Erbe ERBOTOM ICC 200 Instruction Manual
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Erbe ERBOTOM ICC 200 Instruction Manual

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ERBE
ERBOTOM ICC 200
Instruction manual
04.05

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  • Page 1 ERBE ERBOTOM ICC 200 Instruction manual 04.05...
  • Page 3 ERBOTOM ICC 200 V 2.X 10128-002, 10128-009, 10128-303, 10128-027, 10128-403 ERBOTOM ICC 200 E V 2.X 10128-010, 10128-015, 10128-304,10128-028 ERBOTOM ICC 200 EA V 2.X 10128-023, 10128-036, 10128-305, 10128-058, 10128-400 Instruction manual 04.05...
  • Page 4 ERBE ELEKTROMEDIZIN GmbH. The information contained in this instruction manual may be revised or extended without prior notice and represents no obligation on the part of ERBE ELEKTROMEDIZIN GmbH. © ERBE ELEKTROMEDIZIN GmbH, Tübingen 2005 Printed by: ERBE ELEKTROMEDIZIN, Tübingen...

  • Page 5: Table Of Contents

    Chapter Title Page INTRODUCTION ............... 1-1 Intended purpose of the ICC 200 ..........1-1 Explanation of the safety instructions ......... 1-1 INITIAL OPERATION ............2-1 RISKS AND SAFETY OF HIGH-FREQUENCY SURGERY........3-1 Unintentional thermal tissue damage .......... 3-1 3.1.1 - due to HF leakage currents ............3-1 3.1.2 - due to unintentional activation of an HF generator ....
  • Page 6 INSTALLATION ..............6-1 CLEANING AND DISINFECTION OF THE UNIT ....7-1 PERFORMANCE CHECKS ..........8-1 Automatic performance test after switching on the unit ..... 8-1 Automatic performance check during activation ......8-1 Automatic error documentation ..........8-2 Error list ..................8-3 SAFETY CHECKS .............

  • Page 7: Introduction

    INTRODUCTION Intended purpose of the ICC 200 The ICC 200 is a high-frequency surgical unit for cutting and coagulation. The ICC 200 is available in the variations Basic Model, Basic Model with ENDO CUT (ICC 200 E), Basic Model with ENDO CUT and Argon Plasma Coagulation (ICC 200 EA). Explanation of the safety instructions The WARNING! safety instruction indicates a danger which can result in personal injury.

  • Page 9: Initial Operation

    INITIAL OPERATION Read carefully before initial operation of the unit. In the development and production of this high-frequency surgical unit, the relevant, generally recognized rules of technology, as well as the valid occupational safety and accident prevention regulations have been taken into consideration. This ensures that patients, employees and third parties are protected from dangers to life and health during intended application of the high- frequency surgical unit, to the extent permitted by the type of application intended.

  • Page 11: Risks And Safety Of High-Frequency Surgery

    RISKS AND SAFETY OF HIGH-FREQUENCY SURGERY Unintentional thermal tissue damage High-frequency surgery is associated in principle with various risks for the patient, the personnel and surroundings. In order to avoid these risks in practice, the surgeon and his/her assistants must recognize these risks and observe the appropriate rules for prevention of damage. In the following, these risks and rules for prevention of damage are explained.
  • Page 12 3.1.2 Unintentional activation of an HF generator Unintentional activation of an HF generator can lead to burns on the patient if the active electrode hereby touches the patient directly or indirectly through electrically conductive objects or wet cloths. Unintentional activation of an HF generator can, for example, be caused by: Ÿ...

  • Page 13: The Neutral Electrode

    3.1.3 Unintentional thermal tissue damage due to inappropriate application Generally speaking, the bipolar coagulation technique should be applied in preference to the monopolar coagulation technique. This particularly applies to coagulations on straight organs, on which the high-frequency current flows over longer areas through diameters which are approximately equal or become even smaller.
  • Page 14 WARNING! The effective contact surface, i.e. the electrical conductive value between the neutral electrode and the patient must correspond to the HF capacity used, meaning the intensity of the HF current. Here the effective contact surface means the surface of the neutral electrode which has electrically conductive contact to the skin of the patient during high-frequency surgery.

  • Page 15: Gases And/Or Vapors

    3.1.6 Unintentional thermal tissue damage due to inattentiveness Like a scalpel, high-frequency surgery is always a potential source of danger if handled without care. WARNING! The cutting or coagulation electrodes should always be handled with care and laid aside in the intervals between use so that neither the patient nor other persons can come in contact with the electrodes.

