USG-410 Ultrasonic Bipolar Generator Instructions

Contents

Contents Labels and Symbols ... 1 Important Information - Please Read Before Use ... 3 Intended use ... 3 Application of high-frequency treatment ... 3 Instruction manual ... 3 User qualifications ... 3 Ultrasonic bipolar generator compatibility ... 4 Repair and modification ... 4 Signal words ... 4 Dangers, warnings, and cautions ... 5 About Security ... 13

Chapter 1 Inspecting the Package Contents ... 15 1.1

Inspecting the package contents ... 15

Chapter 2 Nomenclature and Functions ... 17 2.1

Symbols and descriptions ... 17

2.2

Front panel ... 20

2.3

Rear panel ... 21

2.4

THUNDERBEAT/SONICBEAT instrument set screen (touch screen) ... 22

2.5

THUNDERBEAT instrument set screen (touch screen) ... 23

2.6

SONICBEAT instrument set screen (touch screen) ... 24

2.7

Footswitch for THUNDERBEAT (MAJ-1870, optional) ... 25

2.8

Footswitch for SONICBEAT ... 26

2.9

PORTABLE MEMORY (MAJ-1925, optional) ... 27

2.10 Communication cable 10 m (MAJ-1872, optional) ... 27 2.11 Adapter for UHI-2/3 (MAJ-1873, optional) ... 28

Chapter 3 Installation and Connections ... 29 3.1

Installation workflow ... 29

3.2

Installation of the ultrasonic bipolar generator ... 30

3.3

Connection to power supply ... 31

3.4

Connection to the high flow insufflation unit (when using automatic mist & smoke evacuation system/function) ... 32 High flow insufflation unit (UHI-4) ... 32 High flow insufflation unit (UHI-3) ... 34

3.5

Connection of footswitch (optional) ... 36

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Contents

Chapter 4 Inspection ... 41 4.1

Verification workflow ... 41

4.2

Power verification ... 43 Checking the illumination of power switch ... 43 Checking the start screen and start tone ... 44

4.3

Verification of the THUNDERBEAT or SONICBEAT instrument connection(s) . 45 Connection of the THUNDERBEAT or SONICBEAT instrument ... 45

4.4

Verification of touch screen ... 49

4.5

Verification of footswitch connection ... 51 Checking the illumination of footswitch indicator(s) ... 51 Footswitch operation check ... 52

4.6

Verification of the ultrasonic output ... 53

4.7

Verification of the high-frequency (RF bipolar) output (when using the THUNDERBEAT instrument) ... 56 Verifying the output level ... 57

4.8

Verification of the high flow insufflation unit (when using automatic mist & smoke evacuation system/function) ... 58

4.9

Verification of the alarm system ... 59

4.10 Procedure after verification ... 60

Chapter 5 Operation ... 61 5.1

Operating steps ... 61

5.2

Turning the ultrasonic bipolar generator ON ... 62

5.3

Connection to the high flow insufflation unit (when using automatic mist & smoke evacuation system/function) ... 62

5.4

Output setting ... 64 Output mode list ... 66

5.5

Energy output ... 69 Energy output ... 71

5.6

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Steps after use ... 72

USG-410 INSTRUCTION MANUAL

Contents

Chapter 6 Settings Button Functions ... 73 6.1

Settings button functions list ... 73

6.2

Settings button hierarchy ... 75

6.3

Settings ... 76 Procedure ... 77 Setup: Handswitch ... 86 Setup: UHI evacuation ... 88 Setup: Volume ... 90 Setup: Brightness ... 92 Setup: Date & time ... 94 Setup: Date format ... 96 Setup: Touch tone ... 98 Setup: Language ... 100 Maintenance: Transducer information ... 102 Maintenance: Error log ... 103 Maintenance: Software version ... 104 Maintenance: Safety test ... 105 Maintenance: Maintenance reminder ... 106 Maintenance: Data transfer ... 108 Maintenance: Memory initialization ... 113 Maintenance: Reset to defaults ... 115 Maintenance: Service ... 117 Maintenance: Software update ... 117 Maintenance: Electromagnetic compatibility (EMC) ... 117

