mylife Pura User Manual

Manuel de l'utilisateur
User manual

Système de mesure de la glycémie
Blood glucose monitoring system

101-3GM550-353

FR+EN

Distribution France

Ypsomed S.A.S
18/20 Rue Soleillet
FR-75020 Paris
Tél.: [phone]
Fax: [phone]
Numéro gratuit: 0800 883058
[e-mail]
www.mylife-diabetescare.fr

Distribution UK

Ypsomed Ltd
Blackwood Hall Business Park
North Duffield
Selby, North Yorkshire
YO8 5DD
Customer Care: [phone]
Fax: [phone]
Email: [e-mail]
www.mylife-diabetescare.co.uk

0197

BIONIME CORPORATION

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

Bionime GmbH

Tramstrasse 16,
CH-9442 Berneck / Switzerland
E-mail: [e-mail]

Manufactured for
Ypsomed Distribution AG
CH-3401 Burgdorf
Switzerland

TM TM

Thank you for choosing the mylife Pura . Please read this

TM

manual thoroughly before testing. It provides all information you need to use the product. The mylife

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Pura must only be used with mylife Pura and

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mylife Pura control solution. The use of other test strips or control solutions may lead to
incorrect results.

It is recommended regularly.

is accurate and easy to use, and is your reliable assistant for

diabetes management.

The

is manufactured by Bionime Corporation and
supported by Ypsomed Distribution AG. If you have any question or , please contact your
local Ypsomed customer service (see page 48).

blood glucose monitoring system

blood glucose meter blood glucose test strips

Control /

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that blood glucose should be monitored The mylife Pura blood

glucose monitoring system therefore

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mylife Softlance lancing device and the mylife Lancets lancets are intended for patient self­monitoring by an individual. They must not be used on more than one person due to the risk of cross­infection.

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The mylife Pura blood glucose monitoring system

concerns

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The mylife Pura blood glucose monitoring system for
diagnostic use for self testing. Coding is automatically detected. achieved using

is of course

Healthcare professionals may use the BGMS for surveillance of the blood glucose levels of patients
in medical facilities in the UK.

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Hereinafter the mylife Pura blood glucose monitoring system will be referred to as

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BGMS; the mylife Pura blood glucose meter as meter; the mylife Pura blood glucose

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test strips as test strips; the mylife Softlance lancing device as lancing device; the mylife

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Lancets as lancets; and the mylife Control / Pura control solution as control solution, for
short.

is intended in vitro (outside the body)

The test result is
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 also available to assist you.

Preface

32

Intended use

54

About BGMS

Package of

meter

test strip

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mylife Pura

TM TM

mylife Pura BGMS

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mylife Pura

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Precautions for mylife Pura BGMS

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mylife Pura

Table of contents

Table of contents

Testing procedure

Performing a
Alternative site testing (AST)
View window appearance

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blood glucose test with mylife Pura BGMS

Quality control

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test with mylife Control / Pura control solution

32

24
28
30

16

18

22

23

6

8

12

14

Preparing for test

Setting the date, time and volume

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Switching the mylife Pura meter on/off

Switching the backlight on/off

Meter activation and battery change

Setting up your meter –

Quality control

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"Lo" and "Hi" readings of mylife Pura meter

Error messages and trouble shooting

Customer service

Warranty

Main parts

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Specification of mylife Pura meter

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Limitations of mylife Pura meter

Meter data transmission management (optional)

Description of used symbols

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Disposing of the mylife Pura meter, test strips and lancets

40

44

46

Review

Performing a quality control test
Recalling test results and averages

your test memory

34
37

31

47

48

48

49

49

50

76

Package of BGMS

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mylife Pura

1. meter (with 2 CR2032 batteries installed)

2. test strips (10 pcs)

3. getting started guide

4. user manual

5.

6. lancing device

7. clear adjustable

8. Disposable lancets (10 pcs)

9.

10. warranty card

11. carrying case

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mylife Pura

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mylife Pura

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mylife Pura

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mylife Pura BGMS

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mylife Pura blood glucose test strip insert

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mylife Softlance

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mylife Pura cap ("AST")

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mylife Lancets

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Instructions for the mylife Softlance lancing device

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mylife Pura

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mylife Pura

Package of BGMS

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mylife Pura

9

432

5

1

6 8

7

150HLA0076

98

Left button ( )
For operating the meter, please
check details in following sections.

Main button ( )
For operating the meter, please
check details in following sections.

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mylife Pura meter

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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

1110

Indicates a test result stored in meter memory
(memory mode)

Indicates a test the
average function of this meter

result which is not included in

Indicates the average result (average mode)

Indicates a control solution test result

Unit of test result according to presetting

Test result

Warns 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 time (time mode) (memory
mode)

Manufacturing use only

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mylife Pura meter

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mylife Pura meter

1312

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Precautions for mylife Pura BGMS

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Precautions for mylife Pura BGMS

- The minimum blood sample size for testing is 1.0 µL ( ).

Please take a minimum of 1.0 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.

µL µL

Make sure your blood sample covers the whole
area of the view window to get an accurate test result. A sample size below 1.0 µL may lead to an
error message "Error 4". (see page 40). If this occurs,

Sample size example

- Before using the BGMS to test your blood glucose, please read for

- The meter must only be used with test strips control
solution. The use of other test strips or control solutions may lead to incorrect results.

- BGMS has not been validated for use on

- BGMS is not intended for arterial testing.

-

- Dispose of used batteries properly.

the instructions use carefully.

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mylife Pura and mylife Control / Pura

The neonates. It should not be used on neonates.

The blood glucose

If the meters and test strips are exposed to a considerable temperature variation, please wait 30
minutes before measurement.

- 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.

3.0 µL 4.0 µL1.0 µL 1.5 µL 2.0 µL

1514

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mylife Pura test strip

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mylife Pura test strip

View window
This window is yellow before applying
blood sample. It gradually turns red

with blood.as it fills

Hand bar
Grip here to insert
test strip into meter.

Sample entry

µL

Apply a drop of blood or control solution here.
The test only 1.0 of blood. requires

Electrode
Sensing signal output terminals.

contacts

Gold electrodes
Electrochemical sensor

Indication symbol
Insert test strip with indication
symbol upfront and down towards
meter.

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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 the test 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.

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mylife Pura

- If the meter and test strips are exposed to considerable temperature variation, please wait
30 minutes before measurement.