  • Page 16: 3.1.9 Unintentional Burns Due To Hot Electrodes

    WARNING! Make certain during high-frequency surgical operations that anesthetics, skin cleaning agents and disinfectants are nonflammable. If their use is unavoidable, they must have completely evaporated and the vapor must be removed from the area of spark formation before switching on the high-frequency surgical unit.

  • Page 17: Cardiac Pacemaker

    During cutting procedures, forced coagulation and spray coagulation, the unavoidable electric arcs between an active electrode and the tissue nevertheless have the effect that a portion of the high-frequency alternating current is rectified, from which more or less strongly modulated, low-frequency current components result which stimulate electrically stimulable structures such as nerves and muscles.
  • Page 19 Standard International...

  • Page 21: Description Of The High-Frequency Surgical Unit

    DESCRIPTION OF THE HIGH-FREQUENCY SURGICAL UNIT General description Cutting with automatic control of the HF voltage (Auto Cut) The ERBOTOM ICC is equipped with automatic open and closed loop control systems which control and regulate the parameters relevant to the cutting quality so that each respectively selected cutting quality is guaranteed to be reproducible and constant.
  • Page 22 Nevertheless, the intensity of the different effects can be varied by power limitation. Operating mode for Argon Gas Coagulation For units equipped with the Argon Coag operating mode, the ERBOTOM ICC 200 supplies a pulsating HF voltage with peak values up to 4,000 V for Argon Gas Coagulation.

  • Page 23: Description Of The Controls

    Description of the controls This symbol, in accordance with EN 60 601-1, is intended to indicate to the user that this unit must only be used on the patient if the user is acquainted with the operation and features of this unit. The figures set in cursive relate to the ICC illustration for this chapter, or to the function fields in the text.

  • Page 24: Auto Cut Function Field

    AUTO CUT function field All parameters can be set in this function field that are relevant to cutting: 2.1 Setting of the coagulation EFFECT when cutting Here the required cutting quality in regard to the coagulation effect on the cutting edges can be adjusted.

  • Page 25: Auto Coag Function Field

    If you nevertheless wish to use the AUTO START function, please consult your local ERBE branch office. You will find the address on the last page of the Instruction Manual. Technical Service will activate the AUTO START function for you on request.

  • Page 26: Connecting Socket For Neutral Electrodes

    ACTIVATION Soft and Forced coagulation can be activated by the blue key or the blue pedal. Bipolar coagulation can be activated by the blue pedal or by Auto Start. Argon Plasma coagulation can be activated via a blue pedal. Activation is signaled by illumination of the triangle symbols in the AUTO COAG function field as well as acoustically.

  • Page 27: Connecting Socket For Bipolar Coagulation Instruments

    Connecting socket for bipolar coagulation instruments Bipolar instruments can be connected to this connecting socket. The bipolar coagulation mode is activated via pedal or Auto Start. CAUTION! When using pointed bipolar coagulation forceps, the tips can be thermally damaged due to electric currents that are too high.

  • Page 28: Description Of The Safety Features

    4.3. Description of the safety features The ICC 200 is equipped with the following safety features: 4.3.1 OUTPUT ERROR = Automatic monitoring of unit-related output error 4.3.2 TIME LIMIT = Automatic monitoring of the time limit 4.3.3 NESSY = Neutral Electrode Safety System 4.3.4 Protection against operating error 4.3.1 Unit-related output error The ICC is equipped with automatic monitoring of the HF output...
  • Page 29 WARNING! For reasons of safety, a change in the automatic limitation of the maximum time limit must only be made if all users of this unit are informed properly and in good time about this change. In addition, a change in the automatic limitation of the maximum time limit must be properly documented, for example in the medical product logbook of the respective unit.
  • Page 30 NESSY is a flexible Neutral Electrode Safety System that can be adapted optimally to the neutral electrodes selected by the user. For appropriate advice and adaptation to suit requirements, please contact your local Erbe office (see Chapter Addresses). 4-10...
  • Page 31 WARNING! For reasons of safety, a change to NESSY may only be made if it has been properly ensured that all users of this unit are informed in good time about this change. In addition, a change to NESSY must be properly documented. When using dual-surface neutral electrodes, NESSY also monitors the application direction of the contact surface relative to the direction of current flow.
  • Page 32 NESSY Settings In the service programs of the unit a technician can perform various NESSY settings according to your requirements. In the following table you can see what effects the settings have on the safety of monitoring. In the first column you can see the safety level. 1 = maximum safety. In the second column you can see the return electrode used.
  • Page 33 Checking for a short in the connecting cord In order to be sure there is no short in the connecting cord proceed as follows: a) In the case of return electrodes without a permanently connected cord Switch on the unit. Plug the connecting cord into the socket for the return electrode. The green NESSY signal (LED) must NOT be lit.
  • Page 34 4-14...