Chapter 7 Care, Storage, Disposal, and Maintenance ... 119 7.1

Care ... 119

7.2

Storage ... 120

7.3

Maintenance ... 121

7.4

Disposal ... 121

Chapter 8 Troubleshooting ... 123 8.1

Troubleshooting ... 123

8.2

Error screen ... 124

8.3

Troubleshooting guide ... 125 What to do when no error code is displayed ... 125 What to do when an error code is displayed ... 131 Error code: U504 ... 131 Error code: U504 other than ... 132

8.4

Returning the ultrasonic bipolar generator for repair ... 138

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Contents

Appendix ... 139 System chart ... 139 Specifications ... 141 Environment ... 141 Specifications ... 141 Mode characteristics ... 143 High-frequency output characteristics ... 144 Specifications of optional items ... 145

EMC information ... 147 Alarm information ... 154 Tone information ... 155 License information of Open Source Software ... 156

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USG-410 INSTRUCTION MANUAL

Labels and Symbols

Labels and Symbols Safety related labels and symbols are shown below. If labels or symbols are missing or illegible, contact Olympus.

 Rear panel

Crossed-out wheeled bin symbol

CE marking

Potential equalization terminal

Manufacturer name

Electrical rating label

Serial number symbol

ULTRASONIC BIPOLAR GENERATOR MODEL USG-410 POWER INPUT 100–240V 50/60Hz 350VA BI 110W/50 380kHz INT 30s/30s

 Front panel

Blue

Refer to instructions manual.

UDI label The UDI label is required by some countries’ regulations regarding the identification of a medical device also known as Unique Device Identification (UDI).

USG-410 INSTRUCTION MANUAL

TYPE CF symbol

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Labels and Symbols

 Back cover of this instruction manual Symbol

Description Manufacturer

Authorized representative in the European Community

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USG-410 INSTRUCTION MANUAL

Important Information - Please Read Before Use

Important Information - Please Read Before Use Electrosurgical interventions are contraindicated if, in the judgment of the physician, tissue coagulation and cutting could have a negative effect on the state of the patient. Electrosurgical tissue coagulation and cutting may be contraindicated for patients with cardiac pacemakers, a weakened immune system, or blood coagulation disorders.

 Intended use The Electrosurgical & Ultrasonic Generator (USG-410) is intended to be used with the THUNDERBEAT Transducer, the SONICBEAT Transducer, the THUNDERBEAT or the SONICBEAT for open, laparoscopic (including single-site 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 the expected prognosis, the properties and purpose of the treatment, its risks and effects, and the possible alternative treatments. Particularly, balance the risks of the treatment with the potential benefits of a given procedure.

 Instruction manual This instruction manual contains essential information on using the ultrasonic bipolar generator safely and effectively. Before use, thoroughly review this manual and the manuals for all instruments that will be used during the procedure. Use the instrument 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 product is to be used by a licensed physician or medical personnel under the supervision of a licensed physician and used after having received sufficient training on clinical procedures and the use of ultrasonic and electrosurgical energy. For the above reason, specific training is not necessary. Therefore, this manual does not refer to clinical surgical procedures. The details of these clinical procedures should be determined from the respective specialists’ perspectives.

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Important Information - Please Read Before Use

 Ultrasonic bipolar generator compatibility The ultrasonic bipolar generator should be used in combination with the ancillary instrument listed in “System chart” on page 139. Using incompatible instruments can result in injury, equipment damage, or decreased product performance. This equipment complies with EMC standard for medical electrical equipment, edition 2 (IEC 60601-1-2: 2001) and edition 3 (IEC 60601-1-2: 2007) and edition 4 (IEC 60601-1-2: 2014). However, when connecting to an instrument that complies with EMC standard for medical electrical equipment, edition 1 (IEC 60601-1-2: 1993), the whole system complies with edition 1.

 Repair and modification The ultrasonic bipolar generator does not contain any user-serviceable parts. Do not disassemble, modify, or attempt to repair it. Patient or user injury or equipment damage can result. If an irregularity appears to be minor, refer to Chapter 8, “Troubleshooting”. If the irregularity cannot be resolved, do not use the ultrasonic bipolar generator and contact Olympus.

 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

4

Indicates additional helpful information.

USG-410 INSTRUCTION MANUAL

Important Information - Please Read Before Use

 Dangers, warnings, and cautions Follow the dangers, warnings, and cautions described below when handling this ultrasonic bipolar generator. This information is supplemented by the dangers, warnings, and cautions described in each chapter.

