Philips SimplyGo - Standards and Classification; Standards Compliance; Device Classification

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SimplyGo User Manual
Standards Compliance
The device is designed to conform to the following standards
- IEC 60601-1, Medical Electrical Equipment, Part 1: General Requirement
for Safety
- IEC 60601-1-2, 2nd edition, Medical Electrical Equipment, Part 1-2: Gen-
eral Requirement for Safety – Collateral Standard: Electromagnetic (EMC)
Compatibility – Requirements and tests�
- RTCA/DO-160Fsection21,categoryM;EmissionofRadioFrequency
Energy
- ISO 8359, Oxygen Concentrators for Medical use – Safety Requirements�
Classication
The SimplyGo is classied as:
• IECClassIIInternallyPoweredEquipment
• TypeBFAppliedPart
• IPX1: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