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4.1 Warnings and cautions
TB-0545PC/IC/FC, TB-0535PC/IC/FC, TB-0520IC, TB-0510IC
INSTRUCTION MANUAL
Ch.4
• During TLH colpotomy or LSH amputation, avoid inserting the probe tip vertically
and deeply into the uterine cervix and activating the THUNDERBEAT instrument.
Do not overfill the grasping section with a large bite of tissue. This may result in
damage to the probe tip. Refer to Figure 4.3 on page 44 for an example of
technique to avoid grasping a large bite of tissue.
Figure 4.2
• Do not use the THUNDERBEAT for treatment aiming at blockage of the bile duct or
bowel. Successful hemostasis may require adjunct measures when
THUNDERBEAT is used on solid organs. Due to the difficulty of visualizing internal
structures, proceed slowly and do not attempt to transect large masses of tissue in
one activation. Avoid the division of large vascular/biliary bundles when using the
instrument under these conditions.
• This instrument is not indicated for female sterilization or circumcision.
• To prevent injury of the surgeon, surgical staff and/or patient due to accidental
activation, do not leave the THUNDERBEAT in contact with the patient or a
flammable object such as a drape while not in use. Also do not leave the
THUNDERBEAT in contact with tissue, the patient or a flammable object such as a
drape after output. Otherwise, burns of the surgeon, surgical staff or patient’s tissue
can be burnt or a fire hazard may result.
• The grasping section and probe tip become hot due to extended ultrasonic output.
Do not let it come in contact with tissues other than the target tissue.
• Do not use a high-frequency therapeutic device or laser in the proximity of the area
being treated with THUNDERBEAT at the same time. Otherwise, sparks transferred to
the mist produced by ultrasonic vibrations may cause burns.
• Do not grasp or let the probe tip contact hard objects such as metal clips, stapler or
other instruments (e.g., uterine manipulator). Also, be careful to avoid contacting
the probe tip with those accidentally. Particularly during activation, a scratch on the
probe tip could occur due to ultrasonic vibration, which leads the probe tip to break
and fall off into the body cavity. In addition, the high-frequency (RF bipolar) current
flows through the metal and generates spark discharge, which may cause burns
and decrease functionalities.
Grasping
section
Probe tip
Cross section of cervix
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