MELAG MELAseal 200 User manual

User Manual
MELAseal® 200
Sealing device
from software version 2.28
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.

Contents
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.........................................................................................................................................................9
Menu structure...................................................................................................................................................................10
Status display and acoustic signals...................................................................................................................................11
4 Commissioning...................................................................................................................................................................12
Requirements of the installation location...........................................................................................................................12
Space requirements...........................................................................................................................................................12
Connecting the sealing device...........................................................................................................................................13
Switching on the sealing device.........................................................................................................................................13
5 Sealing.................................................................................................................................................................................14
Sealing procedure with pre-finished film pouches .............................................................................................................14
Sealing procedure for film reels.........................................................................................................................................15
6 Logging ...............................................................................................................................................................................18
Documenting the sealing process......................................................................................................................................18
Using the USB flash drive as an output medium ...............................................................................................................18
Computer as output medium .............................................................................................................................................19
Structure of the log files.....................................................................................................................................................19
7 Function checks .................................................................................................................................................................21
Function check with MELAcontrol Seal Check ..................................................................................................................21
8 Settings ...............................................................................................................................................................................23
Access settings menu........................................................................................................................................................23
Time...................................................................................................................................................................................23
Date ...................................................................................................................................................................................24
Sealing temperature ..........................................................................................................................................................24
Signal tones.......................................................................................................................................................................25
User administration............................................................................................................................................................25
Eco Mode and Standby .....................................................................................................................................................26
Force calibration ................................................................................................................................................................27
9 Maintenance........................................................................................................................................................................28
Cleaning and regular checks .............................................................................................................................................28
Maintenance ......................................................................................................................................................................28
Validation...........................................................................................................................................................................28
Software update.................................................................................................................................................................28

Contents
10 Pause times ......................................................................................................................................................................30
Pause times.......................................................................................................................................................................30
Transport and storage .......................................................................................................................................................30
11 Optional accessories .......................................................................................................................................................31
Reel dispenser Standard ...................................................................................................................................................31
Reel dispenser Comfort.....................................................................................................................................................31
Reel dispenser Deluxe.......................................................................................................................................................32
Wall mounted reel dispenser .............................................................................................................................................32
12 Malfunctions .....................................................................................................................................................................33
13 Manufacturer's recommendation for routine operation ...............................................................................................36
Performing the peel test.....................................................................................................................................................36
MELAG seal seam stability test.........................................................................................................................................36
14 Standard specifications...................................................................................................................................................37
15 Technical Data ..................................................................................................................................................................38
16 Accessories and spare parts ..........................................................................................................................................39

1 General guidelines
5
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
6
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.

3 Description of the device
7
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 bar sealing device MELAseal 200 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
▪ Sealing device MELAseal 200
▪ User manual
▪ Checklist for installation and record of installation
▪ Declaration of conformity
▪ Warranty certificate
▪ Test and calibration protocol
▪ Power cable
▪ Sealing lever
▪ MELAG USB flash drive
1) DIN=Deutsches Institut für Normung

3 Description of the device
8
Views of the device
View from front
12
1 Knife handle
2 Display with control lamp
View from rear
3453
3 Bracket for reel dispenser
4 Power cable connection
5 USB interface (type B) for connection to
the computer
View from left
67
6 USB interface for the USB flash drive
7 Square hole for sealing lever (on both
sides)

3 Description of the device
9
View from right
10
9
8
8 Power switch (On/Off)
9 Sealing lever
10 Operating keys
Symbols on the device
Type plate
Manufacturer of the product
Date of manufacture of the product
REF
Article number of the product
SN
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

3 Description of the device
10
Menu structure
├Standard display output Key
│ └ 180°C/User 1/Ready Temperature/User/Operational readiness
├User User
│ ├ User 01 User 01
│ ├ User 02 User 02
├ ├ User... User...
│ └ User 10 User 10
├Seal chk Function check with MELAcontrol Seal Check
│ ├ approve? Performing function check with seal check
│ └ reminder Activate reminder for seal check
│ ├ weekly Weekly
│ │ ├ Mon on Mondays
│ │ ├ Tue on Tuesdays
│ │ ├ … …
│ │ ├ Sun on Sundays
│ ├ daily daily
│ └ Off Deactivate reminder for seal check
├Settings Settings
│ ├ Temp Sealing temperature
│ ├ Tone Switch signal tones on/off
│ ├ Time Time
│ │ ├ Adjust Set current time
│ │ └ Auto_DST Autom. change from summer/winter time (CET)
│ ├ Date Date (TT-MM-JJ)
│ ├ Eco Mode Eco Mode
│ │ ├ On/Off Switch Eco mode on/off
│ │ ├ Wait Eco 1. Waiting time: Setting the Eco Mode
│ │ └ Wait Stby 2. Waiting time: Setting the standby
│ └ Adj Frc Force calibration
└Info Information
├ Seal Cnt Counter for the sealing procedures
├ Svc Date Date of the next service
├ Svc Cnt Counter until the next service
├ Version Software version
└ S/N Serial number
Pressing the key or repeatedly enables navigation to the ring menu. Pressing returns you to the next
highest menu level.