Cilag Z01 Blood Glucose Meter With Bluetooth 4.0 Low Energy User Manual
Cilag GmbH International Blood Glucose Meter With Bluetooth 4.0 Low Energy Users Manual
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Contents
- 1. Users Manual
- 2. Users manual
Users Manual
Blood Glucose Monitoring System
Instructions
for Use
Owner's
Booklet
1
Owner's Booklet
Blood Glucose Monitoring System
2
Thank you for choosing OneTouch
Verio Flex™!
The OneTouch Verio Flex™ Blood Glucose Monitoring
System is one of the latest product innovations from
OneTouch®.
Your OneTouch Verio Flex™ Meter is designed to connect
(sync) with a variety of devices running software
applications that let you review and graph your results,
and help identify patterns. Meter results are sent to the
compatible devices either through BLUETOOTH® Smart
(wireless) or USB cable connection.
Every OneTouch® Meter is designed to help you test your
blood glucose and manage your diabetes.
This Owner's Booklet offers a complete explanation of how
to use your new meter and testing supplies. It reviews the
do's and don'ts of testing your blood glucose level. Please
keep your Owner's Booklet in a safe place; you may want
to refer to it in the future.
We hope OneTouch® products and services will continue to
be a part of your life.
3
Meter symbols and icons
Meter Power
Low Battery
Battery Empty
Control Solution
Syncing
BLUETOOTH® Smart Feature On
History Mode (Past results)
Apply Sample
Range Indicator Arrow
Setting Mode
Compatible Wireless Devices
Visit www.OneTouch.ca for information on which wireless
devices are compatible with your OneTouch Verio
Flex™ Meter, and where/how to download the software
application on your compatible wireless device.
4
Other symbols and icons
Cautions and Warnings: Refer to the
Owner's Booklet and inserts that came with
your system for safety-related information.
Direct current
5
Before you begin
Before using this product to test your blood
glucose, carefully read this Owner's Booklet, and
the inserts that come with the OneTouchVerio® Test
Strips, OneTouchVerio® Control Solution and the
OneTouch®Delica® Lancing Device.
IMPORTANT SAFETY INSTRUCTIONS:
• This meter and lancing device are for single patient use
only. Do Not share them with anyone else, including
family members! Do Not use on multiple patients!
• After use and exposure to blood, all parts of this kit are
considered biohazardous. A used kit may potentially
transmit infectious diseases even after you have
performed cleaning and disinfection.
6
Intended use
The OneTouch Verio Flex™ Blood Glucose Monitoring
System is intended to be used for the quantitative
measurement of glucose (sugar) in fresh capillary whole
blood samples drawn from the fingertip. The system is
intended to be used by a single patient and should not be
shared.
The OneTouch Verio Flex™ Blood Glucose Monitoring
System is intended for self-testing outside the body
(in vitro diagnostic use) by people with diabetes at home
and with their healthcare professionals in a clinical setting
as an aid to monitor the effectiveness of diabetes control.
The OneTouch Verio Flex™ Blood Glucose Monitoring
System is not to be used for the diagnosis of or screening
of diabetes or for neonatal use.
7
Test principle
Glucose in the blood sample mixes with the enzyme
FAD-GDH (see page99) in the test strip and a small
electric current is produced. The strength of this current
calculates your blood glucose level. It then displays the
blood glucose result and stores it in the meter memory.
Use only OneTouchVerio® Control Solution and
OneTouch Verio® Test Strips with the OneTouch Verio
Flex™ Meter.
BLUETOOTH® Smart wireless
technology
BLUETOOTH® Smart wireless technology is used by some
smartphones and many other devices. Your OneTouch
Verio Flex™ Meter uses BLUETOOTH® Smart wireless
technology to pair and to send your glucose results to
compatible wireless devices.
The OneTouch Verio Flex™ Meter is designed to work with
the OneTouchReveal® Mobile App.
NOTE: Some diabetes management apps, including the
OneTouchReveal® Mobile App, may not be available
in your country. Visit www.OneTouch.ca to learn if the
OneTouchReveal® Mobile App is available in your country.
8
Visit www.OneTouch.ca for information on which wireless
devices are compatible with your OneTouch Verio
Flex™ Meter, and where/how to download the software
application on your compatible wireless device.
When using the OneTouch Verio Flex™ System, we
suggest you pair your OneTouch Verio Flex™ Meter with
a compatible wireless device and track your results. See
page29 for pairing instructions.
This device complies with Industry Canada license-exempt
RSS standard(s). Operation is subject to the following two
conditions: (1) this device may not cause interference, and
(2) this device must accept any interference, including
interference that may cause undesired operation of the
device.
If you experience meter interference problems, try moving
your meter away from the source of the interference.
You can also move the electronic device or its antenna to
another location to solve the problem.
These guidelines help ensure that your meter will not
affect the operation of other nearby electronic devices.
Additionally, other electronic devices should not affect the
use of your meter.
9
WARNING: The BLUETOOTH® Smart feature on your
meter sends test results to your compatible wireless device.
To prevent other people's results from being sent to your
compatible wireless device, Do Not let anyone else use your
meter to test their blood glucose. This meter is for single
patient use only.
WARNING: In locations where cell phone use is not
permitted, such as hospitals, some healthcare professional
oces and airplanes, you should turn the BLUETOOTH®
Smart feature o. See page27 for more information.
BLUETOOTH® Smart trademark
The BLUETOOTH® word mark and logos are registered
trademarks owned by Bluetooth SIG, Inc. and any use of
such marks by LifeScan Scotland Ltd. is under license.
Other trademarks and trade names are those of their
respective owners.
10
Table of Contents
1 Getting to know your system ...................................12
2 Setting up your system ............................................22
Setting up your meter .....................................................22
Connecting to a compatible wireless device ............... 27
Turning the meter off ...................................................... 33
3 Taking a test ..............................................................34
Testing your blood glucose ............................................34
Testing with control solution..........................................58
4 Reviewing past results ............................................68
11
5 Editing Your Settings ............................................... 74
Editing time and date ..................................................... 74
Editing your range limits ................................................ 75
6 Caring for your system ............................................78
7 Battery .......................................................................82
8 Troubleshooting your system .................................86
9 Detailed information about your system .............96
10 Index ........................................................................108
12
1 Getting to know your
system
Your OneTouch Verio Flex™ Blood
Glucose Monitoring System
Included with your kit:
OneTouch Verio Flex™ Meter
(CR2032 lithium coin cell
battery included)
OneTouch® Delica®
Lancing Device
OneTouch® Delica®
Lancets
13
1
Getting to know your system
NOTE: If any item is missing or defective in your kit,
contact the OneTouch® Customer Care Line at
1800 663-5521, Monday-Friday, 9am – 8pm Eastern,
6am – 5pm Pacific, or visit www.OneTouch.ca.
NOTE: If another type of lancing device was included,
see the separate instructions for that lancing device.
14
1 Getting to know your system
Available separately:
Items pictured below are required, but may not be
included in your kit:
They are sold separately. Refer to your meter carton for a
list of included items.
OneTouchVerio®
Mid Control
Solution*
OneTouchVerio®
Test Strips*
*OneTouchVerio® Control Solution and OneTouch Verio®
Test Strips are available separately. For availability of
test strips and control solution, contact Customer Service
or ask your pharmacist or healthcare professional.