 Interference between devices WARNING • Use care when installing the ultrasonic bipolar generator near, on, or under another device (a device other than the ultrasonic bipolar generator or a series of components of the system including this ultrasonic bipolar generator). Otherwise, electromagnetic interference may cause a malfunction or failure of the ultrasonic bipolar generator or other devices. • For safety, do not use the ultrasonic bipolar generator in combination with the following medical electrical instrument:  Medical electrical instrument that has not been confirmed to be safe when it is used in combination with the ultrasonic bipolar generator.  Medical electrical instrument that has not been confirmed to be safe with regard to leakage current, etc. • Always use the supplied power cord. Use of any other power cord may cause a malfunction of the instrument or burns on the power cord. Additionally, the supplied power cord is for exclusive use with the ultrasonic bipolar generator and must not be used with other devices. • Strictly observe the following cautions when handling the ultrasonic bipolar generator and the transducer cord(s).  Do not loop cords, but separate them so that they will not contact the main bodies or cords of other medical electrical instrument (electrocardiograph, endoscopic video camera, etc.). Otherwise, the high-frequency (RF bipolar) signal generated from the ultrasonic bipolar generator and the noise due to spark discharge during coagulation may be enhanced, causing malfunction including output shutdown of the ultrasonic bipolar generator as well as various adverse effects to other medical electrical instrument.  Separate cords so they will not contact the patient or the metal parts of the operating table. Also, make sure that the patient does not contact the metal part of the operating table or other devices. Otherwise, the patient may suffer burns. It is also recommended to use an electrically non-chargeable bed sheet.  Separate the other devices that may cause electromagnetic interference. • To prevent malfunction, do not use the ultrasonic bipolar generator in a location exposed to a strong electromagnetic field (near a microwave therapeutic device, short-wave therapeutic device, MRI, wireless set, or cellular phone, etc.). USG-410 INSTRUCTION MANUAL

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Important Information - Please Read Before Use

CAUTION • Electromagnetic interference may occur on this instrument near equipment marked with the following symbol or other portable memory 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 equipment, or shielding the location.

• The emission characteristics of this ultrasonic bipolar generator are suitable for industrial and medical environments (CISPR 11, Class A). When used in a residential environment (usually requires compliance with CISPR 11, Class B), this ultrasonic bipolar generator’s emission characteristics may interfere with RF communication services. Should that be the case, you should take measures to reduce the interference such as reorienting or relocating this ultrasonic bipolar generator.

 Temperature and humidity during operation and storage CAUTION Use the ultrasonic bipolar generator in compliance with the “ Environment” on page 141. Otherwise, the ultrasonic bipolar generator may fail.

 Mechanical stress on accessories CAUTION Do not apply excessive force to the cords/cables by bending, straining, or twisting. Doing so may damage the cords/cables and cause the instrument to malfunction.

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USG-410 INSTRUCTION MANUAL

Important Information - Please Read Before Use

 Damage of accessories CAUTION Always inspect the accessories as instructed in the instruction manuals before use. Confirm that the insulation on the transducer cord is not damaged. Do not use an accessory if any irregularity is observed. Otherwise, malfunction, human injury, or equipment damage may result.

 Grounding WARNING • The exterior of the ultrasonic bipolar generator should be grounded to ensure safety. To prevent an electric shock hazard, be sure to connect the power cord plug to a properly grounded hospital-grade 3-conductor power outlet. Do not use an adapter for converting a 3-conductor power plug into a 2-conductor plug as this reduces the safety. • Use a hospital-grade 3-conductor power outlet with a sufficient capacity for all devices connected to the same power supply. If the power capacity is insufficient, a fire hazard may result and tripping of the circuit breaker of the hospital may shut down the power supply to the ultrasonic bipolar generator as well as to other devices connected to the same power supply.

 Electric shock hazard WARNING • Do not drop or spill liquids on the ultrasonic bipolar generator. If liquid gets on or into the ultrasonic bipolar generator, immediately stop using it and contact Olympus. Continued use may deteriorate the insulation and could cause an electric shock incident. • Never moisten the power plug as this may cause an electric shock hazard. If it is moistened, dry it completely before use. • Do not set up or control the ultrasonic bipolar generator with wet hands. Otherwise, an electric shock or burns may result.

