Standards Compliance; Classification - Philips RESPIRONICS SimplyGo Manual De Instrucciones

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Standards Compliance

The device is designed to conform to the following standards
-
IEC 60601-1, Medical Electrical Equipment, Part 1: General Requirement
for Safety
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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�
-
RTCA/DO-160F section 21, category M; Emission of Radio Frequency
Energy
-
ISO 8359, Oxygen Concentrators for Medical use – Safety Requirements�

Classification

The SimplyGo 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
SimplyGo User Manual
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