Covidien Valleylab LS10 Service Manual page 28

Electromagnetic Compatibility (IEC 60601-1-2 and IEC 60601-2-2)
Notice
The system should not be used adjacent to or stacked with equipment other than specified in the
Valleylab LS10, LS Series Single Channel Vessel Sealing Generator User's Guide and Service
Manual. If adjacent or stacked use is necessary, the system should be observed to verify normal
operation in the configuration in which it will be used.
The system intentionally applies RF energy for diagnosis or treatment during activation. Observe
other electronic medical equipment in the vicinity during the system activation for any possible
adverse electromagnetic effects. Ensure adequate separation of electronic medical equipment
based on observed reactions.
The use of accessories, other than specified in the Valleylab LS10, LS Series Single Channel Vessel
Sealing Generator User's Guide and Service Manual, may result in increased emissions or
decreased immunity of the system.
Other surgical equipment that generates RF energy may affect the generator. The generator
should be observed to confirm normal operation when used simultaneously with other
equipment. If an incomplete seal cycle occurs, reactivate the LigaSure instrument.
The generator meets the following requirements:
ESD Immunity (IEC 60601-1-2 sub-clause 36.202 and IEC 61000-4-2)
Radiated Immunity (IEC 60601-1-2 sub-clause 36.202.2 and IEC 61000-4-3)
Electrical Fast Transient/Burst (IEC 60601-1-2 sub-clause 36.202.3.1 and IEC 61000-4-4)
Surge Immunity (IEC 60601-1-2 sub-clause 36.202.3.2 and IEC 61000-4-5)
Emissions (IEC 60601-1-2 sub-clause 36.201.1, IEC 60601-2-2 sub-clause 36 and CISPR
11 Class A)
Harmonic distortion (IEC 60601-1-2 sub-clause 36.201.3.1 and IEC 61000-3-2)
Conducted disturbances (IEC 60601-1-2 sub-clause 36.202.6 and IEC 61000-4-6)
Power frequency magnetic fields (IEC 60601-1-2 sub-clause 36.202.8.1 and IEC 61000-
4-8)
Voltage dips, short interruptions and variations (IEC 60601-1-2 sub-clause 36.202.7 and
IEC 61000-4-11)
This device complies with Part 15 of the FCC Rules. Operation is subject to the following
two conditions:
This device may not cause harmful interference.
1.
This device must accept any interference received, including interference that may
2.
cause undesired operation.
Attention that changes or modifications not expressly approved by the party responsible
for compliance could void the user's authority to operate the equipment.
Note: This product has been tested and found to comply with the limits for a Class A
digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide
reasonable protection against harmful interference when the equipment is operated in a
commercial environment. This product generates, uses, and can radiate radio frequency
energy and, if not installed and used in accordance with the instructions, may cause
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