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
1918
NOTE
- 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 changes
mustrepeated 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 blank
perform a
First pressto switchagain for a
further 7that you havesetting
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 , 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.
flashing
It will then
and it
will move
flashing
it will move
flashing
it will move
1)
2)
3)
2120
4. Time format 12/24h selection
With the time format , press the left or right
button to adjust it. Then press the main button to
confirm it and to hours setting.
flashing
it will move
5. Hour setting
With the hour flashing, press the left or right button until
the current hour appears. Then press the main button to
confirm it and it will move to minute setting.
6. Minute setting
With the minute flashing, press the left or right button to
adjust it. Then press the main button to confirm it. Then
it will move to volume setting.
7. Volume setting
With 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 thanit will automatically exit setting mode and
switch off.
8.
After volume settings, beep (if volume is
on). All the settings are and will return to time
volume is off, the display will return to time screen
without
Finishing setting up
you will hear a confirmation
switchedsaved,the display
mode (ifswitched
the beep).
4a)4b)
5)6)
7a)7b)
Setting up your meter – Setting the date, time and volume
Setting up your meter – Setting the date, time and volume
8)
23
22
Switching the backlight on/off
1. How to on the meter
Press the main button or insert a test strip.
2. Manual power off
button for 4 seconds.
3. Auto power off
switch
Press the main
If the 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 theseconds 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.
2524
Hub
Lancet carrier
Plunger
Release button
Depth-adjustable cap
Performing a
TM®
blood glucose test with mylife Pura BGMS
1. Hold the cap in one hand and hold the
hub in the other hand. Bend the cap
2. Pull off the cap.
3. Insert a new disposable lancet firmly into lancet carrier.
4. Twist off and set aside the protective cover of the
disposable lancet.
5. Replace the cap.
depth-adjustable
to one side.
depth-adjustable
depth-adjustable
1
23
45
TM®
Performing a blood glucose test with mylife Pura BGMS
7. Hold the hub in one hand and pull on the plunger the
other hand. Release the
plunger, automatically 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 is now ready to use.
test strip
test
test switched
6
7
6. Choose by rotating the top portion of the
cap until the depth the window. Settings are
based
penetration depthdepth-adjustable
required settingis indicated in
on skin type " " for soft or thin skin; " " for average skin; " "
for thick or calloused skin.
8
NOTE
The meter will automatically detect number
on
the code
the test strip.
109
Safety switch
27
26
11. A blood drop symbol appears and is accompanied by a
further beep (if volume is on).
12. Place the lancing device against your fingertip and
press the release button.
switchedThe blood
sample must then be applied within the next two
minutes.
13. Touch and hold the drop on the edge of sample entry
until you hear a beep (if volume is switched on) and the
view window is totally filled with blood. If the view
window is not completely filled, or the test does not
start, please discard the test strip and repeat the test
with a new test strip.
14. You will see the countdown mode on the screen. After 5
seconds, the test result will appear.
15. Pull off the
Without touching the used disposable lancet, stick the
lancet tip into protective cover.
16. the release button one hand ee 16,
step 1) and pulling on the plunger the other hand
ee 16, step 2) will safely eject the used lancet.
17. the used lancet into an appropriate puncture-
proof or biohazard container.
18. Replace the cap after finishing the test.
depth-adjustable cap of the lancing device.
its
Pressingwith(sfigure
with
(sfigure
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 "Errorif you apply blood
too soon. repeat the test with a new test strip.
- Record the date opening of a new test strip vial. Discard the
6 months opening.
present
"
"
If this occurs,
of firsttest strip
vial after first
- Always keep the metal contact points of the test strip entry point clean. If
any dust or impurities are present, please clean with a small soft brush,
otherwise the meter may not work correctly when you insert a test strip.
18
1211
Performing a
TM®
blood glucose test with mylife Pura BGMS
TM®
Performing a blood glucose test with mylife Pura BGMS
NOTE
Please dispose of the used test strip and/or the
puncture-proof or biohazard container for your used
lancets according to your local regulations.
13a
14
13b
13c
2017-10
29
28
Alternative site testing (AST)
Alternative site or forearm blood sampling testing: Palm
Pressing for
a few seconds
1. clear and follow on
pages 24 to 26.
2. Massage the puncture area of palm or forearm for a few
seconds.
3.
clear cap
4. Press the release button.
5. Continue holding the lancing device against
and gradually increase pressure for a few
seconds until the blood sample size is sufficient.
6.
to discard the used
disposable lancet.
Selectcap ("AST")steps 1 to 11
Immediately after massaging the puncture area, press
and hold the lancing device with the against it.
the
puncture site,
Follow steps 13 to 14 on page 26 to complete the test.
Follow steps 15 to 18 on page 277.
