USG-400 Ultrasonic 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 generator compatibility ... 4 Repair and modification ... 4 Signal words ... 4 Dangers, warnings, and cautions ... 5

Chapter 1 Inspecting the Package Contents ... 13 1.1

Inspecting the package contents ... 13

Chapter 2 Nomenclature and Functions ... 15 2.1

Symbols and descriptions ... 15

2.2

Front panel ... 17

2.3

Rear panel ... 18

2.4

Top panel ... 19

2.5

All screen (touch screen) ... 20

2.6

THUNDERBEAT instrument set screen (touch screen) ... 21

2.7

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

2.8

Footswitch for THUNDERBEAT (MAJ-1870, optional) ... 23

2.9

Footswitch for SONICBEAT (MAJ-1869, optional) ... 24

2.10 Docking fixture (MAJ-1876, optional, this is required for the connection of the ultrasonic and compatible electrosurgical generator) ... 25 2.11 Communication cable 0.25 m (MAJ-1871, optional, this cable is required for the connection with the compatible electrosurgical generator) ... 26 2.12 Communication cable 10 m (MAJ-1872, optional, this cable is required for the connection with the compatible high flow insufflation unit) ... 27 2.13 Adapter for UHI-2/3 (MAJ-1873, optional, this adapter is required for the connection with the compatible high flow insufflation unit) ... 28

USG-400 INSTRUCTION MANUAL

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Contents

Chapter 3 Installation and Connections ... 29 3.1

Installation workflow ... 29

3.2

Installation of the ultrasonic generator ... 31

3.3

Connection of compatible electrosurgical generator (when using the THUNDERBEAT instrument) ... 32

3.4

Connection to power supply (Ultrasonic Generator) ... 41

3.5

Automatic mist & smoke evacuation system/function (when using the compatible high flow insufflation unit) ... 43 High flow insufflation unit (UHI-4) ... 43 High flow insufflation unit (UHI-2, UHI-3) ... 45 When adding the compatible electrosurgical generator to the compatible high flow insufflation unit and the ultrasonic generator ... 47

3.6

Connection of footswitch (optional) ... 50

3.7

Connection of the THUNDERBEAT and/or SONICBEAT instrument (various options available) ... 53

Chapter 4 Inspection ... 57 4.1

Verification workflow ... 57

4.2

Power verification ... 59 Checking the illumination of power switch, touch screen, and push buttons ... 60 Checking the start screen and start tone ... 60 Checking the touch screen display ... 61

4.3

Verification of communication cable connection between compatible electrosurgical generator and ultrasonic generator (when using the THUNDERBEAT instrument) ... 62 When the communication indicator is illuminated ... 62 If the communication indicator is not illuminated ... 63

4.4

Verification of touch screen and push buttons ... 63 Checking the touch screen operation ... 64 Checking the push button operations ... 68

4.5

Verification of the THUNDERBEAT and/or SONICBEAT instrument connection(s) ... 69 Verify the symbol for the connected THUNDERBEAT and/or SONICBEAT instruments ... 70

4.6

Verification of footswitch connection ... 73 Checking the illumination of footswitch indicator(s) ... 73

4.7

Verification of the high-frequency (RF bipolar) output (when using the THUNDERBEAT instrument) ... 74 Verifying the output level ... 75 Verifying the output ... 76

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4.8

Verification of the alarm system ... 78

4.9

Procedure after verification ... 80

USG-400 INSTRUCTION MANUAL

Contents

Chapter 5 Operation ... 81 5.1

Operating steps ... 81

5.2

Turning the ultrasonic generator ON ... 82

5.3

Automatic mist & smoke evacuation system/function (when using the compatible high flow insufflation unit) ... 83

5.4

Output setting ... 85 Output mode list ... 88 Correlation between cutting speed and output level in SEAL & CUT mode ... 90

5.5

Energy output ... 92 Energy output ... 94

5.6

Steps after use ... 96

Chapter 6 Push Button Functions ... 97 6.1

Function list ... 97

6.2

Push button hierarchy ... 98

6.3

Probe check ... 99

6.4

Select procedure ... 102

6.5

Menu ... 104 Save Procedure: Saving/overwriting of output level ... 105 Delete Procedure: Deleting a procedure ... 112 Select Language ... 114 Touch Tone ... 116 Software Version ... 117 Service ... 118 Output Volume Control ... 118 Brightness Control ... 119

Chapter 7 Care, Storage, and Disposal ... 121 7.1

Care ... 121

7.2

Storage ... 123

7.3

Disposal ... 123

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Contents

Chapter 8 Troubleshooting ... 125 8.1

Troubleshooting ... 125

8.2

Error screen ... 126

8.3

Troubleshooting guide ... 126 Types of error codes ... 126 Pattern 1 Target error code: U001-U014 ... 127 Pattern 2 Target error code: U501-U502, U507 ... 128 Pattern 3 Target error code: U504 ... 129 Pattern 4 Target error code: U508, U513 ... 133 Pattern 5 Target error code: U509, U510, U511, U512, U514, and U601 ... 134 Pattern 6 Target error code: U503, U505, U506 ... 135 What to do when no error code is displayed ... 136 What to do when an error code is displayed ... 142

8.4

Returning the ultrasonic generator for repair ... 148

Appendix ... 149 System chart ... 149 Specifications ... 151 Environment ... 151 Specifications ... 151

EMC information ... 155 Alarm information ... 162 Tone information ... 162 License information of Open Source Software ... 163 GNU GPL ... 163 End User License Agreement of Open Source Software modules ... 163 Others ... 164 newlib ... 164

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USG-400 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. View of docking plug with cover.

