THUNDERBEAT Instruments Instructions

3 Intended Use The THUNDERBEAT Type S hand instruments are intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (ESG-400), and the THUNDERBEAT Transducer, (TD-TB400). Seal & Cut mode: The THUNDERBEAT Type S hand instruments when used in combination with the Seal & Cut mode are indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, adhesiolysis, oophorectomy, hysterectomies (both vaginal assisted and abdominal) etc) and endoscopic surgery or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping, and dissection is performed. These devices have been designed to seal and cut vessels (up to and including 7 mm in diameter), tissue bundles, and lymphatics. Seal mode: The THUNDERBEAT Type S hand instruments when used in combination with the Seal mode are indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, adhesiolysis, oophorectomy, hysterectomies (both vaginal assisted and abdominal) etc), and endoscopic surgery or in any procedure in which vessel sealing, coagulation, grasping is performed. These devices have been designed to seal vessels (up to and including 7 mm in diameter), tissue bundles, and lymphatics. The THUNDERBEAT Type S hand instruments have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.

4 Application of High-frequency Treatment Before proceeding to high-frequency treatment, study well the diagnosis given and the expected prognosis, the properties and purpose of the treatment, its risks and effects, and possible alternative treatments. Particularly, balance the risks of the treatment with the potential benefits of a given procedure.

5 Instruction Manual This instruction manual contains essential information on using the THUNDERBEAT instrument safely and effectively. Before use, thoroughly review this manual and the manuals for all equipment that will be used during the procedure and use the equipment as instructed. Keep all instruction manuals in a safe, accessible location. If you have any questions and comments about any information in this manual, contact Olympus.

6 User Qualification This manual does not explain or discuss clinical surgical procedures. Therefore, the health care professional using the THUNDERBEAT instrument must be a licensed physician or medical personnel under the supervision of a licensed physician and must have received sufficient training in clinical procedures and the use of ultrasonic and electrosurgical energy.

7 Instrument Compatibility The THUNDERBEAT instrument should be used in combination with ancillary equipment listed in “ System chart” on page 23. Using incompatible equipment could result in patient and/or operator injury, equipment damage, and/or decreased product performance. This instrument complies with the EMC standard for medical electrical equipment, edition 4 (IEC 60601-1-2: 2014). When connecting to an instrument that complies with a previous edition of the EMC standard for medical electrical equipment edition, the EMC characteristics could be vulnerable.

8 Reprocessing and Storage The THUNDERBEAT instrument is a sterile single use item. Do not reuse or attempt to sterilize. Reusing or using after resterilization, poses an infection control risk, a product performance risk, and can damage the THUNDERBEAT instrument. Store the instrument as instructed in this instruction manual. If not properly stored, the sterility of the instrument may be compromised. The transducer to be used in combination with the THUNDERBEAT instrument is not sterilized before shipment. Before using the transducer for the first time, reprocess it as described in Chapter 5, “Reprocessing: General Policy” and Chapter 6, “Cleaning, Disinfection, and Sterilization Procedures” in the instruction manual for the transducer.

9 Repair and Modification This THUNDERBEAT instrument contains no user-serviceable parts. Do not modify or attempt to repair; patient, surgeon, or surgical staff injury and/or equipment damage can result.

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10 Signal Words The following signal words are used throughout this manual:

DANGER

Indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury.

WARNING

Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.

CAUTION

Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury. It may also be used to alert against unsafe practices or potential equipment damage.

NOTE

Indicates additional helpful information.

11 Dangers, Warnings, and Cautions Follow the dangers, warnings, and cautions described below when handling the THUNDERBEAT instrument. This information is supplemented by the dangers, warnings, and cautions described in each chapter.

DANGER • Avoid using the THUNDERBEAT instrument in a flammable atmosphere. Do not place flammable gas or liquid near the THUNDERBEAT instrument during use. The THUNDERBEAT instrument is not designed to be explosion-proof and a fire hazard may result. • Before using high-frequency cauterization with a patient wearing a cardiac pacemaker, consult a cardiovascular specialist or the manufacturer of the cardiac pacemaker, and make sufficient preparation to ensure safety. The use of an electrosurgical generator may exert a serious effect on a patient due to malfunction or failure of the cardiac pacemaker. • Do not bundle the transducer cords and the cords of another medical device (electrocardiograph, endoscopic video camera, etc.) during use. Otherwise, high-frequency signals and the spark discharge noise during coagulation may cause malfunction of the medical device and may harm the patient. • When using the high flow insufflation unit, always use CO2 gas. Do not use N2O gas with the THUNDERBEAT instrument because this gas is flammable. • Do not use the THUNDERBEAT instrument in combination with a product other than the compatible equipment shown in the “ System chart” on page 23.

WARNING • Do not set up or control the THUNDERBEAT instrument with wet hands. Otherwise, an electric shock of the user may result. • Keep a defibrillator ready for use to prepare for possible medical emergencies. Be sure to withdraw the THUNDERBEAT instrument from the surgical field before using the defibrillator. • Use the THUNDERBEAT instrument in an environment equipped to accommodate open surgery and have the hospitalization plan prepared in case any problem occurs that may not be resolved by form of endoscopic surgery. • To ensure electrical safety, do not use the THUNDERBEAT instrument with equipment with which the safety of combined use is not ensured or with equipment with which the safety in regard to leakage current, etc. has not been confirmed. • Exercise special care when electrosurgical output is applied in the vicinity of the heart. Current flowing through the heart, or the low-frequency current generated by rectification during spark discharge, may cause ventricular fibrillation. • Be sure that this instrument is not used adjacent to or stacked with other equipment (other than the components of this instrument or system) to avoid electromagnetic interference. • Electromagnetic interference may occur on this instrument near equipment marked with the following symbol or other portable and mobile RF (Radio Frequency) communications equipment such as cellular phones. If electromagnetic interference occurs, mitigation measures may be necessary, such as reorienting or relocating this instrument, or shielding the location.

