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AFTEY

2.1 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

OFF

Switch „ON“ position

Connection to the potential equalization

Seriennummer des Gerätes

Bestellnummer

Herstellungsdatum

Hersteller

Anwendungsteil des Typs BF , Accessory of type BF

Caution

Consult instruction for use

Refer to the Manual!

IPX1

Protected against dripping water

IPX7

Protection agains the effects of temporary immersion in water

Содержание Cervix Coagulator

Страница 1: ...r Device for cold coagulation of the cervix Console 6001 Therapy Probes 6002 6009 Cable 6020 User Manual WISAP Medical Technology GmbH Fichtenstra e 27 85649 Brunnthal Hofolding Germany Tel 49 8104 89...

Страница 2: ...tes derechos de autor Todos los derechos est n protegidos El manual o partes del mismo no pueden ser divulgados o copiados mediante fotocopias microfilms u otros medios sin previo consentimiento por e...

Страница 3: ...ation 15 3 3 User group 15 3 4 Operating principle 16 3 5 Variants of the medical product 16 3 6 Literature 16 3 7 Components of the medical product 17 4 Putting into operation 20 4 1 Kind of Delivery...

Страница 4: ...31 7 Trouble shooting 32 8 Dispose 33 9 List of accessories 33 10 Technical Data 34 11 Overview to EMC 35 12 Technical Service and maintenance 39 12 1 Frequency of maintenance 39 12 2 Inspection befo...

Страница 5: ...caused by using the unit for purposes other than those for which it was designed The high value and quality of our products even beyond the warranty can only be guaranteed if all the service work has...

Страница 6: ...arning 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 NOTE A note contains valuable informati...

Страница 7: ...le Figure 1 Type Label Bildzeichen Bedeutung ON Switch OFF position OFF Switch ON position Connection to the potential equalization Seriennummer des Ger tes Bestellnummer Herstellungsdatum Hersteller...

Страница 8: ...n autorisierten H ndler oder den Hersteller CE Zeichen mit Identifikationsnummer der benannten Stelle Das Produkt entspricht den Grundlegenden Anforderungen der Richtlinie des Rates ber Medizinprodukt...

Страница 9: ...ient DANGER Accessories that are designed for single use are not safe for a second application The sterile single use parts are not designed for processing DANGER Turn off the power before replacing t...

Страница 10: ...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 WARN...

Страница 11: ...nufacturer 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 CAUTION Before connectin...

Страница 12: ...d defects in the instrument cable and or the therapy probe this must be replaced immediately CAUTION Defective instrument cable and therapy probes can be sent for repair to the WISAP Medical Technolog...

Страница 13: ...ensure good dissipation of heat generated during an operation the control unit must not be covered with cloth CAUTION Opening of the housing chassis accessories any repairs modifications and calibrati...

Страница 14: ...portant that the device adapts to the ambient conditions room temperature Please wait about 60 minutes after installation before you begin the application This applies both to the first use and in the...

Страница 15: ...ectric current Duration of treatment under 1 minute No postoperative side structure at the external os uteri No after bleeding Therapy probe head and guiding tube made of stainless steel Probe head is...

Страница 16: ...bothii are initially coagulated with probe A followed by lancing with a scalpel blade and by removing of retention flem The base of the retention cyst producing secretion is destroyed by probe B Chron...

Страница 17: ...GA_Portio Koagulator_E_150914 docx Page 17 of 44 3 7 COMPONENTS OF THE MEDICAL PRODUCT Figure 2 Front Side Figure 3 Back Side 11 15 14 13 12 1 2 3 9 6 8 7 4 10 5...

Страница 18: ...D The flashing red light LED shows Therapy probe is not connected Therapy probe or cable is defective Temperature at the probe head is too high 6 Temperature Selector The temperature selector is used...

Страница 19: ...a 13 Power Connector Power connector Before opening the housing unplug the device Unit can only be operated with the voltage specified on the Product label 12 14 Fuse box Fuse Box holding the mains fu...

