Praxisdienst ES-100V User Manual

Electrosurgical generator

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ES-100V

Electrosurgical Generator

User Manual

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Summary of Contents for Praxisdienst ES-100V

Page 1 Introduction to product manual ES-100V Electrosurgical Generator User Manual...
Page 2: Introduction
Overview of the manual Product name: high-frequency surgical generator; Model: ES-100V Date of manufacture: please refer to the brand tag of the surgical generator; Expiration date: 6 years; Version: SJR-IT-202102001-1.0;...
Page 3: Instructions For Use Of The Manual
Introduction to product manual Instructions for use of the manual Warning It indicates a potentially hazardous condition which, if not avoided, will result in death or serious injury. Note It indicates a hazardous condition which, if not avoided, will result in mild or moderate injuries. Important note It refers to the tips and suggestions for the generator operation.
Page 4: Table Of Contents
Contents of product manual Contents Introduction ..............ii 3.3. 5 Return electrode....... - 25 - Instructions for use of the manual ....... iii 3.3. 6 Others ..........- 25 - Contents ................. V 3.4 Post-surgery guidelines ....... - 26 - Part One Introduction to High Frequency Electrotome- 1 - Part four Preparation before the surgery....
Page 5: Contents
Contents of product manual Part seven Fault analysis and troubleshooting ..- 42 - 9.1.5 Security features ....... - 52 - 7.1 Fault analysis and troubleshooting ....- 43 - 9.1.6 Fuse ..........- 52 - 7.2 Common error code ........- 44 - 9.1.7 Surgical accessories ......
Page 6: Introduction To The Surgical Generator
Product manual. Part two front panel, back panel, figures and symbols Part One Introduction to high-frequency surgical generator Contents of this part include: 1.1 Introduction to the surgical generator 1.2 Software description 1.3 Monopolar mode 1.4 Bipolar mode 1.5 Return electrode monitor system 1.6 Structure and composition 1.7 Range of application 1.8 Contraindication...
Page 7: Software Description
Product manual. Part two front panel, back panel, figures and symbols generator 1.1 Introduction to the surgical is a multi-functional high frequency surgical generator with Product 6 kinds of operating modes, including 3 kinds of monopolar electrosurgical excision modes, kinds monopolar electro-coagulation modes and 1 kind of bipolar modes.
Page 8: Bipolar Mode
Product manual. Part two front panel, back panel, figures and symbols ● Monopolar electro-coagulation modes include spray coagulation, forced coagulation and their respective output powers are adjustable. Spray coagulation: non-contact efficient surface ◆ electro-coagulation with shallow penetration. The tissue removal is achieved by evaporation and a knife-shaped or a spherical electrode is usually adopted for blood coagulation.
Page 9: Part Two Front Panel, Back Panel, Figures And Symbols
Product manual. Part two front panel, back panel, figures and symbols Part two front panel, back panel, figures and symbols Contents of this part include: 2.1 Front panel 2.2 Bipolar controller 2.3 Bipolar output interface 2.4 Monopolar electrosurgical excision controller 2.5 Monopolar electro-coagulation controller 2.6 Monopolar output interface 2.7 Return electrode interface...
Page 10: Front Panel
Product manual. Part two front panel, back panel, figures and symbols 2.1 Front panel ①Monopolar electro-coagulation controller In the monopolar electro-coagulation mode, there are different mode selections and power value settings. ②Monopolar electrosurgical excision controller In the monopolar electrosurgical excision mode, there are different mode selections and power value settings.
Page 11: Bipolar Controller
Product manual. Part two front panel, back panel, figures and symbols 2.2 Bipolar controller ①Bipolar mode indicator The indicator light is on to indicate that the bipolar mode is being used. ②Power increase button in bipolar mode Press this key to increase the power (P) of the selected mode, 1W/time, long press to increase continuously.
Page 12: Bipolar Output Interface
Product manual. Part two front panel, back panel, figures and symbols 2.3 Bipolar output interface This interface only supports two-pin bipolar generator accessories. Bipolar generators can be connected to this gang socket for bipolar electro-coagulation. Bipolar foot switch can be used to start the bipolar electro-coagulation mode.
Page 13: Monopolar Electrosurgical Excision Controller
Product manual. Part two front panel, back panel, figures and symbols 2.4 Monopolar electrosurgical excision controller ①Indicator light in the electrosurgical excision mode If the indicator light is on, it means that the electrosurgical excision mode has been selected. ②Power amplification button in the electrosurgical excision mode Press the button to increase the power (P) of the selected mode,, 1 W/ time.