CAUTION When using this equipment in domestic environments and connected to the public mains network, electromagnetic interference with other devices may occur. If electromagnetic interference occurs, mitigation measures may be necessary, such as reorienting or relocating this equipment, or shielding the location. The emissions characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment.

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12 Checking the Package Contents Confirm that there are the THUNDERBEAT instruction manual and the quick reference guide in the carton (both individual boxes and boxes of five have only one manual). Withdraw the sterile pack from the carton and confirm the “Use by” date has not passed. Next, check that the THUNDERBEAT instrument, torque wrench, and stabilizer are provided in the pack by referring to the following figure. If you accidentally drop the THUNDERBEAT instrument, torque wrench, or stabilizer, be sure to replace it with a new device. If the sterile pack and/or the THUNDERBEAT instrument are damaged, a component is missing, or you have any questions, do not use the THUNDERBEAT instrument; contact Olympus for assistance.

NOTE Torque wrench and stabilizer are also available separately (MAJ-1983 Torque Wrench/Stabilizer Kit).

Torque wrench

Stabilizer

THUNDERBEAT instrument Instruction manual (one instruction manual in the carton)

Quick reference guide (one quick reference guide in the carton)

13 Nomenclature  THUNDERBEAT instrument (Front-actuated grip Type S) 4

5

6

3

7

10

1 2

9

8

Nomenclature

Description

1) Probe tip

During output, ultrasonic vibration and/or bipolar output is activated.

2) Grasping section (jaw)

During output, bipolar output is activated.

3) Shaft

Is inserted into the abdominal cavity. Shaft covered with insulated tube.

4) Rotation knob

Rotates the shaft.

5) Transducer connection

Is connected to the transducer.

6) Symbol

Indicates that this is a THUNDERBEAT instrument.

for THUNDERBEAT

7) Grip handle

During using, it is held.

8) Control handle

By opening the control handle, grasping section is opened. By closing the control handle, grasping section is closed.

9) SEAL button: blue

Press the SEAL button to deliver the high-frequency (RF bipolar) energy for coagulation of tissue or sealing of vessels. The button can be activated by depressing the front or the side.

(handswitch) (with protruding)

10) SEAL & CUT button: purple (handswitch) (without protruding)

Press the SEAL & CUT button to deliver combined ultrasonic and high-frequency (RF bipolar) energy for simultaneous sealing and cutting tissue. The button can be activated by depressing the front or the side.

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 Closeup of the distal end of the shaft 1 2

3

4

Nomenclature

Description

1) Grasping section

Coated with insulating material excluding the gray area.

2) Non-insulated area

-

3) Tissue pad

-

4) Probe tip

Coated with insulating material excluding the gray area.

 Torque wrench (provided) For connecting the transducer (available separately) to the THUNDERBEAT instrument. 1

2

4

3

Nomenclature

Description

1) Head

Slot for attaching torque wrench onto THUNDERBEAT instrument.

2) Assembly index

THIS SIDE UP.

3) Grip

During use, it is held.

4) Assembly index

Securing direction.

 Torque wrench (MAJ-1983 Torque Wrench/Stabilizer Kit, separately available) For connecting the transducer (available separately) to the THUNDERBEAT instrument. 1

2

4

3

Nomenclature

Description

1) Head

Slot for attaching torque wrench onto THUNDERBEAT instrument.

2) Assembly index

THIS SIDE UP.

3) Grip

During use, it is held.

4) Assembly index

Securing direction.

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 Stabilizer (provided) For connecting the transducer (available separately) to the THUNDERBEAT instrument.

NOTE The stabilizer is also available separately (MAJ-1983 Torque Wrench/Stabilizer Kit). 1

Nomenclature 1) Grip

Description During use, it is held.

 THUNDERBEAT transducer (provided separately) 2

1

5

Nomenclature 1) THUNDERBEAT instrument

3

4

Description Is connected to the instrument.

connection

2) Transducer cord

Electrical signal is output from the ultrasonic generator to the instrument.

3) Transducer plug

Connects to the THUNDERBEAT socket of the ultrasonic generator.

4) Symbol

Indicates that this is a THUNDERBEAT transducer.

for THUNDERBEAT

5) Switch contacts

The switch contacts conduct the handswitch signal.

14 Specifications  Transportation, storage, and operating environments Operating environment

Standard storage environment (e.g. within the hospital)

Transportation environment (conditions during transportation and short-term storage)

Ambient temperature

10 – 40C (50 – 104F)

Relative humidity

30 – 85%

Atmospheric pressure

70 – 106 kPa

Altitude

3000 m or less

Ambient temperature

5 – 40C (41 – 104F)

Relative humidity

10 – 90%

Atmospheric pressure

70 – 106 kPa

Ambient temperature

–40 to +60C (–40 to +140F)

Relative humidity

10 – 90%

Atmospheric pressure

70 – 106 kPa

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 Specifications Model

Front-actuated grip TypeS

TB-0520FCS

TB-0535FCS

Frequency

47 kHz

Amplitude

80 μm

Dimensions

Shaft outer diameter Effective length

ø 5.5 mm 200 mm

Rated high-frequency (RF bipolar) voltage Level setting (SEAL&CUT mode)

TB-0545FCS

350 mm

450 mm

229 Vp Output levels for the energy of combined ultrasonic and high-frequency (RF Bipolar) (Time lag from the beginning of high-frequency to the beginning of ultrasonic)  Level 1: 0 s  Level 2: 0.5 s  Level 3: 1 s

Level setting (SEAL mode)

