DreamStation BiPAP autoSV User Manual
6.1 Specifications
6.1.1 Environmental
Operating Temperature
5° to 35° C (41° to 95° F)
Storage Temperature
-20° to 60° C (-4° to 140° F)
Relative Humidity (operating & storage) 15 to 95% (non-condensing)
Atmospheric Pressure:
101 to 77 kPa (0 - 2286 m / 0 - 7500 ft)
6.1.2 Physical
Dimensions
15.7 x 19.3 x 8.4 cm (6.2” L x 7.6” W x 3.3” H)
Weight (Device with power supply)
Approximately 1.28 kg (2.83 lbs)
6.1.3 Service life
The expected service life of the DreamStation therapy device and Link Module is 5 years.
6.1.4 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 60601-1-8: Medical Electrical Equipment – Part 1-8: General Requirements 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 Requirements for Basic Safety and
Essential Performance – Collateral standard: Requirements for medical electrical equipment and
medical electrical systems used in the home healthcare environment
• ISO 10651-6: Lung Ventilators for Medical Use – Particular Requirements for Basic Safety and
Essential Performance, Part 6. Home care ventilatory support devices
• EN 60601-1-2 Electromagnetic Compatibility
• RTCA/DO-160G section 21, category M; Emission of Radio Frequency Energy
The CE0123 mark indicates compliance with the following European Union Directive:
• 93/42/EEC Medical Devices Directive, as amended up to and inclusive of Council Directive 2007/47/
EC
The device is also designed and tested to: 2011/65/EU Restriction of the use of certain Hazardous
Substances (RoHS) in Electric and Electronic Equipment (EEE)
6. Specifications, disposal, and EMC
