WISAP Cervix Coagulator User manual

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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: [e-mail]
http://www.wisap.de
E

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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: [e-mail]
I
D
E
ES

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Table of Contents
1General 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
2Saftey 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
3Product 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
4Putting 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
5Operation 27
5.1 Switch ON the CerviX Coagualtor 6001...........................................................27
5.2 Start of Coagulation Procedure .......................................................................28
5.3 Termination of the Treatment ..........................................................................29
6Hygienic measures 30

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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
7Trouble shooting 32
8Dispose 33
9List 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

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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

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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

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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

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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

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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!

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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.

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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.

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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.

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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.

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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.

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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.

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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)

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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

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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).

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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.

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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!
Install the device onto a plane surface.
NOTE!
The user-manual have to be kept at a well-visible place nearby the unit.