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MELAG Vacuklav 44 B+ Evolution User Manual

MELAG Vacuklav 44 B+ Evolution
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User Manual
Vacuklav
®
40 B+ Evolution
Vacuklav
®
44 B+ Evolution
Steam sterilizer
from software version 3.240
EN
Dear customer,
We thank you for your confidence demonstrated by the purchase of this MELAG product. As an owner-run and operated
family concern founded in 1951, we have a long history of successful specialization in hygiene products for practice-
based use. Our focus on innovation, quality and the highest standards of operational reliability has established MELAG
as the world’s leading manufacturer in the instrument reprocessing and hygiene field.
You, our customer are justified in your demand for the best products, quality and reliability. Providing “competence in
hygiene” and “Quality – made in Germany”, we guarantee that these demands will be met. Our certified quality man-
agement system is subject to close monitoring: one instrument to this end is our annual multi-day audit conducted in ac-
cordance with ENISO13485. This guarantees that all MELAG products are manufactured and tested in accordance with
strict quality criteria.
The MELAG management and team.

Table of Contents

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MELAG Vacuklav 44 B+ Evolution Specifications

General IconGeneral
TypeSteam Sterilizer (Autoclave)
Drying SystemVacuum drying
Control SystemMicroprocessor-controlled
DisplayLCD display
Power Supply230V, 50/60Hz
Power Consumption2.5 kW
Water SupplyIntegrated water reservoir or direct water connection
DocumentationIntegrated memory
Printer OptionOptional printer available

Summary

General guidelines

Symbols used

Explains the meaning of symbols used in the manual and on the device.

Formatting rules

Details the formatting conventions used within this document.

MELAconnect App

Description of the MELAconnect app functions and connectivity.

Disposal

Instructions for the proper disposal of the device and accessories.

Safety

Qualified personnel

Ensures only competent personnel operate the device.

Setup, installation and commissioning

Safety precautions for device setup and initial operation.

Power cable and power plug

Guidelines for safe handling of the power cable and plug.

Spring safety valve

Ensures the proper function of the spring safety valve.

Reprocessing and sterilization

Safety compliance for instrument reprocessing and sterilization.

Program abort

Safety considerations when aborting a sterilization program.

Removing the sterile material

Safety steps for safely removing sterilized materials.

Transport and storage

Safety instructions for transporting and storing the device.

Maintenance

Safety guidelines for performing maintenance tasks.

Repair

Safety warnings concerning device repair by unauthorized personnel.

Malfunctions

Information on handling device malfunctions and error messages.

Notification requirement in the event of serious accidents in the European Economic Area

Procedure for reporting serious accidents involving the medical product.

Performance specifications

Intended use

Defines the primary applications and scope of the steam sterilizer.

Sterilization procedure

Details the fractionated vacuum procedure used for sterilization.

Type of the feed water supply

Specifies the requirements for feed water quality and supply.

Safety equipment

Describes the integrated safety monitoring systems of the device.

Door mechanism

Explains the automatic door locking and pressure compensation system.

Performance characteristics of sterilization programs (type B)

Table detailing performance compliance with EN 13060 standards.

Program sequences

Description of the three main phases of a sterilization program.

Program phases of a standard sterilization program

Detailed breakdown of standard program steps.

Program phases of the vacuum test

Steps involved in performing the vacuum test.

Description of the device

Scope of delivery

Lists all items included in the standard delivery package.

Standard scope of delivery

Detailed list of components provided with the device.

Views of the device

Diagrams identifying all external parts and connections of the device.

Symbols on the device

Explanation of the various symbols and their meanings found on the device.

Load mounts

Information on how to correctly install and use load mounts.

Energy-saving key

Functionality of the energy-saving key and its operation.

Colour touch display

Overview of the user interface and its main display areas.

Symbols in the status bar

Meaning of icons displayed in the status bar on the touch display.

Symbols in the menu bar

Icons used within the device's menu system.

Symbols in the action bar

Icons representing available actions in the device interface.

LED status bar

Explanation of LED colors indicating device status.

First steps

Setup and installation

Instructions and requirements for initial device setup and installation.

