Cervical Cold Coagulator Model 610x User Manual July 2020

Table of Contents 1

2

3

4

5

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 ...8

2.4

Warnings ...9

2.5

Cautions ...10

2.6

Notes ...11

Product Description

13

3.1

Intended Use / Purpose ...13

3.2

Indication / Contraindication ...13

3.3

User group ...13

3.4

Operating principle...14

3.5

Literature ...14

3.6

Components of the medical product ...15

Commissioning

17

4.1

Scope of delivery ...17

4.2

Conditions for operation ...18

4.3

Unpacking the device ...19

4.4

Assembly prior to use ...19

4.5

Functional Test ...20

Operation

21

5.1

activate the heating of the device ...22

5.2

Start of treatment ...22

5.3 END of treatment ...23 5.3.1 Disconnection of power supply unit from handle...24 6

Hygienic measures

25

7

Trouble shooting

25

8

Dispose

25

9

List of accessories

26

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10 Technical Data

27

11 Overview to EMC

28

12 Technical Service and maintenance

32

12.1

Frequency of maintenance ...32

12.2

Inspection before Starting, after Changes and after Repairs ...32

12.3

Service / Repair / Modification ...32

12.4

Product life time ...32

12.5

Service table ...33

12.6

Repair and Returns...34

13 Instruction

34

14 Warrenty / Liability

35

14.1

Liability...35

14.2

Warranty ...35

14.3

Guarantee...35

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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 a 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 damages that can result from 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: Cervical Cold Coagulator - C3 Set

610x

It includes following units: 6110 Handle (Control Unit) 612x Thermo-probe (Application part, contact with patient) Slider (heat-protection without clinical application, contact with patient) 6112/6113/6114/6115 6130 Power Supply (including country-specific cable)

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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.

Icon

Meaning

Power on, when LED is illuminated, the device is connected to a power source

Toggle-button for heating-function

Button for timer-function

Serial Number

Article number

Manufacturer

Applicable part type BF

Refer to the user-manual

IPX0

No protection against water

IPX7

full protection against water

CE-Certification of the notified body

DC Power Supply

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2.2 ICONS AND SYMBOLS ON THE PACKAGING Icon

Meaning

Up

Keep dry

Temperature limitation

Do not leave in open sun

Careful handling

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! This device is intended for use in the electromagnetic environment specified in chapter 11. Non-confirming environment can cause unexpected issues because of electromagnetic compatibility.

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DANGER! The WISAP CERVICAL COLD COAGULATOR (REF 610x) is a precision instrument, which is to be operated exclusively with the original WISAP accessories! DANGER! Accessories, transducers and cables other than specified can result increased emissions or decreased immunity of the device. In this situation, the description regarding electromagnetic compatibility in chapter 11 will be no more applicable. This can cause unexpected issues.

2.4 WARNINGS WARNING! No change on this device is allowed! 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 and disinfection 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! Make sure the applicable parts have gone through an initial cleaning process. WARNING! Do not touch the therapy-probe during operation at the distal end! The treatment-surface is hot! 762-0103-E

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WARNING! Avoid unintentional activation of 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! Before connecting this device to the mains power supply make sure the supply network is in compliance with the specified requirements (power voltage and frequency). A connection to the mains must be carried out in compliance. CAUTION! The handle must not be sterilized! Only surface disinfection! 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.

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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! Please make sure that no liquid enters into the handle or the power unit. 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!

2.6 NOTES 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. 762-0103-E

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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! 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 CERVICAL COLD COAGULATOR is used in conjunction with the WISAP therapy probe (REF 612x) exclusively for the thermal ablation of cervical lesions or CIN 1-3. A distinctive feature is the advantageous and easy handling of the unit:  Coagulation at 100°C  Timer function to aid handling  LED light function for better visibility  Slider acts as heat-protection for the vaginal cavity  Outpatient procedure with no local anesthesia required  Simple handling  Odorless procedure  Rapid healing without inconvenient vaginal discharge  No contact of patient with electric current  No postoperative side structure at the external os  Teflon-coated thermo-probe ensures, that no tissue adheres to the thermo-probe during treatment

3.2 INDICATION / CONTRAINDICATION Indication: The provider can treat a VIA-positive lesion with the WISAP CERVICAL COLD COAGULATOR according this instruction if ALL of the following criteria are met:  The lesion occupies less than 75% of the transformation zone  All of the lesion can be seen  The lesion is not suspicious for cancer  No abnormal blood vessels can be seen  There are no polyps or scarring that prevent the full contact between the cervix and the thermo-probe  The women does not have severe Cervicitis Contraindication: WISAP CERVICAL COLD COAGULATOR is only created for simple treatment of cervical lesions with the given criteria. (See indication) WISAP doesn’t confirm the application of C3 for:  Treatment of other sicknesses  Coagulation of other tissues or body parts  Treatment of cervical lesions but one or more criteria are not met

