Essential Performance; Electromagnetic Safety Guidance - Hologic My Sure Manual De Funcionamiento

International customers, contact your distributor or local Hologic Sales
Representative:
European Representative
Hologic BVBA
Da Vincilaan 5
1930 Zaventem
Belgium
Phone: +32 2 711 46 80

Essential Performance

The MyoSure system has no essential performance.

Electromagnetic Safety Guidance

The following tables provide information on the electromagnetic
environment that the MyoSure Hysteroscopic Tissue Removal System is
capable of operating in safely. Use of this equipement in an enviroment
that exceeds these limits may cause the device to stop working, change
cutting speed, or produce other unknown behavior. It is the responsibility
of the person installing the Hologic MyoSure Hysteroscopic Tissue
Removal System to insure the electromagnetic environment does not
exceed the specification set forth below in Tables 1–4.
Table 1 – Guidance and manufacturer's declaration – electromagnetic
emissions
Guidance and manufacturer's declaration – electromagnetic emissions
The MyoSure Hysteroscopic Tissue Removal System is intended for use in the
electromagnetic environment specified below. The customer or the user of the
MyoSure Hysteroscopic Tissue Removal System should assure that it is used
in such an environment.
Emissions test Compliance
RF emissions Group 1
CISPR 11
RF emissions Class B
CISPR 11
Harmonic emissions Class A
IEC 61000-3-2
Voltage fluctuations/ Complies
flicker emissions
IEC 61000-3-3
Electromagnetic environment
– guidance
The MyoSure Hysteroscopic
Tissue Removal System uses
RF energy only for its internal
function. Therefore, its RF
emissions are very low and
are not likely to cause any
interference in nearby electronic
equipment.
The MyoSure Hysteroscopic
Tissue Removal System
is suitable for use in all
establishments.
Table 2 – Guidance and manufacturer's declaration – electromagnetic
immunity
Guidance and manufacturer's declaration – electromagnetic immunity
The MyoSure Hysteroscopic Tissue Removal System is intended for use in the
electromagnetic environment specified below. The customer or the user of the
MyoSure Hysteroscopic Tissue Removal System should assure that it is used
in such an environment.
Immunity IEC 60601
test test level
Electrostatic ±2 kV, ±4 kV,
discharge ±8 kV Contact
(ESD) IEC
±2 kV,
61000-4-2
±4kV, ±8 kV,
±15 kV, Air
Electrical ±0.5 kV, ±1 kV,
fast ±2 kV for
transient/ power supply
burst IEC lines
61000-4-4
100kHz
repetition
frequency
Surge ±0.5 kV, ±1 kV
line(s) to
IEC
line(s)
61000-4-5
±0.5 kV, ±1 kV,
±2 kV line(s)
to earth
Voltage 0% U ; 0.5
T
dips, short cycle at
interruptions 0°, 45°,
and voltage 90°,135°,
variations 180°, 225°,
on power 270° and
supply input 315°
lines
0% U ;
T
IEC 1 cycle and
61000-4-11 70% U ;
T
25/30 cycles
Single phase:
at 0°
0% U ; 250
T
cycles
Power 30 A/m
frequency
50 Hz
(50/60 Hz)
magnetic
field
IEC
61000-4-8
NOTE U is the a.c. mains voltage prior to application of the test level.
T
9
Compliance Electromagnetic
level environment – guidance
±2 kV, ±4 kV, Floors should be wood,
±8 kV Contact concrete, or ceramic tile.
±2 kV, If floors are covered with
±4kV, ±8 kV, synthetic material, the
±15 kV, Air relative humidity should be
at least 30%.
±0.5 kV, ±1 kV, Mains power quality
±2 kV for should be that of a typical
power supply commercial or hospital
lines environment.
100kHz
repetition
frequency
±0.5 kV, ±1 kV Mains power quality
differential should be that of a typical
mode commercial or hospital
environment.
±0.5 kV, ±1 kV,
±2 kV
common
mode
0% U ; 0.5 Mains power quality
T
cycle at should be that of a typical
0°, 45°, commercial or hospital
90°,135°, environment. If the user of
180°, 225°, the MyoSure Hysteroscopic
270° and Tissue Removal System
315° requires continued
operation during power
0% U ;
T mains interruptions, it is
1 cycle and
recommended that the
70% U ;
MyoSure Hysteroscopic
T
25/30 cycles
Tissue Removal System
Single phase:
be powered from an
at 0°
uninterruptible power supply.
0% U ; 250
T
cycles
30 A/m Power frequency magnetic
fields should be at levels
50 Hz
typical for commercial or
hospital environments.
ENGLISH