HUMMINGBIRD MEDICAL Oracle User Manual

USER GUIDE
62 68 RO -M 01 A1
1. Contents
Section Topic Page
1. Table of Contents
2. Introduction
4. Alternate Site Testing
5. Safety Information
6. Quick Testing Instructions
Date/Time/Alarm/ Memory Deletion)
Preparing for Testing
7. Installing the Battery
8. Settings (
9. Running a Control Solution Test
Blood Testing
10.Running a Blood Glucose Test
11.Recalling the Memory and Viewing the Average
12.Expected Values
13.Transmitting Results
Maintenance
14.Maintenance of Your System
15.Troubleshooting
16.Customer Service
17.Limitations
Important Additional Information
18. Specifications
19. Ordering Supplies
20. Warranty Information
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NOTE: For information about the name of the manufacturer of the lancing device and the lancets, please refer to the package inserts that came with your starter kits.
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2. Introduction to the System
Intended Use / Indications for Use
The Oracle Blood Glucose Monitoring System is for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the forearm. It is intended for use by healthcare professionals and people with diabetes mellitus at home and as an aid in monitoring the effectiveness of a diabetes control program. The Oracle Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, nor for use with neonates.
The alternative site testing (forearm) in this system can only be used during steady-state blood glucose conditions.
Some models of this system contain a speaking function that an audible message of test results for users with low vision.
Contents of the System
This User Guide has been prepared to describe the proper use of the Oracle Blood Glucose Monitoring System. Please read this User Guide and the package insert that comes with the Oracle Glucose Test Strips before testing. The system is available either as a meter alone or as a kit. If you have a meter only, you can purchase the system supplies from your system provider. Please provide your system provider with the 3 digit system reference number marked on the packaging box when you purchase supplies.
The starter kit for Oracle Blood Glucose Monitoring System includes the following items:
1.Oracle Glucose Meter with 2 AAA batteries
2.User Guide
3.Log Book
4.Carrying Case
5.Oracle Glucose Test Strips
6.Oracle Control Solution (Medium)
7.Sterile Lancets
8.Lancing Device
9.Package Inserts for Test Strips, Control Solution, and Lancets/Lancing Device
The Oracle Glucose Meter uses Oracle Glucose Test Strips. Neither the meter nor the test strips will work when used with any other brand of glucose products.
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The principle of the method
When glucose reacts with the reagents on the test strips, an electrical current is produced, which is proportional to the glucose concentration in the blood sample. The glucose concentration is calculated by the meter and based on the current measured.
1.Test strip slot - When the strip is inserted into the slot, the meter will automatically turn on.
2. LCD Display - Guides you through the test using symbols and simple messages.
3. M Key - Power ON/OFF, also for memory recalling mode, please refer to manual for detailed function description.
4. C Key - Setting mode, please refer to manual for detailed function description.
5. Speaker - For voice-enabled models only.
6. RS232 port - Cable connection and data transmitting.
7. Battery Compartment - Where batteries are
located.
8. Ejector - Remove used strip.
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3. Appearance and key functions of the meter
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4. Alternate Site Testing (AST)
What is AST? Sampling from anatomical sites (parts of the body) other than the fingertip (i.e. forearm, upper arm, thigh, calf, palm) to check the blood glucose levels. This system allows you to test on the forearm with the equivalent results to fingertip testing.
There are important limitations to AST. Please consult your healthcare professional before you use AST.
What is the advantage ? It is more painful to take a blood sample from fingertips because fingertips have more nerve endings. Other body sites do not have as many nerve endings, so blood samples in less pain.
When to use AST ? Medication, stress, illness, food and exercise can affect blood glucose levels. Capillary whole blood at the fingertip can reflect test changes faster than capillary blood at other sites of body. If you test your blood glucose level during or immediately after a meal, physical exercise or stressful events, take the blood sample from your fingertip instead of from other sites.
Use AST only:
1. 2 hours or more after taking insulin;
2. 2 hours or more after a meal;
3. 2 hours or more after exercise.
Do not use AST if you are pregnant, or if you are aware that your glucose level is not as stable as usual, or if you think you have hypoglycemia (low blood sugar) or hyperglycemia (high blood sugar).
Do not use AST if you think your blood glucose is low and if your AST results do not match the way you feel.
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Testing Procedure for AST
1.Unscrew the lancing device by turning the end cap counter clockwise. A clear cap will come with the package of a meter kit or a lancing device. The clear cap on the lancing device will make it easy to get a drop of blood for AST.
2.Insert a new lancet firmly into the lancet holder.
3.Twist off the protective top of the lancet.
4.Close the end cap of the lancing device and grasp the lancing device as shown. Slide into locking position. If necessary, please set the lancing device for a deeper puncture.
5.Select a soft, fleshy area on your forearm that is clean and dry, away from bone and free of visible veins and hair.
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6.Massage the selected area gently to increase blood flow to the puncture site. Clean the test location with an alcohol wipe or with soap and water.
7.Open the test strip vial. Take one test strip out of the vial and quickly cover the vial to keep air out.
8.Insert a test strip into the meter while the meter is off. The meter will turn on and a blinking blood drop icon appears on the LCD screen.
9.Press and hold the loaded lancing device against the forearm for a few seconds, then press and release the button.
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10. Wait for a few seconds until the blood drop forms. Make sure you have sufficient blood to fill the small window of the test strip. For individuals who experience difficulty in getting sufficient blood for a test, it may be helpful to rub the puncture site a little longer before using the lancing device.
11. Apply blood to the front edge (the tip) of the test strip, and the meter will start counting down for 6 seconds then display the test results on the screen.
12. Remove the used strip by hand or by pushing the ejector button. The meter will turn off automatically.
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5. Safety Information
Please use this device only for the intended use described in this user guide.
Before using this system to test your blood glucose please read instructions thoroughly and practice the test when you first use this system. Do a quality check on the system by following the instructions and consult with healthcare professionals for questions or problems.
Be aware of the safety of young children or handicapped persons near you when you conduct a glucose test using this system.
Use only Oracle test strips and control solutions with the Oracle meter.
Keep the test strip vial away from children. The test strips and vial cap can present a choking hazard.
Be cautious when removing the lancet. Take the lancet out carefully. Always place the protective cap back on the exposed tip or (if using a twist lancet) place the cap on a hard surface and push the exposed tip into the protective cap and discard properly.
Test your blood glucose using the meter and the test strips with the same reference number as labeled on the outer box of meter and the test strips.
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