3.3 USER GROUP The device may only be operated by Gynecologists. DANGER! The use of this device is restricted to authorized personnel / physicians only. 762-0103-E

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3.4 OPERATING PRINCIPLE By electronic control of destructive heat the temperature of 100 °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 pavement epithelium, provided that simultaneous sanitation of the vaginal flora has taken place. Unlike cryotherapy, which freezes tissue at low temperatures, thermal-coagulation uses heat to destroy the lesions on their protein level. Actually the name “Cold-Coagulator” is a misnomer; the treatment temperature is 100°C. The superficial epithelium blisters off after treatment, and the underlying stroma and glandular crypts are destroyed by desiccation. The treatment of cold coagulation should not be mistaken for electrical coagulation (using HF-current) which destroys tissue at its aqueous level at temperatures around +320°C. During Cold-Coagulation there is no electrical current flowing through the patient’s body, only heat is transferred from the thermo-probe to the tissue.

3.5 LITERATURE YEAR 1988

TYPE AND SUBJECT OF STUDY Pathologic-study_CC “Pathologic study of the cervix after cold coagulation”

KEY FINDINGS OF STUDY Depth of destruction has been established to be close to 4 mm using 100°C for 15 seconds

Published by Domenico de Cristofaro, MD, Paolo Fontana, MD and Carlo Pezzoli, Desenzano, Brescia, Italy

1991

Efficacy-study_CC_CIN3 “Effective destruction of cervical intraepithelial neoplasia (CIN) 3 at 100°C using the Semm cold coagulator: 14 years experience” Published by Helen K. Gordon, Ian D. Duncan, British Journal of Obstretics and Gynaecology, January 1991, Vol 98, pp. 14-20

1993

Efficacy-study “Destruction of CIN 1 and 2 with Semm cold coagulator: 13 years experience with a see-andtreat policy”

A study of 1,628 women with CIN3 treated with overlapping 20second 100° C applications found a primary success rate of 95% at one year. The same treatment protocol successfully treated 97.1% of 485 women with CIN1 and 96.5% of 680 women with CIN2. A study of 725 women with CIN 1, 2, and 3 treated with a 120° C thermoprobe for 30-40 seconds found that 87.2% of women had normal cytology following cold coagulation and long-term negative follow-up.

Published by Henk A. Loobuyck, British Journal of Obstretics and Gynaekology, May 1993, Vol 100, pp. 465468

1993

Outcome-study “Outcome of cold coagulation for the treatment of cervical intraepithelial neoplasia in a department of genitourinary medicine”

125 female patients were treated with cold coagulator at cervical transformation zone following colposcopic assessment and biopsy. Overall success rate 95,6%, no adverse effects

Published by Olwen E. Williams, Margeret Bodha, A. B. Alawettegama, Genittourin Med 1993, 69;63-65

2003

Chart-review “Efficacy of cervical intraepithelial neoplasia (CIN) treatment by cold coagulation” Published by A. Zawislak, J. H. Price, H. R. McClelland, R. G. N. Storey, L. Caughley, The Ulster Medical Journal, Volume 72, No 1, pp. 10-15, May 2003

2015

Efficacy-study “Use of thermo-coagulation as an alternative treatment modality in a “screen-and-treat” programme of cervical screening in rural Malawi” Published by Christine Campbell, Savel Kafwafwa, Hilary Brown, Graeme Walker, Belito Madetsa, Miriam Deeny, Beatrice Kabota, David Morton, Reynier Ter Haar, Liz Grant and heather A. Cubie, International Journal of Cancer, 2016

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A retrospective review of case records analysed 632 female patients which were treated with cold coagulator. Overall success rate 87,1%, no adverse effects. “Cold Coagulation appears safe efficient treatment for cervical intraepithelial neoplasia.” “Our study demonstrates that introduction of thermocoagulation is feasible and acceptable within this LMIC setting. The same day nature of a treatment acceptable to providers and to patients, the ease of transportation to rural health centres and the evidence of clinical effectiveness all argue for more widespread adoption of thermo-coagulation for sustainable and reliable screening provision in LMIC as an alternative to Cryotherapy.”

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3.6 COMPONENTS OF THE MEDICAL PRODUCT

6. LED Light

7. Control panel

1. Handle

5. Treatment-surface

2. Thermo-probe

3. Slider (heat-protection) 4. Plug connection to power supply

CERVICAL COLD COAGULATOR / SIDEVIEW

9. Signal Power-ON

8. Timer button

10. Heating button

CERVICAL COLD COAGULATOR / ISOMETRIC VIEW

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No. Component / Element 1 Handle

Function Is the main part which receives the power plug and the thermo-probe in combination with the slider and carries the control panel. Is the applicable part which is used to enter into the vaginal cavity and carries the treatment surface in the front, which is heated to 100°C.

2

Thermo-Probe

3

Slider (heat-protection)

4

Plug-connector to power supply

5

Treatment-surface

This part is the surface which is heated to 100°C and is designed to come into contact with the cervix. It is coated with a non-stick-surface, so that after treatment it can be retracted from the vaginal cavity without adhering to the cervical tissue.

