Swiscare Technology GM20NBLE Ecare IA Blood Glucose Monitoring System User Manual

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Document ID	2786912
Application ID	xSjDtDxQIiDdW7+bmP0Zxw==
Document Description	User Manual
Short Term Confidential	No
Permanent Confidential	No
Supercede	No
Document Type	User Manual
Display Format	Adobe Acrobat PDF - pdf
Filesize	163.07kB (2038380 bits)
Date Submitted	2015-10-20 00:00:00
Date Available	2016-04-11 00:00:00
Creation Date	2015-10-14 16:34:54
Producing Software	doPDF Ver 8.4 Build 935
Document Lastmod	2015-10-15 17:57:38
Document Title	User Manual

Operation of Lancing device
IA Blood Glucose
Monitoring System
User’s Manual
Protective cover
Lancet point
Control
Solution
Mode
For Model : GM20
Memory
symbol
Please insert the test strip
The temperature is out of range
Please apply blood to the strip
Control solution mode
Preparing your blood sample
Intended for use
The Ecare IA Blood Glucose Monitoring Systems is intended for the
quantitative measurement of glucose in fresh venous whole blood,
or in fresh capillary whole blood from the fingertip. It is intended people
with diabetes mellitus at home or healthcare facilities for monitoring
the effectiveness of diabetes control program. It is not intended for the
diagnosis of or screening for diabetes mellitus, and is not intended for
use on neonates.
Measurement Unit
Milligram per Deciliter
Millimole per Liter
Test Principle
The Ecare IA blood glucose monitoring system is plasma calibrated
to allow easy comparison of results with laboratory methods. Glucose in
the blood sample mixes with special chemicals on the test strip and a
small electrical current is produced. This current is measured by the
Ecare IA Meter and displayed as your blood glucose result. The strength
of these currents changes with the amount of glucose in the blood sample.
2 AAA
1. Wash your hands with soap and warm water.
Then rinse and dry thoroughly.
2. Massage the puncture site.
3. Using lancet device firmly on the side of the fingertip
to get a drop of blood.
4. Press the button on the lancet device.
The blood has been taking as you hear a click sound.
5. Gently squeeze or massage your finger until drop of
blood forms.
Note
• The user must wash hands thoroughly with soap and water after handling
the meter, lancet device or test strips.
• The lancets can not to be re-used or used more than one person to increase
the infection risk.
• Don’t use Povidone Iodine Solution or any org nic solvent for cleaning!
• Wait until hands dry completely!
AST alternate site testing
• Alternative site testing means that people test blood glucose from the forearm,
upper arm or finger tip.
Run a control test by Ecare GDH Control Material (optional accessory)
when you open a new vial of test strips or if you think that your test
result is incorrect. Running a control test lets you know that the meter
and test strips are working properly.
Insert test strip here
• Please consult your doctor to determine if alternative site testing is right for
you.
• Select a soft, fleshy area of skin that is free from hair, moles and visible
veins for alternative site testing.
• Avoid lancing areas with obvious veins or moles to avoid excess bleeding
or where tendons or bones stick out (for example, hand bones and ankle
bones)
1.Press S button 2 seconds into the setting mode.
(no test strip inserted).
Please follow the below steps to change the
parameters.
2.The “L-1” on the display.
Press "M" to select the languages(L-1~L-3)
,then press "S" to confirm language:
Battery cover
3.The “3” on the display.
Press "M" to select the volume(3~0) ,
then press "S" to confirm volume:
3:high volume
0:mute
LCD Display
36.4 x 44.4
1.The year flashes on the display.
Press "M" to select the year(2015~2050)
,then press "S" to confirm year.
Label
Ecare IA Blood Glucose Test strip
2.Repeat the same steps to set
the month, date ,hour and minute.
Note
The hour format is the
12-hour time.
Set the measurement unit
1.The measurement unit flashes.
It is strongly recommend that do AST ONLY in the following intervals
-In a pre-meal or fasting state (more than 2 hours since the last meal).
-Two hours or more after taking insulin.
-Two hours or more after exercise.
Do Not do AST
-You think your blood glucose is low.
-You are unaware of hypoglycemia.
-Your AST results do not match how you feel.
-You are testing for hyperglycemia.
-Your routine glucose results are often fluctuating.
-If you are pregnant.
1. Inserting the test strip. 2. Press “M” button to highlight your status
as “control mode ”, “before meals
”,
“after meals ” or in general mode without
labeling.
a) Pressing once “M” button highlights the
value with
as control solution mode.
(Testing results in control solution mode
will not store in memory.)
b) Pressing once “M” button highlights the
value with as before meals status.
Contr ol Solution M ode.
c) Pressing once “M” button highlights the
value with as after meals status.
d) Pressing one more “M” button removes the
highlight with general mode.