Feed water supply

Details on connecting and supplying feed water to the sterilizer.

Using the external water storage container

Guidance on using an external water storage container.

Use of a water treatment unit

Information on connecting and using a water treatment unit.

Supply with cooling water

Requirements and connection details for the cooling water supply.

Switching on the steam sterilizer

Step-by-step guide to powering on the steam sterilizer.

Opening and closing the door

Procedure for safely opening and closing the sterilizer door.

Manual door emergency-opening

Procedure for manually opening the door in emergency situations.

Manual door emergency-opening

Continued instructions for manual door emergency opening.

Loading the steam sterilizer

Preparing the load

General guidelines for preparing instruments and textiles for sterilization.

Reprocessing the instruments

Detailed steps for cleaning and preparing instruments.

Reprocessing textiles

Specific instructions for reprocessing and preparing textiles.

Loading the steam sterilizer

Best practices for loading the sterilization chamber correctly.

Packaging

Information on suitable packaging materials for sterilization.

Closed sterilization containers

Guidelines for using closed sterilization containers effectively.

Soft sterilization packaging

Instructions for using soft sterilization packaging materials.

Multiple wrapping

Guidance on performing multiple wrapping techniques.

Mixed loads

Recommendations for sterilizing mixed loads of different items.

Sterilization

Important information for routine operation

Key recommendations for daily and weekly operational checks.

Manufacturer's recommendation for the routine operation of type B steam sterilizers

Specific recommendations for type B sterilizer routine checks.

Selecting the program

Guide to choosing the appropriate sterilization program for different loads.

Additional programs

Overview of optional programs like Vacuum test and Bowie & Dick test.

Additional program options

Details on features like additional drying and start time pre-selection.

Start time pre-selection

Instructions for scheduling program start times.

Starting the program

Steps to initiate a sterilization program and handle user authentication.

Program run

Description of program phases and monitoring progress.

Following the program run on the computer

How to monitor program progress remotely via a web browser.

Manual program abort

Procedure for manually stopping a running program.

Program abort before the start of drying

Safety and procedure for aborting before the drying phase.

Program abort after the start of drying

Procedure and considerations for aborting after the drying phase has begun.

Program end

Steps to take when a program completes successfully.

The approval process

Explanation of the batch approval process and user authentication.

Removing the sterile material

Safe procedures for unloading the sterilized load.

Storing sterile material

Guidelines for the proper storage of sterilized materials.

Logging

Batch documentation

How to obtain and archive batch data for quality assurance.

Capacity of the internal log memory

Information on the device's internal memory capacity for logs.

Output media

Available options for outputting and archiving sterilization logs.

Using the CF card as an output medium

Instructions for using a CF card to save log data.

Using the computer as an output medium

Connecting the device to a computer for log transfer.

Reading out a text log on the computer

Steps to access and view log files on a computer.

Using the label printer as an output medium

How to use a label printer for batch traceability.

Outputting text logs automatically after program end (immediate output)

Setting up automatic log output upon program completion.

Subsequent log output

Options for outputting logs manually after program completion.

Outputting a log from the log list

Procedure for selecting and outputting specific logs.

Outputting the daily / weekly log etc.

Methods for outputting logs based on date ranges.

Finding logs

Information on locating log files on storage media.

Storage location for logs

Details on where log files are stored after output.

Log directory

Explanation of the directory structure for log files.

Example log of a successfully completed program

A sample log entry illustrating data format and content.

Function tests

Manual functional checks

Performing manual checks to verify device functions.

Vacuum test

Procedure for conducting a vacuum test to check for leakages.

Bowie & Dick test

Instructions for performing the Bowie & Dick steam penetration test.

Evaluation of the indicator following the colour change

How to interpret the results of the Bowie & Dick test indicator.

Settings

Logging

Configuration options related to log output and management.

Immediate log output

Settings to enable or disable automatic log output.

Deactivating immediate output

Steps to turn off automatic log output.

Outputting graphic logs (optional)

Settings for enabling optional graphic log output.

Outputting graphic logs (optional)

Further configuration for graphic log output.

