MELAG MELAseal Pro Manuale utente

User Manual

MELAseal® Pro

Sealing device

from software version 1.02.03

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

management system is subject to close monitoring: one instrument to this end is our annual multi-day audit conducted in

accordance 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.

Contents

1 General guidelines ...............................................................................................................................................................5

Symbols used ......................................................................................................................................................................5

Formatting rules...................................................................................................................................................................5

Disposal ...............................................................................................................................................................................5

2 Safety.....................................................................................................................................................................................6

3 Description of the device.....................................................................................................................................................7

Intended use ........................................................................................................................................................................7

Scope of delivery .................................................................................................................................................................7

Views of the device..............................................................................................................................................................8

Symbols on the device.........................................................................................................................................................8

Operating and display field ..................................................................................................................................................9

4 Commissioning...................................................................................................................................................................10

Requirements of the installation location ...........................................................................................................................10

Connecting the sealing device...........................................................................................................................................10

Setting the clearance between the cutting edge and the packaging ................................................................................. 10

Switching on the sealing device.........................................................................................................................................11

5 Sealing.................................................................................................................................................................................12

Sealing procedure..............................................................................................................................................................12

Automatic sealing counter .................................................................................................................................................12

Display of the daily batches ...............................................................................................................................................13

Resetting the daily batch counter ......................................................................................................................................13

6 Logging ...............................................................................................................................................................................14

Documenting the sealing process......................................................................................................................................14

Storage structure of the log files ........................................................................................................................................15

Structure of the log files .....................................................................................................................................................15

7 Settings ...............................................................................................................................................................................17

Date and time ....................................................................................................................................................................17

Language...........................................................................................................................................................................17

Sealing temperature ..........................................................................................................................................................18

8 Maintenance........................................................................................................................................................................19

Cleaning and regular checks .............................................................................................................................................19

Maintenance ......................................................................................................................................................................19

Validation ...........................................................................................................................................................................19

9 Pause times ........................................................................................................................................................................20

Pause times .......................................................................................................................................................................20

Transport and storage .......................................................................................................................................................20

10 Optional accessories .......................................................................................................................................................21

Work table Standard ..........................................................................................................................................................21

Work table Comfort............................................................................................................................................................21

Reel dispenser...................................................................................................................................................................21

Foot for the wall mounted reel dispenser...........................................................................................................................21

Contents

11 Malfunctions .....................................................................................................................................................................22

12 Manufacturer's recommendation for routine operation ...............................................................................................24

Performing the peel test.....................................................................................................................................................24

MELAG seal seam stability test .........................................................................................................................................24

13 Standard specifications...................................................................................................................................................25

14 Technical Data ..................................................................................................................................................................26

15 Accessories and spare parts ..........................................................................................................................................27

1 General guidelines

Please read this user manual carefully before commissioning the device. The manual includes important safety instruc-

tions. Make sure that you always have access to digital or printed version of the user manual.

Should the manual no longer be legible, is damaged or has been lost, you can download a new copy from MELAG down-

load centre at www.melag.com.

Symbols used

Symbol Explanation

Indicates a dangerous situation, which if not avoided, could entail slight to life-threatening

injuries.

Draws your attention to a situation, which if not avoided, could result in damage to the

instruments, the practice fittings or the device.

Draws your attention to important information.

Formatting rules

Example Explanation

Universal-

Program

Words or phrases appearing on the display of the device are marked as display text.

Prerequisites for the following handling instruction.

Refer to the glossary or another text section.

Information for safe handling.

Disposal

MELAG devices are synonymous with high quality and a long life-span. When you eventually need to decommission your

MELAG device, the required disposal of the device can take place with MELAG in Berlin. Simply contact your stockist.

Dispose of accessories and consumption media which you no longer require in the appropriate manner. Comply with all

relevant disposal specification in terms of possibly contaminated waste.

The packaging protects the device against transport damage. The packaging materials have been selected for their envi-

ronmentally-friendly disposability and can be recycled. Returning the packaging to the material flow reduces the amount

of waste and saves raw materials.

2 Safety

When operating the device, comply with the following safety instructions as well as those contained in

subsequent chapters. Use the device only for the purpose specified in these instructions. Failure to comply

with the safety instructions can result in injury and/or damage to the device.

Qualified personnel

nOnly competent and trained personnel may use the device.

nThe operator must ensure that the users are regularly trained in the operation and safe handling of the device.

Setup, installation and commissioning

nCheck the device after unpacking for any damage suffered during transport.

nThe device is not suitable for operation in explosive atmospheres.

nInstall and operate the device in a frost-free environment.

nThe device is conceived for use outside the patient area. The device should be located a minimum of 1.5m radius

away from the treatment area.

Power cable and power plug

nOnly the power cable included in the scope of delivery may be connected to the device.

nThe power cable may not be replaced by a cable determined to be insufficient.