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 flow taken from is slower than , we
recommend using the lancing device with for testing other than
fingertip.
blood glucosevary
conditions,rapid changes in glucose levels following a drink or a meal, an
insulin dose, or exercise.the fingertip
or hypoglycemia unawareness.
changes
forearm or palmfrom fingertip
clear cap ("AST")at sites
Alternative site testing (AST)
3a
3b
Releasing
button
45
30
View window appearance
Make sure your blood sample covers the
whole area of the view window to get an
accurate test result. blood
sample will
the test with
a new test strip.
An insufficient
result in an error message
("Er4"). If this occurs, repeat
Insufficient blood sampleSufficient blood sample
PRECAUTION
- Check the date printed on the vial every time you use a test strip. Do not
use expired test strips.
- Use each test strip immediately after removing from the vial.
- Do not reuse test strips.
-
- the blood drop only to the sample entry of the test strip.
- Please do not drip or inject the blood sample directly sample
entry of test . Doing contaminate the meter or
cause and is not recommended.
expirytest strip
If the meters and test strips are exposed to a considerable temperature variation, please
wait 30 minutes before measurement.
Present
onto the
strip using a syringeso may
damage,
Theeter displays results between 0.6 and 33.3 mmol/L. If your test result is
below 0.6 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 their instruction for therapy.
BGMS(above 33.3
mmol/L),using
professional or follow their instruction for therapy.
TM®
"Lo" and "Hi" readings of mylife Pura meter
31
NOTE
- If your blood glucose result is unusually high or low, or if you question your testing
results, repeat the test using a new test strip function. You can also run a quality control
test (see page 32) to check your meter and test strip. If the test result remains unusually
high or low, contact your healthcare professional immediately or follow their instruction
for therapy.
- If you are experiencing symptoms that are not consistent with your blood glucose test
results and you have followed all instructions in this manual, contact your healthcare
professional immediately or follow their instruction for therapy.
If control solution results are out of range, your BGMS may not be working properly. Repeat the
quality control test. If your control solution results do not use the
BGMS. Ypsomed customer service (see page 48).
are still outside the range,
Contact your local
33
32
TM
Quality control test with mylife Control control solution
PRECAUTION
Each time you open a new bottle of control solution, write the
discard date on the label. solution is good for 3
months after opening the bottle, or until the date printed
on the label, whichever comes first.
The control
expiry
Possible reasons
- our control solution has expired or has been opened for more than 3 months.
expired or has been opened for more than 6 months.
- Your control solution is diluted.
has been left open
The test procedure was not performed
- Your control solution test has been performed out of normal temperature 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 TMtest with mylife Control control solution
Please use control solution tested with BGMS under control solution mode. If the test result is
within the control solution range printed on the strip vial label, the BGMS passes
control test. That means your BGMS is working correctly.
the quality
Example of control solution range
printed on your test strip vial label.
Control solution range mg/dL mmol/L
Low 31-52 1,7-2,9
Normal 83-113 4,6-6,3
High 237-321 13,2-17,8
Control solution range:
When should a quality control test be performed?
Whenever you want to check your BGMS is working
Whenever you want to practice testing and check correct procedure.
whether or notproperly.
Example of date:expiry
Exp. date 2017-10
NOTE
Control solution test results do not represent your blood
glucose level.
2017-10
35
34
9. replace the cap on the control solution
bottle.
10. The control solution result appears. Compare your quality control test result
to the control solution range printed on the test strip vial label.
Clean the top of the cap and tightly
Performing a quality control test
CLOSE
1. Take one test strip from vial and recap immediately.
2. Insert the test strip with into
test strip port.
3. While the blood drop symbol press and hold the main
button for 3 seconds until the "CS" symbol appears.
4. You will see " " and "CS" symbols on the screen,
prompting you to apply solution.
5.
Open the bottle and the cap the table.
6. Drip a drop of control solution on the top of the cap.
7. Gently touch the sample entry of the test strip
control solution on top of the cap.
indication symbol upfront and down
is flashing,
more than
flashing
the control
Before opening the cap, shake the bottle of control solution well.
placeupright on
onto the drop of
8. When you hear a beep (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 solution to the sample
entry on test strip because the meter is still an internal check. If you do so, the
meter will show " " and "Error", accompanied by beeps (if volume is on).
- Do not drip the control solution
The reagent on be sucked into the bottle of control
solution and cause the . Doing this
contaminate the meter via the test strip port.
