600x series Cervix Coagulator User Manual Sept 2014

Table of Contents 1

2

3

4

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

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

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

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 5

6

Functional Test ...25

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

Hygienic measures

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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

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

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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 Therapy Probes Cable

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6001 6002-6009 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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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

9

10

1

8

4

7 6 3

5 2 Figure 2: Front Side

11 15 14 12 13

Figure 3: Back Side

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No. Component / Element 1 Power Switch

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

2

Connector for instrument cable

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):        

5

Indicator light “RED”

The flashing red light (LED) shows:   

6

Temperature Selector

7

Temperature Scale

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)

Therapy probe is not connected Therapy probe or cable is defective Temperature at the probe head is too high

The temperature selector is used to select the desired coagulation temperature. 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 11 Fixture for Therapy Probes 12 Product Label

Function Fixture for Therapy Probes 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.

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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! 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.

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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! 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.

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