Standards Compliance; Classification - Philips simplyFLO User Manual

Transportable oxygen concentrator
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AC Power Module
Type
Input
Output

Standards Compliance

The device is designed to conform to the following standards
-
IEC 60601-1, Medical Electrical Equipment, Part 1: General Requirement
for Safety
-
IEC 60601-1-2, 2nd edition, Medical Electrical Equipment, Part 1-2: Gen-
eral Requirement for Safety – Collateral Standard: Electromagnetic (EMC)
Compatibility – Requirements and tests�
-
ISO 8359, Oxygen Concentrators for Medical use – Safety Requirements�

Classification

The simplyFLO is classified as:
IEC Class II Internally Powered Equipment
Type BF Applied Part
IPX1: Drip Proof Equipment
Not suitable for use in the presence of a flammable anesthetic mixture
with air or with oxygen or nitrous oxide�
Continuous Operation
Philips Respironics 1082661
100 to 240 VAC, 50/60 Hz, 1�7 A max
19 VDC, 7�9 A max
simplyFLO User Manual
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