Roche Accutrend GC User manual

Illustrations of the meter are shown on the fold-out page
together with a description of the instrument components.
The abbreviations used by the Accutrend®GC are shown
below with their respective meanings:
CODE code number of the test strip batch in use
GLUC glucose = blood sugar
CHOL cholesterol
MEM memory
seT setting
am morning
pm afternoon
lo low, value below measurement range
hi high, value above measurement range
e,eee error
cl clear/delete
all all
on on
off off, outside range
Last updated: October 2000
Roche Diagnostics GmbH
D-68298 Mannheim
Germany
www.roche.com
Accutrend, Accu-Chek and
Softclix are trademarks of a
Member of the Roche Group.
0088
10/00-1432079 (65)
User’s Manual
POINT OF CARE
TESTING
Accutrend®GC
011553 AccuGC GB_Umschlag 19.02.2002 11:12 Uhr Seite U1

▲▼
MEM ON/OFF
s e CODE
G LU C
Instrument components and display
elements
All components and display elements are explained fully in
the manual. It is best to have your instrument next to you
while reading the manual and to try out each step as it is
described.
Back view
▲▼
MEM ON/OFF
®
s e CODE
M E M L O W B A T
mg/dl
Accutrend®GC
Front view Front view, open
D
A
BC
F
E
J
K
H
L
G
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1
Description
●
ADisplay
All display elements are shown.
●
BRocker button
The button

