WISAP Cervix Coagulator User Manual
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WISAP Cervix Coagulator User Manual

Device for cold coagulation of the cervix
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E
GA_Portio-Koagulator_E_150914.docx
Device for „cold" coagulation of the cervix
Console
Therapy Probes
Cable
Page 1 of 44
Cervix Coagulator
User Manual
WISAP Medical Technology GmbH
85649 Brunnthal-Hofolding
Tel.: +49 8104 / 8908-0
Fax: +49 8104 / 8908-90
mail: info@wisap.de
6001
6002-6009
6020
Fichtenstraße 27
Germany
http://www.wisap.de

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Summary of Contents for WISAP Cervix Coagulator

  • Page 1 Device for „cold“ coagulation of the cervix Console 6001 Therapy Probes 6002-6009 Cable 6020 User Manual WISAP Medical Technology GmbH Fichtenstraße 27 85649 Brunnthal-Hofolding Germany Tel.: +49 8104 / 8908-0 Fax: +49 8104 / 8908-90 mail: info@wisap.de http://www.wisap.de Page 1 of 44...
  • Page 2 WISAP ringrazia per ogni comunicazione di eventuali errori o mancanze di chiarezza contenuti in questo manuale. Ci riserviamo il diritto di effettuare senza alcun annuncio delle modifiche tecniche in seguito alla continua evoluzione dei nostri prodotti.

  • Page 3: Table Of Contents

    Table of Contents General Information Preamble ......................5 Scope of this User Manual ................. 5 Icons in this user manual ................... 6 Abbreviations in this user manual ..............6 Saftey Icons and symbols on the medical product ............7 Icons and symbols on the packaging ..............8 Danger .......................
  • Page 4 Cleaning ......................30 6.1.1 Cleaning of the Unit ................... 30 6.1.2 Cleaning of Therapy Probes and Instrument Cable ........30 Desinfection ..................... 30 6.2.1 Disinfection of Therapy Probes and Instrument Cable ....... 30 Sterilization ...................... 31 Tabular Overview: Disinfection and Sterilization ..........31 Trouble shooting Dispose List of accessories...

  • Page 5: General Information Preamble

    The high value and quality of our products, even beyond the warranty, can only be guaranteed if all the service work has been carried out by the company WISAP Medical Technology GmbH. This includes, inter alia, SRC / LMC Testing and comparative measurements, maintenance and parts replacement.

  • Page 6: Icons In This User Manual

    ICONS IN THIS USER MANUAL DANGER! Failure to observe this warning leads to serious personal damage or injury. WARNING! Failure to observe this warning may lead to serious personal damage or injury. CAUTION! Failure to observe this warning may cause minor personal injury and may cause damage to the product.

  • Page 7: Saftey

    AFTEY ICONS AND SYMBOLS ON THE MEDICAL PRODUCT Icons are for user information and are provided by the type label on the back side of the device for example. Figure 1: Type Label Bildzeichen Bedeutung Switch „OFF“ position Switch „ON“ position Connection to the potential equalization Seriennummer des Gerätes Bestellnummer...

  • Page 8: Icons And Symbols On The Packaging

    Bildzeichen Bedeutung Das Gerät darf nicht über den normalen Klinikmüll entsorgt werden. Für nähere Informationen zur Entsorgung wenden Sie sich bitte an ihren autorisierten Händler oder den Hersteller. CE-Zeichen mit Identifikationsnummer der benannten Stelle. Das Produkt entspricht den Grundlegenden Anforderungen der Richtlinie des Rates über Medizinprodukte 93/42/EWG.

  • Page 9: Danger

    Wait until the device has adjusted to the ambient temperature. DANGER! The WISAP Cervix Coagulator (REF 6001) is a precision instrument, which is to be operated exclusively with the original WISAP accessories! Page 9 of 44...

  • Page 10: Warnings

    WARNINGS WARNING! The device is not destined for operation in explosive-endangered areas. WARNING! If explosive ANESTHETICS are in use, device and accessories must not be operated in the highlighted zone. WARNING! The user is fully responsible for observing the applicable cleaning, disinfection and sterilization regulations.

  • Page 11: Cautions

    CAUTION! Pay attention to the integrity of the packaging of the device. When the packaging is damaged upon arrival, WISAP can no longer guarantee the full functionality of the unit, please contact the manufacturer immediately. CAUTION! This device unit may only be installed by the manufacturer or by authorized personnel.
  • Page 12 CAUTION! Defective instrument cable and therapy probes can be sent for repair to the WISAP Medical Technology GmbH or to an approved contractor. CAUTION! The selection of the proposed intervention and the chosen accessories as...
  • Page 13 Risk of fire, use only fuses as specified on the product label (12). CAUTION! If the CERVIX COAGULATOR is connected into a system with other electrical equipment or medical devices, the system has to comply with the requirements of IEC 60601-1.

