Emc Compliance - Bovie SPECIALIST PRO User Manual

Electrosurgical generator
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EMC COMPLIANCE

Special precautions should be taken regarding the Specialist | PRO. Medical Electrical Equipment needs special
precautions regarding EMC and needs to be installed and put into service according to the EMC information
provided in this manual.
WARNINGS
Use of this equipment adjacent to or stacked with other equipment should be avoided because it
could result in improper operation. If such use is necessary, this equipment and other equipment
should be observed to verify that they are operating normally.
Use of accessories and cables other than those specified or provided by the manufacturer of this
equipment could result in increased electromagnetic emissions or decreased electromagnetic
immunity of this equipment and result in improper operation.
Portable RF communications (including peripherals such as antenna cables and extrenal anten-
nas) should be used no closer than 30 cm (12 inches) to any part of the Specialist | Pro,
including cables specified by Bovie Medical. Otherwise, degradation of the performance of
Specialist | Pro could result.
Understand that only the Accessories supplied with or ordered from Bovie Medical should be used with
your device. The Specialist | Pro and its accessories are not suitable for interconnection with other equipment.
The Specialist | Pro is suitable for use in all establishments other than domestic and those directly connected to the
public low-voltage power supply network that supplies buildings used in domestic purposes.
For the purposes of EN60601-1-2 the Specialist | Pro has an essential performance which is that there shall be no
component failure, change in operating mode or false alarm, the delivered power shall remain within +/-20% of the
set power and there shall be no reset or interruption of the HF power unless this is clearly indicated on the product.
The Specialist | Pro must emit electromagnetic energy in order to perform its intended function. Nearby electronic
equipment may be affected.
The Specialist | Pro is intended for use in the electromagnetic environment listed below. The customer or the user of the Specialist | Pro
should assure that it is used in such an environment. - electromagnetic emissions
Emissions test
RF Emissions CISPR 11
RF Emissions CISPR 11
Harmonic emissions IEC 61000-3-2
Voltage fluctuations/flicker emissions IEC 61000-3-3 Complies
NOTICE
The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and
hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class
B is normally required) this equipment might not offer adequate protection to radio-frequency
communication services. The user might need to take mitigation measures, such as relocating or
re-orienting the equipment.
User's Guide • Specialist | PRO
Compliance
The Specialist | Pro must emit electromagnetic energy in order to
Group 2
perform its intended function. Nearby electronic equipment may be
affected.
Class A
The Specialist | Pro is suitable for use in all establishments other than
domestic and those directly connected to the public low-voltage power
Class A
supply network that supplies buildings used in domestic purposes.
Electromagnetic environment - guidance
45

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