Erbe APC 3 User Manual
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Erbe APC 3 User Manual

Erbe APC 3 User Manual

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USA
USER MANUAL
APC
3
®
V 1.3.x
PLASMASURGERY
80114-770_V23802
2021-01

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  • Page 1 USER MANUAL ® V 1.3.x PLASMASURGERY 80114-770_V23802 2021-01...
  • Page 3 USER MANUAL ®...
  • Page 4 Erbe Elektromedizin GmbH owns these trademarks in the United States: APC, APC 300, AUTO CUT, BICLAMP, ENDO CUT, ERBE, ERBECRYO, erbe power your performance., ERBEJET, ERBELIFT, ERBOKRYO, FIAPC, FORCED COAG, HYBRIDAPC, HYBRIDKNIFE, ICC 200, KYRON, NESSY, NESSY Ω, PRECISE APC, PULSED APC, REMODE, SOFT COAG, SWIFT COAG, THERMO SEAL, TWIN COAG, VIO.

  • Page 5: Table Of Contents

    APC 3 example accessories ........
  • Page 6 Working with the APC 3........33...

  • Page 7: General Instructions For Use

    Compatibility The Argon Plasma Coagulation (APC) Unit Model APC 3 is to be used with an Erbe Elec- trosurgical Unit Model VIO 3 and argon gas. It can also be used in conjunction with oth- er Erbe equipment (e.g. Erbe Water Jet Model ERBEJET 2, etc.) and associated instru- ments.
  • Page 8 1 • General Instructions for Use / 70...

  • Page 9: Safety Instructions

    2 • Safety Instructions Chapter 2 Safety Instructions Safety notations 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.

  • Page 10: Compliance With Safety Information

     In the event of uncertainties or if you have any questions, please contact Erbe USA. You will find the addresses in the address list at the end of this User Manual.

  • Page 11: Risks Due To The Environment

    2 • Safety Instructions Risks due to the environment Unsuitable temperature or level of humidity during operation If you operate the equipment at an unsuitable temperature or level of humidity, it may sustain damage, fail, or not perform properly.  Operate the equipment at a suitable temperature and level of hu- midity.

  • Page 12: Caused By Other Equipment

    “Information on electromagnetic compatibil- ity (EMC)“.  If you are using accessories from other manufacturers, check whether the Erbe device is interfering with other devices or being affected by interference itself. You cannot use the device if there is any interference.

  • Page 13: Electric Shock

    2 • Safety Instructions  In the case of patients having active implants, consult the manu- facturer of the implant or the competent department of your hos- pital prior to performing surgery.  Do not position the return electrode near cardiac pacemakers, in- ternal defibrillators, or other active implants.
  • Page 14 2 • Safety Instructions WARNING Flammable gas mixture in TUR (Transurethral Resection) and TCR (Transcervical Endometrial Resection) Hydrogen and oxygen can ascend into the roof of the bladder, the up- per part of the prostate, and the upper part of the uterus. If you resect into this gas mixture, it could combust.

  • Page 15: Burns

     For your safety and that of the patient: Never attempt to perform repairs or make modifications yourself. Any modification will in- validate liability on the part of Erbe Elektromedizin GmbH. CAUTION HF leakage current flows through metal parts The patient must not have contact with electrically conductive ob- jects.
  • Page 16 2 • Safety Instructions  If the drapes can become wet during the operation due to sweat, blood, irrigation liquid, urine, etc., lay a waterproof plastic sheet under the drapes. CAUTION HF leakage current flows through monitoring electrodes HF current can be discharged through points of contact between the skin and monitoring electrodes accidentally (HF leakage current).
  • Page 17 2 • Safety Instructions WARNING Unintentional activation of the instrument during an endoscopic application If the instrument is activated and remains activated during an endo- scopic application, the patient can suffer burns when the instrument is removed. All points that come into contact with the active part of the instru- ment are at risk.
  • Page 18 2 • Safety Instructions WARNING Activation time too long, effects too high The longer the activation time of the unit and the higher the effect, the higher the risk of accidental tissue damage. Risk of accidental tissue damage to the patient! ...
  • Page 19 You do not hear the signal when the electrosurgical unit is activated. Risk of burns to the patient and medical personnel!  Adjust the activation signal so that it is clearly audible.If signal is still not audible, please contact Erbe USA. WARNING Undesirable contact between the active instrument and metal objects in or on the patient’s body.