Log output in English

Setting the language for log printer output.

Using the computer as an output medium

Configuring the computer as a log output destination.

Connection via FTP

Steps to establish an FTP connection for data transfer.

Connection via TCP

Steps to establish a TCP connection for data transfer.

IP addresses

Information on device IP address configuration.

IP addresses

Details on setting device IP addresses within a network.

Log format

Options for customizing the format of logged data.

User administration

Managing user accounts and PINs for access control.

Adding a user

Procedure for creating new user accounts.

Adding a user

Continuation of instructions for adding users.

Deleting a user

Steps to remove existing user accounts.

Changing the Admin PIN

Instructions for changing the administrator's PIN.

User authentication for sterilization

Configuring user authentication requirements for programs.

Determining options for the user authentication

Setting up program start and batch approval authentication.

Formatting the CF card

Steps to format the CF card, erasing all data.

Additional drying

How to activate or deactivate additional drying for programs.

Activating/deactivating additional drying for the current program run

Enabling additional drying for a single program.

Intelligent drying

Configuring the intelligent drying feature for optimized drying cycles.

Date and time

Instructions for setting the device's date and time.

Brightness

Adjusting the display brightness and contrast.

Volume

Setting the audio volume for device feedback.

View

Options for selecting the user interface display mode.

Switching from MODERN to CLASSIC

Changing the display theme from modern to classic.

Switching from CLASSIC TO MODERN

Changing the display theme from classic to modern.

MELAconnect

Connecting the device to the MELAconnect mobile application.

Key tone

Enabling or disabling audible feedback for button presses.

Screensaver

Activating and configuring the device's screensaver.

Screensaver

Setting display duration and waiting time for the screensaver.

Log printer MELAprint 42/44

Configuration for using the MELAprint 42/44 log printer.

Label printer MELAprint 60

Configuration for using the MELAprint 60 label printer.

Sensitivity

Adjusting the touchscreen sensitivity.

Energy-saving mode

Configuring energy-saving modes and waiting times.

Switching off the display

Setting the display to automatically switch off when inactive.

Maintenance

Servicing intervals

Schedule and measures for routine device maintenance.

Cleaning

General instructions for cleaning the device surfaces.

Sterilization chamber, chamber sealing face, mount, trays

Specific cleaning procedures for key internal components.

Housing parts

Cleaning instructions for the external housing.

External water storage container

Checks and cleaning procedures for the water storage container.

Avoiding staining

Measures to prevent staining on instruments and the device.

Checking and oiling the door lock

Routine checks and lubrication for the door lock mechanism.

Maintenance

Overall guidance on performing regular maintenance and its importance.

Pause times

Frequency of sterilization

Considerations for pause times between sterilization cycles.

Duration of the operating pause

Measures to take based on the length of an operating pause.

Decommissioning

Steps for preparing the device for extended periods of non-use.

Emptying the double jacket

Procedure for draining the steam generator's double jacket.

Transport

General safety precautions for moving the device.

Transport within the practice

Guidelines for safely moving the device within a facility.

Transport over long-distance / dispatch

Procedures for preparing the device for shipping or long-distance transport.

Recommissioning after relocation

Steps for setting up the device after it has been moved.

Malfunctions

Messages

Overview of different types of notifications displayed by the device.

Troubleshooting online

Information on accessing online troubleshooting resources.

Before contacting the technical service

Preparatory steps before contacting customer service for support.

Displaying messages in MELAconnect

How to view malfunction messages via the MELAconnect app.

Warning and error messages

List of specific warning and error messages with causes and solutions.

Warning and error messages

Continuation of error message list and troubleshooting steps.

Warning and error messages

Further error messages and their corresponding solutions.

Warning and error messages

Additional error codes and troubleshooting guidance.

Warning and error messages

More error messages and their resolutions.

Warning and error messages

Extended list of malfunction messages and troubleshooting advice.

Warning and error messages

Further error messages and troubleshooting steps.

Warning and error messages

Continued troubleshooting for various error codes.

Warning and error messages

Additional malfunction messages and solutions.

Warning and error messages

More error conditions and their resolution steps.

