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 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.

Contents
Contents
1 General guidelines ...............................................................................................................................................................5
Symbols used.......................................................................................................................................................................5
Formatting rules ...................................................................................................................................................................5
MELAconnect App ...............................................................................................................................................................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 bags ...................................................................................................................14
Sealing procedure for film rolls...........................................................................................................................................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 tests.....................................................................................................................................................................21
Function test with MELAG 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 controls ............................................................................................................................................28
Maintenance.......................................................................................................................................................................28
Validation ...........................................................................................................................................................................28
Software update.................................................................................................................................................................28

Contents
10 Pause times ......................................................................................................................................................................30
Pause times .......................................................................................................................................................................30
Transport and storage........................................................................................................................................................30
11 Optional accessories .......................................................................................................................................................31
Roll dispenser “standard”...................................................................................................................................................31
Roll dispenser “comfort”.....................................................................................................................................................31
Roll dispenser “Deluxe”......................................................................................................................................................32
Wall-mounted roll dispenser...............................................................................................................................................32
12 Malfunctions .....................................................................................................................................................................33
13 Manufacturer's recommendation for routine operation ...............................................................................................35
Performing the peel test.....................................................................................................................................................36
MELAG seal seam stability test .........................................................................................................................................36
14 Standard specifications...................................................................................................................................................37
15 Technical Data ..................................................................................................................................................................39
16 Accessories and spare parts ..........................................................................................................................................40

1 General guidelines
5
1 General guidelines
Read this user manual carefully before commissioning the device. The user manual includes important
safety information. The functionality and value-retention of this device depends on the care accorded to it.
Store this user manual carefully and in close proximity to your device. It represents a component of the
product.
Should the user manual no longer be legible, damaged or lost, obtain a new copy from MELAG. State the
device type and your address in an e-mail.
The device type is specified on the type plate on the rear of the device.
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
see Chapter 2 Reference to another text section within this document.
Universal-
Program
Words or phrases appearing on the display of the device are marked as display text.
MELAconnect App
The MELAconnect app provides the following functions for MELAG sealing devices integrated in your
practice network from any location in the practice.
▪ Access to user manuals and video tutorials for using the device
▪ Performing quick paperless documentation of routine checks of MELAG sealing devices
▪ Contacting the service technician (contact data must be entered manually)

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 sealing device.
Set-up, 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 circuiting.
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-authorized 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 packaging and
complies with the standardENISO11607-2 and the German standard DIN58953-71).
The bar sealing device MELAseal 200 is not a medical device as defined by the Medical Device Regula-
tion.
Suitable materials
It is suitable for the heat sealing of instruments in transparent sterilization packaging in accordance with
DINEN868-5 e.g. MELAfol. Should you wish to use any other packaging materials, please consult your
stockist or contact MELAG directly.
Unsuitable materials
Sterilization packaging that is not compatible with the requirements of DINEN868-5, is incompatible with
this device:
▪ 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
▪ MELAseal 200 sealing device
▪ User manual
▪ Set up checklist and training protocol
▪ 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
1 2
1 Knife handle
2 Display with control lamp
View from rear
3.1 4 3.2
5
3.1 Bracket for roll dispenser
3.2 Bracket for roll dispenser
4 Power cable connection
5 USB port (type B) for connection
to a computer
View from the left
7
6
6 USB port for USB flash drive
7 Square hole for sealing lever
(both sides)

3 Description of the device
9
View from the right
9
10
8
8 Power switch
9 Sealing lever
10 Operating keys
Symbols on the device
Manufacturer of the product
Date of manufacture of the product
SN
Product serial number from the manufacturer
REF
Article number of the product
Electrical connection of the device: AC current
The user manual includes important safety information. Failure to comply with these
instructions can result in injury and material damage.
Please read this user manual carefully before commissioning the device.
In affixing the CE mark, the manufacturer declares that this product fulfils the
corresponding EU requirements.
The device may not be disposed as domestic waste. The vendor is responsible for
appropriate disposal of the device - it must be delivered to the vendor to be disposed of.

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 test with MELAG seal check
│ ├ Approve? Performing function test 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 keys or repeatedly enables navigation to the ring menu. Pressing returns you
to the next highest menu level.