WARNING: Keep the meter and testing supplies away
from young children. Small items such as the battery door,
batteries, test strips, lancets, protective covers on the
lancets, and control solution vial cap are choking hazards.
Do Not ingest or swallow any items.
15
1
Getting to know your system
This page left blank intentionally.
16
1 Getting to know your system
Meter
Getting to know your OneTouch Verio
Flex™ Blood Glucose Monitoring
System
17
1
Getting to know your system
Meter
18
1 Getting to know your system
Test strip
Getting to know your OneTouchVerio®
Test Strip
19
1
Getting to know your system
The Range Indicator feature
The OneTouch Verio Flex™ Meter automatically lets you
know if your current result is below, above or within your
range limits. It does this by displaying your current result
with a Range Indicator Arrow, pointing to a corresponding
Range Indicator Colour Bar below the meter display. Use
the Range Indicator Arrow and Colour Bar together to
interpret your results.
20
1 Getting to know your system
3 Possible Range Indicator Displays
A Range Indicator Arrow will
appear just below your result
after each test depending upon
how you set your low and high
range limits in the meter.
Things you should know before
using the Range Indicator feature:
• The meter comes with pre-set
range limits. The pre-set low
range limit is 4.0mmol/L and
the pre-set high range limit is
10.0mmol/L. You can change
these limits as needed to meet
your needs. See page75 for
details on the pre-set range
limits and on editing your
range limits.
• If you decide to change
your range limits, the Range
Indicator Arrows stored with
previous results in meter
memory will not change.
However, any new tests will
display Range Indicator Arrows
which reflect your changes.
Example
Below Range Result
Example
In Range Result
Example
Above Range Result
21
1
Getting to know your system
This page left blank intentionally.
22
2 Setting up your system
Setting up your meter
Turn your meter on
To turn your meter on, press
and hold until the start-up
test screen appears. Once the
device is on, release . You
can also turn the meter on by
inserting a test strip.
CAUTION:
If you see any missing segments within the start-up
screen, there may be a problem with the meter. Contact
the OneTouch® Customer Care Line at 1800 663-5521.
NOTE: If you turned the meter on for the first time by
inserting a test strip instead of pressing , you will not
be able to perform a glucose test until you complete the
first time setup.
Every time you turn your meter on, a start-up screen will
appear for a few seconds. All segments of the display
should appear briefly, indicating your meter is working
properly. If the meter does not power on, check the
battery.
23
2
Setting up your system
First time setup
To turn your meter on, press and hold until the start-
up screen appears. Once the device is on, release .
The meter will now automatically prompt you to set the
time and date. The SET icon will appear on the screen to
indicate that the meter has entered setup mode.
Setting the time
Hour will flash
• If the hour displayed
is correct, press to
confirm.
• If the hour displayed is not
correct, press or to
change the hour and press
to confirm.
Minutes will flash
• If the minutes displayed
are correct, press to
confirm.
• If the minutes displayed are
not correct, press or
to change the minutes and
press to confirm.
24
2Setting up your system
Setting the date
After completing the time setup, the meter will
automatically move to date setup.
Year will flash
• If the year displayed
is correct, press to
confirm.
• If the year displayed is not
correct, press or to
change the year and press
to confirm.
AM/PM will flash
• If the AM/PM displayed
is correct, press to
confirm.
• If the AM/PM displayed is
not correct, press or
to change AM/PM and press
to confirm.
25
2
Setting up your system
Setting the date
After completing the time setup, the meter will
automatically move to date setup.
Month will flash
• If the month displayed
is correct, press to
confirm.
• If the month displayed is
not correct, press or
to change the month
and press to confirm.
Day will flash
• If the day displayed is
correct, press to
confirm.
• If the day displayed is not
correct, press or to
change the day and press
to confirm.
You are now ready to take
a test. See the section
Testing your blood glucose
in Chapter 3.
26
2Setting up your system
Adjusting the time and date settings after
first time setup
You can adjust the meter's time and date settings after
first time setup. Press and hold to turn the meter on,
then press and hold and at the same time. The SET
screen will appear. See page74.
After adjusting the settings, your meter will exit settings
mode and your last result screen will appear.
NOTE: After completing first time setup, a screen with
three dashes will appear. Once you begin testing, your last
result will appear in place of the three dashes, along with
the date and time the test was taken.
27
2
Setting up your system
Connecting to a compatible wireless
device
Turning the BLUETOOTH® Smart feature on
or o
In order to connect your meter with your compatible
wireless device, the BLUETOOTH® Smart feature will
need to be turned on. The symbol will appear on the
meter screen when the BLUETOOTH® Smart feature is
on. When the symbol is not present on the screen the
BLUETOOTH® Smart feature is off.
• To turn the BLUETOOTH® Smart feature on press
and at the same time.
• To turn the BLUETOOTH® Smart feature off press
and at the same time.
The symbol indicates
the BLUETOOTH® Smart
feature is on
NOTE: The BLUETOOTH® Smart feature will turn OFF
during a blood glucose test.
28
2Setting up your system
Pairing Overview
Pairing allows your OneTouch Verio Flex™ Meter to
communicate with compatible wireless devices. The
devices must be within 8meters of each other to pair and
sync. Download the OneTouchReveal® Mobile App from
the appropriate app store before pairing your meter and
compatible wireless device.
NOTE: Some diabetes management apps, including the
OneTouchReveal® Mobile App, may not be available
in your country. Visit www.OneTouch.ca to learn if the
OneTouchReveal® Mobile App is available in your country.
Multiple OneTouch Verio Flex™ Meters can be paired
with your compatible wireless device. For example, your
compatible wireless device can be paired with a meter at
home and another at work. To pair multiple meters, repeat
the pairing instructions for each meter. See page29 for
pairing instructions.
Your OneTouch Verio Flex™ Meter can be paired with
multiple compatible wireless devices. To pair multiple
compatible wireless devices, repeat the pairing
instructions for each compatible wireless device.
29
2
Setting up your system
Pairing Instructions
1. Start by turning your meter on using the button
2. The BLUETOOTH® Smart feature is turned on by
pressing and together
The symbol will appear to
indicate that the BLUETOOTH®
Smart feature is on.
3. Open the OneTouchReveal® Mobile App and follow
instructions to pair meter with your compatible
wireless device
30
2Setting up your system
4. Look for "OneTouch" and the last 4 characters of the
meter serial number on the compatible wireless device
display to correctly identify your meter
31
2
Setting up your system
5. When prompted by the OneTouchReveal® Mobile App,
the meter will display a six digit PIN number
Enter the PIN number into your wireless compatible device
using the keypad on your compatible wireless device.
Example of PIN number
display on meter
CAUTION:
Make sure the PIN you enter on your compatible device
matches the PIN on your meter display. If a PIN number
unexpectedly appears on your meter display, cancel the
PIN request by either inserting a test strip to take a test or
press the button to enter History Mode.
6. Wait for your compatible wireless device to indicate
that your meter and compatible wireless device are
paired
32
2Setting up your system
Syncing to send results wirelessly to the
OneTouchReveal® Mobile App
After pairing the meter with your compatible
wireless device, you are ready to send results to the
OneTouchReveal® Mobile App.