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Important Information - Please Read Before Use

 Burns of the patient or surgeon WARNING • During surgery, the THUNDERBEAT or SONICBEAT instrument should be placed in an electrically insulated location when not in use. The THUNDERBEAT or SONICBEAT instrument should never be placed on the patient when not in use. Doing so may cause patient or user burns. • Separate cords so they will not contact the patient or the metal parts of the operating table. Also make sure that the patient does not contact the metal part of the operating table or other devices. Otherwise, the patient may suffer burns. It is also recommended to use an electrically non-chargeable bed sheet. • When using an electrocardiograph or other physiological monitoring instrument simultaneously with the ultrasonic bipolar generator on a patient, any monitoring electrodes should be placed as far away as possible from surgical sites. If placed too close, high-frequency (RF bipolar) signals or spark discharge noise from the ultrasonic bipolar generator may interfere with the operation of an electrocardiograph or other physiological monitoring instrument. Needle monitoring electrodes should not be used, as they may cause patient burns. Physiological monitoring instrument incorporating high-frequency (RF bipolar) current limiting devices is recommended. • Do not use near a conductive implantable device. There is a danger of burns due to concentration of high frequency current and change of current path.

 High frequency leakage current CAUTION Wherever possible, the patient should not be able to come into contact with electrically conductive components that are grounded. Route all connecting cables so that they are not in direct contact with the patient or other cables. Capacitive coupling may occur.

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USG-410 INSTRUCTION MANUAL

Important Information - Please Read Before Use

 Impacts on the heart DANGER • Do not use the ultrasonic bipolar generator in combination with a product other than the compatible instrument shown in the “System chart” on page 139. Otherwise, an electrical shock may result. • When treating the heart or working in close proximity to the heart, set the output power to the minimum effective level. Otherwise, the spark discharge during coagulation may stimulate the heart.

 Impacts on cardiac pacemaker or defibrillator DANGER Before using the ultrasonic bipolar generator with a patient wearing a cardiac pacemaker, cardioverter defibrillator, or other active implanted device, consult a cardiovascular specialist and the manufacturer of the device, and make sufficient preparation to ensure safety. The use of high-frequency energy may have a serious effect on the patient due to malfunction or failure of the cardiac pacemaker, etc.

 Use of cardioverter defibrillator WARNING Always have a defibrillator ready in case of cardiac emergency. Be sure to withdraw all endoscopic and the THUNDERBEAT/SONICBEAT instruments from the body cavity before using the defibrillator.

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Important Information - Please Read Before Use

 Flammable anesthetic and gases DANGER • The risk of flammable gases or other materials being ignited exists with any surgical application of electrical energy. Precautionary measures must be taken to keep flammable materials and substances away from the site of intervention (do not use flammable anaesthetics, nitrous oxide, or oxygen). Otherwise, explosion or fire may result and cause serious injuries. This electrosurgical generator is not explosion-proof. Do not use the electrosurgical generator within an explosion zone. • The ultrasonic bipolar generator is not designed to be explosion-proof and cannot be used in a flammable atmosphere. Otherwise, an explosion or fire hazard may result. • In an environment where the air has a high oxygen concentration, flammable items such as cotton pads or gauze may be ignited by sparks generated by an electrosurgical device in normal usage.

 Ignitable gas in the gastro-intestinal tract WARNING If flammable gasses are present in the digestive tract, replace the gasses with noncombustible gas (e.g., CO2) before using this product. Otherwise, ignition or explosion may occur.

 Operation WARNING Wear personal protective equipment to guard against dangerous chemicals and potentially infectious material. During operation, wear appropriate personal protective equipment, such as eyewear, a face mask, moisture-resistant clothing, and chemical-resistant gloves that fit properly and are long enough so that your skin is not exposed.

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USG-410 INSTRUCTION MANUAL

Important Information - Please Read Before Use

 Ignitable cleaning-and disinfection agents WARNING • Flammable agents used for cleaning and disinfection must be allowed to evaporate before the electrosurgical generator is used. Also ensure that flammable solutions are neither on the patient’s skin (e.g., under neutral electrode) nor in the patient’s body cavity when the electrosurgical generator is used. • Non-flammable agents should be used for cleaning and disinfection wherever possible.

