ALLIANCE i-QARE User manual

Dear i-QARE Blood Glucose Monitoring System Owner,
Thank you for choosing i-QARE Glucose Monitoring System. The
i-QARE Blood Glucose Monitoring System is easy, comfortable, and
convenient to operate; also it helps you monitor blood sugar every
day.
This Owner’s Booklet will help you understand your i-QARE Blood
Glucose Monitoring System. It also provides you with services,
tools, and information, helping you to manage your monitoring
system and blood sugar.
To start testing quickly, you can also refer to the Quick Start
Guide.
If you have any questions, please contact Alliance International
Co., Ltd. Customer Service Center toll-free at 1-866-400-3336 or
visit www.alliance-intl.com.tw. Assistance is available 24 hours
a day, 7 days a week. You can also contact your local agent for
assistance.
Again, thanks for choosing i-QARE Blood Glucose Monitoring
System.

Welcome to use i-QARE Blood Glucose Monitoring System.
i-QARE Blood Glucose Meter utilizes the latest amperometric
biosensor technology to measure blood glucose level. In order to
keep your meter in good working condition, please follow the
correct operation procedures in the Owner’s Booklet.
Read this Owner’s Booklet carefully and completely before
testing your blood glucose. To verify the accuracy of any glucose
meter or test strip, the control solution can be purchased from
your local distributor.
The i-QARE DS-A Blood Glucose Monitoring System is used with
the i-QARE DS-A Draw-In Blood Glucose Test Strips and 2-level
Controls for the measurement of glucose in whole blood. Testing
is done outside the body (in vitro diagnostic use). It is indicated
for use at home (over-the-counter [OTC]) by person with diabetes,
or in clinical setting by health care professionals, as an aid to
monitor the effectiveness of diabetes control. It is not intended for
the diagnosis of or screening for diabetes mellitus, and is not
intended for use on neonates. The frequent monitoring of blood
glucose is an adjunct to the care of persons with diabetes.
INTRODUCTION
INDICATION FOR USE

5-Year Warranty
Alliance International Co., Ltd. warrants to the original
purchaser of the meter that your i-QARE Blood Glucose Meter will
be free from defects in materials and workmanship for 5 years
from the date of purchase. If the meter does not work properly
because of the defect in material or workmanship during this
5-year period, Alliance International Co., Ltd. will repair it or
replace it with a new i-QARE Blood Glucose Meter. The warranty of
the repaired or replacement meter will expire on the date of the
original warranty expiration or 90 days after the shipment of a
replacement meter, whichever period is longer.
This warranty applies only to the original purchaser of the meter.
This warranty does not apply to the performance of a Glucose
Meter that has been damaged by accident or has been altered,
misused, tampered with, or abused in any way.
Alliance International Co., Ltd. will handle meters that show
damage or abuse according to its Non-Warranty Service Policy,
described below.
In no event shall Alliance International Co., Ltd. be liable to the
purchaser or any other person for any incidental, consequential, or
punitive damages arising from or in any ways connect with the
purchase, the operation of the glucose meter, or its parts.
WARRANTY

Non-Warranty Service Policy
The i-QARE Blood Glucose Meter Non-Warranty Service Policy
applies to meters where the above warranty has not become
effective, has become inapplicable, or has expired. Alliance
International Co., Ltd. will repair or replace at its option meters
returned to it for a service charge. Replacement will be the same
series or similar product. Replacement or repaired meter will be
warranted for a period of 90 days from the shipment under a
limited warranty providing for replacement of parts and labor at
no charge.
Warranty and Service Instructions
All requests for return of the i-QARE Blood Glucose Meter under
the above Warranty or Non-Warranty Service Policy must be
made to the Customer Service Center by calling 1-866-400-3336
(Alliance International Co., Ltd.) or local distributor.
Customer experiencing difficulties of operating meter should
review troubleshooting or Error Message of this manual. For
more information or inquiries, please contact Alliance
International Co., Ltd. or local distributor. Be sure to fill out
your warranty form and return it with your i-QARE Blood Glucose
Meter to Alliance International Co., Ltd. or the local distributor.
Alliance International Co., Ltd. Customer Service:
No. 54 Ying-Tao Rd., Yingge Dist. New Taipei City 239, Taiwan
Customer Service Line: 1-866-400-3336
(Our service is available 24 hours a day, 7 days a week)
E-mail: [e-mail]

