Electrical Connections - Hologic MyoSure XL Notice D'utilisation

Impact of Mobile and Portable HF Communication Devices
The emission of high frequency energy by mobile communication devices may impact the function of the electrical medical device. Operating
such devices (e.g., cell phones, GPS phones) in the proximity of the electrical medical device is prohibited.

Electrical Connections

Do not touch electrical connections identified with this warning label.
Do not establish a connection between these plugs and sockets without first implementing precautionary ESD (electrostatic discharge) measures.
The following are ESD precautionary measures:
• Apply potential equalization (PE), if available on your equipment, to all devices to be connected.
• Use only the listed equipment and accessories.
Employees have to be informed about and trained in ESD precautionary measures.
Guidelines and Manufacturer's Statement
Electromagnetic Emissions
The FLUENT FLUID MANAGEMENT SYSTEM is intended for use in the electromagnetic environment specified below. The customer or the user of
the FLUENT FLUID MANAGEMENT SYSTEM should assure that it is used in such an environment.
Emissions test
RF emissions
CISPR 11
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations / flicker emissions
IEC 61000-3-3
Guidance and Manufacturer's Declaration
Electromagnetic Immunity
The FLUENT FLUID MANAGEMENT SYSTEM is intended for use in the electromagnetic environment specified below. The customer or the user of
the FLUENT FLUID MANAGEMENT SYSTEM should assure that it is used in such an environment.
Immunity test
Electrostatic discharge (ESD)
IEC 61000-4-2
Electrical fast transients / bursts
IEC 61000-4-4
Surge
IEC 61000-4-5
English
MyoSure XL Tissue Removal Device for Fluent
®
Compliance Electromagnetic environment - guidance
Group 1 The FLUENT FLUID MANAGEMENT SYSTEM uses RF energy only for its internal
function. Therefore, its RF emissions are very low and are not likely to cause
interference in nearby electronic equipment.
Group 2 The FLUENT FLUID MANAGEMENT SYSTEM must emit electro-magnetic energy
in order to perform its intended function. Nearby electronic equipment may be
affected.
Class A The FLUENT FLUID MANAGEMENT SYSTEM is suitable for use in all establish-
ments other than domestic and those directly connected to the public low-volt-
age power supply network that supplies buildings used for domestic purposes.
Complies
NOTE: The EMISSIONS characteristics of this equipment make it suitable
for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a
Complies
residential environment (for which CISPR 11 class B is normally required) this
equipment might not offer adequate protection to radio-frequency commu-
nication services. The user might need to take mitigation measures, such as
relocating or re-orienting the equipment.
IEC 60601 Compliance level
test level
± 8 kV contact ± 8 kV contact
± 15 kV air ± 15 kV air
± 2 kV for power supply ± 2 kV for power supply
lines lines
± 1 kV for input / output
lines
± 1 kV line(s) to line(s) ± 1 kV line(s) to line(s)
± 2 kV line(s) to earth ± 2 kV line(s) to earth
Electromagnetic environment - guidance
Floors should be wood, concrete or ceramic tile.
If floors are covered with synthetic material, the
relative humidity should be at least 30%.
Mains power quality should be that of a typical
commercial or hospital environment.
Mains power quality should be that of a typical
commercial or hospital environment.
3