Roche Accu-chek Performa User manual

User’s Manual
Blood Glucose Meter
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Roche USA – 84367
09250859061A_09250859001(02)
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1
E
Contents
Introduction .................................................................................................................... 2
Chapter 1: Your New System.......................................................................................... 4
Chapter 2: Blood Glucose Tests...................................................................................... 8
Chapter 3: Meter Memory, Setup and Data Transfer..................................................... 13
Chapter 4: Control Tests............................................................................................... 21
Chapter 5: Maintenance and Troubleshooting............................................................... 25
Chapter 6: Technical Information.................................................................................. 30
Index ............................................................................................................................ 34
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2
Introduction
The Accu‑Chek Performa System
The Accu-Chek Performa meter is designed
to be used with the Accu-Chek Performa
test strip to quantitatively measure glucose
in fresh venous, arterial, neonatal and
capillary whole blood as an aid in
monitoring the eectiveness of glucose
control. Capillary whole blood for testing of
blood glucose can be obtained from
fingertip and approved alternative sites (for
example, forearm). Refer to the Alternative
Site Testing (AST) section of this manual for
approved alternative sites and associated
limitations. The Accu-Chek Performa meter
with the Accu-Chek Performa test strips
provide a complete test system that is
meant for in vitro diagnostic use by
healthcare professionals in clinical settings
and by people with diabetes at home. The
system is not for use in diagnosis or
screening of diabetes mellitus. Healthcare
professional blood sample collection and
preparation is described in the test strip
package insert.
For use only with the Accu-Chek Performa
test strips and control solutions
Suitable for self-testing
The system includes:
• Accu‑Chek Performa meter with
battery
• Accu‑Chek Performa test strips*
• Accu‑Chek Performa control
solutions*
*Some items may not be included in the
kit. They are a separate purchase.
wWARNING
• Inspect the test strip container before
using the test strips for the first time.
If you see any damage to the
container, if anything prevents the cap
from closing properly, or if the
container was open before using for
the first time, do not use the test
strips. Do not perform a control test.
Contact Roche. Damaged test strips
can cause inaccurate results, which
could lead to improper therapy.
• 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
• The meter comes with a preset time and
date. You may need to change the time to
your time zone.
• 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 Performa Meter
1. Power/Set Button
Turns meter on or o and sets
options.
2. Display
Shows results, messages and test
results stored in memory.
3. Right Arrow and Left Arrow Buttons
Press to enter memory, adjust settings
and scroll through test results.
4. Test Strip Slot
Insert a test strip here.
5. Battery Door
6. Infrared (IR) Window
Transfers data from meter to
computer.
1
2
3
5
61
4
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5
Your New System
1
7. Test Strip Container*
(for example)
8. Test Strip* — Metallic End
Insert this end into meter.
9. Test Strip* — Yellow Edge
Touch blood drop or control solution
here.
10. Control Solution Bottle*
(for example)
11. Battery
*Some items may not be included in the
kit. They are a separate purchase.
B
8
9
A
7
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6
Your New System
1
Using the Accu‑Chek Performa
System
• Use only Accu-Chek Performa 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.
wWARNING
Do not store test strips in high heat and
moisture areas (bathroom or kitchen)!
Heat and moisture can damage test
strips.
Button Functions
Here are the functions of the power/set and arrow buttons on the meter. These functions
are used throughout this manual. For more information on using these buttons during
meter setup, see Chapter 3, Meter Memory, Setup and Data Transfer.
Button Function Action
(power/set
button)
Turn the meter on or o. Press and release .
Enter the set-up mode. Turn the meter on. Press and hold
until set‑up appears on the display.
Set the chosen feature. Press and release .
Exit the set-up mode at any
time.
Press and hold until the flashing
test strip symbol appears on the
display.
Check the display segments.
or
Turn the meter o. Press and hold
to see the complete display.
If one of the segments is missing or
looks dierent from the picture, do
not use the meter. Contact Roche.
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7
Your New System
1
Button Function Action
(right arrow and
left arrow
buttons)
Adjust settings for time and
date, beeper, test reminders
and hypoglycaemic alert.
Press and release or .
Press and hold or to scroll
faster.
Enter memory. Press and release or .
