and volume ranges Use of capillary pipet or plastic blood collector ensures a sufficient volume of blood has been applied to the test strip 6 Make sure the test strip is inserted all the way into the test strip insert opening 7 Use the test strip and lancet one time only Dispose of properly Precaution Handle and dispose of all materials coming in contact with blood according to universal precautions and guidelines 23 VI RUNNING A TEST continued How to Run a Test 1 2 oo Insert correct MEMo Chip for the lot of strips in use Insert MEMo Chip with finger notch top side up lot number code facing down Turn CardioChek PA device ON by pressing either button When INSERT STRIP is displayed insert the test strip into the device as far as it will go Obtain a blood drop following the correct technique When APPLY SAMPLE is displayed apply bl
10. e CardioChek PA for Printing For complete details refer to each printer s User Guide al 99 on Ill SETUP continued How to Print Results From Memory Up to 30 test results per chemistry up to 10 Control results 1 Turn the CardioChek PA device ON by pressing either button Press Enter until RUN TEST is displayed From the RUN TEST menu press Next MEMORY will be displayed Press Enter Press Enter to select CHEM Press Next to select the type of test LIPIDS for example Press Next to select the date time of the test result you want to print 8 Press Enter to print the selected number of copies of results 9 Control results can be printed by selecting CONTROL instead of CHEM and then selecting the type of result as stated above AD pt d WN IV CHECKING THE SYSTEM Device Check Strip A Ouality Control of the device operation can be performed using the gray check strip The check strip included in the device carrying case verifies that the CardioChek PA device s electronic and optical systems are functioning properly Each gray check strip is calibrated to read a specific reflectance To perform this verification insert the check strip into the device The device will read the reflectance of the gray check strip and indicate if the reading is within the acceptable range When the check strip is not in use please store it in the device carrying case It is recommended that the check strip
11. e read the test strip package insert for storage and handling information that applies to each test strip 28 Vill CARE AND CLEANING continued Cleaning Instructions 1 Locate the optical glass and the test strip insert opening 2 Open an alcohol wipe prep pad 3 Fold the wipe and carefully wipe the optical glass and test strip guides clean If the area is especially dirty this may require additional wipes 4 Immediately dry the optical glass completely with gauze Make sure the glass is clean dry and completely free from any fingerprints dust or smudges The glass must look clean when held at different angles If the exterior of the device needs cleaning wipe with a damp not wet alcohol wipe or dampen cloth with water or medical grade disinfectant such as Sporocidin and wipe surfaces and the display area very carefully Be careful not to get the test strip insert opening where the test strip is inserted wet Do not use bleach window cleaner or hydrogen peroxide 29 IX TROUBLESHOOTING PROBABLE Desired language Language has been set is not displayed incorrectly Date and time have not been set correctly The wrong date and or time is displayed FAILED is displayed during a check strip test Device needs to be cleaned Check strip is dirty or damaged TOO MUCH Test is being performed Test inside away from windows LIGHT in direct light or outside and away from d
12. ed Press Enter Press Next until SET TIME is displayed Press Enter and the clock format is displayed 12 24 HR Press Next to alternately display the 12 hour AM PM clock or the 24 hour clock Press Enter to accept the displayed clock format The display will read HOUR and the numerical hour If 12 hour clock was chosen AM PM appears in the upper right hand corner of the display Press Next to increment the hour Press Enter to accept the displayed hour The display will read MINUTE and the numerical minute Press Next to increment the minutes Ill SETUP continued How to Set the Time continued 9 10 TE Press Enter to accept the displayed minute The display will read SET TIME To set the date proceed to How to Set the Date Step 4 To exit press Next until EXIT is displayed Press Enter Press Next to return the display to RUN TEST How to Set the Date 1 MO uU BN 0 o 10 11 12 13 If RUN TEST is displayed go to Step 3 If the device is OFF press either button to turn the device ON Wait for the display to read INSTALL MEMO CHIP or INSERT STRIP Press Next The display will read RUN TEST Press Next until USER SET is displayed Press Enter Press Next until SET DATE is displayed Press Enter and the numerical month is displayed Press Next to increment the month Press Enter to accept the displayed month The display will read DAY and the numerical day of the month Press Next t
