Optium

MediSense^®

Optium^TM

Blood Glucose Electrodes

Important: To ensure accurate results, you must read the MediSense^®Optiumä User's Guide before testing.

Important!Information when changing to end-fill electrodes: Previously stored test results between 27.8 mmol/l or 500 mg/dL and 33.3 mmol/l or 600 mg/dL are now displayed as "HI". When using the result averaging function, your average should be slightly lower. As older results are removed from memory this problem will correct itself. We strongly recommend that you do not use our original electrode again.

If using Precision Link· Data Management Systems, please contact Customer Service, for additional information, BEFORE using these electrodes.

Intended Use

For use outside the body (in vitro diagnostic use). The MediSense Optium System quantitatively measures glucose (D-glucose) in fresh capillary whole blood (i.e., from the finger).

Important: Use only with MediSense Opium System. Not for use with any other MediSense Systems.

Test Principle

When the blood sample is applied to the electrode, the glucose in the blood reacts with the chemicals on the electrode, producing a small electrical current. This current is measured and then a result is displayed by the sensor. The size of the current depends on the amount of glucose in the blood sample.

Storage and Use

• Store the electrodes at temperatures between 4º and 30ºC (39º and 86º F). Keep away from direct sunlight and heat.
• Do not use the electrodes beyond the expiration date printed on the foil packet and outer box.
• Use the electrodes immediately after opening the foil packet.
• Do not use wet, bent, scratched or damaged electrodes.
• Use the electrodes only once.

Precautions

• Always calibrate (code) the Optium Sensor with each new box of electrodes.
• Use only the calibrator supplied with the electrodes. Keep the calibrator until all the electrodes in the box have been used.
• Use only MediSense Optium Electrodes with the MediSense Optium Sensor.

Sample Collection and Preparation

Before obtaining a blood sample, use warm soapy water to wash your hands and dry completely. Warm water helps to increase the blood flow to your fingertips. If you have difficulty in obtaining a blood sample, hanging your arm down before lancing your finger may also help increase the blood flow. Avoid excessive squeezing of the puncture site. When the capillary blood sample is obtained, it must be used immediately.

Healthcare Professionals

Note: Capillary blood may be collected into heparin-containing or potassium EDTA-containing capillary tubes and used within 30 minutes. Do not use tubes containing fluoride or oxalate.

Procedure

Refer to the MediSense Optium User's Guide for detailed testing instructions.

Materials provided: MediSense Optium Blood Glucose Electrodes and Calibrator.

Materials required but not provided: MediSense Optium Sensor and User's Guide, Precision Controls, lancing device and lancets.

Blood Application

• Wash and dry hands thoroughly.
• Insert the lancet using the lancing device instructions.
• Open the electrode packet by gently tearing at the notch.
• Insert the electrode contact bars into the test port of the sensor.
• Push the electrode into the test port until it stops.
• Lance your finger to obtain a hanging drop of blood.
• While Apply Blood appears, touch blood drop to white target area at tip of electrode.
• Hold finger in place until test begins.
• Test will start when sample is detected.

NOTE: If the test fails to start, a second drop of blood may be applied within 30 seconds. If the test fails to start after the second drop is applied or if more than 30 seconds have passed, discard the electrode and repeat the test with a new electrode.

• There will be a 20-second countdown, after which the blood glucose result will be displayed.

MediSense Optium Test Messages

• If LO appears, the sensor has determined that your blood glucose result is lower than 1.1 mmol/l or 20 mg/dL. Repeat the test with a new electrode. If LO appears again, contact your healthcare professional immediately.
• If HI appears, the sensor has determined that your blood glucose result is higher than 33.3 mmol/l or 600 mg/dL. Repeat the test with a new electrode. If HI appears again, contact your health-care professional.
• If Test Error 4 appears, this may mean your blood glucose result is extremely high and beyond the measuring capabilities of your sensor or there may be a problem with the glucose electrode. Repeat the test with a new electrode. If Test Error 4 appears again, contact your healthcare professional.

Important: High or low results that are incorrect may have serious medical consequences. If your blood glucose result is unusually high [greater than 16.7 mmol/l (300 mg/dL)] or low [lower than 2.8 mmol/l (50 mg/dL)], or if you question your results, repeat the test correctly with a new electrode. Consult your healthcare professional before making any changes to your diabetes medication program.