1. Open the OneTouchReveal® Mobile App on your
compatible wireless device
2. Press and hold to turn the meter on and make sure
the BLUETOOTH® Smart feature is ON as indicated by ( )
If needed, press and at the same time to turn the
BLUETOOTH® Smart feature on.
The Sync symbol ( )
flashes on the meter display.
"Syncing Data" will appear
on the app to notify you that
the meter is communicating
with the app. Syncing Data
After syncing, the Sync symbol will disappear, the
"Syncing Data" message will disappear on the app, and
the app will display a list of any new results sent from the
meter.
NOTE: Inserting a test strip during the transmission will
cancel the transfer of all results. The flashing symbol
appears on the screen and you can proceed with testing.
33
2
Setting up your system
Turning the meter o
There are three ways to turn your meter off:
• Press and hold for several seconds until the meter
turns off.
• Remove the test strip.
• Your meter will turn off by itself if left alone for two
minutes.
NOTE: Following a glucose test, the meter will still be
available for BLUETOOTH® Smart connection for up to 4
hours. See page69 for more details.
34
Testing your blood glucose
Preparing for a blood glucose test
NOTE: Many people find it helpful to practice testing with
control solution before testing with blood for the first
time. See page58.
Have these things ready when you test:
OneTouch Verio Flex™ Meter
OneTouchVerio® Test Strips
Lancing device
Sterile lancets
3 Taking a test
NOTE:
• Use only OneTouchVerio® Test Strips.
• Unlike some blood glucose meters, no separate step
to code your OneTouch Verio Flex™ System is required.
• Testing must be done within operating temperature
range (6-44°C).
• Make sure your meter and test strips are about the
same temperature before you test.
• Keep test strips in a cool, dry place between 5°C
and 30°C.
35
3
Taking a test
• Do Not test if there is condensation (water build-up)
on your meter. Move your meter and test strips to a
cool, dry spot and wait for the meter surface to dry
before testing.
• Do Not open the test strip vial until you are ready to
remove a test strip and perform a test. Use the test
strip immediately after removing it from the vial.
• Tightly close the cap on the vial immediately after use
to avoid contamination and damage.
• Store unused test strips only in their original vial.
• Do Not return the used test strip to the vial after
performing a test.
• Do Not re-use a test strip that had blood, control
solution, or any contaminants applied to it. Test strips
are for single use only.
• With clean, dry hands, you may touch the test strip
anywhere on its surface. Do Not bend, cut or modify
the test strip in any way.
• When you first open a vial of test strips, record the
discard date on the label. Refer to the test strip insert
or vial label for instructions on determining the
discard date.
36
3 Taking a test
• Comparing your blood glucose test results taken with
this meter to your results taken from a different meter
is not recommended. Results may differ between
meters and are not a useful measure of whether your
meter is working properly.
IMPORTANT: If another person assists you with testing,
the meter and lancing device should always be cleaned
prior to use by that person. See page78.
CAUTION:
• The OneTouch Verio Flex™ Blood Glucose Monitoring
System should not be used for patients within 24 hours
of receiving a D-xylose absorption test as it may cause
inaccurately high results.
• Do Not use the OneTouchVerio® Family of Meters when
PAM (Pralidoxime) is known or suspected to be in the
patient's whole blood sample.
• Do Not use your test strips if your vial is damaged or
left open to air. This could lead to error messages or
inaccurate results. Contact the OneTouch® Customer
Care Line at 1 800 663-5521 immediately if the test strip
vial is damaged.
37
3
Taking a test
• If you cannot test due to a problem with your testing
supplies, contact your healthcare professional. Failure
to test could delay treatment decisions and lead to a
serious medical condition.
• The test strip vial contains drying agents that are
harmful if inhaled or swallowed and may cause skin or
eye irritation.
• Do Not use test strips after the expiration date (printed
on the vial) or the discard date, whichever comes first,
or your results may be inaccurate.
38
3 Taking a test
Getting to know your OneTouch®Delica®
Lancing Device
39
3
Taking a test
NOTE:
• The OneTouch®Delica® Lancing Device uses ONLY
OneTouch®Delica® Lancets.
• If another type of lancing device was included, see the
separate instructions for that lancing device.
• The OneTouch Verio Flex™ Blood Glucose Monitoring
System has not been evaluated for Alternate Site
Testing (AST). Use only fingertips when testing with
the system.
40
3 Taking a test
Lancing precautions
CAUTION:
To reduce the chance of infection and disease spread by
blood:
• Make sure to wash the sample site with soap and warm
water, rinse and dry before sampling.
• The lancing device is intended for a single user. Never
share a lancet or lancing device with anyone.
• Always use a new, sterile lancet each time you test.
• Always keep your meter and lancing device clean (See
page78).
• The meter and lancing device are for single patient use
only. Do Not share them with anyone, including family
members! Do Not use on multiple patients!
• After use and exposure to blood, all parts of this kit
are considered biohazardous. A used kit may transmit
infectious diseases even after you have performed
cleaning and disinfection.
41
3
Taking a test
Preparing the lancing device
1. Remove the lancing device cap
Remove the cap by turning
it counterclockwise and then
pulling it straight off of the
device.
42
3 Taking a test
2. Insert a sterile lancet into the lancing device
Align the lancet as shown
here, so that the lancet fits
into the lancet holder. Push
the lancet into the device
until it snaps into place and is
fully seated in the holder.
Twist the protective
cover one full turn until it
separates from the lancet.
Save the protective cover
for lancet removal and
disposal. See page55.
43
3
Taking a test
3. Replace the lancing device cap
Place the cap back onto the device; turn clockwise to
secure the cap.
Do Not overtighten.
44
3 Taking a test
4. Adjust the depth setting
The lancing device has seven
puncture depth settings,
numbered 1 through 7.
Smaller numbers are for a
shallower puncture and the
larger numbers are for a
deeper puncture. Shallower
punctures work for children
and most adults. Deeper
punctures work well for people with thick or callused skin.
Turn the depth wheel to choose the setting.
NOTE: A shallower fingertip puncture may be less painful.
Try a shallower setting first and increase the depth until
you find the one deep enough to get a blood sample of
the proper size.
5. Cock the lancing device
Slide the cocking control
back until it clicks. If it does
not click, it may already
have been cocked when you
inserted the lancet.
45
3
Taking a test
Preparing the meter
1. Insert a test strip to turn the meter on
Insert a test strip into the test strip port with the gold side
of the test strip and the two silver prongs facing you.
NOTE: No separate step to
code the meter is required.
The flashing blood drop icon
() appears on the display.
You can now apply your
blood sample to the test
strip.
46
3 Taking a test
Getting a blood sample from the fingertip
Choose a different puncture site each time you test.
Repeated punctures in the same spot may cause soreness
and calluses.
Before testing, wash your hands thoroughly with warm,
soapy water. Rinse and dry completely.
1. Puncture your finger
Hold the lancing device firmly
against the side of your finger.
Press the release button.
Remove the lancing device
from your finger.
47
3
Taking a test
Getting a blood sample from the fingertip
Choose a different puncture site each time you test.
Repeated punctures in the same spot may cause soreness
and calluses.
Before testing, wash your hands thoroughly with warm,
soapy water. Rinse and dry completely.
1. Puncture your finger
Hold the lancing device firmly
against the side of your finger.
Press the release button.
Remove the lancing device
from your finger.