Output levels for the energy of high-frequency (RF Bipolar) (Minimum time of output)  Level 1: 3 s  Level 2: 4 s  Level 3: 5 s

NOTE This product has been designed for use in the duty cycle (ON: 5 s/OFF: 10 s). Medical Devices Directive

This device complies with the requirements of Directive 93/42/EEC concerning medical devices. Classification: Class II b RoHS Directive

This device complies with the requirements of Directive 2011/65/EU and (EU) 2015/863 concerning electrical and electronic equipment. EMC

Applied standard

IEC 60601-1-2: 2001 IEC 60601-1-2: 2007 IEC 60601-1-2: 2014 IEC 60601-2-2: 2006 IEC 60601-2-2: 2009 IEC 60601-2-18: 1996 IEC 60601-2-18: 2009 • This instrument complies with the EMC standard for medical electrical equipment, edition 4 (IEC 60601-1-2: 2014). When connecting to an instrument that complies with a previous edition of the EMC standard for medical electrical equipment edition, the EMC characteristics could be vulnerable. • CISPR 11 of emission: Group 1, Class A (standby mode)

Year of manufacture

Indication

The last digit of the year of manufacture is the first digit of the lot number. In this example, the year is 2010. Ex. 01K (lot number)

This device complies with the requirements of Directive 93/42/EEC concerning medical devices.

Classification: TYPE CF applied part electromedical equipment. The degree of protection against electric shock of this instrument depends upon the electromedical equipment employed. Refer to the particular unit and its instruction manual.

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15 Storage WARNING • Do not store the sterile instrument packs in a place where they may be damaged, the stickers may be peeled off or they may be exposed to moisture. Otherwise, sterility of the THUNDERBEAT instrument may be compromised and inflammation of tissue and infection may result. • Do not store this instrument in a place that is exposed to direct sunlight, X-rays, radioactivity, strong electromagnetic waves (e.g., the vicinity of a microwave therapeutic device, short-wave therapeutic device, MRI, wireless set, cellular phone, etc.), high temperatures, high humidity, or water/moisture. Otherwise, the instrument may be damaged and/or could present an infection control risk. • Do not store this instrument in the box in which it was shipped. This may present an infection control risk. • Do not subject this instrument to strong impacts during transportation and storage. Doing so may damage the instrument. Store this instrument in a clean place under normal temperature and humidity where it will not be exposed to direct sunlight.

16 Preparation and Inspection 16.1 Warnings and cautions: preparation and inspection WARNING • As a precaution, prepare a secondary method for achieving hemostasis or desection, e.g. a spare of the THUNDERBEAT instrument, and a backup of the transducer. • The THUNDERBEAT instrument including the torque wrench and the stabilizer is a single-use product and is to be discarded after use. Do not attempt to resterilize or reuse it. Otherwise, infection or instrument damage may result and the THUNDERBEAT would be unable to manifest the intended functionality and durability. • The transducer to be used in combination with this instrument was not sterilized before shipment. Before using the transducer for the first time, process it as described in Chapter 5, “Reprocessing: General Policy” and Chapter 6, “Cleaning, Disinfection, and Sterilization Procedures” in the instruction manual for the transducer. • Do not use the THUNDERBEAT instrument if the “Use by” date printed on the sterile pack has passed. Otherwise, inflammation of tissue and infection may result. • Do not use the THUNDERBEAT instrument, torque wrench, or stabilizer if they are dropped before the packages are opened. If the sterilized pack is damaged, the sterility may be compromised. • Be sure to perform the preparation and inspection described in this chapter before use. Also, inspect the ancillary equipment to be combined with the THUNDERBEAT instrument according to the instruction manuals for the equipment. Should any irregularity be observed with the THUNDERBEAT instrument, do not use it. Inspect it as described in Chapter 8, “Troubleshooting” in the instruction manual for the ultrasonic generator. If the irregularity is still not resolved after troubleshooting, contact Olympus. Using the THUNDERBEAT instrument while any irregularity is observed may cause malfunction and may injure the surgeon, surgical staff, and/or patient. • To prevent injury to 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 instrument in contact with tissue, the patient, or a flammable object, such as a drape, after the output has ceased. Otherwise, unintentional burns of the surgeon, surgical staff, and/or patient, or a fire hazard may result. • To prevent malfunction or damage, be careful not to apply excessive force to the transducer connecting sections during assembly. If the connection is difficult, it is probable that a part is crushed, bent, or deformed. Check the THUNDERBEAT instrument sufficiently and do not use it if an irregularity is observed. • Avoid overtightening the rotation knob while holding the transducer. Always use the torque wrench and stabilizer provided when assembling or disassembling the THUNDERBEAT transducer. Overtightening may cause damage to the THUNDERBEAT instrument. • Do not attempt to clean the contacts inside the transducer plug with a sharp object such as the tips of tweezers. Do not use metal brushes for cleaning. Otherwise, deformation or damage of the contact will cause conduction failure, making energy delivery impossible. • Be sure to fully insert the transducer plug into the USG-400. Otherwise, an unsecure connection may result in unexpected disconnection of the transducer plug, resulting in no output, which could lead to potential bleeding.

CAUTION • When inspecting the transducer, do not touch the transducer plug contacts. Static electricity that was accumulated during autoclaving may cause an electric shock. • Place the transducer on a level surface to prevent it from rolling and accidentally dropping to the floor. • If the circumference of the contacts of the transducer plug or the switch contacts turns black, replace the transducer. Otherwise, the transducer may short-circuit and damage the ultrasonic generator. • Handle the THUNDERBEAT instrument with care when placing it on a hard surface to avoid unintentional damage of the THUNDERBEAT instrument.