  • Page 20: Risk Of Infection

    2 • Safety Instructions Risk of infection WARNING The unit is contaminated Danger of infection to the patient and medical personnel.  Follow the instructions for cleaning and disinfecting the unit. WARNING Alternate use of disinfectant solutions based on different active ingredients The agents may affect one another.

  • Page 21: Stimulation Of Nerves And Muscles

    2 • Safety Instructions Stimulation of nerves and muscles WARNING Low-frequency currents stimulate nerves and muscles (Neuro- muscular Stimulation) Low-frequency currents arise either due to low-frequency power sources or partial rectification of the HF current. Spasms or muscle contractions can occur. Risk of injury to the patient.

  • Page 22: Damage To The Unit And Accessories

    Note: All HF sockets and the return electrode socket (applied parts) meet Type CF re- quirements and are protected against the effects of defibrillator discharge. Measures against smoke during Note: Erbe recommends using a smoke extraction system, protective goggles, and a respirator. electrosurgical procedures...

  • Page 23: Additional Safety Instructions For Apc

    3 • Additional safety instructions for APC Chapter 3 Additional safety instructions for APC The safety instructions are structured according to the following risks: • Fire / explosion • Burns • Risks due to gas embolisms or excessive intraluminal gas pressure •...

  • Page 24: Burns

     Set argon flow as low as possible.  Do not press the activated APC applicator into tissue or against the organ wall.  Observe the settings for APC recommended by Erbe. WARNING The argon introduced can not escape from body cavities...

  • Page 25: Risk Of Infection

    If you connect up the wrong pressure regulator or wrong pressure lines, the device can be damaged.  Only connect argon bottles to the device using the pressure reg- ulator and pressure lines specified by Erbe. WARNING Wrong gas The device may only be operated with argon.
  • Page 26  Make sure the connections of the pressure lines to the APC 3 are gastight. The same applies to the connection of the pressure reg- ulator to the gas bottle.

  • Page 27: Accessories

    Chapter 4 Accessories Introduction The following offers an overview of example accessories for each accessory category. A complete overview is available in the Erbe accessories catalog and on the Erbe web- site. We recommend the use of Erbe accessories. / 70...

  • Page 28: Apc 3 Example Accessories

    4 • Accessories APC 3 example accessories Instruments for the APC Accessories for subsystems Accessories for the APC / 70...

  • Page 29: Use Of Apc Instruments

    Use of APC instruments You can only connect Erbe APC instruments with an integrated filter to the APC socket of the APC 3. You can only set the mode, effect and argon flow within a specified range with these instruments.
  • Page 30 4 • Accessories / 70...

  • Page 31: Description Of The Controls

    Instrument sockets Connect HF instruments at these sockets. The APC 3 always has an APC socket for APC instruments. The other socket cartridge slot can be configured with any socket from the VIO 3 program.

  • Page 32: Controls On The Back

    5 • Description of the Controls Controls on the back Argon connector Pressure sensor Purge pin Grounding terminal terminal connection Fig. 5-2 Purge pin Serves to purge the residual argon from the pressure line when changing the gas bottle. Argon connector Connection for the pressure line from the gas bottle or from the central gas supply.

  • Page 33: Working With The Apc 3

    Chapter 6 Working with the APC 3 The APC 3 can only be operated together with the VIO 3. For this reason, you must be familiar with the VIO 3 User Manual in order to work with the APC 3.
  • Page 34 6 • Working with the APC 3 Depending on the application, a lower argon flow may be appropriate (e.g. the risk of blowing argon into body cavities, gas embolism) or also a higher flow. 1. If the instrument symbol for the required instrument is not highlighted, touch the relevant instrument symbol.

  • Page 35: Changing Further Apc Settings

    6 • Working with the APC 3 Fig. 6-3 The window opens to set the argon flow 4. Select the required Argon flow with the + / - buttons. 5. Close the window. The change is not stored in the program. After switching off the unit, it no longer ex- ists.
  • Page 36 6 • Working with the APC 3 Fig. 6-4 The APC argon plasma module window is displayed. 4. Select the setting you wish to change. A different setting screen opens depending on the setting selected. 5. Carry out the required setting.

  • Page 37: Description Of Socket Hardware

    You can individually configure the sockets of your unit when ordering the unit. The APC socket is installed as standard in the APC 3. You can combine the APC socket with all the instrument sockets available for the VIO 3 electrosurgical unit. You can find information about these sockets in the User Manual for the VIO 3.
  • Page 38 7 • Description of socket hardware / 70...