2. Get a round drop of blood
Gently squeeze and/or
massage your fingertip until
a round drop of blood forms
on your fingertip.
NOTE: If the blood smears or
runs, Do Not use that sample.
Dry the area and gently squeeze
another drop of blood or
puncture a new site.
48
3 Taking a test
Applying blood and reading results
Applying the sample
1. Apply the sample to the test strip
You can apply blood to either side of the test strip.
Apply your sample to the opening of the channel.
Be sure to apply your sample immediately after you get a
drop of blood.
Holding the meter at a
slight angle, guide the
channel to the blood drop.
49
3
Taking a test
Applying blood and reading results
Applying the sample
1. Apply the sample to the test strip
You can apply blood to either side of the test strip.
Apply your sample to the opening of the channel.
Be sure to apply your sample immediately after you get a
drop of blood.
When it touches your
sample, the test strip wicks
blood into the channel.
2. Wait for the channel to fill completely
The blood drop will be drawn into the narrow channel. The
channel should fill completely.
The channel turns red and the meter will count down from
5 to 1.
Blood should not be applied on the top of the test strip or
to the top edge of the test strip.
50
3 Taking a test
NOTE:
• Do Not smear or scrape the sample with the test strip.
• Do Not press the test strip too firmly against the
puncture site or the channel may be blocked from filling
properly.
• Do Not apply more blood to the test strip after you
have moved the drop of blood away.
• Do Not move the test strip in the meter during a test or
you may get an error message or the meter may turn
off.
• Do Not remove the test strip until the result is
displayed or the meter will turn off.
51
3
Taking a test
Viewing your result
Your result appears on the display,
along with the unit of measure,
and the date and time of the test.
After your glucose result appears,
the meter will also display a Range
Indicator Arrow below your glucose
result to indicate if your result is
below, above or within your range
limits (see page19). The arrow
will point to the appropriate Range
Indicator Colour Bar on the meter
as a visual reminder.
Example
Below Range Result
Example
In Range Result
Example
Above Range Result
CAUTION:
Do Not make immediate treatment
decisions based on the Range
Indicator feature. Treatment
decisions should be based on the
numerical result and healthcare
professional recommendation and
not solely on where your result
falls within your range limits.
WARNING: Confirm that the unit of measure mmol/L is
displayed. If your display shows mg/dL rather than mmol/L,
stop using the meter and contact Customer Service.
52
3 Taking a test
Interpreting unexpected results
Refer to the following cautions when your results are
higher or lower than what you expect.
CAUTION:
Low results
If your result is below
4.0mmol/L or is shown
as LO (meaning the result
is less than 1.1mmol/L), it
may mean hypoglycemia (low blood glucose). This may
require immediate treatment according to your healthcare
professional's recommendations. Although this result
could be due to a test error, it is safer to treat first, then do
another test.
NOTE: When your glucose result is below 1.1mmol/L, both
the LO and the Range Indicator Arrow will flash on the
meter screen.
CAUTION:
Dehydration and low results
You may get false low results if you are severely
dehydrated. If you think you are severely dehydrated,
contact your healthcare professional immediately.
53
3
Taking a test
Interpreting unexpected results
Refer to the following cautions when your results are
higher or lower than what you expect.
CAUTION:
High results
• If your result is above 10.0mmol/L, it may mean
hyperglycemia (high blood glucose) and you should
consider re-testing. Talk to your healthcare professional
if you are concerned about hyperglycemia.
• HI is displayed when your
result is over 33.3mmol/L.
You may have severe
hyperglycemia (very high
blood glucose). Re-
test your blood glucose
level. If the result is HI again, this indicates a severe
problem with your blood glucose control. Obtain and
follow instructions from your healthcare professional
immediately.
NOTE: When your glucose result is above 33.3mmol/L,
both the HI and the Range Indicator Arrow will flash on
the meter screen.
54
3 Taking a test
CAUTION:
Repeated unexpected results
• If you continue to get unexpected results, check your
system with control solution.
• If you are experiencing symptoms that are not
consistent with your results and you have followed
all instructions in this Owner's Booklet, call your
healthcare professional. Never ignore symptoms or
make significant changes to your diabetes management
program without speaking to your healthcare
professional.
Unusual red blood cell count
A hematocrit (percentage of your blood that is red blood
cells) that is either very high (above 60%) or very low
(below 20%) can cause false results.
55
3
Taking a test
Removing the used lancet
NOTE: This lancing device has an ejection feature, so you
do not have to pull out the used lancet.
1. Remove the lancing device cap
Remove the cap by turning
it counterclockwise and then
pulling it straight off of the
device.
2. Cover the exposed lancet tip
Before removing the lancet, place the lancet protective
cover on a hard surface then push the lancet tip into the
cupped side of the cover.
56
3 Taking a test
3. Eject the lancet
Slide the ejection control
forward until the lancet
comes out of the lancing
device. Return the ejection
control to its back position.
If the lancet fails to eject
properly, cock the device
again and then slide the
ejection control forward until
the lancet comes out.
57
3
Taking a test
4. Replace the lancing device cap
Place the cap back onto the device; turn clockwise to
secure the cap.
Do Not overtighten.
It is important to use a new lancet each time you obtain a
blood sample. Do Not leave a lancet in the lancing device.
This will help prevent infection and sore fingertips.
58
3 Taking a test
Disposing of the used lancet and test strip
Discard the used lancet carefully after each use to avoid
unintended lancet stick injuries. Used lancets and test
strips may be considered biohazardous waste in your
area. Be sure to follow your healthcare professional's
recommendations or local regulations for proper disposal.
Wash hands thoroughly with soap and water after
handling the meter, test strips, lancing device and cap.
Testing with control solution
Control solution testing precautions
OneTouchVerio® Control Solution is used to check that the
meter and test strips are working together properly and
that the test is performing correctly. (Control solution is
available separately.)
NOTE:
• Use only OneTouchVerio® Control Solution with your
OneTouch Verio Flex™ Meter.
• When you first open a new vial of control solution,
record the discard date on the vial label. Refer to the
control solution insert or vial label for instructions on
determining the discard date.
59
3
Taking a test
• Tightly close the cap on the control solution vial
immediately after use to avoid contamination or
damage.
See page34 for more information on testing.
CAUTION:
• Do Not swallow or ingest control solution.
• Do Not apply control solution to the skin, eyes, ears or
nose as it may cause irritation.
• Do Not use control solution after the expiration
date (printed on the vial label) or the discard date,
whichever comes first, or your results may be
inaccurate.
60
3 Taking a test
When to do a control solution test
• When you open a new vial of test strips.
• If you suspect that the meter or test strips are not
working properly.
• If you have had repeated unexpected blood glucose
readings.
• If you drop or damage the meter.
Preparing your meter for a control solution
test
1. Insert a test strip to turn the meter on
61
3
Taking a test
Preparing your meter for a control solution
test
1. Insert a test strip to turn the meter on Preparing the control solution
1. Before removing the cap, shake the vial gently
2. Remove the vial cap and place it on a flat surface with
the top of the cap pointing up
3. Squeeze the vial to discard
the first drop
2. Wait for the flashing blood
drop icon ( ) to appear on
the display
3. Press or until the
control solution icon ( )
appears on the display
62
3 Taking a test
4. Wipe both the tip of the
control solution vial and the
top of the cap with a clean,
damp tissue or cloth
5. Squeeze a drop into the
small well on the top of the
cap or onto another clean,
non-absorbent surface
63
3
Taking a test
Applying the control solution
1. Hold the meter so that the
side edge of the test strip is
at a slight angle to the drop
of control solution
3. Wait for the channel to fill
completely
2. Touch the channel on the side of the test strip to the
control solution
64
3 Taking a test
Viewing your control solution result
After the control solution
is applied, the meter will
count down until the test
is complete. Your result is
displayed along with the date,
time, unit of measure, and
(for control solution) and stored in the meter.