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16.2 Preparation of the equipment Prepare the THUNDERBEAT instrument, the ultrasonic generator, compatible electrosurgical generator, the transducer compatible ancillary equipment (shown in the “ System chart” on page 23) and other equipment to be used with the THUNDERBEAT instrument. Also, prepare the required personal protective equipment, such as eyewear, a face mask, moisture-resistant clothing, and chemical-resistant gloves that fit properly to prevent skin exposure. Refer to the respective instruction manuals for each piece of ancillary equipment.

16.3 Connection of the transducer

 Connect the transducer to the THUNDERBEAT instrument to complete the THUNDERBEAT WARNING • Make sure that the THUNDERBEAT instrument and the transducer are connected firmly. If they are secured erroneously or only with the hand, energy output may not be available and damage to the transducer or excessive heating of the exterior may also result. Even if output is available, the functionality and durability may be compromised. • Use the provided torque wrench and stabilizer for the connection and disconnection and be sure to follow the instructions given in this manual. If another tool, a hand, or excessive force is used for securing, incomplete connection or damage may result to the THUNDERBEAT instrument or the transducer, resulting in the impossibility of disconnection. If proper connection is impossible, there may be a deformation such as crushing or bending in some parts. Inspect the instrument well and immediately stop using it if any irregularity is observed. • If the rotation knob is not rotating freely upon attaching a transducer to the THUNDERBEAT instrument, loosen the rotation knob once and rotate it again. Rotating the rotation knob with excessive force or putting the transducer in a slanted angle may damage the threads. • When using the torque wrench, securely hold only its grip section. Holding any other part of the wrench may cause the operator’s hand being pinched in the gap of the torque wrench and result in injury and/or insufficient tightening or over-tightening of the transducer connection. • Stop application of force to the torque wrench when an audible click is heard. Otherwise, the system may not work properly and serious injury to the surgeon, surgical staff, and/or the patient may result. • Both torque wrench and stabilizer are single-use products and have to be discarded after every procedure. Do not resterilize or reuse them. Otherwise, infection or instrument damage may result and the THUNDERBEAT would be unable to manifest the intended functionality and durability. • When mounting the stabilizer on the transducer, do not damage the transducer cord. Otherwise, an electric shock and/or burns may result. • When attaching the head of the torque wrench to the rotation knob, do not damage the shaft insulation. Otherwise, it may cause burns due to current leakage and/or decrease functionalities.

1 Confirm that the “Use by” date has not passed and the sterile pack shows no signs of damage such as a break, peeled stickers, contamination, or the presence of moisture. If any damage is detected to the package, the sterility may be compromised. Do not use the THUNDERBEAT instrument and replace it with a new THUNDERBEAT instrument.

2 Open the sterile pack and carefully take out the packaging spacer and the THUNDERBEAT instrument from the sterile pack using good sterile technique.

Packaging spacer Position to open

Figure 1

3 Check the appearance of the instrument, especially confirming the following: • The shaft is not torn, cut, peeled, or rolled up. • The metallic section on the shaft and the grasping section is not corroded or discolored. • The appearance is free of bending, deformation, and other irregularity. Should any damage and/or irregularity be observed, do not use the THUNDERBEAT instrument and replace it with a new THUNDERBEAT instrument.

4 Take out the torque wrench and stabilizer from the sterile pack.

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5 Check the appearance of the transducer for rust, disconnection, cracks, loosening, and transducer cord damage. Should any irregularity be observed, replace it with a new one.

6 Be sure to disconnect the transducer plug from the ultrasonic generator before connecting or disconnecting the transducer to/from the THUNDERBEAT instrument.

7 Insert the instrument connection of the transducer into the transducer connection of the THUNDERBEAT instrument.

Figure 2

8 Turn the rotation knob clockwise with a light force, holding the transducer by the other hand until the rotation knob stops.

Figure 3

WARNING Avoid overtightening the rotation knob while holding the transducer. Always use the torque wrench and stabilizer provided when assembling or disassembling the THUNDERBEAT transducer. Overtightening may cause damage to the THUNDERBEAT instrument.

9 Mount the stabilizer on the transducer.

Figure 4

10 Grasp the stabilizer grip mounted on the transducer and attach the head of the torque wrench to the proximal end of the shaft with the side marked “THIS SIDE UP” facing the distal end of the shaft.

Figure 5

11 Grasp the stabilizer grip mounted on the transducer and attach the head of the torque wrench down onto the rotation knob.

Figure 6

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12 Grasp both the grip of the torque wrench and the stabilizer mounted on the transducer and then rotate the rotation knob clockwise slowly with the torque wrench until the torque wrench clicks once.

Figure 7

CAUTION • Do not hold the grip handle and transducer together while rotating the rotation knob with the torque wrench. • Do not dispose of the torque wrench and the stabilizer but keep them in a sterile condition, because they will be used for changing and withdrawing the transducer during the procedure and post-procedure.

13 Detach the torque wrench and the stabilizer. 14 Confirm the following: • The grasping section at the distal end of the shaft can be opened and closed smoothly when you move the control handle until the control handle strikes the grip handle to stop. • The rotation knob can be turned smoothly when the grasping section is open. Should any irregularity be observed, replace the THUNDERBEAT instrument with a new one.

16.4 Preparation and inspection of compatible electrosurgical generator and ultrasonic generator WARNING Always use the THUNDERBEAT in combination with the compatible electrosurgical generator and the ultrasonic generator. The THUNDERBEAT cannot be combined with other generators. Ultrasonic Generator

Electrosurgical Generator

USG-400

ESG-400

Table 1 Prepare and inspect the generators according to their instruction manuals. Should any irregularity be observed, do not use them; contact Olympus.

16.5 Connection to ultrasonic generator

 Connecting/disconnecting the transducer plug to/from the ultrasonic generator

WARNING Do not connect the transducer plug to the ultrasonic generator while the transducer, transducer cord, and/or transducer plug are wet. Otherwise, an electric shock and/or burns may result.

