Professional Documents
Culture Documents
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P O I N T O F
T E S T I N G
C A R E
Accutrend GC
The abbreviations used by the Accutrend GC are shown
below with their respective meanings:
CODE
GLUC
CHOL
MEM
seT
am
pm
lo
hi
e, eee
cl
all
on
off
10/00-1432079 (65)
0088
Users Manual
Last updated: October 2000
19.02.2002
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Seite U4
GLUC
seCODE
seCODE
mg/ dl
MEM
ON/OFF
MEM
ON/OFF
Accutrend GC
C
L
E
K
F
G
Front view
Back view
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Seite 1
Description
A
Display
All display elements are shown.
Rocker button
The button MEM has several functions.
ON/OFF button
The right button switches the instrument on and off.
Flap
Protects the optics.
Measurement window
The measurement is carried out here.
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Contents
1.
Introduction
2.
3.
4.
5.
7
7
9
13
19
21
21
29
29
29
41
47
47
49
53
59
59
71
75
77
6.
Troubleshooting
6.1 Error messages and important displays
6.2 Possible causes of errors
6.3 Roche Diagnostics service
81
81
96
97
7.
99
99
100
100
8.
General information
8.1 Technical data
8.2 System components
8.3 Manufacturers warranty and guarantee
8.4 International addresses
101
101
103
104
105
9.
Index
107
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1.
1. Introduction
Please read this manual carefully and completely
before performing the first measurement.
The packaging material, the identification plate on the instrument and the manual may contain the following symbols or
abbreviations:
For in vitro diagnostic use
IVD
0088
REF
Accutrend GC is a modern, reliable, and easy-to-use instrument 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
meters 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 potential 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 danger that you might damage the device, e.g.
through improper cleaning.
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2.
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Accutrend GC
2.
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seCODE
seCODE
mg/ dl
mmol/l
seCODE
10
11
2.
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12
13
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2.
Switch the Accutrend GC on using the ON/OFF button
C and wait until the function test is complete.
14
15
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2.
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.
16
17
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18
19
2.
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20
21
3.
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CODE/
ACCUTREND
Glucose
50 TESTS /
REF 1443054
Accutrend mini
+30C
+2C
Accutrend alpha
LOT
50
2,7
+
Accutrend Control G
mg/dl
mmol/l
50-90
156-224
8,7-12,4
IVD
Accutrend Cholesterol
CODE
3159728(60) V3
048
seCODE
2,8-5,0
600
33,3
+++
TGLUCHOL
250
13,8
++
EV.
Glucose
mg/dl
0
mmol/l
0
neg.
seCODE
2044277(60) V4
TGLUCHOL
10:40 Uhr
5 Tests /
REF 1 418 254
EV.
+30C
LOT
22
+2C
IVD
23
3.
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seCODE
MEM
ON/OFF
CODE GLU
CODE GLU
24
With the flap D closed, insert the code strip into the
slot F in 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.
25
3.
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GLUC
seCODE
Seite 26
CHOL
26
seCODE
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.
27
3.
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3.2
MEM
ON/OFF
CHOL
CHOL
GLU
GLU
28
3.
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GLUC
MEM
Seite 30
must be cleaned and disinfected each time (see Section 5). Please read the detailed description in Section
3.3 if you are performing measurements on several persons.
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.
seCODE
ON/OFF
GLU
GLU
30
3.
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GLU
GLU
Incorrect
Test area on top of the strip incompletely
covered with blood.
GLU
GLU
Correct
Test area on top of the strip completely
covered with blood.
GLU
GLU
32
3.
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34
3.
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Incorrect
Seite 36
Correct
36
3.
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ACCUTREND
Glucose
+30C
+2C
Accutrend alpha
50
2,7
+
2,8-5,0
8,7-12,4
IVD
600
33,3
+++
156-224
250
13,8
++
50-90
LOT
Accutrend Control G
mg/dl
mmol/l
Glucose
mg/dl
0
mmol/l
0
neg.
