
Title (with LTR): Precision Xceed Glucose Procedure (LTR19678)
Last Approved: Gregory, Kimberly (Electronic Signature Timestamp: 8/11/2014 3:20:23 PM)
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monitor and discard when finished with
testing.
13. The operator can select one of the
following options:
Press 1 - Next Patient
Press 2 - Repeat Test
Press 3 - Patient History
If 1 is selected, the scan Patient ID
screen will appear. Return to step 4
to continue with testing on the next
patient.
If 2 is selected, the scan or enter the
test strip lot screen will appear.
Return to step 5 to repeat the test.
If 3 is selected, the monitor will
display the last test result for this
patient as well as allow the operator
to view previous results.
Refer to the action entitled Data
Review for Patient History for further
information.
14. After each use, disinfect the
meter with a disinfectant wipe.
Documentation
The patient’s results must be recorded in one of the following manners:
1. in the patient’s record, or
2. on a patient log, or
3. on another approved permanent record.
All records must be retained and retrievable for 4 years.
Quality Control
Critical Elements
Please follow the recommended guidelines so the most accurate results will be obtained.
Use only MediSense Precision Control Solutions
Store the control solutions at room temperatures, between 39° and 86°F (4° and 30°C)
Keep bottle caps fully tightened
Each bottle of control solution is stable for 90 days after opening
When a new bottle is first opened, write the current date on the bottle label. Discard all
unused solutions 90 days after initial 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, since
incorrect assay results may be generated
After each use, replace the correct cap on each bottle and immediately tighten the cap
Do not use control solutions after the expiration date printed on the bottles and the box. The
Precision Xceed Pro Monitor does not accept control solutions that have passed their expiration
date.
Frequency
Two levels (low and high) every 24 hours when meter is in use for patient testing. Meter is locked
out from patient testing if QC fails or is not performed.
Validates instrument performance and proper operator technique
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