Safety Regulations - Interacoustics Virtual SVV Manual De Instrucciones

Virtual SVV™ Instructions for Use - EN
IEC / EN 61000-4-3
NOTE1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
(a)
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which
Virtual SVV™ is used exceeds the applicable RF compliance level above, Virtual SVV™ should be observed
to verify normal operation, If abnormal performance is observed, additional measures may be necessary,
such as reorienting or relocating Virtual SVV™ .
(b)
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Safety regulations

Declaration of conformity
The CE marking confirms that the Virtual SVV™ system conforms to the relevant requirements of the
guideline 93/42/EEC. The Virtual SVV™ system is classified accordingly as a Class 1 medical device.
Safety standards
This device is specified to comply with the international standards, IEC/EN/ES 60601-1 Medical electrical
equipment – Part 1: General requirements for basic safety and essential performance.
RoHS compliance – 2011/65/EU
The Virtual SVV™ system fulfils the European guidelines for the limited use of dangerous materials in
electrical and electronic equipment.
80 MHz to 2,5 GHz
Page 44
=
d 2 3 , P
800 MHz to 2,5 GHz
Where P is the maximum output
power rating of the transmitter in
watts (W) according to the
transmitter manufacturer and d is
the recommended separation
distance in meters (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey, (a)
should be less than the compliance
level in each frequency range (b)
Interference may occur in the
vicinity of equipment marked with
the following symbol: