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MELAG Vacuklav 41 B+ Evolution User Manual

MELAG Vacuklav 41 B+ Evolution
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User Manual
Vacuklav
®
41 B+ Evolution
Vacuklav
®
43 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 treatment 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 41 B+ Evolution Specifications

General IconGeneral
Chamber Volume23 liters
MaterialStainless steel
TypeAutoclave
Sterilization Temperature Range121°C to 134°C
Sterilization Time Range3 to 60 minutes
Power Supply230 V / 50-60 Hz
Power Consumption2.5 kW
ProgramsTest programs
ControlMicroprocessor
DisplayLCD

Summary

General Guidelines

Symbols Used

Explains symbols used in the manual for clarity and safety.

Formatting Rules

Outlines conventions for text and references within the document.

MELAconnect App

Describes the mobile app for monitoring device status and progress.

Safety

Qualified Personnel

Specifies that only competent personnel should operate the sterilizer.

Set-up, Installation and Commissioning

Details requirements for safe device installation and initial operation.

Power Cable and Power Plug

Provides safety instructions for handling the power cord and plug.

Spring Loaded Safety Valve

Emphasizes ensuring the proper function of the safety valve.

Reprocessing and Sterilization

Guides on following manufacturer instructions for instruments and textiles.

Program Abort

Warns about steam emission and potential unsterility after program abort.

Removing the Sterilized Equipment

Advises on safe handling of hot equipment and checking packaging.

Transport and Storage

Outlines precautions for moving and storing the device safely.

Maintenance

Stresses that maintenance must be done by authorized technicians.

Malfunctions

Advises turning off the device for repeated malfunctions.

Notification Requirement in the Event of Serious Accidents

Mandates reporting serious accidents involving the medical product.

Performance Specifications

Intended Use

Defines the device's purpose and application in medical contexts.

Sterilization Procedure

Explains the fractionated vacuum procedure for steam sterilization.

Type of the Feed Water Supply

Describes the one-way feed water system and its quality monitoring.

Safety Equipment

Details internal process monitoring and door mechanism safety features.

Overview of Sterilization Programs (Type B)

Summarizes compliance of different programs with EN 13060 standards.

Program Sequences

Details the phases of a standard sterilization program and vacuum test.

Description of the Device

Scope of Delivery

Lists all items included in the standard package for the device.

Views of the Device

Provides detailed diagrams and labels for front and rear views.

Service Hatch

Explains the procedure for opening and closing the service hatch.

Symbols on the Device

Identifies and explains various symbols found on the device itself.

Load Mounts

Describes how to fix and use mounts for various load holders.

Energy-Saving Key

Explains activation and deactivation of the energy-saving mode.

Colour-Touch Display

Details the interface elements of the 5-inch colour touch display.

LED Status Bar

Explains the meaning of different LED colours on the status bar.

First Steps

Setup and Installation

Notes compliance with technical manual for building-side requirements.

Record of Installation and Setting Up

Describes the process for documenting installation and commissioning.

Feed Water Supply

Covers requirements for distilled/demineralized water and connections.

Using the Internal Water Storage Tank

Explains how to fill and use the internal water storage tank.

Switching on the Steam Sterilizer

Guides on powering on the device and initial screen interaction.

Opening and Closing the Door

Details the automatic door locking mechanism and safe operation.

Closing the Door

Provides instructions for securely closing the door and engaging the lock.

Manual Door Emergency-Opening

Explains the procedure for manually opening the door in emergencies.

Loading the Steam Sterilizer

Preparing the Sterilization Material

Emphasizes cleaning, disinfection, and drying of instruments and textiles.

Decontaminating the Instruments

Provides detailed steps for instrument preparation and warnings.

Decontaminating Textiles

Outlines procedures for textile preparation and warnings about improper handling.

Loading the Steam Sterilizer

Gives instructions for correct loading to ensure effective sterilization and drying.

Packaging

Specifies requirements for packaging materials and systems.

Closed Sterilization Containers

Explains how to use closed containers for optimal results.

Soft Sterilization Packaging

Provides guidance on using soft packaging materials like MELAfol.

Multiple Wrapping

Explains the use of multiple wrapping layers for sterilization.

Mixed Loads

Offers advice on arranging mixed loads for proper sterilization.

Sterilization

Important Information Regarding Routine Operation

Highlights compliance with RKI and DIN standards for daily checks.

Manufacturer's Recommendation for Routine Operation

Provides a table for necessary checks and their frequency.

Selecting the Program

Guides on choosing the correct program based on material and packaging.

Additional Programs

Lists and describes optional programs like Vacuum test and Bowie & Dick test.

Additional Program Options

Explains options like additional drying and start time pre-selection.

Start Time Pre-Selection

Details how to schedule program start times.

Starting the Program

Instructs on initiating a sterilization program, including user authentication.

Program Run

Describes the program phases and how to monitor progress.

Following the Program Run on the Computer

Explains remote monitoring of the program via a web browser.

Manual Program Abort

Details how to cancel a program and the implications.

Program Abort Before Drying

Warns about unsterile loads if drying is interrupted early.

Program Abort After Drying

Advises on aborting during drying and potential issues.

Program End

Describes successful program completion and viewing results.

The Approval Process

Explains the batch indication and approval process requiring user authentication.

Removing the Sterilized Equipment

Provides safety guidelines for unloading sterilized items.

Storing Sterilized Equipment

Offers recommendations for proper storage of sterile items.