Control solution results can be seen when reviewing past
results on the meter.
CAUTION: Make sure you press or until the control
solution icon appears before you begin a control solution
test. Invalid results may be logged into your history if you
applied control solution to the test strip without following the
steps beginning on page60.
65
3
Taking a test
Checking if the result is in range
Example range
OneTouchVerio® Mid
Control Solution Control
Range 5.7-7.7mmol/L
Compare the result
displayed on the meter to
the range printed on your
OneTouchVerio® Control
Solution vial. If your
control solution result
falls outside the expected
range, repeat the test
with a new test strip.
CAUTION:
The range printed on the control solution vial is for control
solution tests only and is not a recommended range for
your blood glucose level.
66
3 Taking a test
Causes of out-of-range results
Out-of-range results may be due to:
• Not following the instructions for performing a control
solution test.
• Control solution is contaminated, expired, or past its
discard date.
• Test strip or test strip vial is damaged, expired, or past
its discard date.
• Meter, test strips and/or control solution were not all at
the same temperature when the control solution test
was performed.
• A problem with the meter.
• Dirt or contamination in the small well on the top of the
control solution cap.
CAUTION:
If you continue to get control solution results that fall
outside the range printed on the control solution vial, Do
Not use the meter, test strips, or control solution. Contact
the OneTouch® Customer Care Line at 1800 663-5521.
67
3
Taking a test
Cleaning the control solution cap
Clean the top of the control solution cap with a clean,
damp tissue or cloth.
68
4 Reviewing past results
2. Scroll through your results by pressing to move
backwards and to move forward through your results
Reviewing past results on your meter
Your meter stores your most recent 500 blood glucose and
control solution test results and displays them in the order
the tests were taken. The ( ) symbol will appear on your
screen when in History Mode.
1. When the meter is o, press and hold to turn
History Mode on
The ( ) symbol indicates you are viewing your past
results.
The ( ) symbol indicates if the result was below,
above or within range at the time of the test, by pointing
to the appropriate colour bar.
69
4
Reviewing past results
Using the meter without syncing to
an app
The meter can be used without a compatible wireless
device or the app. You can still test your blood glucose
and review up to 500 results on the meter.
Sending your results to the app
If the BLUETOOTH® Smart feature on the meter is turned
on, indicated by the BLUETOOTH® Smart symbol ( ),
the meter will automatically send the latest result to
any paired wireless compatible device. The compatible
wireless device must have the app running and have
already been paired to the meter before sending a result.
NOTE: The compatible wireless device must have the app
open and have already been paired to the meter before
sending a result. See page28.
NOTE: If the BLUETOOTH® Smart feature on the meter is
turned off, or the meter is out of range, the result is not
sent to the compatible wireless device. The result is saved
in the meter memory with the current date and time, and
will be sent to the app the next time you sync. The sent
results are also stored in the meter. To sync, the app must
be open and running on your compatible wireless device.
70
4 Reviewing past results
To ensure that glucose test results are successfully sent to
the app, turn on the BLUETOOTH® Smart feature and check
the following:
• The compatible wireless device and meter are both
turned on, and the app is running.
• The meter is correctly paired with your compatible
wireless device.
• The BLUETOOTH® feature on both devices is running
(indicated by ) and the devices are within 8meters of
each other.
• The meter will attempt to transmit results up to 4 hours
after a test, even if the meter appears to be off. This
is indicated by the BLUETOOTH® Smart symbol ( )
remaining on the meter screen.
Example
71
4
Reviewing past results
If you are still unable to send results to the compatible
wireless device, please call the OneTouch® Customer Care
Line at 1800 663-5521.
NOTE: Inserting a test strip during the transmission will
cancel the transfer of all results. The symbol appears on
the screen and you can proceed with testing.
72
4 Reviewing past results
Downloading results to a computer
Your meter can work with diabetes management
software, which provides a visual way to track key
factors that affect your blood sugar. To learn more about
diabetes management tools available to you, contact
the OneTouch® Customer Care Line at 1800 663-5521,
Monday-Friday, 9am – 8pm Eastern, 6am – 5pm Pacific,
or visit www.OneTouch.ca.
Connect only to a computer certified to UL 60950-1 ( ).
To transfer meter data, follow the instructions provided
with the diabetes management software product to
download the results from the meter. You will need a
standard micro USB interface cable to connect your
OneTouch Verio Flex™ Meter to a computer to download
results (not included).
73
4
Reviewing past results
Downloading results to a computer
Your meter can work with diabetes management
software, which provides a visual way to track key
factors that affect your blood sugar. To learn more about
diabetes management tools available to you, contact
the OneTouch® Customer Care Line at 1800 663-5521,
Monday-Friday, 9am – 8pm Eastern, 6am – 5pm Pacific,
or visit www.OneTouch.ca.
Connect only to a computer certified to UL 60950-1 ( ).
To transfer meter data, follow the instructions provided
with the diabetes management software product to
download the results from the meter. You will need a
standard micro USB interface cable to connect your
OneTouch Verio Flex™ Meter to a computer to download
results (not included).
Once the command to start
the download is sent from the
computer to the meter, the
meter display will show the
flashing Sync symbol ( )
indicating that the meter is in
communication mode.
Do Not insert a test strip while the meter is connected to
a computer.
If you are unable to download your results to a computer,
please call the OneTouch® Customer Care Line at
1800 663-5521.
74
5 Editing Your Settings
Editing time and date
You can adjust the meter's time and date settings after
first time setup. Press and hold to turn the meter on,
then press and hold and at the same time. The SET
screen will appear, and the hour will flash.
For instructions on adjusting the time and date, see
page23.
After adjusting the settings, you will exit settings mode
and your last glucose result screen will appear. The
adjusted time and date will be displayed once a new
glucose test has been completed and the result appears on
the screen.
NOTE: You will not be able to perform a blood glucose test
until you finish editing the time and date.
NOTE: The OneTouchReveal® Mobile App on your
compatible wireless device checks and updates the time
and date in your meter each time you sync. Check the time
and date often on your compatible wireless device to be
sure they are correct. See the App instructions for more
information.
75
5
Editing Your Settings
Editing your range limits
Your meter uses low and high range limits to tell you
when your result is below, above or within your set range.
The meter comes with pre-set range limits that can be
changed. The pre-set low range limit is 4.0mmol/L and
the pre-set high range limit is 10.0mmol/L. To edit the
pre-set range limits press and hold and at the
same time. The SET screen will appear with the current
low range limit displayed, and the number and range
indicator arrow will flash.
NOTE: The low and high range limits you set apply to
all glucose test results. This includes tests taken before
or after mealtimes, medications and around any other
activities that may affect your blood glucose.