 Risk of treatment and complications WARNING • If any irregularity is observed during the use of the ultrasonic bipolar generator, immediately stop using it and take proper measures by referring to Chapter 8, “Troubleshooting”. Also, refer to the instruction manual for the THUNDERBEAT or SONICBEAT instrument in use. If the irregularity cannot be resolved, contact Olympus. • Always maintain an alternative means to complete a procedure to avoid interruption of treatment. • Use this equipment properly. If not properly used, it may cause deformation, breakage, patient or operator injury, malfunction of the cardiac pacemaker, burns of the surgeon, surgical staff or patient, electric shock, abnormal output or malfunction, perforation, bleeding, postoperative bleeding, tissue damage and infection to the surgeon, surgical staff or patient. • Should any unintended output be observed during surgery, immediately stop using the ultrasonic bipolar generator and turn OFF the power switch. Unintended increase in the output may occur in the case of equipment failure.

 Safety measures during the procedure WARNING Smoke and aerosol produced during the treatment could be carcinogenic or infective. They should be treated by referring to your national laws and guidelines.

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Important Information - Please Read Before Use

 Intelligent Tissue Monitoring*1 The Intelligent Tissue Monitoring detects a small change of impedance on ultrasonic vibrations when a part of living tissue is divided. When it detects the change, it stops output with a stop tone*2. The Intelligent Tissue Monitoring can be set either ON or OFF on the touch screen display. When ON is selected, the Intelligent Tissue Monitoring is enabled.

WARNING • The Intelligent Tissue Monitoring is not guaranteed to operate optimally under all procedures. The output stop function of the Intelligent Tissue Monitoring does not work in all cases because it depends on several factors such as patient condition, living tissue condition, living tissue type, how the instrument handle is gripped, and how a part of living tissue is grasped. Once a part of living tissue is divided, stop the output immediately regardless of absence of the stop tone. Otherwise, the THUNDERBEAT/SONICBEAT instrument may be damaged. • There may be cases in which the living tissue is not completely dissected even after the Intelligent Tissue Monitoring works. The detection rate of the Intelligent Tissue Monitoring can be influenced by tissue thickness, tissue hardness, and vessel thickness. The Intelligent Tissue Monitoring is not a substitute for surgical experience. Vessel not completely dissected may not have sufficient sealing. If the Intelligent Tissue Monitoring works when cutting a vessel, confirm that adequate hemostasis has been achieved. If bleeding is observed, conduct hemostasis with appropriate techniques. • If the Intelligent Tissue Monitoring works, confirm that the tissue/vessel was divided properly. If the tissue or vessel is not divided properly, reapply treatment to the same region and verify the tissue condition again after the treatment. If bleeding is observed, conduct hemostasis with appropriate techniques. • If the situation of the procedure suggests that it is not suitable to use the Intelligent Tissue Monitoring, examine the possibility of performing the procedure by turning off this function.

*1 The Intelligent Tissue Monitoring can be set independently for the THUNDERBEAT instrument and the SONICBEAT instrument. Before using either instrument, be sure to check the current setting by referring to Section 5.4, “Output setting”. *2 When the SEAL & CUT mode with the THUNDERBEAT instrument is activated and the Intelligent Tissue Monitoring is operated, both ultrasonic output and high-frequency output are stopped. When the MAX mode with the SONICBEAT instrument is activated and the Intelligent Tissue Monitoring is operated, ultrasonic output is stopped.

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USG-410 INSTRUCTION MANUAL

Important Information - Please Read Before Use

 About Security Considering the possibility of leakage of personal information and data theft, corruption, and falsification by third parties, check that the portable memory is not infected with a computer virus and then make connections. As for the storage management for the product, follow the facility’s security policy.

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Important Information - Please Read Before Use

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USG-410 INSTRUCTION MANUAL

1.1 Inspecting the package contents

Chapter 1

1.1

Inspecting the Package Contents Ch.1

Inspecting the package contents

Match all items in the packaging with the components shown below. Inspect the ultrasonic bipolar generator and each accessory for damage. If the ultrasonic bipolar generator is damaged, a component is missing, or you have any questions, do not use the ultrasonic bipolar generator and contact Olympus.

ULTRASONIC BIPOLAR GENERATOR (USG-410)

Certificate of compliance

Instruction manual

NOTE • Keep the instruction manual in an easily accessible location. • The ultrasonic bipolar generator is designed for use with the dedicated instruments. Additional compatible instruments may be available in the future. Contact Olympus periodically for updated information.

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