MEM

has several functions.
●
CON/OFF button
The right button switches the instrument on and off.
●
DFlap
Protects the optics.
●
EMeasurement window
The measurement is carried out here.
●
FSlot for test strip
The test strip is inserted in the slot at the bottom of the
meter.
●
GTest strip guide
Holds the test strip in the correct position.
●
HBattery compartment lid
●
JBeeper button
●
KSET button for time and date
●
LConnector for data transmission
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2 3
Contents
1. Introduction 5
2. Using Accutrend®GC for the first time 7
2.1 Inserting/changing the batteries 7
2.2 Switching the meter on for the first time 9
2.3 Setting the time and date 13
2.4 Switching the beeper on and off 19
3. Performing a measurement with Accutrend®GC 21
3.1 Coding of the meter 21
3.2 Measuring glucose and cholesterol 29
3.2.1 Practising a measurement 29
3.2.2 Performing a measurement 29
3.3 Measurements on several people 41
4. Storing results in memory 47
4.1 Automatic storage of results 47
4.2 Retrieving results from memory 49
4.3 Deleting results from memory 53
5. Checking the performance of Accutrend®GC 59
5.1 Checking the measurement system 59
5.2 Cleaning the meter 71
5.3 Battery life and changing the batteries 75
5.4 Measurement and storage conditions 77
6. Troubleshooting 81
6.1 Error messages and important displays 81
6.2 Possible causes of errors 96
6.3 Roche Diagnostics service 97
7. Additional information for medical personnel
and laboratories 99
7.1 Measuring principle 99
7.2 Software 100
7.3 Downloading data to a PC 100
8. General information 101
8.1 Technical data 101
8.2 System components 103
8.3 Manufacturer’s warranty and guarantee 104
8.4 International addresses 105
9. Index 107
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1.
4 5
1. Introduction
Accutrend®GC is a modern, reliable, and easy-to-use instru-
ment for the determination of two important blood parameters:
glucose and cholesterol. Using the proven test-strip principle,
Accutrend®GC allows rapid monitoring of these blood values.
Accutrend®GC is also suitable for self-testing. With Accutrend®
Glucose you can determine your blood sugar in only 12
seconds and with Accutrend®Cholesterol you can determine
your cholesterol level in 180 seconds.
The instructions below take you step by step through the
meter’s operation, cleaning and care. Please take time to read
the instructions and practise using the instrument. Fold out the
page with the description of the instrument components. These
components, indicated by letters of the alphabet, are referred to
frequently in the text. The fold-out page is a helpful orientation.
Warning! You will find this sign when there is a poten-
tial danger to health, e.g. the danger that you
might calculate the insulin dose incorrectly.
Caution! You will find this sign when there is a dan-
ger that you might damage the device, e.g.
through improper cleaning.
Please read this manual carefully and completely
before performing the first measurement.
The packaging material, the identification plate on the instru-
ment and the manual may contain the following symbols or
abbreviations:
For in vitro diagnostic use
This product fulfils the requirements of Directive
98/79/EC on in vitro diagnostic devices
Order/catalogue number
Please consult instructions for use
Caution (refer to accompanying documents).
Please refer to safety-related notes in the manual
accompanying this instrument
Manufactured by
0088
IVD
REF
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2.
6 7
2. Using Accutrend®GC for the first time
Accutrend®GC is supplied with a storage pouch, 3 batteries
and these operating instructions. If any of these items are
missing or damaged please contact your supplier.
2.1 Inserting/changing the batteries
Accutrend®GC is supplied with three AAA alkaline manganese
batteries. The batteries must be inserted before using the
meter.
Procedure for inserting/changing the batteries:
Always switch off the Accutrend®GC before inserting
or changing the batteries. Then turn the meter over and
hold it with both hands.
Slide the battery compartment lid ● Hgently in the
direction of the arrow using both thumbs and remove.
Accutrend®GC
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2.
8 9
Take out old batteries if necessary.
Insert the new batteries, making sure that the terminals
are the right way round (shown by the ●●
+symbols in the
battery compartment and on the battery).
Replace the battery compartment lid ● Hand slide it
closed until it locks into place.
Press the ON/OFF button ● Cto check that the batteries
have been inserted correctly. A function test lasting
2 seconds appears on the display (see Section 2.2).
Accutrend®GC switches off automatically after one minute if
none of the buttons have been pressed during this time.
2.2 Switching on the meter for the first time
After you have inserted the batteries, you can switch on the
meter using the ON/OFF switch ●
C. Immediately after switch-
ing on, the meter always performs an automatic function test
lasting about 2 seconds, checking all instrument functions and
display elements. No entries can be made during this test. The
automatic function test is performed every time the instrument
is switched on using the ON/OFF switch ●
Cwith the flap
closed.
When the Accutrend®GC is switched on for the first time, you
should check each display element during the function test. To
do this follow the instructions given below.
Accutrend®GC
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2.
10 11
Procedure for checking the display elements during the
function test
Before switching on the meter, open the flap ● Dby
gently pressing at the bottom edge. The respective
display elements will now remain displayed for a longer
time.
Check whether the units displayed are the ones
required. Depending on the version of the instrument
the display will show either mg/dl (milligrams per
decilitre) or mmol/l (millimoles per litre) If you are not
sure whether you require mg/dl or mmol/l please ask
your doctor.
If the unit you are familiar with does not appear in the
display, please ask your dealer to exchange the instru-
ment.
Make sure that all three digits of the display appear as
888. If any of the lines making up these digits are
missing, the values displayed later might be incorrect.
If at any time during the function test the display does
not correspond to either of the diagrams on the left,
please notify the Roche Diagnostics service (see pages
97 and 105).
Close flap ● Dagain, exerting slight pressure.
When the function test is complete the word CODE flashes
and --- is displayed.
s e CODE
M E M L O W B A T
mg/dl
s e CODE
m mol /l
M E M L O W B A T
s e CODE
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2.
12 13
2.3 Setting the time and date
The time and date of the Accutrend®GC can be set and
changed. The time must also be changed from summer to win-
ter time and vice versa, and 29 February must be entered in a
leap year. The buttons are recessed to protect them from being
pressed inadvertently. To operate these two buttons you can
use – for example – a ballpoint pen.
For your data to be stored with the important information “date
and time”, these must first be set correctly.
The time can be displayed in either the 12-hour or 24-hour for-
mat. If the 12-hour format is chosen, the time is displayed as
numbers from 1 to 12 with the addition of AM (before 12
noon) or PM (after 12 noon), e.g. PM 3:43.
If the 24-hour format is chosen, the time is displayed in num-
bers from 1 to 24, e.g. 15:43.
The default setting for Accutrend®GC is the 24-hour format.
The following instructions describe how to change it to the
12-hour format.
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2.
14 15
Procedure for setting time and date
Switch the Accutrend®GC on using the ON/OFF button
●
Cand wait until the function test is complete.
Open flap ● D. seT appears on the display ● A.
Briefly press the SET button ● Kbelow the clock symbol
, using a ballpoint pen, for example. Time and date
begin to flash in the display.
To change the display from the 24-hour to the 12-hour
clock format gently lift up the flap ●
Dand press the
rocker button

MEM

●
B. AM or PM appears on the
display.
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2.
16 17
Press the SET button briefly. The hours flash on the
display.
Keep pressing

MEM

●
Buntil the desired hour is
displayed.
Press the SET button briefly. The minutes flash on the
display.
Keep pressing

MEM

to set the minutes in the same
way as the hour.
Press the SET button briefly. The day flashes on the
display.
Keep pressing

MEM

to set the day in the same way
as the hour.
Press the SET button briefly. The month flashes on the
display.
Keep pressing

