iHelmet (Model: LTD200S) User Manual
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distance between portable and mobile RF communications equipment (transmitters) and the
iHelmet (Model: LTD200S) as recommended below, according to the maximum output power
of the communications equipment.
Rated maximum
output power of
transmitter (W)
Separation distance according to frequency of transmitter (m)
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2
1.2
2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (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.
NOTE1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.
NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
a. MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC and
needs to be installed and put into service according to the EMC information provided in the
ACCOMPANYING DOCUMENTS.
b. Portable and mobile RF communications equipment can affect MEDICAL ELECTRICAL
EQUIPMENT.
9.3 Biocompatibility Requirements
The user indirect contacting material used for the sensing catheter component of the device is
biocompatible for its intended use. Complies with biocompatibility standards ISO
10993-5:2009 (Cytotoxicity) and ISO 10993-10:2010 (Irritation and Sensitization).
9.4 FCC Requirements
Caution:
The user is cautioned that changes or modifications not expressly approved by the
party responsible for compliance could void the user's authority to operate the equipment.