Logging

Batch Documentation

Explains the importance of batch documentation for quality assurance.

Output Media

Lists available media for outputting logs (CF card, printer, computer).

Using the CF Card as an Output Medium

Details how to insert and use a CF card for log storage.

Using the Computer as an Output Medium

Guides on connecting the sterilizer to a computer for log transfer.

Reading Out a Text Log on the Computer

Explains how to open and view log files on a PC.

Using the Label Printer as an Output Medium

Describes using a label printer for batch traceability.

Outputting Text Logs Automatically

Covers automatic log output upon program completion.

Subsequent Log Output

Explains how to output logs manually after the program has ended.

Outputting a Log from the Log List

Details how to select and output specific logs from the memory.

Outputting Daily/Weekly Logs

Provides steps for outputting logs by specific timeframes.

Finding a Log

Guides on locating and storing logs on memory media.

Storage Location for Logs

Describes where log files are stored on CF cards and computers.

Log Directory

Explains the folder structure for log files.

Example Log of a Completed Program

Shows a sample log entry with explanations of its fields.

Function Tests

Manual Functional Checks

Mentions following program runs and using logs for success determination.

Vacuum Test

Explains how to perform a vacuum test to check for leakages.

Bowie & Dick Test

Details the Bowie & Dick test for steam penetration assurance.

Indicator Evaluation

Guides on interpreting the results of the Bowie & Dick test indicator.

Settings

Logging

Covers settings for text/graphic log output, medium, and format.

Immediate Log Output

Explains how to activate or deactivate automatic log output.

Deactivate Immediate Output

Details steps to disable immediate log output.

Outputting Graphic Logs (Optional)

Describes how to enable graphic log output.

Log Output in English

Guides on setting the log printer language to English.

Using the Computer as an Output Medium

Explains network connection for log transfer to computer.

Connection via FTP

Details FTP connection settings for computer output.

Connection via TCP

Details TCP connection settings for computer output.

IP Addresses

Lists default IP addresses for device network integration.

Log Format

Explains different formats for outputting log data.

User Administration

Covers setting up user IDs and PINs for authentication.

Adding a User

Details the process of creating new user accounts.

Deleting a User

Explains how to remove user accounts.

Changing the Admin PIN

Guides on changing the administrator password.

User Authentication for Sterilization

Explains options for requiring user PIN for operations.

Determining Options for User Authentication

Details settings for user authentication requirements.

Formatting the CF Card

Guides on formatting the CF card, including data loss warning.

Additional Drying

Explains activating/deactivating additional drying features.

Intelligent Drying

Describes the intelligent drying process.

Water Supply

Covers selecting internal or external water supply sources.

Date and Time

Guides on setting the device's date and time accurately.

Brightness

Explains how to adjust display brightness and contrast.

Volume

Details how to adjust the device's audio volume.

View

Allows selection between classic and modern interface views.

Switching from MODERN to CLASSIC

Explains changing the interface from modern to classic view.

Switching from CLASSIC to MODERN

Explains changing the interface from classic to modern view.

MELAconnect

Guides on connecting the sterilizer to the mobile app.

Key Tone

Explains how to enable or disable key press tones.

Screensaver

Covers activating the screensaver and selecting images.

Select Images for the Slide Show

Details how to choose pictures for the screensaver.

Set Display Duration and Waiting Time

Explains setting display timing for the screensaver.

Sensitivity

Allows adjustment of touchscreen sensitivity.

Energy-Saving Mode

Explains how to activate and configure energy-saving settings.

Switching off the Display

Guides on configuring the display to switch off automatically.

Maintenance

Servicing Intervals

Lists recommended maintenance tasks and their frequency.

Cleaning

Provides general cleaning advice and warnings about damage.

Door Seal, Chamber, Mounts, Trays

Details weekly checks and cleaning of these components.

Housing Parts

Explains how to clean external housing parts.

Internal Storage Tank

Covers checks and cleaning for the internal water storage tank.

Emptying the Internal Storage Tank

Provides step-by-step instructions to drain the storage tank.

Cleaning Feed and Waste Water Sides

Details cleaning procedures for the water tank's feed and waste sides.

Avoiding Staining

Explains how to prevent staining caused by instrument decontamination.

Oiling the Door Spindle

Guides on lubricating the door spindle every two months.

Maintenance

Stresses timely maintenance by authorized technicians and its importance.

Pause Times

Frequency of Sterilization

Notes that chamber temperature is maintained between programs.

Duration of the Operating Pause

Outlines measures for different pause durations to save energy or maintain device.

Decommissioning

Provides steps for preparing the sterilizer for long periods of inactivity.

Emptying the Double Jacket

Explains how to drain the double jacket steam generator.

Transport

Gives safety precautions for moving the device.

Transport Within the Practice

Details safe transport procedures within the facility.

Transport Over Long-Distance / Dispatch

Mentions preparation for external transport.

Recommissioning After Relocation

Refers to the technical manual for recommissioning after a move.

Malfunctions

Messages

Explains informational messages that support operation.

Warnings

Describes warning messages that help prevent issues.

Malfunction Messages

Details error messages indicating unsafe operation or sterilization failure.

Displaying Events in MELAconnect

Guides on transferring malfunction messages to a mobile device.

Warning and Error Messages

Provides detailed troubleshooting for specific error codes.

Technical Data

Accessories and Spare Parts

Glossary

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