Classification - Philips Respironics SimplyGo Mini Manual De Instrucciones

SimplyGo Mini User Manual
- IEC 60601-1-8 Medical electrical equipment – Part 1-8: General
Requirements for Basic Safety and Essential Performance – Collateral
Standard: General requirements, tests, and guidance for alarm systems in
medical electrical equipment and medical electrical systems
- IEC 60601-1-11 Medical electrical equipment – Part 1-11: General
Requirements for Basic Safety and Essential Performance – Collateral
Standard: Requirements for medical electrical equipment and medical
electrical systems used in the home healthcare environment
- ISO 10993-1, Biological Evaluation of Medical Devices, Part 1: Evaluation
and Testing (Biocompatibility)
- ISO 18779, Medical Devices for Conserving Oxygen and Oxygen Mixtures:
Particular Requirements
- ISO 80601-2-67, Medical electrical equipment, Part 2-67: Particular
requirements for basic safety and essential performance of oxygen-
conserving equipment
- ISO 80601-2-69, Medical electrical equipment, Part 2-69: Particular
requirements for basic safety and essential performance of oxygen
concentrator equipment

Classification

The SimplyGo Mini is classified as:
• IEC Class II Internally Powered Equipment
• Type BF Applied Part
• IP22: 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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