Standards Compliance; Iec 60601-1 Classification; Electrical; Water Capacity - Philips DreamStation 2 User Manual

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 classification

Type of Protection
Against Electric Shock
Degree of Protection
Against Electric Shock
Degree of Protection
Against Ingress of Water
Mode of Operation

Electrical

Water capacity

- 52 -
Class II Equipment
Type BF Applied Part
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 finger
and protected against solid foreign objects of 12.5 mm diameter and
greater.
Second characteristic numeral - 2 - Protection against ingress of water
with harmful effects dripping (15° tilted).
Explanation: Protected against vertically falling water drops when
enclosure tilted up to 15°.
Continuous
AC Power Consumption: 100–240 VAC, 50/60 Hz, 2.0-1.0 A
325 ml (11 oz.) at recommended water level