View of docking plug without cover.

Consult instructions for use

Caution 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).

Crossed-out wheeled bin symbol (Only EU model)

Blue Refer to instruction manual/booklet

Intelligent Tissue Monitoring ID sticker

Potential equalization terminal Serial number symbol

Electrical rating label

Serial number plate Fuse rating Manufacturing name label

CSA/UL marking (Only USA model)

CE marking (Only EU model)

Electrical rating label POWER INPUT : 120 V 50/60 Hz 360 VA : 1 min/1 min INTERVAL

POWER INPUT : 220 - 240 V 50/60 Hz 360 VA INTERVAL : 1 min/1 min

120 V (USA model)

220 - 240 V (EU model)

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Labels and Symbols

 Back cover of this instruction manual Symbol

Description Manufacturer

Authorized representative in the European Community

Importer (into European Union)

 Fonts displayed on the touch screen Ricoh bitmap fonts designed by RICOH Company, Ltd. are used.

 Package Symbol

Description Keep away from sunlight

Keep dry

+70°C -25°C

Temperature limitation

Date of Manufacture

For US Customers only For a Symbols Glossary, visit us: http://www.olympus-global.com/en/common/pdf/symbolsglossary.pdf

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USG-400 INSTRUCTION MANUAL

Important Information - Please Read Before Use

Important Information - Please Read Before Use

 Intended use The Ultrasonic Generator (USG-400) is intended to be used with the Electrosurgical Generator (ESG-400), the THUNDERBEAT Transducer (TD-TB400), the SONICBEAT Transducer (TD-SB400), the THUNDERBEAT, and / 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 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 manual does not explain or discuss clinical surgical procedures. Therefore, the health care professional using the ultrasonic generator 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.

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Important Information - Please Read Before Use

 Ultrasonic generator compatibility The ultrasonic generator should be used in combination with the ancillary instrument listed in “System chart” on page 149. Using incompatible instruments can result in 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. When the ultrasonic generator is combined with the compatible electrosurgical generator, the EMC information shall comply with the compatible electrosurgical generator.

 Repair and modification The ultrasonic generator does not contain any user-serviceable parts. Do not disassemble, modify, or attempt to repair it. Patient or user injury and/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 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-400 INSTRUCTION MANUAL

Important Information - Please Read Before Use

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

 Interference between devices WARNING • 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. • For safety, do not use the ultrasonic 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 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 generator and must not be used with other devices. • Strictly observe the following cautions when handling the ultrasonic 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 generator and the noise due to spark discharge during coagulation may be enhanced, causing malfunction including output shutdown of the ultrasonic 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 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.).

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Important Information - Please Read Before Use

WARNING • 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 equipment, or shielding the location.

 Temperature and humidity during operation and storage CAUTION Use the ultrasonic generator in compliance with the “ Environment” on page 151. Otherwise, the ultrasonic 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.

 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, and/or equipment damage may result.

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USG-400 INSTRUCTION MANUAL

Important Information - Please Read Before Use

 Grounding WARNING • The exterior of the ultrasonic 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 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 generator. If liquid gets on or into the ultrasonic 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 generator with wet hands. Otherwise, an electric shock or burns may result.

 Burns of the patient and/or surgeon WARNING • During surgery, the THUNDERBEAT and/or SONICBEAT instrument should be placed in an electrically insulated location when not in use. The THUNDERBEAT and/or SONICBEAT instrument should never be placed on the patient when not in use. Doing so may cause patient and/or user burns. • When the compatible electrosurgical generator is used in conjunction with the ultrasonic generator, keep the THUNDERBEAT and/or SONICBEAT instrument connected to the generator not in use away from the surgical site while the other generator is in operation. Otherwise, patient or user injury may result due to the concentration of electric current. • When using the compatible electrosurgical generator together with the ultrasonic generator, connect the two generators to separate power outlets. Otherwise, burns of the patient may result. USG-400 INSTRUCTION MANUAL

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Important Information - Please Read Before Use

WARNING • Avoid contact between two skin parts (between an arm and flank, for example) by inserting a non-conductive material such as a blanket or piece of dry gauze between them or positioning the patient to avoid contact. Be sure to withdraw metallic accessories (including rings, wristwatch, necklace, and hairpins) from the patient and ensure the patient is not in contact with any metallic object such as a surgical bed. • When using an electrocardiograph or other physiological monitoring instrument simultaneously with the ultrasonic 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 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.

