Ace Medical ACEZIN GLUGlod User manual

User’s Manual
ACEZIN GLUGlod
Blood Glucose
Monitoring System
A
Model No.
AM100 plus

1
This booklet has important information you must know
about ACEZIN GLUGold AM100 plus Blood Glucose
Monitoring System with detailed directions and illustrations.
To ensure that you use properly and obtain the best test
results possible, please read the entire User’s Manual before testing.
This package contains 2 new AAA alkaline batteries. Insert them
into AM100 plus Blood Glucose Monitoring System by following
steps in this manual to ensure normal function.
Any concerns? Or need any assistance about maintenance? Please
call our Ace Medical Technology Co., Ltd. office or authorized
distributor during business hours.
Message to Our Dear User

2
To make sure that you operate AM100 plus Blood Glucose Monitoring
System safely and accurately, please follow the user’s manual.
Please keep AM100 plus Blood Glucose Monitoring System away from any
liquid or sprays, keep them dry.
Do not use AM100 plus Blood Glucose Monitoring System on purposes
outside “Intended Use”.
Only use accessories supplied or recommended by the manufacturer.
Avoid severe impact on the meter. It may cause malfunction.
Do not take AM100 plus Blood Glucose Meter apart, or modify anything.
Such action may void your warranty.
Do not place anything on top of AM100 plus Blood Glucose Meter.
Keep the whole AM100 plus Blood Glucose Monitoring System away from
children. They may choke on battery, or tiny component parts by accident.
Keep AM100 plus Blood Glucose Meter free from dust, hair, etc. Store the
meter in its container after use.
If you feel you are suffering from severe dehydration, stop using and
consult healthcare professionals right away.
If your symptoms are not consistent with blood glucose test results and
you have followed all instructions this manual, seek your healthcare
professional for help.
Dispose of medical waste per local regulations.
Warning for potential biohazard: Healthcare professionals using this
system on multiple patients should be aware that all products or
objects that come in contact with human blood, even after cleaning,
should be handled as if capable of transmitting viral disease. So the
healthcare professionals should wear disposable gloves and have an
inoculation regularly to prevent infections.
Caution

3
Explanation of Symbols
Caution!
Authorized representative in the European Community
This product meets the requirements of Directive 98/79/EC in
vitro diagnostic medical devices
Consult instructions for use
In vitro diagnostic medical device
Use-by date
Manufacturer
Date of manufacture
Temperature limit
Humidity limitation
Keep away from sunlight
Do not re-use
Batch code
Catalogue number
2 AAA (1.5 V) Alkaline Batteries
Biological Risks
Discard the used product to the recycling collection point
according to local regulations
Appendices

4
About AM100 plus Blood Glucose Monitoring System…...……..…… 05
Intended Use
Measuring Principle
System Kit
Component Description
Key Features……………………………………………….……….…... 12
Eject Strip Design
Meal Comment Function
Get Ready for Testing…………………………………………..…...…. 14
Battery Installation
Presetting Date and Time
Quality Control of the System……………………………….…..…….. 16
Using Glucose Control Solution
Perform the Blood Glucose Test……………………..…………...…… 18
Perform the Blood Glucose Test
LO and HI Readings
Memory Recall
Maintain Your Meter…………………………...……….…….……...... 29
System Specifications…………………………………….………...…... 30
Limitations
Product Specifications
Display Messages and Troubleshooting……………...……………….. 33
Device Information……..…………………………..…………….…..… 35
Table of Contents

About AM100 plus SMBG System
5
Thank you for choosing AM100 plus Blood Glucose Monitoring System.
Designed for ease of use, the device can help you and your healthcare
professional monitor and adjust your treatment plan to gain better control
of your diabetes.
Record the opening date of test strips on its vial. Discard all unused strips
90 days after opening date. The strips are for single use only.
If your symptoms are not consistent with blood glucose test results and you
have followed all instructions this manual, seek your healthcare professional
for help.
Warning of potential biohazard: Healthcare professionals using this system
on multiple patients should be aware that all products or objects that come in
contact with human blood, even after cleaning, should be handled as if
capable of transmitting viral disease.
 Test results below 70 mg/dl (3.9 mmol/l) mean low blood glucose
(hypoglycemia).

Test results greater than 240 mg/dl (13.3 mmol/l) mean high blood
glucose (hyperglycemia).
 If you get results below 70 mg/dl (3.9 mmol/l) or above 240 mg/dl
(13.3 mmol/l), and do not have symptoms, repeat the test.

If you have symptoms or continue to get results that fall below 70 mg/dl
(3.9 mmol/l) or above 240 mg/dl (13.3 mmol/l), follow the treatment
advice of your healthcare professional.
ImportantInformation!
Expected Results for Non-Diabetic, Non-Pregnant Adults:
The normal fasting glucose range is 70 ~ 100 mg/dl (3.9 ~ 5.6 mmol/l).
Two hours after meals, normal glucose values should be less than
140 mg/dl (7.8 mmol/l).
Severe dehydration resulting from excessive water loss may cause false
results. If you feel you are suffering from severe dehydration, consult the
healthcare professionals immediately.