Contents
Introduction & Indication For Use 2
Warranty 3
Contents 6
Standard Kit Contents, Supplies, andAccessories 8
Specification of i-QARE Blood Glucose Meter 9
Specification of i-QARE Draw-In Test Strip 11
Chapter 1: UnderstandingYour New System 13
Introduction of i-QARE Draw-In Test Strip 15
Symbols Introduction of the LCD Screen 16
Connecting (or changing) the Battery 17
Setting Year, Time, and Date 18
Coding the Meter 19
Chapter 2 Control Testing 20
Control Solution 20
Verifying Strip Accuracy Using Control Solution 21
Notes 22
Chapter 3 Testing Your Blood Glucose 23
Running a Blood Glucose Test 25
Expected Blood Glucose Value 28
CONTENT

Chapter 4: Using Your Meter Memory 30
Chapter 5: Care, Cleaning and Maintenance 32
Blood Glucose Meter 32
Lancing device 32
Battery 33
Meter Operational Status Checking 33
Suggestions 34
Chapter 6: Safety and Disposal 35
Chapter 7: Screen Message and Troubleshooting 36
Message Description and Proceeding Solution 36
Troubleshooting 40

Standard Kit Contents, Supplies, and
Accessories
Standard Kit of i-QARE Blood Glucose Meter
1. i-QARE Blood Glucose Meter x 1
2. CR2032 3V Battery x 1
3. Lancing Device x 1
4. Lancet x 10
5. CODE CARD x 1
6. Draw-In Glucose Test Strip x 10
7. Wallet x 1
8. User’s Manual x 1
9. Quick Reference Guide x 1
10.Diary for Self-Monitoring x 1
11.Control Solution (Normal) x 1
Supplies andAccessories (Need to be purchased separately)
1. Draw-In Glucose Test Strip 50 pcs (25/2vials)
2. Lancing device
3. Lancets
4. Battery (CR2032 3V)
5. Control Solution (2 levels - Normal and High) 2x2ml
Note
The above supplies and accessories are available in
Alliance International Co., Ltd. or your local
distributor.

Specification of i-QARE Blood Glucose Meter
1.Dimensions: 94.5mm x 56mm x 27.5mm
2. Weight: 56g (with battery)
3. Power Source: CR2032 3V lithium coin battery x 1
4. Battery Life: about 500 times or last 10 months without using
5. Display: Large LCD
6. Memory: 360 results with time and date
7. Automatic power-on: Electrode inserting detection
8. Sample size: 1μL
9. Measuring time: 6 seconds
10.Sleep Mode: Power consumption less than 20uA
11.Automatic power off: After 1 minute without action
12.Temperature warning function
13.Operation Condition: 14℃- 40℃(57.2℉- 104℉)
14.Storage/Transportation Condition: 4℃-32℃(39.3℉- 89.6℉),
< 95% R.H.
15. Altitude Limit: under 2610 meters (8562 ft.)
16. Measurement Unit: mg/dL or mmol/L

Applied Standards
This product conforms to the provisions of the FDA 510(K) and
EC directive IVDD (98/79/EC). The following standards apply to
the design and/or manufacturing of the product:
IEC 60601-1
Medical electrical equipment
Part 1: General requirement for safety
IEC60601-1-2
Medical electrical equipment
Part 2: Collateral standard: Electromagnetic
compatibility-requirements and test
IEC 61010-1
Safety requirements for electrical equipment for measurement,
control and laboratory use
Part 1: General requirement

Specification of i-QARE Draw-In Test Strip
1.Strip Size: 35mm x 7mm x 0.35mm
2.Required Blood Sample: 1µL
3.Hematocrit: 30% - 55%
4.Sample Type: Fresh capillary whole blood
5.Test Range: 20 - 600 mg/dL
6.Operation Condition: 14℃- 40℃(57.2℉- 104℉)
7.Validity: Can be used within 90 days after opening or within 18
months after the production date
8.Unit of Packaging: 25 strips x 2 vials/box
9.Storage/Transportation Condition: 4℃- 32℃(39.3℉- 89.6℉),
< 95% R.H. DO NOT REFRIGERATE
Caution
1. Do not use any expired strips.
2. The strips are only used with i-QARE glucose meter.
3. Do not use any blood that has been preserved (e.g. by
fluoride).
4. It is not recommended to test the blood level to
newborn baby.
5. Taking high dose of vitamin C or having high level of
uric acid may influence the blood glucose level, which
may cause inaccurate test results.
6. Hematocrit above 55% may cause lower blood glucose
level; hematocrit lower than 30% may cause higher
blood glucose.

