Electromagnetic Compatibility - Coltene PerFect TCS II Manuel De L'utilisateur

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6. Electromagnetic Compatibility

The following are guidance and manufacturer's declarations regarding electromagnetic compatibility for the Perfect
1.1 EN/IEC 60601-1-2 Table 1
The Perfect TCSII is intended for use in the electromagnetic environment specified below. The customer or the end user of the Perfect
®
TCSII should assure that it is used in such an environment.
Emissions test
RF emissions CISPR 11:2004
RF emissions CISPR 11:2004
Harmonic emissions IEC 61000-3-2
Voltage fluctuations/Flicker emissions IEC 61000-3-3
Guidance and Manufacturer's Declaration – Electromagnetic Emissions
EN
Compliance
Group 1
Class B
Class A
Complies
PerFect TCS II Tissue Contouring System
®
TCSII.
®
Electromagnetic environment -
guidance
The Perfect ® TCSII must emit electro-
magnetic energy in order to perform
its intended function. Nearby electronic
equipment may be affected. Specifically
the Perfect TCSII intentionally emits RF
®
energy at 3.68 MHz to perform its in-
tended use. It must comply with Group
1 emissions when switched 'on' with
the RF output inactive.
The Perfect TCSII unit is suitable for
®
use in all establishments other than
domestic, and may be used in domestic
establishments and those directly con-
nected to the public low-voltage power
supply network that supplies buildings
for domestic purposes, provided the
following warning is heeded:
Warning: This equipment is intended
for use by healthcare professionals only.
This equipment may cause radio inter-
ference or may disrupt the operation of
nearby equipment. It may be necessary
to take mitigation measures such as
re-orienting or relocating the Perfect
TCSII unit or shielding the location.
®
®