Guidelines And Manufacturer's Statement - Electromagnetic Interference Immunity - For The Fluid Safe Fluid Management System - Stryker Fluid safe Instrucciones De Uso

Initial Use of the Device
4.5
Guidelines and Manufacturer's Statement - Electromagnetic Interference Immunity - for the FLUID SAFE Fluid
EN
Management System
Electromagnetic interference
immunity tests
Conducted RF interference
quantities according to
IEC 61000-4-6
Radiated RF interference
quantities according to
IEC 61000-4-3
Note 1: The higher frequency range applies at 80 MHz and 800 MHz.
Note 2: These guidelines are probably not realizable in all cases. The distribution and spread of electromagnetic quantities differs
depending on the absorption and reflection of buildings, objects, and people.
a
The field strength of stationary transmitters such as base stations of mobile phones and land mobile devices, ham radio
stations, AM and FM radio, and TV broadcasters are theoretically not 100% predictable. A site study is recommended to
determine the electromagnetic environment as it pertains to the stationary transmitters. If the measured field strength at the
proposed FLUID SAFE Fluid Management System installation and operation site exceeds the concordance levels listed above, the
FLUID SAFE Fluid Management System should be monitored to document proper functionality and operation as intended.
Additional measures might become necessary, e.g., modifying orientation or a different location for the FLUID SAFE Fluid
Management System if unusual performance characteristics are observed.
b
The field strength should be less than 3 V/m for the frequency range of 150 kHz to 80 MHz.
12
IEC 60601 test level
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
Compliance Electromagnetic environment
guidelines
Portable and mobile wireless devices
should not be used in closer
proximity to the FLUID SAFE Fluid
Management System (including
cables/lines) than the recommended
safety distance calculated based on
the transmitting frequency and the
applicable formula. Recommended
safety distance:
In compliance
d= 1.2 √P for 150 kHz to 80 MHz
d = 1.2√ P for 80 MHz to 800 MHz
In compliance
d = 2.3 √ P for 800 MHz to 2.5 GHz
With P as the rated output of the
transmitter in watts [W] according to
the information provided by the
manufacturer of the transmitter and
d as recommended safety distance in
meters [m].
The field strength of stationary
transmitters should remain lower for
all frequencies than the concordance
level tested on site
possible in the proximity of devices
featuring the following pictograph.
a b
. Interference is