Owner's Guide
XIII. EMC Information, Warnings and Considerations:
1 . This equipment generates, uses, and can radiate radio frequency energy . If not installed and used in accordance with the instruction
manual, it 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 their own expense, will need 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
Dent4You Inc . , we recommend that the handpiece and cables be kept at least 6 inches (15 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 BioSonic US200 cables and accessories, other than those provided by Dent4You, may result in increased emissions or decreased
immunity .
4 . Listed cables:
• Handle & Cord Assembly – COLTENE Part # 60034543
• Footswitch & Cord Assembly – COLTENE Part # 60034542
5 . Electromagnetic Compatibility:
The following are guidance and manufacturer's declarations regarding electromagnetic compatibility for the BioSonic US200 .
Conforms to UL STDS:
60601-1
60601-1-6
60601-2-60
NOTE 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
5 . 1 EN/IEC 60601 - 1 -2 Table 1
The BioSonic US200 is intended for use in the electromagnetic environment specified below . The customer or the user of the BioSonic US200 should
assure that it is used in such an environment .
Emissions test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/Flicker emissions
IEC 61000-3-3
14
Conforms to CSA STDs:
C22 . 2 No . 60601-1
C22 . 2 No . 60601-1-6
C22 . 2 No . 60601-2-60
Guidance and Manufacturer's Declaration – Electromagnetic Emissions
Compliance
Group 1
Class A
Class A
Complies
Electromagnetic environment - Guidance
The BioSonic US200 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 US200 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 for domestic purposes .