7. To protect the environment, dispose of the used lancets
and strips in appropriate collection sites according to
national or local regulations. Avoid other people
touching the used lancets or test strips, which may
cause cross infection.
8. Keep the test strip vial away from children; the cap is
a choking hazard. In addition, the cap may contain
drying agents which can harm the body if swallowed
or inhaled. It may cause skin or eye irritation.

Chapter 1: Understanding Your New System
*Items may be sold separately.
Display-
Shows blood glucose
results, messages, and
the results stored in
memory.
Test Strip Slot-
Insert test strip here
Function Button-
Press this button to
enter to the Set Mode,
move between fields
(such as time, date,
etc.)
Power Button-
Press this button to
enter or exit the
Memory mode or
change values in the
Set mode.
Front View
Data Slot-
Transfer date from the
meter to a computer.
Side View

Battery Cover
Slide out cover to
change battery
Back View
Lanyard Hole
Test Strip Vial
Code Card
Cap with Comfort Dial
Depth Selection
Plunger
Release Button
Ejector
Test Strip
Reaction
Zone
Lancet
Cover Protective

Introduction of Draw-In Test Strip
1. Reaction Zone
This is located in the middle of the test strip. This area must be
completely filled with blood sample.
2. Application Zone
This is located on the top side of the reaction zone. When a
drop of blood is applied to the reaction zone, it will be rapidly
drawn in.
3. Introduction Zone
On the test strip, black bars are located in the bottom area, and
it must be inserted into the strip slot of the meter with the black
bars facing up.
Caution
1. Blood sample should not be applied to the
Introduction Zone (black bars).
2. Avoid touching the reaction and application zones for
long periods as moisture may affect the reaction and
reading.
Reaction Zone
Introduction Zone Application Zone

Symbols Introduction of the LCD Screen
Display Symbols
The blood glucose meter displays symbols to guide you through
the test and to assist you to determine whether the test strip and
display function are ready or not. To check that all the display
symbols are working, press the power button or insert the test
strip electrodes into the meter. When a test strip or CODE CARD
is inserted, the display will turn on automatically. Each time the
meter is on, all the symbols should appear briefly.

Connecting (or Changing) the battery
Caution
The battery symbol on the screen means the
battery is low, and should be changed soon.
3. Place a new battery in a
45 degree to the tray with
the + side facing up.
4. Push the top of the battery
until it is firmly positioned.
1. Use your thumb to slide the
battery cover out of the
meter.
2. Slightly pull back the
buckle to loosen the
battery.

Setting Year, Time, and Date
Setting the time and date is important if you use meter’s memory
or connect to your computer.
4. Press to change the
month, until the desired
month is displayed.
5. Repeat step 3 and 4 to
change day, hour, minute,
and unit.
1. With meter off, press
(Set button), the year will
flash.
2. Press (power button) to
change the year, until the
desired year is displayed.
6. Press to finish set-up and the meter will turn off
automatically.
3. Press again, the month
will flash.

Coding the Meter
1. With the meter off, insert the code card
into the test strip slot. Please make sure
the number on the code card matches the
code on your display.
2. When you insert a test strip
(see Running a Blood Glucose
Test), the meter will turn on
automatically and show the
strip code number. Please
make sure the code number on
the meter screen matches the
code on the test strip vial.
3. Throw away the old code card.
Caution
1. Each box of test strip contains one CODE CARD
designed specially with one code number.
REMEMBER to change the CODE CARD every
time you open a new box of test strip.
2. DO NOT insert different brands or models of
CODE CARD or strip, which cannot turn on and
function the meter.
3.
Same