  • Page 14: Notes

    NOTES NOTE! The user-manual have to be kept at a well-visible place nearby the unit. NOTE! Install the device onto a plane surface. NOTE! For the correct use of this device it is important that the device adapts to the ambient conditions (room temperature). Please wait about 60 minutes after installation before you begin the application.

  • Page 15: Product Description Intended Use / Purpose

    RODUCT ESCRIPTION INTENDED USE / PURPOSE The WISAP 6001 coagulator is used in conjunction with the WISAP Therapy probes (REF 6002-6009) exclusively for the treatment of benign erythroplakia, cervical endometriosis, ovula nabothii, chronical cervicitis and haemostasis after knife conisation. A distinctive feature is the advantageous and easy handling of the unit: ...

  • Page 16: Operating Principle

    OPERATING PRINCIPLE By electronic control of destructive heat in the temperature range between 90 °C and 110 °C, benign cervical changes, e. g. the cervical epithelium growing at the wrong place, is destroyed down to the matrix without pain. After thermic destruction of misplaced tissue, the epithelium is replaced after 4 –...

  • Page 17: Components Of The Medical Product

    COMPONENTS OF THE MEDICAL PRODUCT Figure 2: Front Side Figure 3: Back Side Page 17 of 44 GA_Portio-Koagulator_E_150914.docx...
  • Page 18 No. Component / Element Function Power Switch Power switch to turn the device ON = I OFF = 0 Switch on the device after all connections are made. The rocker switch illuminates green when the unit is turned on. Connector for instrument The instrument cable (REF 6020 for treatment probes) cable is connected to this connector.
  • Page 19 No. Component / Element Function Fixture for Therapy Fixture for Therapy Probes Probes Product Label On the Product label you can find the technical data and the type and serial number of your device. When ordering spare parts you must always specified these data.

  • Page 20: Putting Into Operation

    Read the instructions carefully before use. CAUTION! Pay attention to the integrity of the packaging of the device. When the packaging is damaged upon arrival, WISAP can no longer guarantee the full functionality of the unit, please contact the manufacturer immediately. NOTE! Install the device onto a plane surface.

  • Page 21: Scope Of Delivery

    SCOPE OF DELIVERY The standard delivery of this device includes: Image Definition Article Number Controller-unit 6001 Power-Cord Instrument Cable 6020 6002 … 6009 Therapy probe User Manual CONDITIONS FOR OPERATION Operation + 5°C bis + 40°C Storage and transport - 20°C bis + 60°C Humidity max.

  • Page 22: Assembling

    CAUTION! Defective instrument cable and therapy probes can be sent for repair to the WISAP Medical Technology GmbH or to an approved contractor. FIRST PUTTING INTO OPERATION CAUTION! Please make sure that no liquid enters into the Controller unit or that the unit does not get in touch with liquids.

  • Page 23: Connection To The Equipotential Bonding

    (12). Only then can you connect your device to the mains power supply. Plug the power cord into the connector (13) on the back of the Cervix Coagulator 6001. Before mains connection of Cervix Coagulator 6001 bring the mains power switch (1) in position "0"...
  • Page 24 Plug the power cord into the connector (13) at the rear of Cervix Coagulator 6001. CAUTION! The device unit may only be installed by the manufacturer or by AUTHORIZED PERSONNEL. CAUTION! The device may only be operated in medically utilized rooms, which have been installed according to the guidelines of DIN VDE 0107.

  • Page 25: Functional Test

    FUNCTIONAL TEST The execution of the functional test is dictated by the standards of IEC 60601-1. It has to be performed prior to each operative intervention. Functional test serves for inspection of the device in conjunction with its accessories. Description of the Functional Control Join device with central potential equalization through grounding cable.
  • Page 26  Therapy probe 4 is heated to the Increase coagulation temperature with temperature preselected temperature; actual selector 6 to 120 °C. temperature of therapy probe 4 is indicated on temperature display 9.  Control lamp, green: „coagulation temperature“ 8 lights up after the preselected temperature is reached (120 °C -10% );...

  • Page 27: Operation

    PERATION DANGER! The WISAP Cervix Coagulator (REF 6001) is a precision instrument, which is to be operated exclusively with the original WISAP accessories! WARNING! The user is fully responsible for observing the applicable cleaning, disinfection and sterilization regulations. Errors caused by non-observance of the above regulations are not at the expense of the manufacturer and exclude any warranty and damage claims.

  • Page 28: Start Of Coagulation Procedure

    WARNING! Make sure the Therapy probes have been gone through an initial cleaning process. Turn the unit on by setting the Power switch (1) from 0 to 1:  The rocker switch illuminates GREEN and the Therapy Probe tip begins to heat START OF COAGULATION PROCEDURE Select the desired temperature (60°C to 120°C) by using the temperature selector (6).

