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�
-
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
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