6

LED light

7

Control panel

The LED light is switched on when the heating is activated. It shows that the thermo-probe is hot and increases visibility inside of the vaginal cavity. The control panel shows when the device is properly connected to a power-source, allows the operator to activate and deactivate the heating of the thermoprobe and comprises a timer function to keep track of treatment time effectively.

8

Timer button

9

Indicator for POWER ON

10

Heating button

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The Slider is used as heat protection for the vaginal walls. It can be easily attached to the thermo-probe by clicking it onto the bottom part of the thermo-probe. When the slider is pushed to distal end of the thermoprobe the hot treatment surface is covered all around and is hindered from touching accidentally the unprotected vaginal walls. At this position the power supply is attached to the handle part.

The operator can activate the timer-function by pressing once the timer button. When the button is pressed an acoustic feedback can be heard (single beep) and the Led-light starts to flash blue for the duration timer function. After 30 seconds: 1beep After 45 seconds: 1 beep After 60 seconds: 2 beeps, end of timer function The green LED-light illuminates when the device is properly connected to a power-source. The heating-button allows the operator to activate and deactivate the heating of the thermo-probe. When the heating is activated the green Led-light starts to blink green during the initial heating phase. After the temperature has reached 100°C, the Led-light is illuminated constantly green. Page 16 of 36

4 COMMISSIONING 4.1 SCOPE OF DELIVERY The device and its accessories are carefully packed with different protecting materials. Remove the device and all its accessories from the packaging.

WARNING! The user is fully responsible for observing the applicable cleaning and disinfection 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. 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. NOTE! Please make sure that the plug-in connection to the energy supply is not obscured and the disconnection is possible all time. NOTE! Device has no “switch off” button and it can be shut down by disconnection of energy supply any time.

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The scope of delivery for article Number: 610x comprises:

6130

612x

6110 6112 6113 6114 6115 6130

Definition

Article Number

Handle

611x

Thermo-probe

612x

Slider

6112/6113/6114/6115

Power supply including country-specific cable

6130

User Manual

GA Cervical Cold Coagulator

4.2 CONDITIONS FOR OPERATION Operation

+ 5°C bis + 40°C

Storage and transport

+ 10°C bis + 50°C

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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.

4.3

UNPACKING THE DEVICE

Take all components from the packaging and place them onto a clean 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.

4.4 ASSEMBLY PRIOR TO USE Connect the country-specific power plug into the power grid and to the power supply. Connect the power plug to the handle and make sure the self-ledging mechanism is properly engaged. You can hear a click sound and the green Power-On LED-light illuminates. After having disinfected the thermo-probe (see Cleaning and Disinfection Instruction), make sure it has been dried properly. Insert the probe into the opening on the front of the handle, so that the arrow on the probe is in line with the arrow on the handle.

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Push the probe against handle until it is fully inserted.

Turn the probe against the handle in the direction of the second arrow for about 45°.

After having disinfected the slider (see cleaning instructions “RA Cervical Cold Coagulator”) hold the slider in your left hand. Hold the handle with the attached thermoprobe in your right hand. Slide the probe-tip along the tubal length of the slider until the probe-tip has entered the distal end (protective zone) of the slider. Clip the back-part of the slider onto the backpart of the thermo-probe. Place the device onto a stand (optional), otherwise place it in such a position that ensures that the thermo-tip and the slider do not touch any non-disinfected surfaces and does not touch any flammable materials (like cloth or paper).

CAUTION! In case of obvious or suspected defects in the instrument cable and / or the therapy probe, this must be replaced immediately.

4.5 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. GA_Cervical-Cold-Coagulator_610x_E_2020-07-22

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Description of the Functional Control 1.Assemble device according to 4.4

-Green power-on LED-light illuminates

2.Turn heating on by pressing the heating button.

Green LED-light first blinks for about 20 – 30 seconds, then turns to a steady green

3.Turn timer on by pressing the timer button.

Blue LED-light is illuminated and a single beep sound occurs

4.Wait for 60 seconds

The blue LED-light goes off and a double beep-sound occurs

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

5 OPERATION DANGER! This device is intended for use in the electromagnetic environment specified in chapter 11. Non-confirming environment can cause unexpected issues because of electromagnetic compatibility. DANGER! The WISAP CERVICAL COLD COAGULATOR (REF 610x) is a precision instrument, which is to be operated exclusively with the original WISAP accessories! DANGER! Accessories, transducers and cables other than specified can result increased emissions or decreased immunity of the device. In this situation, the description regarding electromagnetic compatibility in chapter 11 will be no more applicable. This can cause unexpected issues. WARNING! The user is fully responsible for observing the applicable cleaning and disinfection 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! During operating, the portable and mobile RF communications equipment can affect this device and cause unknown issues. The in chapter 11 descript least distance must be kept from the device. 762-0103-E

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