Blood Glucose Monitoring System

Owner's
Guide
Instructions for Use

Simply insert a test strip to

turn the meter on and begin
testing.
LifeScan self-test blood glucose monitoring devices
conform to the following EU Directives:
IVDD (98/79/EC):
Blood Glucose Meter, Test Strips, and Control
Solution

MDD (93/42/EEC):

Lancets

Lancing Device

LifeScan Europe GmbH Kindly contact Customer

Gubelstrasse 34 Care at 1800 225544 or
6300 Zug visit www.OneTouch.in.
Switzerland

Meter Made in China

Rev. Date: 02/2020

© 2018-2020 LifeScan IP Holdings, LLC

AW 07262801A
Table of contents

 1  Getting to know your system.............................1

 2  Blood glucose testing........................................ 6

 3  Control solution testing................................... 22

 4  Caring for your system..................................... 27

 5  Battery................................................................ 29

 6  Troubleshooting................................................ 31

 7  Detailed information about your system....... 37

Meter symbols and icons

Low battery
Battery empty
History mode (last result)
Apply sample
Range Indicator Arrow

Other symbols and icons

Cautions and Warnings: Refer to the Owner's

Guide and inserts that came with your system for
safety-related information.
Direct current
Consult Instructions for Use

Manufacturer

Lot Number
Serial Number

Storage Temperature Limits

In Vitro Diagnostic Device

Do Not Re-use

Sterilised by irradiation

Not for general waste

Use By Date

Contains sufficient for n tests

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.

Before you begin

Before using this product to test your blood glucose, carefully
read this Owner's Guide and the inserts that come with the
OneTouch Select® Plus Test Strips, OneTouch Select® Plus
Control Solution and the OneTouch® Delica® Plus Lancing
Device.
Intended use
The OneTouch Select Plus Simple® 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 Select Plus Simple® 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 Select Plus Simple® Blood Glucose Monitoring
System is not to be used for the diagnosis of or screening of
diabetes or for neonatal use.
The OneTouch Select Plus Simple® Blood Glucose Monitoring
System is not for use on critically ill patients, patients in shock,
dehydrated patients or hyperosmolar patients.
Test principle
Glucose in the blood sample mixes with the enzyme Glucose
Oxidase in the test strip and a small electric current is produced.
The strength of this current changes with the amount of glucose
in the blood sample. Your meter measures the current, calculates
your blood glucose level, displays the result, and stores it in its
memory.
 1 Getting to know your system

Your OneTouch Select Plus Simple® Blood

Glucose Monitoring System
Included with your kit:

OneTouch Select Plus
Simple® Meter (CR2032
lithium coin cell battery
included)

Lancing device Lancets

GET TING TO KNOW YOUR SYSTEM

1
NOTE: If any item is missing or defective in your kit, contact
Customer Care. Contact information for Customer Care is listed
at the end of this Owner's Guide.

NOTE: If another type of lancing device was included, see the

separate instructions for that lancing device.

Available separately:
Items listed below are required, but may not be included in
your kit
Use only OneTouch Select® Plus Control Solutions and Test Strips
with the OneTouch Select Plus Simple® Meter.

OneTouch Select® Plus OneTouch Select®

Mid Control Solution* Plus Test Strips*

Lancets*

*Lancets, OneTouch Select® Plus Control Solution and Test Strips

are available separately. For availability of lancets, test strips
and control solution, contact Customer Care or your 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.

GET TING TO KNOW YOUR SYSTEM

2
Getting to know your OneTouch Select Plus
Simple® Blood Glucose Monitoring System

Meter

1 Test strip port 5 Colour Range Indicator

Bars
2 Battery icon
6 Range Indicator Arrow
3 Last result icon
7 Display
4 mg/dL is the pre-set
8 Serial number
unit of measure
9 Battery cover

GET TING TO KNOW YOUR SYSTEM

3
Getting to know your OneTouch Select® Plus
Test Strip

Test strip

1 Edge to apply sample

2 Confirmation window
3 Contact bars
Insert into test strip port

GET TING TO KNOW YOUR SYSTEM

4
The Range Indicator feature
The OneTouch Select Plus Simple® Meter automatically lets
you know if your glucose result is below, above or within the
meter's range limits. It does this by displaying your current
glucose result with a Range Indicator Arrow pointing to a
corresponding Colour Range Indicator Bar below the meter
display. Use the Range Indicator Arrow and Colour Bar to
interpret your results.
A Range Indicator Arrow will appear just below your result
after each test.