MEM

to set the month in the same
way as the hour.
Store the changes by closing flap ● Dor by pressing
the ON/OFF button ●
C. Your settings will be stored
automatically.
Leap year
In a leap year the date will not change automatically from
28.02 to 29.02 but to 01.03. In order to change the date,
proceed as described above.
The date will then change automatically from 29.02 to 01.03.
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2.
18 19
2.4 Switching the beeper on and off
The beeper signals provide useful support.
For example, Accutrend®GC uses one beep to confirm
successful coding and a series of beeps to indicate the
approaching end of a measurement.
If the beeper is switched on, the bell symbol appears to the
right of the date. We recommend leaving the beeper switched
on. However, if you find the sound annoying you can switch off
the beeper as follows.
Procedure for switching the beeper on and off
Switch on the meter with the ON/OFF button ● Cand
wait until the function test is complete.
Open flap ● D. seT appears on the display ● A.
Press the beeper button ● Jbriefly using a ballpoint
pen. The bell symbol disappears.
Close the flap.
Switch off the meter. The setting will be stored automatically.
You can switch the beeper back on again at any time by
following the procedure described above.
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3.
20 21
3. Performing a measurement with
Accutrend®GC
3.1 Coding of the meter
The properties of the test strips can vary slightly from pack to
pack. Accutrend®GC must therefore be adjusted to accom-
modate these differences. This adjustment is referred to as
coding.
It is performed with the help of code strips which enter the
specific characteristics of the respective Accutrend®Glucose
and Accutrend®Cholesterol strips used. Accutrend®GC must
be coded:
●After switching on for the first time, when no code number
is stored in the meter.
●Whenever a new pack of test strips is used. The instrument
is coded only for the pack from which you take the test
strips for the measurement of blood glucose or cholesterol.
Individually wrapped code strips are included in each pack
of strips.
CODE GLU
CODE GLU
CODE CHOL
CODE CHOL
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3.
22 23
During each measurement the coded meter performs the
essential checks automatically. Since each code strip and test
strip is characterized by a bar code on the back, the meter
recognizes whether a blood glucose (GLUC) or cholesterol
(CHOL) strip is being used. It then checks automatically
whether the code number on the inserted test strip is the same
as the code number it has stored. If the wrong test strip is
inadvertently used, the error message e-1 appears.
T G LU C H O L
s e CODE
EV.
T G LU C H O L
s e CODE
EV.
2044277(60) V4
1
2
Glucose
mg/dl
Glucose γλθκόζης
50
2,7
+
250
13, 8
++
600
33,3
+++
0 0
neg.
mg/dl mmol/l
Accutrend
®
mini
Accutrend
®
, GC, GCT, DM
Accutrend
®
alpha
ACCUTREND
®
mmol/l
Accutrend
®
Control G
REF 1443054 +3 0°C
+2°C
LOT
IVD
CODE/ΚΩ∆ΙΚΟΣ
50 TESTS / Μετρήσεις
50-90
156-224
2,8-5,0
8,7-12,4
Accutrend® Cholesterol
3159728(60) V3
CODE
+2°C
+30°C
IVD
LOT
REF 1 418 254
5 Tests / Μετρήσεις
048
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3.
24 25
Procedure for coding Accutrend®GC
Switch on the meter. When the function test is complete
the word CODE flashes. If the instrument has not been
coded before, the display shows ---. If it has been
coded previously, the “old” three-digit code is displayed.
Take the code strip out of the wrapping and hold it
between the thumb and forefinger with the arrows
pointing away from you. Be careful not to touch the
black horizontal line.
With the flap ● Dclosed, insert the code strip into the
slot ●
Fin one smooth, brisk movement as far as it will
go, then withdraw the strip immediately. If the beeper is
switched on, successful coding is acknowledged by a
beep. The display shows a three-digit code number. The
code has been read in and stored.
If the error message e-2 or e-3 appears, coding was
unsuccessful (see Section 6.1). In this case, repeat the coding
as follows: open flap, close flap, insert code strip and then
withdraw again immediately.
s e CODE
▲▼
MEM ON/OFF
CODE
GLU
CODE
GLU
®
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3.
26 27
After coding a measurement can be carried out with any test
strip whose code number is stored in the meter. When the test
strip is inserted the display automatically switches to the cor-
rect symbol for the strip.
After coding do not throw away the test strip in case recoding
is necessary later on.
Store the code strip in its wrapping and not in the test
strip container because the print on the code strip may
impair test strip quality and lead to erroneous results.
s e CODE
G LU C
s e CODE
C H O L
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3.
28 29
3.2 Measuring glucose and cholesterol
3.2.1 Practising measurement
If you have little or no experience of self-monitoring and want
to get used to using the meter and the test strips you can prac-
