Roche Accu-Chek Performa Nano User manual

User’s Manual
Blood Glucose Meter
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Roche USA –79718
V4/1 – 07255233050(01) – Black
Roche USA –79718
V4/2 – 07255233050(01) – Cyan
Roche USA –79718
V4/3 – 07255233050(01) – Magenta
Roche USA –79718
V4/4 – 07255233050(01) – Yellow
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LAN
HORRIXM - Mai 23, 2019
ANDREWC2 - Jun 03, 2019
ANDREWC2 - Jun 03, 2019
BROWNIND - Jun 03, 2019

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1
This file may not print or view at 100%.
Die lines and color breaks do not print.
“Holding Area” text, box and rules do
not print.
Roche USA –79718
V2/1 – 07255233050(01) – Black
Roche USA – 79718
V2/2 – 07255233050(01) – PMS 287
CVC 30%
Contents
Introduction ........................................................................................................................ 3
Chapter 1: Your New System .............................................................................................. 5
Chapter 2: Blood Glucose Tests........................................................................................... 9
Chapter 3: Meter Memory, Setup, and Data Transfer......................................................... 17
Chapter 4: Control Tests.................................................................................................... 27
Chapter 5: Maintenance and Troubleshooting ................................................................... 31
Chapter 6: Technical Information ...................................................................................... 37
Index ................................................................................................................................ 43
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2
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Introduction
3
The Accu‑Chek Performa Nano System
The Accu‑Chek Performa Nano 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 Nano 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 Nano meter with batteries and pre‑inserted activation chip
• Accu‑Chek Performa test strips*
• Accu‑Chek Performa control solutions*
*Some items may not be included in the kit. They are a separate purchase.
Introduction
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Introduction
4
WARNING
• 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 – Third Edition; CLSI
document M29‑A3, 2005).
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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Your New System
5
1
1. Display
Shows results, messages, and test results
stored in memory.
2. Test Strip Slot
Insert test strip here.
3. Activation Chip Slot
Activation chip is pre‑inserted here.
4. Battery Drawer
24
33
6
5
5. Power/Set Button
Turns meter on or o and sets options.
6. Activation Chip
7. Right Arrow and Left Arrow Buttons
Press to enter memory, adjust settings, and
scroll through test results.
8. Infrared (IR) Window
Transfers data from meter to computer.
Chapter 1: Your New System
The Accu‑Chek Performa Nano Meter
Front View Back View Left Side View Right Side View
Top View
(for example)
1
8
7
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Your New System
6
1
9. Test Strip Container*
10. Insert this end into the meter.
11. Yellow Window
Touch blood drop or control solution here.
12. Control Solution Bottle*
13. Batteries
*Some items may not be included in the kit. They are
a separate purchase.
(for example)
910
11
12
13
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Your New System
7
1
Using the Accu‑Chek Performa Nano 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.
WARNING
Do not store test strips in high heat and moisture areas (bathroom or kitchen)! Heat and moisture can
damage test strips.
NOTE
Your meter is already coded and comes with a pre‑inserted black activation chip that you never need to
change. Even if you use test strips from test strip boxes that contain another chip that is a dierent color
or has dierent code numbers, you never need to change the black activation chip again.
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Your New System
8
1
Button Functions
Here are the functions of the power/set button 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. 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.
(right arrow
and left
arrow
buttons)
Adjust settings for time and date,
beeper, test reminders, and
hypoglycemic 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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Blood Glucose Tests
9
2
WARNING
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.
Performing a Blood Glucose Test with Blood from Your Fingertip
Chapter 2: Blood Glucose Tests
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.
mg/dL or mmol/L is printed here
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Blood Glucose Tests
10
2
1
Before you perform your first blood glucose test, set up the meter correctly. You need the meter with
pre‑inserted activation chip, a test strip, a lancing device, and a lancet.
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.
6
Gently squeeze your
finger to assist the blood
flow.
This helps you get a
blood drop.
7
Wash and dry your
hands.
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.
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Blood Glucose Tests
11
2
8
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.
or
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Blood Glucose Tests
12
2
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.
Read the next section before you try testing from the forearm or upper arm.
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Blood Glucose Tests
13
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 (hypoglycemia).
• 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.
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Blood Glucose Tests
14
2
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.
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.
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.
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Blood Glucose Tests
15
2
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 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. 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.
2. 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.
3. 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.
4. Were the test strips stored in a cool, dry
place?
Repeat the blood glucose test with a properly stored
test strip.
5. Did you follow the directions? See Chapter2, Blood Glucose Tests, and repeat the
blood glucose test. Contact Roche if you still have
problems.
6. Are the meter and test strips working
properly?
Perform a control test. See Chapter4, Performing a
Control Test, for instructions.
7. Are you still unsure of the problem? Contact Roche.
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Blood Glucose Tests
16
2
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 (hypoglycemia): Symptoms of hypoglycemia 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 (hyperglycemia): Symptoms of hyperglycemia may include, but are not limited to,
increased thirst, frequent urination, blurred vision, drowsiness, and/or unexplained weight loss.
WARNING
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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Meter Memory, Setup, and Data Transfer
17
3
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 batteries are 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.
Chapter 3: Meter Memory, Setup, and Data Transfer
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Meter Memory, Setup, and Data Transfer
18
3
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.
WARNING
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.
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
(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.
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