  • Page 39: Installation

    8 • Installation Chapter 8 Installation Ambient conditions WARNING Ignition of anesthetics, skin cleansers, and disinfectants in poten- tially explosive atmospheres If you place the device in a potentially explosive atmosphere, anes- thetics, skin cleansers, and disinfectants can ignite. Risk of fire and explosion to the patient and medical personnel! Risk of damage to property.

  • Page 40: State Of The Unit And Accessories

     If the equipment or equipment cart is damaged, please contact our customer service.  For your safety and that of the patient: Never attempt to perform repairs or make modifications yourself. Any modification will in- validate liability on the part of Erbe Elektromedizin GmbH. / 70...

  • Page 41: Risks Due To The Pressure Gas Bottle

    If you connect up the wrong pressure regulator or wrong pressure lines, the device can be damaged.  Only connect argon bottles to the device using the pressure reg- ulator and pressure lines specified by Erbe. WARNING Wrong gas The device may only be operated with argon.

  • Page 42: Installation Of The Vio 3 On An Apc 3

    (40135-004). You may only remove the cap if you install the VIO 3 on an APC 3. When the unit is activated, the interconnections carry HF voltage. Keep the cap in a safe place. If you disconnect the VIO 3 from the APC 3, you must replace the cap on the interconnections.

  • Page 43: Installation Of The Apc 3 On An Overhead Suspension Arm System

    WARNING! HF voltage when the unit is activated. Installation of the APC 3 on an overhead suspension arm system For the installation of the APC 3 on an overhead suspension arm system, you require fastening set no. 20180-143. Installation instructions are included with the fastening set.

  • Page 44: Installation Of The Rear Of The Apc 3

    8 • Installation Installation of the rear of the APC 3 Argon connector Pressure sensor Purge pin Grounding terminal terminal connection Fig. 8-5 Purge pin Serves to purge the residual argon from the pressure line when changing the gas bot- tle.

  • Page 45: Installation Of The Argon Gas Cylinder Into The Vio Cart, Connection Of The Apc 3 Pressure Reducer With Sensor To The Cylinder And Apc 3, As Well As Disconnection Of The Cylinder

    8 • Installation Installation of the argon gas cylinder into the VIO Cart, connection of the APC 3 pressure reducer with sensor to the cylinder and APC 3, as well as disconnection of the cylinder Follow all applicable national/international requirements for transporting, storing, handling, securing, using, disposing, etc.
  • Page 46 Place the argon gas tank into the well. Wrap the strap around the tank and connect it to the hook (1). Secure the cylinder to the VIO Cart by firmly pulling on the strap and tightly overlapping the Velcro (2). 4. Connect the APC 3 pressure reducer with sensor to the argon gas cylinder Fig.
  • Page 47 8 • Installation 2. Attach the APC 3 pressure reducer with sensor to the argon gas tank. Fit the con- nector of the reducer into the 580 CGA outlet connection of the tank. The "O" ring of the connector goes directly into the outlet. Secure the connection by manually turning the collar of the connector clockwise until tight.
  • Page 48 8 • Installation / 70...

  • Page 49: Cleaning And Disinfection

    9 • Cleaning and disinfection Chapter 9 Cleaning and disinfection Safety Instructions WARNING Connection of unit / equipment cart and power supply during cleaning and disinfection Risk of electric shock to the medical personnel!  Switch off the device. Unplug the power cord of the device/equip- ment cart.

  • Page 50: Wipe Disinfection

    Wipe disinfection For cleaning and disinfecting the surfaces of the unit or of the equipment cart, Erbe recommends a wipe disinfection. Use only disinfectant which complies with the rele- vant national standards.
  • Page 51 9 • Cleaning and disinfection 3. Carry out a visual inspection after cleaning. If you find any residual contamination, repeat cleaning until all contamination has been removed. 4. Carry out wipe disinfection. Make sure the surfaces are treated uniformly. Observe the information provided by the manufacturer regarding the prescribed reaction time.
  • Page 52 9 • Cleaning and disinfection / 70...

