4.1 Warnings and cautions
37
TB-0545PC/IC/FC, TB-0535PC/IC/FC, TB-0520IC, TB-0510IC
INSTRUCTION MANUAL
Ch.4
• If the THUNDERBEAT is used to treat a patient with blood hypertension, coronary
disease, arteriosclerosis, diabetes, and/or cirrhosis, or a patient with blood vessel
irregularities such as calcification, sufficient sealing performance may not be
possible. To ensure high sealing capability, use the THUNDERBEAT to seal healthy
normal vessels.
• Coagulation may be incomplete due to thick vessels or certain blood
characteristics. Study well using the other instruments such as, the metal clips and
stapler at the same time.
• Confirm the state of tissue and/or vessel when using the THUNDERBEAT. After
removing the instrument, be sure to examine the tissue for hemostasis. If bleeding
is observed, conduct hemostasis with appropriate techniques.
• When treating a blood vessel and/or tissue, squeeze the control handle firmly until
the control handle touches the grip handle to stop. Otherwise, incomplete sealing
may cause bleeding.
• Always position a vessel in the middle of the grasping section. If the vessel extends
beyond the distal tip of the grasping section, the coagulation may be incomplete
and the THUNDERBEAT may wear out prematurely.
• Do not pull or twist the blood vessel and/or tissue with a strong force during the
procedure. Otherwise, the coagulation may be incomplete.
• Thermal denaturation of the proximal tissue may occur when treating the target
tissue in SEAL & CUT mode. The higher the output level, the wider the range of
thermal denaturation becomes. To select the proper output level considering the
state of target tissue.
• In the SEAL mode, the lower output setting may cause degradation of seal
performance.
• If the THUNDERBEAT is used with SEAL mode level 1 for sealing of blood
vessel (s) with diameter over 2 mm or if the THUNDERBEAT is used with SEAL
mode level 2 for sealing of blood vessel (s) with diameter over 4 mm, sufficient
sealing performance may not be possible.
• Ultrasonic and high-frequency (RF bipolar) energy is delivered to the tissue through
the probe tip and the grasping section during activation. The energy may change
water into vapor and the thermal energy of vapor may cause unintended damage to
the tissue which is in proximity to the probe tip and/or the grasping section. Be
careful to the above situations during the surgery.
• To seal adjacent tissue, overlap the edge of the existing seal. The second seal
should be distal to the first seal to increase seal margin. Otherwise, incomplete
sealing may cause bleeding and/or the existing seal may be opened.
• Do not cut the existing seal performed with SEAL mode by using another
instruments which cause thermal diffusion such as electrosurgical pencil or
ultrasonic scalpel.
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