Olympus THUNDERBEAT TB-0535FC Instructions Manual
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Olympus THUNDERBEAT TB-0535FC Instructions Manual

Olympus THUNDERBEAT TB-0535FC Instructions Manual

5 mm, 45 cm, pistol grip, 5 mm, 35 cm, pistol grip, 5 mm, 45 cm, inline grip, 5 mm, 35 cm, inline grip, 5 mm, 20 cm, inline grip, 5 mm, 10 cm, inline grip, 5 mm, 45 cm, fr
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INSTRUCTIONS
THUNDERBEAT 5 mm, 45 cm, Pistol Grip
TB-0545PC
THUNDERBEAT 5 mm, 35 cm, Pistol Grip
TB-0535PC
THUNDERBEAT 5 mm, 45 cm, Inline Grip
TB-0545IC
THUNDERBEAT 5 mm, 35 cm, Inline Grip
TB-0535IC
THUNDERBEAT 5 mm, 20 cm, Inline Grip
TB-0520IC
THUNDERBEAT 5 mm, 10 cm, Inline Grip
TB-0510IC
THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip
TB-0545FC
THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip
TB-0535FC
USA: CAUTION: Federal law restricts this device to sale by or on the order of a physician.
Labels and Symbols
Important Information — Please Read Before
Use
Chapter 1
Checking the Package Contents
Chapter 2
Instrument Nomenclature and
Specifications
Chapter 3
Preparation and Inspection
Chapter 4
Operation
Chapter 5
Storage and Disposal
Chapter 6
Troubleshooting
Appendix
1
2
7
9
19
35
49
51
53

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Summary of Contents for Olympus THUNDERBEAT TB-0535FC

  • Page 1 INSTRUCTIONS Labels and Symbols Important Information — Please Read Before THUNDERBEAT 5 mm, 45 cm, Pistol Grip Chapter 1 Checking the Package Contents TB-0545PC Chapter 2 Instrument Nomenclature and Specifications THUNDERBEAT 5 mm, 35 cm, Pistol Grip TB-0535PC Chapter 3 Preparation and Inspection THUNDERBEAT 5 mm, 45 cm, Inline Grip TB-0545IC...

  • Page 3: Table Of Contents

    Contents Contents Labels and Symbols ......................1 Important Information — Please Read Before Use ............2 Intended use .......................... 2 Application of high-frequency treatment ................2 Instruction manual ......................... 3 User qualification ........................3 Instrument compatibility ......................3 Reprocessing and storage ..................... 3 Repair and modification ......................
  • Page 4 Contents Chapter 5 Storage and Disposal ............49 Storage ........................49 Disposal ........................49 Chapter 6 Troubleshooting ..............51 Troubleshooting ..................... 51 Appendix ....................53 System chart ........................53 THUNDERBEAT series ....................... 55 EMC information ......................57 Temperature of the shaft, grasping section and probe tip during activation ..... 61 TB-0545PC/IC/FC, TB-0535PC/IC/FC, TB-0520IC, TB-0510IC INSTRUCTION MANUAL...

  • Page 5: Labels And Symbols

    Labels and Symbols Labels and Symbols Safety-related labels and symbols are attached to the instrument at the locations shown below. If labels and symbols are missing or illegible, contact Olympus.  THUNDERBEAT instrument (Pistol grip) Symbol 1 for THUNDERBEAT Lot number ...

  • Page 6: Important Information - Please Read Before Use

    Important Information — Please Read Before Use Important Information — Please Read Before Use  Intended use The THUNDERBEAT 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 &...

  • Page 7: Instruction Manual

    Before use, thoroughly review this manual and the manuals of all equipment which 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.  User qualification This manual does not explain or discuss clinical surgical procedures.

  • Page 8: Repair And Modification

    Important Information — Please Read Before Use  Repair and modification This THUNDERBEAT instrument contains no user-serviceable parts. Do not modify or attempt to repair; patient or surgeon, surgical staff injury and/or equipment damage can result.  Signal words The following signal words are used throughout this manual: Indicates an imminently hazardous situation which, if not avoided, will result in DANGER death or serious injury.