  • Page 53: Messages

    Note: The unit cannot be used. Please contact the service department. b) Status messages. c) Messages that prompt you to take action. Messages of categories b) and c) that concern APC 3 are found in the following table. The messages are sorted alphabetically by their code. Code...
  • Page 54 Argon gas (Ar) Argon gas is required for the selected program, but no argon gas pressure is detected. Connect the gas hose at the rear of the APC 3 argon plasma module. S-A-152 APC instrument Automatic argon gas filling of the instrument has been started.

  • Page 55: General Technical Data

    11 • General Technical Data Chapter 11 General Technical Data Connections Low voltage Via VIO 3 electrosurgical unit Via VIO 3 electrosurgical unit Grounding terminal Gas specification Type of gas Argon Argon minimum purity Argon 4.8 (99.998% purity) or higher, e.g. argon 5.0. Density (relative;...
  • Page 56 11 • General Technical Data Gas-specific unit data Residual pressure display Manometer on the gas bottle The APC 3 switches off at an input pressure of < 3 x 10 < 3 bar < 43.5 psi Dimensions and weight Width x height x depth 415 x 100 x 375 mm / 16.3“...

  • Page 57: Information On Electromagnetic Compatibility (Emc)

    “Information on electromagnetic compatibil- ity (EMC)“.  If you are using accessories from other manufacturers, check whether the Erbe device is interfering with other devices or being affected by interference itself. You cannot use the device if there is any interference.
  • Page 58 12 • Information on electromagnetic compatibility (EMC)  Position the electrosurgical unit, the cords of the instruments, and the cord of the return electrode as far away as possible from elec- tronic equipment.  Position the cords as far away as possible from the cords of elec- tronic equipment.
  • Page 59 12 • Information on electromagnetic compatibility (EMC) Guidance and manufacturer's declaration - electromagnetic emissions HF emissions CISPR 11 Class A The properties of this device in terms of its emissions mean it can only be used in medical facilities that are Harmonic emissions IEC 61000-3-2 Class A connected to supply systems specifically provided for...
  • Page 60 12 • Information on electromagnetic compatibility (EMC) Guidance and manufacturer's declaration - electromagnetic immunity The equipment is intended for use in the electromagnetic environment specified below. The user of the equipment should ensure that it is used in such an environment. Immunity test IEC 60601-1-2 test Compliance level...
  • Page 61 EMC-relevant accessories refers to the cable specified. The cable can affect the device’s electromagnetic interference or the electromagnetic immunity of the device. b) When connecting Erbe instruments, the overall cord length increases by max. 0.5 m. Operating environment For the intended use, the unit may only be operated in premises used for medical pur- poses.
  • Page 62 12 • Information on electromagnetic compatibility (EMC) / 70...

  • Page 63: Maintenance, Customer Service, Warranty, Disposal

    If you are interested in a service contract, please contact Erbe (Technical Services). Servicing Procure service work as follows: 1. Contact the Technical Services Department at Erbe USA, Inc. for a Service Call or to obtain a Return Authorization Number. This Number must appear on all corre- spondences. ...

  • Page 64: Warranty

    2225 Northwest Parkway Marietta, GA 30067 3. If the product is being returned to Erbe USA, Inc.; the shipment must be insured as well as safely and securely packed, preferably in the original shipping carton, and should include a letter explaining the problem and make reference to the Return Authorization Number.

  • Page 65: Disposal

    13 • Maintenance, Customer Service, Warranty, Disposal The sole and exclusive remedy under this warranty shall be repair or replacement. In no event will Erbe be liable for any damages arising out of the loss of use, or any other incidental or consequential damages.
  • Page 66 13 • Maintenance, Customer Service, Warranty, Disposal / 70...

  • Page 67: Symbols

    14 • Symbols Chapter 14 Symbols Individual details of the symbols in this chapter may deviate from your product. Not all symbols may necessarily appear on your device or its packaging. Standard Ref. no. Symbol Title Explanation ISO 15223-1 Medical devices – 5.4.4 Caution Indicates the need for the user to consult...
  • Page 68 14 • Symbols Standard Ref. no. Symbol Title Explanation ISO 15223-1 Medical devices – 5.3.9 Atmospheric Indicates the range of atmospheric pres- Symbols to be used with medi- pressure limita- sure to which the medical device can be cal device labels, labelling and tion safely exposed.
  • Page 69 Quantity (x) Quantity of the product. x pieces of the product are supplied in one packaging unit. – – Erbe Communi- Indicates an ECB connection. ECB is a sys- cation Bus tem for transferring data between Erbe units. / 70...
  • Page 70 14 • Symbols / 70...

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