Mark a blood glucose result. Press and release or
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8
2Blood Glucose Tests
Performing a Blood Glucose Test
with Blood from Your Fingertip
NOTE
Blood samples taken from the palm are
equivalent to blood samples taken from
the fingertip. To receive Alternative Site
Testing (AST) instructions and an AST
cap for obtaining blood from the palm,
contact Roche.
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
Before you perform your first blood glucose
test, set up the meter correctly. You need
the meter, a test strip, a lancing device and
a lancet.
1
Wash and dry your
hands.
2
Prepare the lancing device.
3
Check the use by date
on the test strip
container.
Do not use test strips
past the use by date.
4
Insert the test strip
into the meter in the
direction of the
arrows.
The meter turns on
and beeps.
5
When the blood drop
symbol flashes, perform a
fingerstick with the
lancing device.
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9
Blood Glucose Tests
2
6
Gently squeeze your
finger to assist the
blood flow.
This helps you get a
blood drop.
7
Touch the blood drop to
the front edge of the
yellow window of the
test strip.
Do not put blood on top
of the test strip.
The meter beeps and flashes when
there is enough blood in the test strip.
8
or
The test result appears on the display.
To assign a marker to the test result,
leave the test strip in the meter. See
Chapter 2, Marking Blood Glucose
Results and Setting the Post-Meal Test
Reminder.
Otherwise, remove and discard the used
test strip.
After a successful test, the meter turns
itself o 5 seconds after the test strip is
removed.
Performing a Blood Glucose Test
with Blood from Your Palm,
Forearm or Upper Arm
(Alternative Site Testing)
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.
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10
Blood Glucose Tests
2
Read the next section before you try testing from the forearm or upper arm.
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.
Marking Blood Glucose Results and Setting the Post‑Meal Test
Reminder
You can mark a blood glucose result to indicate a special event. If you select a test result
marker, it is automatically stored in memory. When you review the test results in memory,
these markers can help you remember what was dierent about the test result.
Symbol Function
Pre‑Meal Marker
Marking blood glucose results with a pre-meal marker provides more
information about your test results to help you and your healthcare
professional in the management of your diabetes.
Pre‑Meal Marker with Post‑Meal Test Reminder
When a pre-meal result is marked with a post-meal test reminder, the
meter beeps 1 or 2 hours after you test to remind you to do a post-meal
test.
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11
Blood Glucose Tests
2
Symbol Function
Post‑Meal Marker
Marking blood glucose results with a post-meal marker provides more
information about your test results to help you and your healthcare
professional in the management of your diabetes. The post-meal
marker automatically appears with the test result if a test is performed
15 minutes before or after the post-meal test reminder is programmed
to beep. Set the post-meal test reminder time to 1 or 2 hours in the
set-up mode. The meter will beep 1 or 2 hours after the pre-meal test
to remind you to do a post-meal test.
General Marker
You might want to use the general marker to mark an event such as an
AST result or exercise.
Here is how to mark a test result and initiate a post-meal test reminder:
1. Perform a blood glucose test. The blood glucose result appears on the display.
2. Leave the test strip in the meter. Press and release or to toggle through the test
result markers and post-meal test reminder.
3. When the marker or test reminder that you wish to select appears on the display,
remove the test strip from the meter.
Unusual Blood Glucose Results
If your blood glucose result does not match how you feel, check this list to help solve the
problem.
Troubleshooting Checks Action
1. 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.
2. 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.
3. Was the cap on the test strip
container closed tightly?
Replace the test strips if you think the test strip
container was uncapped for some time. Repeat the
blood glucose test.
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12
Blood Glucose Tests
2
Troubleshooting Checks Action
4. 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.
5. Were the test strips stored in
a cool, dry place?
Repeat the blood glucose test with a properly stored
test strip.
6. Did you follow the directions? See Chapter 2, Blood Glucose Tests and repeat the
blood glucose test. Contact Roche if you still have
problems.
7. Are the meter and test strips
working properly?
Perform a control test. See Chapter 4, Performing a
Control Test, for instructions.
8. Are you still unsure of the
problem?
Contact Roche.
Symptoms of Low or High Blood
Glucose
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 color, 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.
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.
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13
3Meter Memory, Setup and Data Transfer
Memory
Storing Blood Glucose and Control
Results
The meter automatically stores up to 500
blood glucose results and up to 20 control
results with the time and date of the result
and any test result marker which you can
review at any time. Test results are stored
from the newest to the oldest, so set the
time and date correctly in the meter.
