English
3
MyoSure
®
XL Tissue Removal Device for Fluent
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
Compliance
Electromagnetic environment - guidance
RF emissions
CISPR 11
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.
RF emissions
CISPR 11
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.
RF emissions
CISPR 11
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.
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
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.
Harmonic emissions
IEC 61000-3-2
Complies
Voltage fluctuations / flicker emissions
IEC 61000-3-3
Complies
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
IEC 60601
test level
Compliance level
Electromagnetic environment - guidance
Electrostatic discharge (ESD)
IEC 61000-4-2
± 8 kV contact
± 15 kV air
± 8 kV contact
± 15 kV air
Floors should be wood, concrete or ceramic tile.
If floors are covered with synthetic material, the
relative humidity should be at least 30%.
Electrical fast transients / bursts
IEC 61000-4-4
± 2 kV for power supply
lines
± 1 kV for input / output
lines
± 2 kV for power supply
lines
Mains power quality should be that of a typical
commercial or hospital environment.
Surge
IEC 61000-4-5
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
Mains power quality should be that of a typical
commercial or hospital environment.