CAUTION • Always hold the transducer plug when connecting or disconnecting the transducer plug to the ultrasonic generator. Holding a part other than the plug may unexpectedly bend, stretch, twist, or squeeze the transducer cord, and result in snapping of the wires. • Do not touch the transducer plug contacts. Static electricity that was accumulated during autoclaving may cause an electric shock. • If a liquid or foreign object gets inside the transducer plug, withdraw the object by referring to the instruction manual for the transducer. Otherwise, equipment malfunction may result. • Do not attempt to clean the contacts inside the transducer plug with a sharp object such as the tips of tweezers. Also, when cleaning the contacts with a brush, do not poke or rub the contacts with the metal tip on the bristles of the brush. Otherwise, deformation or damage of the contact will cause conduction failure, making energy delivery impossible. • Be sure to fully securely insert the transducer plug. Otherwise, the unsecure connection may result in unexpected disconnection of the transducer plug, resulting in no output, which could lead to potential bleeding.

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 Connecting the THUNDERBEAT to the ultrasonic generator 1 Confirm that the symbol 1 for THUNDERBEAT on the transducer plug and transducer socket are identical.

The symbols are identical.

Figure 8

2 Fully insert the transducer plug into the transducer socket of the ultrasonic generator until it is fully seated.

 Disconnecting the THUNDERBEAT Hold the ultrasonic generator with one hand and the transducer plug with the other hand, and then pull out the transducer plug.

Figure 9

16.6 Inspection of ancillary equipment

 Inspecting the system CAUTION • During the inspection, also refer to the instruction manual for THUNDERBEAT transducer, ultrasonic generator, and compatible electrosurgical generator. • After the transducer plug is connected to the generator and the ultrasonic generator is turned ON, the generator touch-screen should show the corresponding symbol that is identical to the symbol on the transducer plug. If these symbols are not identical, the ultrasonic generator or transducer may malfunction. If this occurs, immediately stop using the system and contact Olympus.

1 Prepare and connect ancillary equipment to be used with the THUNDERBEAT by referring to their respective instruction manuals.

2 Inspect the system by referring to the instruction manual for the ultrasonic generator. 3 Confirm that the selected output level is appropriate for the procedure to be performed. • If the selected output level is not appropriate, press the plus or minus button to set the appropriate output level. • When both the THUNDERBEAT and the SONICBEAT are connected, set the output level in the corresponding “Set screen” (referring to Section 5.4, “Output setting” in the instruction manual for the ultrasonic generator).

4 If the software version of ultrasonic generator (USG-400) is 2.00 or later, set the Intelligent Tissue Monitoring by referring to the instruction manual for USG-400.

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 Output mode Output Mode

Energy

Output Level (Default Level)

Main Purpose

Characteristics • The output setting that has been validated for vessel sealing is level 1.

SEAL & CUT

Ultrasonic + High frequency (RF bipolar output)

1-3 (1)

Tissue sealing/cutting

• The lower the output level setting, the faster the cutting speed.

Blood vessel sealing/cutting

• The higher the output level setting, the longer the RF bipolar output time. • The sealing performance is not changed regardless of the output level.

SEAL

1-3 (3)

High frequency (RF bipolar output)

Tissue sealing/hemostasis

• The output setting that has been validated for vessel sealing is level 3.

Blood vessel sealing/ hemostasis

• The higher the output level setting, the longer the RF bipolar output time.

Table 2 For the high-frequency (RF bipolar) output of SEAL & CUT and SEAL mode, refer to the instructions manual for the compatible electrosurgical generator.

 Correlation between cutting speed and output level in SEAL & CUT mode Output level Cutting speed indicator bars

1

2

3

3 (High/Fast)

2 (Middle/Median)

1 (Low/Slow)

Table 3

The cutting speed indicator bars

THUNDERBEAT Set screen of the ultrasonic generator

Figure 10

 Verification of the high-frequency (RF bipolar) output WARNING • The output should always be verified outside the body cavity to avoid unintended tissue damage. Otherwise, tissues may be burnt. • Verify the high-frequency (RF bipolar) energy delivery before surgery. Otherwise, the THUNDERBEAT may not function properly during the surgery. • For inspecting the output in SEAL mode, do not press the SEAL & CUT button (purple) of handswitch or the SEAL & CUT pedal (left pedal: purple) of the footswitch accidentally. Otherwise, malfunction of the THUNDERBEAT instrument may not be detected correctly.

CAUTION • Do not touch the probe tip during output. Otherwise, the high-frequency (RF bipolar) current may cause burns. • If the output tone does not sound or the output screen is not displayed even when the handswitch or footswitch pedal is pressed, immediately stop using the system and turn the system OFF. The ultrasonic generator, the THUNDERBEAT, or the footswitch may be defective. Take proper measures as instructed in Chapter 8, “Troubleshooting” in the instruction manual for the ultrasonic generator. Continuing to use of the ultrasonic generator in this condition may result in burns of the surgeon, surgical staff, and/or patient. • If the output tone does not cease to sound even when the handswitch or footswitch pedal is released, immediately stop using the system and turn the system OFF. The ultrasonic generator, the THUNDERBEAT, or the footswitch may be defective. Take proper measures as instructed in Chapter 8, “Troubleshooting” in the instruction manual for the ultrasonic generator. Continuing to use the ultrasonic generator in this condition may result in burns of the surgeon, surgical staff, and/or patient. • Do not touch the container with the probe tip or grasping section during activation. Also, do not fully submerge the grasping section in saline. Otherwise, an error window could be displayed along with an error tone.