- Do not touch the of the control solution bottle. If you have touched it,
please clean with water.
test resultsincluded inreading calculations,
can stillwith the
suggested temperature rangethe control℃(59~104°F).
present
performing
switched
directly from the bottle onto the sample entry of the test
strip.
the test strip could
couldsolution's degenerationcould
potentionally
nozzle
it carefully
OPEN
4
5
6
2
7
1
8
37
36
Recalling test results and averages
Theeter is able to store 500 test results with time and date automatically. If your meter has
stored 500 results, which is the maximum memory, the newest test result will replace the oldest
one. To recall your test memory, the meter without a test strip inserted.
m
switch on
2. To press main button again, and you will enter the averages
the button and the display shows "AVG" in the upper right corner and
the average value for the day. By continually pressing the right button you will get to
7-day, 14-day, 30-day and 90-day of your blood glucose values. You will see
the number of calculated days in the lower left corner and the number of calculated readings in
the lower right corner.
end review of tests in memory,
mode. Pressright hand
handthe
1-day,averages
1. Press the main button to switch from the time mode to the memory First
you will see the symbol in the upper left corner of the display. When you
press the button, the latest 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 handis
handpreviousdate
display,
Caring for your meter
Maintenance
Keep your meter and test strip free of dust, water or any other liquid. Store the meter in the
carrying case If is dropped or damaged, perform a quality control test
before doing a blood glucose test
Cleaning
Clean the outside of the meter with a damp cloth and mild soap
when not in use.the meter
, to insure that the meter is still functioning correctly.
the meter
or detergent. Do not wet the test
strip port.
Always keep the metal contact points of the test strip entry point clean. If any dust or impurities
are present, please clean with a small soft brush, otherwise the meter may not work correctly
when you insert a test strip.
NOTE
The right hand button is for reviewing the tests in ascending order, and the left hand button
is for reviewing in descending order. The number "1" is the latest test result, while the
number "500" is the oldest test result.
38
Recalling test results and averages
4. Quick searching: If you want to see all values automatically displayed in sequence, first enter
the memory mode. Then the right or left button for 2 seconds.
Anytime you want to just release the button.
pressThe right hand button is
for scrolling the most recent to oldest results; the left hand button scrolls from the oldest to the
most recent.stop,The current value will be
displayed. Any particular reading can thus be checked.
5. Reading immediately after test: If you have just finished a test, press the main button to enter
the "mem" (memory) mode and review this latest test result.
NOTE
Your control solution will be automatically but be
recalled. CS symbol memory .
test resultsnon-averaged,may still
They will appear under the ""in themode
3. Non-averaging set and canceled:
You may select the unwanted or doubtful test exclude them from the average
calculation, after
After
your you can exclude an unwanted
the
button pressed and press the main button simultaneously to confirm the value as
"non-average".
. This value flagged by the
If you want to cancel this setting, stay in the test mode . the
button until the "NO AVG" symbol changes to "AVG" in the upper corner of the
screen. 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 you see the symbol "NO AVG" in the top right hand corner of the screen. Keep
right hand
After removing the test strip from the meter the measured test result will be
stored in memory mode and cannot be amendedwill now remain
"NO AVG" symbol.
non-average""Pressright hand
right hand
button
now be
Recalling test results and averages
NOTE
- The average function is related to the time setting. Time and date must be set correctly to
PRECAUTION
-
- results, control solution results and test results out of normal
temperature range ( are not in the
Time and date must be set in order to activate the average function.
"Lo" and "Hi"recorded
<10℃ and >40°C resp. <50°F and >104°F).included
averages calculations.
39
enable averages to show. For example, the 14-day average will show no figure if there
have been no tests recorded in the 14 days prior to, and including, the current date.
""
have a resultmemory mode ("mem"), this action cannot be performed.
- The non-averaging/re-averaging function only works in the test mode and when you
. In the
41
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Error messages and trouble shooting
Er1 - The inserted test strip has been used or . Please
use a new test strip from vial.
Er2 - Meter has malfunctioned. a quality control
or reinstall the batteries to check if the meter
works
Er3 - Signal transmission is disrupted; repeat the
is damaged
Performtest with
control solution,
properly. Check once more meter function.
test with a new test
strip.
Er4 - Applied blood volume is insufficient, please repeat the test with
a new test strip.
If theappears,(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.
flashesChange
possibleThe test may still be performed.
flashingbattery
powerThe meter cannot perform
Error messages and trouble shooting
NOTE
- When the meter backlight doesn't function, please change your backlight battery.
- When the backlight battery runs out of power, the meter will still work properly, but
without backlight illumination.
1a
2
1b
43
42
Error messages and trouble shooting
Sampling error
Please do not the blood drop to the sample entry of the test strip before
the meter displays . If you do so, the meter will display "Error" and " "
accompanied by beeps (if volume is on). Please discard the test strip
and repeat the test with a new
present
" "
switched
one.
Meter malfunction
If the meter be started, please follow the steps below:
1. Open the battery cover, remove the batteries.
2. Wait for 5 and insert
the batteries as Meter activation and battery change on pages 16 to 17.
