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.