mylife PURA X User manual

Preface 32Intended useTM®Thank you for choosing the mylife Pura blood glucose monitoring system. Please read this manual thoroughly before testing. It provides all information you need to use the product. The TM®TM®mylife Pura blood glucose meter must only be used with mylife Pura blood glucose test TMstrips and mylife Control control solution. The use of other test strips or control solutions may lead to incorrect results.TM®It is recommended that blood glucose should be monitored regularly. The mylife Pura blood glucose monitoring system is accurate and easy to use, and is therefore your reliable assistant for diabetes management.TMTMThe mylife Softlance lancing device and the mylife Lancets lancets are intended for patient self-monitoring by an individual. They must not be used on more than one person due to the risk of cross-infection.TM®The mylife Pura blood glucose monitoring system is manufactured by Bionime Corporation and supported by Ypsomed Distribution AG. If you have any question or concerns, please contact your local Ypsomed customer service (see page 48).TM®The mylife Pura blood glucose monitoring system is intended for in vitro (outside the body) diagnostic use for self testing. Coding is automatically detected. The test result is achieved using fresh capillary whole blood samples from the fingertip, palm or forearm. You may consult your healthcare professional for instructions on how to use the system correctly. Our customer support staff is of course also available to assist you.®Healthcare professionals may use the mylife™ Pura for surveillance of the blood glucose levels of patients in medical facilities.TM®Hereinafter the mylife Pura blood glucose monitoring system will be referred to as TM®TM®BGMS; the mylife Pura blood glucose meter as meter; the mylife Pura blood glucose TMTM test strips as test strips; the mylife Softlance lancing device as lancing device; the mylifeTMLancets as lancets; and the mylife Control control solution as control solution, for short.

54About BGMSPackage of meter test stripTM®mylife PuraTM®mylife Pura BGMSTM®mylife PuraTM®Precautions for mylife Pura BGMSTM®mylife PuraTable of contentsTable of contents
Testing procedurePerforming a Alternative site testing (AST)View window appearanceTM®blood glucose test with mylife Pura BGMSTMQuality control test with mylife Control control solution3224283016182223681214Preparing for testSetting the date, time and volumeTM®Switching the mylife Pura meter on/offSwitching the backlight on/offMeter activation and battery changeSetting up your meter – Quality controlTM®"Lo" and "Hi" readings of mylife Pura meterError messages and trouble shootingCustomer serviceWarrantyMain partsTM®Specification of mylife Pura meterTM®Limitations of mylife Pura meterMeter data transmission management (optional)Description of used symbolsTM®Disposing of the mylife Pura meter, test strips and lancets404446Review Performing a quality control testCaring for your meterRecalling test results and averagesyour test memory34363731474848494950

76Package of BGMSTM®mylife Pura
1.meter (with 2 CR2032 batteries installed)2.test strips (10 pcs)3. getting started guide4. user manual5.6. lancing device7. clear adjustable 8. Disposable (10 pcs)9. 10. warranty card11. carrying caseTM® mylife Pura TM® mylife Pura TM®mylife PuraTM®mylife Pura BGMS TM® mylife Pura blood glucose test strip insertTM mylife SoftlanceTM®mylife Puracap ("AST")TMmylife Lancets lancetsTMInstructions for the mylife Softlance lancing deviceTM®mylife PuraTM®mylife Pura Package of BGMSTM®mylife Pura94325168 7 2017-10

98Left button ( )For operating the meter, please check details in following sections.Main button ( )For operating the meter, please check details in following sections.TM®mylife Pura meterTM®mylife Pura meterDisplay windowShows test result, messages and information.relevantTest strip portInsert test strip here until you hear a click.Right button ( )For operating the meter, please check details in following sections.Product nameBattery coverSlide cover to change batteries.Meter serial numberMeter batteryBacklight battery150HLA0076

1110Indicates a test result stored in meter memory (memory mode)Indicates a test the average function of this meterresult which is not included in Indicates the average result (average mode)Indicates a control solution test resultUnit of test result according to presettingTest resultWarns when the battery is low or must be replacedIndicates when to apply the blood sampleTest strip (internal calibration and autocoding)Warns if test strip is not inserted correctly or wrong test strip has been usedCurrent date (time mode)(memory mode) or testing date Indicates if environmental temperature exceeded during testingparameters areIndicates the time in 12h formatCurrent time or testing time (time mode) (memory mode)Manufacturing use onlyTM®mylife Pura meterTM®mylife Pura meter

