Coltene BioSonic US100R, Owner'S Manual

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10 BioSonic
®
Ultrasonic Scaler
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 ® Ultrasonic Scaler has ever been reported to COLTENE, we
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 COLTENE, 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
®
US100R.
5.1 EN/IEC 60601 - 1 -2 Table 1
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
The Biosonic
®
US100R is intended for use in the electromagnetic environment specified below. The customer or the end user of the
Biosonic ® US100R should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions CISPR 11:Ed. 5.0
(with A1:2010)
Group 1 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.
RF emissions CISPR 11: Ed. 5.0
(with A1:2010)
Class B The Biosonic
®
US100R unit is suitable for use in all establishments other
than 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 profession-
als only. This equipment may cause radio interference or may disrupt the
operation of nearby equipment. It may be necessary to take mitigation
measures such as re-orienting or relocating the Biosonic
®
US100R unit or
shielding the location.
Harmonic emissions IEC 61000-3-2 Ed 4.0
(2014-05)
Class A
Voltage fluctuations/Flicker emissions
IEC 61000-3-3 Ed. 3.0 (2013-05)
Complies
Conforms to UL STDS:
60601-1
60601-1-6
80601-2-60 Conforms to CSA STDS:
C22.2 No. 60601-1
C22.2 No. 60601-1-6
C22.2 No. 80601-2-60