50 TESTS /
REF 1443054
Accutrend mini
2044277(60) V4
CODE/
10:40 Uhr
38
39
3.
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40
41
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GLU
GLU
GLU
GLU
After lancing the finger remove the test strip from the
open meter and place on a piece of clean, absorbent
material, e.g. paper towel. Then apply the drop of blood
as described.
Repeat the described procedure for the next person to be tested, using a new piece of paper towel or similar absorbent
material.
Acc
MEM
utr
end
GC
ON/O
FF
If Accutrend GC is used for performing measurements on several people and the blood is always applied to the strip using
an application device (e.g. capillary pipettes) the sample may
also be applied with the test strip in the instrument (see Section
3.2). In this case a new application device must be used for
each measurement.
42
43
3.
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Hospital and laboratory users should note that specimens containing human material are to be handled as
potentially infectious material. The relevant regulations
or guidelines applying to your institute or laboratory
should be observed.
The used test strips and consumables (e.g. lancets, swabs) are
to be disposed of as potentially infectious waste according to
the relevant regulations or guidelines applying to your institute
or laboratory.
44
45
3.
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4.
4.1
4.
When you perform a measurement, the Accutrend GC automatically stores this latest result in the position 01 in the corresponding directory. The previous value is moved automatically to position 02. Thus, the higher the number of the
memory position, the older the value occupying this position.
When all available memory positions are occupied, the next
measurement automatically leads to deletion of the oldest
value from the directory and the latest value is stored in
memory position 01.
46
47
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4.2
MEM
e.g.
GLUCHOL
seCODE
e.g.
CHOL
48
seCODE
49
4.
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MEM
Seite 50
GLUC MEM
GLUC MEM
mg/ dl
e.g.
GLUC MEM
50
51
4.
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4.3
GLUC MEM
MEM
Note that these two steps can only be performed one after the
other in the given order.
4.
Clearing the most recent value stored
52
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MEM
GLUC MEM
mg/ dl
mg/ dl
GLUC MEM
mg/ dl
54
55
4.
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GLUC MEM
mg/ dl
MEM
Seite 56
56
57
4.
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5.
58
Accutrend GC meter.
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GLUC
MEM
seCODE
ON/OFF
Note:
The procedure for checking the measuring system is identical
to the procedure for practising how to perform a measurement. You can therefore practise performing a measurement
by following the steps described below for checking the
measuring system.
Procedure for the performance check
GLU
GLU
60
61
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GLU
GLU
With the flap D closed, insert the test strip into the
slot F in the direction of the arrows. Make sure that
the strip is inserted as far as it will go and that the
word GLU on the strip can no longer be seen. When
the Accutrend GC has successfully read the strip code
it emits one short and one long beep (if the beeper is
switched on) and GLUC for Accutrend Glucose
appears on the display. CODE stops flashing.
MEM
Acc
utr
end
GC
ON/O
FF
If the test strip code is not read in correctly, error messages appear (e.g. e-1, e-2 or OFF). Consult Section
6.1 and proceed according to the instructions given
there. If the inserted test strip is not shown correctly on
the display (e.g. if you have inserted an Accutrend
Glucose test strip but GLUC is not displayed), switch
off the meter and start again.
62
63
5.
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TGLUCHOL
seCODE
(
(
(
(
)
)
)
)
Seite 64
GLUCHOL
5.
mg/dl
((
64
))
65
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66
Vertrauensbereiche Vertrauensbereiche
Scattering ranges
Scattering ranges
Intervalles de rfrence Intervalles de rfrence
Ranges di riferimento Ranges di riferimento
Intervalos de dispersin Intervalos de dispersin
Intervalos de referncia Intervalos de referncia
Gewijzigde grenswaarden Gewijzigde grenswaarden
Spridningsomrde
Spridningsomrde
Enkelte omrder
Enkelte omrder
Spredningsomrder Spredningsomrder
Viitealueet
Viitealueet
ria ajiopista ria ajiopista
Ch.-B./Lot.:
mg/dl
mmol/l
256 113
256 500
165222
4,265,74
165222
4,265,74
Check whether the result displayed is within the specified range given on the label of the test strip container
or on a separate leaflet enclosed with the container.
