mylife PURA X User Manual Download Page 26

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Main parts

mylife Pura meter, mylife Pura test strip, mylife Control control solution

Bionime Corporation

No. 100, Sec. 2, Daqing St., South Dist., Taichung City 40242, Taiwan

The products comply

EU Representative

9442 Berneck, Switzerland

mylife Softlance

Bionime Corporation

No. 100, Sec. 2, Daqing St., South Dist., Taichung City 40242, Taiwan

The product complies

mylife

The

EU Representative

Manufacturer:

with In vitro Diagnostic Directive 98/79/EC (CE 0197).

: Bionime GmbH, Tramstrasse 16,

lancing device

Manufacturer:

with Medical Device Directive 93/42/EEC.

Disposable

Lancets lancets

Manufacturer:

EU Representative: Bionime GmbH, Tramstrasse 16, 9442 Berneck, Switzerland

SteriLance Medical Inc.,

No. 68 Litanghe Road, Xiangcheng, Suzhou, China 215133

Product complies with Medical Device Directive 93/42/EEC (CE 0197).

Emergo Europe, Molenstraat 15, 2513 BH The Hague, The Netherlands

Version: June 2016

Summary of Contents for PURA X

Page 1: ......

Page 2: ...m 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 bloo...

Page 3: ...ime and volume TM Switching the mylife Pura meter on off Switching the backlight on off Meter activation and battery change Setting up your meter Quality control TM Lo and Hi readings of mylife Pura meter Error messages and trouble shooting Customer service Warranty Main parts TM Specification of mylife Pura meter TM Limitations of mylife Pura meter Meter data transmission management optional Desc...

Page 4: ...Disposable 10 pcs 9 10 warranty card 11 carrying case TM mylife Pura TM mylife Pura TM mylife Pura TM mylife Pura BGMS TM mylife Pura blood glucose test strip insert TM mylife Softlance TM mylife Pura cap AST TM mylife Lancets lancets TM Instructions for the mylife Softlance lancing device TM mylife Pura TM mylife Pura Package of BGMS TM mylife Pura 9 4 3 2 5 1 6 8 7 2017 10 ...

Page 5: ...ylife Pura meter TM mylife Pura meter Display window Shows test result messages and information relevant Test strip port Insert test strip here until you hear a click Right button For operating the meter please check details in following sections Product name Battery cover Slide cover to change batteries Meter serial number Meter battery Backlight battery 150HLA0076 ...

Page 6: ...ns when the battery is low or must be replaced Indicates when to apply the blood sample Test strip internal calibration and autocoding Warns if test strip is not inserted correctly or wrong test strip has been used Current date time mode memory mode or testing date Indicates if environmental temperature exceeded during testing parameters are Indicates the time in 12h format Current time or testing...

Page 7: ...g 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 glucos...

Page 8: ...d 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...

Page 9: ... and volume retained 3 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 change Your 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 me...

Page 10: ...in 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 blank perform a First press to switch again for a further 7 that you have setting mode Setting up your meter Setting the date time and volume Setting up your meter Setting the date time and volume 1 Year setting With the year format...

Page 11: ... the volume flashing press the left or right button to switch it on or off Then press the main button to confirm and finish the settings NOTE 2 minutes Your meter is now ready for use The meter default will depend upon the units of measurement normally used in your country If the meter is unused for more than it will automatically exit setting mode and switch off 8 After volume settings beep if vo...

Page 12: ...e meter is unused for more than 2 minutes it will automatically switch off TM Switching the mylife Pura meter on off 1 How to on the backlight main button for 2 2 Manual backlight off the main button for another 2 seconds switch Press the seconds after power is on Press 3 Auto backlight off The meter backlight will automatically switch off if the meter is unused for more than 10 seconds ...

Page 13: ...matically move back to its original position 8 Wash your hands with warm soapy water and dry thoroughly 9 Take one from the vial Recap the vial immediately 10 Insert the test strip into the strip port of the meter with the indication symbol facing down The meter confirms the insertion of the strip with a beep if volume is on with This cocks the lancing device which will against the hub The device ...

Page 14: ...propriate puncture proof or biohazard container 18 Replace the cap after finishing the test depth adjustable cap of the lancing device its Pressing with s figure with s figure Dispose depth adjustable 17 15 1 2 16 PRECAUTION Do not your blood drop to the sample entry on the test strip until you see the appear The meter is performing an internal test and will display and Error if you apply blood to...