The meter should be working normally after above steps. If not, please contact
your local Ypsomed customer service (see page 48).
cannot
minutes or press the main button several times until the screen is blank
described in ""
completing the
Error messages and trouble shooting
Temperature error
In order to accurate test perform testing between 10~40 (50~104).ensureresults,°C°F
1. When the ambient temperature is 0~9 (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
environment temperature and repeat the
test after 30 minutes.
°C°F°C°F
flashesperform
within these temperature ranges it may
" "
; repeatwithin the normal
If the meters and test strips are exposed to a considerable temperature
variation, please wait 30 minutes before measurement.
°C°F°C°F
cannot performflash together
showing " " screen
within the normaloperating range
1a
3
Code error
The test strip is not inserted correctly. Please reinsert the test strip following the
instructions of use. If "Code Error" reappears, it could mean you are using the
wrong test strip. After making sure you are using the right test strip and the test
strip is inserted correctly, "Code Error" still appears, please contact your local
Ypsomed customer service (see page 48).
1b
45
44
Hematocrit
Power supply
Meter battery life
Meter dimension
Meter weight
30 - 57 %
2 CR2032 batteries
About 1,000 tests
90.6 mm x 46.0 mm x 16.5 mm (H x W x D)
53.0 g ± 5.0 g with batteries
TM®
Specification of mylife Pura meter
Monitor
Display area
Meter storage conditions
Test strip storage conditions
Meter data transmission management
Memory capacity
10 - 40 ℃ (50 - 104 ℉)
10 - 90 %
Automatic shutdown
the main button
2 minutes after last user
action. 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 can be transmitted to a computer with the PC-Link
adapter. The data being managed by the four different
®®
softwares: Diabass, diasend , SiDiary and mylife™ Software.
LCD display
47.0 mm x 33.5
-10 - 60 ℃ (14 - 140 ℉)
4 - 30 ℃ (39 - 86 ℉),< 90 % relative humidity
mm (H x W)
47
46
TM®
Limitations of mylife Pura meter
NOTE
- Do not use this meter close to strong electromagnetic radiation sources, in order to avoid
interference with normal operation.
- Keep the meter free of dust, water or any liquid.
Meter data transmission management (optional)
- The BGMS is not intended for serum or plasma testing (for capillary whole blood testing only).
- Inaccurate 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 transmitted to the computer with mylife Pura PC-Link adapter. The
®®
data must be managed by four different softwares: Diabass, diasend , SiDiary and mylife™
Software.
48
Warranty
49
The manufacturer warrants that your meter will be free from defects in materials
and workmanship for four years from the date of purchase.
This warranty does not apply to the performance of ameter that has been altered,
misused, tampered with or abused in any way.
This warranty applies only to the original purchaser of the meter.
Please complete and return the enclosed warranty card to your local Ypsomed affiliate.
TM®
mylife Pura
TM®
mylife Pura
TM®
mylife Pura
TM
This warranty does not apply for any damage caused by the use of other test strips than mylife
®
Pura test strips.
TM®
If the mylife Pura meters and test strips are exposed to a considerable variation in temperature,
please wait 30 minutes before measurement.
Disposing of the
TM®
mylife Purameter, test strips and lancets
NOTE
m
mm
batteriesfollowingdisposal regulations
- Used test strips and lancets are potentially infected. Please dispose of the used test strip
and/or the puncture-proof or biohazard container for your used lancets according to your
local regulations.
- During blood glucose measurement, theeter 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 comprehensive service to our customers. Please review all the
instructions to ensure that you are performing all the steps correctly. If you have any questions, or
TM®
in event of any problems with mylife Pura products, please contact your local Ypsomed
customer service.
Description of used symbols
For in vitro diagnostic use
Temperature limitations
Manufacturer
LOT
IVD
Lot number
Use by
For single use only
Sterilized using irradiation
EC
REP
CE Mark with number of Notified Body
Consult instructions for use
EU Representative
Serial number
Reference number
CE Mark
Caution (consult instructions for
use and warnings)
Distribution UK:
Ypsomed Ltd.
1 Park Court, Riccall Road
Escrick, North Yorkshire
UK-YO19 6ED
Customer Care: 0344 856 7820
info@ypsomed.co.uk
www.mylife-diabetescare.co.uk
Main parts
TM®TMTMTM
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 Representative9442 Berneck, Switzerland
TM
mylife Softlance
Bionime Corporation
No. 100, Sec. 2, Daqing St., South Dist., Taichung City 40242, Taiwan
The 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
Product complies with Medical Device Directive 93/42/EEC (CE 0197).
Emergo Europe, Molenstraat 15, 2513 BH The Hague, The Netherlands
50
Version: June 2016
Distribution UK:
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