Coltene BioSonic US100R Benutzerhandbuch Seite 9

Owner's Guide
XIV. EMC Information, Warnings and Considerations:
1. This equipment generates, uses, and can radiate radio frequency energy, and if not installed and used in accordance with the instruction manual, may
cause interference to radio communications. Operation of this equipment in a manner inconsistent with this manual is likely to cause interference in
which case the user, at his own expense, will be required to take whatever measures may be required to correct the interference.
2. Persons fitted with cardiac pacemakers have been cautioned that some types of electronic equipment might interfere with the operation of a pacemaker.
Although no instance of pacemaker interference relating to a BioSonic
recommend that the handpiece and cables be kept at least 6 to 9 inches (15 to 23 cm) away from any pacemaker and pacemaker leads during use. If
use of this product is in question, consult patient's cardiologist.
3. Use of US100R cables and accessories, other than those provided by Coltène/Whaledent, may result in increased emissions or decreased immunity.
4. Listed cables:
a. Handle & Cord Assembly – Coltene Part # 50008850
b. Footswitch & Cord Assembly – Coltene Part # 50008843
5. Electromagnetic Compatibility:
The following are guidance and manufacturer's declarations regarding electromagnetic compatibility for the BioSonic
5.1 EN/IEC 60601 - 1 -2 Table 1
The Biosonic US100R is intended for use in the electromagnetic environment specified below. The customer or the end user of the Biosonic
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US100R 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
Compliance
Group 1
Class B
Class A
Complies
Ultrasonic Scaler has ever been reported to Coltène/Whaledent Inc., we
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Electromagnetic environment - guidance
The Biosonic ® US100R 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.
The Biosonic US100R unit is suitable for use in all establishments other than
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domestic, and may be used in domestic establishments and those directly
connected 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 interference or may disrupt the opera-
tion of nearby equipment. It may be necessary to take mitigation measures
such as re-orienting or relocating the Biosonic
location.
US100R.
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US100R unit or shielding the
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