mylife PURA X User Manual
Preface
32
Intended use
TM®
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
TM
strips 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.
TMTM
The 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 mylife
TM
Lancets as lancets; and the mylife Control control solution as control solution, for short.
54
About BGMS
Package of
meter
test strip
TM®
mylife Pura
TM®
mylife Pura BGMS
TM®
mylife Pura
TM®
Precautions for mylife Pura BGMS
TM®
mylife Pura
Table of contents
Table of contents
Testing procedure
Performing a
Alternative site testing (AST)
View window appearance
TM®
blood glucose test with mylife Pura BGMS
TM
Quality control test with mylife Control control solution
32
24
28
30
16
18
22
23
6
8
12
14
Preparing for test
Setting the date, time 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)
Description of used symbols
TM®
Disposing of the mylife Pura meter, test strips and lancets
40
44
46
Review
Performing a quality control test
Caring for your meter
Recalling test results and averages
your test memory
34
36
37
31
47
48
48
49
49
50
76
Package of BGMS
TM®
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 (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 Puracap ("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
432
5
1
68
7
2017-10
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.
TM®
mylife 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
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
TM®
mylife Pura meter
TM®
mylife Pura meter
1312
TM®
Precautions for mylife Pura BGMS
TM®
Precautions for mylife Pura BGMS
- The minimum blood sample size for testing is µL ( ).0.75
Please 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.
0.75 µLµL
Make 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 example
0.75µL1.0µL1.5µL 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.
1514
TM®
mylife Pura test strip
TM®
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 0.75 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.
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.regulations
4. 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.
after
Setting the date, time 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 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 to
the meter willproperly,
illumination.
150HLA0076
1
5
0
HL
A
0
0
7
6
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