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Standards compliance

This device is designed to conform to the following standards:

• IEC 60601-1 General Requirements for Basic Safety and Essential Performance of

Medical Electrical Equipment

• IEC 60601-1-11 General Requirements for Basic Safety and Essential Performance in the

Home Healthcare Environment

• IEC 60601-1-6 General Requirements for Safety - Usability

• IEC 62366 Application of Usability Engineering in Medical Devices

• IEC 62304 Medical Device Software – Software Life-cycle Processes

• ISO 80601-2-70 Sleep Apnea Breathing Therapy Equipment

• ISO 80601-2-74 Respiratory Humidifying Equipment

• EN 60601-1-2 Electromagnetic Compatibility

IEC 60601-1 classication

Type of Protection

Against Electric Shock

Class II Equipment

Degree of Protection

Against Electric Shock

Type BF Applied Part

Degree of Protection

Against Ingress of Water

Device: Drip Proof, IP22

First characteristic numeral - 2 - Protection against ingress of solid

foreign objects ≥ 12.5 mm diameter.

Explanation: Protected against access to hazardous parts with a nger

and protected against solid foreign objects of 12.5 mm diameter and

greater.

Second characteristic numeral - 2 - Protection against ingress of water

with harmful eects dripping (15° tilted).

Explanation: Protected against vertically falling water drops when

enclosure tilted up to 15°.

Mode of Operation Continuous

Electrical AC Power Consumption: 100–240 VAC, 50/60 Hz, 2.0-1.0 A

Water capacity 325 ml (11 oz.) at recommended water level

Philips DreamStation 2 User Manual

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