Expected Results for Non-Diabetic, Non-Pregnant Adults¹ Fasting values: 4.1 to 5.9 mmol/l (74 to 106 mg/dL)

Two hours after 75 grams of glucose: Less than 7.8 mmol/l (140 mg/dL)

Quality Control

It is recommended that the performance of the MediSense Optium System be tested in the following cases: when you adjust your diabetes medication plans, when blood glucose results are questionable, when electrodes have been exposed to temperatures outside the storage condition 4º and 30ºC (39º to 86ºF), or when a new lot of electrodes has been opened. Use only the Precision Control Solutions designed for use with the MediSense Optium System. Results obtained from the glucose controls should be compared with the "Expected Results for Use with Precision Control Solutions" printed on the electrode package insert for the electrodes being used. Results within the expected ranges mean that the electrodes are working properly. Refer to the MediSense Optium User's Guide for detailed instructions on how to perform a glucose control test.

Reagents

The reagent area of each electrode contains:

Glucose dehydrogenase (Microbial)	> 0.05 U
NAD+ (as sodium salt)	> 7.2 m g
Phenanthroline quinone	> 0.4 m g
Non-reactive ingredients	> 16.0 m g

 

Limitations of Procedure

• This system has not been evaluated for use with arterial, venous, serum, neonatal or plasma samples.
• Blood glucose results are displayed as mg/dL or mmol/l. It is important that the correct units are selected.
• Use between 15º and 40ºC(59º and 104ºF) and between 10% and 90% relative humidity.
• Clinical testing demonstrates that altitudes up to 2,195 meters (7,200 feet) above sea level do not affect results.
• Hematocrit range is 20-70% for glucose measurements
  < 16.7 mmol/l (300 mg/dL) and 20-65% for glucose measurements
  > 16.7 mmol/l (300 mg/dL).
• High levels of paracetamol, up to (10 mg/dL) 662 m mol/l, will not affect results.
• Test results may be erroneously low if the patient is severely dehydrated, or severely hypotensive, in shock or in a hyper-glycemic-hyperosmolar state (with or without ketosis). Similar observations have been reported in the literature for other blood glucose monitoring systems.
• Extremely high levels of the following substances at the following concentrations do not affect results: uric acid, 1.2 mmol/l (20 mg/dL); ascorbic acid, 170 m mol/l (3 mg/dL); unconjugated bilirubin, 684 m mol/l (40 mg/dL); cholesterol, 13.0 mmol/l (500 mg/dL); and triglycerides, 33.9 mmol/l (3000 mg/dL).
• Xylose may produce elevated results, which may occur only during a xylose absorption test for diagnostic evaluation of malabsorption.

Performance Characteristics

MediSense Optium Blood Glucose Electrodes are calibrated to give plasma-equivalent glucose values.

Assay Range: 1.1-27.8 mmol/l (20-500 mg/dL).

Test Time: 20 seconds

Precision

Precision testing shows that result typically vary by no more than 2.9% to 5.1%. Testing was performed within a laboratory using venous blood samples on the system.

	Low	Mid-Low	Mid-High	High
Mean mmol/l	2.2	4.2	12.1	17.8
(mg/dL)	(40)	(76)	(218)	(320)
SD mmol/l	0.11	0.17	0.39	0.50
(mg/dL)	(2.0)	(3.0)	(7.0)	(9.0)
CV %	5.1	3.5	3.4	2.9

Accuracy

Accuracy testing shows that results compare well with a laboratory reference method and that results are comparable between trained operators and lay users. The accuracy of the system was assessed at three independent sites by comparison with the YSI Glucose Analyzer as used in clinical laboratories. The data was obtained using fresh capillary whole blood. The glucose range was 3.1-25.8 mmol/l (56-464 mg/dL).

YSI Samples	Plasma
No. of samples	167
Slope	0.90
Intercept mmol/l (mg/dL)	0.92 (16.6)
r (corr. coef.)	0.98

Reference

1. Burtis, C.A. & Ashwood, E.R., Clinical Chemistry, Third Edition, Philadelphia, W.B. Saunders Co. (1999) p. 1815.

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