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CAUTION • If an error window is displayed together with an error tone during the inspection of the output, wipe any remaining saline from the probe tip and the grasping section with dry, sterile gauze. Then, retry the verification submerging the probe tip and the grasping section in saline correctly. • If you retry the verification correctly and the error window and error tone still persist, stop using the system and take remedial measures by referring to Chapter 8, “Troubleshooting”, in the instruction manual for the ultrasonic generator.

NOTE When the high-frequency output is activated for a long time (more than 15 seconds), the SEAL incomplete error occurs. This is a normal operation and does not mean malfunction of the equipment.

1 Prepare a sterile container (like a bowl) with dimensions as shown in Figure 11. Fill it with saline. Saline

Sterile container

Depth: more than 5 cm.

Diameter: more than 10 cm.

Figure 11

2 Open the grasping section completely and submerge only the distal half of the grasping section (different color area) and the probe tip in saline.

Different color area

Figure 12

3 Press and hold the SEAL button (blue) of the handswitch or the SEAL pedal (right pedal: blue) of the footswitch for the high-frequency (RF bipolar) output.

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4 Confirm the following items during the SEAL mode output: • During activating, the activation in “All screen” or “Set screen” is displayed on the touch-screen of the ultrasonic generator, no error window. • The output tone sounds from the compatible electrosurgical generator. Output inspection when only the THUNDERBEAT is connected

Set screen

Activation in Set screen with SEAL mode

Output inspection when both the THUNDERBEAT and the SONICBEAT are connected

All screen

Activation in All screen with SEAL mode

Figure 13

5 After the confirmation, take the probe tip and the grasping section out of the saline and release the SEAL button of the handswitch or the SEAL pedal of the footswitch.

6 Wipe any remaining saline on the probe tip with dry, sterile gauze.

 Inspecting the combination with the trocar WARNING • The outer diameter of the shaft of the THUNDERBEAT instrument is 5.5 mm. Use a trocar with a corresponding size. Be sure to confirm the THUNDERBEAT instrument and trocar compatibility prior to use. • When inserted through a trocar whose inner diameter has a sharp edge or tight fit, damage may occur to the shaft insulation. Prior to use, insert the THUNDERBEAT into the trocar and confirm that the insulation of the shaft is not damaged.

CAUTION When inserting or withdrawing the THUNDERBEAT into or from the trocar, close the control handle by hand firmly. Do not open the control handle while inserting or withdrawing the THUNDERBEAT. This would put excessive stress on the grasping section and may cause the handle and trocar to be broken. There is a case where manipulation of the handle would not be relayed to the grasping section. This is because the internal mechanism of the handle is designed to break when excessive stress is applied to the grasping section during use.

1 Hold the control handle to close the grasping section of the THUNDERBEAT instrument, and carefully insert the THUNDERBEAT into the trocar.

2 Confirm that the grasping section and the probe tip of the THUNDERBEAT instrument are extending from the end of the trocar.

3 Make sure that the shaft moves smoothly in the trocar tube. If not, replace the trocar. 4 After confirming the compatibility, keep the grasping section closed and carefully withdraw the THUNDERBEAT from the trocar.

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17 Operation 17.1 Warnings and cautions The surgeon and/or surgical staff using this instrument must be a physician or medical personnel under the supervision of a physician and must have received sufficient training in clinical endoscopic technique. This manual, therefore, does not explain or discuss clinical surgical procedures. It only describes basic operation and important information related to the operation of this instrument.

WARNING • When using any energy source (e.g., electrosurgical, laser, ultrasonic, etc.), be aware that the smoke or aerosols generated when energy is applied to the tissue may be carcinogenic or infectious. Wear personal protective equipment to guard against dangerous chemicals and potentially infectious material. During operation, wear appropriate personal protective equipment, such as eye wear, a face mask, moisture-resistant clothing, and chemical-resistant gloves that fit properly and are long enough so that your skin is not exposed. • Before use, be sure to read the instruction manuals for the compatible electrosurgical generator and ultrasonic generator that operate in conjunction with the THUNDERBEAT. • Should any irregularity (error window, abnormal noise, abnormal output, abnormal operation, abnormal appearance, etc.) or malfunction be observed while using the THUNDERBEAT, stop the use and withdraw the instruments from the body cavity. Do not withdraw the transducer plug from the ultrasonic generator. Check the equipment by referring to Chapter 8, “Troubleshooting”, in the instruction manual for the ultrasonic generator. If the irregularity remains after troubleshooting, replace the transducer. If this does not resolve the issue, replace the THUNDERBEAT instrument. If the irregularity remains unresolved, contact Olympus. • Use the THUNDERBEAT instrument properly. Improper use may cause the probe tip to fall off inside the body cavity, premature wear, partial separating, deformation, breakage, patient and/or operator injury, malfunction of the cardiac pacemaker, burns of the surgeon, surgical staff and/or patient, electric shock, abnormal output or malfunction, perforation, bleeding, postoperative bleeding, tissue damage and infection to the surgeon, surgical staff and/or patient. • Should any crack, scratch, deformation, split, protrusion, or partial separating be observed on the probe tip, grasping section, tissue pad, shaft, the surface of the transducer, transducer cord, or transducer plug, do not use them and replace the damaged instrument or the transducer with a spare. Using a damaged device may cause burns due to abnormal output or high-frequency (RF bipolar) current leakage or breakage of the probe tip, the tissue pad, and the grasping section. Typical damaged phenomenon of tissue pad Partial separation of the tissue pad

Exposed metal part due to severe wear of the tissue pad

Figure 14 • The probe tip, the tissue pad, and the grasping section of the THUNDERBEAT instrument wear due to ultrasonic vibrations. An excessive wear occurs depending on the way of use during the procedure, which may cause accidental destruction or deterioration of coagulating, coagulating/cutting, sealing, or sealing/cutting performances. To avoid such an event, be sure to prepare a spare THUNDERBEAT instrument, torque wrench, and stabilizer. • Do not use the THUNDERBEAT to seal a blood vessel with a diameter over 7 mm. Otherwise, sufficient sealing may not be achieved. • Even when using this instrument on blood vessel(s) with diameter of 7 mm or less depending on the condition of the patient or the blood vessel(s) and usage of THUNDERBEAT, coagulation or sealing by the instrument could be insufficient, and patient bleeding may result. When using this instrument on blood vessel(s) with a diameter over 4 mm, be careful to avoid rebleeding. The recommended output setting for the Seal & Cut mode is level 1, and/or the recommended output setting for the Seal mode is level 3. • 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.