Page 15: ... Follow steps 13 to 14 on page 26 to complete the test Follow steps 15 to 18 on page 27 7 PRECAUTION The test results of blood samples taken from different sites might in certain such In these cases only should be used DO NOT test on the palm or forearm if you are testing for hypoglycemia low blood glucose Fingertip samples can show rapid of glucose faster than palm or forearm samples As the blood...

Page 16: ... 6 mmol L Lo will appear on the screen Please repeat your test a new test strip If you still get a Lo result you should immediately contact your healthcare If your test result is above the high end of the detection range Hi will appear on the screen Please repeat your test a new test strip If you still get a Hi result you should immediately contact your healthcare m using professional or follow th...

Page 17: ...erature range 10 C and 40 C resp 50 F and 104 F your control solution results are out of range Y correctly Malfunction of the meter or the test strip Your test strip has The cap of the test strip vial or the control solution for a long time Quality control TM test with mylife Control control solution Please use control solution tested with BGMS under control solution mode If the test result is wit...

Page 18: ...if volume is switched on please wait for the test result You will see the countdown mode on the screen After 5 seconds the test result will appear Performing a quality control test 9 PRECAUTION Your control solution will not be average but be recalled The control solution test result will be shown CS symbol on the screen Our for solution test is 15 40 Before and CS appear please do not the control...

Page 19: ...result displayed By pressing the right button continually test results will be shown in order You will see the sequence number in the lower right corner and the year in the lower left corner of the followed by date and time of the measurement mode mem right hand is hand previous date display Caring for your meter Maintenance Keep your meter and test strip free of dust water or any other liquid Sto...

Page 20: ...reen To confirm this original status you again simultaneously press the main The value will stored as a regular value and included in the average values results and each test After measurement as long as the test strip is clicked in the meter it is called test mode After removing the test strip it is called memory mode finishing test in the test mode result by pressing the right hand button until ...

Page 21: ...t the test with a new test strip If the appears see page 48 error screen still contact your local Ypsomed customer service Battery error 1 The symbol when battery power is low meter battery as soon as 2 The and Error symbols are when the is too low the test Please change the battery immediately flashes Change possible The test may still be performed flashing battery power The meter cannot perform ...

Page 22: ... 9 32 48 or 41 50 106 122 the warning symbol 1a you still can the test but the result is only for reference because not be correct In the memory mode this value will be flagged with the symbol 1b the test in an area temperature operating range 2 3 When the temperature is below 0 32 or over 50 122 the meter the test and the Error symbol will with thermometer symbol on Please move the BGMS to enviro...

Page 23: ...ion Press for 4 seconds Measurement technology Measurement Sample calibration Minimum sample volume Measuring range Test time Coding 0 75 µL Autocoding 0 6 33 3 mmol L 5 seconds Oxidase electrochemical sensor Plasma Capillary whole blood Operating temperature Operating relative humidity Power saving 500 blood glucose test results with date and time TM Specification of mylife Pura meter Meter data ...

Page 24: ...naccurate test results may be obtained at altitude of more than about 3 048 meters 10 000 feet Severe dehydration may cause inaccurately low results The BGMS has not been validated for use on neonates The following compounds may interfere with the glucose measurement at the concentration listed Ascorbic acid 0 34 mmol L Glutathione reduced 2 28 mmol L Uric Acid 0 96 mmol L TM The meter data can be...

Page 25: ...ard container for your used lancets according to your local regulations During blood glucose measurement the eter may come into contact with blood Used eters therefore carry a risk of infection Please dispose of your used eter after removing the the applicable in your country For information about correct disposal please contact your local authority Customer service We are keen to provide a compre...

Page 26: ...e product complies TM mylife The EU Representative Manufacturer with In vitro Diagnostic Directive 98 79 EC CE 0197 Bionime GmbH Tramstrasse 16 lancing device Manufacturer with Medical Device Directive 93 42 EEC Disposable Lancets lancets Manufacturer EU Representative Bionime GmbH Tramstrasse 16 9442 Berneck Switzerland SteriLance Medical Inc No 68 Litanghe Road Xiangcheng Suzhou China 215133 Pro...

Page 27: ...Distribution UK ...

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