Electromagnetic Compatibility; Iec 60601-1-2 Table 201 - ConMed SYSTEM 5000 Operator's Manual

Electrosurgical unit
Hide thumbs Also See for SYSTEM 5000:
Table of Contents

Advertisement

• This electrosurgical unit should be tested by
a Hospital Qualified Biomedical Technician
on a periodic basis to ensure proper and safe
operation. It is recommended that examina-
tion of the ESU be performed at least yearly.
• Refer all servicing to a Hospital Qualified
Biomedical Technician. Your CONMED sales
representative will be happy to assist you in
getting your equipment serviced.
• High voltages are developed within the ESU
that are accessible when the top cover is
removed. These voltages are potentially dan-
gerous and should be treated with extreme
caution.
• The high voltage DC power supply in the
System 5000™ is equipped with a bleeder
resistor to dissipate the charge on the filter
capacitor. However, it takes several seconds
after power is removed to bleed that charge
down to a safe level. It is recommended that
at least thirty (30) seconds be allowed to
elapse before touching or attempting to per-
form any maintenance involving the power
supply or power amplifier.
• Never remove or install any parts with the
power cord connected to AC mains.
• Avoid contact with the output leads when the
ESU is activated. Periodically inspect the
test leads used for the output connections for
obvious defects.
1.1.5

Electromagnetic Compatibility

Following are guidance and manufacturer's declarations regarding electromagnetic compatibility for the
System 5000™.
1.1.5.1 EN/IEC 60601-1-2 Table 201
Guidance and Manufacturer's Declaration – Electromagnetic Emissions
The System 5000™ Electrosurgical Unit is intended for use in the electromagnetic environment specified below. The
customer or the end user of the System 5000 Electrosurgical Unit should assure that it is used in such an environment.
Emissions test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
Flicker emissions
IEC 61000-3-3
1-6
Compliance
Electromagnetic environment - guidance
Group 2
The System 5000 Electrosurgical Unit must emit electromagnetic
energy in order to perform its intended function. Nearby elec-
tronic equipment may be affected.
Class A
The System 5000 Electrosurgical Unit is suitable for use in all
establishments, other than domestic establishments and those
directly connected to the public low-voltage power supply net-
Class A
work that supplies buildings used for domestic purposes.
Complies
• Although this ESU will withstand momentary
short circuits on the output, prolonged short
circuits may damage the ESU. Short-circuit-
ing the output should be avoided since it is
neither necessary nor desirable.
• Since the clinical use of electrosurgical units
is intermittent in nature with duty cycles on
the order of 10%, this ESU is not designed
to operate for extended periods of continu-
ous output. When testing, it is recommended
that duty cycles be limited to 10 seconds
activation with delays of 30 seconds between
activations.
• Activating the System 5000™ in other than its
normal operating position impairs the heat
dissipation capability of the heat sink.
• Ensure that the two top cover screws are tight-
ened and always perform a power-up check to
confirm a normal power-up sequence before
returning the ESU to service.
• Improperly connecting test equipment can
cause electric shock and destruction of equip-
ment.
• Turn unit off and wait until storage capacitors
have discharged before connecting test equip-
ment.
• Loss of power supply isolation can cause elec-
trical shock. When servicing the high voltage
power supply, assume internal isolation is
compromised until verified otherwise.

Hide quick links:

Advertisement

Table of Contents
loading

Table of Contents