Range Indicator

Low In range High

Colour Range Indicator Bars

(Blue) (Green) (Red)

Below In range Above
range range
Example
In range result

For details about the Range Indicator, see “Viewing your

result” in Section 2.

GET TING TO KNOW YOUR SYSTEM

5
 2 Blood glucose testing

Test your blood glucose

Preparing for a test
Have these things ready when you test:
OneTouch Select Plus Simple® Meter
OneTouch Select® Plus Test Strips
Lancing device
Sterile lancets
NOTE:
• Use only OneTouch Select® Plus Test Strips.
• Make sure your meter and test strips are about the same
temperature before you 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.
• Keep test strips in a cool, dry place between 5°C and 30°C.
• 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, especially in high humidity
environments.
• 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 or control solution
applied to it. Test strips are for single use only.
• Do Not test with a test strip that is bent or damaged.
• 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.
IMPORTANT: If another person assists you with testing,
the meter, lancing device and cap should always be cleaned
and disinfected prior to use by that person. See “Cleaning and
disinfection” in Section 4.

BLOOD GLUCOSE TESTING

6
NOTE: 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. To
check your meter accuracy, you should periodically compare
your meter results to those obtained from a lab. See “Comparing
meter results to laboratory results” in Section 7.
CAUTION:
• Do Not use the OneTouch Select Plus Simple® System when
PAM (Pralidoxime) is known or suspected to be in the patient's
whole blood sample, as it may cause inaccurate results.
• A haematocrit (percentage of your blood that is red blood
cells) that is either very high (above 55%) or very low (below
30%) can cause false results.
• 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 Customer Care immediately if the test strip vial is
damaged. Contact information for Customer Care is listed at
the end of this Owner's Guide.
• 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.
• Do Not use test strips after the expiry date printed on the vial.

BLOOD GLUCOSE TESTING

7
Getting to know your OneTouch® Delica® Plus
Lancing Device

1 Release button
2 Slider control
3 Depth indicator
4 Depth wheel
5 Lancing device cap
6 Protective cover

BLOOD GLUCOSE TESTING

8
NOTE:
• The OneTouch® Delica® Plus Lancing Device uses
OneTouch® Delica® or OneTouch® Delica® Plus Lancets.
• If another type of lancing device was included, see the
separate instructions for that lancing device.
• The OneTouch Select Plus Simple® Blood Glucose
Monitoring System has not been evaluated for Alternate
Site Testing (AST). Use only fingertips when testing with
the system.
• The OneTouch® Delica® Plus Lancing System does not
include the materials needed to perform Alternate Site
Testing (AST). The OneTouch® Delica® Plus Lancing
System should not be used on the forearm or palm
with the OneTouch Select Plus Simple® Blood Glucose
Monitoring System.

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 “Cleaning and disinfection” in Section 4).
• Do Not use lancets after the expiry date printed on the
lancet packaging.

BLOOD GLUCOSE TESTING

9
Preparing your lancing device
1. Remove the lancing device cap
Remove the cap by rotating it and then pulling it straight off
the device.

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 “Removing the used lancet”.

BLOOD GLUCOSE TESTING

10
3. Replace the lancing device cap
Place the cap back onto the device; turn the cap or push the cap
straight on to secure it.
Ensure the cap is aligned as shown in the image.

4. Adjust the depth setting

The device has 13 puncture depth
settings (each dot shown between
numbers 1 to 7 on the Depth Wheel
indicates an additional available
depth setting). Adjust the depth by
turning the depth wheel. Smaller
numbers are for a shallower
puncture and larger numbers for a
deeper puncture.
NOTE: 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

Pull the slider back until it clicks.
If it does not click, it may already
have been cocked when you
inserted the lancet.

BLOOD GLUCOSE TESTING

11
Prepare the meter and view the last result
1. Insert a test strip to turn the meter on
Insert a test strip into the test strip port with the contact bars
facing you.
Contact bars

Test strip port

A start-up screen will appear for a

few seconds. All segments shown
here should appear briefly on the
display, indicating your meter is
working properly.

CAUTION:
If any segments shown here are missing in the start-up
screen, there may be a problem with the meter. Contact
Customer Care.
If the meter does not power on, check the battery. See
“Replacing the battery” in Section 5.

