User's Manual

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INFOPIA CO., LTD Page 1 UM-M (Rev.0)

Operation Manual

Dear IGM-1001D Blood Glucose Monitoring System

Owner,

Thank you for choosing the IGM-1001D Blood Glucose

Monitoring System. This manual contains everything you

need to know about your new glucometer and how it works.

Please take a moment to read the instructions carefully.

We understand that self-testing of blood glucose level

provides a way to control your diabetes and may give you

peace of mind by testing regularly. As a result, IGM-1001D

has been developed to provide you with a fast and accurate

reading in a convenient and simple process. Our goal for the

IGM-1001D Blood Glucose Monitoring System is to provide

you with the best quality healthcare products coupled with

superior customer service. Always consult with your

healthcare professional, before making any changes to your

diabetes management. The IGM-1001D Blood Glucose

Monitoring System is for in-vitro diagnostic use only.

Customer Service is available 24 hours a day, 7 days a week,

and 365 days a year. Please call customer support center in

your local area.

Important Information

The IGM-1001D Blood Glucose Monitoring System is

intended for use outside the body (in-vitro diagnostic use

only). It should be used only for testing blood glucose and

only with fresh capillary whole blood samples. It should not

be used for the diagnosis of diabetes.

Consult with your physician or diabetic healthcare

professional about daily management of your diabetes and

proper use of the glucometer.

Please pay close attention when handling blood. Improper

procedures may cause serious hazards to your health.

The IGM-1001D Blood Glucose Monitoring System contains

small parts, which could be a choking hazard for children if

swallowed.

Test Principle

IGM-1001D blood glucose test strip is the bio-sensor which

has been made by the FAD-dependent glucose

dehydrogenase(enzyme). FAD-GDH(enzyme) quantitatively

reacts with the glucose in the whole blood and the mediator.

At this moment, mediator Fe(CN)

is reduced to Fe(CN)

This Fe(CN)

generated by the reaction is re-oxidized on

carbon electrode, for which the method is called

amperometry. The measured oxidation current exists in

proportion to the glucose concentration in the whole blood.

WARNING:

1. All parts of the kit are considered bio-hazardous and can

potentially transmit infectious diseases, even after you

have taken cleaning and disinfection measures.

2. Always use a new, sterile lancet. Lancets are for single

use only.

3. Avoid getting hands lotions, oil, dirt or debris in and/or on

the lancets and reusable lancing device.

4. Please refer to page 12 for cleaning and disinfecting IGM-

1001D Blood Glucose Monitoring System.

5. Do not change your medication based on the IGM-1001D

meter test results without contacting your physician or

healthcare professional first.

6. Do not assemble or disassemble the blood glucose

test meter

7. Keep out of direct sunlight.

CAUTION:

Following list of IMPORTANT SAFETY INSTRUCTIONS provided:

1. Close supervision is necessary when equipment is used

by, on, or near children, handicapped persons or invalids.

2. Do not place the equipment in liquid, nor put it where it

could fall into liquid. If the equipment becomes wet,

remove the batteries and dry the device.

3. Use the equipment only for the purpose described in the

instructions for use.

4. Do not use accessories which are not supplied or

recommended by the manufacturer.

5. Do not place anything on top of the equipment.

Summary of content (16 pages)

