Symbol
What it means
Action
Low battery power.
Replace the batteries.
“LO” flashes five times
before the meter turns off. Replace the batteries.
The ambient temperature is
too low.
Repeat the test in a warmer
place,about 57.2°F~104°F
(14°C~40°C). You may need to
wait as long as 20 minutes before
testing again.
The ambient temperature is
too high.
Repeat the test in a cooler place,
about 57.2°F~104°F (14°C~40°C).
You may need to wait as long as
20 minutes before testing again.
mg/dL
Glu
Your blood glucose test
result is over 240 mg/dL.
Consider ketone testing.
Re-check your blood glucose
level. Follow the instructions of
your healthcare provider regarding
ketone testing.
Glu
Your blood glucose level
is higher than 600 mg/dL
(33.3 mmol/L). Consider
ketone testing.
Re-check your blood glucose
level. If “HI” is displayed again,
call your doctor immediately.
Glu
Your blood glucose level
is lower than 20 mg/dL
(1.1mmol/L).
Re-check your blood glucose
level. If “LO” is displayed again,
call your doctor immediately.
Your blood cholesterol level
is higher than 400 mg/dL
(10.4 mmol/L).
Re-check your blood cholesterol
level. If “HI” is displayed again,
call your doctor immediately.
Your blood cholesterol level
is lower than 100 mg/dL
(2.6 mmol/L).
Re-check your blood cholesterol
level. If “LO” is displayed again,
call your doctor immediately.
Your blood uric acid level is
higher than 20 mg/dL
(1190 μmol/L).
Re-check your blood uric acid
level. If “HI” is displayed again,
call your doctor immediately.
Your blood uric acid level is
lower than 3 mg/dL
(179 μmol/L).
Re-check your blood uric acid
level. If “LO” is displayed again,
call your doctor immediately.
X
Operating procedure is
incorrect. The test strip has
been used, or the meter is
not performing correctly.
Repeat the test with a new test
strip. If the symbol is displayed
again, contact customer service.
The oldest test result
stored in memory appears.
The meter turns off
automatically after three
seconds.
No action required.
1. Using a wrong code key
or the code key is inserted
improperly.
2. Meter hasn’t been coded
yet.
1. Be sure the code key is
inserted into the code key
slot completely.
2. Insert the code key.
The code key is damaged. Contact customer service.
Performance Error
Press any botton or re-install the
batteries again.
If the symbol is displayed again,
contact customer service
The
EasyTouch
®
GCU
Meter automatically stores the 200 most recent
glucose, 50 most recent cholesterol, and 50 most recent uric acid test
results. You can review the test results in order from the newest to the
oldest. If the memory is full, the oldest result is deleted as the newest
result is added. The memory is not affected by replacing or removing
the batteries
.
1. Insert the uric acid code key and press “M” to
access the memory feature.
2. The most recent result will appear.
3. Each press of "M" will display in the second-most
recent result.
4. Review more test results in order of the most
recent to the oldest by repeatedly pressing “M”.
After you review the oldest test result, the meter
displays “---” and automatically turns off.
Reviewing Uric Acid Results
Reviewing Blood Cholesterol Results
•
Do not submit your meter to strong impact or pressure.
•
Keep your meter between -10°C and 60°C (14°F and 140°F)
and less than 95% relative humidity. Do not store the meter in
areas such as the kitchen, bathroom, laundry room, or car.
•
Keep the meter away from water.
•
Do not use glass/household-cleaning solutions to clean the
meter. Simply use an alcohol pad to wipe the surface of the
meter, but do not wipe the test strip slot or code key slot.
•
Do not disassemble the meter.
•
If you have any questions, please contact customer service
or your healthcare provider.
Clean the meter with a 70% isopropyl alcohol swab.
•
DO NOT spray any cleaning solution directly onto the meter.
•
DO NOT dampen the code key slot or the test strip slot.
•
DO NOT immerse the meter in liquid.
When the symbol “
” is displayed on the screen, replace the
batteries immediately.
1. Slide battery cover off the back of the meter.
•
Remove the old batteries and insert 2 new AAA size batteries
(1.5V) into the battery compartment.
2. Slide battery cover back in place and turn on your meter.
1. Insert the cholesterol code key and press “M” to
access the memory feature.
2. The most recent result will appear.
3. Each press of "M" will display in the second-most
recent result.
4. Review more test results in order of the most
recent to the oldest by repeatedly pressing the “M”
button. After you review the oldest test result, the
meter displays “---” and automatically turns off.
Troubleshooting
Maintenance
-
Taking Care of Your Meter
Changing the Batteries
Cleaning the Meter
Thank you for choosing the
EasyTouch
®
GCU
Monitoring System.