  • Page 9: Dangers, Warnings, And Cautions

    Important Information — Please Read Before Use  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 •...
  • Page 10 Important Information — Please Read Before Use TB-0545PC/IC/FC, TB-0535PC/IC/FC, TB-0520IC, TB-0510IC INSTRUCTION MANUAL...

  • Page 11: Chapter 1 Checking The Package Contents

    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).
  • Page 12 1.1 Checking the package contents Ch.1 TB-0545PC/IC/FC, TB-0535PC/IC/FC, TB-0520IC, TB-0510IC INSTRUCTION MANUAL...

  • Page 13: Chapter 2 Instrument Nomenclature And Specifications

    2.1 Symbols and descriptions Chapter 2 Instrument Nomenclature and Specifications Symbols and descriptions Ch.2 Symbol Description Symbol Description Refer to instructions. Single use only Use by (expiration date) Sterilized using ethylene oxide Sterilization lot number Lot number Keep away from sunlight Keep dry Do not use if package is Do not resterilize...

  • Page 14: Nomenclature

    2.2 Nomenclature Nomenclature  THUNDERBEAT instrument (Pistol grip) Ch.2 Nomenclature Description Probe tip During output, ultrasonic vibration or bipolar output is activated. Grasping section During output, bipolar output is activated. (jaw) Shaft Shaft covered with insulated tube. Rotation knob Rotates the shaft. Transducer Connect the THUNDERBEAT Transducer.
  • Page 15 2.2 Nomenclature  THUNDERBEAT instrument (Inline grip) Ch.2 Nomenclature Description Probe tip During output, ultrasonic vibration or bipolar output is activated. Grasping section During output, bipolar output is activated. (jaw) Shaft Shaft covered with insulated tube. Rotation knob Rotates the shaft. Control handle By opening or closing the control handle, grasping section is opened or closed.
  • Page 16 2.2 Nomenclature  THUNDERBEAT instrument (Front-actuated grip) Ch.2 Nomenclature Description Probe tip During output, ultrasonic vibration or bipolar output is activated. Grasping section During output, bipolar output is activated. (jaw) Shaft Is inserted into the abdominal cavity. Rotation knob Rotates the shaft. Transducer Is connected to the transducer.
  • Page 17 2.2 Nomenclature  Closeup of the distal end of the shaft Ch.2 Nomenclature Description Upper surface of Coated with insulating material excluding the gray area. the grasping section Non-insulated area – PTFE pad – TB-0545PC/IC/FC, TB-0535PC/IC/FC, TB-0520IC, TB-0510IC INSTRUCTION MANUAL...
  • Page 18 2.2 Nomenclature  Torque wrench (provided) For connecting the transducer (available separately) to the THUNDERBEAT instrument. NOTE The torque wrench is also available separately (MAJ-1983 Torque Wrench/Stabilizer Kit). Ch.2 Nomenclature Description Head Mounts on the knob of the instrument. Assembly index THIS SIDE UP.
  • Page 19 2.2 Nomenclature  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). Ch.2 Nomenclature Description Grip During use, it is held. TB-0545PC/IC/FC, TB-0535PC/IC/FC, TB-0520IC, TB-0510IC INSTRUCTION MANUAL...
  • Page 20 2.2 Nomenclature  THUNDERBEAT Transducer (separately available) Ch.2 Nomenclature Description THUNDERBEAT Is connected to the instrument. instrument connection Transducer cord Electrical signal is output from the ultrasonic generator to the instrument. Transducer plug Connects to the THUNDERBEAT socket of the ultrasonic generator. Symbol Indicates that this is a THUNDERBEAT transducer.

