Optium

Product Information

Optium is a diabetes meter, which measures blood glucose and blood ketone in the some meter.

Some of the important features of Optium are:

Superior Biosensor Technology
- Provides accurate reading
Accuracy unaffected by common interference from over 60 common drugs & metabolites unlike other meters*

Visual control of sample volume
Sample reapplication possible within 30 seconds, if necessary.

Now, easy-to-open individually foil wrapped test strips
Avoids strip contact with oxygen or moisture in air
Assures longer shelf life

Fill trigger electrode
Starts only after applying enough blood
Prevents inaccuracies due to insufficient sampling

Also checks blood ketone

The Advanced Diabetic Management System
with TrueMeasure Technology

Instructions for the Auto-Lancet

The auto-Lancet is used for obtaining capillary blood samples for glucose monitoring or for other tests, which require one or two drops of blood. An adjustable tip allows the best depth of skin penetration for each individual user. Whichever level you choose on the adjustable tip, a drop of blood is most easily obtained by first washing your hands in warm soapy water.

Directions

1. Unscrew the Auto-Lancet tip and insert a new lancet firmly into the carrier. Next pinch the lancet and twist off the protective cover. Replace the threaded tip.



2. The new comfort tip offers 5 different levels of skin penetration.

To select best depth :

1-2 for soft or thin skin

2-3 for average skin

4-5 for thick or calloused skin

To select a desired depth, move the number to match the arrow.



3. Next hold the tip in one hand and pull on the sliding barrel with the other hand. The device will be cocked when a click is felt, as the ends are pulled apart.

   
   

4. Release the sleeve. It will automatically move back to its original position near the trigger hub.
   
   
   

5. Place the auto-Lancet against the tip of the finger. Next press trigger and lift up the device.
   
   
   

6. Set aside the auto-Lancet and wait a few seconds for a blood drop to form. The flow of blood will be helped by keeping the hand warm, by lowering the hand to waist level, and by gentle massage of the finger.

Lancet Removal:

Unscrew the auto-Lancet tip. Carefully stick the protective disk cover back on the used lancet. Grip the holder firmly and pull the lancet safely out of the holder. Screw the tip back on the auto-Lancet.

Safety Recommendations:

Never reuse or share lancets. Never share tips. If the lancing device is to be used for another person, a new tip and lancet must be used. Used lancets should be discarded in a plastic or cardboard container for safety reasons.

Cleaning of the Lancing Device:

Use alcohol or soap and water to wipe the outside of the lancing device. For more complete cleaning, remove the tip, wash it in warm water and rinse well.

Limited Warranty:

PALCO Labs warrants that the auto-Lancet will function effectively for a period of five (5) years from the date of purchase. A malfunctioning device should be returned to your supplier or to PALCO Labs for replacements.

U. S. patent: # 5,613,978

RE 32,922

Other patents pending.

Placo Labs 8030 Soquel Avenue Santa Cruz, CA U.S.A. 95062-2032

 

MediSense^®English

Control Solutions

For external use (in vitro diagnostic use)

Intended use

The MediSense^® Low and High Control Solutions are designed for use with all MediSense Blood Glucose and β -Ketone(β-hydroxybutyrate) Systems, except the ExacTech^® System. The controls are used to check the performance of your system.

Controls Should Be Used:

• When your diabetic medication plans are adjusted or changed.
• When you question your blood glucose or ketone results.
• When your electrodes have been exposed to temperatures outside the storage conditions (4º - 30ºC, 39º - 86ºF).
• When you open a new lot of electrodes.

Healthcare Professionals Please Note:

In addition to the above recommendations, daily control testing is recommended in a multi-user setting to ensure that the systems are operating properly.

Reagent Composition

Storage and Handling

Store the control solution at temperatures between 4º and 30ºC (39º and 86º F). The control solutions are stable until the expiration date printed on the box. Each bottle of control solution is stable for 90 days after opening (replace cap tightly after each use). When you open a new bottle, write the date of opening on the bottle label. Always make sure that the cap is returned to the correct bottle and tightly closed immediately after use.

Precautions and Warnings

• Do not use the control solutions if they have been opened for more than 90 days or if they are expired (check the expiration date printed on each bottle and on the box they were packaged in).

• Please refer to your electrode package insert for acceptable temperature and humidity test conditions.
• Invert the control bottles three to four times to ensure through mixing before use.
• Do not re-use electrodes.
• Do not swallow or inject the solution.
• Do not use with ExacTech System.

Procedure

Please refer to the appropriate manual for performance testing instructions.

Expected Results

Compare the control results to the "Expected Results For MediSense Control Solutions" printed on the electrode package insert found in the box of electrodes or on the electrode barcode label (if applicable) currently in use. Check that the lot number printed on the electrode packet and insert and/or barcode label matches. Please keep in mind that the results obtained from the control testing do not reflect your personal blood glucose or ketone level. If the control results are outside the expected ranges for the electrodes currently in use, repeat the test. Check that the instructions are followed correctly. If the results are outside the ranges again, contact your local MediSense office or distributor.

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