Danger of short circuit

nLiquids may not be permitted to reach the interior of the device. This could result in an electrical shock or short circu-

iting.

Repair

nNever open the device housing. Incorrect opening and repair can compromise electrical safety and pose a danger to

the user. The guarantee and warranty are forfeited as soon as the device is opened by anyone other than a MELAG-

authorised technician.

Fan

nThe fan in the device floor must be free at all times and may not be allowed to become blocked or congested. Failure

to comply with this provision can result in the overheating of the electrical components in the interior of the device

and malfunctions.

nCheck the fan grating regularly for cleanliness in order to prevent it from becoming clogged with dust and thereby

preventing insufficient cooling.

Light sensor for automatic in-feed

nEnsure that small components (e.g. from instrument) do not enter the in-feed with the sterilization packaging to be

sealed. The small components could cause damage to the transport mechanism of the device, the sterilization mate-

rial and the sterilization packaging.

nNever introduce any objects into the sealing device other than the packaging materials specified in the user manual.

3 Description of the device

Intended use

This sealing device is designed for application in a medical context, e.g. clinics and medical and dental practices. It was

developed especially for the heat sealing of instruments in sterilization packages and complies with the stand-

ardENISO11607-2 and the German standard DIN1)58953-7.

The rotary sealing device MELAseal Pro is not a medical device as defined by the Medical Device Regulation.

Suitable materials

For the heat sealing of transparent sterilization packages in accordance with EN868-5 e.g. MELAfol reels and pouches

are suitable. Should you wish to use any other packaging materials, please consult your stockist or contact MELAG di-

rectly.

Unsuitable materials

Sterilization package that is not compatible with the requirements of EN868-5, is incompatible with this device. The

following materials are not suitable:

▪ Pure hose film (double-sided film), as these tends to become adhere to the sealing rail, and can restrict the

functionality of the sealing device.

▪ Polyethylene film

▪ Soft PVC film

▪ Hard PVC film

▪ Polyamide film

▪ Polypropylene film

NOTICE

The use of unsuitable packaging materials carries the risk of damage to or malfunction of the device.

nComply with the manufacturer’s recommendations for the sealing temperatures suitable for each type of

packaging material.

Scope of delivery

Please check the scope of delivery before setting up and connecting the device.

Standard scope of delivery

▪ Rotary sealing device MELAseal Pro

▪ User manual

▪ Checklist for installation and record of installation

▪ Declaration of conformity

▪ Warranty certificate

▪ Test and calibration protocol

▪ Power cable

1) DIN=Deutsches Institut für Normung

3 Description of the device

Views of the device

View from front

1 Operating and display panel

2 Conveyor belt

View from left

3 Adjustment wheel for adjusting the

clearance between the seal seam to the

packaging cutting edge

4 Guide rails

View from rear

5678

5 Type plate

6 Serial interface (RS232)

7 Power cable connection

8 Power switch (On/Off)

Symbols on the device

Type plate

Manufacturer of the product

Date of manufacture of the product

3 Description of the device

REF

Article number of the product

Serial number of the product

Observe user manual or electronic user manual

Do not dispose of product in household waste

CE marking

Electrical connection of the product: Alternating current (AC)

Symbols on the power switch

Switching on device

Switching off device

Operating and display field

Key Description

TEMP

Setting the temperature

Reverse key – removing the sterilization packaging upon a blockage of the conveyor belt

COUNT

Setting the total number of batches of a day

OFF

Switch signal tone on and off upon the pre-set total number of batches having been reached

4 Commissioning

Requirements of the installation location

CAUTION

Failure to comply with the set-up conditions can result in injuries, malfunctions and/or damage to the

device.

nComply with all the specifications of this chapter for initial commissioning.

nThe device is not suitable for operation in explosive atmospheres.

nThe device is only intended for use in interior spaces.

nThe device is conceived for use outside the patient area. The device should be located a minimum of 1.5m radius

away from the treatment area.

nInstall the device in a dry and dust-protected location.

nMaintain sufficient clearance to the surrounding surfaces in order to ensure sufficient ventilation.

nEnsure that the sealing device is located away from direct sunshine and outside the range of other sources of heat.

nSet-up the device protected against blows or vibrations.

PLEASE NOTE

In rare cases, direct light can result in the activation of the sealing device conveyor belt which is

controlled by a light-sensitive sensor.

Connecting the sealing device

üThe sealing device has been switched off.

üThe power cable, delivered in the scope of delivery, is present.

uConnect the IEC plug of the power cable to the rear side of the sealing device and connect the power plug in the

power socket.

Setting the clearance between the cutting edge and the packaging

The sealing device permits individual setting of the clearance of the seal seam to the cutting edge of the packaging. An

adjusting screw in a slot is located on the left-hand side of the sealing device.

uLoosen the screw a little in order to slide the guide rail forwards or

backwards.

The scale next to the adjusting screw on the right displays the overhang in millimeters (measured from the outer edge of

the sealed seam).

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