  • Page 21: Specifications

    2.3 Specifications Specifications  Transportation, storage, and operating environments Operating Ambient temperature 10 – 40C (50 – 104F) environment Relative humidity 30 – 85% Atmospheric Ch.2 70 – 106 kPa pressure Altitude 3000 m or less Transportation and Ambient temperature –40 to +60C (–40 to +140F) storage environment Relative humidity 10 –...
  • Page 22 2.3 Specifications Medical Devices Directive This device complies with the requirements of Directive 93/42/EEC concerning medical devices. Classification: Class II b Applied standard IEC 60601-1-2: 2007 • This instrument complies with the EMC standard for medical electrical equipment; edition 3 (IEC 60601-1-2: 2007). However, when connecting to an instrument that complies with the EMC Ch.2 standard for medical electrical equipment, edition 1...

  • Page 23: Chapter 3 Preparation And Inspection

    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.
  • Page 24 3.1 Warnings and cautions: preparation and inspection WARNING • 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 otherwise deformed. Check the THUNDERBEAT instrument sufficiently and do not use it if an irregularity is observed.

  • Page 25: Preparation Of The Equipment

    3.2 Preparation of the equipment Preparation of the equipment Prepare the THUNDERBEAT instrument, the ultrasonic generator, compatible electrosurgical generator, the transducer compatible ancillary equipment (shown in the “System chart” in the Appendix) and other equipment to be used with the THUNDERBEAT instrument. 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.
  • Page 26 3.3 Connection of the transducer • When attaching the head of the torque wrench to the rotation knob, do not damage the shaft insulation. 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.
  • Page 27 3.3 Connection of the transducer Turn the rotation knob clockwise with a light force, holding the transducer by the other hand until the rotation knob stops. Front-actuated Pistol grip Inline grip grip Ch.3 Figure 3.2 Mount the stabilizer on the transducer. Front-actuated Pistol grip Inline grip...
  • Page 28 3.3 Connection of the transducer Grasp the stabilizer grip mounted on the transducer and attach the head of the torque wrench down onto the rotation knob. Front-actuated Pistol grip Inline grip grip Ch.3 Figure 3.5 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.
  • Page 29 3.3 Connection of the transducer CAUTION • In the case of the inline grip model, do not hold the grip handle and transducer together while rotating the rotation knob with the torque wrench. Ch.3 Inline grip Figure 3.7 • 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.

  • Page 30: Preparation And Inspection Of Compatible Electrosurgical Generator And Ultrasonic Generator

    Electrosurgical Generator USG-400 ESG-400 Table 3.1 Prepare and inspect the generators according to their instruction manuals. Should any irregularity be observed, do not use them; contact Olympus. Connection to ultrasonic generator  Connecting/disconnecting the transducer plug to/from the ultrasonic generator...
  • Page 31 3.5 Connection to ultrasonic generator CAUTION • 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.

  • Page 32: Inspection Of Ancillary Equipment

    If these symbols are not identical, the ultrasonic generator or transducer may malfunction. If this occurs, immediately stop using the system and contact Olympus. Prepare and connect ancillary equipment to be used with the THUNDERBEAT by referring to their respective instruction manuals.
  • Page 33 3.6 Inspection of ancillary equipment  Output mode Output Output Level Energy Main Purpose Characteristics Mode (Default Level) • This mode is same as the setting 39 of FineCoag mode of the ESG-400. • The output setting that has been validated Tissue for vessel sealing is level 1.
  • Page 34 3.6 Inspection of ancillary equipment The cutting speed indicator bars THUNDERBEAT Set screen of the ultrasonic generator Figure 3.9 Ch.3 TB-0545PC/IC/FC, TB-0535PC/IC/FC, TB-0520IC, TB-0510IC INSTRUCTION MANUAL...

  • Page 35: Verification Of The High-Frequency (Rf Bipolar) Output

    3.6 Inspection of ancillary equipment  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.
  • Page 36 3.6 Inspection of ancillary equipment NOTE When the high frequency output activated for a long time (more than 15 seconds) the SEAL incomplete error is occur, but the THUNDERBEAT doesn’t have any problem. Because it is normal. Prepare a sterile container (like a bowl) with dimensions similar to those shown in Figure 3.10.
  • Page 37 3.6 Inspection of ancillary equipment 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 (see Figure 3.12). •...

