MELAG MELAseal 100+ User manual

Operating Manual
MELAseal® 100+
Sealing device
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 man-
agement system is subject to close monitoring: one instrument to this end is our annual multi-day audit conducted in ac-
cordance 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 ...............................................................................................................................................................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 .......................................................................................................................................8
4 Commissioning.....................................................................................................................................................................9
Requirements of the installation location .............................................................................................................................9
Wall mounting ......................................................................................................................................................................9
Connecting the sealing device ...........................................................................................................................................10
Switching on the sealing device .........................................................................................................................................10
5 Sealing.................................................................................................................................................................................11
Sealing temperature...........................................................................................................................................................11
Sealing procedure with pre-finished film bags ...................................................................................................................11
Sealing procedure for film rolls...........................................................................................................................................12
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 DIN Specifications............................................................................................................................................................21
11 Technical Data ..................................................................................................................................................................23
12 Accessories and spare parts ..........................................................................................................................................24

1 General guidelines
4
1 General guidelines
Please read this operating manual carefully before commissioning the product. The instructions include im-
portant 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
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, please ensure that you observe the following safety
instructions as well as those contained in the following 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.
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 sealing 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 especially developed for the heat sealing of instruments in sterilization packaging and
complies with the standards DINENISO11607-2 and DIN58953-7.
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
▪ Operating manual
▪ Declaration of conformity
▪ Warranty certificate
▪ Power cable
▪ Lever
▪ Torx key for the fixing screws of the rear housing cover

3 Description of the device
7
Views of the device
1 2
Fig.1: Front view
1 Knife handle
2 Control lamp
3.1 4 3.2
Fig.2: View from rear
3.1 Bracket for roll dispenser (left)
3.2 Bracket for roll dispenser (right)
4 Socket for power cable
6
5
Fig.3: Fore left view
5 Rotary knob for temperature
adjustment
6 Square hole for lever (on both
sides)
78
Fig.4: Fore right view
7 Lever
8 Power switch (ON/OFF)

3 Description of the device
8
Symbols on the device
Date of manufacture of the product
Please read this operating 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.
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 lever is depressed during the
heating phase.
▪ The sealing temperature has not yet
been reached.
Wait until the LED is
constantly illuminated green.
LED Illuminates
green
▪ The sealing device has reached the pre-
set sealing temperature and is ready for
operation.
▪ The pre-set sealing time (4s) 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 (4s).
Wait until the LED is
constantly illuminated green.
LED flashes red,
warning signal
sounds (malfunction)
The lever has been raised early, despite
the required sealing time not having been
reached.
Keep the lever depressed
until the green LED is
constantly illuminated.
The lever has not been raised, despite the
required sealing time having been
completed.
Lift the lever as soon as the
sealing time has been
reached so that the film is
not burnt.
Device fault: The heating phase is taking
too long (>5min); the sealing device does
not reach the pre-set sealing temperature.
Upon repeated occurrence,
inform your stockist/MELAG
customer services.
PLEASE NOTE
If further status displays or acoustic signals occur, contact the MELAG customer service/
service technician.

4 Commissioning
9
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
10
Connecting the sealing device
Check the following points before connecting:
ü The sealing device has been switched off.
ü Use only the power cable included in the scope of delivery.
1. Connect the one end of the power cable with the
port on the rear of the sealing device and the other
end with a mains socket with an approved voltage
supply.
2. Insert the lever in the square hole on the left or right
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
11
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 knob leftwards in an anti-clockwise direction. To increase the
sealing temperature, turn the rotary knob rightwards in a clockwise direction.
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 cutting bar or in the area of the rear and fore paper
guide directly.
NOTICE
Should the packaging be inserted incorrectly, this could result in the deposit of film
residue on the sealing rail.
nThe film side of the packaging must always face upwards.
PLEASE NOTE
When sealing MELAfol bags with a side crease, ensure compliance with the
specifications of the relevant operating manual, especially when wishing to seal
cassettes.
In order to perform a sealing procedure with prefabricated foil bags, proceed as follows:
1. Introduce the packaging in the paper guide with the
foil side facing upwards and push the packaging
through the pressure rail and sealing rail. Ensure
maintenance of the correct clearance between the
instrument and seal seam (consult the section DIN
Specifications [}page21]).