3. Put your blood drop to the Reaction Area on the strip.
2.Set the measurement unit:
Press "M"to select the unit :mg/dL or mmol/L.
Now Testing.
3.Press "S" to confirm measurement unit.
Note
1.Ecare IA Meter should only be used with Ecare IA Blood Glucose Test Strip. Using
other test strips with this meter can produce inaccurate results.
2.The front side of the Ecare IA Blood Glucose Test Strip should face up when inserting
the Ecare IA Blood Glucose Test Strip.
3.The strips are for single use only, please do not reuse or use the used strip and repeat the test.
Note
1. The unit can be changed in setting mode.
2. If you can not change unit during step 2, it means the
system was fixed the unit by default setting.
Delete the test result
1. Ecare IA Meter × 1 .Lancet device × 1
3. Ecare IA Blood Glucose
Test Strip vial × 1
1. The “dEL” display, press “S” goes to sleep
mode.
Please apply blood
into the test strip.
4. After dropping the blood , you will hear a beep sound, then it
starts 6 seconds count down at the same time.
2. Or press “M” 2 sec, it displays “OK”
to delete all memory, then goes to
sleep mode.
1. Wash hands with soap and warm water.
Rinse and dry thoroughly.
Blood glucose
120 mg/dL.
5. The result will appear on the display,
auto-saving in memory.
6.Remove the used test strip, then it goes to sleep mode.
4. Lancet × 10
5.Ecare GDH Control Material
(Optional)
6.AAA Alkaline Battery
2. Pull out a test strip from the box and
must re-cap the box immediately.
3. Insert the test strip, the front side of the
test strip face up, into the test port.
The meter will automatically turn on.
Note
1. Please do not touch on the strip by your finger or use
the smearing blood sample.
2. Do not remove the strip before complete 6 seconds
count down, or it will be automatically shut down.
3. The test strips cannot be re-used.
The meter can store up to 300 test results.
Enter the memory mode
1.Press "M"2 seconds with the meter off to enter the memory mode.
Please insert the test strip.
Note
1.No result appears when first time using the new Ecare Meter.
And appears three dashes on the display.
2.You will not be able to perform a blood glucose test in this mode.
2.The first result appears on the display
is the 7 days average of the test results,
and numbers of the result in 7 days
displayed on upper right side.
‧Never immerse the meter or lancet device in water, and do not get any
moisture in the test strip slot.
‧Do not get wet at the computer port.
‧Make sure the meter is off.
Situation
Action
1. Wipe the meter or lancet device by
following recommended material:
‧CaviWipes™
(EPA* reg. no. 46781-8)
Note
Do not use vinegar or scouring agents to clean meter because
they can harm the display and measurement window.
* Environmental Protection Agency.
3.Press"M" continuously, the consecutive 14/28-days average results
will be shown on display in order.
Equilibrate the control
material at room temperature
for 30 minutes.
2. Wipe the meter dry with a soft cloth or gauze .
The test of control
solution is out of the
range.
Note
The consecutive 7/14/28-day average is calculated from the blood
glucose results obtained during the last consecutive 7/14/28-day.
1.When "1" appears on the display, the value of the first
result will appear later automatically.
2."1"means the most recent result with the result appears
on the display .
3.Press the "M" button continually to review the results until last one.
4.Press the "M" button once, than it will be into the sleep mode and
turned off automatically.
5.If you do not review memory during step 1~4,press "S"button to turn
off the meter.
3. CaviWipes TM can be purchased from the following sources:
‧Amazon.com
‧Officedepot.com
‧Walmart.com
Maintenance
‧Please store the system in a safe and dry location.
‧ Avoid long-term sun exposure.
‧ Avoid the meter to strong shocks, such as dropping the unit on the floor.
‧ If the meter will not be used every day, please remove the battery.
Name
Ecare IA Blood Glucose
Monitoring System
Bettery
2 × AAA Alkaline
Bettery Life
Approximately 1,000 tests
Dimension & Weight
97 × 54 × 20 mm &
83 g( with battery )
Measurement Range
20 mg/dl ~ 600 mg/dl
(1.1mmol/l ~ 33.3mmol/l)
Operation Temperature
10～40°C (50～104 °F)
Operation Humidity
10～90 %
Storage Circumstance
Meter：-20～70°C (-4～158 °F)
Strip：6～42°C (42.8～107.6F)
RH:10～90%
Response Time
6 seconds
Average
7/14/28 days average results
Hematocrit
20%～60 %
Warning message
Situation
Blood glucose testing is
higher then 600 m g/dl
(33.3mm ol/L)
If you would like to review the results from the computer, please
contact the sales distributor for assistance.
Upload
successful
If you want to transfer your blood
glucose testing data to computer(PC),
please transfer your data by using
"Ecare BGMs Data Transfer Software".
Your blood glucose data shall be automatic
transfered successfully by performing
following steps:
1. Connect one end of the USB Cable to the
USB port of your meter.
