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SimplyGo Mini User Manual
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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)
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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
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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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Chapters

Table of Contents

   Also See for Philips Respironics SimplyGo Mini

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