MELAG MELAseal 101 Comfortable User manual

We reserve the right to make technical alterations
Operating manual
Package Sealing Device
MELAseal®101 “comfortable”
Dear Doctor:
Thank you very much for the trust which you have shown by purchasing this package sealing
device.
For 50 years now, MELAG — a medium-sized family-owned and -operated business — has
specialized in the production of sterilization equipment for medical practice. During this period,
MELAG has succeeded in becoming a leading manufacturer of sterilization equipment. More
than 335,000 MELAG units sold throughout the world testify to the exceptional quality of our
sterilizers.
This package sealing device has also been produced and tested in accordance with the strictest
quality criteria. Please read the operating Instructions. Careful use and maintenance will ensure
that our product has a long working life and maintains ist value.
The staff and management of MELAG

Contents
1. Installation.................................................................................................................................................1
1.1. Overview of appliance............................................................................................................1
1.2. Power cable and pressure lever............................................................................................1
1.3. Sealing temperature...............................................................................................................1
1.4. Wall mounting ........................................................................................................................1
2. Every-day use ...........................................................................................................................................2
2.1. Sealing procedure..................................................................................................................2
2.2. Packaging cutter....................................................................................................................2
2.3. Working with packaging rolls.................................................................................................2
3. Accessories...............................................................................................................................................3
3.1. Work platform.........................................................................................................................3
3.2. Unit-mounted roll holder "Comfort"........................................................................................3
3.3. Wall-mounted roll holder........................................................................................................3
3.4. Acrylic hood ...........................................................................................................................3
3.5. "Standard" roll holder.............................................................................................................3
4. Servicing....................................................................................................................................................3
4.1. Exchanging the sealing rail....................................................................................................3
4.2. Exchanging or turning the cutting blade ................................................................................4
4.3. Spare parts ............................................................................................................................4
4.4 Exploded view of appliance ...................................................................................................5
5. DIN regulations .........................................................................................................................................5
5.1. Width of sealed seams and clear space................................................................................5
5.2. Storage life.............................................................................................................................5
5.3. VDE regulations.....................................................................................................................6

Operating manual MELAseal®101
Page 1
1. Installation
1.1. Overview of appliance _______________________________________________________
1 Cutter 5 Mounting provisions for working
platform
2 Pressure rail 6 Knob (temperature)
3 Sealing rail 7 Lever with cylindrical knob
4 Signal lamp
1.2. Power cable and pressure lever ______________________________________________
The power cable should be plugged into a safety
socket with earthing. The pressure lever can either be inserted in the bottom right or the left bottom side of the appliance.
1.3. Sealing temperature_________________________________________________________
The MELAseal®101 has a very precise regulation
system for the sealing temperature, which is
adjusted by turning the temperature knob (6). With
the transparent packaging material such as
MELAfol®most commonly used in autoclaves by
doctors and dentists (one side paper - one side foil
as described in DIN 58953 Part 4) the temperature
knob should be set to the first third of the area
marked with "MELAfol®". Turning the knob anti-
clockwise lowers the heating power, turning
clockwise increases it. In continuous operation
(more than 20 seals consecutively), the sealing
temperature should be rechecked so that the foil
does not melt and the quality of the seals remains
constant. As long as the same packaging material is
being used, it is then not necessary to adjust the
sealing temperature again during the sealing
operations. A safety delay of 5 seconds between
sealing impulses protects against overheating during
continuous operation.
The use of transparent sterilization packaging with
the MELAseal®foil sealer leads to seals of a uniform
quality. Since this uniformity cannot be guaranteed
with almost all types of tubular foil and these also
lead to excessive wear of the pressing and sealing
rails, the use of the MELAseal®101 is not
recommended with these foils.
1.4. Wall mounting _____________________________________________________________
Holes are provided for wall mounting of the
MELAseal. These are 22 cm apart. The appliance should only be mounted on load-bearing walls using S 6 plugs.
6
1
4
5
2
3
7
MELAseal

