Roche Accu-chek Performa User manual

Operator’s Manual / Manuel de l’utilisateur
BLOOD GLUCOSE METER / GLYCOMÈTRE

Contents
Chapter 1: Introduction ....................................................................................... 7
The Accu-Chek Performa Meter ..................................................................... 7
Coding the Meter ........................................................................................... 9
Adjusting the Time and Date – First Time Use.............................................. 11
Using the Accu-Chek Performa System........................................................ 13
Chapter 2: Patient Testing for Healthcare Professionals ................................ 15
Sample Handling.......................................................................................... 15
Performing a Blood Glucose Test ................................................................. 16
Flagging Test Results................................................................................... 19
Unusual Test Results.................................................................................... 20
Recommending Alternate Site Testing to Patients ........................................ 22
Chapter 3: Control Testing for Healthcare Professionals................................ 23
Introduction.................................................................................................. 23
Testing Intervals........................................................................................... 23
About the Control Solutions.......................................................................... 24
Performing a Control Test ............................................................................ 25
Control Test Results..................................................................................... 29
1

Chapter 4: Linearity Testing for Healthcare Professionals.............................. 31
Introduction.................................................................................................. 31
Testing Intervals........................................................................................... 31
Performing Linearity Tests ........................................................................... 32
Linearity Test Results................................................................................... 33
Chapter 5: Meter Memory, Setup, and Downloading....................................... 35
Memory ....................................................................................................... 35
Viewing Results ........................................................................................... 36
Meter Setup ................................................................................................. 37
Setting the Time and Date............................................................................ 38
Setting the Beeper On/Off ............................................................................ 41
Setting the Alarm Clock Function ................................................................. 44
Setting the Hypoglycemic (Hypo) Alarm Function.......................................... 48
Transferring Data Directly to a Computer or PDA Using Specialized
Software and Infrared Cable ................................................................... 51
Chapter 6: Maintenance and Troubleshooting................................................. 53
Changing the Battery.................................................................................... 53
Cleaning the Meter....................................................................................... 54
Maintenance and Troubleshooting................................................................ 55
Screen Messages and Troubleshooting ........................................................ 56
2

Chapter 7: Technical Information..................................................................... 63
Product Limitations ...................................................................................... 63
Specifications............................................................................................... 63
Product Safety Information........................................................................... 66
Disposing of the Meter................................................................................. 66
Explanation of Symbols ............................................................................... 67
Guarantee .................................................................................................... 68
Additional Supplies....................................................................................... 68
Chapter 8: Blood Glucose Testing for Consumers........................................... 69
Performing a Blood Glucose Test ................................................................. 70
Flagging Test Results................................................................................... 74
Alternate Site Testing (AST).......................................................................... 75
Unusual Test Results.................................................................................... 80
Symptoms of High or Low Blood Glucose..................................................... 82
Chapter 9: Control Testing for Consumers....................................................... 83
Why Perform Control Tests........................................................................... 83
About the Control Solutions.......................................................................... 84
Performing a Control Test ............................................................................ 85
Understanding Control Test Results.............................................................. 89
Index .................................................................................................................. 93
3

The Accu-Chek Performa System
The Accu-Chek Performa Meter is for quantitative blood glucose testing using Accu-Chek
Performa Test Strips.
Intended Use
Test strips for quantitative blood glucose measurements in fresh capillary or arterial blood, as
well as in anticoagulated venous blood. Refer to the test strip package insert for acceptable
anticoagulants.
For use only with the Accu-Chek Performa Meter.
The meter may be used by people with diabetes to test their own blood glucose as well as
for blood glucose determination by healthcare practitioners in a professional setting.
Suitable for self-testing
The system includes:
• Accu-Chek Performa Meter with battery
• Accu-Chek Performa Test Strips and code chip
• Accu-Chek Performa Control Solutions
4

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).
Important Information About the Meter
• Thismeterisdesignedfortestingfreshwholebloodsamples.Themeterisforinvitro
(outside the body) use. It should not be used to diagnose diabetes.
• ThemeterrequiresAccu-ChekPerformaTestStrips.Otherteststripswillgiveinaccurate
results.
• Themetercomeswithapresettimeanddatewhichmayneedtobesettothelocaltime
zone.
5
Patients receiving peritoneal dialysis using solutions containing icodextrin
(e.g. Extraneal) should not use the Accu-Chek Performa Test Strip. It could cause
an overestimation of glucose results.