Страница 20: ...GER Only use sterilized accessories for each patient CAUTION Read the instructions carefully before use CAUTION Pay attention to the integrity of the packaging of the device When the packaging is dama...

Страница 21: ...1 Power Cord Instrument Cable 6020 Therapy probe 6002 6009 User Manual 4 3 CONDITIONS FOR OPERATION Operation 5 C bis 40 C Storage and transport 20 C bis 60 C Humidity max 85 rH WARNING The device is...

Страница 22: ...probes can be sent for repair to the WISAP Medical Technology GmbH or to an approved contractor 4 5 FIRST PUTTING INTO OPERATION CAUTION Please make sure that no liquid enters into the Controller unit...

Страница 23: ...t be operated in the highlighted zone CAUTION Run a visual inspection of this device before each use When detecting damage set the unit aside immediately and do not perform any operation with it Conta...

Страница 24: ...his unit must be connected only to a supply with protective conductor CAUTION If the Cervic Coagulator is connected into a system with other electrical equipment or medical devices the system has to c...

Страница 25: ...e 4 is indicated on temperature display 9 Control lamp green coagulation temperature 8 lights up after preselected temperature 60 C 10 is reached if LED goes out shortly a new heating impulse is signa...

Страница 26: ...to the preselected temperature the actual temperature of therapy probe 4 is indicated on temperature display 9 Control lamp green coagulation temperature 8 lights up after the preselected temperature...

Страница 27: ...nd disinfecting agents are thoroughly removed WARNING Do not touch the therapy probe during operation at the distal end CAUTION Run a visual inspection of the device before each use When detecting dam...

Страница 28: ...light 8 goes out for a short period of time the therapy probe has momentarily fallen below the desired temperature range and a new heating impulse is signalized Now you can start the coagulation proce...

Страница 29: ...witch 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 forw...

Страница 30: ...h disinfectant Entering of fluid into the unit has to be avoided CAUTION The controlling unit must not be sterilized 6 1 2 Cleaning of Therapy Probes and Instrument Cable Flush therapy probes 4 and in...

Страница 31: ...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...

Страница 32: ...witch 1 illuminates no device function Internal device failure Have device serviced by manufacturer or authorized dealer Device does not heat up control lamp RED 3 illuminates Heating is electronicall...

Страница 33: ...ehold waste If you want to discard this product please contact your dealer or supplier for further information This symbol applies only to the countries within the EEA EEA European Economic Area which...

Страница 34: ...perature regulation Continuous Case w x h x d 195 x 110 x 175 mm Weight total 3 6 kg Ambient temperature Operation 5 C to 40 C Storage and transport 20 C to 60 C Humidity max 85 Barometer Operating 70...

Страница 35: ...such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The 6001 uses RF energy only for its internal function Therefore its RF emissions are...

Страница 36: ...for power supply lines 1 kV for input output lines Mains power quality should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV d...

Страница 37: ...lated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF IEC 61000 4 6 3 Vrms 150 kHz to 80 MHz 3 Vrms d 3 5 V1 x P 1 2 x P Radiated RF IEC 6...

Страница 38: ...1 The 6001 is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the 6001 can help prevent electromagnetic interference by...

Страница 39: ...e conducted in a regular interval Change Fuses when appropriate Check mechanical condition of the unit including the accessories Check the tight fit of all electrical equipment including the protectiv...

Страница 40: ...rewdriver into the right recess and press the lock to the left so that the fusebox comes out slightly Slide a suitable tool screwdriver into the left recess and press the lock to the right so that the...

Страница 41: ...ulator_E_150914 docx Page 41 of 44 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 Descrip...

Страница 42: ...repared in accordance with the information in this manual THE CONTAMINATION OF CERTIFICATE SHOULD CLEARLY THE ACCOMPANYING THIS PACKAGE If this is not possible the contaminated product must be clearly...

Страница 43: ...ling are not covered by warranty In case of unauthorized opening modifications and or repairs we cannot be held liable for proper and safe function of the device All warranty claims are declared null...

Страница 44: ...ulator_E_150914 docx Page 44 of 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...

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