En 60601-1 Compliance - Somnetics Transcend User Manual

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EN 60601-1 compliance

Protection against electric shock:
Degree of protection against ingress of water:
Use of flammable gasses:
Interface physical characteristics
Interface (shell/seal) weight:
Seal dead space
9" CPAP hose dimensions:
6' CPAP hose dimensions:
6' Standard hose dimensions:
Performance
Sound power level (@ 10cm
H O pressure, static)
2
Sound pressure level (@
10cm H O pressure, static)
2
Resistance to flow of the
mask and application
accessories
Working pressure range:
Pressure limit:
Vent flow rate curve:
Appendix: Specifications
Class II
Type BF
IPX0
Equipment not suitable for use in the presence of a flammable anesthetic
mixture with air or oxygen, or with nitrous oxide.
0.14 lbs (62 g)
Less than 301 cc
16-mm diameter, 20 cm long
16-mm diameter, 1.9 m long
21-mm diameter, 1.8 m long
37.0 dB
29.0 dB
0.140 hPa (cm H O) @ 50 l/min
2
0.278 hPa (cm H O) @ 100 l/min
2
H O
4 to 20 cm
2
H O
30 cm
2
Sleep Apnea Therapy User Manual