Your last result will then appear

and the last result icon will blink
( ). If this is your first time
using the meter, dashes will
appear instead of a result. See
“Error and other messages” in
Section 6.

Next, the flashing blood drop

icon ( ) will appear on the
display. You can now apply your
blood sample to the test strip.

BLOOD GLUCOSE TESTING

12
Sampling blood 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 and the sample site
with warm, soapy water. Rinse and dry completely.
Contaminants on the skin may affect results.
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.

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.

BLOOD GLUCOSE TESTING

13
Applying the sample
Line up the test strip with the blood drop.

Channel

NOTE: Do Not apply blood on the

top of the test strip.

Gently touch the channel to the

edge of the blood drop.

BLOOD GLUCOSE TESTING

14
Wait for the confirmation window
to fill completely.
The blood drop will be drawn into
the channel and the confirmation
window should fill completely.

Confirmation window full

Full Not full

CAUTION:
You may get an error message or an inaccurate result if
the blood sample does not fill the confirmation window
completely. Discard the used strip and re-start the test
process with a new test strip.
• Do Not smear or scrape the drop of blood with the
test strip.
• 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.

When the confirmation

window is full, this means you
have applied enough blood.
The Countdown screen will
appear. Now you can move the
test strip away from the drop of Countdown screen
blood and wait for the meter to
count down (about 5 seconds).

BLOOD GLUCOSE TESTING

15
Viewing your result
Your result appears on the display, along with the unit of
measure.
After your blood glucose result appears, the meter will
display a Range Indicator Arrow below your glucose result to
indicate if your result is below, above or within the meter's
range limits (see “The Range Indicator feature” in Section 1).
The arrow will point to the appropriate Colour Range
Indicator Bar on the meter as a visual reminder.

NOTE: When testing with blood, if the Range Indicator Arrow

is not shown along with your blood glucose reading, the
meter has detected a problem with the test strip. Repeat the
test with a new test strip.

BLOOD GLUCOSE TESTING

16
 Below range In range Above range Above range
Colour Bar: Blue Green Red Red
Range Indicator Arrow:
Blinks Does not blink Does not blink Blinks
Screen:

Blood glucose range: 20 mg/dL to 69 mg/dL 70 mg/dL to 179 mg/dL 180 mg/dL to 239 mg/dL 240 mg/dL to 600 mg/dL

CAUTION: WARNING: Confirm that the unit of measure mg/dL is

displayed. If your display shows mmol/L rather than mg/dL,
Do Not make immediate treatment decisions based on the Range
stop using the meter and contact Customer Care.
Indicator feature. Treatment decisions should be based on the
numerical result and healthcare professional recommendation NOTE: If you get an error message instead of a result, see
and not solely on where your result falls within the meter's “LO and HI blood glucose messages” in Section 6.
range limits.

BLOOD GLUCOSE TESTING

17
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 70 mg/dL
or is shown as LO (meaning the
result is less than 20 mg/dL), it
may mean hypoglycaemia (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.
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.

CAUTION:
High results
• If your result is above 179 mg/dL, it may mean hyperglycaemia
(high blood glucose) and you should consider re-testing. Talk
to your healthcare professional if you are concerned about
hyperglycaemia.
• HI is displayed when your result
is over 600 mg/dL. You may have
severe hyperglycaemia (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.

BLOOD GLUCOSE TESTING

18
 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 Guide, call your healthcare professional.
Never ignore symptoms or make significant changes to
your diabetes management programme without speaking
to your healthcare professional.

Turning the meter off

There are two ways to turn your meter off:
• Remove the test strip.
• Leave your meter alone for two minutes and it will turn
off by itself.

BLOOD GLUCOSE TESTING

19
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 rotating it
and then pulling it straight off
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
flat side of the disk.

3. Eject the lancet

Holding the lancing device directed
downwards, push the slider
forward until the lancet comes out
of the lancing device. If the lancet
fails to eject properly, cock the
device then push the slider control
forward until the lancet comes out.

BLOOD GLUCOSE TESTING

20
4. Replace the lancing device cap
Place the cap back onto the device; turn the cap or push the cap
straight in to secure it.
Ensure the cap is aligned as shown in the image.

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.

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.

BLOOD GLUCOSE TESTING

21
 3 Control solution testing

Control solution testing precautions

OneTouch Select® Plus 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:
• 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.
• Tightly close the cap on the control solution vial immediately
after use to avoid contamination or damage.
• 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, especially in high humidity
environments.
• Control solution tests must be done at room temperature
(20-25°C). Make sure your meter, test strips and control
solutions are at room temperature before testing.