Page 2
2. Every-day use
2.1. Sealing procedure __________________________________________________________
The sterilisation packaging should be placed
between the pressure rail (2) and the sealing rail (3)
with the paper side downwards. The sealing impulse
is generated by pressing down the lever until this
engages. This ensures that the sealing pressure is
maintained automatically.
Note! If the lever is not pressed down far enough,
the sealing rail may overheat and burn out because
the sealing pressure is insufficient. During the
sealing process both signal lamps (4) light up. After
two to four seconds the lights go out and the
pressure rail can be disengaged by returning the
lever to its starting position. A relay protects against
overheating if the lever is left in the engaged
position. After the signal lamps have gone out
indicating the end of the sealing process, then
before the next sealing impulse the lever must be
returned to its initial vertical position.
2.2. Packaging cutter ___________________________________________________________
The cutting blade must be dragged quickly across
the foil using the round black knob (1). If the blade is
moved too slowly then the sterilisation packaging
will not be cut properly but will only wrinkle up. The
cutting blade functions when moved to the right and
to the left.
2.3. Working with packaging rolls ________________________________________________
Lay the roll in the holder as shown in the diagram,
inserting it from behind between the pressure and
sealing rails and leading it out at the front. The
paper side must be underneath, so that this is in
contact with the sealing rail (3). Pull out the foil to
the length required, seal and cut off. Insert the item
for sterilisation in the bag formed and seal the open
end.

Operating manual MELAseal®101
Page 3
3. Accessories
3.1. Work platform _____________________________________________________________
The sealing rail is 250 mm wide, so that it is possible
to seal several narrow packages next to one another
in one sealing operation. The work platform, which
can be attached at the two mounting points (5) at
the front of the MELAseal® Package Sealing Device,
makes it easier to seal packages, especially if these
contain heavy instruments.
MELAG Art. No. 104
3.2. Unit-mounted roll holder "Comfort" ___________________________________________
The "Comfort" unit-mounted roll-holder can be used
to save space by mounting the rolls of sterilisation
pack directly onto the MELAseal® Package Sealing
Device. Bolts are supplied to attach it to the rear
side of the Sealing Device.
MELAG Art. No. 105
3.3. Wall-mounted roll holder ____________________________________________________
If the MELAseal®Package Sealing Device is placed
against the wall, or if it is mounted directly on the
wall, then it is best to have a wall-mounted roll
holder positioned directly above it. The wall-
mounted roll-holder can also be installed in a wall
cupboard above the package sealing device, and
the packaging foil fed through a slit in the base of
the cupboard.
Three different positions can be selected, depending
on the width of the roll used, in order to ensure that
the packaging foil is fed properly to the package
sealing device.
MELAG Art. No. 106
3.4. Acrylic hood _______________________________________________________________
The acrylic hood fits over either the "Comfort" roll
holder or the wall-mounted roll holder, to protect the
packaging roll from dust, soiling, etc.
MELAG Art. No. 107
3.5. "Standard" roll holder _______________________________________________________
The "Standard" roll holder can be used to hold the
packaging role directly on the MELAseal® Package
Sealing Device. This roll holder is fixed on the two
mounting points on the rear side of the package
sealer.
MELAG Art. No. 109
4. Servicing
4.1. Exchanging the sealing rail __________________________________________________
First, always disconnect the MELAseal®Package
Sealing Device from the mains power supply. This is
important for all repairs, maintenance and servicing
work. The sealing rail (3) is supplied as a complete
unit by your dealer. Remove the screw to the left of
the defective sealing rail, then push the rail to the
left, and pull it up and forward to remove it.
Disconnect the electrical leads, and attach the
connections to the new sealing rail. Position the
replacement sealing rail on the package sealing
device and then push it to the right until it sits tightly,
Wall

