MELAG MELAseal 200 User manual

Operating Manual
MELAseal® 200
Sealing device
from software version 2.22
EN
Dear doctor,
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
management system is subject to close monitoring: one instrument to this end is our annual multi-day audit conducted in
accordance with 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
2 Safety.....................................................................................................................................................................................6
3 Description of the device.....................................................................................................................................................7
Scope of delivery..................................................................................................................................................................7
Intended use ........................................................................................................................................................................7
Views of the device ..............................................................................................................................................................8
Menu structure .....................................................................................................................................................................9
Status display and acoustic signals ...................................................................................................................................10
4 Commissioning...................................................................................................................................................................11
Requirements of the installation location ...........................................................................................................................11
Space requirements...........................................................................................................................................................11
Connecting the sealing device ...........................................................................................................................................12
Switching on the sealing device.........................................................................................................................................12
5 Sealing procedure ..............................................................................................................................................................13
Sealing procedure with pre-finished film bags ...................................................................................................................13
Sealing procedure for film rolls...........................................................................................................................................14
6 Logging ...............................................................................................................................................................................17
Documenting the sealing process......................................................................................................................................17
Using the USB flash drive as an output medium................................................................................................................17
Computer as output medium..............................................................................................................................................18
Structure of the log files .....................................................................................................................................................18
7 Function tests.....................................................................................................................................................................20
Function test with MELAG seal check................................................................................................................................20
8 Settings ...............................................................................................................................................................................22
Access settings menu ........................................................................................................................................................22
Time ...................................................................................................................................................................................22
Date....................................................................................................................................................................................23
Sealing temperature...........................................................................................................................................................23
Signal tones .......................................................................................................................................................................24
User administration ............................................................................................................................................................24
Eco Mode and Standby......................................................................................................................................................24
Force calibration.................................................................................................................................................................26
9 Maintenance........................................................................................................................................................................27
Cleaning and regular controls ............................................................................................................................................27
Maintenance.......................................................................................................................................................................27
Validation ...........................................................................................................................................................................27
Software update.................................................................................................................................................................27
10 Pause times ......................................................................................................................................................................29
Pause times .......................................................................................................................................................................29
Transport and storage........................................................................................................................................................29

Contents
11 Optional accessories .......................................................................................................................................................30
Roll dispenser “standard”...................................................................................................................................................30
Roll dispenser “comfort”.....................................................................................................................................................30
Roll dispenser "Deluxe“......................................................................................................................................................31
Wall-mounted roll dispenser...............................................................................................................................................31
12 Malfunctions .....................................................................................................................................................................32
13 Manufacturer's Recommendation for Routine Operation ............................................................................................35
14 DIN Specifications............................................................................................................................................................37
15 Accessories and spare parts ..........................................................................................................................................39
16 Technical Data ..................................................................................................................................................................40

1 General guidelines
5
1 General guidelines
Please read this operating manual carefully before commissioning the product. The instructions include
important safety information. The functionality and value-retention of this device depend primarily on the
care accorded to it. Make sure to keep the Operating Manual near to the device. It represents a
component of the product.
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.

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.
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 housing of the device. 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 member of a MELAG-authorized technical customer service.

3 Description of the device
7
3 Description of the device
Scope of delivery
Please check scope of delivery before connecting the device.
Standard scope of delivery
▪ 1x MELAseal 200 sealing device
▪ 1x Operating Manual
▪ 1x Instruction protocol
▪ 1x Declaration of conformity
▪ 1x Warranty certificate
▪ 1x Test and calibration protocol
▪ 1x Power cable
▪ 1x Lever
▪ 1x MELAG USB flash drive
▪ 1x Torx key for the fastening screws of the rear housing cover
Intended use
This sealing device is designed for application in a medical context, e.g. clinics and medical and dental
practices. It was especially developed for the heat sealing of instruments in sterilization packaging and
complies with the standards DIN EN ISO 11607-2 and the German DIN 58953 part 7.
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 as those named
above, please consult your stockist first or contact MELAG directly.
Unsuitable materials
▪ Pure hose film (double-sided film), as these types tend to become glued together in the sealing bar, and
can restrict the functionality of the sealing device.
▪ Polythene 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.
nPlease observe the manufacturer information regarding the respective packaging materials
as well as the recommended sealing temperatures.

3 Description of the device
8
Views of the device
1 2
Fig.1: Front view
1 Knife handle
2 Display with control lamp
3.1 4 3.2
5
Fig.2: View from rear
3.1 Bracket for roll dispenser
3.2 Bracket for roll dispenser
4 Socket for power cable
5 USB interface (type B) for
connection to the computer
7
6
Fig.3: Fore left view
6 USB interface for the USB flash
drive
7 Square hole for lever (double-
sided)

3 Description of the device
9
9
10
8
Fig.4: Fore right view
8 Power switch
9 Lever
10 Operating keys
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

3 Description of the device
10
Pressing the keys or repeatedly enables navigation to the ring menu. Pressing returns you
to the next highest menu level.
Status display and acoustic signals
Table1: The meaning of the control lamps and signal tones
Control lamp/
acoustic signal
Possible cause Measure
LED Illuminates orange
Sealing device is in the heating up
or cooling down phase
Please wait until the pre-set sealing
temperature has been reached.
LED flashes red,
Warning signal sounds
The lever is depressed during the
heating phase
The sealing temperature has not
yet been reached.
The lever has been raised early,
despite the required sealing time
not having been reached.
The lever has not been raised,
despite the required sealing time
having been completed.
Clear the display message with .
Please wait until the LED is constantly
illuminated green.
Clear the display message with . Leave
the lever depressed until the message Open
is issued.
Raise the lever as soon as the display
message Open is issued. Otherwise the
sealing procedure will not be completed
successfully. Failure to observe these
provisions can result in the melting of the
film and damage to the sealing device.
LED Illuminates green
The sealing device has reached
the pre-set sealing temperature
and is ready for operation.
The minimum sealing time has
been reached and the sealing
procedure has been ended.
Raise the lever and remove the packaging.
LED flashes green
The sealing procedure runs when
the lever is depressed. The
progress bar will be displayed.
Wait until the green LED control lamp is
constantly illuminated / the display outputs
Open.
LED flashes red, Warn-
ing signal sounds
(fault)
Device fault: The heating phase is
taking too long (> 5 min.); the
sealing device cannot reach the
pre-set sealing temperature.
Switch off sealing device and switch on
again. Upon repeated occurrence, inform
your stockist/customer services