  • Page 35: Technical Data, Signals, Diagrams

    Automatic power control (PPS) Activation of the cutting mode via key or via pedal HF connecting sockets CUTTING / ENDO CUT Applies only to ERBOTOM ICC 200 with Endo Cut Automatically arc-triggered, fractionated cutting Basic setting = 50 ms, = 750 ms...
  • Page 36 ARGON PLASMA COAGULATION Applies only to ERBOTOM ICC 200 with Endo Cut and Argon Coag HF voltage waveform pulse-modulated alternating voltage Crest factor C, at R =500 ohms C = 8 at 99 W , C=15 at 5 W Rated frequency of the HF voltage...
  • Page 37 DOCUMENTATION Automatic storage of operating errors Automatic storage of performance errors Automatic storage of safety errors Power connection Rated power voltage 240 V / 230 V / 115 V / 110 V / 100 V ± 10 % Rated power frequency 50 / 60 Hz Power current 3.0 A at 230 - 240 V / 6.0 A at 100 - 115 V...

  • Page 38: Visual And Acoustic Signals

    Visual and acoustic signals STATUS visual acoustic HF off • Power switch on •• •• •• Operating error on the front panel •• •• HF generator on •• red •• •• Output error •• red Max. activation time reached •• red ••...

  • Page 39: Diagrams

    Diagrams AUTO CUT MODE, Effect 1, 2, 3, 4 Peak value of the HF output voltage U at no load, as a function of the power limitation P for EFFECT 1 to 4.
  • Page 40 SOFT COAGULATION AUTO BIPOLAR Peak value of the HF output voltage U at no load, as a function of the power limitation P...
  • Page 41 FORCED COAGULATION Peak value of the HF output voltage U at no load, as a function of the power limitation P...
  • Page 42 CUT MODE, Effect 1, 2, 3, 4 Power output as a function of load resistance for power limitation of 200 watts Power output as a function of load resistance for power limitation of 100 watts...
  • Page 43 SOFT COAGULATION AUTO BIPOLAR Power output as a function of load resistance for 1) power limitation of 120 watts 2) power limitation of 60 watts...
  • Page 44 AUTO CUT MODE, Effect 1, 2, 3, 4 Power output as a function of the power limitation = 500 ohms 5-10...
  • Page 45 SOFT COAGULATION AUTO BIPOLAR Power output as a function of the power limitation = 125 ohms 5-11...
  • Page 46 FORCED COAGULATION Power output as a function of the power limitation = 350 ohms 5-12...
  • Page 47 ARGON PLASMA COAGULATION Power output as a function of load resistance 1) for a power limitation of 99 watts 2) for a power limitation of 60 watts 5-13...
  • Page 48 NESSY Dependence of the warning signals on contact resistance R between the two contact surfaces of ü a divided neutral electrode and the HF current I flowing through the entire surface of the neutral electrode: A = In this range, I is sufficiently small relative to R .

  • Page 49: Installation

    INSTALLATION Spatial requirements High-frequency surgery units must only be operated in medically used rooms. The spatial requirements, in regard to electric installation, affect e.g. the grounded conductor system, the ground fault interrupt system, as well as measures for preventing electrostatic charges. The unit is used in rooms in which personnel can pick up electrostatic charges, for example in rooms with electrically nonconductive floors, thus touching the front panel of the units can lead to a brief illumination of light diodes or seven-segment displays due to discharge of an electrostatic...
  • Page 50 WARNING! Footswitches are also potential sources of ignition. Due to their application, it is not always possible to avoid setting them up in or near to the danger zone. Footswitches must therefore meet the special safety requirements of the "AP Class" in accordance with IEC 60 601-1 and be marked with corresponding labels, if they are set up in the danger zone.
  • Page 51 6.11 Custom adaptation of the maximum time limit In consideration of the risk of thermal tissue damage due to unintentional switching on of an HF generator, an unintentionally switched-on HF generator should be switched off again as soon as possible automatically. Since the unit cannot automatically distinguish between intentional and unintentional switching on of an HF generator, the automatic switching off of an HF generator must not occur too quickly, because this would hinder the operator during cutting and/or coagulation.
  • Page 52 6.12 Versions of Forced Coagulation For Forced coagulation, the ICC generates brief voltage pulses with a high peak voltage. In this way, an effective hemostasis is achieved even with very small-surface electrodes, such as with TUR resection loops or laparoscopic retractors. However, these voltage pulses can cause more or less intensive disturbances in other electronic equipment, such as in video monitors.
  • Page 53 6.13 Basic setting and custom programming of the basic setting If the unit is briefly (approx. 15 s) switched off and on again, the previous setting on the front panel appears and the unit can be used again immediately. If the unit is switched off for longer and switched on again, a freely programmable basic setting for the front panel appears, whereby all displays 2.3, 3.6 blink and the unit cannot be activated until this basic setting is confirmed by pressing any key.
  • Page 54 The unit is equipped with a specific front panel basic setting. The specific basic setting is defined at the factory and cannot be changed by the user. This specific basic setting only appears if the basic setting freely programmable by the user is lost due to an error. For the ICC 200 unit, the following specific basic setting is defined at the factory: AUTO CUT EFFECT AUTO CUT MAX.WATT...