Page 14: Monopolar Electro-Coagulation Controller
Product manual. Part two front panel, back panel, figures and symbols 2.5 Monopolar electro-coagulation controller ①Indicator light in the electro-coagulation mode If the indicator light is on, it means that the electro-coagulation mode has been selected. ②Power amplification button in the electro-coagulation mode Press the button to increase the power (P) of the selected mode, 1 W/ time, Long press on the button and the power will keep increasing.
Page 15: Monopolar Output Interface
Product manual. Part two front panel, back panel, figures and symbols 2.6 Monopolar output interface Monopolar output interface The monopolar handle can be connected to the interface for electrosurgical excision or monopolar electro-coagulation. Monopolar foot switch or the switch on the monopolar handle can be used to start the electrosurgical excision or monopolar electro-coagulation modes.
Page 16 Product manual. Part two front panel, back panel, figures and symbols - 11 -...
Page 17 Product manual. Part two front panel, back panel, figures and symbols 2. 8 Back panel ①Power input module ②Audio frequency and volume knob To control the volume of the sound signals. Turn clockwise to increase the volume and turn counterclockwise to decrease the volume.
Page 18: Foot Switch Socket
Product manual. Part two front panel, back panel, figures and symbols 2.9 Foot switch socket Monopolar and Bipolar foot switch socket Use together with the monopolar foot switch. Note Foot switch socket belongs to generator accessory and it shall meet the requirements in part nine. The use of substandard accessories may result in the failure to plug and start up, REM alarm, abnormal output and so on.
Page 19: Figures And Symbols
Product manual. Part two front panel, back panel, figures and symbols 2.11 Figures and symbols Description Application Figures and symbols Dangerous voltage External marking Symbol for patients whose circuits are External marking of high frequency insulation CF applied part/defibrillation-p External marking roof Attention! Please External marking, package...
Page 20 Product manual. Part two front panel, back panel, figures and symbols Monopolar socket with multiple External marking modes Return electrode External marking socket Description Application Figures and symbols Dangerous voltage External marking Symbol for patients whose circuits are External marking of high frequency insulation CF applied...
Page 21 Product manual. Part two front panel, back panel, figures and symbols Monopolar socket External marking with manual switch Monopolar socket with multiple External marking modes Return electrode External marking socket Description Application Figures and symbols Monopolar foot External marking switch socket Bipolar foot switch External marking socket...
Page 22 Product manual. Part two front panel, back panel, figures and symbols There are fragile articles in the transport package. Package marking Please handle with care The transport package should be Package marking kept out of the rain The maximum weight that the Package marking transport package could bear...
Page 23 Product manual. Part two front panel, back panel, figures and symbols Description Application Figures and symbols The maximum number of layers that can be stacked for the same Package marking transport packages Trademark External marking Specification and model of the Generator External marking surgical generator...
Page 24: Part Three Safety Guidelines For The Surgical Generator
ES-100V product manual. Part three safety guidelines for the surgical equipment Part three safety guidelines for the surgical generator Contents of this part include: 3.1 Overview of the safety guidelines 3.2 Pre-surgery guidelines 3.3 Guidelines for the ongoing surgery 3.4 Post-surgery guidelines...
Page 25: Overview Of The Safety Guidelines
ES-100V product manual. Part three safety guidelines for the surgical equipment 3.1 Overview of the safety guidelines 3.1.1 Training Warning 1)Unqualified medical staff are not allowed to use this surgical generator, which may cause electric shock and burns to the patients and the medical staff.
Page 26: Pre-Surgery Guidelines
ES-100V product manual. Part three safety guidelines for the surgical equipment 3.2 Pre-surgery guidelines 3.2.1 Accessories activation Note 1)Accessories shall meet the requirements of the manufacturer to ensure the normal operation of the generator. 2)Before using the accessories, please check the manual for all warnings, attentions and cautions, important tips and notes related to the accessories.
Page 27: Host Machine Of The Surgical Generator
ES-100V product manual. Part three safety guidelines for the surgical equipment compatibility with the monitor of the generator. If compatible monitoring returen electrode is not adopted, REM alarm may be disabled when a safe contact is lost between the return electrode and the patient.
Page 28: Others
ES-100V product manual. Part three safety guidelines for the surgical equipment 1)The host machine carries out a eight-second self-examination when starting up, and the sequence of the self-examination is monopolar electrosurgical excision controller, monopolar electro-coagulation controller, bipolar controller and REM. After...
