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MedSource MS-131002 - Operation; Battery Installation; Pre-Operation Checks

MedSource MS-131002
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Indicator Calculated Value
Clinical Bias (∆cb) -0.027 °C
Standard Deviation (σj) 0.14 °C
Limits of Agreement (LA) 0.26 °C
Clinical Repeatability (σr) 0.07 °C
07
2 - Operation
2.1 Battery Installation
1) Pull the battery cover forward as indicated by the arrow.
2) Insert two AAA-size batteries. Ensure correct polarity as indicated inside the
battery cover.
3) Slide the battery cover back in until it snaps in place.
2.2 Before Using the Thermometer
Be sure to read and understand all warnings listed in the instructions before use.
If the ambient temperature changes too much, such as moving the thermometer from a cold room
to a warm room, allow the thermometer to adjust to the new temperature. This may take up to 30
minutes.
The ambient temperature around the patient should be stable. Keep away from large air flows
such as fans or air-conditioning vents.
• Do not use the thermometer in bright sunlight.
• If a patient moves from a colder environment into a warmer test environment, they should remain
in the test environment for at least 5 minutes prior to taking a measurement. This will ensure the
patient is consistent with the ambient temperature.
Front Panel and Case Labeling EN/ISO 15223-1:2012
Temperature EN/ISO 80601-2-56:2012
Home Healthcare Environment EN 60601-1-11:2010
Calculated Values of the Indicators According to EN/ISO 80601-2-56
Safety Classification of ME Equipment
Protection against electric shock Internally Powered ME Equipment
Applied Part No Applied Parts
Protection against harmful ingress of IP22
water or particulate matter
Mode of Operation Continuous Operation
Note: Not intended to be sterilized. Not for use in an OXYGEN RICH ENVIRONMENT.

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