  • Page 55: Cleaning And Disinfection Of The Unit

    CLEANING AND DISINFECTION OF THE UNIT Cleaning and disinfection of the unit The unit housing should only be cleaned and disinfected with nonflammable and nonexplosive agents. Make certain here that no moisture penetrates into the unit. We recommend a spray or wipe-down disinfection. However, the information from the disinfectant manufacturer absolutely must be observed here.

  • Page 57: Performance Checks

    PERFORMANCE CHECKS Before every application, the user should check the functional efficiency of the unit and the accessories. The ICC is equipped for this with various automatic performance checks that, each time the power switch is switched on, are performed briefly and then signal and display recognized errors.

  • Page 58: Automatic Error Documentation

    Automatic error documentation Error numbers (ERROR No.) are assigned to the various errors recognized by the error recognition system. If an error occurs, it is not only immediately reported visually and/or acoustically, but also the corresponding error number is additionally stored in the unit, where it then also remains stored when the unit is switched off.
  • Page 59 Error Error How to proceed No error No HF output voltage Notify the Technical Service HF output voltage too high Notify the Technical Service No HF output voltage Notify the Technical Service HF output voltage too high Notify the Technical Service Activation error Notify the Technical Service Activation error...
  • Page 60 The internal temperature of the unit was Always set up the unit in such a way that air can reach too high. The maximum HF power was the housing. automatically reduced. 28 to 29 These errors concern functions in the unit Please notify the Technical Service The load resistance of the unit was too Either the contact surface of the active electrode was too large or the power limitation set too low, or there...

  • Page 61: Safety Checks

    SAFETY CHECKS To prevent a reduction in safety for the unit due to age, wear etc., § 6 of the regulation concerning the installation, operation and use of active medical products (BetreibVaMP) prescribes regular safety checks. The operator must have the safety checks which have been established for this unit properly performed to the prescribed extent.
  • Page 63 MAINTENANCE, CARE AND DISPOSAL OF THE UNIT 10.1 Maintenance of the unit including reusable accessories Maintenance of the unit including the reusable accessories includes preventive and corrective measures for servicing. Therefore established, regularly performed safety checks (see Chapter 9) represent preventive measures, while changes and repairs can be summarized under the category of corrective maintenance.
  • Page 64 10-2...

  • Page 65: Guarantee

    Other claims, particularly claims of damage compensation, are excluded. Repair must only be performed by ERBE, one of our representatives, or by an authorized retailer. The claim of guarantee becomes void if improper changes or repairs were made.
  • Page 66 11-2...

  • Page 67: Information On Electromagnetic Compatibility (Emc)

    INFORMATION ON ELECTROMAGNETIC COMPATIBILITY (EMC) Where EMC is concerned, medical electrical equipment is subject to special safety measures and must be installed and commissioned according to the EMC instructions stated herein. Guidelines for avoiding, recognizing, and rectifying unwanted electromagnetic effects on other equipment or systems that are the result of operating the ICC electrosurgical unit.
  • Page 68 Guidance and manufacturer's declaration - electromagnetic emissions The equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the equipment should ensure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance HF emissions CISPR 11...
  • Page 69 Guidance and manufacturer's declaration - electromagnetic immunity The equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the equipment should ensure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance...
  • Page 70 Guidance and manufacturer's declaration - electromagnetic immunity The equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the equipment should ensure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance...
  • Page 71 Guidance and manufacturer's declaration - electromagnetic immunity Note 1: At 80 MHz equation 2) applies At 800 MHz equation 3) applies Note 2: These guidlines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.
  • Page 72 12-6...

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