Omron HEA-232 Instruction Manual

Blood Glucose Monitoring System
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Chapter 1 OMRON Blood Glucose Monitoring
1.1 Introduction
1.2 List of Kit Contents
1.3 Product and Meter Display
Chapter 2 Installing and Setting up the HEA-232
2.1 Inserting / replacing batteries
Chapter 3 Finger Blood Glucose Testing
3.1 Preparation before glucose testing
3.2 Fingertip blood measurement
Chapter 4 Glucose Control Solution Testing
(Optional)
4.1 Control test
Chapter 5 Memory Function
5.1 Reviewing past results
Chapter 6 Instructions on Caring and Storing
for Your Strips and Meter
6.1 Caring for the strip
6.2 Caring for the meter
Chapter 7 Troubleshooting
Chapter 8 HEA-232 Performance
Characteristics
Chapter 9 Specication
Contents
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IMPORTANT SAFETY PRECAUTIONS
READ BEFORE USE
1. Use this device ONLY for the intended use described in this manual.
2. Do NOT use accessories which are not specified by the manufacturer.
3. Do NOT use the device if it is not working properly or if it is damaged.
4. Do NOT use the equipment in places where aerosol sprays are being used or where oxygen is being administered.
5. Do NOT use under any circumstances use the device on neonates or infants.
6. This device does NOT serve as a cure for any symptoms or diseases. The data measured is for reference only. User should not take any decision of medical relevance without first consultation of medical practitioner. Always consult your doctor to have the results interpreted.
7. Before using this device to test blood glucose, read all instructions thoroughly and practice the test. Carry out all the quality control checks as directed.
8 Use this instrument in a dry environment, if synthetic materials
are present (synthetic clothing, carpets etc.) it may cause damaging static discharges that may cause erroneous results.
9. Do not use this instrument in close proximity to sources of strong electromagnetic radiation, as these may interfere with the accurate operation.
10. Do not use this meter near cellular or cordless telephones,
walkie talkies, garge door openers, radio transmitter, or other electrical or electronical equipment that are sources of electromagnetic radiation, as these may interfere with the proper operation of the meter.
11. The device for self-testing is used for the monitoring of an
existing disease (eg., diabetes) the patient should only adapt the treatment if he has received the appropriate training to do so.
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Chapter 1 OMRON Blood Glucose Monitoring
System HEA-232
1.1 Introduction
The HEA-232 uses state-of-art bioelectrochemistry detecting
technology; it needs approximately 1μL of fresh capillary whole
blood for one test. The blood glucose concentration is displayed in 5 seconds after the blood has been applied to the test zone. The device is intended for use by diabetics to monitor their own glucose levels. Please read the instruction manual carefully before using. Hea-232 is an in vitro diagnostic medical device for self-testing. Capillary action
automatically lls the reaction zone with the test sample from the front
channel. The device should not be used for screening or diagnosis of diabetes or for testing on neonates.
Intended Use
The HEA-232 is an in-vitro diagnostic medical device intended for the quantitative measurement of glucose in fresh capillary whole blood
samples drawn from the ngertips. Testing is done outside the body.
It is designed for self-testing to monitor the effectiveness of diabetes control. The device should not be used for screening or diagnosis of diabetes or for testing neonates.
Principle of the method
The auto-filling process precisely controls the sample volume. The blood glucose test strip is a kind of electrochemical sensor. When the blood sample reacts with the strip, the glucose meter displays a reading that depends on the number of electrons detected as a result of the reaction.
The current generated by the reaction on the test strip is used to calculate the glucose concentration of the sample which is then displayed by the device.
Warning: The Glucose Results provided by HEA-232 is only for
reference; never make significant changes in your diabetes treatment program without consulting a
doctor.
Warning: Evaluations using the HEA-232 by lay persons in
different countries will depend on their uency, or otherwise, in the
understanding and the assessment of ease of use and interpretation of the results.
Measuring principle
Amperometric biosensors are quite sensitive and more suited for mass production. The working electrode of the amperometric biosensor is usually a screen-printed layer covered by the bio-recognition component. The dried reagent was applied on a pair of carbon
electrodes. Glucose can be specically catalyzed by the enzyme, and
then the reaction current can be measured according to the glucose
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Strip Port- Insert Strip Here
Button- Turn / off meter Query test record
Meter Display
Battery Cover
levels of the test sample by electronic devices. HEA-232 utilizes electrochemical biosensing technology (Amperometric biosensor) to measure the glucose level in fresh capillary whole blood. At the applied potential after blood draw into the reaction zone of strips, conversion of electroactive species generated in the enzyme layer occurs at the
electrode and the resulting current is measured by HEA-232 .
1.2 List of Kit Contents
1. Blood Glucose Meter
2. Sterile Lancets
3. Lancing device
4. Instructions for the lancing device
5. Carrying Case
6. Instruction Manual
7. Log Book
8. CR2032 Battery
1.3 Product and Meter Display
A. HEA-232 Blood Glucose Meter Display
Caution:The HEA-232 meter measurement unit was set as mg/dL
or mmol/L from manufacturer side. the unit exchange ratio is as the followings: 1 mmol / L = 18.02 mg/dL
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B. HEA-STP30 Glucose Test Strip
C. Function Display
Battery
mg/dL mmol/L
Test Unit Temperature
Error Message Test Result
Battery
Error Message
Test Unit
Test Result
Temperature
Top Edge- Apply blood sample here.
Inserting Bar- Insert this test strip port with this side facing up.
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a. Open battery
compartment
c. Reinstall battery cover
b. Place a new battery inside
Chapter 2 Installing and Setting up the HEA-232
2.1 Inserting / replacing batteries
When should users change the batteries?
If the battery power is too low to perform a test, the and error symbol will appear on the display after the device is powered on. In this case, the system will shut down automatically after 120 seconds. The battery will have to be replaced before the HEA-232 can be used. However previously recorded results will not be lost. There are two conditions which might occur depending on battery power status
1. The battery power is low:
However, you can still use HEA-232 and results will still be accurate, but we still strongly suggest you replace the batteries as soon as possible.
2. The battery symbol ashes on the display after powering on:
The system will shut down automatically after 120 seconds when
only the battery symbol ashes on the display after powering on. It
means the battery power is too low to perform a measurement. You have to replace the battery in order to continue using the HEA-232; past results remain recorded.
How to replace HEA-232’s batteries
1. Turn HEA-232 meter over and open the battery cover.
2. Replace one CR-2032 battery with the (+) sign side of battery facing
up.
3. Insert battery cover back to the battery compartment until a
“click”sound is heard.
4. Turn on the device to see whether the HEA-232 is powered on. If
not, please re-examine battery replacing procedures.
5. Please dispose of used batteries according to local regulations.
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