CAUTION:
Be sure to talk to your healthcare professional about the
low and high range limits that are right for you. When
selecting or changing your limits, you should consider
factors such as your lifestyle and diabetes therapy. Never
make significant changes to your diabetes care plan
without consulting your healthcare professional.
76
5Editing Your Settings
1. Review the pre-set low range limit displayed
• To accept the pre-set low
range limit, press .
• To edit the pre-set
low range limit, press
or to change
the value between
3.3mmol/L-6.1mmol/L, and
then press .
2. Review the pre-set high range limit displayed
• To accept the pre-set high
range limit, press .
• To edit the pre-set
high range limit, press
or to change
the value between
5.0mmol/L-16.7mmol/L,
and then press .
Your meter will exit settings mode and your last result
screen will appear.
77
5
Editing Your Settings
NOTE: If you change your range limits, this will only affect
whether future test results are displayed as below, above
or within your range limits. Changing your range limits
does not affect how past results are displayed.
NOTE: You will not be able to perform a glucose test until
you finish editing the range limits.
NOTE: You can use the OneTouchReveal® Mobile App on
your compatible wireless device to change the range limits
stored in your meter. See the instructions that came with
the app for more information.
78
6 Caring for your system
Cleaning and disinfection
Cleaning and disinfection are different and both should
be performed. Cleaning is part of your normal care
and maintenance and should be performed prior to
disinfection, but cleaning does not kill germs. Disinfection
is the only way to reduce your exposure to disease. For
cleaning information, see page78 and for disinfecting
information, see page80.
Storing your system
Store your meter, test strips, control solution and other
items in your carrying case. Keep in a cool, dry place
between 5°C and 30°C. Do Not refrigerate. Keep all items
away from direct sunlight and heat.
Cleaning your meter, lancing device
and cap
The meter, lancing device and cap should be cleaned
whenever they are visibly dirty and before disinfection.
Clean your meter at least once per week. For cleaning
obtain regular strength liquid dish soap and a soft cloth.
Prepare a mild detergent solution by stirring 2.5mL of
regular strength liquid dish soap into 250mL of water.
79
6
Caring for your system
Cleaning your meter, lancing device
and cap
The meter, lancing device and cap should be cleaned
whenever they are visibly dirty and before disinfection.
Clean your meter at least once per week. For cleaning
obtain regular strength liquid dish soap and a soft cloth.
Prepare a mild detergent solution by stirring 2.5mL of
regular strength liquid dish soap into 250mL of water.
• Do Not use alcohol or any other solvent.
• Do Not allow liquids, dirt, dust, blood or control
solution to enter the test strip port or the data port.
(See page16.)
• Do Not spray cleaning solution
on the meter or immerse it in
any liquid.
1. Holding the meter with the test strip port pointed
down, use a soft cloth dampened with water and mild
detergent to wipe the outside of the meter and lancing
device
Be sure to squeeze out any
excess liquid before you wipe
the meter. Wipe the outside of
the cap.
80
6Caring for your system
Disinfecting your meter, lancing device
and cap
The meter, lancing device and cap should be disinfected
periodically. Clean your meter, lancing device and cap
prior to disinfecting. For disinfecting, obtain regular
household bleach (containing a minimum of 5.5% sodium
hypochlorite as the active ingredient)*. Prepare a solution
of 1 part household bleach and 9 parts water or obtain
equivalent (0.55% sodium hypochlorite*) wipes.
*Follow manufacturer’s instruction for handling and
storage of bleach.
2. Wipe dry with a clean,
soft cloth
81
6
Caring for your system
Disinfecting your meter, lancing device
and cap
The meter, lancing device and cap should be disinfected
periodically. Clean your meter, lancing device and cap
prior to disinfecting. For disinfecting, obtain regular
household bleach (containing a minimum of 5.5% sodium
hypochlorite as the active ingredient)*. Prepare a solution
of 1 part household bleach and 9 parts water or obtain
equivalent (0.55% sodium hypochlorite*) wipes.
*Follow manufacturer’s instruction for handling and
storage of bleach.
1. Hold the meter with the test strip port pointed down
Use a soft cloth dampened
with this solution or a 0.55%
equivalent sodium hypochlorite
wipe to wipe the outside of the
meter and lancing device until
the surface is damp. Be sure to
squeeze out any excess liquid
before you wipe the meter.
2. After wiping, cover the surface you are disinfecting
with the soft cloth dampened with the bleach solution
or 0.55% equivalent sodium hypochlorite wipe for
1 minute
Wipe with a clean, damp soft
cloth and allow to air dry.
Wash hands thoroughly with
soap and water after handling
the meter, lancing device and
cap.
If you see signs of wear, please contact the OneTouch®
Customer Care Line at 1800 663-5521.
82
7 Battery
Replacing the battery
Your OneTouch Verio Flex™ Meter uses one CR2032 lithium
coin cell battery.
IMPORTANT: Use only one CR2032 lithium coin cell battery
with your meter. Do Not use rechargeable batteries. Use
of an incorrect battery type may result in your meter
providing fewer tests than normal.
If the meter does not turn on, you may need to replace the
battery. See below for instructions.
WARNING: Certain batteries may cause leaking which can
damage the meter or cause the battery to lose power sooner
than normal. Replace leaking battery immediately.
NOTE: After replacing the battery, you will be prompted
to set time and date, as if you are turning the meter on for
the first time.
1. Remove the old battery
Start with the meter turned off.
Remove the battery cover by
sliding it downward.
83
7
Battery
Replacing the battery
Your OneTouch Verio Flex™ Meter uses one CR2032 lithium
coin cell battery.
IMPORTANT: Use only one CR2032 lithium coin cell battery
with your meter. Do Not use rechargeable batteries. Use
of an incorrect battery type may result in your meter
providing fewer tests than normal.
If the meter does not turn on, you may need to replace the
battery. See below for instructions.
WARNING: Certain batteries may cause leaking which can
damage the meter or cause the battery to lose power sooner
than normal. Replace leaking battery immediately.
Pull up on the battery ribbon
to lift the battery out of the
compartment.
Do Not remove the battery while
the meter is connected to a
computer.
2. Insert the new battery
Insert one CR2032 lithium coin
cell battery on top of the battery
ribbon, with the plus (+) side up.
If the meter does not power on after you have replaced
the meter battery, check that the battery is correctly
installed. If the meter still does not power on, contact the
OneTouch® Customer Care Line at 1800 663-5521.
84
7Battery
3. Replace battery cover by
sliding it upwards onto the meter
5. Dispose of battery
Dispose of the battery according to your local
environmental regulations.
4. Check your meter settings
Removing the meter battery will not affect your stored
results. However, you will need to check your date and
time settings.
85
7
Battery
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86
8 Troubleshooting your
system
Error and other messages
The OneTouch Verio Flex™ Meter displays messages when
there are problems with the test strip, with the meter or
when your glucose levels are above 33.3mmol/L or below
1.1mmol/L. Improper use may cause an inaccurate result
without producing an error message.
NOTE: If the meter is on but does not operate (locks-up),
contact the OneTouch® Customer Care Line at 1800 663-5521.
What it means
You may have a very
low blood glucose level
(severe hypoglycemia),
below 1.1mmol/L.
NOTE: When your glucose result is below 1.1mmol/L, both
the LO and the Range Indicator Arrow will flash on the
meter screen.