Bioptik Technology, Inc. is honored to present this new product to you.
Our customers are entitled to free repair and replacement of parts.
However, damage resulting from improper use or accidents is
excluded: strong impact or pressures, moisture intrusion, unauthorized
repair, disassembly, and natural disasters. If you have problems with
the product,
please contact the local distributor or agent for further
information. For EU customer service, dial +49-6894-581020.
Bioptik Technology, Inc.
is not responsible for any accidents or
worsening illness resulting from buyers’ or users’ improper use of the
device without the instructions of professionals (e.g. medical personnel).
Consumers may not request compensation in this regard.
Please read this manual thoroughly before using this monitoring system.
Warranty Information
Product Liability
Labeling and Information
* The Meter has been safety and EMC tested and approved according to the
requirements of EN 61010-1/EN 61010-2-101/EN 60601-1-2/EN 61326-1/EN61326-2-
6, and EN60601-1.
Rev.A4 11/17
P/N 12020315
Item
Description
Item
Description
Do not reuse
Consult instructions for
use
Temperature limitation
Keep away from sunlight
Manufacturer
Use by
Caution, consult
accompanying documents
Authorized representative
in the European
Community
Batch code
Catalogue number
Serial number
Control
In vitro diagnostic medical
device
Sterilized using irradiation
Keep dry
Date of Manufacture
Chol
Chol
Model ET-301
Glucose
Cholesterol
Uric Acid
Measuring Range 20 ~ 600 mg/
dL (1.1 ~ 33.3
mmol/L)
100 ~ 400 mg/dL
(2.6 ~ 10.4 mmol/L)
3 ~ 20 mg/dL
(179 ~ 1190 μmol/
L)
Memory Capacity 200 results
50 results
50 results
Test Time
10 sec.
150 sec.
20 sec.
Sample Volume
≧
4μl
≧
15 μl
≧
4 μl
Shelf-Life
24 month
90 days after
first opening
18 month
60 days after first
opening
24 month
60 days after first
opening
Calibration
Plasma equivalent
Sample Type
Finger capillary whole blood
Measurement
Method
Amperometric
Operating
Conditions
14 ~ 40 °C; 20 ~ 85% R.H.
Storage Conditions
-10 ~ +60 °C (14 ~ 140 °F) ≤95% R.H. (for meter)
4 ~ 30 °C (39 ~ 86 °F)(for strips)
Hematocrit Range
35 ~ 50%
30 ~ 55%
Weight
59 g without batteries
Dimensions
88 x 64 x 22 HxWxD (mm)
Display
LCD (35 x 45 mm)
Battery
AAA * 2 Alkaline
Battery Life
More than 1,000 tests
Specifications
Using the Meter Memory
KETONES?
KETONES?
The following are ranges for uric acid levels:
Male
3.5 ~ 7.7 mg/dL (309 ~ 680.68 μmol/L)
Female
2 ~ 6 mg/dL (176.58 ~ 530.4 μmol/L)
The above range is just for reference, and it may not apply to everyone.
If your blood uric acid is high, discuss these results with your healthcare
provider.
Consult your healthcare provider for the appropriate range for you.
UA
UA
Pus
h
The first time you use the
EasyTouch
®
GCU
Meter or
open a new test strip vial, insert the code key from
the test strip vial. Each test strip vial contains one
code key. Make sure the number on the code key
matches the code number on the vial of test strips
you use.
1. Take one strip from the vial of uric acid test strips.
Close the vial quickly.
2. Insert the test strip into the test strip slot on the
meter. The meter first displays the code number,
and then the blood symbol "
S
".
3.
Clean your finger with an alcohol swab. Let it dry
completely.
4.
Place the puncturer on your finger.
5. Press the trigger on the puncturer.
6. Withdraw the puncturer.
7.
Wipe away the first drop of blood and allow a
second one to form.
8. Touch the drop of blood to the side of the test strip
target area. The target area turns red as the strip
absorbs the blood. Apply blood until the meter
sounds a beep. The meter then counts down from
20, shows your result on the screen, and stores
your result in its memory automatically.
9. Record your uric acid value on the provided log
sheet.
Guidance and manufacturer’s declaration – electromagnetic emissions
This device is intended for use in the electromagnetic environment specified below. The customer
or the user of this device should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment –
guidance
RF emissionsCISPR 11
Group 1
This device uses RF energy only for
its internal function. Therefore, its RF
emissions are very low and are not
likely to cause any interference in
nearby electronic equipment.
RF emissionsCISPR 11
Class B
This device is suitable for use in all
establishments, including domestic
establishments and those directly
connected to the public low-voltage
power supply network that supplies
buildings used for domestic purposes.
