Stryker Visum User Manual

38
S
Guidance and Manufacturer's Declaration - Electromagnetic Immunity
The Visum® Blade LED Surgical Light System is intended for use in the electromagnetic environment
specied below. The customer or the user of the Visum® Blade LED Surgical Light System should assure that
it is used in such an environment.
Immunity Test IEC 60601 Test Level Compliance Level
Electromagnetic Environment -
Guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2,5 GHz
3 Vrms
3 V/m
Portable and mobile RF
communications equipment should
be used no closer to any part of the
Visum® Blade LED Surgical Light
System, including cables, than the
recommended separation distance
calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation distance
d = 1,2√P
d = 1,2√P 80 MHz to 800 MHz
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 metres (m).
Field strengths from xed 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:
Note:
• At 80 MHz and 800 MHz, the higher frequency range applies.
• These guidelines may not apply in all situations. Electromagnetic propagation is aected
by absorption and reection from structures, objects and people.
a
Field strengths from xed 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 xed RF transmitters, an
electromagnetic site survey should be considered. If the measured eld strength in the location in which
the Visum® Blade LED Surgical Light System is used exceeds the applicable RF compliance level above,

Stryker Visum Specifications

General

Category	Medical Equipment
Type	Mobile C-Arm
Manufacturer	Stryker
Model	Visum
Power Requirements	50/60 Hz
Applications	Orthopedic, Pain Management