Page 29: Guidelines For The Ongoing Surgery
ES-100V product manual. Part three safety guidelines for the surgical equipment 3.3 Guidelines for the ongoing surgery 3.3.1 Power settings Note For power settings, please refer to part four for more information. There is no coefficient ratio for the power set value of this surgical generator and the displayed value on the instrument is the set value.
Page 30: Return Electrode
ES-100V product manual. Part three safety guidelines for the surgical equipment 2)Activated surgical electrode is not allowed to get close to combustible materials, which may cause fire. 3)Activated electrodes that are not used for the moment should be placed in the protective sheath or a place that is clean, dry, non-conductive, readily accessible and available, with no combustible materials and no contact with patients.
Page 31: Post-Surgery Guidelines
ES-100V product manual. Part three safety guidelines for the surgical equipment the confirmation. 4)If electrosurgery is performed on the posterior area of the chest, flammable anesthetics and oxidizing gases such as Nitrous Oxide O) and oxygen are prohibited, unless these reagent haven been removed (before the operation).
Page 32: Part Four Preparation Before The Surgery
ES-100V Product manual. Part four preparation before the surgery Part four Preparation before the surgery Contents of this part include: 4.1 Host machine preparation 4.2 Bipolar surgical preparation 4.3 Monopolar surgical preparation 4.4 Parameter memory preparation Note Please read the manual of the surgical generator and accessories for all the warnings,attentions and cautions, important tips and other notes.
Page 33: Host Machine Preparation
ES-100V Product manual. Part four preparation before the surgery 4.1 Host machine preparation Important note For more information about the host machine, please refer to part two. Note Please read the manual of the surgical generator and accessories for all the warnings,attentions and cautions, important tips and other notes.
Page 34 ES-100V Product manual. Part four preparation before the surgery When the sound prompts, 10 lights of REM display screen emit green light; indicator light of electrode plate and the failure indicator light emit red light; and indicator lights of electrosurgical excision controller all emit yellow light;...
Page 35: Bipolar Surgical Preparation
ES-100V Product manual. Part four preparation before the surgery 4.2 Bipolar surgical preparation Important note Bipolar surgical electrode of the surgical generator must be used together with bipolar foot switch. 4.2.1 Connection of the bipolar generator accessories Note Please read the manual of the surgical generator and accessories for all the warnings,attentions and cautions, important tips and other notes.
Page 36: Monopolar Surgical Preparation
ES-100V Product manual. Part four preparation before the surgery 4.3 Monopolar surgical preparation Important note The monopolar surgical electrode of this surgical generator must be used together with the monopolar foot switch. You can also choose a monopolar surgical electrode with a manual switch.
Page 37: Attach The Return Electrode To The Patient
ES-100V Product manual. Part four preparation before the surgery interface(4-pin). 4.3.2 Attach the return electrode to the patient Before performing this step, please refer to 3.2 pre-surgery guidelines -- return electrode for more information and follow the safety guidelines. 1.The entire surface area of the return electrode should be securely connected to the patient's body.
Page 38: Parameter Memory Preparation
ES-100V Product manual. Part four preparation before the surgery Monopolar electro-coagulation ⑦ will emit blue light. The maximum power can be adjusted to controller (Please refer to 2.5 for 90W. more information) 4.4 Parameter memory preparation Automatic memory: the generator automatically memorizes the recently used mode and power, and the most recently used parameters can be invoked by default when starting up.
Page 39: Part Five The Ongoing Surgery
ES-100V product manual. Part five the ongoing surgery Part five the ongoing surgery Contents of this part include: 5.1 Check the connection of power and accessories 5.2 Check the connection of return electrode 5.3 Mode selection, power setting and power change 5.4 Surgical electrode activation...
Page 40: Check The Connection Of Power Supply And Accessories
ES-100V product manual. Part five the ongoing surgery 5.1 Check the connection of power supply and accessories Before performing this step, please refer to 3.2 pre-surgery guidelines -- accessories activation for more information and follow the safety guidelines. Before starting the surgical electrode, please check once again whether the power supply and accessories are connected normally.To reduce abnormal conditions, make sure that there is no...
Page 41: Surgical Electrode Activation
ES-100V product manual. Part five the ongoing surgery 5.4 Surgical electrode activation 5.4.1 Monopolar mode electrode activation If the monopolar surgical electrode is equipped with a manual switch, it can be started with the manual switch or the monopolar foot switch. The corresponding relationship between the manual...
Page 42 ES-100V product manual. Part five the ongoing surgery - 37 -...
