Instructions
68 Pages
Preview
Page 1
INSTRUCTIONS THUNDERBEAT Transducer
TD-TB400 SONICBEAT Transducer
TD-SB400
Contents
Contents Symbols...
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Important Information - Please Read Before Use 3 Intended use ... Application of high-frequency treatment ... Instruction manual ... User qualifications ... Instrument compatibility ... Reprocessing before the first use/reprocessing and storage after use ... Repair and modification ... Signal words ... Dangers, warnings, and cautions ...
3 3 4 4 4 5 5 5 6
Chapter 1
Checking the Package Contents...
Chapter 2
Instrument Nomenclature and Specifications ... 10
2.1 2.2 2.3
Symbols and descriptions... Nomenclature ... Specifications...
Chapter 3 3.1 3.2 3.3
Preparation and Inspection ... 14
Operation ... 19
Procedure after use ...
Chapter 5 5.1 5.2 5.3 5.4
10 11 12
Preparation of the equipment ... 16 Inspection of the transducer and ancillary equipment 17 Connection and inspection of the system ... 18
Chapter 4 4.1
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19
Reprocessing: General Policy ... 20
Importance of reprocessing ... Precautions... Compatible Reprocessing... Signs of degradation from reprocessing and its number of times ...
THUNDERBEAT Transducer SONICBEAT Transducer
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Contents
Chapter 6 6.1 6.2 6.3 6.4 6.5 6.6
Reprocessing procedures... Equipment needed... Preparing reprocessing... Manual cleaning... Reprocessing using a WD ... Sterilizing ...
Chapter 7 7.1 7.2
Reprocessing Procedures ... 35
Storage and Disposal ... 46
Storage ... Disposal ...
Chapter 8
35 37 38 39 42 44
46 48
Troubleshooting ... 49
Appendix... 51 System chart ... EMC information ...
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THUNDERBEAT Transducer SONICBEAT Transducer
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Symbols
Symbols Safety-related symbols are attached to the transducer at the locations shown below. If symbols are missing or illegible, contact Olympus.
THUNDERBEAT Transducer (TD-TB400) Symbol 1 for THUNDERBEAT
Symbol 1 for THUNDERBEAT
Serial number TYPE CF symbol CE mark
THUNDERBEAT Transducer SONICBEAT Transducer
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Symbols
SONICBEAT Transducer (TD-SB400) Symbol 2 for SONICBEAT Symbol 2 for SONICBEAT
Serial number TYPE CF symbol CE mark
Back cover of this instruction manual
Manufacturer
Authorized representative in the European Community Importer (into European Union)
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THUNDERBEAT Transducer SONICBEAT Transducer
Important Information - Please Read Before Use
Important Information - Please Read Before Use Intended use THUNDERBEAT Transducer The THUNDERBEAT Transducer (TD-TB400) is intended to be used with the Ultrasonic Generator (USG400), the Electrosurgical Generator (ESG-400), and the THUNDERBEAT for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels.
SONICBEAT Transducer The SONICBEAT Transducer (TD-SB400) is intended to be used with the Ultrasonic Generator (USG-400) and the SONICBEAT for open, laparoscopic (including singlesite surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels.
Application of high-frequency treatment Before proceeding to high-frequency treatment, study well the diagnosis given and expected prognosis, the properties and purpose of the treatment, its risks and effects, and the possible alternative treatments. Particularly, for the risks of the treatment, examine thoroughly their properties, magnitudes, probabilities and imminences, and begin high-frequency treatment only after judging that its effectiveness will be larger than its risks.
THUNDERBEAT Transducer SONICBEAT Transducer
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Important Information - Please Read Before Use
Instruction manual This instruction manual contains essential information on using the transducer safely and effectively. Before use, thoroughly review this manual and the manuals of 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 or comments about any information in this manual, contact Olympus.
User qualifications This manual does not explain or discuss clinical surgical procedures. Therefore, the health care professional utilizing of the transducer 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 use of ultrasonic and electrosurgical energy.
Instrument compatibility 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.
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THUNDERBEAT Transducer SONICBEAT Transducer
Important Information - Please Read Before Use
Reprocessing before the first use/reprocessing and storage after use The transducer was not cleaned or sterilized before shipment. Before using the transducer for the first time, reprocess it according to the instructions given in Chapter 5, “Reprocessing: General Policy” and Chapter 6, “Reprocessing Procedures”. After using the transducer, reprocess and store it according to the instructions given in Chapter 5, “Reprocessing: General Policy” to Chapter 7, “Storage and Disposal”. Improper and/or incomplete reprocessing or storage can pose an infection control risk, cause equipment damage or reduce performance.
Repair and modification The transducer contains no user-serviceable parts. Do not modify or attempt to repair; patient or surgeon, surgical staff injury and equipment damage can result.
