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Cervix Coagulator 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: [email protected] http://www.wisap.de

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Diese Gebrauchsanweisung enthält eigentumsrechtlich geschützte Informationen, die dem Urheberrecht unterliegen. Alle Rechte sind geschützt. Ohne ausdrückliche, schriftliche Genehmigung von WISAP darf diese Gebrauchsanweisung weder vollständig noch in Auszügen durch Photokopie, Mikrofilm oder andere Verfahren vervielfältigt oder verbreitet werden. Bezeichnungen, die zugleich eingetragenes Warenzeichen sind, wurden nicht besonders gekennzeichnet. Es kann nicht aus dem Nichtvorhandensein des Warenzeichens geschlossen werden, daß eine Bezeichnung ein freies Warenzeichen ist. WISAP ist Anwendern dankbar für jeden Hinweis auf mögliche Fehler oder Unklarheiten in dieser Gebrauchsanweisung. Durch die ständige Weiterentwicklung unserer Produkte behalten wir uns technische Änderungen ohne Ankündigung vor. This manual contains proprietary information that is protected by copyright. All rights are reserved. This manual or excerpts thereof may not be reproduced by photocopy, microfilm, or other means, or otherwise distributed without the express written consent of WISAP. Names that are registered trademarks have not been identified as such. The absence of such identification should not be regarded as evidence that a name is not registered as a trademark. WISAP would appreciate any comments from users regarding possible errors or unclear passages in this manual. Since the improvement of our products is an ongoing process, we reserve the right to make design changes without notice. Este manual contiene información protegida por las leyes de propiedad y está sometido a los correspondientes derechos de autor. Todos los derechos están protegidos. El manual o partes del mismo no pueden ser divulgados o copiados mediante fotocopias, microfilms u otros medios sin previo consentimiento por escrito de WISAP. En este manual, las denominaciones que a la vez sean marcas registradas no son destacadas de manera especial. Por tanto, no es posible deducir de la ausencia de una marca que la correspondiente denominación es una marca libre. WISAP agradece expresamente todo tipo de indicaciones que el usuario pueda darnos sobre eventuales errores o vaguedades contenidos en el presente manual. Dado que seguimos perfeccionando constantemente nuestros productos, nos reservamos el derecho a introducir modificaciones técnicas sin previo aviso. Questo manuale contiene delle informazioni protette dal diritto di proprietà e tutelate dal diritto d'autore. Tutti i diritti sono protetti. Questo manuale non può venire copiato o distribuito completamente o in parte tramite fotocopia, microfilm o altre procedure senza l'autorizzazione espressa e scritta della WISAP. Le denominazioni, che sono nel contempo anche un marchio registrato, non sono state contrassegnate in modo particolare per cui dall'assenza di un marchio non si può dedurre che una denominazione sia un marchio libero. 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.

CE marking according to Directive 93/42/EEC Ihr Fachhändler / Hersteller / Your dealer / Manufacturer / Su distribuidor / Fabricante / Il vostro concessionario / Costruttore /

WISAP Medical Technology GmbH Fichtenstraße 27 85649 Hofolding Germany Tel.: ++49 8104/8908-0 Fax: ++49 8104/8908-90 e-mail: [email protected]

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Table of Contents

1 General Information 5

1.1 Preamble ........................................................................................................... 5

1.2 Scope of this User Manual ................................................................................. 5

1.3 Icons in this user manual ................................................................................... 6

1.4 Abbreviations in this user manual ...................................................................... 6

2 Saftey 7

2.1 Icons and symbols on the medical product ........................................................ 7

2.2 Icons and symbols on the packaging ................................................................. 8

2.3 Danger ............................................................................................................... 9

2.4 Warnings ......................................................................................................... 10

2.5 Cautions .......................................................................................................... 11

2.6 Notes ............................................................................................................... 14

3 Product Description 15

3.1 Intended Use / Purpose ................................................................................... 15

3.2 Indication/Contraindication .............................................................................. 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................................................................................................ 20

4.2 Scope of delivery ............................................................................................. 21

4.3 Conditions for operation ................................................................................... 21

4.4 Assembling ...................................................................................................... 22

4.4.1 Connection of Instrument Cable 3 and Therapy Probe 4 ........................... 22

4.5 First putting into operation ............................................................................... 22

4.5.1 Connection to the equipotential bonding .................................................... 23 4.5.2 Connection to the power supply................................................................. 23