Page 43: Response To The Alarm Information
ES-100V product manual. Part five the ongoing surgery 5.7 Response to the alarm information Important note After the self-examination is completed, REM self-examination will give out two sound prompts of "beep", and the indicator light of the electrode plate will emit red light, which is a normal phenomenon and it indicates that the return electrode is not connected with the tissue.
Page 44: Part Six Post-Surgery
ES-100V product manual. Part six post-surgery Part six Post-surgery Contents of this part include: 6.1 Prepare for the next use 6.2 Storage of the surgical generator Note Please read the manual of the surgical generator and accessories for all the warnings,attentions and cautions, important tips and other notes.
Page 45: Prepare For The Next Use
ES-100V product manual. Part six post-surgery 6.1 Prepare for the next use Note Accessories marked with "disposable" cannot be reused and they shall be handled in accordance with the "Medical Waste Regulations" and the local laws on the handling of the medical waste.
Page 46: Storage Of The Surgical Generator
ES-100V product manual. Part six post-surgery 6.2 Storage of the surgical generator The non-operating temperature for this surgical generator is 5℃ ~ 40℃. If the storage environment does not meet the requirement of the non-operating temperature, it shall be stored at room temperature for more than 1h before use.
Page 47: Part Seven Fault Analysis And Troubleshooting
ES-100V product manual. Part seven fault analysis and troubleshooting Part seven Fault analysis and troubleshooting Contents of this part include: 7.1 Fault analysis and troubleshooting 7.2 Common error code Important note If the cause of failure is not identified through the troubleshooting...
Page 48: Fault Analysis And Troubleshooting
ES-100V product manual. Part seven fault analysis and troubleshooting 7.1 Fault analysis and troubleshooting Phenomenon Analysis Troubleshooting When the switch is turned on, the 1)AC 220V 50HZ power is 1)To check whether the power indicator light is off. unplugged; supply is normal;...
Page 49: Common Error Code
ES-100V product manual. Part seven fault analysis and troubleshooting attached to the surgical generator, please contact the manufacturers of both sides to solve the problem. 7.2 Common error code Error code (ERR) Description Troubleshooting 0～7 Micro-controller failure Please contact manufacturer after-sales service.
Page 50: Part Eight Maintenance And Repair
ES-100V product manual. Part eight maintenance and repair Part eight Maintenance and repair Contents of this part include: 8.1 Care and maintenance 8.2 Repair 8.3 Scrapping of the generators and accessories 8.4 After-sales service center Description Disassemble the machine or replace the accessories without the authorization of the manufacturer.
Page 51: Care And Maintenance
ES-100V product manual. Part eight maintenance and repair 8.1 Care and maintenance Warning 1. Surgical generator repairman must be experienced electricians or senior electronic engineers who have been trained in the high-frequency surgical generator. Non-professional workers are allowed to examine and repair the generator.
Page 52 ES-100V product manual. Part eight maintenance and repair - 47 -...
Page 53: Repair
ES-100V product manual. Part eight maintenance and repair 8.2 Repair 8.2.1 Accessories replacement Description Contact the manufacturer for after-sales service when the foot switch or reusable surgical electrode is damaged. Note Use or replace the fuse and power line that is supplied by the manufacturer.
Page 54: Scrapping Of The Generators And Accessories
ES-100V product manual. Part eight maintenance and repair or other means to confirm the hospital department information, product information and product failure information with the after-sales service center. When troubleshooting is possible, it saves time and economic cost for both parties to adopt the way of non-return-to-depot;...
Page 55: Part Nine Technical Features
ES-100V Product manual. Part nine technical features Part nine Technical features Contents of this part include: 9.1 Performance features 9.2 Available power value 9.3 Curve graph of output power to the resistance - 50 -...
Page 56: Performance Features
ES-100V Product manual. Part nine technical features 9.1 Performance features 9.1.1 Appearance 1.The appearance should be neat and with uniform color, and no obvious scratches, damage and deformation. 2.The words and markings should be clear. 3. The control mechanism should be safe and reliable with no loose fasteners 9.1.2 Performance...
Page 57: Alarm Information
ES-100V Product manual. Part nine technical features 9.1.4 Alarm information When using monitoring return electrode (return electrode monitoring circuit is the REM test), the resistance of the contact area is greater than or equal to 150 Ω, and the generator will give out sound and light alerting signals.