  • Page 38: Inspecting The Combination With The Trocar

    3.6 Inspection of ancillary equipment  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.

  • Page 39: Chapter 4 Operation

    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...
  • Page 40 4.1 Warnings and cautions Typical damaged phenomenon of PTFE pad Partial separation of the PTFE pad Exposed metal part due to severe wear or the PTFE pad Figure 4.1 Ch.4 WARNING • The probe tip, the PTFE pad, and the grasping section of the THUNDERBEAT instrument wear due to ultrasonic vibrations.
  • Page 41 4.1 Warnings and cautions WARNING • 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.
  • Page 42 4.1 Warnings and cautions WARNING • 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.
  • Page 43 4.1 Warnings and cautions WARNING • 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.
  • Page 44 4.1 Warnings and cautions WARNING • 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.
  • Page 45 4.1 Warnings and cautions WARNING • 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. Please refer to “Temperature of the shaft, grasping section and probe tip during activation”...
  • Page 46 4.1 Warnings and cautions WARNING • Do not pinch or contact the transducer cord with 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.
  • Page 47 4.1 Warnings and cautions WARNING • 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.

  • Page 48: Operation

    4.2 Operation 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.
  • Page 49 4.2 Operation  Setting the output level Confirm that the output level displayed on the touchscreen is appropriate for the procedure. Press the plus or minus button to change the output level, if desired. Set the appropriate output level by referring to “ Output mode” on page 29. When both the THUNDERBEAT and SONICBEAT are connected to the ultrasonic generator, press the “THUNDERBEAT”...
  • Page 50 4.2 Operation Output mode SEAL & CUT mode • In the SEAL & CUT mode, stop the output after finding that the vessel or tissue is transected. • Always grasp a blood vessel in the middle of the grasping section. •...

  • Page 51: Procedure After Use

    4.3 Procedure after use Procedure after use CAUTION • Do not withdraw the trocar and the THUNDERBEAT simultaneously. Otherwise, the grasping section or the probe tip may damage the surrounding tissue, or the THUNDERBEAT itself may be damaged. • Do not pull the transducer cord when disconnecting the transducer from the THUNDERBEAT instrument.
  • Page 52 Figure 4.4 If a THUNDERBEAT instrument cannot be disconnected from the transducer, contact Olympus. Dispose of the THUNDERBEAT instrument, torque wrench, and stabilizer, and clean and sterilize the transducer as described in Chapter 5, “Reprocessing: General Policy” and Chapter 6, “Cleaning, Disinfection, and Sterilization Procedures” of the instruction manual for the transducer.

  • Page 53: Chapter 5 Storage And Disposal

    5.1 Storage Chapter 5 Storage and Disposal 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.
  • Page 54 5.2 Disposal Ch.5 TB-0545PC/IC/FC, TB-0535PC/IC/FC, TB-0520IC, TB-0510IC INSTRUCTION MANUAL...

  • Page 55: Chapter 6 Troubleshooting

    6.1 Troubleshooting Chapter 6 Troubleshooting Troubleshooting If any irregularity is observed, take proper remedial actions by referring to Chapter 8, “Troubleshooting” in the instruction manual for the ultrasonic generator. WARNING Do not use the THUNDERBEAT instrument on the patient if any irregularity is observed with the equipment.
  • Page 56 6.1 Troubleshooting Ch.6 TB-0545PC/IC/FC, TB-0535PC/IC/FC, TB-0520IC, TB-0510IC INSTRUCTION MANUAL...