Having the correct time and date setting
helps ensure appropriate interpretation of
stored blood glucose results by you and
your healthcare team.
NOTE
• The memory is not lost when the
battery is replaced; however, confirm
that the time and date are still
correct. See Chapter 3, Setting the
Time and Date.
• Once 500 blood glucose results are in
memory, adding a new test result
causes the oldest one to be deleted.
• If more than 500 blood glucose tests
are performed within a 90-day period,
only the most recent 500 test results
are included in the 90-day average.
• Control results are stored in memory,
but cannot be reviewed on the meter.
To view stored control results, first
transfer them to a compatible
software application. Contact Roche
for product availability.
• Control results are not included in the
7, 14, 30 and 90-day averages.
• Only test results that have been
assigned a pre-meal or post-meal
marker are included in pre-meal and
post-meal averages. All blood glucose
results are included in the general 7,
14, 30 and 90-day averages.
Memory
Viewing Test Results in Memory
With the meter on or o, press and release or to enter memory. The most recent
test result appears on the display.
Button Function Action
(left arrow
button)
Previous test
results
Press to view previous test results from newest to
oldest.
(right arrow
button)
General averages Press to view 7, 14, 30 and 90-day averages.
n = number of test results in the average
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14
Meter Memory, Setup and Data Transfer
3
Button Function Action
(right arrow
button)
Pre-meal
averages
Post-meal
averages
Continue to press to view 7, 14, 30 and 90-day
pre-meal and post-meal 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.
Setup
Using the Set‑Up Mode
The following features can be customised as required.
Symbol Function Action Factory
Pre‑set
Time and date Set the time and date.
Beeper Select On or OFF. Setting the beeper to OFF
does not aect test results.
The beeper must be On to use the test
reminders feature.
Post‑meal test
reminder
Select 1 hour or 2 hours. The meter will beep
1 or 2 hours after the pre-meal test to remind
you to do a post-meal test.
Test reminders Select On or OFF. You can set up to 4 test
reminders per day.
A-1 8:00
A-2 12:00
A-3 18:00
A-4 22:00
Hypoglycaemic
alert
Select On or OFF. The hypoglycaemic alert
can be set to a level between 50 and
90 mg/dL or 2.8 and 5.0 mmol/L to let you
know when your blood glucose is possibly
too low.
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15
Meter Memory, Setup and Data Transfer
3
Setup
Setting the Time and Date
1
Press and release
(power/set button) to
turn the meter on.
The flashing test strip
symbol appears on
the display.
2
Press and hold until
set‑up appears on the
display.
The hour flashes.
3
Press and release or
to decrease or
increase the hour.
Press and release to
set the hour.
The minutes flash.
4
Repeat step 3 to set
minutes, day, month and
year.
To set up more options,
press and release .
To exit, press and hold
until the flashing test strip symbol
appears on the display.
Setup
Setting the Beeper On or OFF
NOTE
The beeper prompts you:
• to apply blood or control solution to
the test strip.
• when enough blood or control
solution is drawn into the test strip.
• when the blood glucose or control
test is complete.
• when a button is pressed.
• when it is time to perform a test (if
you set the test reminders or
post-meal test reminder).
• if an error occurred while performing
a blood glucose or control test (even
if the beeper is o, it still beeps for
an error).
1
Press and release
(power/set button) to
turn the meter on.
The flashing test strip
symbol appears on
the display.
Press and hold until set‑up appears
on the display.
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16
Meter Memory, Setup and Data Transfer
3
2
or
Press and release repeatedly until the
flashing beeper symbol and On or OFF
appear on the display.
3
Press and release or to switch
between On and OFF.
To set up more options, press and
release .
To exit, press and hold until the
flashing test strip symbol appears on the
display.
Setup
Setting the Post‑Meal Test
Reminder
NOTE
The post‑meal test reminder:
• beeps 1 or 2 hours after the blood
glucose test to remind you to do a
post-meal test.
• beeps every 2 minutes up to 3 times.
• turns o by inserting a test strip or
pressing any button.
• If a test was performed within 15
minutes of a test reminder, the test
reminder does not beep.
• If the meter is on at the test reminder
time, the test reminder does not beep.
• Exposure to cold conditions may
disable test reminders until the meter
is turned on.
1
Press and release
(power/set button) to
turn the meter on.
