iBreeze CPAP Clinical Guide
25
13 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
Air filter
Air filter: Filter Efficiency: >75% (7 micron dust)
Pressure
Setting Range: 4-20 cmH
2
O
Max Single Fault Steady Pressure: 40 cmH
2
O
Pressure Control Accuracy: ±0.5 cmH
2
O
Dynamic Pressure Variation: < 1 cmH
2
O
Pressure monitoring Accuracy: ± (2%*full scale r 4%*actual reading)
Flow
Flow: >120 L/min
Humidifier
Water capacity: 290 ml (MAX Water Level)
Humidity: >10 mg/L BTPS (Within the set pressure range)