2. Connect the other end of the USB Cable to
the USB port of your personal computer(PC).
Blood glucose testing is
lower then 20 mg/dl
(1.1mmol/L)
1. Connect to the PC by
USB cable.
2. Please follow the
procedures described
in “Ecare BGMs Data
Transfer Software”.
1. Run a control solution
test and restart the test.
2. If the result of control
solution test is in normal
range, please t est again.
Sample Volume
Test Sample
Operating tem perature
is below 10°C.
Action
Date transferring
starts connection and
will upload successfully
automatically.
Capillary or Venous whole blood
Consult operating instructions
The “Ketone” flashes 5 s econds
and displayed on screen.
Operating temperature
is above 40°C.
1.0ul
THE SYMBOL
High blood glucose level,
possibly ketones.
Guidance for condition
Situation
Action
Caution need consult the instruction for use
Your test strips' lot number
Please operate the meter
in the appropri ate
temperature: 10-40°C
(50-104°F)
Serial number
Please operate the meter
in the appropri ate
temperature: 10-40°C
(50-104°F)
Use-by date
For in vitro diagnostic use
Low battery.
Change the battery.
CONTROL
Removing the used lancet
USB disconnection when
remove the meter or the
USB cable during the
transfer.
Try again. If the same
is sue occurs, please ask
for help for the local
distributors.
Damaged or used strips.
Damaged or used strip,
please discard it and test
again.
Met er internal
self-checking error.
Please contact your local
distributor.
Insufficient blood
volume.
Please prepare s ufficient
blood volume and test
again by new strip.
Control Material
Do not reuse
Temperature Limitation
EU Authorized Representative
Manufacturer
FCC Marking:
1 .Place the lancet cover on a hard surface.
Push the lancet point into the cover.
2. Place the lancet cover back on the exposed lancet point.
3. Discard the used lancet and test strip.
Storage of strips
‧ The expiration time of a strip vial is
(YYYY-MM).
‧ Once you open it , the expired time is 90 days.
‧ It is recommended to write the date when you open the strip vial.
‧ Please do not use the strip past the expired date which may lead to the
wrong result .
‧ A drying agent is included in the strip vial.
‧ Please keep the strips and the vial away from the children, prevent them
from eating.
‧ Storage Circumstance:
Meter：-20～70°C (-4～158 °F) RH:10～90 %
Strip：6～42°C (42.8～107.6 °F)
‧ Keep away from moisture and sunlight.
‧ Please store the strip vial in a safe and dry location, and avoid long-term
sun exposure.
‧ Do not store the strips outside the vial.
‧ Do not store the strip in the other vial.
‧ Please do not touch the strip by a wet hand.
‧ Once you take the strip from the vial, please use it as soon as possible.
And re-cap the vial immediately.
‧ Please do not bend or cut the strip.
Customer service line:
+1-949-702-0769, 24 hours a day, 365 days a year.
Swiscare Technology Co., Ltd.
2F., No.43,45, Lane3, Sec.1,Zhongzheng E. Rd.,
Tamsui Dist.,New Taipei City 251, Taiwan (R.O.C.)
TEL : +886-2-2629-0878
FAX：+886-2-2629-0118
E-mail：service@swiscare.com
Lancet
Manfactured by:
Shandong Lianfa Medical Plastic Products Co.,Ltd
No.1 Shuangshan Sanjian Road 250200 Zhangqiu City,Jinan,
Shandong PEOPLE’S REPUBLIC CHINA
This device complies with part 15 of the FCC Rules.
Operation is subject to the following two conditions:
(1) This device may not cause harmful interference, and
(2) this device must accept any interference received, including
interference that may cause undesired operation.
NOTE: This equipment has been tested and found to comply with the limits
for a class B digital device, pursuant to part 15 of the FCC Rules. These
limits are designed to provide reasonable protection against harmful
interference in a residential installation. This equipment generates, uses
and can radiate radio frequency energy and, if not installed and used in
accordance with the instructions, may cause harmful interference to radio
communications. However, there is no guarantee that interference will not
occur in a particular installation. If this equipment does cause harmful
interference to radio or television reception, which can be determined by
turning the equipment off and on, the user is encouraged to try to correct
the interference by one or more of the following measures:
—Reorient or relocate the receiving antenna.
—Increase the separation between the equipment and receiver.
—Connect the equipment into an outlet on a circuit different from that to
which the receiver is connected.
—Consult the dealer or an experienced radio/TV technician for help.
Dispose of used test strip as well as lancets carefully to
prevent injury or contamination. Please dispose of in
accordance with your local ordinances
For environmental reasons, do not dispose of the device
with the household waste at the end of its service life.
If you have any questions, please contact the local
authorities responsible for waste disposal.
Rev. 20151013
P/N:8-3003002

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