13. es with triglycerides of 400 mg dL 4 52 mmol L or greater XI CLIA INFORMATION General CLIA Information US Only Please read before testing CLIA waived Each laboratory or testing site using the PTS Panels test strips MUST have a CLIA Certificate of Waiver or other CLIA operating license before testing To obtain a Certificate of Waiver or any other type of laboratory license call your state health department or PTS Inc at 1 877 870 5610 Toll free or 1 317 870 5610 for an application 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 rating and subject the facility to all applicable CLIA requirements for high complexity testing For complete information including performance please refer to the product specific package insert and User Guide 3 CLIA waived for whole blood fingerstick and venous EDTA or heparin testing only 34 rrr FW SE EN XII SPECIFICATIONS CardioChek PA Device Calibration Curve Input from MEMo Chip per test strip lot Battery 2 AAA 1 5 volt alkaline The device Storage Conditions and Operating Range are as follows Storage Conditions Optimal Operating Conditions 18 35 C 20 27 C 64 95 F 68 80 F Humidity Range Between 20 and 80 RH Dimensions Width 3 0 in 7 62 cm Le
14. irect lamp light MEMO ERR MEMO Chip is defective Use another MEMo Chip from the same lot TEST ERR Insufficient sample has been added to test strip LANGUAGE Device is new or lan guage option has not been set Test selected by MEMo Chip installed cannot be run on your device LOW TEMP Device is below accept able operating tempera ture HI TEMP Device is above accept able operating tempera ture 30 Turn device OFF See Section Ill Setup How to Reset the Language See Section Ill Setup to set the correct date and time Wipe the test strip insert opening with a clean damp and lint free cloth Use spare check strip If check strip still fails call Customer Service Test again with a new test strip and make sure the correct volume of sample is used Follow User Guide instructions to set language Check MEMo Chip and make sure that the correct MEMo Chip is inserted Call Customer Service Move to warmer environment and test after device reaches proper temperature Move to acceptable environment and test after device reaches proper temperature IX TROUBLESHOOTING continued PROBABLE INSTALL MEMO CHIP MEMO Chip is not properly inserted or is defective EXPIRED LOT Test strips are expired wrong MEMo Chip is inserted or date is not set properly CHANGE BATTERY Batteries need to be replaced TEST ABORTED Test strip was not properly inserted
15. is button to turn the device ON or to accept the current menu choice eM ras g to select g to select i i I I I I I I USE CODE r P CHEM g to select ES co E cu ES Ho EP Ts E EP KET EP rps EP Er INSERT STRIP t P CONTROL I I La EXIT return to a lt a MEMORY return to CHEM L Ill SETUP continued NEXT pD Button Press this button to turn the device ON or to advance to the next menu option Hold Q and down at the same time to shut off device from one of the main menus RUN TEST MEMORY UTILITY or USER SET AE N UTILITY H 8 USER SET g to select g to select i I I I I I I p CK STRIP p PRINT L L I I Li L p RUN CONTROL p SOUND i i I I um CLEAR MEMORY m SET TIME I I I Ep EXIT return to E SET DATE a UTILITY 1 1 return to CK STRIP D UNITS I I Ep EXIT ss return to a USER SET return to PRINT Units may be locked and therefore UNITS will not appear Ill SETUP continued How to Turn the Device OFF To turn device OFF press both buttons at the same time for three seconds at any of the following Main Menu headings RUN TEST MEMORY UTILITY or USER SET After three minutes of idle time without a test strip or check strip inserted the device will perform a 10 second count down and turn OFF To stop shutdown press either button You can also remove the batteries to t
16. l MEMORY Test results are automatically stored in the device s memory A CardioChek PA device can store up to 30 results of each chemistry and at least 10 results of each control test The device allows review of the results in order from the most recent to the oldest Each result is displayed with time and date Results stored in memory are not deleted when the batteries are changed How to Review Results Stored in Memory 1 e Press either button to turn the device ON If the display reads INSTALL MEMO CHIP go to Step 2 If the display reads INSERT STRIP press Enter Press Next until MEMORY is displayed Press Enter CHEM is displayed 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 Press Enter to view the test result including time and date a To recall Control results press Next until EXIT is displayed Press Enter Press Next until CONTROL is displayed b Press Enter when the desired Control test is displayed c For example to review Lipid Panel results from the CHEM display press Next until LIPIDS is displayed then Enter The time and date will be displayed Press Enter when the desired test time and date is displayed Press Next to scroll through results To exit press Next until the display reads EXIT then press Enter Repeat this step until you return to RUN TEST 26 Vil MEMORY continued
