Roche ACCU-Chek Guide Me User manual

User’s Manual
Blood Glucose Meter
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Roche USA – 81383
V1/1 09241493001
09241493001_01 – Black
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1
E
Contents
Introduction .................................................................................................................... 2
Chapter 1: Your New System.......................................................................................... 4
Chapter 2: Blood Glucose Tests...................................................................................... 9
Chapter 3: Control Tests............................................................................................... 14
Chapter 4: Review Your Data........................................................................................ 17
Chapter 5: Wireless Communication, Meter Pairing, and Data Transfer......................... 19
Chapter 6: Meter Maintenance and Troubleshooting..................................................... 22
Chapter 7: Technical Information.................................................................................. 28
Chapter 8: Guarantee................................................................................................... 32
Index ............................................................................................................................ 33
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2
Introduction
The Accu-Chek Guide Me System
The Accu-Chek Guide Me blood glucose
monitoring system is comprised of the
Accu-Chek Guide Me meter and
Accu-Chek Guide test strips.
The Accu-Chek Guide test strips with the
Accu-Chek Guide Me meter are intended
to quantitatively measure glucose in fresh
capillary whole blood from the finger,
palm, forearm, and upper arm as an aid in
monitoring the eectiveness of glucose
control.
The Accu-Chek Guide test strips with the
Accu-Chek Guide Me meter are intended
for in vitro diagnostic self-testing by
people with diabetes.
The Accu-Chek Guide test strips with the
Accu-Chek Guide Me meter are intended
for in vitro diagnostic use by healthcare
professionals in clinical settings. Venous,
arterial, and neonatal blood testing is
limited to healthcare professional use.
This system is not for use in diagnosis of
diabetes mellitus, nor for testing neonate
cord blood samples.
Suitable for self-testing
The system includes:
Accu-Chek Guide Me meter with batteries,
Accu-Chek Guide test strips,* and
Accu-Chek Guide control solutions*.
*Some items may not be included in the
kit. They are a separate purchase.
wWARNING
• Choking hazard. Small
parts. Keep away from
children under the age of
3 years.
• Keep new and used batteries away
from children. Ingestion or
insertion into the body may cause
chemical burns, perforation of soft
tissues, and death. Severe burns
may occur within 2 hours of
swallowing. If you think a battery
might have been swallowed or
placed inside any part of the body,
seek medical attention
immediately.
• If the battery compartment does
not close securely, stop using the
product and keep it away from
children. Contact Roche.
• Any object coming into contact
with human blood is a potential
source of infection (see: Clinical
and Laboratory Standards
Institute: Protection of Laboratory
Workers from Occupationally
Acquired Infections; Approved
Guideline – Fourth Edition; CLSI
document M29-A4, May 2014).
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3
Introduction
wWARNING - KEEP
BATTERIES OUT OF REACH
OF CHILDREN
• In Australia: If you suspect your
child has swallowed or inserted a
button battery, immediately call
the Australian 24-hour Poisons
Information Centre on 13 11 26 for
fast, expert advice.
Why Regular Blood Glucose
Testing Is Important
Testing your blood glucose regularly can
make a big dierence in how you manage
your diabetes every day. We have made it
as simple as possible.
Important Information About
Your New Meter
• It is strongly recommended to have a
back-up testing method available.
Failure to test could cause a delay in
therapy decisions and lead to a serious
medical condition. Examples of back-up
testing methods include a back-up
meter and test strips. Ask your
healthcare professional or pharmacist
about other possible back-up methods.
• The meter prompts you to set the time
and date the first time you turn it on.
• Check the time and date on the meter
before you begin testing. Adjust the time
and date if necessary.
• Sample data screens are shown
throughout the manual. Your data will
dier.
• If you follow the steps in this manual but
still have symptoms that do not seem to
match your test results, or if you have
questions, talk to your healthcare
professional.
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4
1Your New System
The Accu-Chek Guide Me Meter
1
4
5
3
7
6
Front View Back View Side View
1. Power/Set Button
Turns meter on or o and sets
options.
2. Display
Shows results, messages, and test
results stored in memory.
