MELAG MELAseal 100+ User manual

User Manual
MELAseal® 100+
Sealing device
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 ...............................................................................................................................................................4
Symbols used.......................................................................................................................................................................4
Formatting rules ...................................................................................................................................................................4
MELAconnect App ...............................................................................................................................................................4
2 Safety.....................................................................................................................................................................................5
3 Description of the device.....................................................................................................................................................6
Intended use ........................................................................................................................................................................6
Scope of delivery..................................................................................................................................................................6
Views of the device ..............................................................................................................................................................7
Symbols on the device .........................................................................................................................................................8
Status display and acoustic signal .......................................................................................................................................9
4 Commissioning...................................................................................................................................................................10
Requirements of the installation location ...........................................................................................................................10
Wall mounting ....................................................................................................................................................................10
Connecting the sealing device ...........................................................................................................................................11
Switching on the sealing device .........................................................................................................................................11
5 Sealing.................................................................................................................................................................................12
Sealing temperature...........................................................................................................................................................12
Sealing procedure with pre-finished film bags ...................................................................................................................12
Sealing procedure for film rolls...........................................................................................................................................13
6 Maintenance........................................................................................................................................................................15
Cleaning and regular controls ............................................................................................................................................15
7 Pause times ........................................................................................................................................................................16
Pause times .......................................................................................................................................................................16
Transport and storage........................................................................................................................................................16
8 Optional accessories .........................................................................................................................................................17
Roll dispenser “standard” ...................................................................................................................................................17
Roll dispenser “comfort” .....................................................................................................................................................17
Roll dispenser “Deluxe”......................................................................................................................................................18
Wall-mounted roll dispenser...............................................................................................................................................18
9 Manufacturer's recommendation for routine operation .................................................................................................19
Performing the peel test .....................................................................................................................................................20
MELAG seal seam stability test .........................................................................................................................................20
10 Standard specifications...................................................................................................................................................21
11 Technical Data ..................................................................................................................................................................23
12 Accessories and spare parts ..........................................................................................................................................24

1 General guidelines
4
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.
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
5
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
6
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 100+ 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 100+ sealing device
▪ User manual
▪ Declaration of conformity
▪ Warranty certificate
▪ Power cable
▪ Sealing lever
1) DIN=Deutsches Institut für Normung

3 Description of the device
7
Views of the device
View from front
1 2
1 Knife handle
2 Control lamp
View from rear
3.1 4 3.2
3.1 Brackets for roll dispenser left
3.2 Brackets for roll dispenser right
4 Power cable connection
View from the left
6
5
5 Rotary knob for temperature
setting
6 Square hole for sealing lever (on
both sides)

3 Description of the device
8
View from the right
78
7 Sealing lever
8 Power switch (On/Off)
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
9
Status display and acoustic signal
Control lamp /
acoustic signals
Possible cause Measure
LED illuminates
orange
The sealing device is in the heating or
cooling phase.
Wait until the pre-set sealing
temperature has been
reached.
LED flashes red,
warning signal
sounds
▪ The sealing lever is depressed during
the heating phase.
▪ The sealing temperature has not yet
been achieved.
Wait until the LED is
continuously illuminated
green.
LED illuminates
green
▪ The sealing device has reached the pre-
set sealing temperature and is ready for
operation.
▪ The pre-set sealing duration (4 s) has
been reached. The sealing procedure
has been completed.
Raise the sealing lever and
remove the packaging.
LED flashes green The sealing procedure runs when the
sealing lever is depressed (4s).
Wait until the LED is
continuously illuminated
green.
LED illuminates red,
warning signal
sounds (malfunction)
The sealing lever has been raised early,
despite the required sealing duration not
having been reached.
Keep the sealing lever
depressed until the green
LED is continuously
illuminated.
The sealing lever has not been raised,
despite the required sealing duration
having been completed.
Lift the sealing lever as soon
as the sealing duration has
been reached so that the film
is not burnt.
Device malfunction: The heating phase
takes too long (>5min). The sealing
device does not reach the pre-set sealing
temperature.
Upon repeated incidence,
contact an authorized
customer services or stockist
technician.
PLEASE NOTE
Should further status displays or acoustic signals be issued, contact an authorized
customer services or stockist technician.