4.6 Functional Test ................................................................................................ 25

5 Operation 27

5.1 Switch ON the CerviX Coagualtor 6001 ........................................................... 27

5.2 Start of Coagulation Procedure ....................................................................... 28

5.3 Termination of the Treatment .......................................................................... 29

6 Hygienic measures 30


6.1 Cleaning .......................................................................................................... 30

6.1.1 Cleaning of the Unit ................................................................................... 30 6.1.2 Cleaning of Therapy Probes and Instrument Cable ................................... 30

6.2 Desinfection ..................................................................................................... 30

6.2.1 Disinfection of Therapy Probes and Instrument Cable ............................... 30

6.3 Sterilization ...................................................................................................... 31

6.4 Tabular Overview: Disinfection and Sterilization .............................................. 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 before Starting, after Changes and after Repairs ........................ 39

12.3 Safety inspection (Repeated tests) ............................................................... 39

12.4 Changing the fuses ....................................................................................... 40

12.5 Service / Repair / Modification ...................................................................... 40

12.6 Product life time ............................................................................................ 41

12.7 Service table ................................................................................................. 41

12.8 Repair and Returns ....................................................................................... 42

13 Instruction 42

14 Warrenty / Liability 43

14.1 Liability .......................................................................................................... 43

14.2 Warranty ....................................................................................................... 43


1 GENERAL INFORMATION

1.1 PREAMBLE

Dear customer, Thank you for your confidence in WISAP Medical Technology GmbH. This product combines our longstanding experience and thorough workmanship. You have decided for reliable, high-quality WISAP device. Please read these instructions carefully before you put your new unit into operation for the first time. This will prevent damage that can result from the wrong electrical connection or improper use. Use the device only for the purposes described in these instructions. We will assume no liability for damage 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 been carried out by the company WISAP Medical Technology GmbH. This includes, inter alia, SRC / LMC Testing and comparative measurements, maintenance and parts replacement. The manufacturer reserves the right to modify the appearance and technical performance of the product through continued development of the product.

THIS MANUAL DOES NOT CONTAIN A DETAILED DESCRIPTION OF LAPAROSCOPY AND IS NOT SUITABLE FOR INTRODUCING A BEGINNER TO THIS SURGICAL TECHNIQUE.

Your WISAP Team

1.2 SCOPE OF THIS USER MANUAL

This user manual covers the following products: Console 6001 Therapy Probes 6002-6009 Cable 6020


1.3 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.

NOTE!

A note contains valuable information or offers measures with which the handling of the product can be made more efficient and easier.

1.4 ABBREVIATIONS IN THIS USER MANUAL

SRC Safety-related Checks

LMC Legal metrological Control


2 SAFTEY

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

ON

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


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.

2.2 ICONS AND SYMBOLS ON THE PACKAGING

Bildzeichen

Bedeutung

Up

Keep Dry

Temperature Limitation

Non-Sterile

Do not Use if Package is damaged

Atmospheric pressure Limitation

Humidity Limitation


2.3 DANGER

DANGER!

The use of this device is restricted to authorized personnel / physicians only.

DANGER!

The device must never be operated with a defective power cord.

DANGER!

Only use sterilized accessories for each patient.

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 the fuse and disconnect the power cord from the power supply! 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!


2.4 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. Errors caused by non-observance

of the above regulations are not at the expense of the manufacturer and exclude any warranty and damage claims.

WARNING!

It is important to ensure that before surgery, cleaning and disinfecting agents are thoroughly removed.

WARNING!

Make sure the Therapy probes have been gone through an initial cleaning process.

WARNING!

Do not touch the therapy probe during operation at the distal end!

WARNING!

Avoid unintentional switching on the device.


2.5 CAUTIONS

CAUTION!

Read the instructions carefully before use.

CAUTION!

Observe all operating instructions and safety warnings listed in this user manual!

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.

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 connecting this device to the mains power supply make sure the supply network is in compliance with the specified requirements (power

voltage, frequency and fuses). A connection to the mains must be carried out in compliance.

CAUTION!