3. Left Arrow Button
Press to enter memory, adjust
settings, and scroll through test
results.
4. Right Arrow Button
Press to enter memory, adjust
settings, and scroll through averages.
5. Test Strip Slot
Insert test strip here.
6. Battery Door
Open to replace batteries.
7. Micro USB Port
Transfers data from meter to a
computer (PC).
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5
Your New System
1
8
9
A
B
C
D
8. Test Strip Container*
9. Test Strip* – Metallic End
Insert this end into meter.
10. Test Strip* – Yellow Edge
Touch blood drop or control solution
here.
11. Control Solution Bottle*
12. Batteries
13. USB Cable*
Connects meter to a PC.
*Some items may not be included in the
kit. They are a separate purchase.
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6
Your New System
1
Using the Meter Buttons
When instructed to press a meter button,
press it briefly and release it.
When instructed to press and hold a
meter button, press and hold it for 3 or
more seconds.
Button Functions
Here are the functions of the power/set
button and arrow buttons on the meter.
These functions are used throughout this
manual.
Button Function Action
[power/set
button]
Turn the meter on or o.
Navigate to an option or set a
selection.
Press and release.
Check the meter display.
memory
set-up
or
memory
set-up
With the meter o, press and hold
to see the complete meter display.
If one of the segments is missing or
looks dierent from this picture, do
not use the meter. Contact Roche.
[right arrow
and left
arrow
buttons]
Adjust settings for time and date and
scroll through test results in memory.
Press and release or press and hold
to scroll faster.
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7
Your New System
1
Symbols
Symbol Description
7-day average symbol. This indicates that you are viewing the 7-day
average of your blood glucose results.
14-day average symbol. This indicates that you are viewing the 14-day
average of your blood glucose results.
30-day average symbol. This indicates that you are viewing the 30-day
average of your blood glucose results.
90-day average symbol. This indicates that you are viewing the 90-day
average of your blood glucose results.
Bluetooth symbol
Control bottle symbol
Drop symbol
Hourglass symbol
Low battery symbol
No data to display
Pairing symbol. A flashing symbol indicates the meter is attempting to pair
with a device. A solid symbol indicates the meter pairing was successful.
Temperature warning symbol
Test strip symbol. A flashing symbol indicates the meter is ready for you to
insert a test strip.
Wireless symbol. A flashing symbol indicates the meter is attempting to
connect to the paired device. A solid symbol indicates the meter is
connected to a paired device.
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8
Your New System
1
Setting the Time and Date
1
Press and release
to turn the meter
on.
The flashing test
strip symbol
appears on the
display.
2
set-up Press and hold
until set-up
appears on the
display. The hour
flashes.
Press or to
decrease or increase the hour.
3
set-up Press to set the
hour and move to
the next field.
4
Repeat steps 2 and
3 to adjust each
field. Press and
hold until the
flashing test strip
symbol appears.
Insert a test strip to perform a test.
NOTE
• The meter prompts you to set the
time and date the first time you turn
the meter on or if an error occurs.
• Press and hold at any time until
the flashing test strip symbol
appears to perform a test.
• The time and date on the meter
synchronises to the time and date on
the paired device each time the
meter sends data to the paired
device. See the chapter Wireless
Communication, Meter Pairing, and
Data Transfer.
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9
2Blood Glucose Tests 2
wWARNING
Blood glucose results can be
displayed in either mg/dL or mmol/L.
The back label of the meter shows
the unit of measurement. If the
meter shows the wrong unit, contact
Roche. If you do not know which
unit of measurement is correct for
you, contact your healthcare
professional. Using the wrong unit of
measurement may cause
misinterpretation of your actual
blood glucose level and may lead to
improper therapy.
mg/dL or mmol/L is printed here
Using the Accu-Chek Guide Me
System
wWARNING
• If you drop the meter or drop the
meter with a test strip inserted,
the meter and/or test strip could
be damaged. Discard the test strip
and perform a control test with
control solution and a new,
unused test strip to ensure the
meter and test strips are both
working properly. Then repeat the
blood glucose test with a new test
strip.
• Do not store test strips in high
heat and moisture areas
(bathroom or kitchen)! Heat and
moisture can damage test strips.