Harmonic emissionsIEC 61000-3-2
Not applicable
Voltage fluctuations/flicker emissionsIEC
61000-3-3
Not applicable
Guidance and manufacturer’s declaration – electromagnetic immunity
This device is intended for use in the electromagnetic environment specified below. The customer
or the user of this device should assure that it is used in such an environment.
Immunity test
IEC 60601test
level
Compliance
level
Electromagnetic environment –guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30%.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical commercial or
hospital environment.
NOTE
U
T is the a.c. mains voltage prior to application of the test level.
Guidance and manufacturer’s declaration – electromagnetic immunity
This device is intended for use in the electromagnetic environment specified below. The customer
or the user of this device should assure that it is used in such an environment.
Immunity test
IEC 60601 test
level
Compliance
level
Electromagnetic environment – guidance
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2,5
GHz
3 V/m
Portable and mobile RF communications
equipment should be used no closer to any
part of this device, including cables, than
the recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.
Recommended separation distance
d = 1,2
d = 1,2 80 MHz to 800 MHz
d = 1,2 800 MHz to 2,5 GHz
where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter manufacturer
and d is the recommended separation
distance in metres (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic
site survey,
a should be less than the
compliance level in each frequency range.
b
Interference may occur in the vicinity
of equipment marked with the following
symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which this
device is used exceeds the applicable RF compliance level above, this device should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be necessary, such as
reorienting or relocating this device.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Recommended separation distances between portable and mobile RF communications equipment
and this device
This device is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of this device can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and this device as recommended below, according to the
maximum output power of the communications equipment.
Rated maximum output
power of transmitter
W
Separation distance according to frequency of transmitterm
150 kHz to 80 MHz
d = 1,2
80 MHz to 800 MHz
d = 1,2
800 MHz to 2,5
GHz
d = 2,3
0,01
0,12
0,12
0,23
0,1
0,38
0,38
0,73
1
1,2
1,2
2,3
10
3,8
3,8
7,3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in metres (m) can be estimated using the equation applicable to the frequency of the
transmitter, where
P
is the maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects and people.
Reviewing Blood Glucose Results
1. Insert the glucose code key and press “M” to access
the memory feature.
2.
On each press of "M", the 7-day average, 14-day
average, and the 28-day average will be displayed
on the screen in order.
3.
On the fourth button press, after the 28-day
average, the newest blood glucose test result with
date will be displayed by pressing and releasing
“M”.
4. The stored results with date are displayed in order
from the most recent to the oldest with each press
of “M”. The meter will turn off
automatically in 3
seconds when the symbol “----” is displayed on the
screen.
Deleting Results from Memory
When reviewing results, only the most recent result in memory
can be deleted.
1. Simply press and hold “S” to delete the most recent test result.
2.
The meter then sounds a beep as the memory icon flashes
once.
3. Release “S” and the meter sounds three beeps in rapid
succession to confirm that the result has been deleted.
4. The meter then displays the next-most-recent result.
MT Promedt Consulting GmbH
Altenhofstrasse 80, 66386 St. Ingbert/Hassel,
Germany
Tel: +49-6894-581020
Bioptik Technology, Inc.
No. 188, Jhonghua South Road, Gongguan Village,
Jhunan Township, Miaoli County, Taiwan 35057
E-mail: [email protected]
Blood Uric Acid Testing
After Blood Testing
1. Pull the test strip out of the meter. The meter
turns off by itself. Unscrew the adjustable tip of
the puncturer.
2. Put the protective cover back on the lancet.
Place the protective cover on a flat stable
surface, and stick the lancet tip in the center.
Follow the instruction on the puncturer's
instruction for use manual.
3. Carefully remove an alcohol swab from its
packaging.
4. Thoroughly clean the tip of the puncturer with
the alcohol swab.
5.
Dispose of the used alcohol swab, lancet and test strip, and
store the puncturer in a clean location.
Be sure to follow your local regulations for disposal of used test strips
and lancets.
Lancet (lncluded in the package)
Specification: Sterile, 30G
Manufacturer: SteriLance Medical (SuZhou) Inc.
Address: No. 68 Litanghe Road, Xiangcheng, Suzhou 215133, China
Do not reuse
Sterilized using irradiation
EMERGO EUROPE
Prinsessegracht 20, 2514AP, The Hague, The Netherlands
TURN BACK FOR MOR
E INFORMA
TION.
TURN BACK FOR MORE IN
FORMA
TION.
TURN BACK FOR MORE INFORMA
TION.
TUR
N BACK FOR MORE INFOR
MA
TION.