To avoid the risk of electrical shock, this unit must be connected only to a supply with protective conductor:

CAUTION!

Proper grounding is only guaranteed when a connection between the terminal on the device and the stationary potential equalization rail is made.


CAUTION!

The controlling unit must not be sterilized!

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. Contact the manufacturer immediately.

CAUTION!

Check the appliance and all accessories for proper operation before each procedure. In case of detected or suspected defects the products is not to

be used

CAUTION!

In case of obvious or suspected 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 Technology GmbH or to an approved contractor.

CAUTION!

The selection of the proposed intervention and the chosen accessories as well as the determination of the coagulation time and temperature,

regardless of the instructions given in these general recommendations, lay in the sole responsibility of the treating physician.

CAUTION!

Place the unit out of the reach of the patient!

CAUTION!

The probe head is hot immediately after turning on the product and cools only slowly after the device has been switched off.


CAUTION!

If the probe comes into contact with tissue, no sizzling sound may be audible. Such sound would signalize exceeded coagulation temperature

(above 100°C).

CAUTION!

Please make sure that no liquid enters into the unit or that the controller unit does not get in touch with liquids.

CAUTION!

In order to 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 calibrations may only be performed by the manufacturer or by

personnel explicitly authorized by the manufacturer!

CAUTION!

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.


2.6 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. This applies both to the

first use and in the event that the device is transported to another environment.

NOTE!

Retain the instructions for use during the service life of the device.

NOTE!

Please consult the pertinent medical literature for techniques, complications and hazards.


3 PRODUCT DESCRIPTION

3.1 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:

Coagulation at 60-120 °C

Painless application during the consulting hours in a medical office

Accurate control of intensity

Odorless procedure

Rapid healing without inconvenient vaginal discharge

No contact of patient with electric 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 Teflon-coated, eloxated metal handle with precision plug connection for instrument cable

3.2 INDICATION/CONTRAINDICATION

The application of the Cervix coagulator and its accessories is not indicated:

in all cases if there is no benign erythroplakia existing.

if there is an endocervical therapy is contraindicated.

for a suspected result/malign tissue. There are no product-relevant unwanted side effect known.

3.3 USER GROUP

The device may only be operated by surgeons with experience in endoscopic procedures during minimal invasive surgery and gynecology.

DANGER!

The use of this device is restricted to authorized personnel / physicians only.


3.4 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 – 6 weeks by nonkeratinized pavement epithelium, provided that simultaneous sanitation of the vaginal flora has taken place.

3.5 VARIANTS OF THE MEDICAL PRODUCT

The different types of therapy probes are to be used as follows (Recommendations for the type of application):

Large-area erythroplakia is coagulated with probe A for approx. 20 to 30 seconds at a temperature between 90 °C and 100 °C depending on extension and depth.

The area slightly protruding into the os uteri is coagulated by probe B to avoid relapses.

If minor erythroplakial changes have occurred, probe B has to be used only.

Small endometriosis foci need to be coagulated with probe C.

Large areas of Ovula Nabothii 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.

Chronical cervicitis is repeatedly treated with probe D at approx. 60 – 70 °C.

Probe E serves for cervical destruction of tissue in the cavum uteri, e. g. partial Ablatio endometrii.

Probe F and G serve for coagulation of particularly configured displacements

3.6 LITERATURE

[1] Research Study:

„Impiego del Termocoagulatore di SEMM nella terapia della condilomatosi genitale subclinica“. Daniele Pungetti, Maria Adelaide Calderara, Giovanni Vicini. II Div. Ost/Gin. Osp. Maggiore (sez. D´Azeglio), Bologna, Italia. Primario : Prof. Ettore Zanardi. 1991

[2] Research Study: „Die Therapie der gutartigen Erythroplakie durch gezielte Koagulation“ von Kurt Semm, vom Juni 1989

[3] Research Study: „Die kolposkopische und zytologische Differentialdiagnose mit besonderer Berücksichtigung der atypischen Umwandlungszone“ from Dr. med. Koloman Schlagetter of the journal „Der Frauenarzt“, Issue 1, Januar 1977

[4] Research Study: „Beurteilungskriterien für die kolposkopische Diagnostik der Cervix uteri“ from H.-H. Riedel and K. Semm aus special print of „der Arzt im Krankenhaus“ , Issue 6/83

(Selection)


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


No. Component / Element Function

1 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.

