4400-0024 enFlow Operator’s Manual EN Rev. T 05/12
Page 20 of 26
Altitude, Operating and Storage
up to 15,000 ft
Air Pressure, Operating and Storage
570 hPa, (17 inHg) to 1060 hPa (31 inHg)
Shock/Drop Abuse Tolerance
MIL-STD-810F
Vibration
MIL-STD-810F
Radiated Magnetic Field Emissions
MIL-STD 461D, RE101 (7 cm test limit 30 Hz-100Khz); EMC
IEC 60601-1-2:2007
Safety Classifications
Type of protection against electrical
shock
Class I, or Internally Powered
Degree of protection against electric
shock
Type BF, Defibrillation-Proof
Mode of operation
Continuous
Note
Electromagnetic Compatibility (EMC)
The enFlow IV Fluid / Blood Warmer System has been tested and found to comply with the limits for
medical devices as set forth in IEC 60601-1-2: (2001) and related standards. These limits are designed
to provide reasonable protection against electromagnetic interference (EMI) in a typical medical
installation. The enFlow System generates, uses, and can radiate radio frequency energy and, if not
installed and used in accordance with the instructions, may cause interference to other devices in
the vicinity. However, there is no guarantee that interference will not occur in a particular
installation. If the enFlow System does cause interference to other devices, which can be determined
by turning the Controller off and on, the user is encouraged to try to correct the interference by one
or more of the following measures:
-
Reposition the Warmer and any intertwined cables.
-
Check ECG monitoring electrode contact and impedance.
-
Confirm monitoring lead wires are functioning properly and shielding is intact.
-
Connect the Controller into an outlet on a circuit different from that to which the other
device(s) are connected.
-
Consult the manufacturer for help.