What to do
This may require immediate treatment. Although this
message could be due to a test error, it is safer to treat
first and then do another test. Always treat according to
your healthcare professional’s recommendations.
87
Troubleshooting your system 8
What it means
You may have a very
high blood glucose level
(severe hyperglycemia),
over 33.3mmol/L.
NOTE: When your glucose result is above 33.3mmol/L,
both the HI and the Range Indicator Arrow will flash on
the meter screen.
What to do
Re-test your blood glucose level. If the result is HI
again, obtain and follow instructions from your healthcare
professional right away.
88
Troubleshooting your system
8
What it means
Meter is too hot (above 44°C)
to perform a test.
What to do
Move the meter and test strips to a cooler area. Insert a
new test strip when the meter and test strips are within
the operating range (6-44°C). If you do not get another
HI .t message, you can proceed with testing.
If this message continues to appear, contact the
OneTouch® Customer Care Line at 1800 663-5521.
89
Troubleshooting your system 8
What it means
Meter is too cold (below 6°C)
to perform a test.
What to do
Move the meter and test strips to a warmer area. Insert a
new test strip when the meter and test strips are within
the operating range (6-44°C). If you do not get another
LO.t message, you can proceed with testing.
If this message continues to appear, contact the
OneTouch® Customer Care Line at 1800 663-5521.
90
Troubleshooting your system
8
Example Error
Screen Code
Error Screens
If there is a problem with your meter, there are six possible
error screens that may appear. Along with an error
number, there is also an error code in the upper left corner
of your meter screen. If you cannot resolve the error with
your meter, contact the OneTouch® Customer Care Line at
1800 663-5521. They will refer to the error number and
code to help troubleshoot the problem.
91
Troubleshooting your system 8
What it means
There is a problem with
the meter.
What it means
Error message could be
caused either by a used test
strip or a problem with the
meter or test strip.
What to do
Do Not use the meter. Contact the OneTouch® Customer
Care Line at 1800 663-5521.
What to do
Repeat the test with a new test strip; see page48 or
page63. If this message continues to appear, contact
the OneTouch® Customer Care Line at 1800 663-5521.
92
Troubleshooting your system
8
What it means
The sample was applied
before the meter was ready.
What to do
Repeat the test with a new test strip. Apply a blood or
control solution sample only after the flashing symbol
appears on the display. If this message continues to
appear, contact the OneTouch® Customer Care Line at
1800 663-5521.
93
Troubleshooting your system 8
What it means
One of the following may
apply:
• Not enough blood or
control solution was
applied or more was added
after the meter began to
count down.
• The test strip may have been damaged or moved
during testing.
• The sample was improperly applied.
• There may be a problem with the meter.
What to do
Repeat the test with a new test strip; see page48 or
page63. If the error message appears again, contact
the OneTouch® Customer Care Line at 1800 663-5521.
94
Troubleshooting your system
8
What it means
Meter battery power is low
but there is still enough
battery power to perform
a test. The flashing low
battery ( ) icon will
continue to appear until the
battery is replaced.
What to do
Replace the meter battery soon.
What it means
The meter has detected a
problem with the test strip.
Possible cause is test strip
damage.
What to do
Repeat the test with a new test strip; see page48 or
page63. If the error message appears again, contact
the OneTouch® Customer Care Line at 1800 663-5521.
95
Troubleshooting your system 8
What it means
There is not enough battery
power to perform a test.
What to do
Replace the battery immediately.
What it means
No result in memory, such
as the first time use or when
you have chosen to delete all
the results after downloading
to a computer.
What to do
Contact Customer Service to report this occurrence,
unless this is your first use of the meter. You can still
perform a blood glucose test or control solution test and
get an accurate result. Contact the OneTouch® Customer
Care Line at 1800 663-5521.
96
9 Detailed information
about your system
Comparing meter results to laboratory
results
Results obtained from the OneTouch Verio Flex™ Meter and
laboratory tests are reported in plasma-equivalent units.
However, your meter result may differ from your lab result
due to normal variation. A result from your OneTouch
Verio Flex™ Meter is considered accurate when it is within
0.83mmol/L of a laboratory method when the glucose
concentration is lower than 5.55mmol/L and within 15%
of laboratory method when the glucose concentration is
5.55mmol/L or higher.
Meter results can be affected by factors that do not affect
lab results in the same way. Specific factors that may
cause your meter result to vary from your lab result may
include:
• You have eaten recently. This can cause a result from
fingertip testing to be up to 3.9mmol/L higher than a
lab test using blood drawn from a vein.1
• Your hematocrit is above 60% or below 20%.
• You are severely dehydrated.
For additional information, refer to the OneTouchVerio®
Test Strip Insert.
1Sacks, D.B.: "Carbohydrates." Burtis, C.A., and Ashwood
E.R. (ed.), Tietz Textbook of Clinical Chemistry,
Philadelphia: W.B. Saunders Company (1994), 959.
97
Detailed information about your system 9
Guidelines for obtaining an accurate
meter to lab comparison
Before going to the lab:
• Perform a control solution test to make sure your
meter is working properly.
• Do Not eat for at least 8 hours before you test your
blood.
• Take your meter and testing supplies with you to
the lab.
98
Detailed information about your system
9
Comparing your meter results to those
taken from another meter
Comparing your blood glucose test results taken with this
meter to your results taken from a different meter is not
recommended. Results may differ between meters and are
not a useful measure of whether your meter is working
properly.
Testing with your OneTouch Verio Flex™
Meter at the lab:
• Test within 15 minutes of the lab test.
• Use only a fresh, capillary blood sample from your
fingertip.
• Follow all instructions in this Owner's Booklet for
performing a blood glucose test.
99
Detailed information about your system 9
Technical specifications
Assay method FAD-GDH (flavin adenine dinucleotide
dependent glucose dehydrogenase)
Automatic shuto Two minutes after last action
Battery ratings 3.0 V d.c. (CR2032 lithium coin cell
battery),
Battery type One replaceable 3.0 Volt CR2032
lithium coin cell battery (or equivalent)
BLUETOOTH® Smart
Technology
Frequency range: 2.4-2.4835 GHz
Operating Range Distance: minimum
8meters (unobstructed)
Operating Channels: 40 Channels
Security Encryption: 128-bit AES
(Advanced Encryption Standard)
Calibration Plasma-equivalent
Data port type Compatible with USB 2.0
Memory 500 test results
100
Detailed information about your system
9
Operating ranges Temperature: 6-44°C
Relative humidity: non-condensing
10-90%
Altitude: up to 3048meters
Hematocrit: 20-60%
Reported result range 1.1-33.3mmol/L
Sample Fresh capillary whole blood
Sample volume 0.4µL
Size 52.0(W) x 86.0(L) x 16.0(T)mm
Test time 5 seconds
Unit of measure mmol/L
Weight Approximately 50grams
101
Detailed information about your system 9
System Accuracy
Diabetes experts have suggested that 95% of glucose meter
results should agree within 0.83mmol/L of a laboratory
method when the glucose concentration is lower than
5.55mmol/L, and within 15% of a laboratory method when
the glucose concentration is 5.55mmol/L or higher.
Samples from 100 patients were tested using both the
OneTouch Verio Flex™ System and the YSI 2300 Glucose
Analyzer laboratory instrument.