2 Connector for instrument cable

The instrument cable (REF 6020 for treatment probes) is connected to this connector.

3 Instrument Cable The therapy probe (4) is connected to the instrument cable (3).

4 Therapy Probe The following Therapy Probes can be connected to coagulator with help of the instrument cable (3):

Therapy Probe Model A (REF 6002)

Therapy Probe Modell B (REF 6003)

Therapy Probe Modell C (REF 6004)

Therapy Probe Modell D (REF 6005)

Therapy Probe Modell E (REF 6006)

Therapy Probe Modell F (REF 6007)

Therapy Probe Modell G (REF 6008)

Therapy Probe Modell H (REF 6009)

5 Indicator light “RED” 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 to select the desired coagulation temperature.

7 Temperature Scale Temperature scale for use with recommendation for the type of application:

Temperature scale between 60°C (140°F) and 70°C (158°F) for therapy probe D and E

Temperature scale between 70°C (158°F) and 100°C (212°F) for therapy probe A, B, C, F, G

Temperature scale between 100°C (212°F) and 120°C (248°F) only for therapy probe H

8 Indicator light “GREEN” The green indicator light illuminates when the Therapy probe has reached the selected coagulation temperature. Momentary Lapse indicates a heat pulse.

9 Temperature Display The three-digit temperature display shows the temperature at the probe head when a Therapy Probe is connected.

10 Application recommendations

The graphic on the cover indicates the schematic representation of the application of the Therapy probes (Models A to H).


No. Component / Element Function

11 Fixture for Therapy Probes

Fixture for Therapy Probes

12 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.

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 fuses:

CAUTION!

Risk of fire, use only fuses as specified on the product label (12).

15 Connection to the

potential equalization Connection to the potential equalization.

CAUTION!

Proper grounding is only guaranteed when a connection between the terminal on the device and the stationary potential equalization rail is made.


4 PUTTING INTO OPERATION

4.1 KIND OF DELIVERY

The device and its accessories are carefully packed with different protecting materials. Remove the Device and all its accessories from the packaging.

DANGER!

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 damaged upon arrival, WISAP can no longer guarantee the full functionality of the unit, please contact the manufacturer immediately.

NOTE!


NOTE!

The user-manual have to be kept at a well-visible place nearby the unit.


4.2 SCOPE OF DELIVERY

The standard delivery of this device includes:

Image Definition Article Number

Controller-unit 6001

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!


WARNING!


zone.


4.4 ASSEMBLING

4.4.1 Connection of Instrument Cable 3 and Therapy Probe 4

Take the therapy probe (4) and join with receptacle (2) of the unit through instrument cable (3). Rest the Therapy Probe in one of the fixtures for the therapy probes (11) and make sure the tip is not in contact with cloth or any other material.

CAUTION!

In case of obvious or suspected 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 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 or that the unit does not get in touch with liquids.

CAUTION!

In order to ensure good dissipation of heat generated during an operation the control unit must not be covered with cloth.

NOTE!


NOTE!




4.5.1 Connection to the equipotential bonding

Ground the units by connecting a bonding conductor with the plug-in connector (14) (according to DIN 42801). The potential equalization connection 15 of Cervix Coagulator 6001 has to be connected via a suitable grounding cable to the central potential equalization or if installed in / on a trolley with the potential equalization connection of the trolley.

DANGER!

The device must never be operated with a defective power cord.

WARNING!


WARNING!


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


CAUTION!

Check the appliance and all accessories for proper operation before each procedure. In case of detected or suspected defects the products is not to

be used

4.5.2 Connection to the power supply

Check before first use, whether the local mains voltage matches the voltage specified on the product label (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" = OFF. Connect the power cord to the power connector (13), and then connect to the mains.


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.

CAUTION!

To avoid the risk of electrical shock, this 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 comply with the

requirements of IEC 60601-1.

CAUTION!

Place the unit out of the reach of the patient!

NOTE!




