Satelec Implant Center 2, User Manual

Page: 28 / 248

28
13. 5 CABLE LENGTHS
XIV - DISPOSAL AND
RECYCLING
As electrical and electronic equipment, the device
must be disposed of according to a specialized
procedure for collection, pick-up and recycling or
destruction (in particular on the European market,
with reference to Directive 2002/96/EC of
27/01/2003).
When your device reaches the end of its life, we
consequently recommend that you contact your
dental equipment dealer (or, failing this, the ACTEON
Group website, the address of which is given in
chapter 18), for information on how to proceed.
XV - MANUFACTURER'S
LIABILITY
The manufacturer is not liable if:
- the manufacturer's installation recommendations
have not been followed (supply voltage,
electromagnetic environment, etc.)
- repairs or other work have been done on the device
by persons not authorized by the manufacturer
- the device has been used connected to an electrical
system that does not comply with current
regulations
- the device has been used in ways other than those
specified in this manual
- accessories (tips, handpiece, irrigation lines, etc.)
other than those supplied by SATELEC have been
used
- the instructions in this document have not been
followed.
Note: The manufacturer reserves the right to modify
the device and/or the user’s manual without notice.
XVI - REGULATIONS
This medical device is classified as class IIa according
to European Directive relevant to Medical Devices
currently in force.
This equipment is manufactured in compliance with
the current IEC 60601-1 standard.
This equipment has been designed and manufactured
according to an ISO 13485-certified quality assurance
system.
Cables and accessories Maximum length Complies with:
Handpiece cords
Footswitch cord
Power supply cord
Less than 3m
RF emission, CISPR 1 - Class A/Group 1
Harmonic current emission: IEC61000-3-2
Voltage fluctuation: IEC61000-3-3
Immunity to electrostatic discharge: IEC61000-4-2
Immunity to electrical fast transients/bursts: IEC61000-4-4
Immunity to surges: IEC61000-4-5
Immunity to voltage dips, short interruptions and voltage variations:
IEC61000-4-11
Immunity to conducted disturbances induced by radiofrequency fields: IEC61000-4-6
Immunity to radiated radiofrequency electromagnetic fields: IEC61000-4-3