Classification - Philips RESPIRONICS SimplyGo Manual De Usuario

- IEC 60601-1-6 Medical electrical equipment - Part 1-6: General Requirements for Basic
Safety and Essential Performance - Collateral Standard: Usability
- 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 medi-
cal electrical equipment and medical electrical systems used in the home healthcare
environment
- ISO 80601-2-69, Medical Electrical Equipment, Part 2-69: Particular Requirements for
Basic Safety and Essential Performance of Oxygen Concentrator Equipment
- ISO 80601-2-67, Medical Electrical Equipment, Part 2-67: Particular Requirements for
Basic Safety and Essential Performance of Oxygen Conserving Equipment
- ISO 8359, Oxygen Concentrators for Medical Use - Safety Requirements
- IEC 62366-1 Medical devices - Part 1: Application of usability engineering to medical
devices
- ISO 10993-1, Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing
(Biocompatibility)
- RTCA/DO-160G Section 21, Category M; Emission of Radio Frequency Energy
NOTE: The SimplyGo has Essential Performance as defined in ISO 80601-2-69
and ISO 80601-2-67� The SimplyGo will deliver oxygen in both normal
and single fault conditions per the specifications in this manual, or
in the case of a power supply failure, battery nearing depletion, low
oxygen concentration or device malfunction, an alarm condition will
occur�

Classification

The SimplyGo is classified as:
• IEC Class II Internally Powered Equipment
• Type BF Applied Part
• IP 22 Degrees of protection provided by enclosure
- protection against ingress of solid foreign objects ≥ 12�5 mm
diameter
- protection against ingress of water with harmful effects dripping
(15° tilted)
• 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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