pts Diagnostics CardioChek User Manual Download Page 22

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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 European

Directive 98/79/EC for

vitro

diagnostic medical

devices.

Product requires separate

collection for electrical and

electronic equipment per the

WEEE Directive

Keep away from sunlight

Keep dry

Control

Humidity limitation

Batch code

Use by

Caution

Analyzer Introduction

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Battery Installation

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Blood Testing

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Check Strip

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Cleaning and Disinfection

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Contact Information

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Date (Setting)

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Help

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Language (Setting)

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Memory

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Quick Reference - How to Run a Test

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Quality Control

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Results

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Shut Down

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Sound (Setting)

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Specifications

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Symbols

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Testing (Blood)

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Time (Setting)

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Troubleshooting

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Unexpected Results

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Units (Setting)

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Warranty

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Index

Summary of Contents for CardioChek

Page 1: ...User Guide For Self Testing Use PortableWhole BloodTest System ...

Page 2: ...5 Quality ControlTesting 23 Quality Control 23 How to Run a Quality ControlTest 24 6 Running aTest 25 BloodTesting 25 Testing Supplies 25 Helpful Hints on Getting a Good Drop of Blood 25 How to Obtain a Blood Sample from a Fingerstick 26 Quick Reference How to Run aTest 27 Table of Contents Materials Provided REF 1709 CardioChek analyzer system 1 Materials Needed but Not Provided PTS Panels self t...

Page 3: ...diagnosis and treatment of patients with diabetes mellitus nephrosis liver obstruction other diseases involving lipid metabolism or various endocrine disorders Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus neonatal hypoglycemia and idiopathic hypoglycemia and of pancreatic islet cell carcinoma The CardioChek analyzer f...

Page 4: ...portant Safety Instructions This is a medical device and needs to be treated with care In particular there is the risk of disease transmission when using blood glucose monitoring systems and they should be used with caution and care 1 2 The analyzer and lancing device are for single patient use For safety reasons do not share them with anyone including other family members Do not use on multiple p...

Page 5: ...eading into a test result that is displayed on the screen A B C D E About the CardioChek Test System 2 9 9 MEMo Chip Port The MEMo Chip port is located at the top of the analyzer 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 Next Button Press this button to turn on the analyzer or...

Page 6: ...l with the test name and lot number Always make sure you insert the MEMo Chip into the port with the finger notch facing up What does the MEMo Chip do The MEMo Chip contains proper settings for the test strip lot you are using The MEMo Chip Stores 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 strip lot ...

Page 7: ...yzer Setup 3 How to Install Replace the Batteries 1 Open the battery door on the back of the CardioChek 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 ...

Page 8: ...GLU HDL TRIG 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 SOUND SETTIME SET DATE UNITS EXIT return to SETTINGS return to SOUND ...

Page 9: ...ter down 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 INSTALL ME...

Page 10: ... mg dL Note If the SETTINGS menu does not display UNITS the instrument 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 RUNTEST 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 mmo...

Page 11: ...e CardioChek analyzer s electronic and optical systems The check strip provides a color standard read by the analyzer When the check strip is not in use please store it in the analyzer carrying case It is recommended that you check your analyzer with the check strip when You first receive it You drop the analyzer You get a result that is not expected How to Use the Analyzer Check Strip 1 Turn on t...

Page 12: ...ntaining an analyte known to be within a certain range Use quality control materials provided by PTS Diagnostics Contact Customer Service for ordering information Refer to the range card provided with the controls or visit http www ptsdiagnostics com for control specifications Home users should run quality control materials With each new lot number If it has been more than a month since using the ...

Page 13: ... 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 CardioChekanalyzer PTS Panelsself test strips Lot specific MEMo Chip Sterile lancet Capillary blood collector or pipet Gauze or cotton balls Alcohol wipe optional This analyzer requires whole blood for testing Do not operate the analyzer in ...

Page 14: ...the way into the test strip slot 12 Use the test strip and lancet one time only Dispose of properly 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 ...

Page 15: ...ardioChek analyzer s memory The analyzer can store up to 30 results of each chemistry and at least 10 results for control tests The analyzer 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 Press either button to turn o...

Page 16: ...umidity RH Do not freeze If storage temperature is below 68º F 20º C allow the device to warm to room temperature 68º F 20º C before using If the analyzer has been stored under excessive conditions or above 86º F 30º C allow at least 30 minutes at room temperature for the analyzer to equilibrate to these temperatures Do not scratch or damage the surface of the check strip Please read the test stri...

Page 17: ...your analyzer 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 assi...

Page 18: ...ways make sure the analyzer is dry before use After disinfection user s gloves should be removed and hands should be thoroughly washed with soap and water The CardioChek analyzer has been validated for 1 825 cleaning and disinfection cycles Please obtain a new analyzer after cleaning and disinfecting once the lifetime of the analyzer 5 years has been reached whichever comes ﬁrst Stop using the ana...

Page 19: ...3 Setup SettingtheLanguage TESTNOT ALLOWED TestselectedbyMEMoChipinstalled cannotberunonyouranalyzer CheckMEMoChipandmakesurethatthecorrect MEMoChipisinserted CallCustomerService LOWTEMP Analyzerisbelowacceptable operatingtemperature Movetowarmerenvironmentandtestafter analyzerreachespropertemperature HIGHTEMP Analyzerisaboveacceptable operatingtemperature Movetoacceptableenvironmentandtestafter a...

Page 20: ...ge of the test Ifyouhavesymptomscallahealthcareprofessional immediately Repeatthetest Runcontrolsand confirmthatcontrolsareinrange A displayed result reads greater than a value Result is above the measuring range of the test Ifyouhavesymptomscallahealthcare professionalimmediately Runtestagain Run controlsandconfirmthatcontrolsareinrange Display reads _ _ _ _ or N A Result is not available due to ...

Page 21: ... 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 Diagnostics If the analyzer becomes inoperative during this time PTS Diagnostics will replace the analyzer with equivalent analyzer at its option at no cost to the purchaser The warranty...

Page 22: ...or electrical and electronic equipment per the WEEE Directive Keep away from sunlight Keep dry Control Humidity limitation Batch code Use by Caution Analyzer Introduction 5 Battery Installation 13 BloodTesting 25 Check Strip 21 Cleaning and Disinfection 31 Contact Information 40 Date Setting 18 Help 40 Language Setting 16 Memory 29 Quick Reference How to Run aTest 27 Quality Control 23 Results 28 ...

Page 23: ...l other trademarks and product names are the property of their respective owners Copyright 2018 PolymerTechnology Systems Inc PS 002460 EN Rev 2 03 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 Schiffgraben 4...

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