Recommended Separation Distances; Cable Lengths; Manufacturer's Liability; Regulations - Acteon Endocenter Benutzerhandbuch

(a): The electromagnetic field strengths of fixed radiofrequency emitters, such as base stations for mobile telephones (cellular /cordless),
mobile radios, amateur radio, AM/FM radio broadcasts and TV broadcasts cannot be determined exactly by theory. To assess the
electromagnetic environment due to fixed radiofrequency emitters, an electromagnetic environment measurement must be made. If the
measured radiofrequency field strength in the immediate environment where the product is used exceeds the complian ce level specified
above, the performance of the product must be tested to verify whether it conforms to the specification. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or relocating the product.
(b): In the 150 kHz to 80 MHz frequency range, the electromagnetic field strengths must be less than 3 V/m.

12.4 RECOMMENDED SEPARATION DISTANCES

The device is intended for use in an electromagnetic environment in which radiated radiofrequency disturbances are con trolled.
The device user and/or installer can help prevent electromagnetic interference by maintaining a minimum distance between portable and
mobile radiofrequency communications equipment emitters and the device, according to the maximum output power of the equipment, as
recommended in the table below.
Rated max. power of the emitter (W)
0.01
0.1
1
10
100
For emitters rated at max. power not listed above, the recommended separation distance d in meteres (m) can be estimated using the
equation applicable to the frequency of the emitter, where P is the max. power rating of the emitter in watts (W) according t he
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These specifications may not be applicable in all situations. Electromagnetic propagation is affected by absorption and reflection
from structures, objects and persons.

12.5 CABLE LENGTHS

Cables and accessories Maximum length
Handpiece cords
Footswitch cord Less than 3m
Power supply cord

13. 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
- 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.

14. 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.
Separation distance in metres (m) according to emitter frequency
150 kHz to 80 MHz
P
d = 1.2
0.12 m
0.38 m
1.2 m
3.8 m
12 m
manufacturer.
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
80 MHz to 800 MHz
P
d = 1.2
0.12 m
0.38 m
1.2 m
3.8 m
12 m
Complies with:
®
have been used
800 MHz to 2,5 GHz
P
d = 2.3
0.23 m
0.73 m
2.3 m
7.3 m
23 m
22