• Use only Accu-Chek Guide test strips.
• Use the test strip immediately after
removing it from the test strip container.
• Do not apply blood or control solution to
the test strip before inserting it into the
meter.
• Close the test strip container tightly
immediately after removing a test strip
to protect the test strips from humidity.
• Store the unused test strips in their
original test strip container with the cap
closed.
• Check the use by date on the test strip
container. Do not use the test strips after
that date.
• Store the test strip container and meter
in a cool, dry place such as a bedroom.
• Refer to the test strip package insert for
test strip storage and system operating
conditions.
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10
Blood Glucose Tests
2
Performing a Blood Glucose Test
with Blood from Your Fingertip
NOTE
• Before you perform your first blood
glucose test, set the meter time and
date.
• You need the meter, a test strip, and
a lancing device with a lancet
inserted to perform a blood glucose
test.
• A blood glucose test cannot be
performed while the meter is
connected to a PC with a USB cable.
• The meter turns o 90 seconds after
a successful test or 15 seconds after
the test strip is removed, provided no
other action is taken.
• There are 2 ways to start a blood
glucose test.
• Insert a test strip into the meter.
• Turn the meter on by briefly
pressing and insert a test strip.
1
Wash your hands
with warm soapy
water. Rinse and dry
thoroughly.
Prepare the lancing
device.
2
Check the use by date
on the test strip
container.
Do not use test strips
past the use by date.
3
Remove a test strip
from the test strip
container.
Close the cap tightly.
4
Insert the metallic end
of the test strip into
the meter. The meter
turns on.
5
When the flashing drop
symbol appears, prick
your finger with the
lancing device.
6
Gently squeeze your
finger to assist the
blood flow. This helps
you get a blood drop.
2
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11
Blood Glucose Tests
2
7
Touch the yellow
edge of the test strip
to the blood drop. Do
not put blood on top of
the test strip.
8
Remove your finger
from the test strip
when the flashing
appears. Failure to
move your finger
away from the test strip could give
inaccurate test results.
9
or
mmol/L
The test result appears on the display.
Remove and discard the used test strip.
Performing a Blood Glucose Test
with Blood from Your Palm,
Forearm, or Upper Arm
(Alternative Site Testing, AST)
wWARNING
• Do not use alternative site testing
to calibrate a continuous glucose
monitoring system.
• Do not use alternative site testing
to make insulin dosing
calculations.
You have the option of obtaining a blood
sample from other sites on your body
besides the fingertip. Alternative sites
include the palm, forearm, and upper arm.
Blood obtained from the fingertip and palm
can be used at any time to perform a
blood glucose test.
If blood from the forearm or upper arm is
used, there are certain times when testing
is not appropriate. This is because your
blood glucose level changes faster in your
fingertip and palm than in the forearm and
upper arm. These dierences may cause
you to misinterpret your actual blood
glucose level, leading to improper therapy
and potential adverse health eects. Read
the next section before you try testing
from the forearm or upper arm.
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12
Blood Glucose Tests
2
You may perform a
forearm or upper arm
test
• immediately before a meal.
• while fasting.
You may NOT perform a
forearm or upper arm
test
• up to 2 hours following a meal, when blood glucose
values can rise quickly.
• after injecting bolus insulin, when blood glucose values
can decrease rapidly.
• after exercise.
• if you are sick.
• if you think your blood glucose is low (hypoglycaemia).
• if you sometimes do not notice when your blood glucose
is low.
If you are interested in AST, talk to your healthcare professional first.
To obtain an AST cap and detailed AST instructions, contact Roche.
Unusual Blood Glucose Results
If your blood glucose result does not match how you feel, check the following list to help
solve the problem.
Troubleshooting Checks Action
Did you wash your hands? Wash your hands with warm soapy water
and dry thoroughly. Repeat the blood
glucose test with a new test strip.
Were the test strips expired? Discard the test strips if they are past the
use by date. Repeat the blood glucose test
with an unexpired test strip.
Was the cap on the test strip container
always closed tightly?
Replace the test strips if you think the test
strip container was uncapped for some time.