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WARNING • Coagulation may be incomplete due to thick vessels or certain blood characteristics. Consider using other instruments, 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. Otherwise, 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 is, the wider the range of thermal denaturation becomes. Select the proper output level after 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 vessels with diameter over 2 mm or if the THUNDERBEAT is used with SEAL mode level 2 for sealing of blood vessels with diameter over 4 mm, sufficient sealing performance may not be possible. • If a blood vessel is dissected inappropriately, sufficient sealing may sometimes be impossible. • 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 that 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 other instrument that causes thermal diffusion such as electrosurgical pencil or ultrasonic scalpel. • When applying energy to a blood vessel, confirm that the distal end of the shaft is not submerged in fluids such as pooled blood or saline. Such conditions could potentially reduce the effectiveness of the THUNDERBEAT and could cause unintended tissue damage. • Do not activate the THUNDERBEAT simultaneously during suctioning and/or irrigating the surgical site. Otherwise, an unexpected current path may cause unintended tissue burns or degradation of treatment performance. • When a body fluid or tissue is present on the grasping section, probe tip or shaft surface during the procedure, immediately remove it by immersing the grasping section and probe tip in saline or wiping with sterile gauze. Otherwise, the performance may be degraded. To avoid the load increasing around the distal end of the grasping section in order not to become hard to open or close, try to keep a clean grasping section during treatment by users. Otherwise vibration failure or other issues may occur. • If an error is generated due to the start of output while blood or saline is attached, remove it with gauze. • The THUNDERBEAT gives priority to the function of a switch pushed earlier. During the procedure, be very careful not to accidentally activate the handswitch or footswitch as this may result in unintentional coagulation or cutting of tissue. Particularly, never mistake the SEAL & CUT button for the SEAL button because this may lead to unintentional cutting of tissue. • During the seal mode, do not stop activation until the “SEAL Complete” tone is heard. Otherwise, the target tissue may not be coagulated and may bleed. Particularly, the seal mode output period may be elongated while blood or saline is attached to the grasping section and probe tip or while these are immersed in blood or while holding a thick tissue with activating seal mode. • If the grasping section, the tissue pad, or the probe tip falls off, stop using the THUNDERBEAT immediately and retrieve it by appropriate means. • 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 result in various forms of damage in the probe tip and/or the tissue 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 tissue 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.

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WARNING • 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.g., 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/splitting/protruding/partial separating of the tissue pad. In turn, the probe may break before displaying an error window or generating an alarm tone. • Contact with other device may damage the handle and cause the internal parts to drop inside the body cavity. • Do not activate output while applying the probe tip to the tissue with a strong force, grasping thick tissue, positioning the tissue, 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/splitting/protruding of tissue 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. • During the treatment, do not activate output while applying the probe tip to the tissue with a strong force, grasping thick tissue, or twisting the handle. Also, do not activate the output, while torque is applied to tissue over the handle, in this instance release the torque, re-grasp the tissue, and re-activate output. Otherwise, the probe tip and/or grasping section may be damaged, which may result in falling of the probe tip and/or tissue pad.

View of the handle twisted after grasping

Grasping while twisting the handle

Figure 15 • If the grasping section, metal-exposed area around it or the probe tip gets sticked tissue during treatment, wipe it with a soft object such as a piece of gauze or a brush. Do not attempt to scrape it with a sharp object such as a scalpel or the tip of tweezers. Otherwise, the grasping section, metal-exposed area around it, the fluorine resin part, a coated surface or the probe tip may be scratched and damaged, which may lead to fall-off of the damaged part into the body cavity or burns of the tissue by a high-frequency leak current output due to destruction of the insulation structure. • During colpotomy and/or 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 17 on page 20 for an example of technique to avoid grasping a large bite of tissue. Grasping section

Probe tip Cross section of cervix

Figure 16 • 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, after output, do not leave the THUNDERBEAT in contact with tissue, the patient, or a flammable object such as a drape. Otherwise, burns of the surgeon, surgical staff, or patient or a fire hazard may result. • The grasping section, probe tip, and shaft become hot during output. Do not touch them to avoid burning your hand.