About AM100 plus SMBG System
6
Intended Use
ACEZIN GLUGold AM100 plus Blood Glucose Monitoring System is self-
test medical device and intended for home testing to monitor the blood
glucose (β-D-glucose) levels in fresh capillary whole blood from fingertip
and venous whole blood. ACEZIN GLUGold AM100 plus Blood Glucose
Monitoring System is for In-vitro use only.
It is indicated to be used by diabetics at home or in a clinical setting by
professional healthcare personnel to measure the glucose concentration for
aiding diabetes management. The owner can only use AM100 plus
Blood Glucose Meter with AMG011 Blood Glucose Test Strips.
MeasuringPrinciple
We design AM100 plus Blood Glucose Monitoring System by using the
latest biosensor technology. It measures the glucose levels of the blood
specimen by using a disposable dry reagent strip which can produce
an electrical current. And the current will transfer to the meter for
measurement. The amount of the current is proportional to the amount of
glucose present in the blood sample. Test results are “plasma equivalent”.
The system consists of three main products: AM100 plus Blood Glucose
Meter, AMG011 Blood Glucose Test Strips, and ACEZIN GLUGold
Control Solution. These products have been designed, tested, and proven to
work together and perform accurate results.
Note
The accuracy of AM100 plus Blood Glucose Monitoring System was
compared with YSI 2300 Analyzer.

About AM100 plus SMBG System
7
System Kit
•
AM100 plus Blood Glucose Meter
•
AMG011 Blood Glucose Test Strips (Sold separately)
•
ACEZIN GLUGold Control Solution (Sold separately)
•
Lancing Device
•
50 Lancets
•
AAA(1.5 V) Alkaline Battery x 2
•
Pouch
•
Complete instructions:
1. User’s Manual for AM100 plus Blood Glucose Monitoring System
2. Quick Reference Guide
3. Logbook
Note
Please consult your provider/local distributor for extra
Blood Glucose Test Strips and Glucose Control Solution
pack.
If contents of your package do not meet the system kit list
above, please return the whole package to local
distributor.
“If the equipment is used in a manner not specified by the
manufacturer, the protection provided by the equipment
may be impaired.”

About AM100 plus SMBG System
8
ComponentDescription
AM100 plus Blood Glucose Meter
LCD Screen
Displays blood
glucose results,
messages, and
glucose results
stored in memory.
M Button
Press to enter
different mode.
Test Strip Slot
Insert test strip here.
Strip Eject Button
Press to eject the used
strip
S Button
Press to adjust
settings and digits

About AM100 plus SMBG System
9
ComponentDescription
Meter Display
1
&
2
Hour & Minute
7
Wireless transmission
12
Low Battery Symbol
Appears when battery is low
3
Month or Year
8
Apply Blood Symbol
Your meter is ready to
measure.
13
Temperature Symbol
Appears when ambient
temperature exceeds
operating temperature.
4
Day or Year
9
Decimal Point
Appears when LCD displays
blood glucose result in
mmol/l unit.
14
Control Solution Test
Symbol
Appears while performing
Control Solution Mode.
5
MEM
Appear while LCD displays
past results.
10
mg/dl
This device can display
results in unit mg/dl.
15
Pre-meal or Post-meal
Symbol
Indicates whether the test
result is taken before or after
meal.
6
AVG
Appear while LCD displays
average of past 7 /14/ 30/ 60
days result.
11
mmol/l
This device can display results
inmmol/lunit.

About AM100 plus SMBG System
10
ComponentDescription
Blood Glucose Test Strips (Sold Separately)
Contact Electrode
Insert into the test strip slot.
Insert the test strip as far as it will go.
TopEdge (Collection Zone)
Move blood sample or glucose control solution
close to the top edge of the test strip.
WARNING
Keep the strip vial away from children; in case any choking hazard
happens. The desiccate reagent in the vial may cause skin or eye
irritation by contact.
Note
Only use AMG011 Blood Glucose Test Strips with AM100 plus
Blood Glucose Meter only.
Do not touch the strip when your hands are wet.
Record the first opening date on the vial, and use them within 90
days after first opening. If not, discard them in case inaccurate
results may occur.
Blood Glucose Test Strips are for single use only. Never reuse.
Keep Blood Glucose Test Strips in vial always.
Bending, cutting, or twisting strips are prohibited.
Read User’s Manual for AMG011 Blood Glucose Test Strips for
more information.

About AM100 plus SMBG System
11
ComponentDescription
Lancing Device
Lancets
Protective Cap Needle Handle
Depth Settings & Indicator
Release Button
Cocking Handle

Key Features
12
Meal Comment Function
Meal Comment Function enables our user to add pre-meal or post-meal
symbols on each test result. AC symbol represents pre-meal
results, while PC symbol represents post-meal results.
It benefits user to better manage the glucose control plan, also your
healthcare professional by providing data when diagnosing and prescribing.
Follow below steps to activate Meal Comment Function:
Under Standby Mode (Right Figure), press S
button to enter Meal Comment Setting Mode.
Our default setting is off (Upper Right). Press S
button to switch the function on (Lower
Right), or off.
When done, press M button and return to
Standby Mode.
1
2

Key Features
13
Eject Strip Design
AM100 plus meter features it’s eject strip function,
which provides user can take out the used strip by
pushing and slide the strip eject button after taking
measurement.
Note
For those who do not wish to change meal comment to test results,
simply remove test strip from test strip port after measurement ends. Meter
will automatically store your test result in its memory with previous
set symbol.
With Meal Comment Function on:
Pre-meal: Test result appears with Symbol .
Post-meal: Our default setting. Test result appears with Symbol .
When measurement ends, users can press and hold the S button for 1
second, then waiting to hear a “beep” sound while LCD displaying
the or Symbol, depending on their physical status.