Signal words The following signal words are used in this manual: Indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury. Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury. 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. Indicates additional helpful information. THUNDERBEAT Transducer SONICBEAT Transducer
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Important Information - Please Read Before Use
Dangers, warnings, and cautions Follow the dangers, warnings and cautions described below when handling the transducer. This information is supplemented by the dangers, warnings and cautions described in each chapter.
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•
Avoid using the transducer in a flammable atmosphere or approach flammable gas or liquid to the transducer during use. The transducer 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 pacemaker, and make sufficient preparation to ensure safety. The use of an electrosurgical generator may exert a serious effect on the patient due to malfunction or failure of the pacemaker.
•
Do not bundle the transducer cord and the cords of another medical device (electrocardiograph, endoscope’s video camera, etc.) during use. Otherwise, high-frequency signals and the spark discharge noise during cauterization 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 transducer because this gas is flammable.
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Do not use the transducer in combination with an equipment that is not shown in the “System chart” in the “Appendix”.
THUNDERBEAT Transducer SONICBEAT Transducer
Important Information - Please Read Before Use
•
Do not set up or control the transducer with wet hands. Otherwise, an electric shock of the user may result.
•
Keep a defibrillator ready for use to prepare for possible danger. Be sure to remove the transducer from the surgical field before using the defibrillator.
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In the event the laparoscopic procedure needs to be converted to open surgery, have all necessary equipment available before using the transducer.
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To ensure electrical safety, do not use the transducer with equipment with which the safety of combined use is not ensured or with equipment with which the safety in regard to leak current, etc. has not been confirmed.
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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.
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Use this instrument properly. If not properly used, it may cause 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, tissue damage and infection to the surgeon, surgical staff and/or patient.
•
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.
THUNDERBEAT Transducer SONICBEAT Transducer
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Important Information - Please Read Before Use
•
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.
(TD-TB400) 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 healthcare facilities (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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THUNDERBEAT Transducer SONICBEAT Transducer
Chapter 1 Checking the Package Contents
Chapter 1
Checking the Package Contents
Match all items in the package with the components shown below. Inspect each item for damage. If the transducer is damaged, a component is missing or you have any questions, do not use the transducer; contact Olympus. The transducer was not cleaned, or sterilized before shipment. Before using the transducer for the first time, reprocess it according to the instructions given in Chapter 5, “Reprocessing: General Policy” and Chapter 6, “Reprocessing Procedures”. The appearance of the product is different according to each package. The item shown below is the THUNDERBEAT Transducer.
Transducer
THUNDERBEAT Transducer SONICBEAT Transducer
Instruction manual
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Chapter 2 Instrument Nomenclature and Specifications
Chapter 2
2.1
Instrument Nomenclature and Specifications
Symbols and descriptions Refer to instructions
Serial number
Keep away from sunlight
Keep dry
Not Made with Natural Rubber Latex +60°C -40°C
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Temperature limitation
THUNDERBEAT Transducer SONICBEAT Transducer
Chapter 2 Instrument Nomenclature and Specifications
2.2
Nomenclature THUNDERBEAT Transducer (TD-TB400) Transducer cord
THUNDERBEAT instrument connection
Transducer plug Connects to the THUNDERBEAT socket of the ultrasonic generator. Switch contacts The switch contacts conduct the handswitch signal.
SONICBEAT Transducer (TD-SB400) Transducer cord
SONICBEAT instrument connection
Transducer plug Connects to the SONICBEAT socket of the ultrasonic generator. Switch contacts The switch contacts conduct the handswitch signal.
THUNDERBEAT Transducer SONICBEAT Transducer
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Chapter 2 Instrument Nomenclature and Specifications
2.3
Specifications Environment
Operating environment
Transportation and storage environment
Ambient temperature
10 – 40°C (50 – 104°F)
Relative humidity
30 – 85%
Atmospheric pressure
70 – 106 kPa
Altitude
3000 m or less
Ambient temperature
–40 to +60°C (–40 to +140°F)
Relative humidity
10 – 90%
Atmospheric pressure
70 – 106 kPa
Specifications Item
Specification
Model
TD-TB400
Ultrasonic output
Frequency
Size
Outer diameter Weight
TD-SB400 47 kHz
ø 33 mm
ø 31 mm
60 g (Not including the transducer cord and transducer plug)
Length of the
3100 mm
transducer cord Rated high-frequency (RF bipolar) voltage
229 Vp
Duty cycle
ON: 5 s/ OFF: 10 s
(Normal cycle)
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THUNDERBEAT Transducer SONICBEAT Transducer
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Chapter 2 Instrument Nomenclature and Specifications
Medical Devices
This device complies with the requirements of
Directive
Directive 93/42/EEC concerning medical devices. Classification: Class II b This device complies with the EMC requirements of EN 60601-1-2: 2015 when used in combination with devices bearing CE marking either on the products or in its instructions for use. Emission: Class B of EN 55011
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: 1998 (TD-TB400) IEC 60601-2-2: 2009 (TD-TB400) • 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: TD-TB400: Group 1, Class A TD-SB400: Group 1, Class B (standby mode)
Year of
9012345
manufacture
The last digit of the manufacturing year is the second digit of the serial number.