If Accutrend Control G 1 was used, for example, the
result must be within the range given in the first line
on the label (e.g. 5090 mg/dl or 2.85.0 mmol/l). If
Accutrend Control G 2 was used, the result must be
within the range given in the second line (e.g. 156224
mg/dl or 8.712.4 mmol/l). Since the specified range
(confidence interval) may vary from pack to pack, it is
important to pay attention to any additional pack information.
Proceed in the same way for cholesterol.
If the measured value does not fall within the specified
range, repeat the performance check. If the result is
again outside the specified range, consult your nearest
Roche Diagnostics representative (for addresses see
page 105).
If the word OFF appears, please turn to Section 6.1
(Error messages) and proceed as instructed there.
Open the flap and slide out the test strip horizontally.
67
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ACCUTREND
Glucose
REF 1443054
Accutrend mini
+30C
+2C
LOT
50
2,7
+
Accutrend Control G
mg/dl
mmol/l
156-224
2,8-5,0
8,7-12,4
IVD
600
33,3
+++
50-90
250
13,8
++
Glucose
mg/dl
0
mmol/l
0
neg.
50 TESTS /
Accutrend alpha
2044277(60) V4
CODE/
10:40 Uhr
68
69
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MEM
ON/OFF
70
71
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After removal from the meter, clean the test strip guide
with warm water and allow to dry completely.
72
73
5.
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5.
Always change all three batteries at the same time. It is advisable to always have a complete set of three batteries in
reserve.
Use micro LR 03 type batteries (e.g. UCAR Micro 1.5 V AAA,
KODAK Micro or VARTA Micro AAA).
If the batteries are changed within 2 minutes no data will
be lost.
Hand in used batteries at collection points, or return them to
the shop for disposal.
Procedure for changing the batteries
Please proceed as described in Chapter 2.1
Inserting/changing the batteries.
74
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5.
The reading was obtained under temperature conditions outside the admissible range. It must therefore be
interpreted with particular caution and may only be
used for orientation.
Allow the meter and test strips to adjust slowly to room temperature. Never try to speed up the temperature adjustment by
placing on a radiator or in a refrigerator.
76
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Storage conditions
Do not store the Accutrend GC at temperatures below 25C
or above +65C.
Humidity
In the presence of high humidity or large temperature changes
condensation may form on the meter, e.g. when it is taken
from a cold to a warm environment. In such cases Accutrend
GC either switches itself off or cannot be switched on (see
Section 6.1).
Allow the meter to warm up or cool down slowly at room temperature.
Possible sources of interference
Interference, e.g. frequent display of the safety warning eee,
cannot be ruled out in the presence of strong magnetic fields
such as those induced by transmitters (CB radio devices,
radios, televisions), household electrical appliances (microwave ovens, high frequency equipment), and particularly
mobile telephones. It is advisable to keep the meter at least
two meters away from such equipment. If the error warning
continues to display after moving the meter to a different
place, please contact your nearest service centre. See Section
8.4 for addresses.
78
79
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6. Troubleshooting
6.1 Error messages and important displays
Display window
Batteries have run out or have been incorrectly inserted.
Display remains empty when
you switch on the instrument
No code stored.
80
81
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seCODE
GLUC
seCODE
82
83
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The code on the test strip does not match the code in the
meter.
Recode the meter with the code strip from the pack
of test strips you are using (see Section 3.1).
Open the flap, take out the strip, close the flap and
insert the strip again.
84
85
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86
87
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GLUC
Seite 88
CHOL cholesterol
GLUC
CHOL cholesterol
6.
88
89
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6.
90
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GLUC
mg/ dl
Seite 92
92
93
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6.
94
95
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Has the shelf life of the test strips or the control solutions
expired?
96
The staff there will try to help you solve the problem. A list of
Roche Diagnostics representatives in the different countries is
given in Section 8.4.
Repair service: Please note that any repairs or adjustments to
the meter, or any further modifications should only be carried
out by persons authorized by Roche Diagnostics.
