4.1 Warnings and cautions
39
TB-0545PC/IC/FC, TB-0535PC/IC/FC, TB-0520IC, TB-0510IC
INSTRUCTION MANUAL
Ch.4
• If the alarm tone sounds and an error window is displayed during the procedure,
immediately stop the procedure. During surgical procedures, withdraw the
THUNDERBEAT instrument from the body cavity. Do not remove the transducer
plug from the ultrasonic generator. Follow Chapter 8, “Troubleshooting”, in the
instruction manual for the ultrasonic generator. Otherwise, the probe tip may break
and fall off inside the body cavity.
• Do not activate output in Seal & Cut mode while the grasping section is closed
without contacting tissue or vessel, or ensuring that tissue is transected.
Otherwise, a local increase of the temperature due to a friction between the probe
tip and the grasping section may resultin various forms of damage in the probe tip
and/or the PTFE pad, such as premature wear, breakage, deformation, and/or
falling off inside the body cavity and/or partial separating.
• If sparks are discharged frequently from the grasping section during output, the
grasping surface (white PTFE pad surface) may be worn out. Continued use under
this condition may result in a scratch on the probe tip. This could lead to the probe
tip breaking and falling off into the body cavity during output.
• The THUNDERBEAT instrument should be used for soft tissue. Do not activate
output while grasping hard tissue such as bone or highly calcified tissue, or hard
objects such as metal clips, stapler, or other instruments (e.q., uterine manipulator,
forceps, and others). Otherwise, it may cause the probe tip to be scratched or come
into direct contact with the metal area of the grasping section as the heat generated
by the friction between the hard object and the probe tip could cause
wear/deforming/split/protruding/partial separating of the PTFE pad. In turn, the
probe may break before displaying an error window or generating an alarm tone.
• Do not activate output while applying the probe tip to the tissue with a strong force,
grasping thick tissue, or positioning the tissue, or twisting the shaft, or rotating the
rotation knob. Manipulate and isolate the targeted tissue with another instrument,
grasp the targeted tissue with the THUNDERBEAT instrument, and then activate.
Otherwise, it may cause the deforming/split/protruding of PTFE pad or a scratch on
the probe tip by interference with the other parts, which could result in the probe tip
breaking and falling off inside the body cavity.
• Do not activate output while grasping thick, harder tissue, such as the uterine
cervix, with the distal part of the probe tip and the grasping section. Otherwise, the
grasping surface (white PTFE pad surface) may be worn out partially. Continued
use under this condition may result in exposure of the metal area of the grasping
section and a scratch on the probe tip. This could lead the probe tip to breaking and
falling off into the body cavity during the output.
• When tissue or coagulum build-up, on the grasping section or the probe tip, use a piece
of moistened, soft gauze to clean the grasping section or probe tip. Do not attempt to
scrape it with a sharp object such as a scalpel. Otherwise, the grasping section, PTFE
pad or the probe tip may be scratched, which leads the probe tip to break and fall off
into the body cavity during treatment.
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