Page 58: Packaging
ES-100V Product manual. Part nine technical features 9.1.8 Packaging 1. Size Length × width × height: 520×480×380 (mm) 2. Gross weight 10（kg） 3. Packing list Number Name Unit Quantity Remarks Host machine Piece Power line Piece Certificate of soundness Copy...
Page 59: Available Power Value
ES-100V Product manual. Part nine technical features 9.2 Available power value Available power value (W) Monopolar electrosurgical excision: pure cut Monopolar electrosurgical excision: blend cut 1 Monopolar electrosurgical excision: blend cut 2 Monopolar electro-coagulation: Spray coagulation - 54 -...
Page 60: Curve Graph Of Output Power To The Resistance
ES-100V Product manual. Part nine technical features Available power value (W) Monopolar electro-coagulation: forced coagulation Bipolar: standard mode 9.3 Curve graph of output power to the resistance 9.3.1 Monopolar pure cut Functional relationship between power output and load impedance at full and half power.
Page 61: Monopolar Blend Cut 1
ES-100V Product manual. Part nine technical features 9.3.2 Monopolar blend cut 1 Functional relationship between power output and load impedance at full and half power. Blend1 100W 200 400 600 800 1000 1200 1400 1600 1800 2000 X: impedance (Ω), y: power (W) ①full power, ②half power...
Page 62: Monopolar Spray Coagulation
ES-100V Product manual. Part nine technical features 9.3. 4 Monopolar spray coagulation Functional relationship between power output and load impedance at full and half power. Spray 0 200 400 600 800 100012001400160018002000 X: impedance (Ω), y: power (W) ①full power, ②half power 9.3.
Page 63: Bipolar Standard Mode
ES-100V Product manual. Part nine technical features 9.3. 6 Bipolar standard mode Functional relationship between power output and load impedance at full and half power. Bipolar 100 200 300 400 500 600 700 800 900 1000 X: impedance (Ω), y: power (W) 阻抗...
Page 64: Part Ten Electromagnetic Compatibility
Part ten Electromagnetic compatibility Contents of this part include: Precautions Table 1 electromagnetic radiation Table 2: electromagnetic immunity 1 Table 3: electromagnetic immunity 2 Table 4: recommended safe distance Exceptional situations...
Page 65 The information in this section, such as the isolation distance, is general information specifically designed for this product model. The content provided, while not ensuring trouble-free operation of the generator, provides such reasonable assurance. This information may not be applicable to other medical electrical generators; Aging generators may be particularly vulnerable to interference.
Page 66 (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required) this generator 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 generator. Guidance and manufacturer’s declaration -electromagnetic emissions and Immunity Table 1 Guidance and manufacturer’s declaration - electromagnetic emissions...
Page 67 Electrical fast ±2 kV for power supply lines ±2 kV for power supply lines transient/burst ±1 kV signal input/output ±1 kV signal input/output IEC 61000-4-4 100 kHz repetition frequency 100 kHz repetition frequency Surge ± 0.5 kV, ± 1 kV differential ±0.5 kV, ±1 kV differential mode IEC 61000-4-5 mode...
Page 68 IEC61000-4-3 80 MHz – 2,7 GHz 80 MHz – 2,7 GHz 80 % AM at 1 kHz 80 % AM at 1 kHz NOTE U is the a.c. mians voltage prior to application of the test level. Table 3 Guidance and manufacturer’s declaration - electromagnetic Immunity Radiated RF Test Band...
Page 69 800/900, modulation TETRA 18 Hz 800, iDEN 820, CDMA 850, LTE Band 1720 1 700 Pulse – 1800; modulation 1845 1 990 CDMA 217 Hz 1970 1900; 1900; DECT; LTE Band 1, 3, UMTS 2450 2 400 Bluetoot Pulse – modulation 2 570 WLAN,...
Page 70 802.11 b/g/n, RFID 2450, LTE Band 5240 5 100 WLAN Pulse – 802.11 modulation 5500 5 800 217 Hz 5785 Table 4: recommended safe distance Recommended isolation distance between portable and mobile radio-frequency communication generators and the High frequency surgical generator High frequency surgical generators are intended for use in electromagnetic environment with the radio-frequency interferences controlled.
Page 71 above table, d is the recommended isolation distance and the unit is in meters (m).The formula of transmitter frequency in the corresponding column can be used. P is the maximum rated output power of the transmitter provided by the transmitter manufacturer and the unit is in watts (W).
Page 72 Warning 1.In addition to the transducers and cables sold by the manufacturer of the generator or system as spare parts for internal components, the use of non-specified accessories, transducers and cables can result in increased emission or reduced immunity of the generator or system.