Philips Respironics SimplyGo Mini - Classification

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SimplyGo Mini User Manual
English
systems used in the home healthcare environment
- ISO 80601-2-69, Medical Electrical Equipment, Part 2-69: Particular Re-
quirements for Basic Safety and Essential Performance of Oxygen Con-
centrator Equipment
- ISO 80601-2-67, Medical Electrical Equipment, Part 2-67: Particular
Requirements for Basic Safety and Essential Performance of Oxygen Con-
serving 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 Mini has Essential Performance as dened in ISO 80601-
2-69 and ISO 80601-2-67� The SimplyGo Mini will deliver oxygen
in both normal and single fault conditions per the specications 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�
Classication
The SimplyGo Mini is classied as:
• IEC Class II Internally Powered Equipment
• Type BF Applied Part
• IP22: Degrees of protection provided by enclosure
- protection against ingress of solid foreign objects ≥ 12�5 mm
diameter
- protection against ingress of water with harmful eects 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