IFU-001 Rev D June 2014
FDA 510(k) Cleared
X. INFORMATION REGARDING ELECTROMAGNETIC COMPATABILITY (EMC)
Table 1: Guidance and Manufacturers Declarations
- Electromagnetic Emissions
The CP Relief Wand® is designed to produce very low levels of radio frequency
(RF) emissions (interference), to be immune to the effects of interference
produced by other equipment operating in the vicinity, and to be immune to
damage due from electrostatic discharge, all when operating in a domestic or
clinical environment. For more information, please refer to the tables below.
Emissions
Test
Compliance
Electromagnetic Environment Guidance
RF
Emissions
CISPR 11
Group 1
The CP Relief Wand® uses RF energy only for
its internal function. Therefore its RF emissions
are very low and are not likely to cause any
interference in nearby electronic equipment.
RF
Emissions
CISPR 11
Class B
The CP Relief Wand® is suitable for use in all
establishments including domestic
establishments and those directly connected to
the public low voltage power supply network
that supplies buildings used for domestic
purposes.
Table 2: Guidance and manufacturer’s declaration
- electromagnetic immunity
The CP Relief Wand® is intended for use in the electromagnetic
environment specified below. The customer or the user
should assure that it is used in such environment
Immunity
test
IEC 60601
test level
Compliance
level
Electromagnetic
Environment
guidance
Electrostatic
Discharge
(ESD) IEC
61000-4-2
± 6 KV
Contact
± 8 KV
air
± 6 KV
Contact
± 8 KV
air
Floors should be wood,
concrete, or ceramic tile.
If floors are covered with
synthetic material, the
relative humidity should
be at least 30%