tise measuring without a blood sample. The procedure is iden-
tical to that for checking the performance of the meter; go to
Chapter 5.1 “Checking the Measurement System” and follow
the instructions given there.
3.2.2 Performing a measurement
To perform a measurement you require:
●The Accutrend®GC meter which you have already coded;
you have also set the time, date and beeper.
●Accutrend®test strips (Accutrend®Glucose for blood glu-
cose measurement; Accutrend®Cholesterol for determina-
tion of cholesterol).
●A lancing device (e.g. Accu-Chek®Softclix®Pro with
Accu-Chek®Softclix®Pro Lancet).
●Possibly alcohol wipes and cellulose pads.
Procedure
Carefully read the pack inserts that come with the test
strips and the lancing device.
Warning! If measurements are performed on several
persons there is a potential risk of infection (e.g. hepati-
tis, AIDS). Before using the meter for another person it
▲▼
MEM ON/OFF
2
®
CHOL
CHOL
GLU
GLU
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3.
30 31
must be cleaned and disinfected each time (see Sec-
tion 5). Please read the detailed description in Section
3.3 if you are performing measurements on several per-
sons.
Users in the office and laboratory sector should note
that samples containing human material must be
handled as potentially infectious material. Please
observe the appropriate regulations and guidelines.
Wash and dry your hands thoroughly.
Prepare the lancing device.
Switch on the Accutrend®GC.
When the function test is complete GLUC or CHOL
appears – or GLUC and CHOL alternately if the meter
has been coded for both.
The corresponding code number, the time and the date
appear below. The word CODE flashes and the
Accutrend®GC is now ready for the measurement of
the coded parameters.
Take a test strip out of the test strip container. Close
the container immediately otherwise the desiccant in
the stopper will be exhausted and the test strips will
become unusable.
With flap ● Dclosed, insert the strip into the slot ● Fin
the direction of the arrow with the square yellow test
area facing upwards until the strip locks into place and
the inscription GLU or CHOL on the test strip is no
longer visible.
▲▼
MEM ON/OFF
GLU
GLU
®
s e CODE
G LU C
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3.
32 33
Successful reading of the test strip code is indicated
by two beeps (one short, one long), if the beeper is
switched on, and by display of the test strip type: either
GLUC or CHOL. Then CODE stops flashing.
If the strip code has not been read in correctly, error
messages appear (e.g. e-1, e-2, or OFF). In this case,
consult Section 6.1 “Error messages” and follow the
instructions given there. If the inserted strip is not
shown correctly on the display (e.g. if GLUC is not dis-
played although you have inserted an Accutrend®Glu-
cose test strip), switch off the meter and start again.
Open the flap.
The measurement time in seconds flashes on the
display: 12 sec for GLUC, 180 sec for CHOL.
Rub and knead the side of a fingertip to facilitate the
withdrawal and application of blood.
Lance the massaged site with the lancing device.
With the test strip still in the meter, allow a hanging
drop of blood to form without applying too much pres-
sure. For determination of cholesterol wipe off the first
drop of blood with a cellulose pad and use the second
drop of blood for the test. Carefully apply the drop of
blood to the yellow test area (pad) on the strip without
touching the test pad directly with the finger.
Incorrect
Test area on top of the strip incompletely
covered with blood.
Correct
Test area on top of the strip completely
covered with blood.
GLU
GLU
GLU
GLU
GLU
GLU
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3.
34 35
The test pad must be completely covered with
blood, otherwise the results obtained may be
incorrect (i.e. too low). If too little blood is
applied, do not try to spread it or apply a second
drop as this may also produce incorrect results.
Repeat the measurement with a fresh test strip.
Close the flap immediately after applying the drop of
blood. The display now counts down in seconds to 0.
During the last four seconds a series of beeps is heard
(one beep per second), followed by a longer beep at the
end of the measurement. The measured value (in mg/dl
or mmol/l) appears on the display ●
A. The result is
stored.
Accutrend®GC measures values only within certain
ranges:
glucose 20–600 mg/dl (1.1–33.3 mmol/l)
cholesterol 150–300 mg/dl (3.88–7.76 mmol/l).
If the value obtained is above these ranges the meter
displays hi (= high), if the value obtained is below
these ranges the meter displays lo (= low).
The meter also displays lo when too little blood is
applied, i.e. if the yellow test pad is not completely
covered with blood. If this message appears, you should
therefore turn the test strip over and check whether the
round window on the back is uniformly coloured. If it is
only partly coloured, the measurement must be repeat-
ed with a new test strip.
011553 AccuGC GB 19.02.2002 10:40 Uhr Seite 34