Warning and error messages

Final set of error messages and troubleshooting guidance.

Technical data

Device type

Specifications for Vacuklav 40 B+ and 44 B+ models.

Device dimensions (H x W x D)

Physical dimensions of the steam sterilizer.

Sterilization chamber

Details on the chamber's diameter, depth, and volume.

Electrical connection

Power supply requirements and fuse ratings.

Surrounding conditions

Environmental operating parameters like noise and temperature.

Cooling water connection

Specifications for the cooling water supply.

Feed water connection

Requirements for the feed water supply.

Wastewater connection

Details on the wastewater discharge connection.

Accessories and spare parts

Mounts

Types of mounts available for trays and MELAstore boxes.

Trays

Different tray models and their specifications.

MELAstore System

Information on the MELAstore system for load storage.

Test body system

Details on test body systems for performance checks.

Water treatment

Available water treatment units for feed water.

For the documentation

Accessories related to device documentation and data transfer.

Other

Miscellaneous accessories not fitting other categories.

Spare parts

Specific spare parts for the device, including part numbers.

Glossary

Air leakage

Definition of air leakage and its significance in sterilization.

AKI

Abbreviation for 'Arbeitskreis Instrumentenaufbereitung'.

Authorised technician

Definition of a technician authorized by MELAG.

Batch

Definition of a batch in the context of reprocessing.

Bowie & Dick test

Explanation of the Bowie & Dick test for steam penetration.

CF card

Description of the CF card as a memory medium.

Competent personnel

Definition of personnel qualified for specific tasks.

Condensate

Definition of fluid produced by cooling and separation.

Conductivity

Definition of the ability of a substance to conduct energy.

Corrosion

Definition of chemical alteration of metal materials.

Delay in boiling

Explanation of the phenomenon of superheating fluids.

Demineralised water

Definition of demineralized water and its use.

DGSV

Abbreviation for 'Deutsche Gesellschaft für Sterilgutverordnung'.

DGUV Regulation 1

Reference to German statutory accident insurance regulations.

DIN 58946-7

Standard for steam sterilizers in healthcare.

DIN 58953

Standard for sterilization and sterile equipment supply.

Distilled water

Definition of distilled water and its applications.

Double jacket steam generator

Explanation of the steam generator's function.

Dynamic pressure test of the sterilization chamber

Purpose of the dynamic pressure test.

Empty chamber test

Description of the empty chamber test procedure.

EN 13060

Standard for small steam sterilizers.

Network cable (crossover)

Explanation of crossover network cables.

EN 867-5

Standard for non-biological systems and test bodies.

Porous

Definition of porous materials.

EN ISO 11140-1

Standard for sterilization of products using chemical indicators.

Porous full load

Explanation of the porous full load test.

EN ISO 11607-1

Standard for sterile barrier systems and packaging.

Porous partial load

Explanation of the porous partial load test.

Evacuation

Definition of creating a vacuum.

Process evaluation system

Explanation of the device's self-monitoring system.

Feed water

Definition and purpose of feed water.

Product with narrow lumen

Definition of products with narrow lumens.

Fractionated vacuum procedure

Description of the fractionated vacuum sterilization technique.

Qualified electrician

Definition of a qualified electrician.

FTP

Definition of File Transfer Protocol.

RKI

Abbreviation for Robert Koch Institute.

Heat-up phase

Time required for the steam sterilizer to reach operating temperature.

Simple hollow bodies

Definition of simple hollow body articles.

Load

Definition of items processed in one cycle.

Single wrapping

Definition of single wrapping technique.

Mixed loads

Definition of mixed loads.

Soft sterilization packaging

Definition of soft sterilization packaging.

Multiple wrapping

Definition of multiple wrapping.

Solid

Definition of solid items without gaps.

Solid load

Explanation of the solid load test.

Sterile barrier system

Definition of a sterile barrier system.

Sterile material

Definition of sterilized material.

Sterilization chamber

Definition of the sterilizer's interior.

TCP

Definition of Transmission Control Protocol.

Vacuum

Definition of vacuum in technical terms.

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