Classification - Philips RESPIRONICS SimplyGo Mini Mode D'emploi

- IEC 60601-1-8 Medical electrical equipment – Part 1-8: General Require-
ments 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 Require-
ments 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-con-
serving equipment
- ISO 80601-2-69, Medical electrical equipment, Part 2-69: Particular re-
quirements for basic safety and essential performance of oxygen concen-
trator 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
AMSR oxygenconcentratorstore.com
SimplyGo Mini User Manual
1-877-774-9271
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