CAUTION:
• Do Not swallow or ingest control solution.
• Do Not apply control solution to the skin or eyes as it may
cause irritation.
• Do Not use control solution after the expiry date (printed on
the vial label) or the discard date, whichever comes first, or
your results may be inaccurate.

Do a control solution test

• If you suspect that the meter or test strips are not working
properly.
• If you have had repeated unexpected blood glucose results.
• If you drop or damage the meter.

CONTROL SOLUTION TESTING

22
Preparing your meter for a control
solution test
1. Insert a test strip to turn the meter on
Insert the test strip with the test strip port and contact bars
facing you.
Contact bars

Test strip port

2. Wait for the flashing blood

drop icon ( ) to appear on the
display

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

CONTROL SOLUTION TESTING

23
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

Applying the control solution

1. Hold the meter so that the channel
at the top edge of the test strip is at
a slight angle to the drop of control
solution

2. Touch the channel on the top

edge of the test strip to the control
solution
3. Wait for the channel to fill
completely

CONTROL SOLUTION TESTING

24
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 unit of
measure. Your meter will not display
a Range Indicator Arrow with a
control solution result.
NOTE: Your meter does not store a control solution result after
it is turned off. When you turn your meter on, your last blood
glucose result will appear along with the History Mode icon ( ).

Checking if the result is in range

Each vial of test strips has
the OneTouch Select® Plus
Mid Control Solution range
printed on its label. Compare
the result displayed on the
meter to the OneTouch
Select® Plus Mid Control
Solution range printed on
the test strip vial. Example range
OneTouch Select® Plus
Mid Control Solution
Control Range
102-138 mg/dL

If your control solution result falls outside the expected range,

repeat the test with a new test strip.
CAUTION:
The control solution range printed on the test strip vial is for
control solution tests only and is not a recommended range for
your blood glucose level.

CONTROL SOLUTION TESTING

25
Causes of out-of-range control solution 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 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 test strip vial, Do Not use the meter,
test strips, or control solution. Contact Customer Care.

Cleaning the control solution cap

Clean the top of the control solution cap with a clean, damp
tissue or cloth.

CONTROL SOLUTION TESTING

26
 4 Caring for your system

Storing your system

Store your meter, test strips, control solution and other
items in a cool, dry place between 5°C and 30°C. Do Not
refrigerate. Keep all items away from direct sunlight and
heat.
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.
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 2.5 mL of regular strength
liquid dish soap into 250 mL 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. (See “Getting to know your
OneTouch Select Plus Simple® Blood Glucose Monitoring
System” in Section 1.)
• Do Not spray cleaning solution on the meter or immerse
it in any liquid.

CARING FOR YOUR SYSTEM

27
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
Be sure to squeeze out any
excess liquid before you wipe
the meter.

2. Wipe dry with a clean,

soft cloth

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.

*Follow manufacturer's instruction for handling and storage of

bleach.

1. Use a soft cloth dampened with this solution to wipe the

outside of the meter and lancing device until the surface
is damp
Be sure to hold the meter with the test strip port pointed down.
2. After wiping, cover the surface you are disinfecting with the
soft cloth dampened with the bleach solution for 1 minute
Then wipe with a clean, damp, soft cloth.
Wash hands thoroughly with soap and water after handling the
meter, lancing device and cap.
If you see signs of wear, please contact Customer Care.

CARING FOR YOUR SYSTEM

28
 5 Battery

Replacing the battery

Your OneTouch Select Plus Simple® 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. The meter
will not function if an incorrect battery type is installed.
If the meter does not turn on, you may need to replace the
battery. See below for instructions.
WARNING: CHEMICAL BURN HAZARD. DO NOT INGEST
BATTERY. This product contains a coin/button cell battery.
If swallowed, it can quickly cause severe internal burns and
can lead to death. Keep new and used batteries away from
children. If you think batteries might have been swallowed,
seek immediate medical attention.
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.

1. Remove the old battery

Start with the meter turned off.
Remove the battery cover by pressing
and sliding it downward.

Battery cover

Pull up on the battery ribbon to lift the

battery out of the compartment.

BAT TERY
29
2. Insert the new battery
Insert one CR2032 lithium coin cell
battery on top of the battery ribbon,
with the plus (+) side up.

3. Replace battery cover by sliding it

upwards onto the meter
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 Customer Care.

