Microlife 200 Series User Manual page 4

• Use the pulse oximeter outside of its specified operation temperature and humidity
rating, or if stored outside of its specified storage temperature and humidity rating.
Avoid storage in direct sunlight.
• Immerse in water or use abrasive agents when cleaning.
STANDARDS
In addition to the standards stated in the Instruction Manual:
• This device is compliant with the following standards:
AAMI/ANSI ES60601-1, ES60601-1-2, AAMI/ANSI/ISO 14971, ISO 80601-2-61, and
• Electromagnetic standards IEC 60601-1-2 along with FCC Part 15
Test Protocol (for laboratory use)
A functional tester cannot be used to assess the accuracy of a pulse oximeter monitor
sensor as clinical testing is used to establish the accuracy of the device. However, a
functional tester (Index2 FLUKE simulator version 2.1.3) may be used to measure how
accurately the pulse oximeter is reproducing a specified test value
TYPE
IP22: Protected against solid foreign objects of 12.5 mm diameter and greater.
Protected against the ingress of angled falling water drops with the device
positioned on a turntable. Keep Dry.
Type BF Applied Part
SERVICE
When the device is not in use, battery/access (if applicable) may be replaced by the
user. No other parts/components are accessible.
Batteries and electronic instruments must be disposed of in accordance with the
locally applicable regulations, not with domestic waste.
This device does not require routine calibration or maintenance other than battery
replacement.
Expected life of pulse oximeter: 5 Years
Federal Communications Commission (FCC) Statement
This device complies with part 15 of the FCC Rules. Operation is subject to the follow-
ing two conditions: (1) This device may not cause harmful interference, and (2) this
device must accept any interference received, including interference that may cause
undesired operation. Changes or modifications to the product are not approved by
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