  • Page 29: Termination Of The Treatment

    TERMINATION OF THE TREATMENT Replace the therapy probe in the fixture (11) after finishing of the treatment. Turn the unit off by setting the Power switch (1) from 1 to 0. The rocker switch stops being illuminated GREEN. The Therapy Probe tip begins to cool down. After cooling to room temperature please remove all equipment from the coagulator and forward the accessories and the unit to the necessary cleaning process.

  • Page 30: Hygienic Measures

    YGIENIC MEASURES In order to maintain effectiveness of the unit, care, maintenance and storage need to be thoroughly effected. The accessories coming into contact with human tissue need to be sterilized for avoiding infections to the patient. The different steps described below are to be performed in the order of their appearance.

  • Page 31: Sterilization

    Please read the tabular overview on chapter 6.4 for further cleaning, disinfection and sterilization information. WISAP would recommend that the personnel responsible for sterilization study the operator manuals of the different sterilizing units. Please read the instructions for metal articles with lumen and porous articles with lumen. It is important to note that these recommended sterilization parameter is only valid, if the sterilizing equipment has properly been maintained and calibrated.

  • Page 32: Trouble Shooting

    ROUBLE SHOOTING Fault Description Possible Causes Remedy  No device function  Failure at mains supply  Have supply network checked  No display is activated  Defective mains fuses  Exchange fuses  Mains switch 1 does not (observe type of fuse, light up see „Technical Data) ...

  • Page 33: Dispose

    This symbol applies only to the countries within the EEA (*). (*) EEA = European Economic Area, which comprises the EU Member States plus Norway, Iceland and Liechtenstein IST OF ACCESSORIES The following product-related accessories could purchased about the WISAP customer service: Item No. Product...

  • Page 34: Technical Data

    10 T ECHNICAL Classification by:  93/42/EEC:  Protection against electric shock type B. Shock: Class I  Degree of protection against electric d. Shock: Type BF  Degree d protection against ingress of water: IPX1 (console), IPX7 (Instrument cable, Therapy Probe) Mode of operation: Continuous operation...

  • Page 35: Overview To Emc

    VERVIEW TO Manufacturer's Declaration for Electro-Technical Compatibility Acc.to IEC 60601-1-2 For the WISAP Cervix Coagulator 6001 incl. Accessories Guidance and manufacturer's declaration - electromagnetic emissions The 6001 is intended for use in the electromagnetic environment specified below. The customer or the user of the 6001 should assure that it is used in such an environment.
  • Page 36 Guidance and manufacturer's declaration - electromagnetic immunity (1/2) The 6001 is intended for use in the electromagnetic environment specified below. The customer or the user of the 6001 should assure that it is used in such an environment. Electromagnetic environment - Immunity test Compliance level IEC 60601 test level...
  • Page 37 Guidance and manufacturer's declaration - electromagnetic immunity (2/2) The 6001 is intended for use in the electromagnetic environment specified below. The customer or the user of the 6001 should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment -...
  • Page 38 NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. 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 39: Technical Service And Maintenance

    12 T ECHNICAL ERVICE AND MAINTENANCE 12.1 FREQUENCY OF MAINTENANCE In order to avoid accidents due to aging or normal wear-and-tear, the unit including accessories need to pass a regular function and safety test according to IEC 60601-1. Annual maintenance is therefore required. CAUTION! Opening of the housing, any repairs, modifications and calibrations may only be performed by the manufacturer or by personnel explicitly...

  • Page 40: Changing The Fuses

    12.4 CHANGING THE FUSES DANGER! Turn off the power before replacing the fuse and disconnect the power cord from the power supply! Wait until the device has adjusted to the ambient temperature. Turn OFF the device by pressing the OFF switch on the front of the device.

  • Page 41: Product Life Time

    12.6 PRODUCT LIFE TIME In observance and execution of all maintenance / service work a minimum service life of 10 years can be expected. 12.7 SERVICE TABLE Date Description Signature Page 41 of 44 GA_Portio-Koagulator_E_150914.docx...

  • Page 42: Repair And Returns

    12.8 REPAIR AND RETURNS If a repair should be required, please advise us or your local dealer. In order to process your repair as quickly as possible, please request an RMA NUMBER. Pack the cleaned (not contaminated*) device only in its original packaging and return it to us free.

  • Page 43: Warrenty / Liability

     the instructions in the operator manual are strictly observed when operating the unit. 14.2 WARRANTY WISAP - Medical Technology granted a 12 Months warranty on production- and material faults. Faults or defects caused by mishandling are not covered by warranty.
  • Page 44 WISAP Medical Technology GmbH Fichtenstrasse 27 85649 Brunnthal-Hofolding Deutschland Telefon: +49 (0) 8104 89 08 00 Fax: +49 (0) 8104 89 08 90 E-Mail: info@wisap.de Web: www.wisap.com 0123 Page 44 of 44 GA_Portio-Koagulator_E_150914.docx...

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