User manual

19User Manual
Specications
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 This device is designed to conform to the following standards:
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 Classication
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 Humidier.
Sound Power Level: < 38 dB(A)
Minimum Alarm Sound Level: 45 dB(A)
Pressure Accuracy
Pressure Increments: 4.0 to 25.0 cm H
2
O (in 0.5 cm H
2
O increments)
Pressure Stability:
Static Dynamic
< 10 cm H
2
O
Dynamic
≥ 10.0 to 25 cm H
2
O
Device ± 0.5 cm H
2
O ≤ 0.5 cm H
2
O ≤ 1.0 cm H
2
O
Device w/ Humidier ± 0.5 cm H
2
O ≤ 0.5 cm H
2
O ≤ 1.0 cm H
2
O
Control Accuracy
Parameter Range Accuracy
Breath Rate 4 to 30 BPM greater of ± 1 BPM or ± 10% of setting
Inspiration time 0.5 to 3 seconds ± (10% of setting + 0.1 second)
Displayed Parameter Accuracy
Parameter Accuracy Resolution Range
Estimated Leak Rate ± (5 + 15% of reading) LPM 1 LPM 0 to 200 LPM
Exhaled Tidal Volume ± (25 + 15% of reading) ml 1 ml 0 to 2000 ml
Respiratory Rate greater of ± 1 BPM or ± 10% of reading 1 BPM 0 to 60 BPM
Exhaled Minute Ventilation ± (1 + 15% of reading) LPM 1 LPM 0 to 99 LPM