26
User Manual
Specifications
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)
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 1.33 kg (2.94 lbs)
Service Life
The expected service life of the DreamStation Therapy Device and Link Module is 5 years.
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
ISO 80601-2-70 Sleep Apnea Breathing Therapy Equipment
EN 60601-1-2 Electromagnetic Compatibility
RTCA/DO-160G section 21, category M; Emission of Radio Frequency Energy
IEC 60601-1 Classification
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
Link Module: Drip Proof, IP22
80W power supply: Drip Proof, IP22
Mode of Operation: Continuous
Electrical
AC Power Consumption
(with 80W power supply)
: 100 – 240 VAC, 50/60 Hz, 2.0-1.0 A
Note:
Power supply is part of the medical electrical equipment.
DC Power Consumption: 12 VDC, 6.67 A
Fuses: There are no user-replaceable fuses.
Radio Specifications
Operating Frequency Range: 2402 - 2480 MHz
Maximum Output Power:
4.0 dBm
Modulation:
GFSK, P/4 DQPSK, 8DQPSK
Intake Port Filters
Pollen Filter:
100% Polyester
88% Efficient @ 7-10 micron size
Ultra-fine Filter:
Blended Synthetic Fiber
95% Efficient @ 0.5-0.7 micron size
Declared Dual-Number Noise Emissions Values
In accordance with ISO 4871
The A-weighted sound pressure level is:
Device: 25.8 dB(A) with and uncertainty of 2 dB(A).
Device with Humidifier: 27.9 dB(A) with and uncertainty of 2 dB(A).
The A-weighted sound power level is:
Device: 33.8 dB(A) with an uncertainty of 2 dB(A).
Device with Humidifier: 35.9 dB(A) with an uncertainty of 2 dB(A).
Note:
Values determined according to noise test code given in ISO 80601-2-70:2015, using the basic
standards ISO 3744 and ISO 4871.