4.6 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

1. Join device with central potential equalization through grounding cable.

-

2. Connect mains cable to the unit and join with supply network.

-

3. Attach instrument cable 3 and therapy probe 4 to the coagulator.

4. Set coagulation temperature with selector switch 6 to 60 °C.

5. Activation of mains switch 1 Rocker switch lights up green.

Therapy probe 4 is heated up 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 preselected

temperature (60 °C 10% ) is reached; if LED goes out shortly, a new heating impulse is signalized

6. Increase coagulation temperature with temperature selector 6 to 70 °C.

Therapy probe 4 is heated 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 is reached (70 °C 10% ); if LED goes out shortly, a new heating impulse is signalized.


Therapy probe 4 is heated 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 (100 °C 10% ) is reached; if LED goes out shortly, a new heating impulse is signalized.



Therapy probe 4 is heated 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 is reached (120 °C -10% ); if LED goes out shortly, a new heating impulse is signalized.

9. After completion of the functional test, turn mains switch 1 off.


5 OPERATION

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.

WARNING!

It is important to ensure that before surgery, cleaning and 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 damage set the unit aside immediately and do not perform any operation


NOTE!

Please consult the pertinent medical literature for techniques, complications and hazards.

5.1 SWITCH ON THE CERVIX COAGUALTOR 6001

Select the correct therapy probe (4) required for the intended treatment and join with receptacle (2) of the unit through instrument cable (3). Rest the Therapy Probe in one of the fixtures for the therapy probes (11) and make sure the tip is not in contact with cloth or any other material.


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 up.

5.2 START OF COAGULATION PROCEDURE

Select the desired temperature (60°C to 120°C) by using the temperature selector (6). The therapy probe is being heated to the selected temperature. If the preselected temperature is reached at the therapy probe head, the indicator Light (8) illuminates GREEN. If the Indicator 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 process.

CAUTION!


(above 100°C).

The System can keep the temperature constant at a hysteresis of about ( 10%). The actual temperature at the tip of the therapy probe is displayed on the Temperature Display (9). If the red indicator light “Probe defective” (5) illuminates, a failure is indicated which can have many reasons:

Therapy Probe is not plugged

Instrument cable is defective

Therapy probe is defective

Temperature is too high (see chapter 7 „Trouble shooting“)


5.3 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.

CAUTION!

The probe head is hot immediately after turning on the product and cools only slowly after the device has been switched off.


6 HYGIENIC 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.

6.1 CLEANING

6.1.1 Cleaning of the Unit

After use, the device has to be switched off followed by removing mains cable and all other accessories. For cleaning the outer surfaces of the unit, an aqueous disinfectant is suitable. Please observe the manufacturer’s recommendations on solution concentration. Wipe surface of the unit with a cloth dampened with 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 instrument cable 3 with running cold and warm water. After thorough cleaning with demineralized water, the parts have to be dried with sterile cloths.

6.2 DESINFECTION

6.2.1 Disinfection of Therapy Probes and Instrument Cable

Only parts thoroughly cleaned may be disinfected. Soak parts in solution and observe the manufacturer’s recommendations on disinfectant concentration and soaking time. Prolonged soaking time or wrongful concentration may lead to damage at the parts. Do not pile up parts. Disinfectant residues need to be rinsed off with sterile water under sterile conditions. Dry all parts with a sterile cloth followed by wrapping them into a sterile cloth. The disinfected parts need to be stored in a closed, sterile container.


6.3 STERILIZATION

The parts to be sterilized should be cleaned, disinfected and dried. Wrapping into transparent, sterile packaging, transport after sterilization and determined ventilation time are described in the operator manual of the sterilizing unit.

WISAP recommends the following sterilization method:

Steam sterilization at 134°C/3 bar/3-5 min (Manufacturing date as of 03/2002)

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.

6.4 TABULAR OVERVIEW: DISINFECTION AND STERILIZATION

Correct method:

x = yes, - = no

Cleaning Disinfection Drying Sterilization

Mechani-cally

Chemi-cally

Ultra-sound

Washing machine

Spraying In

solution

Hot air up to 120°C

Ethylene oxide

Steam Hot air 180°C

121°C/ 2,1bar

134°C/ 3,0bar

Chassis x - - - - - - - - - -

Therapy probes

x - - x - x x x

x

Manufacturing

date as of

03/2002

x

Manufacturing

date as of

03/2002

-

Instrument cable

x - - x - x x x x x -


7 TROUBLE SHOOTING

Fault Description Possible Causes Remedy

No device function

No display is activated

Mains switch 1 does not light up

Failure at mains supply

Defective mains fuses

Have supply network checked

Exchange fuses (observe type of fuse, see „Technical Data)

Have device serviced by manufacturer or by authorized dealer

Mains switch 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 electronically interrupted

therapy probe 3 is defective or not plugged in.