6

Chapter 1: Introduction
The Accu-Chek Performa Meter
Display –
Shows results,
messages, and
results stored in
memory.
Right and Left
Arrow Buttons –
Press to enter
memory, adjust
settings, and scroll
through results.
Test Strip Slot –
Insert test strip here.
Infrared (IR) Window –
Transfers data from the
meter to a computer or
PDA.
On/Off/Set Button –
Turns the meter on or off
and sets options.
Battery Door –
Flip open the battery
door by pushing the
tab in the direction of
the arrow.
Code Chip Slot –
Insert code chip into
this opening.
7

Code Chip
(example)
Battery – Insert with
(+) symbol facing up.
Test Strip Container Control Solution
Bottle
(example)
Contacts –
Insert this end of
the test strip into
the meter.
Yellow Window –
Touch blood
drop or control
solution here.
Test Strip
Top View
On/Off/Set
Button
Infrared (IR)
Window
8

1. Make sure the meter
is off.
2. Turn the meter over. 3. Remove the old code
chip (if there is one in the
meter) and discard it.
Coding the Meter
Change the code chip every time a new box of test strips is opened!
9

4. Turn the code chip over so the code
number faces down. Push the code
chip into the code chip slot until it
stops.
5. Leave the code chip in the meter
until a new box of test strips is
opened.
Notes:
• Donotforcethecodechipintothemeter.Itisdesignedtogointothemeteronlyone
way.
• Ifcode“---”isdisplayed,insertacodechipintothemeter.
10

Adjusting the Time and Date – First Time Use
The meter is preset with the time and date which may need to be adjusted to the local time
zone. Setting the correct time and date in the meter is important to review the results in
memory or to download the results to a computer.
1. Press and release to
turn the meter on. The
time and date appear on
thedisplay.“Set-up”and
the hour flash. If the
correct time and date are
displayed, press and
hold to exit.
2. Press and release or
to decrease or
increase the hour. Press
and hold or
down to scroll faster.
3. Press and release to
set the hour. The minutes
flash.
decrease increase
11

4. Press and release
or to adjust the
minutes. Press and
release to set the
minutes.
5. Repeat to set the day,
month, and year.
6. Once the year is set, press
and hold until the
flashing test strip symbol
appears. The time and
date are now set.
7.SeeChapter5“Meter
Setup”tosetother
options.
Note: After the battery is changed, the meter automatically prompts the operator to
confirm the time and date when it is turned on.
decrease increase
12

Using the Accu-Chek Performa System
• OnlyuseAccu-ChekPerformaTestStrips.
• Replacethecodechipeverytimeanew
box of test strips is opened.
• Storetheunusedteststripsintheir
original container with the cap closed.
• Closethecontainertightlyimmediately
after removing a test strip to protect the
test strips from humidity.
• Usetheteststripimmediatelyafter
removing it from the container.
• Checktheexpiry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.
• Refer to the test strip package insert for
test strip storage and system operating
conditions.
• Do not apply blood or control solution to
the test strip before inserting it into the
meter.
Do not store test strips in high heat and humidity! Heat and moisture can
damage the test strips.
13

Consumers:
Please proceed to Chapters 5 through 9. Chapters 2, 3, and 4 are for healthcare
professionals only.
14

Chapter 2: Patient Testing for Healthcare
Professionals
Sample Handling
Always wear gloves and follow your facility’s infection control procedures when handling
blood-contaminated items. Always adhere to the recognized procedures for handling objects
that are potentially contaminated with human material. Follow the hygiene and safety policy
of your laboratory or institution. Prepare the selected blood collection site per facility policy.
A drop of fresh, whole blood is required to perform a blood glucose test. Fresh venous,
capillary, or arterial blood may be used. Caution should be taken to clear arterial lines
before blood is drawn. Blood glucose determination with venous or arterial blood must be
performed within 30 minutes of sample collection. Avoid air bubbles with the use of pipettes.
Refer to the test strip package insert for appropriate anticoagulants for fresh venous blood
specimens.
15

Performing a Blood Glucose Test
Before performing a blood glucose test on patients, set up the meter correctly. The
meter, a test strip, and a disposable lancet or blood collection device are required.
1. Prepare the lancet or blood collection
device.
2. Insert the test strip into the meter in the
direction of the arrows. The meter turns
on.
3. Make sure the code number on the
display matches the code number on the
test strip container. If the code number
is overlooked, remove the test strip and
reinsert it into the meter.
16

4. A test strip and flashing blood drop
symbol appear on the display.
5. Obtain blood from the patient per facility
policy.
6. 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.
When flashes, sufficient blood is in
the test strip.
17

7. The result appears on the display. To flag
a result, leave the test strip in the meter.
(See the next section.) Otherwise, remove
and discard the used test strip and blood
collection device per facility infection
control policy.
18
Note: After a successful test, the meter turns itself off five seconds after the test strip
is removed.