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Specifications - Philips BiPAP autoSV advanced system One User Manual

Non-invasive ventilatory support to treat adult patient.
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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: 18 x 14 x 10 cm (7" L x 5.5" W x 4" H)
Weight (Device with power supply): Approximately 1.53 kg (3.37 lbs)
Standards Compliance
IEC 60601-1 General Requirements for Safety of Medical Electrical Equipment
IEC 10651-6 Homecare Ventilatory Support Devices
EN 60601-1-2 Electromagnetic Compatibility
RTCA/DO-160F 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 & AC power supply): Drip Proof, IPX1
Mode of Operation: Continuous
Electrical
AC Power Consumption: 100 - 240 VAC, 50/60 Hz, 2.1 A
DC Power Consumption: 12 VDC, 5.0 A
Fuses: There are no user-replaceable fuses.
noise
Sound Pressure Level: < 30 dB(A)
This measurement applies to the therapy device with or without the optional Humidifier.
Sound Power Level: < 38 dB(A)
Minimum Alarm Sound Level: 45 dB(A)
Pressure accuracy
Pressure Increments: 4.0 to 25.0 cm H
Pressure Stability:
Device
Device w/ Humidifier
Control accuracy
Parameter
Breath Rate
Inspiration time
Displayed Parameter accuracy
Parameter
Estimated Leak Rate
Exhaled Tidal Volume
Respiratory Rate
Exhaled Minute Ventilation
User Manual
This device is designed to conform to the following standards:
O (in 0.5 cm H
2
Static
± 0.5 cm H
± 0.5 cm H
Range
4 to 30 BPM
0.5 to 3 seconds
accuracy
± (5 + 15% of reading) LPM
± (25 + 15% of reading) ml
greater of ± 1 BPM or ± 10% of reading
± (1 + 15% of reading) LPM
O increments)
2
Dynamic
< 10 cm H
2
O
≤ 0.5 cm H
2
2
O
≤ 0.5 cm H
2
2
greater of ± 1 BPM or ± 10% of setting
± (10% of setting + 0.1 second)
1 LPM
1 ml
1 BPM
1 LPM
Dynamic
o
≥ 10.0 to 25 cm H
O
≤ 1.0 cm H
O
2
O
≤ 1.0 cm H
O
2
accuracy
Resolution
Range
0 to 200 LPM
0 to 2000 ml
0 to 60 BPM
0 to 99 LPM
o
2
19

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