Degree of protection against
Classification: TYPE CF applied part electromedical
electric shock of applied part
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.
THUNDERBEAT Transducer SONICBEAT Transducer
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Chapter 3 Preparation and Inspection
Chapter 3
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Preparation and Inspection •
Before use, prepare and inspect the transducer as instructed below. Inspect other equipment to be used with the transducer as instructed in their respective instruction manuals. Should the slightest irregularity be observed, do not use the transducer and refer to Chapter 8, “Troubleshooting” in the instruction manual for the ultrasonic generator. If the irregularity is still observed after consulting the “Troubleshooting” chapter contact Olympus. Damage or irregularity may compromise patient or operator safety and may result in more severe equipment damage.
•
To ensure that the procedure can be completed without complications in case of malfunction, have a spare transducer ready and make the proper preparations for emergency treatments.
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The transducer was not cleaned or sterilized before shipment. Before using the transducer for the first time, reprocess it according to the instructions given in Chapter 5, “Reprocessing: General Policy” and Chapter 6, “Reprocessing Procedures”.
THUNDERBEAT Transducer SONICBEAT Transducer
Chapter 3 Preparation and Inspection
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If the surface of the transducer is cracked, scratched, broken or deformed, current leakage from the damaged part may burn the operator or patient. If the surface is damaged, stop using the transducer and contact Olympus.
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Wear chemical-resistant gloves when preparing and inspecting the transducer.
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When assembling or disassembling the THUNDERBEAT or SONICBEAT instrument and the transducer, do not apply excessive force. Use only the torque wrench and the stabilizer provided with the THUNDERBEAT or SONICBEAT instrument. If the transducer is difficult to assemble, examine the components thoroughly for irregularities. If you observe a problem with any of the components, do not use them and contact Olympus.
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Do not touch switch contacts with metallic instruments such as forceps. It may cause malfunction.
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If the circumference of the contacts of the transducer plug or the switch contacts turn black, replace the transducer. Otherwise, the transducer could short-circuit and damage the ultrasonic generator.
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When inspecting the transducer, do not touch the transducer plug contacts. Static electricity that was accumulated during autoclaving may cause an electric shock.
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Place the transducer on a level surface to prevent it from rolling and accidentally dropping to the floor.
THUNDERBEAT Transducer SONICBEAT Transducer
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Chapter 3 Preparation and Inspection
•
Do not drop the transducer or strike it forcefully. Even if the transducer appears undamaged, its durability may have been impaired. If the transducer is dropped or subjected to a forceful impact, do not use it, and contact Olympus. Some national or professional guideIines recommend reprocessing endoscopes prior to their first use of the day, when the certain time passes after disinfecting/ steriIizing, or in case the storage time recommended by the nationaI authorities is exceeded.
3.1
Preparation of the equipment Prepare the transducer, the ultrasonic generator, the THUNDERBEAT or SONICBEAT instrument, and the compatible electrosurgical generator (in case of using the THUNDERBEAT instrument) compatible ancillary equipment (shown in the “System chart” in the “Appendix”) and other equipment to be used (paper towels, basin, lint-free cloth and personal protective equipment, such as eyewear, face mask, moisture-resistant clothing and chemical-resistant gloves) for the particular case. Refer to the respective instruction manuals for each piece of ancillary equipment.
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THUNDERBEAT Transducer SONICBEAT Transducer
Chapter 3 Preparation and Inspection
3.2
Inspection of the transducer and ancillary equipment •
The performance and function of the transducer may deteriorate after repeated use for an extended period. Olympus has confirmed that the performance is maintained sufficiently for up to 100 cases. Therefore, replace the transducer with a new one after 100 times of use, even if the performance and function do not seem to be deteriorated. Otherwise, equipment damage and/or patient injury may result.
•
Confirm either whether one year has passed since the transducer was delivered or the use of the transducer has exceeded 100 cases. If it is applied to at least one of them, replace the transducer with a new one.
1. Inspect the THUNDERBEAT or SONICBEAT instrument, the ultrasonic generator and ancillary equipment following their instruction manuals.
2. Confirm that the transducer is free from rust, dislocation, cracks or looseness, and that the transducer cord is not damaged. If any irregularity is observed, replace it with a spare one.
3. Confirm that no foreign substance or water is trapped inside the transducer plug or the THUNDERBEAT or SONICBEAT instrument connection. If a foreign substance or water is present, reprocess the transducer according to the instructions given in Chapter 5, “Reprocessing: General Policy” and Chapter 6, “Reprocessing Procedures”.
THUNDERBEAT Transducer SONICBEAT Transducer
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