Page 4
then fasten it in place by replacing the screw to the
left of the rail.
If a defective sealing rail has to be replaced because
it is burnt in places, then the pressure rail must also
be replaced at the same time.
If there are burns on the sealing rail, then the Teflon
cover and the elastic intermediate layer on the
pressure rail are very probably also damaged or
burnt. This then results in imperfect contact between
sealing rail and pressure rail at such points, so that
heat will not be conducted away from the sealing
rail. The consequence will be that the new sealing
rail will overheat and will suffer premature damage
and have a much shorter working life.
To replace the pressure rail, loosen the left fastening
bolt and push the rail over the right bolt.
4.2. Exchanging or turning the cutting blade _______________________________________
Loosen the four fastening screws and unscrew the
round black knob, then lift up the cover from the
pressure rail. Undo the fastening screw of the
cutting blade (Warning: The blade is very sharp!).
Turn the blade, or replace it with a new one and
screw back into position. Replace the cover of the
pressure rail. Check that the cutting carriage is
aligned properly with the slot in the cover, and screw
the black knob back into place.
4.3. Spare parts ________________________________________________________________
Article Name Article Name
10105 Sealing rail 26390 Transformer
10115 Pressing rail 20320 Microswitch for pulse initiation
17780 Cutting blade 58700 Microswitch for guide rail
from factory no.: 98 101 11 00
16181 Guide rail 20320 Microswitch for guide rail
to factory no.: 98 101 11 00
17390 Guide wire 39200 Signal lamp, red with pin terminal
19175 Blade holder 24120 Signal lamp, red with cable
19635 Knob for cutting carriage 25080 Spacer (for Art. No. 105, 106)
14405 Knob for temperature regulation 12355 Lever with cylinder knob

Operating manual MELAseal®101
Page 5
4.4 Exploded view of appliance __________________________________________________
1011
5
1010
5
16181
17780
17390 1917
5
1963
5
1440
5
26390
58700
20320
39200
24120
1235
5
5. DIN regulations
5.1. Width of sealed seams and clear space ________________________________________
German Standard DIN 58953 Part 7 requires that
sealed seams in transparent packaging material
should have a width of at least 8 mm. With a width of
10 mm for its sealed seams, the MELAseal® 101 is
considerably better than this minimum requirement.
DIN 58953 Part 7 specifies that a clear space of at
least 30 mm be left below the sealing border
between the sterilisation goods and the seam in
order to ensure a perfect seal without wrinkles. This
applies both for bags and transparent material from
the roll.
5.2. Storage life ________________________________________________________________
Sterile goods packaging Type of packaging Length of storage
unprotected 1Length of storage
protected 2
Paper bags in accordance
with DIN 58 953 Part 3 Sterile goods single packaging 24 hours 6 weeks
Transparent sterilization packaging
in accordance with
DIN 58953 Part 4
Two-stage sterile
goods packaging 6 weeks 6 months
Sterile-goods store
packaging 3 years 3,4
1) E.g. on shelves
2) E.g. in cupboards or drawers
3) Before opening sterile-goods store packaging, dust shall be removed from it in accordance with
regulations.
4) The storage life of sterile-goods store packaging which has been opened is not altered if it has been
closed again in accordance with regulations.

Page 6 Revision 3 – 99/0214 BA_1_GB_seal101comfort.doc
A comment on the table in Section 8.2 of the DIN
standard says:
"The information in the table only represents standard
values. These do not mean that longer storage
periods are not possible under particularly favourable
storage conditions, or that a longer duration of storage
necessarily leads to the pack contents being
recontaminated during storage, but signify that if
these periods are observed, recontamination of the
contents when they are opened and correctly
removed is extremely unlikely."
An additional explanatory note goes into further detail:
"The risk in storing sterile goods is not that micro-
organisms may penetrate the sterile goods
packaging, provided that dry storage conditions
are ensured and the packaging material has the
required germ-proof qualities, but that when the
sterile goods packaging is opened after storage,
micro-organisms contained in dust particles may
be stirred up and could recontaminate the sterile
objects when these are removed.
"The extent of dust loading depends upon the
dust content of the air and on the duration of
storage. For these reasons the storage period
should be kept as short as possible."
5.3. VDE regulations ____________________________________________________________
In accordance with current VDE regulations, this appliance is not suitable for use in areas at risk of
explosion.
It should only be serviced by the manufacturer or a specially authorised agent (dealer or customer service).