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: info@wisap.de
http://www.wisap.de
E

WISAP Cervix Coagulator Specifications

General

Brand	WISAP
Model	Cervix Coagulator
Category	Medical Equipment
Language	English

Summary

1 General Information

1.1 Preamble

Introduction and thank you message from WISAP.

1.2 Scope of this User Manual

Lists the products covered by this manual.

1.3 Icons in this user manual

Explains various warning and information icons used in the manual.

1.4 Abbreviations in this user manual

Lists abbreviations used in the manual.

2 Saftey

2.1 Icons and Symbols on Medical Product

Details icons and symbols found on the device's type label.

2.2 Icons and Symbols on Packaging

Explains symbols used on the product packaging.

2.3 Danger Warnings

Lists critical safety warnings related to device use and accessories.

2.4 General Warnings

Provides important safety warnings for device operation.

2.5 Initial Setup Cautions

Lists cautions for initial setup and basic operation.

2.6 Operational Safety Cautions

Covers sterilization, inspection, defects, patient safety, and probe handling.

2.7 Device Operation Cautions

Details cautions for probe contact, liquid ingress, maintenance access, and system connection.

3 Product Description

3.1 Intended Use / Purpose

Describes the coagulator's intended applications and features.

3.2 Indication/Contraindication

Lists conditions for which the device is indicated or contraindicated.

3.3 User Group

Specifies the qualified personnel for operating the device.

3.4 Operating Principle

Explains how the device functions to coagulate cervical tissue.

3.5 Variants of the Medical Product

Details different therapy probes and their applications.

3.6 Literature

Lists references and research studies related to the product.

3.7 Components Overview

Illustrates and labels the main components of the device.

3.8 Component Details

Provides detailed descriptions of each component and its function.

4 Putting Into Operation

4.1 Kind of Delivery

Instructions for unpacking and initial handling of the device.

4.2 Scope of Delivery

Lists the items included in the standard delivery package.

4.3 Conditions for Operation

Specifies environmental and operating conditions for the device.

4.4 Assembling

Step-by-step guide for connecting the instrument cable and probe.

4.5 First Putting Into Operation

Details connection to equipotential bonding and power supply.

4.5.1 Setup Safety and Adaptation

Covers safety precautions and ambient adaptation during initial setup.

4.6 Functional Test

Outlines the procedure for performing a functional test of the device.

5 Operation

5.1 Switch On the CerviX Coagualtor 6001

Step-by-step guide for powering on the device.

5.2 Start of Coagulation Procedure

Details how to select temperature and initiate the coagulation process.

5.3 Termination of the Treatment

Instructions for safely ending a treatment session and cooling down.

6 Hygienic Measures

6.1 Cleaning

Procedures for cleaning the main device unit.

6.1.2 Cleaning of Therapy Probes and Instrument Cable

Steps for cleaning the therapy probes and instrument cable.

6.2 Disinfection

Guidelines for disinfecting probes and instrument cable.

6.3 Sterilization

Recommends steam sterilization parameters for reusable parts.

6.4 Tabular Overview: Disinfection and Sterilization

Summary table of cleaning, disinfection, and sterilization methods.

7 Trouble Shooting

7 Trouble Shooting

Lists common faults, possible causes, and remedies.

8 Dispose

8 Dispose

Instructions for proper disposal of the device at its end of life.

9 List of Accessories

9 List of Accessories

Catalog of available accessories for the device.

10 Technical Data

10 Technical Data

Provides detailed technical specifications and classifications.

11 Overview to EMC

Electromagnetic Emissions

Manufacturer's declaration on electromagnetic emissions (CISPR 11, IEC 61000).

Electromagnetic Immunity

Guidance on electromagnetic immunity according to IEC 60601 (ESD, transients, surge, dips).

Electromagnetic Immunity (cont.)

Guidance on electromagnetic immunity (conducted/radiated RF) and separation distances.

12 Technical Service and Maintenance

12.1 Frequency of Maintenance

Specifies the need for annual maintenance for safety and function.

12.2 Inspection Before Starting, After Changes and After Repairs

Lists tests required before use, after modifications, and after repairs.

12.3 Safety Inspection (Repeated Tests)

Details periodic safety checks and their responsibility.

12.4 Changing the Fuses

Step-by-step instructions for replacing device fuses.

12.5 Service / Repair / Modification

States that services must be performed by authorized personnel.

12.6 Product Life Time

Indicates the expected minimum service life of the device.

12.7 Service Table

A table for recording maintenance and service history.

12.8 Repair and Returns

Procedures for requesting repairs and returning the device.

13 Instruction

13 Instruction

Section for recording unit serial number and training details.

14 Warranty / Liability

14.1 Liability

Manufacturer's liability conditions based on proper use and maintenance.

14.2 Warranty

Details the 12-month warranty terms and exclusions.