PAGE 1
Operation Manual Dear IGM-1001D Blood Glucose Monitoring System Owner, Thank you for choosing the IGM-1001D Blood Glucose Monitoring System. This manual contains everything you need to know about your new glucometer and how it works. Please take a moment to read the instructions carefully. We understand that self-testing of blood glucose level provides a way to control your diabetes and may give you peace of mind by testing regularly.
PAGE 2
Learning the System Table of Contents Intended use of Blood Glucose Test Meter The IGM-1001D Blood Glucose Monitoring System is intended for use outside the body only (in-vitro diagnostic use) and self-testing. Recorded results make it easier for your doctor to access your metabolic control. However, the self-testing should not take the place of overall diabetes management assessment from your doctor. It should be used for testing blood glucose (sugar) only with fresh capillary whole blood samples.
PAGE 3
IGM-1001D Kit Components 1. IGM-1001D Meter 2. IGM-1001D Test Strip 3. Reusable Lancing Device 4. Lancets 5. Operation Manual 6. Warranty Registration Card 7. Carrying Case 8. Patient Logbook 9. 2EA of 3V Coin Battery (CR2032) Your IGM-1001D Blood Glucose Monitoring System has been sealed to protect the contents. If you find your seal has been broken, please return it to the place of purchase. CAUTION 1.
PAGE 4
Setting Your Meter CAUTION 1. Store the IGM-1001D test strip vials in a cool, dry place. Keep out of direct sunlight. Do not freeze. 2. Store test strips in their original vial only. Do not mix the test strips in new vials or in any other container. 3. Immediately replace the vial cap and close tightly after removing any test strips from the vial. 4. Make a note of the expiry date, which is three months from the date you first open a new vial of strips.
PAGE 5
Auto-coding Function Performing a Control Solution Test 1. IGM-1001D has automatic code recognition function(e.g. C26) IGM-1001D control solutions contain a known amount of glucose that reacts with IGM-1001D test strip. By comparing your control solution test results with the expected range printed on the test strip vial, it is able to check the meter and test strips are working properly and that you are performing the test correctly.
PAGE 6
Please call customer support toll: 82-31-460-0300 4. Dip the test strip into the control solution. Results will appear in 5 seconds. Compare the result to the range printed on the test strip vial, the result should fall within that range CAUTION 1. Control solutions is for in-vitro diagnostic use only. This means that it is only used for testing outside the body. 2. Control solution is exclusively made for the IGM-1001D Blood Glucose Monitoring System.
PAGE 7
Performing a blood test with your fingertip Components Step 1 1. Firmly insert the test strip into the meter test port. Insert down firmly in direction of arrow on test strip (arrow up). Please do not insert the glucose test strip upside down. When you insert the glucose test strip into the glucose test meter, the power automatically turns on with the code and temperature. Using the Clear Tip(AST) 1.
PAGE 8
Step 3 1. Unscrew the lancing device cap. 2. Insert a sterile lancet into the lancing device. 3. Twist the protective cover off. Do not discard. IGM-1001D test meter only requires 0.5 ul sample volume.  Place the edge of the test strip to the drop of blood.  The blood will automatically be ‘drawn’ into the test strip channel.  When your sample blood is enough, your meter will automatically count down 4. Put the lancing cap back and twist it tightly. 5.
PAGE 9
 Record the result value in your logbook. When glucose test strip is removed, the glucose test meter turns off automatically. CAUTION 1. If the test result is out of the test range, “Hi/Lo” message will be shown on the LCD window. 2. Safely discard used glucose test strips and lancets in the proper place, according to the local regulation. CAUTION 1. If you push the ejector button forward too much, it may be part of the failure. 2. Do not give strong impact to blood glucose test meter. 3.
PAGE 10
Deleting all test results To delete all test results in the memory press ▲ and ▼ button for 3 seconds, while the test result is to delete, displayed blinking. After the third beep sound you may hear, the test results are deleted. alternate site is less painful than using a fingertip. Getting a blood sample from your forearm or palm is different than getting a sample from your fingertip. Ventral palm/Dorsal hand Choose a fleshy area on the palm, below your thumb or pinky finger.
PAGE 11
The lancing device clear cap is used for alternate site testing Lance the test site with the lancing device 1. Remove the lancing cap by twisting off. 2. Insert lancet and replace with the clear cap. 3. To bring fresh blood to the surface of the test site, rub the test site vigorously for a few seconds until you feel it getting warm. Applying heat may be helpful. REMEMBER 1. Consult with your healthcare professional before using alternate site testing. 2.
PAGE 12
Caring for your IGM-1001D System Cleaning your meter and maintenance Blood glucose test meter : Your blood glucose test meter does not require special maintenance or cleaning. Avoid getting dirt, dust, blood, glucose control solution, or liquids on the blood glucose test meter, the test port, or data port. Your blood glucose test meter’s operation temperature is 10~40°C(50~104°F). It is recommended that you store the blood glucose test meter in the portable pouch after each use.
PAGE 13
Transferring your results lithium batteries (CR2032), which are included. When replacing the batteries, only CR2032 or equivalent lithium battery should be used. USE to Data Transfer CABLE(Option) You can transfer test results from the IGM-1001D meter to a computer. You will need to download to software from the following web site (http://www.infopia21.com) and purchase the computer cable from your local representative. This is sold separately. Follow-up Action 1.
PAGE 14
Troubleshooting Message What it means The following chart may help you identify certain problems, but may not solve all problems that can occur. Contact your authorized representative or Infopia Co.,Ltd. customer support if the problem persists. Message What it means Action required Problem with the blood glucose test meter Place the battery again, and set the blood glucose test meter. If the problem persists, Please contact your authorized representative or customer support.
PAGE 15
Inconsistent or Unexpected Test Results Declaration of Conformity If you continue to get unexpected results, check your system with control solution. If you experience symptoms that are not consistent with your glucose results, review and follow all instruction in this manual. Never ignore symptoms or make significant changes to you diabetes control program. Inform health care professional of symptoms and/or concerns. FCC CAUTION 1.
PAGE 16
Specifications Separate collection of batteries Sample Type Sample Volume Test Range Reading Time Hematocrit Altitude Operating Temperature Operating Humidity Strip Storage Temperature Display Type Dimension(HxDxT) Weight Power Source Batter Life Capillary, venous, arterial whole blood 0.5 ㎕ 10 ~ 600 mg/dL 5 seconds 20 ~ 60% 3048 meter Up to (10,000 feet) 10 ~ 40℃ (50 ~ 104℉) 10 ~ 90% Store 2~30 ℃ or 36~86 ℉ and no direct sunlight. Do not Freeze LCD (Including backlight model) 96 X 56 X 23.