MELAG SiroSeal Professional Manual de usuario
User Manual
SiroSeal Professional
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 ENISO13485. 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 .....................................................................................................................................................19
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
Please read this user manual carefully before commissioning the device. The manual includes important
safety instructions. Make sure that you always have access to digital or printed version of the user manual.
Should the user manual no longer be legible, is damaged or has been lost, you download a new copy from
MELAG. download centre at www.melag.com.
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
1.5m 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 standardENISO11607-2 and the German standard DIN58953-71).
The bar sealing device is not a medical device as defined by the Medical Device Regulation.
Suitable materials
It is suitable for the heat sealing of instruments in transparent sterilization packaging in accordance with
DINEN868-5 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 DINEN868-5, 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
▪ Sealing device SiroSeal Professional
▪ 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 (4s).
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 (>5min). 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
1.5m 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 Ø6mm boreholes in the wall with a clearance of 16.5mm at the desired mounting height.
16.5 cm
3. Insert two rawl plugs (Ø6mm) with round-head screws (Ø3.5x45mm) in the boreholes.
4. Hang the sealing device on the screws.
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