17. nd test Use MEMo Chip and test strips strips are not the same with the same lot number lot number 32 X INTERPRETING RESULTS All test results must be assessed by a qualified medical professional Depending on the analyte being assessed high or low results may have medical consequences If the result reads greater than or less than or results are not as expected always repeat the test correctly with a new unused test strip If a test result is displayed that is not expected consult the following table PROBABLE A displayed result reads less than a value A displayed result reads greater than a value Display reads or N A TRIGS TOO HIGH LDL N A Result is below the measuring range of the test Result is above the measuring range of the test Result is not available due to a missing value from a calculation or a value is outside the measuring range Lipid Panel triglycerides test result was 400 mg dL 4 52 mmol L or greater 33 If you or your patient have symptoms call a healthcare professional immediately Repeat the test Run controls and confirm that controls are in range If you or your patient have symptoms call a healthcare professional immediately Run test again Run controls and confirm that controls are in range Run test again Run controls and confirm that controls are in range No action needed LDL will not be calculated on sampl
18. ngth 5 5 in 13 97 cm Height 1 0 in 2 54 cm Weight without batteries 4 6 oz 113 4 170 19 PTS Panels test strips Please read the instructions package insert included with the test strips for information specific to each chemistry Optional CardioChek PA Thermal Printer Power Supply For complete details refer to each printer s User Guide 35 XIII CONTACT INFORMATION Help For assistance with the CardioChek PA test system please contact Polymer Technology Systems Inc 1 877 870 5610 Toll free inside USA 1 317 870 5610 Direct 1 317 870 5608 Fax E mail inforeguest cardiochek com Web site www cardiochekpa com 36 TE mm me PR A AN mm A PM es h mm EE yr lm XIV WARRANTY CardioChek PA Device Limited One Year Warranty PTS Inc warrants to the original purchaser only that the device shall be free of any defects in materials or workmanship for a period of one year from the date of original purchase Activation of this warranty shall be conditioned upon completion and return of the warranty registration card to PTS Inc If the equipment becomes inoperative during this time PTS Inc will replace the equipment with equivalent equipment at its option at no cost to the purchaser The warranty becomes void if the equipment is modified improperly installed or operation not in accordance with the User Guide damaged by accident or neglect or if any parts are impr
19. o increment the day Press Enter to accept the displayed day The display will read YEAR and the numerical year Press Next to increment the year Press Enter to accept the displayed year The display will read SET DATE To set the units proceed to UNITS Press Next until EXIT is displayed Press Enter Press Next to return the display to RUN TEST lt See OM a Ill SETUP continued How to Set the Units The CardioChek PA device may be shipped with preset units NOTE e If the USER SET menu does not display UNITS the device is locked in preset units The units cannot be changed if the system has been locked To confirm current configuration of the device s units run a check strip in the RUN TEST mode and observe the units that are displayed If your device 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 3 If the device is OFF press either button to turn the device ON Wait for the display to read INSTALL MEMO CHIP or INSERT STRIP Press Enter The display will read RUN TEST Press Next until USER SET is displayed Press Enter The display will read PRINT Press Next until UNITS is displayed If UNITS is not shown on the display the units on this device have been locked and cannot be changed If UNITS appears on the display screen proceed to the next step 6 Press Enter The display will read mg dL If mmol
20. ollowing contact information Polymer Technology Systems Inc 7736 Zionsville Road Indianapolis IN 46268 USA 1 317 870 5610 Direct 1 877 870 5610 Toll free inside the US inforeguest cardiochek com E mail www cardiochekpa com 4 N 1 N A o A o EE e PER LA ma me MS a o Il INTRODUCTION TO THE CARDIOCHEK PA TEST SYSTEM The CardioChek PA Test System The CardioChek PA test system consists of three main parts These include the device PTS Panels test strips and a MEMO Chip The CardioChek PA Test System amp Operating Principle The device employs light reflectance to measure an end point enzymatic chemical reaction The test strips are impregnated with enzymes which are specific for the analyte to be measured Refer to the individual PTS Panels test strip package inserts for detailed information related to the enzymatic reaction When blood is applied to the test strip the ensuing sequence of chemical reactions results in a color change on the test strip which is measured by light reflectance The intensity of this colorimetric substance is directly proportional to the amount of analyte in the blood Using a stored standard calibration curve the device calculates and displays the result on the screen Il INTRODUCTION TO THE CARDIOCHEK PA TEST SYSTEM continued MEMo Chip Port a The MEMo Chip port is located at the top of the device Display b Display shows test results me