4 Commissioning
10
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.
uThe device is not suitable for operation in explosive atmospheres.
uThe device is only intended for use in interior spaces.
uThe 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.
uInstall the device in a dry and dust-protected location.
uMaintain sufficient clearance to the surrounding surfaces in order to ensure sufficient ventilation.
uEnsure that the sealing device is located away from direct sunshine and outside the range of other
sources of heat.
uSet-up the device protected against blows or vibrations.
Wall mounting
If the device is not to be placed on a table, it can be mounted on a wall. If this is the case, we recommend
using the wall-mounted roll bracket optionally available. Proceed as follows:
1. Remove the perforated metal wall-mounting metal panels from the base of the sealing device.
2. Drill two Ø6mm boreholes in the wall with a clearance of 16.5mm at the desired mounting height.
16.5 cm
3. Insert two rawl plugs (Ø6mm) with round-head screws (Ø3.5x45mm) in the boreholes.
4. Hang the sealing device on the screws.

4 Commissioning
11
Connecting the sealing device
ü The sealing device has been switched off.
ü Use the power cable included in the scope of delivery.
1. Connect the rubber connector of the power cable to
the rear side of the sealing device and connect the
power plug in the mains socket.
2. Insert the sealing lever in the square hole on the right
or left hand side of the device as required.
Switching on the sealing device
}Switch on the sealing device at the power switch. The
control lamp on the fore side of the sealing device will
illuminate yellow after activation.
Operational Readiness
As soon as the control lamp is continuously illuminated green, the pre-set sealing temperature has been
reached and the sealing device is ready to operate.

5 Sealing
12
5 Sealing
Sealing temperature
Infinitely variable temperature control is performed via the rotary knob on the left-hand side of the sealing
device. The sealing temperature is determined by the type of sterilization packaging. When using MELAfol
transparent sterilization packaging as provided by MELAG, turn the rotary knob to point to the middle of
the area marked with “MELAfol” (corresponds to 180°C).
To reduce the sealing temperature, turn the rotary knob anti-clockwise. To increase the sealing tempera-
ture, turn the rotary knob clockwise.
Sealing procedure with pre-finished film bags
CAUTION
Danger of burns from hot metal parts. The sealing rail is heated continuously when the
sealing device is switched on.
nNever touch the metal surfaces on the sealing rail and in the area of the rear and fore paper
guide directly.
NOTICE
Inserting the packaging inverted can result in the adhesion of film residue to the sealing
rail.
The film side of the packaging must always face upwards.
PLEASE NOTE
When sealing MELAfol bags with a side gusset, ensure compliance with the
manufacturer’s specifications (e.g. the operating manual of MELAfol) especially when
wishing to seal cassettes.
In order to perform a sealing procedure with a prefabricated film bag, proceed as follows:
1. Lead the packaging (the film side facing upwards)
from the front into the paper guide between the
pressure and sealing rail. Ensure maintenance of the
correct clearance between the instrument and seal
seam (see Standard specifications [}page21]).

5 Sealing
13
2. Press the sealing lever down until it latches.
3. Leave the sealing lever depressed until the control lamp flashes green in short intervals (approx. 4s).
4. When the control lamp is continuously illuminated green again, return the sealing lever upwards to its
starting position.
5. Perform a visual inspection of the film after every successful sealing procedure.
PLEASE NOTE
With bags with side gussets, perform weekly controls of the seal seam using an ink test
(e.g. MELAink test).
Sealing procedure for film rolls
Produce film bag
To package instruments in transparent sterilization packaging bags from the roll, proceed as follows:
1. Guide the end of the film roll along the device rear
panel into the lower paper guide with the paper side
facing downwards (lower slit). Slide the film forwards
and between the pressure and sealing rail to the
desired length.
2. Press the sealing lever down until it latches.
3. Leave the sealing lever depressed until the control
lamp flashes green in short intervals (approx. 4s).

5 Sealing
14
4. Ideally, the film should be cut off during the sealing
procedure: Move the knife handle to the other end of
the sealing device quickly; the sealing lever should
remain depressed. Do not return the knife handle.
5. As soon as the LED control lamp is continuously
illuminated green, raise the sealing lever and
remove the film bag thus produced.
Sealing film bags
NOTICE
Inserting the packaging inverted can result in the adhesion of film residue to the sealing
rail.
The film side of the packaging must always face upwards.
To seal the film bag cut to the corresponding length, proceed as follows:
1. Place the instruments to be sterilized in the film bag.
Ensure maintenance of the correct clearance between
the instrument and seal seam (see Standard
specifications [}page21]).
2. Slide the open side of the film bag into the paper
guide from the front.
3. Press the sealing lever down until it latches.
4. Leave the sealing lever depressed until the control lamp flashes green in short intervals (approx. 4s).
5. When the control lamp is continuously illuminated green again, return the sealing lever upwards to its
starting position.
6. Perform a visual inspection of the film after every successful sealing procedure.