System Accuracy Results for Glucose
Concentrations <5.55mmol/L
Percent (and number) of meter results that match the
laboratory test
Within
±0.28mmol/L
Within
±0.56mmol/L
Within
±0.83mmol/L
82.0% (123/150) 98.0% (147/150) 100% (150/150)
102
Detailed information about your system
9
System Accuracy Results for Glucose
Concentrations ≥5.55mmol/L
Percent (and number) of meter results that match the
laboratory test
Within ±5% Within ±10% Within ±15%
62.9% (283/450) 94.7% (426/450) 99.3% (447/450)
System Accuracy Results for Glucose
Concentrations between 2.1mmol/L
and 25.9mmol/L
Within ±0.83mmol/L or ±15%
99.5% (597/600)
NOTE: Where 2.1mmol/L represents the lowest glucose
reference value and 25.9mmol/L represents the highest
glucose reference value (YSI value).
103
Detailed information about your system 9
Regression Statistics
Samples were tested in duplicate on each of three test
strip lots. Results indicate that the OneTouch Verio Flex™
System compares well with a laboratory method.
# of Subjects # of Tests Slope Intercept
(mmol/L)
100 600 1.01 -0.02
95% CI
Slope
95% CI
Intercept
(mmol/L)
Std. Error
(Sy.x)
(mmol/L)
R2
1.00 to 1.01 -0.12 to 0.08 0.64 0.99
104
Detailed information about your system
9
User Performance Accuracy
A study evaluating glucose values from fingertip capillary
blood samples obtained by 167 lay persons showed the
following results:
93.1% within ±0.83mmol/L of the medical laboratory
values at glucose concentrations below 5.55mmol/L, and
98.6% within ±15% of the medical laboratory values at
glucose concentrations at or above 5.55mmol/L.
97.6% of the total number of samples were within
±0.83mmol/L or ±15% of the medical laboratory values.
105
Detailed information about your system 9
Precision
Within Run Precision (300 Venous Blood Samples Tested
per Glucose Level)
Data generated using the OneTouch Verio Flex™ Meter.
Target
Glucose
(mmol/L)
Mean
Glucose
(mmol/L)
Standard
Deviation
(mmol/L)
Coecient
of Variation
(%)
2.2 2.0 0.05 2.26
5.0 4.9 0.10 1.95
7.2 7.1 0.14 1.95
11.1 11.1 0.22 1.98
19.4 19.1 0.34 1.79
Results show that the greatest variability observed
between test strips when tested with blood is 0.10mmol/L
SD or less at glucose levels less than 5.55mmol/L, or
1.98% CV or less at glucose levels at 5.55mmol/L or above.
106
Detailed information about your system
9
Total Precision (600 Control Solution Tests per Glucose
Level)
Data generated using the OneTouch Verio Flex™ Meter.
Glucose
Level Ranges
(mmol/L)
Mean
Glucose
(mmol/L)
Standard
Deviation
(mmol/L)
Coecient
of Variation
(%)
Low
(1.39–2.72)
2.06 0.05 2.48
Mid
(5.67-7.67)
6.53 0.13 2.05
High
(16.56-22.39)
19.37 0.46 2.38
107
Detailed information about your system 9
Guarantee
LifeScan guarantees that the OneTouch Verio Flex™ Meter
will be free of defects in material and workmanship
for three years, valid from the date of purchase. The
guarantee extends only to the original purchaser and is
not transferable.
Electrical and safety standards
This meter complies with CISPR 11:Class B
(Radiated Only). Emissions of the energy
used are low and not likely to cause
interference in nearby electronic equipment.
The meter has been tested for immunity to electrostatic
discharge as specified in IEC 61326-2-6. This meter
complies with immunity to radio frequency interference
as specified in IEC 61326-1 and 61326-2-6.
The meter meets the requirements for immunity to
electrical interference at the frequency range and test level
specified in international standard ISO 15197.
Do Not use the equipment where aerosol sprays are being
used, or when oxygen is being administered.
108
AST 39
Batteries 82
Batteries, replacing 82
Battery empty icon 3
Battery empty warning 95
Battery low icon 3, 94
BLUETOOTH® Smart feature 7, 9, 27, 69
Buttons on meter 16
Cleaning your meter, lancing device and cap 78
Comparing meter results to laboratory results 96
Compatible wireless devices 3
Control solution 60
Control solution, discard and expiration dates 58, 59
Control solution, testing 58, 64, 66
Data port 16
Date setting 24, 26
Dehydration 52, 96
Disinfecting your meter, lancing device and cap 80
Display check 22
Disposal, lancets and test strips 58
Downloading results to a computer 72
Edit date 74
Edit range limits 75
Edit time 74
10 Index
109
Index 10
Error messages 86
EXTREME HIGH GLUCOSE message 53, 87
EXTREME LOW GLUCOSE message 52, 86
Fingertip testing procedure 34
First time setup 23, 28
Guarantee 107
Hyperglycemia 53, 87
Hypoglycemia 52, 86
Icons 3, 5
Infection, reduce the chance 40
Intended use 6
Kit components 12
Lancing device 12, 38, 41, 78
mmol/L 16, 100
Pairing 28, 29
PIN 31
Plasma calibration 96, 99
Range Indicator feature 19
Range limits setting 75
Results, reviewing past 68
Serial number 30
Settings 23, 26, 74
Software, diabetes management 72
Start-up screen 22
110
Index
10
Storing your system 78
Symbols 3, 5
Syncing 32, 69
Technical specifications 99
Temperature 34, 66, 78, 88, 89, 100
Test principle 7
Test strip 18, 45, 60
Test strip, applying drop of blood 48
Test strip, discard and expiration dates 35
Test strip, silver prongs 18
Time setting 23, 26
Turning meter off 33
Turning meter on 22, 45, 60
Unexpected results 52, 54
Unit of measure 16, 100
Unusual red blood cell count (hematocrit) 96, 100
111
Notes
112
Notes
C3
©2015-2016LifeScan, Inc.
Manufactured by:
LifeScan Europe
Division of Cilag
GmbH International
Gubelstrasse 34
6300 Zug
Switzerland
Contact the OneTouch® Customer Care Line at 1 800 663-5521,
Monday-Friday, 9am – 8pm Eastern, 6am – 5pm Pacific, or visit
www.OneTouch.ca.
Rev:
06932601C
Contents of package and use of monitoring device protected by one or
more U.S. patents: 6,179,979, 6,193,873, 6,284,125, 6,716,577, 6,749,887,
6,797,150, 6,863,801, 6,872,298, 7,045,046, 7,498,132, 7,846,312,
8,449,740, 8,529,751, 8,398,664, 6,413,410, 6,890,421, 8,163,162,
7,749,371, 8,449,740 and 8,529,751 as well as corresponding patents
in other jurisdictions. Purchase of this package does not act to grant a
use license under these patents in any jurisdiction outside of Canada.
A license for use in Canada is granted only when the monitoring device
is used with OneTouch Verio® Test Strip. No test strip supplier other
than LifeScan is authorized to grant such a license. The accuracy of
results generated with LifeScan meters using test strips manufactured
by anyone other than LifeScan has not been evaluated by LifeScan.
05/2016
If you have questions about the use of any OneTouch® product,
contact the OneTouch® Customer Care Line at 1 800 663-5521. If
you cannot reach the OneTouch® Customer Care Line, contact your
healthcare professional for advice.
AW 06932601C