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WARNING • 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. • Whenever possible, avoid contacting the shaft other than the grasping section to the tissue as the temperature of the shaft can become elevated and could cause unintentional burns. Refer to “ Temperature of the shaft, grasping section, and probe tip during activation” on page 27 for details of the temperature. • Only the grasping section should come in contact with the tissue. If other parts (e.g., the metal area around the grasping section or shaft of the THUNDERBEAT instrument) come in contact with the tissue, they may cause burns due to current leakage. • If releasing the switch does not stop energy delivery, immediately turn the ultrasonic generator off and withdraw the THUNDERBEAT instrument from the patient. • Before pressing a handswitch or footswitch pedal, make sure that it is the target switch for the desired application. Otherwise, burns of the surgeon, surgical staff, and/or patient may result. • Do not pinch or contact the transducer cord with a sharp object. Otherwise, the cord may break and malfunction, which could cause burns due to a possible leakage of RF bipolar current. • Before activating the output, be sure that neither the grasping section nor the probe tip comes into contact with the surrounding tissue. Do not use the THUNDERBEAT if you do not have a sufficient view to confirm the above or if the grasping section and probe tip are penetrating into the tissues. Otherwise, perforation, bleeding, or burns may result. Do not use the THUNDERBEAT if you do not have a sufficient view of the grasping section and probe tip to ensure that only the intended tissue is in contact with the grasping section. • The probe tip of the THUNDERBEAT instrument tapers off at the end. Do not activate the THUNDERBEAT instrument if you do not have a sufficient view to confirm the probe tip. Such condition could cause unintended tissue damage. • Incomplete or partial cutting tends to occur with thin membranous tissues. Even if a tissue or vessel (especially thin membranous tissue) cannot be cut completely, do not continue output for a longer period. Otherwise, this may cause patient injury and/or deterioration of the equipment. In addition, if the distal end of the shaft is stuck to desiccated tissue, bleeding may also result if you attempt to withdraw it by force. • If desiccated tissue or coagulum is present on the probe tip in the SEAL mode output, activate the SEAL & CUT mode with the grasping section open. This will assist in the cleaning of the probe tip via ultrasonic vibrations. While doing so, do not touch tissue with the probe tip accidentally. • Do not hold the transducer surface for an extended period of time. Otherwise, the rise of the surface temperature may result in burns. • When cutting and vessel sealing is performed in SEAL & CUT mode, apply light tension on the tissue so that users can confirm it is transected. Also, stop activation immediately after tissue is transected. Otherwise, the grasping section, the tissue pad, or the probe tip may break and fall off, and partial separating of the tissue pad may occur due to a local increase of temperature caused by the friction between tissue pad and the probe tip during activation. • If an irregular noise is generated during output, the THUNDERBEAT instrument or the transducer may be damaged. Continuing to use them may cause the probe tip to break and fall off inside the body cavity. Replace the damaged THUNDERBEAT instrument or transducer with a spare one. • Take care not to drop the transducer or not to subject the transducer to strong impacts. Even if the transducer appears undamaged, do not use it and replace it with a new transducer. Its durability and capability may have been impaired. • This system will only allow the activation of one instrument at a time. Confirm that other instruments are not being activated before activating a selected instrument. • For hemostasis in the SEAL mode, grasp a bleeding point with the grasping section and the probe tip. Do not use the outside surface of the grasping section for hemostasis because that surface coated with insulating material is not conductive so as not to stop bleeding. • Do not apply excessive bending, straining, or squeezing force to the cords. It may cause malfunction. • Do not submerge the handle in any liquid. Otherwise, an electric shock of the user may result. • Be careful not to break the probe tip or separate the tissue pad by the load imposed on the probe tip and the tissue pad when the instruments are withdrawn from the body cavity and/or the instruments are cleaned.

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CAUTION • Activation for extended period of time may cause malfunction. • Treatment of hard or thick tissue in the SEAL & CUT mode may result in failure to cut/coagulate because of the overload imposed on the probe tip. • If the SEAL & CUT mode is activated for a long time (3 – 5 seconds) with the grasping section open, the output stops as an error due to a function of the THUNDERBEAT. • When inserting the THUNDERBEAT into or withdrawing it from the trocar tube, gently hold the control handle and make sure that the grasping section is closed. If the THUNDERBEAT is inserted or withdrawn with the grasping section open, the probe tip/grasping section may become damaged, or it may become impossible to withdraw it from the trocar. • When inserting the THUNDERBEAT into or withdrawing it from the trocar, do not apply excessive force. If the THUNDERBEAT is difficult to insert into or difficult to withdraw it from the trocar, make sure that it is not damaged. Attempting to insert or withdraw the THUNDERBEAT with excessive force may cause the insulation on the THUNDERBEAT instrument’s shaft to be peeled and/or make it impossible to withdraw the THUNDERBEAT from the trocar. • When using the THUNDERBEAT in combination with the trocar, do not apply strong bending pressure to the shaft. If the THUNDERBEAT instrument comes in strongly contact with the opening of the trocar, it could cause the insulation on the THUNDERBEAT instrument’s shaft to be peeled and/or cause other damage to the THUNDERBEAT instrument. • Do not turn the shaft more than necessary. Doing so will twist the transducer cord, which can cause a malfunction. Also, do not apply excessive force to the transducer cord by bending, straining, or twisting it too much. Otherwise, the damaged cord may cause malfunction. • An error may be generated if the seal mode output is applied to a thin membrane tissue.

NOTE • When the THUNDERBEAT instrument is withdrawn from the patient due to the occurrence of an error display or other irregularities, the probe tip may break and fall off due to friction between the trocar and the instrument or due to the stress caused by cleaning the probe tip. • The material of the probe tip is titanium alloy. It is radio-opaque. • Use a plastic uterine manipulator. • The following technique, drilling with small biting, is just one example for colpotomy and/or amputation to avoid grasping a large bite of tissue, and tips/techniques are not limited to this. Details on clinical surgical technique are the responsibility of trained specialists. Patient safety in surgical examinations and surgical treatment can be ensured through appropriate handling by the physician and the medical facility.  Narrowly open the grasping section and use the probe tip to drill in laterally at a shallow angle while activating the Seal & Cut mode. Close the grasping section slowly and cut through tissue using the distal half of the grasping section to achieve a slow cut and shallow bites around the cervix. Distal half of the grasping section Grasping section

Shallow angle Probe tip

Cross section of cervix

Figure 17

17.2 Operation

 Turning power ON Confirm that the components are appropriately connected for the procedure to be performed as described in “16 Preparation and Inspection”. Then turn the compatible electrosurgical generator and ultrasonic generator ON.

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