PAGE 3-51097626, VER. 03
3.7 STANDARDS COMPLIANCE
SimplyGo and SimplyFlo are 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: General Requirement for
Safety - Collateral Standard: Electromagnetic (EMC) Compatibility - Requirements and tests.
• ISO 8359, Oxygen Concentrators for Medical use - Safety Requirements
SimplyGo is designed to conform to the following standard
• RTCA/DO-160F section 21, category M; Emission of Radio Frequency Energy
3.8 CLASSIFICATION
The SimplyGo and SimplyFlo are 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
To Next Page
Loading...