Temperature is too high.

Internal device failure.

Turn device off, connect new probe and turn device on again

Have device serviced by manufacturer or authorized dealer

CAUTION!


(above 100°C).


8 DISPOSE At the end of product life, the components of this device should be disposed of properly. Pay attention to a careful separation of materials. The materials used do not contain dangerous goods. The housing material is recyclable. The electronics boards should be disposed through an appropriate recycling process.

This symbol on the product and/or accompanying documents means, that the product must not be mixed with general household 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 comprises the EU Member States plus Norway, Iceland and

Liechtenstein

9 LIST OF ACCESSORIES The following product-related accessories could purchased about the WISAP customer service:

Item No. Product

6002 Therapy Probe A

6003 Therapy Probe B

6004 Therapy Probe C

6005 Therapy Probe D

6006 Therapy Probe E

6007 Therapy Probe F

6008 Therapy Probe G

6009 Therapy Probe H

6020 Instrument Cable

1110NC Power Cord

1110NCH Power Cord

1110ND2 Power Cord

1110NI Power Cord

1110NU Power Cord


10 TECHNICAL DATA Classification by:

93/42/EEC: IIa

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 Power supply:

AC voltage available for: 100V, 110V, 115V, 220V, 230V, 240V (for 50/60Hz)

Fuses: 2x0, 5 AT for 220V / 230V / 240V

2x1 AT for 100V / 110V / 115V Power consumption: 68 VA Temperature range: 60-120 ° C ± 10% Temperature 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: 700 -1060 hPa

Storage and transport: 700 -1060 hPa The nameplate contains technical data such as the type and serial number of your unit, which must always be specified when ordering replacement parts or requesting other information. CE-labeling is performed in conformity with the EC-guidelines 93/42/EWG Annex II. Upon request, circuit diagrams, spare part lists, descriptions, adjusting instructions and other documents will be made available to qualified technicians for repairing of unit parts, if the manufacturer considers them to be repairable.


11 OVERVIEW TO EMC

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.

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 very low and are not likely to cause any interference in nearby electronic equipment. The 6001 is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

RF emissions CISPR 11 Class B

Harmonic emissions IEC 61000-3-2

Class A

Voltage fluctuations/ flicker emissions IEC 61000-3-3

Not applicable


Guidance and manufacturer's declaration - electromagnetic immunity (1/2)


Immunity test IEC 60601 test level Compliance level Electromagnetic environment -

guidance

Electrostatic discharge (ESD) IEC 61000-4-2

±6 kV contact ±8 kV air

±6 kV contact ±8 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.

Electrical fast transient/burst IEC 61000-4-4

±2 kV for power supply lines ±1 kV for input/output lines

±2 kV 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 differential mode ±2 kV common mode

Mains power quality should be that of a typical commercial or hospital environment.

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

<5 % UT (>95 % dip in UT) for 0,5 cycle 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles <5 % UT (>95 % dip in UT) for 5 sec

Complies Mains power quality should be that of a typical commercial or hospital environment.

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

NOTE: UT is the a. c. mains voltage prior to application of the test level.


Guidance and manufacturer's declaration - electromagnetic immunity (2/2)


Immunity test IEC 60601 test level Compliance level Electromagnetic environment -guidance

Portable and mobile RF communications equipment should be used no closer to any part of the 1608A, including cables, than the recommended separation distance calculated 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 61000-4-3

3 V/m 80 MHz to 2,5 GHz

3 V/m

At 80 bis 800 MHz:

d = [3,5/E1] x P = 1,2 x P At 800 MHz bis 2,5 GHz:

d = [7/V1] x P = 2,3 x P

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as deter-mined by an electromagnetic site survey, a should be less than the compli-ance level in each frequency range. b Interference may occur in the vicinity of equipment marked with the following symbol:


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.