  • Page 57: Appendix

    The recommended combinations of equipment and accessories that can be used with this instrument are listed below. New products released after the introduction of this instrument may also be compatible for use in combination with this instrument. For further details, contact Olympus. WARNING If combinations of equipment other than those shown below are used, the full responsibility is assumed by the medical treatment facility.
  • Page 58 System chart CISPR 11 Class A Electrosurgical Generator THUNDERBEAT (ESG-400) series (TB-XXXXXX) Communication Cable 0.25 m (MAJ-1871) Docking Fixture (MAJ-1876) THUNDERBEAT Transducer (TD-TB400) Energy cart (TC-E400) Ultrasonic Generator (USG-400) Communication Cable SONICBEAT 10 m (MAJ-1872) Transducer (TD-SB400) Communication Cable 0.25 m (MAJ-1871) App.

  • Page 59: Thunderbeat Series

    System chart  THUNDERBEAT series  Instrument TB-0545PC TB-0535PC TB-0510IC TB-0520IC App. TB-0535IC TB-0545IC TB-0535FC TB-0545FC TB-0545PC/IC/FC, TB-0535PC/IC/FC, TB-0520IC, TB-0510IC INSTRUCTION MANUAL...
  • Page 60 System chart  Torque wrench  Stabilizer App. TB-0545PC/IC/FC, TB-0535PC/IC/FC, TB-0520IC, TB-0510IC INSTRUCTION MANUAL...

  • Page 61: Emc Information

    EMC information EMC information This model is intended for use in the electromagnetic environments specified below. The user and the medical staff should ensure that it is used only in these environments.  Magnetic emission compliance information and recommended electromagnetic environments Emission standard Compliance Guidance...
  • Page 62 EMC information  Electromagnetic immunity compliance information and recommended electromagnetic environments IEC 60601-1-2 Immunity test Compliance level Guidance test level Electrostatic Contact: Same as left Floors should be made of wood, concrete, or 2, 4, 6 kV discharge (ESD) ceramic tile that hardly produces static. If IEC 61000-4-2 floors are covered with synthetic material that Air:...
  • Page 63 EMC information  Cautions and recommended electromagnetic environment regarding portable and mobile RF communications equipment, such as cellular phones IEC 60601-1-2 Compliance Immunity test Guidance test level level Conducted RF 3 Vrms 3 V (V Formula for recommended separation distance IEC 61000-4-6 (150 kHz –...
  • Page 64 EMC information  Recommended separation distance between portable and mobile RF communications equipment and this instrument Separation distance according to frequency of transmitter (m) (calculated as V =3 and E Rated maximum output 150 kHz – 80 MHz 80 MHz – 800 MHz 800 MHz –...

  • Page 65: Temperature Of The Shaft, Grasping Section And Probe Tip During Activation

    Temperature of the shaft, grasping section and probe tip during activation Temperature of the shaft, grasping section and probe tip during activation Nomenclature Description Grasping section Over 200C and probe tip Distal end of the Over 135C by the continuous activation. shaft Shaft up to 60 mm Over 60C by the continuous activation.
  • Page 66 Temperature of the shaft, grasping section and probe tip during activation App. TB-0545PC/IC/FC, TB-0535PC/IC/FC, TB-0520IC, TB-0510IC INSTRUCTION MANUAL...
  • Page 67 ©2012 OLYMPUS MEDICAL SYSTEMS CORP. All rights reserved. No part of this publication may be reproduced or distributed without the express written permission of OLYMPUS MEDICAL SYSTEMS CORP. OLYMPUS is a registered trademark of OLYMPUS CORPORATION. Trademarks, product names, logos, or trade names used in this document are generally registered trademarks or trademarks of each company.
  • Page 68 A8F, Ping An International Financial Center, No. 1-3, Xinyuan South Road, Chaoyang District, Beijing, 100027 P.R.C. Fax: (86)10-5976-1299 Telephone: (86)10-5819-9000 Olympus-Tower, 114-9 Samseong-Dong, Gangnam-Gu, Seoul 135-090 Korea Fax: (02)6255-3494 Telephone: (02)6255-3210 491B, River Valley Road #12-01/04, Valley Point Office Tower, Singapore 248373 Fax: 6834-2438 Telephone: 6834-0010 31 Gilby Road, Mount Waverley, VIC., 3149, Australia...

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