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MARA OPERATOR’S MANUAL
MARA OPERATOR’S MANUAL
Note 1:
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.
For the Mara Water Vapor Ablation System, Essential Performance is
listed as:
• The System shall deliver water vapor to the uterus at a pressure of
20-52 mmHg, or prevent treatment, or discontinue treatment.
• The System shall detect a sealed uterus when the Water Vapor
Probe is placed, or prevent treatment.
Table A3
Guidance and Manufacturer’s Declaration (Electromagnetic Immunity)
The GEA-SYS-16-0500 is intended for use in the electromagnetic environment specified
below. The customer or the user of the GEA-SYS-16-0500 should assure that it is used in
such an environment.
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
80 MHz to 2.7 GHz
3 V/m
3 Vrms
150 kHz to 80 MHz
80 MHz to 2.7 GHz
3 V/m
Portable and mobile RF
communications
equipment (including
peripherals such as
antenna cables and
external antennas)
should be used no
closer than 30 cm (12
inches) to any part of
the GEA-SYS-16-0500,
including cables.
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:
Immunity
Test
IEC 60601
Test Level
Compliance
Level
Electromagnetic
Environment – Guidance
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 the GEA-SYS-16-0500
is used exceeds the applicable RF compliance level above, the GEA-SYS-16-0500 should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be necessary, such as
reorienting or relocating the GEA-SYS-16-0500.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