Repeat the blood glucose test.
Was the test strip used immediately
after it was removed from the test
strip container?
Repeat the blood glucose test with a new
test strip.
Were the test strips stored in a cool,
dry place?
Repeat the blood glucose test with a
properly stored test strip.
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13
Blood Glucose Tests
2
Troubleshooting Checks Action
Did you follow the directions? Read the chapter Blood Glucose Tests and
repeat the blood glucose test. Contact Roche
if you still have problems.
Are the meter and test strips working
properly?
Perform a control test. See the chapter
Control Tests for instructions.
Are you still unsure of the problem? Contact Roche.
Symptoms of Low or High Blood
Glucose
wWARNING
If you are experiencing any of these
symptoms, or other unusual
symptoms, test your blood glucose
from the fingertip or palm. If your
blood glucose result is displayed as
LO or HI, contact your healthcare
professional immediately.
Being aware of the symptoms of low or
high blood glucose can help you
understand your test results and decide
what to do if they seem unusual.
Low blood glucose (hypoglycaemia):
Symptoms of hypoglycaemia may include,
but are not limited to, anxiety, shakiness,
sweating, headache, increased hunger,
dizziness, pale skin colour, sudden change
in mood or irritability, fatigue, diculty
concentrating, clumsiness, palpitations,
and/or confusion.
High blood glucose (hyperglycaemia):
Symptoms of hyperglycaemia may
include, but are not limited to, increased
thirst, frequent urination, blurred vision,
drowsiness, and/or unexplained weight
loss.
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14
3Control Tests
When to Perform a Control Test
Performing a control test lets you know
the meter and test strips are working
properly. You should perform a control test
when:
• you open a new test strip box.
• you left the test strip container open.
• you think the test strips are damaged.
• you want to check the meter and test
strips.
• the test strips were stored in extreme
temperatures, humidity, or both.
• you dropped the meter.
• your test result does not match how you
feel.
• you want to check if you are performing
the test correctly.
About the Control Solutions
• Use only Accu-Chek Guide control
solutions.
• Close the control solution bottle tightly
after use.
• Write the date you open the control
solution bottle on the bottle label. The
control solution must be discarded
3 months from the date the control
solution bottle was opened (discard
date) or on the use by date on the bottle
label, whichever comes first.
• Do not use control solution that is past
the use by or discard date.
• Refer to the control solution package
insert for control solution storage
conditions.
• The meter automatically recognises the
dierence between the control solution
and blood.
• The control results are not displayed in
memory.
• The control solution can stain fabric.
Remove stains by washing with soap
and water.
Performing a Control Test
You need the meter, a test strip, and
control solution Level 1 or Level 2.
1
Check the use by date
on the test strip
container. Do not use
test strips past the
use by date.
2
Remove a test strip
from the test strip
container.
Close the cap tightly.
3
Insert the metallic end
of the test strip into
the meter. Place the
meter on a flat
surface.
The meter turns on.
A flashing drop
symbol appears.
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15
Control Tests
3
4
Select the control
solution to test. You
will confirm the level
later in the test.
5
Remove the bottle
cap. Wipe the tip of
the bottle with a
tissue. Squeeze the
bottle until a tiny
drop forms at the tip.
6
Touch the drop to the
yellow edge of the
test strip. Do not put
control solution on top
of the test strip.
7
A flashing appears
when there is enough
control solution in the
test strip.
8
or
mmol/L
or
mmol/L
The control result, the bottle symbol,
and the flashing L1 or L2 appear on the
display. Press to confirm the control
level you tested.
Press or to alternate between L1
and L2.
9
or
OK appears if the control result is within
range.
Err appears if the control result is out of
range.
10
Wipe the tip of the
bottle with a tissue.
Cap the bottle tightly.
Remove and discard
the used test strip.
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16
Control Tests
3
NOTE
The meter turns o 90 seconds after a
successful test or 15 seconds after the
test strip is removed, provided no other
action is taken.
Understanding Out-of-Range
Control Results
wWARNING
The control ranges are printed on
the test strip container label. If the
control result is out of range, check
this list to help solve the problem.
