Control Test

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This section describes the steps to be taken to test Control Solutions in order to verify the performance of the Precision PCx Monitor and Precision PCx and Precision PCx Plus Test Strips.

The quality control features of the monitor can be customized to fit the requirements of each facility. The monitor can be set to require:

Tests of Low, Normal, and High Control Solutions or any variation of this depending on the facility’s policy

Tests of Control Solutions at regular times or time intervals, or by number of patient tests

Control test results will appear as Numeric or Pass/Fail.

These quality control features can be set through the Menu Mode menu (Change Setup/Test Setup Menu).

Operating Guidelines for Control Solution Testing

Observe the following guidelines to obtain optimal quality control results using the Precision PCx System:

Use only control solutions approved for use on the test strip instructions for use to verify the performance of the Precision PCx and Precision PCx Plus Test Strips and the Precision PCx Monitor.

When opening a new bottle, write the current date on the bottle label. Each bottle of control solution is stable for 90 days after opening (replace cap tightly after each use). Discard all unused solutions 90 days after opening.

Invert the control solution bottle several times to ensure thorough mixing before use.

Invert and tap the capped control solution bottle to remove air bubbles from the nozzle of the bottle.

Do not scan one test strip packet’s barcode and use a test strip from another packet. This may cause incorrect assay results to be generated.

Replace the correct cap on the bottle and tighten the cap immediately after each use.

Store the control solutions at temperatures between 39º and 86ºF (4º and 30ºC).

Do not use control solutions after the expiration date printed on the bottles and the box. The Precision PCx Monitor does not accept control solutions that have passed their expiration date.

When To Test Control Solutions

• As required by your facility’s quality policy or local regulatory requirements.

• When you question blood glucose results

• When you open a new lot of test strips

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Questions? Refer to Page 10-13 For Customer Care Information.

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MediSense PCx manual Control Test, Operating Guidelines for Control Solution Testing, When To Test Control Solutions