6 Maintenance
15
6 Maintenance
Cleaning and regular controls
Comply with the following information when cleaning:
uSwitch off the sealing device at the power switch and remove the power plug before cleaning.
uThe cleaning cloth may never be allowed to become entirely wet in order to prevent water from
entering the interior of the sealing device.
Frequency Measure
When necessary
and every 6
months
Clean the exterior of the sealing device with a dry or damp, non-fuzzing cloth and
where necessary with a neutral fluid cleaner or spirit. Only at persistent soiling, use a
mild stainless steel cleaning agent with a pH value between 5 and 8.

7 Pause times
16
7 Pause times
Pause times
The sealing device can remain switched on over longer operating pauses of many hours. MELAG recom-
mends switching off the device during long operating pauses to save energy.
Transport and storage
NOTICE
Damage to the housing and the device interior as a result of using unsuitable transport
packaging.
nOnly transport the device in its original packaging or other suitable packaging.
▪ Store and transport the device frost-free.
▪ Avoid strong shocks/vibrations.
▪ Store the device in a fashion protected against moisture.

8 Optional accessories
17
8 Optional accessories
Roll dispenser “standard”
The roll dispenser “standard” is placed directly behind the
sealing device. The rolls of film are placed into the cavity
and held in position using additional spacers located to the
left and right. This prevents them from slipping.
}Hook the roll dispenser “standard” into the outside
brackets to fix it on the rear panel of the sealing
device.
Roll dispenser “comfort”
The roll dispenser “comfort” enables space-saving storage
of the film rolls over the sealing device. The rolls are slid
onto the rod laterally and held in position via additional
spacers to the left and right. This prevents the roll from
slipping.
}Hook the roll dispenser into the outside brackets to fix
it on the rear panel of the sealing device.

8 Optional accessories
18
Roll dispenser “Deluxe”
In the roll dispenser “Deluxe”, the rolls of film are stored
above the sealing device, thus saving space. The
integrated feeding device enables easy feeding of the film
via a hand wheel.
Further information regarding assembly and operation is
specified in the appendent operating manual.
Wall-mounted roll dispenser
Mounted on the wall directly over the sealing device, the
wall-mounted roll dispenser saves space.

9 Manufacturer's recommendation for routine operation
19
9 Manufacturer's recommendation for
routine operation
See also “Manufacturer’s Recommendation for Routine Operation”.
Video tutorial
Frequency Check: Measures
Daily before operation Making and checking a
test seal seam
Visual check:
▪ The seal seam should be distinct and even and
not contain any creases or defects.
▪ The colour of the seal seam should be identical
with the works seal seam (industrial seam).
▪ The seal seam may not be too light or brown (too
light: Sealing temperature and/or contact
pressure (sealing force) too low; brown sealing
temperature too high or sealing duration too
long).
Mechanical check:
▪ Tear-resistance check: the strength required to
open the seal seam must be exactly equal to that
required to open the works-side seam, i.e.
industrial seam, see Performing the peel test
[}page20].
▪ During peeling, the paper should free itself from
the film, leaving almost no residue.
Following every
sterilization
Batch-related seal seam
check
▪ Control the entire packaging for dryness and
integrity.
▪ Clearance after sterilization, documentation within
the scope of process approval.
▪ Check for dryness and integrity once again,
before using the instruments.
Weekly Check the seal seam with
resources
Perform a visual control using MELAG Seal Check
and document the results (e.g. using the
MELAconnect app) – for criteria and further
information, see the MELAG Seal Check operating
manual.
Annually Check the seal seam for
tear-resistance in
accordance with
DINEN868-5, AppendixD
See MELAG seal seam stability test [}page20]
Upon malfunction
messages or obviously
faulty seals
Remedying the
malfunction
Do not operate a defective sealing device. Inform
an authorized customer services.

9 Manufacturer's recommendation for routine operation
20
Performing the peel test
1. Seal a transparent sterilization packaging in the sealing device.
2. Place the sealed transparent sterilization packaging in a sterilization cycle.
3. Working by hand, pull the seal seam apart slowly along the direction of peeling. Perform a visual
check to verify whether the seal seam extends consistently along its entire width and length. No more
than 10 mm paper fraying is permitted on the seal seams.
4. Document the results.
MELAG seal seam stability test
For validating your sealing processes MELAG provides a seal seam stability test for a cost price of
125.00€ plus V.A.T. (state 01/2020). After the film test strips have been tested successfully, MELAG will
issue a certificate. This certificate confirms conformity of the seal seam with the standard DINEN868-5,
AppendixD. Use the MELAG seal seam stability test application form. The application form can be down-
loaded from the MELAG homepage (Service/Download Center).