Troubleshooting Checks
Action
Were the test strips or control
solutions expired?
Discard the test strips or control solution if either
is past the use by date. If the control solution was
opened more than 3 months ago, discard it.
Repeat the control test with an unexpired test strip
and an unexpired control solution.
Did you wipe the tip of the control
solution bottle before use?
Wipe the tip of the bottle with a tissue. Repeat the
control test with a new test strip and a fresh drop
of control solution.
Were the caps on the test strip
container and the control solution
bottle always closed tightly?
Replace the test strips or control solution if you
think either was uncapped for some time. Repeat
the control test.
Was the test strip used
immediately after it was removed
from the test strip container?
Repeat the control test with a new test strip and a
fresh drop of control solution.
Were the test strips and control
solutions stored in a cool, dry
place?
Repeat the control test with a properly stored test
strip or control solution.
Did you follow the directions?
Read the chapter Control Tests and repeat the
control test.
Did you choose the correct control
solution level, either 1 or 2, when
you performed the control test?
If you chose the wrong control solution level, you
can still compare the control result to the range
printed on the test strip container.
Are you still unsure of the
problem?
Contact Roche.
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17
4Review Your Data
Overview
• The meter automatically stores up to
720 blood glucose results in memory
with the time and date of the test.
• Once 720 blood glucose results are in
memory, adding a new blood glucose
result deletes the oldest blood glucose
result.
• If more than 720 blood glucose tests are
performed within a 90-day period, only
the 720 most recent test results are
included in the 90-day average.
• The meter automatically stores at least
30 control results in memory, but only
the current control result can be viewed
on the meter. To view stored control
results, transfer them to compatible
software.
• Once 30 control results are in memory,
adding a new control result deletes the
oldest control result.
• Control results are not included in the 7,
14, 30, or 90-day averages.
wWARNING
Do not change your therapy based on
an individual test result in memory.
Talk to your healthcare professional
before changing therapy based on
test results in memory.
NOTE
The meter has time and date auto-sync
capability when paired with a mobile
device that will update the meter time
and date automatically. Even if you use
your meter in multiple time zones,
results are stored from newest to
oldest and not by time and date.
Reviewing Blood Glucose Results
in Memory
1
memory
or
memory
mmol/L
With the meter o, press or to
view blood glucose results stored in
memory. The most recent stored blood
glucose result appears on the display.
2
memory
or
memory
mmol/L
Press to view previous test results
from newest to oldest.
NOTE
scrolls from newest to oldest test
result.
scrolls from oldest to
newest test result.
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18
Review Your Data
4
Reviewing 7, 14, 30, and 90-day
Averages
1
memory
or
memory
mmol/L
With the meter o, press or to
view blood glucose results stored in
memory. The most recent blood glucose
result appears on the display.
2
memory
or
memorymemory
mmol/L
With the most recent test result on the
display, press . The 7-day average
appears on the display.
3
memory
or
memory
mmol/L
Press to scroll through 7, 14, 30,
and 90-day averages. The number of
test results in the average = n. Press
to scroll back from 90, 30, 14, and
7-day averages.
To return to the most recent blood
glucose result, press from the 7-day
average screen.
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19
5Wireless Communication, Meter Pairing, and Data Transfer
Overview
The process of creating a connection
between the meter and the mobile device
is called pairing. You will need an
application on your mobile device that can
accept the meter’s data. You can use this
application to wirelessly and automatically
synchronise your diabetes information
between the meter and the mobile device.
Pairing
The meter can only pair with 1 device at a
time. Pairing with a second device
overwrites the first pairing.
The meter and the device to be paired
should be within 1 metre of each other.
1
On Your Mobile Device
Ensure Bluetooth is on and open the
diabetes management app.
2
On Your Meter
With the meter o,
press and hold and
at the same time
until appears. Both
and appear and
flash on the display.
6-digit PIN
Locate the 6-digit PIN on the back of
your meter.
3
On Your Mobile Device
Within the app, follow the instructions
and select your meter. When prompted,
enter the meter’s 6-digit PIN.
The meter times out after 30 seconds
once you are prompted to enter the PIN.
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