4. Dispose of battery
Dispose of the battery according to your local environmental
regulations.

BAT TERY
30
 6 Troubleshooting

LO and HI blood glucose messages

What it means
You may have a very low
blood glucose level (severe
hypoglycaemia), below
20 mg/dL.

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.

What it means
You may have a very high
blood glucose level (severe
hyperglycaemia), over
600 mg/dL.
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.

TROUBLESHOOTING
31
Temperature messages
What it means
The 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 (10-44°C). If you do not get another HI .t message, you
can proceed with testing.

What it means
The meter is too cold (below 10°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 (10-44°C). If you do not get
another LO.t message, you can proceed with testing.
If you continue to get HI .t or LO.t messages, contact Customer
Care.

TROUBLESHOOTING
32
Error and other messages
What it means
There is a problem with the meter.
What to do
Do Not use the meter. Contact
Customer Care.

What it means
Error message could be caused either by a used test strip or a
problem with the meter.
What to do
Repeat the test with a new test strip.
If this message continues to appear,
contact Customer Care.

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33
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 Customer Care.

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. If the error message appears
again, contact Customer Care.

What it means
One of the following may apply:
• Not enough blood or control
solution was applied.
• Blood or control solution 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. If the error message appears
again, contact Customer Care.

TROUBLESHOOTING
34
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. If the error message
appears again, contact Customer Care.

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.

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35
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 of the meter.
or
Your meter was unable to recall
the last result.
What to do
Contact Customer Care 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.

TROUBLESHOOTING
36
 7 Detailed information about your system

Comparing meter results to laboratory results

If you wish to check your meter's accuracy, compare it to a lab
result. See “Guidelines for obtaining an accurate meter to lab
comparison”. Results obtained from the OneTouch Select Plus
Simple® Meter and laboratory tests are reported in plasma-
equivalent units. However, your meter result may differ from
your lab result for any of several reasons. Your meter measures
glucose (sugar) in capillary blood, but the lab measures glucose
in venous blood. When your blood sugar is changing because
you have eaten, exercised, or taken medication, the difference
between venous and capillary blood may be greater than when
you are fasting. For example, if you have eaten recently, a result
from fingertip testing may be up to 70 mg/dL higher than a lab
test using blood drawn from a vein.1 Therefore, when comparing
a meter to a lab, it is important to fast for at least 8 hours. (It is
OK to drink water.)
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:
• Your haematocrit is above 55% or below 30%.
• You are severely dehydrated.
For additional information, refer to the OneTouch Select® Plus
Test Strip Insert.
According to an international standard2 a result from your
OneTouch Select Plus Simple® Meter is considered accurate
when it is within 15 mg/dL of a laboratory method when the
glucose concentration is lower than 100 mg/dL and within
15% of laboratory method when the glucose concentration is
100 mg/dL or higher.

Sacks, D.B.: "Carbohydrates." Burtis, C.A., and Ashwood E.R. (ed.),

1

Tietz Textbook of Clinical Chemistry, Philadelphia: W.B. Saunders

Company (1994), 959.
2
ISO 15197:2013. In vitro diagnostic test systems —Requirements
for blood-glucose monitoring systems for self-testing in
managing diabetes mellitus.

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37
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.

Testing with your OneTouch Select Plus Simple®

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 Guide for performing a
blood glucose test.

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.

DETAILED INFORMATION ABOUT YOUR SYSTEM

38
Technical Specifications

Assay method Glucose Oxidase biosensor

Automatic shutoff 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
Biological source Aspergillus Niger
Calibration Plasma-equivalent
Memory Last glucose test result only
Operating ranges Temperature: 10-44°C
Relative humidity: non-condensing
10-90%
Altitude: up to 3048 metre
Haematocrit: 30-55%
Reported result range 20-600 mg/dL
Sample Fresh capillary whole blood
Sample volume 1.0 µL
Size 52(W) x 86(L) x 16(T) millimetres
Test time Average test time is 5 seconds
Unit of measure mg/dL
Weight Approximately 50 grams

DETAILED INFORMATION ABOUT YOUR SYSTEM

39
System Accuracy
Diabetes experts have suggested that glucose meters should
agree within 15 mg/dL of a laboratory method when the
glucose concentration is lower than 100 mg/dL, and within
15% of a laboratory method when the glucose concentration
is 100 mg/dL or higher. Samples from 100 patients were
tested using both the OneTouch Select Plus Simple® System
and the YSI 2300 Glucose Analyzer laboratory instrument.

