Standards Compliance; Classification - Philips SimplyGo User Manual

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
SimplyGo User Manual
35