21. ood to the test strip Refer to each specific test strip package insert for sample volume and sample application instructions Within one to two minutes the results will be displayed Remove test strip and discard The device automatically shuts down after three minutes of idle time with no test strip inserted IMPORTANT Do not leave a used test strip or check strip in the device test strip opening This prevents the device from automatically shutting down and shortens battery life 24 VI RUNNING A TEST continued Quick Reference Testing Guide 1 Insert MEMo Chip with lot number that matches test strip vial lot number Press either button to turn the CardioChek PA device ON Device will display lot code 2 When INSERT STRIP is displayed hold by the raised lines and insert test strip into the device as far as it will go 3 When APPLY SAMPLE is displayed apply whole blood sample with a capillary pipet to blood application window 4 Within two minutes the result will appear on the display Remove and discard strip Do not add more blood to a test strip that has been used Cardio Chek LLLI dL rr LL a Ribs that guide the strip oe into the device ia Blood application window Hold test strip by this end Example of a PTS Panels test strip Refer to each specific test strip package insert for sample volume and sample application instructions 25 Vi
22. operly installed or replaced by the user Note Removing or loosening screws from the back of the device voids all warranties There are no user serviceable parts inside the case 37 XV EXPLANATION OF SYMBOLS CardioChek PA Test System Symbols Consult Instructions for Use Temperature Limitation de lt 0 In vitro diagnostic medical device Serial Number Z Manufacturer Catalog Number Authorized representative in the European Community JEL This product fulfills the reguirements of the European Directive 98 79 EC for in vitro diagnostic medical devices 7 P 38 XVI INDEX Device Introd Tissot teinte SERE EE 4 6 Battery InstallabOlice aes eer APER Dee 9 Blood les ee UD REG PRO 22 24 CHIA oie ge EE up veri aav CR TLF UR EE DN 34 Check ID ne ed odds ndi tS 18 19 ASC INMNG rac ao ere deerit EE ed 28 29 Contact lhfortridtiol sesse Re eese 36 Date GEMMER RUD OU EV Fond d RH EAR 14 je e 36 Interpreting Reus GO OP En ees 33 Language Setting se ERGER aa pda 12 13 See MEE EE OE EE 7 8 Merle OE ee ee 26 27 Quick Reference For Running a Test oe 23 Qu lity CONTO l NE EE EE EN 19 21 STA Be RE EI EE EE EN 12 Sound SEE es DE ii ERES TUN ONUS 16 Seel AG ee 35 SYMDO l ans EG m Bee 38 Testing Blood ee ke Ge EE Ges 22 24 Time Setting EET T 13 14 Troubleshooting Table sei Wee edes 30 32 Units SET UNG is eel Qm etes e con on an ele s 15 Warran
23. place the Batteries The device will give you an indication on the display that the batteries need to be changed When the display reads CHANGE BATTERY no more tests can be run until the batteries are changed Always replace the batteries with high quality alkaline batteries It is recommended to keep a spare set of batteries on hand To extend battery life remove the test strip as soon as a result is displayed The time date and results stored in memory will not be erased when the batteries are changed How to Install Replace the Batteries 1 Open the battery door on the back of the CardioChek PA device by pressing and sliding it in the direction of the arrow toward the MEMo Chip port Remove old batteries from the compartment and safely discard Insert the new batteries into the battery compartment with the positive terminal facing to the left on the top battery and to the right on the bottom battery as marked on the inside compartment Replace the battery door To make sure the batteries were installed correctly push either of the two buttons on the front of the device to turn the CardioChek PA device ON WARNING Dispose of the old batteries properly Ill SETUP continued CardioChek PA System Menus This diagram provides a layout of the menus within the CardioChek PA device Detailed information on the use of each menu follows in the Setup section of this User Guide Buttons ENTER C Button Press th
24. re past the expiration date printed on the label 3 Make sure the MEMo Chip matches the test strip lot Repeat the test again using fresh materials 5 Call Customer Service for assistance B 21 VI RUNNING A TEST Blood Testing A test strip package insert is included with each box of test strips Please read the test strip package insert along with this section of the User Guide completely and carefully before testing Testing Supplies To perform a blood test you need e CardioChek PA device PTS Panels test strips Lot specific MEMo Chip Sterile lancet Capillary blood collector or pipet Gauze or cotton balls e Alcohol wipe optional This device requires whole blood for testing Do not operate the device in direct light Reference the Care and Cleaning section for more information Helpful Hints on Getting a Good Drop of Blood 1 Warm the fingers to increase blood flow 2 Letthe arm hang down at the person s side briefly to allow blood flow to the finger tips 3 Instruct the patient to wash hands in warm soapy water Rinse well and dry completely If an alcohol wipe is used let the finger air dry before testing 22 dem A mem VI RUNNING A TEST continued How to Obtain a Blood Sample To perform a fingerstick 1 Clean the finger Be sure the finger is completely dry 2 Useanew sterile disposable lancet to puncture the skin 3 Stickthe finger on the side of the fingertip instea