If you suspect a fault in your meter you should first contact the
advisory service at your nearest Roche Diagnostics office. The
staff there will try to sort out the problem with you on the telephone.
In exceptional cases problems cannot be cleared up on the
telephone. If this is the case, you should send your Accutrend
GC meter to your nearest Roche Diagnostics office together
with the test strips used and if the meter is still under guarantee the warranty card.
97
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98
99
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8. General information
7.2 Software
Apart from the software programmed into the meter for performance and analysis of the test and the software for the
automatic checks performed by the meter, Accutrend GC also
contains software that allows you to select and call up various
basic settings and recurring functions using the buttons on the
meter.
The individual steps for performing these operations are
described in the respective chapters. The information appearing on the display is also described or shown there.
Type:
Serial No.:
Measurement time:
Measurement principle:
Optical system:
Measurement range:
Memory capacity:
Dimensions:
Weight:
Display:
Automatic cut-off:
Data output:
Power supply:
100
Accutrend GC
See name plate
(on underside of instrument)
Determination of glucose or
cholesterol in fresh capillary blood
by reflectance photometry.
LED (657 nm)
Glucose
20600 mg/dl
(1.133.3 mmol/l)
Cholesterol 150300 mg/dl
(3.887.76 mmol/l)
Glucose 12 seconds
Cholesterol 180 seconds
50 blood glucose results
15 cholesterol results,
all values with time and date
115 x 62 x 18.5 mm
Approx. 90 g (without batteries)
Liquid crystal display
After 2 minutes with test strip
inserted; after 1 minute if no
button was pressed and no test
strip has been inserted.
3-pin connector, serial
3 x 1.5 V batteries type:
micro LR 03, e.g. UCAR Micro
1.5 V AAA, KODAK Micro or
VARTA Micro AAA.
101
8.
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Battery life:
Storage conditions:
Disposal:
0088
10:40 Uhr
Seite 102
8.
102
103
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105
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9. Index
Roche Diagnostics K.K., Nippon Roche Building 6-1
Shiba 2-chome, 105-0014 Minato-ku, Tokyo, JAPAN
Roche Diagnostics Asia Pacific Pte. Ltd.
298, Tiong Bahru Road
#16-01-06 Tiong Bahru Plaza
Singapore 168730
Tel. +652727500
Roche Products (Pty) Ltd. South Africa
Diagnostics Division
9, Will Scarlet Road/Ferndale
P.O. Box 1927
Randburg 2125
South Africa
Tel. +27-11-8861300
Roche Diagnostics Sistemleri Ticaret A.S.
Gazeteciler Sitesi - Matbuat Sokak 3
80300 Esentepe - Istanbul
Turkey
Tel.: +90-212-213-3280
106
Ambient temperature
Batteries
Beeper
Blood collection
Blood, application of
Checking the measuring system
Cleaning the meter
Code strip
Coding
Cut-out time
Data transfer
Date
Deletion of results
Disinfection
Disposal
Error messages
Function test (display)
Humidity
Instrument components
Interface
Interference, causes of
Magnetic fields
Measurements on several persons
Measuring principle
Measuring range
Measuring time
Memory capacity
Page
77
7, 75, 101
19
31
35, 43
59
71
21, 25, 27
21
69, 101
100
13
53
41, 73
39, 102
81ff.
9
79, 81
fold-out section
100
79
79
41
99
35, 101
33
47, 101
107
9.
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Parameters
Performance check
Plausibility check
Practising measurement
Retrieval of results from memory
Storage conditions
Switching on
Symbols
Technical data
Test procedure
Test strip
Test window
Time
Units of measurement
Warranty
108
Seite 108
Page
5, 61
59ff.
37, 69
29ff, 59
49ff.
77
9
4, 5
101-102
29ff.
29, 103
37, 69
13
11
104
109
9.
Telephone No.
City/post code
Street
Signature
11:30 Uhr
Name
Date of purchase
Serial No.
19.02.2002
Warranty Card