Ener-C CTM Controller 1600 - Therapeutic Cooling Procedure

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Table 3 for RF Electromagnetic Immunity
The CTM Controller® 1600 is intended for use in the electromagnetic environment specied below.
The customer or the user of the CTM Controller® 1600 should assure that it is used in such an environment.
Immunity Test
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
IEC 60601 Test
Level
10 Vrms
150 kHz to 80 MHz
10 V/m
80 MHz to 800 MHz
10 V/m
800 MHz to 2.5 GHz
Recommended Separation distance
Portable and mobile RF communications
equipment should be used no closer to any part
of the CTM Controller® 1600, including cables,
than the recommended separation distance
calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance
d = 1.2 √P 80 MHz to 800 MHz
d = 1.2 √P 80 MHz to 800 MHz
d = 2.3 √P 800 MHz to 2.5 GHz
Where P is the maximum output power rating
of the transmitter in watts (W) according to the
transmitter manufacturer and d is the recom-
mended separation distance in meters (m).
Field strengths from xed RF transmitters, as
determined by an electromagnetic site survey
a
should be less than the compliance level in each
frequency range.
b
Interference may occur in the
vicinity of equipment marked with the following
symbol:
Compliance –
Level
V1 = 10 Vrms
150 kHz to 80 MHz
E1 = 10 V/m
80 MHz to 800 MHz
E2 = 10 V/m
800 MHz to 2.5 GHz
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is aected by
absorption and reection from structures, objects and people.
a
Field strengths from xed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to xed RF transmitters,
an electromagnetic site survey should be considered. If the measured eld strength in the location in which
the CTM Controller® 1600 is used exceeds the applicable RF compliance level above, the CTM Controller® 1600
should be observed to verify normal operation. If abnormal performance is observed, additional measures
may be necessary, such as reorienting or relocating the CTM Controller® 1600.
b
Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.
Ener-C | CTM Controller® 1600 | Operating manual | Appendix B – Manufacturer's declaration | Rev. 1.1 | 2017-12-12 Ener-C | CTM Controller® 1600 | Operating manual | Rev. 1.1 | 2017-12-12
Ener-C AG
Museggstrasse 8
6004 Lucerne
Switzerland
Optimizing Pain Management and Rehabilitation
T +41 41 226 45 68
F +41 41 226 45 73
info@ener-c.com
www.ener-c.com
Dispose of the unit and pads in a manner that is consistent
with your federal, state, and local laws and regulations.