5 Sealing
12
2. Press the lever forwards to its fullest extent until it
snaps.
3. Leave the lever depressed as long as the control lamp flashes green in short intervals (for approx.
four seconds).
4. When the control lamp is continually illuminated green again, return the lever upwards to its starting
position.
5. Perform a visual inspection of the film after every successful sealing procedure.
ÊThe sealing procedure has been completed successfully.
Sealing procedure for film rolls
Produce film bag
If the instruments are packaged from the roll in transparent sterilization packaging bags, proceed as fol-
lows:
1. Introduce the film in the paper guide from the rear
with the film side pointing upwards (lower slit) and
slide the film forward between the pressure and
sealing rail up to the desired length.
2. Press the lever forwards to its fullest extent until it
snaps.
3. Leave the lever depressed as long as the control
lamp flashes green in short intervals (for approx.
four seconds).

5 Sealing
13
4. Ideally, the film should be cut off during the sealing
procedure: Move the knife to the other end of the
sealing device quickly; the lever should remain
depressed. Do not return the knife handle.
5. As soon as the control lamp is continuously
illuminated green, raise the lever and remove the
film bag thus produced.
Sealing film bags
NOTICE
Should the packaging be inserted incorrectly, this could result in the deposit of film
residue on the sealing rail.
nThe film side of the packaging must always face upwards.
To seal on the corresponding length, proceed as follows:
1. Place the instrument in the film bag. Ensure
maintenance of the correct clearance between the
instrument and seal seam. Consult the section DIN
Specifications [}page21].
2. Slide the open side of the film bag from the front into
the paper guide.
3. Press the lever forwards to its fullest extent until it
snaps.
4. Leave the lever depressed as long as the control lamp flashes green in short intervals (for approx.
four seconds).

5 Sealing
14
5. When the control lamp is continually illuminated green again, return the lever upwards to its starting
position.
6. Perform a visual inspection of the film after every successful sealing procedure.
ÊThe sealing procedure has been completed successfully.

6 Maintenance
15
6 Maintenance
Cleaning and regular controls
Frequency Action
Every 6 months Clean the exterior of the sealing device with a dry or damp, non-fuzzing cloth and a
stainless steel-cleaning agent suitable for use with medical devices. It should not
deposit any oily residue.
Comply with the following information when cleaning:
▪ Switch off the sealing device at the mains and remove the cable before cleaning.
▪ The cleaning cloth may never be allowed to become entirely wet in order to prevent
water from entering the interior of the sealing device.

7 Pause times
16
7 Pause times
Pause times
The sealing device can remained switched on over longer operating pauses of many hours. We re-
commend that the device remain switched off during long operating pauses so as 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.
Storage
Store the device in such a way to protect it against humidity.

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/action Criteria
Daily before operation Making and checking a
sample seal seam
Visual check:
▪ The seal seam should be distinct and even and
not contain any creases or defects.
▪ The sealing seam should be almost identical with
the works sealing seam, i.e. an industrial seal
with an identical edge in terms of colour.
▪ The seal seam may not be too light or exhibit a
brown colour. If too light: sealing temperature
and/or contact pressure (sealing force) is too low;
brown: sealing temperature is too high/sealing
duration too long.
Mechanical check:
▪ Tear-resistance check: the strength required to
open the seam must be exactly equal to that
required to open the factory-produced seam, see
Performing the peel test [}page20].
▪ When peeled off, the paper should free itself from
the film, leaving almost no residue.
Following every
sterilization
Batch-related test of the
seam
▪ Check 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 Checking the seal seam
with resources
Perform a visual check using MELAG seal check
and document the results (e.g. with the
MELAconnect App) - for criteria and further
information, see the MELAG seal check operation
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 sterilization package in the sealing device.
2. Process the sealed sterilization package 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 sealing seam extends consistently along the whole width and length of the
sterilization package just sterilized. No paper residue greater than 10mm is permitted on the seal
seam.
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 01/2019). 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).