25. ssages time date and stored results ENTER QJ Button c Press this button to turn the device ON or to accept the current menu choice NEXT E Button d Press this button to turn the device ON or to advance to the next menu option Test Strip Insert Opening e The test strip insert opening is positioned in the lower front of the device The test strip is inserted here with the raised lines facing up Xo Il INTRODUCTION TO THE CARDIOCHEK PA TEST SYSTEM continued The MEMo Chip Each package of PTS Panels test strips contains a color coded MEMo Chip The color coded MEMo Chip contains the settings for each test The top of the MEMo Chip has a Cholesterol finger notch The bottom has a label pud with the test name and lot number Always make sure you insert the Lo ULU meme Chip into the port with the Top Bottom finger notch facing up MEMo Chip Top and Bottom What does the MEMo Chip do The MEMo Chip contains proper settings for the test strip lot you are using The MEMo Chip Reads the test strip expiration date Tells the device which test s to run Contains the calibration curve and the lot number for the specific test strip lot Controls test sequences and timing Establishes the measuring range for the test Guidelines for using the MEMo Chip The MEMo Chip must be in place to run a test Use only the MEMo Chip that is included with each package of test strips The lot num
26. ty P ror tisi uis siS r oosid tss 37 39 The CardioChek CardioChek PA and associated test strips are covered by one or more of the following patents U S Patent Nos 7 435 577 7 625 721 7 087 397 7 214 504 7 374 719 7 494 818 5 597 532 and D534444 Australian Patent No 2002364609 Eurasian Patent No 010414 Mexican Patent No 267323 South African Patent Nos 2004 4929 and 2006 06561 EP Patent No 0750739 DE FR GB IT Polymer Technology Systems Inc 7736 Zionsville Rd Indianapolis IN 46268 USA 1 877 870 5610 Toll free inside USA 1 317 870 5610 Direct 1 317 870 5608 Fax E mail inforeguest cardiochek com www cardiochekpa com C oie Authorized European Representative MDSS Schiffgraben 41 30175 Hannover Germany Copyright 2010 Polymer Technology Systems Inc PS 002461E Rev 3 11 10
27. urn the device OFF The first time the device is turned on you will be required to set the language date and time Setting Language The language menu consists of the following choices English ENGLISH Spanish ESPANOL Italian ITALIANO German DEUTSCH French FRANCAIS Portuguese PORTUGSE and Dutch NEDERL How to Set the Language 1 Turn the device ON by pressing either button Enter or Next 2 The display will read LANGUAGE Press Enter 3 ENGLISH will be displayed Press Enter if English is desired 4 For other languages press Next until the desired language is displayed then press Enter To set the time proceed to How to Set the Time M m M day Ill SETUP continued How to Reset the Language 1 Allow the device to automatically turn OFF or remove the batteries and replace them Press and hold Enter down for approximately 5 seconds during the analyzer power up stage until LANGUAGE is displayed Press Enter Press Next to scroll through the language choices Press Enter to select the language that is displayed SET TIME will be displayed How to Set the Time 1 A HM Ne If the device is OFF press either button to turn the device ON Wait for the display to read either INSTALL MEMO CHIP if a current MEMo Chipis not installed or INSERT STRIP if a current MEMo Chip is installed Press Enter The display will read RUN TEST Press Next until USER SET is display
28. verification be performed Daily If the device has been dropped e When a result is not consistent with prior results How to Use the Device Check Strip 1 Turn the device ON 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 CK STRIP is displayed 4 Hold the check strip at base and insert the check strip ribbed side up into the test strip insert opening when INSERT STRIP is displayed 5 The device should display PASSED If the display reads FAILED see the NOTE at the end of this section Re move the check strip and store it in the device carrying case 6 Press Next until EXIT is displayed Press Enter Press Next until RUN TEST is displayed 8 Press Enter The device is ready to run tests D oW PN EE mmm A A N P o M p Pp e mmm y EE eee IV CHECKING THE SYSTEM continued How to Use the Device Check Strip continued Note If the device displays FAILED 1 Clean the CardioChek PA device test strip insert opening where the check strip is inserted into the device See the Care and Cleaning section page 29 of this User Guide 2 Inspect the check strip to make sure it is not dirty or damaged Use the spare check strip and repeat 3 Seethe Troubleshooting section Quality Control Controls also known as Quality Control materials are solutions for which an expected analyte
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