21
O
2
asis User Guide
Electrical
The device shall only receive power from the included Globtek GMTM46402-
3612 power supply.
AC Power Input . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100-240 VAC ~ 50-60 Hz, 1.0 A
DC Power Output . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 VDC, 3.0 A
Power Rating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36W
Fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .There are no user-replaceable fuses.
Use Durations
Component
Single Patient Use
Only?
Duration of Use /
Expected Service Life
Shelf Life
Base Unit
No, Reusable
3 Years
3 Year
Water Well
Cartridge
Yes, Single Patient Use
30 Days
3 Year
Power Supply
No, Reusable
3 Years
n/a
Cannula
Yes, Single Patient Use
1 Week
n/a
Water Fill Pump
Yes, Single Patient Use
1 Year
n/a
Standards Classification
• This device is an US FDA cleared Class II medical device.
• This device is considered an IEC Class II, continuous operation, ordinary
equipment device.
• The heated line with cannula is considered an IEC applied part Type BF. This
is a means of classification stating the degree of protection against electric
shock.
• This device is classified as
IP22
. This means that the degree of protection
against ingress of water is drip proof.
• This device is classified as a Class II humidifier per the ISO 80601-2-74
standard.
• This device is designed for use in professional and home healthcare envi-
ronments. All parts and accessories included with the device are suitable
for use in a patient environment. The patient is an intended operator.
• The power supply is specified as part of the ME equipment.
PP-19-1 REV. 15