System Accuracy Results for Glucose

Concentrations <100 mg/dL
Percent (and number) of meter results that match the
laboratory test

Within ±5 mg/dL Within ±10 mg/dL Within ±15 mg/dL

61.3% (103/168) 94.6% (159/168) 99.4% (167/168)

System Accuracy Results for Glucose

Concentrations ≥100 mg/dL
Percent (and number) of meter results that match the
laboratory test

Within ±5% Within ±10% Within ±15%

69.0% (298/432) 95.4% (412/432) 99.1% (428/432)

System Accuracy Results for Glucose

Concentrations Between 39.9 mg/dL
and 451 mg/dL
Percent (and number) of meter results that match the
laboratory test

Within ±15 mg/dL or ±15%

99.2% (595/600)
NOTE: Where 39.9 mg/dL represents the lowest glucose
reference value and 451 mg/dL represents the highest
glucose reference value (YSI value).

DETAILED INFORMATION ABOUT YOUR SYSTEM

40
User Performance Accuracy
A study evaluating glucose values from fingertip capillary blood
samples obtained by 160 lay persons showed the following
results:
96.6% within ±15 mg/dL of the medical laboratory values at
glucose concentrations below 100 mg/dL, and 94.7% within
±15% of the medical laboratory values at glucose concentrations
at or above 100 mg/dL.
95.0% of the total number of samples were within ±15 mg/dL or
±15% of the medical laboratory values.

Regression Statistics
Samples were tested in duplicate on each of three test strip lots.
Results indicate that the OneTouch Select Plus Simple® System
compares well with a laboratory method.

# of Subjects # of Tests Slope Intercept

(mg/dL)
100 600 1.00 -2.19

95% CI Slope 95% CI Std. Error (Sy.x) R2

Intercept (mg/dL)
(mg/dL)
0.99 to 1.00 -3.64 to -0.73 9.19 0.99

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41
Precision
Within Run Precision (300 Venous Blood Samples Tested per
Glucose Level)
Data generated using the OneTouch Select Plus Simple® Meter.

Target Mean Glucose Standard Coefficient of

Glucose (mg/dL) Deviation Variation (%)
(mg/dL) (mg/dL)
25 25.43 1.50 5.88
40 40.33 1.56 3.86
65 63.01 2.11 3.35
120 117.43 3.07 2.61
200 196.55 4.42 2.25
350 349.25 7.83 2.24
560 562.88 11.61 2.06
Results show that the greatest variability observed between test
strips when tested with blood is 2.11 mg/dL SD or less at glucose
levels less than 100 mg/dL, or 2.61% CV or less at glucose levels
at 100 mg/dL or above.

Total Precision (600 Control Solution Tests per

Glucose Level)
Data generated using the OneTouch Select Plus Simple® Meter.

Glucose Level Mean Glucose Standard Coefficient of

Ranges (mg/dL) Deviation Variation (%)
(mg/dL) (mg/dL)
20 - 30 25.74 1.13 4.41
30 - 50 46.19 1.29 2.80
96 - 144 111.93 2.27 2.03
280 - 420 362.94 6.09 1.68
420 - 600 546.34 10.27 1.88

DETAILED INFORMATION ABOUT YOUR SYSTEM

42
Guarantee
LifeScan guarantees that the OneTouch Select Plus Simple® 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.
Use of this meter near electrical or electronic equipment that are
sources of electromagnetic radiation, may interfere with proper
operation of this meter. It is advisable to avoid testing in close
proximity to sources of electromagnetic radiation.
Common sources of electromagnetic radiation include mobile
phones, walkie talkies or garage door openers.
Do Not use the equipment where aerosol sprays are being used,
or when oxygen is being administered.

Customer care
Kindly contact Customer Care at 1800 225544 or visit
www.OneTouch.in.
Contents covered by one or more of the following U.S.
patents: 8,066,866, 8,093,903 and 8,486,245. Purchase of
this device does not act to grant a use licence under these
patents. Such a licence is granted only when the device is
used with OneTouch Select® Plus Test Strip. No test strip
supplier other than LifeScan is authorised to grant such a
licence. The accuracy of results generated with LifeScan
meters using test strips manufactured by anyone other than
LifeScan has not been evaluated by LifeScan.

DETAILED INFORMATION ABOUT YOUR SYSTEM

43