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. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the 1608A is used exceeds the applicable RF compliance level above, the 1608A should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the 1608A.

b: Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Recommended separation distance between portable and mobile RF communications equipment and the 6001

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 maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the 6001 as recommended below, according to the maximum output power of the communications equipment.

Rated maximum

output power of

transmitter

W

Separation distance according to frequency of transmitter m

150 kHz to 80 MHz

d = [3,5/V1] x P

= 1,2 x P

(for V1 = 3 Veff)

80 MHz to 800 MHz

d = [3,5/E1] x P

= 1,2 x P

(for E1 = 3 V/m)

800 MHz to 2,5 GHz

d = [7/E1] x P

= 2,3 x P

(for E1 = 3 V/m)

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance din meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watt (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for 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.


12 TECHNICAL SERVICE 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

authorized by the manufacturer!

12.2 INSPECTION BEFORE STARTING, AFTER CHANGES AND AFTER REPAIRS

Testing prior to the first intended use, any modification and after maintenance is carried out in accordance with DIN EN 62353 ("Medical electrical equipment – Iteration-test and test after repair of medical electrical equipment"). Following tests must be 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 protective conductor connection

Check the readability of all functionally important inscriptions and the nameplate

Check the availability of all necessary documentation (instructions for use)

Check the function of all controls, sockets and lights on the device

Check the protective conductor resistance according to DIN EN 62353:2008-08, Section 5.3.2

Check the leakage according to DIN EN 62353:2008-08, Section 5.3.3.

12.3 SAFETY INSPECTION (REPEATED TESTS)

The safety checks are carried out according to DIN EN 62353 ("Medical electrical equipment - Loop test and test after repair of medical electrical equipment"). The safety test is the responsibility of the operator, but should regularly (12 month interval) be carried out by the manufacturer or a person authorized by him. The individual test points can be found in chapter 12.2.


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.

Disconnect the power cord from the power supply by removing the mains plug of the power cord from the power outlet.

Remove the power cord from the power connector of the device and keep it close to the device.

The fuses are located above the mains socket.

Slide a suitable tool (screwdriver) 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 fusebox comes out entirely.

Pull out the fusebox.

Remove the fuse and install the new one(s). Only use fuses with the correct electrical values (specification see chapter 0)

Install the fuse. Correct assembly on both sides is indicated by an audible "click".

12.5 SERVICE / REPAIR / MODIFICATION

All services such as regular maintenance, inspection, repair, modification, calibration, etc., shall be carried out with consideration of the special safety regulations for medical equipment by the manufacturer or by expressly authorized by him shall. Performed services are filled in the table in chapter 12.7.

Fuse


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


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. Describe the error or malfunction and call us a competent person for further inquiries *) The repair must be shipped devices and accessories must, to protect service personnel and transport security, have been prepared 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 visible in and double-wrapped in a security film with an indication of the contamination. The repair accept contaminated products may refuse the manufacturer.

13 INSTRUCTION The unit with serial number: __________________ was released to the customer on _____________________.

Training was conducted by Mr./Ms.: _______________________________________

The following person(s) received training: ________________________ Function: ____________________________________ ________________________ Function: ____________________________________


14 WARRENTY / LIABILITY This device is made with great care and has been thoroughly checked before delivery.

14.1 LIABILITY

We, as manufacturer of this device consider ourselves only liable for safety, reliability and efficiency of the unit, if:

maintenance, assembly, extensions, readjustment, modifications or repairs have been performed by our service personnel or by personnel authorized by us.

the electric installation of the respective room corresponds to the standards of VDE 0107

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. 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 and void then.

The unit is handled Improperly,

Operator-errors cause damage to the unit,

Failure to observe the instructions for use,

Implementation of changes to the device (modifications, alterations extensions etc.) without written permission,

Opening of the housing by unauthorized persons,

Use of non-original accessories,

Acts of God (such as lightning),

Transport damage resulting from improper packaging when returning; in order to avoid transport damages, we advise you to pack the device including all components safe for transport,

In case of defective packaging Repair costs are invoiced. Even during the warranty period will void any warranty,

If the complaint is unlawful, we are entitled to charge a reasonable fee for inspection and delivery of the unit.


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: [email protected] Web: www.wisap.com

0123

http://www.wisap.com/

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