3 Description of the device
7
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 58953-7
1)
.
The bar sealing device MELAseal 200 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.
n
Comply 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 200 sealing device
▪ User manual
▪ Set up checklist and training protocol
▪ Declaration of conformity
▪ Warranty certificate
▪ Test and calibration protocol
▪ Power cable
▪ Sealing lever
▪ MELAG USB flash drive
1)
DIN = Deutsches Institut für Normung
