iBreeze BPAP Systems User Manual
28
15 Specification
Physical
Dimension (L*W*H): 235*148*125 mm
Weight: Approximately 1.55 kg
Operating Environmental
Temperature:5℃~35 ℃
Relative Humidity: 10%~95% (non-condensing)
Atmospheric Pressure: 70 kPa~106 kPa
Storage Environmental
Temperature: -25℃~70℃
Relative Humidity: 5%~95% (non-condensing)
Atmospheric Pressure: 70 kPa~106 kPa
Noise Value
A-weighted sound pressure level: ≤ 28 dBA (uncertainty of 2 dBA)
A-weighted sound power level: ≤ 36 dBA (uncertainty of 2 dBA)
Standards compliance
IEC 60601-1:2005Medical electrical equipment - Part 1: General requirements
for basic safety and essential performance.
IEC 60601-1-2:2014Medical electrical equipment - part 1-2: general
requirements for basic safety and essential performance -
collateral standard: electromagnetic disturbances -
requirements and tests.
ISO 80601-2-70:2015 Medical electrical equipment - Part 2-70: Particular
requirements for basic safety and essential performance
of Sleep apnea breathing therapy equipment.
ISO 8185:2009 Respiratory tract humidifiers for medical use - Particular
requirements for respiratory humidification systems.
IEC 60601-1-11:2015 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.
Electrical
AC Power Input: 100~240 V～ 50/60 Hz 2.0 A Max
DC Power Input: 24 V, ≤2.5 A
Safety Specifications
Class II
Type BF
Ingress Protection: IP22
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