The flashing test strip
symbol appears on the
display.
Press and hold until set‑up appears
on the display.
2
or
Press and release repeatedly until
set‑up and the flashing 1Hr or 2Hr
appear on the display.
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17
Meter Memory, Setup and Data Transfer
3
3
Press and release or to select 1Hr
or 2Hr.
Press and release to set the option.
To set up more options, press and
release .
To exit, press and hold until the
flashing test strip symbol appears on the
display.
This display appears when
a post-meal test reminder
occurs.
Setup
Setting the Test Reminders
NOTE
Test reminders:
• beep at the same time each day.
• beep every 2 minutes up to 3 times.
• turn o by inserting a test strip or
pressing any button.
• If a test was performed within 15
minutes of a test reminder, the test
reminder does not beep.
• If the meter is on at the test reminder
time, the test reminder does not beep.
• Exposure to cold conditions may
disable test reminders until the meter
is turned on.
• If a test reminder is o in set-up
mode, any subsequent test reminders
are also o. For example, if you set
A-1 but turn o A-2, then A-3 and A-4
will automatically be o.
1
Press and release
(power/set button) to
turn the meter on.
The flashing test strip
symbol appears on the
display.
Press and hold until set‑up appears
on the display.
2
or
Press and release repeatedly until the
bell symbol, OFF, set‑up and the
flashing A‑1 appear on the display.
3
Press and release or
to switch between On
and OFF.
Press and release to set
your choice.
If On is selected, the hour
flashes.
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18
Meter Memory, Setup and Data Transfer
3
4
Press and release or
to adjust the hour.
Press and release to set
the hour.
The minutes flash.
5
Press and release or
to select 00, 15, 30 or
45. These are the only
choices.
Press and release to set
the minutes.
The bell symbol, OFF and the flashing
A‑2 appear on the display.
6
Either set the A‑2 test reminder or press
and release to set up more options.
To exit, press and hold until the
flashing test strip symbol appears on the
display.
Setup
Setting the Hypoglycaemic Alert
wWARNING
• This function is no substitute for
hypoglycaemia training by your
healthcare professional.
• Consumer: Before you set the
hypoglycaemic alert, talk to your
healthcare professional to help you
decide what blood glucose level is
your hypoglycaemic level.
• Healthcare professionals: The
hypoglycaemic level may vary from
person to person. It is recommended
to turn the hypoglycaemic alert OFF
when using the meter in a
professional setting.
1
Press and release
(power/set button) to
turn the meter on.
The flashing test strip
symbol appears on the
display.
Press and hold until set‑up appears
on the display.
2
or
Press and release repeatedly until
set‑up, OFF and the flashing appear
on the display.
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19
Meter Memory, Setup and Data Transfer
3
3
Press and release or to switch
between On and OFF.
Press and release to set your choice.
If you select On, set‑up appears and
flashes.
4
or
Press and release or to adjust the
level.
Press and release to set the level.
To exit, press and hold until the
flashing test strip symbol appears on the
display.
The set-up mode is complete.
Data Transfer
Transferring Results to a Computer
We oer a variety of software to help you
transfer your results. For information on
Accu-Chek software, contact Roche.
You can transfer your stored results to a
computer to track, identify patterns and print.
wWARNING
Transferring data to a computer from
meters used for multiple-patient testing
is NOT recommended since individual
patient results cannot be identified.
Transferring Data Directly to a
Computer Using Specialised
Software and an Infrared Cable
1. Install the software according to the
instructions.
2. To transfer the results to a computer,
connect the infrared cable according to
the instructions.
3. Run the software program and follow
the instructions for data transfer. Make
sure the software is ready to accept
data from the meter.
4. With the meter o, press and hold both
and until 2 arrows on the display
alternately flash.
5. Locate the infrared (IR) window on the
top of the meter.
6. Locate the IR window on the infrared
cable.
7. Place the meter on a flat surface. Point
the 2 IR windows toward each other.
They should be 3–10 cm apart.
8. Do not move the infrared cable or
meter during the data transfer.
9. Follow the prompts on the software.
10. The software program may shut o the
meter automatically when the data
transfer is complete. Should this occur,
follow the prompts on the computer
screen.
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84367_09250859061A_09250859001_02.indd 1984367_09250859061A_09250859001_02.indd 19 2/16/2022 8:20:21 AM2/16/2022 8:20:21 AM