Get Ready for Testing
14
Battery Installation
The meter uses 2 pieces of AAA alkaline battery as power source. For new
users, please insert 2 new batteries before use, and please replace old batteries
with new ones when Low Battery Symbol shows up.
Slide battery cover from back of meter.
Install 2 new AAA alkaline batteries in
accordance with correct polarities.
Put the battery cap back.
To avoid inaccurate results caused by electromagnetic interference
between electrical and electronic equipment, do not use the device
near a mobile phone or microwave oven.
Note
Flashing Symbol means the battery power is too low
to work.
Past results in storage are intact after battery replacement.
After battery replacement, please reset year, date and time.
Do not mix new and old batteries.
To save the power, please take batteries out if you do not use
the meter for a long period (approx. 2 months or more).

Get Ready for Testing
15
Presetting Date/ Time/ Unit
Please pre-set your meter whenever you insert or replace the batteries. See
following steps for details.
1Under Standby Mode, press and hold M button
for 3 seconds to enter Setting Mode.
Note: After battery replacement, meter
automatically activates Setting Mode.
2When YEAR digits flash, press S button to
select current year. When done, press M
button to confirm.
To complete date and time settings, repeat
above steps by setting MONTH, DATE,
HOUR and MINUTE in sequence.
3After setting the correct year, select
preferable unit by pressing S button. When
done, press M button to confirm.

Quality Control of the System
16
Using Glucose Control Solution (Sold Separately)
The purpose of ACEZIN GLUGold Control Solution is to perform a quality
control test to verify whether your meter and test strips are working
together properly.
There are two levels of Glucose Control Solutions for different acceptable
ranges: High Level and Medium Level. We recommend testing with both
levels of Glucose Control Solution.
• How does it work?
A known amount of glucose in the control solution reacts with AMG011
Blood Glucose Test Strip.
• Who or when to perform a control solution test?
 Handling your meter at the first time.
After opening a new vial of test strips.
Strong impact on the meter.
When your symptoms do not agree with the way you feel, or when the result
is higher or lower than expectation.
Whenever users wish to check whether Blood Glucose Test Strip and Blood
Glucose Meter are working properly.
1 Insert test strip into test strip slot.
When symbol flashes, press S button to activate
Quality Control Mode.
With symbol on, your meter is ready to perform
quality control test.
Note
For accurate results on both blood glucose measurements and quality
control tests, use ACEZIN GLUGold Control Solution only.
Results of quality control tests will not be stored in the memory.

Quality Control of the System
17
3Shake the vial of Glucose Control Solution well
before use. Squeeze the vial but discard the first
droplet.
Squeeze the second droplet to your clean fingertip or on
a clean object such as a transparency.
Move the collection zone of test strip close to Glucose
Control Solution droplet. Collection zone automatically
drink the droplet in. When full, your meter beeps and
counts down for 5 seconds.
4When results match with acceptable range printed on
the Test Strip vial, your System is working properly.
NOTE
To avoid contamination,
do not apply the control
solution to the test strip
directlyfromthebottle.
Note
Check the Test Strip vial for acceptable ranges for High
and Medium Levels. Refer to Glucose Control Solution
instruction before use.
Understanding Your TestResults
When results match with acceptable range printed on the Test Strip vial,
your System is working properly, and your test results are reliable.
If your results do not match with the acceptable range, please check the
following:
Are the control solutions or test strips within the expiration date?
Has the control solution been contaminated?
Did you follow the test procedures correctly?
Please repeat the test. If results still do not match, contact your local Ace
Medical office or the authorized distributor.

Perform the Blood Glucose Test
18
Perform the Blood Glucose Test
1Twist the cap of the lancing device to remove it.
2
Insert the lancet firmly into the circular lancet
holder of lancing device until it is fully
seated.
3
Twist off the protective cap of the lancet
and save it for later use.
CAUTION
To avoid infection, do not share the lancing device and lancets with
other people. The lancet is for single use only. Never reuse them.
Be sure to save the protective cap of the lancet for later use.
Remember to put it back on to the lancet before disposal.
When or appears, ambient temperature falls out of acceptable
range (10 °C ~ 40 °C / 50 °F ~ 104 °F). Leave your meter in a room
around 10 °C ~ 40 °C (50 °F ~ 104 °F) for 15 minutes, then repeat the
test. Do not artificially heat or cool the meter.
The strip is for single use only. Dispose of Test Strip that has blood or
control solution on it.