 Impacts on the heart DANGER • Do not use the ultrasonic generator in combination with a product other than the compatible instrument shown in the “System chart” on page 149. 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 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.

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USG-400 INSTRUCTION MANUAL

Important Information - Please Read Before Use

 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.

 Flammable anesthetic and gases DANGER • Do not install the ultrasonic generator in the following locations: − In a place with high oxygen concentration. − In an atmosphere of oxidized substance such as nitrous oxide (N2O). − In a place where flammable anesthetic gas is used. • The ultrasonic generator is not designed to be explosion-proof and cannot be used in a flammable atmosphere. Otherwise, an explosion or fire hazard may result. • Do not activate the ultrasonic generator while directing oxygen to the cauterized region. Otherwise, the cauterized region may combust.

 Flammable disinfectant WARNING After wiping the ultrasonic generator with gauze moistened with disinfectant alcohol, be sure to dry it completely before use. Otherwise, a fire hazard may result.

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Important Information - Please Read Before Use

 Risk of treatment and complications WARNING • If any irregularity is observed during the use of the ultrasonic generator, immediately stop using it and take proper measures by referring to Chapter 8, “Troubleshooting”. Also, refer to the instruction manual for the THUNDERBEAT and/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. • The ultrasonic generator and the THUNDERBEAT and/or SONICBEAT instrument combined with it are designed for use in cutting and coagulation of tissue during surgical procedures. Do not use the THUNDERBEAT and/or SONICBEAT instrument for other purposes, as this may lead to perforation, tearing, bleeding, burns, pain and infection, as well as equipment damage. • Use this equipment 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, bleeding, postoperative bleeding, tissue damage and infection to the surgeon, surgical staff and/or patient. • Should any unintended output be observed during surgery, immediately stop using the ultrasonic generator and turn OFF the power switch.

 Neuromuscular stimulation WARNING Patients may feel a neuromuscular stimulus when a spark discharges from the THUNDERBEAT instrument or a metallic object such as forceps occurs during activation. The neuromuscular stimulus is caused by low frequency components generated during discharging. To prevent this, minimize the discharge by activating the output keeping the grasping section in good contact with the tissue to be cauterized.

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USG-400 INSTRUCTION MANUAL

Important Information - Please Read Before Use

 Intelligent Tissue Monitoring*1, *2 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*3. 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 completed 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 has 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. • Regardless of the setting of the Intelligent Tissue Monitoring, do not use the THUNDERBEAT instrument to seal a blood vessel with a diameter over 7 mm or the SONICBEAT instrument to seal a blood vessel with a diameter over 5 mm. Otherwise, sufficient sealing may not be achieved.

*1 The Intelligent Tissue Monitoring is available with software version 2.00 or later. To check the current software version, refer to Section 6.5, “Menu”. *2 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”. *3 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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Important Information - Please Read Before Use

WARNING • Regardless of the setting of the Intelligent Tissue Monitoring, squeeze the control handle firmly until the control handle touches the grip handle to stop and grasp a blood vessel in the middle of the grasping section when treating the blood vessel. Otherwise, incomplete sealing may cause bleeding. • Regardless of the setting of the Intelligent Tissue Monitoring, sufficient sealing may not be achieved to treat thick blood vessels or certain blood characteristics. Consider the combination use of suture, ligation or the metal clips in advance. • Regardless of the setting of the Intelligent Tissue Monitoring, sufficient sealing may not be achieved if the THUNDERBEAT instrument or the SONICBEAT instrument is used to treat a patient with hypertension, coronary disease, arteriosclerosis, diabetes, hepatocirrhosis or a patient with blood vessel irregularities such as calcification. To ensure high sealing capability, use the instrument to seal healthy normal vessels.

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USG-400 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 generator and each accessory for damage. If the ultrasonic generator is damaged, a component is missing or you have any questions, do not use the ultrasonic generator, contact Olympus.

Ultrasonic generator (USG-400)

Power cord

Instruction manual

NOTE • Keep the instruction manual in an easily accessible location. • The ultrasonic 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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1.1 Inspecting the package contents

Ch.1

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USG-400 INSTRUCTION MANUAL

2.1 Symbols and descriptions

Chapter 2

2.1

Nomenclature and Functions

Symbols and descriptions Ch.2

 Front panel Symbol

Description

Symbol

Description

Power-ON/OFF

Symbol 1 for THUNDERBEAT instrument

Symbol 2 for SONICBEAT instrument

Select procedure

Probe check

Menu

 Touch screen Symbol

Description

Symbol

Description

Footswitch indicator Footswitch for THUNDERBEAT (left: purple, right: blue) Footswitch for SONICBEAT (left: light gray, right: dark gray)

Plus: increment of output level, output tone, or brightness.

Minus: decrement of output level, output tone, or brightness.

Return

OK

Cancel

Save procedure

Delete procedure

Languages

Touch tone (ON/OFF)

Software version

Service

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