CAIRE FreeStyle Comfort User Manual page 29

Recommended separation distances between portable and mobile RF
communications equipment and the FreeStyle Comfort
The FreeStyle Comfort is intended for use in an electromagnetic environment in which radiated RF distur-
bances are controlled. The customer or the user of the FreeStyle Comfort can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the FreeStyle Comfort as recommended below, according to the maximum output power of
the communications equipment.
Rated maximum
output power of
transmitter
W
0,01
0,1
1
10
100
For transmitters rated at a maximum output power not listed above, the recommended separation distance d
in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is
the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
Classification
Type of protection against electric shock:
Class II Protection from electric shock is
achieved by double insulation.
Degree of protection against electric shock:
Type BF Equipment providing a particular
degree of protection against electric
shock regarding
1) allowable leakage current;
2) reliability of protective earth connection
(if present).
Not intended for direct cardiac application.
Independent testing for Medical Electrical Equip-
ment Standard:
Tested to be in compliance with
• IEC 60601-1 edition 3.1: Medical Electrical
equipment - Part 1 General Requirements for
safety.
• CAN/CSA C22.2 No. 60601-1-8 edition
2.1, Medical Electrical Equipment – Part 1:
General Requirements for Safety
Protection against potential electromagnetic or
other interference between the equipment and other
devices.
• Tested to be in compliance with EN 60601-1-2
/IEC 60601-1-2: 4th Edition.
Separation distance according to frequency of transmitter
150 kHz to 80 MHz
d P
1 2 .

0.12
0.38
1.2
3.8
12
FreeStyle Comfort
m
80 MHz to 800 MHz
d P
1 2 .

0.12
0.38
1.2
3.8
12
• Tested to be in compliance with RTCA/DO160
Section 21 Category M.
• CISPR 11 / EN 55011 Class B Group 1,
"Industrial, Scientific, and Medical (ISM)
Equipment"
• FCC Part 15, Subpart B – Class B
Unintentional Radiators
IP22 - Protection against ingress of fingers or
similar objects greater than 12.5 mm diameter.
Vertically dripping water shall have no harmful
effect when the enclosure is tilted at an angle of
15° from its normal position.
Method of cleaning and infection control allowed:
Please refer to "Cleaning, Care, and Proper
Maintenance" section of this FreeStyle User
Manual.
Degree of safety of application in the presence of
flammable anesthetic gases:
Equipment not suited for such application.
Mode of operation: Continuous duty.
800 MHz to 2,5 GHz
d P
1 2 .

0.23
0.73
2.3
7.3
23
PN MN232 C | User Manual ENG - 29