1312
TM®Precautions for mylife Pura BGMSTM®Precautions for mylife Pura BGMS - The minimum blood sample size for testing is µL ( ).0.75Please take a minimum of to do the test on the BGMS. A blood sample size above 3.0 might contaminate the test strip port and the meter. repeat the test with a new test strip.0.75µLµLMake sure your blood sample covers the whole area of the view window to get an accurate test result. A sample size below 0.75 µL may lead to an error message "Error 4". (see page 40). If this occurs,Sample size example0.75µL1.0µL1.5µL 2.0 µL3.0µL- Before using the BGMS to test your blood glucose, please read the instructions for use carefully.TM®TM- The meter must only be used with mylife Pura test strips and mylife Control control solution. The use of other test strips or control solutions may lead to incorrect results.- The BGMS has not been validated for use on neonates. It should not be used on neonates.- The BGMS is not intended for arterial blood glucose testing.- If the meters and test strips are exposed to a considerable temperature variation, please wait 30 minutes before measurement.- Dispose of used batteries properly. - Please note the BGMS contains small parts (e.g. test strips) which are a potential choking hazard for children.- Do not allow water to enter the meter. Never immerse the meter or hold it under running water.

1514TM®mylife Pura test stripTM®mylife Pura test stripView windowThis window is yellow before applying blood sample. It gradually turns red with blood.as it fillsHand barGrip here to insert test strip into meter.Sample entryµL Apply a drop of blood or control solution here. The test only 0.75 of blood. requiresElectrode Sensing signal output terminals. contactsGold electrodesElectrochemical sensorIndication symbolInsert test strip with indication symbol upfront and down towards meter.TM®TM®The meter must only be used with mylife Pura test strips and mylife Control / Pura control solution.The use of other test strips or control solutions may lead to incorrect results.PRECAUTION- Recap the test strip vial immediately after taking out a test strip.- Do not reuse test - Do not use expired test strips.- Record the date of opening a new test strip vial for the first time. Discard the vial of test strips 6 months - Store the test strips in a cool (4-30℃ and dry location (<90% relative humidity). Do not expose - For detailed information, please refer to thetest strips package insert.strips. Test strips are intended to be used only once.after first opening. resp. 39-86°F)to heat or direct sunlight.TM® mylife Pura - If the meter and test strips are exposed to considerable temperature variation, please wait 30 minutes before measurement.

1716 Meter activation and battery change
1. Turn the meter over. Press and push battery cover to open.PRECAUTION- Please follow local and discard used battery properly.regulations4. The meter performs a self test.5. Press any button to exit the self test and enter setting mode.6. Set the time and date the batteries are replaced. See chapter "Setting up your meter – Test results are still in the memory.afterSetting the date, time and volume".retained3. Slide the battery cover back until it snaps into place.2. Install the battery. Be sure to put battery in correct way with the "+" symbol up. Meter activation and battery changeYour meter comes with two CR2032, 3 volt, batteries installed. Two new batteries will provide power to perform about 1,000 tests under normal use. Press the main button or insert a test strip to activate your meter.NOTE- When the meter backlight function, please change your backlight battery.- When the backlight battery runs out of power still work but without backlight ceases tothe meter willproperly,illumination.
150HLA0076
150HLA0076

1918NOTE- main button for 2 seconds, - main button for seconds - press main button allows . However, if you want to return to the time mode, you go through all the settings first by After pressing thethe screen backlight is activated. Press the main button for another 2 seconds and the backlight and display switch off.Continued pressure on thea further 3elicits a beep, and the meter enters setting mode.A quickof thesetting changesmustrepeated pressing of the main button. You can enter setting mode in two ways:1. Reload meter battery After removing the meter battery, press the main button several times until , then follow the battery installation steps to load batteries. The meter will self test. Press the main button to exit the self test and enter setting mode.2. With battery inserted the main button on the meter. Then press the main button seconds until you hear a beep, indicating successfully entered The display screen will show setting data.the screen is blankperform aFirst pressto switchagain for a
further 7that you havesetting mode.Setting up your meter –Setting the date, time and volumeSetting up your meter – Setting the date, time and volume1. Year setting With the year format , press the left or right button to adjust it. Then press the main button to confirm it. shift to next digit for setting. Repeat the above action until the year setting is completed to month setting.2. Month setting With the month , press the left or right button until the current month appears. Then press the main button to confirm it and to day setting.3. Day setting With the day , press the left or right button until the current day appears. Then press the main button to confirm it and to time format setting.flashingIt will then and it will moveflashingit will moveflashingit will move1)2)3)