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User Manual
MELAseal
Sealing device
from software version 1.02.03
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 reprocessing and hygiene field.
You, our customer are justified in your demand for the best products, quality and reliability. Providing
hygiene"
and
"Quality – made in
management system is subject to close monitoring: one instrument to this end is our annual multi-day audit conducted in
accordance 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.
®
Pro
Germany", we guarantee that these demands will be met. Our certified quality
"competence in
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Related Manuals for MELAG MELAseal Pro
Summary of Contents for MELAG MELAseal Pro
- Page 1 1.02.03 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.
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Page 3: Table Of Contents
Contents Contents 1 General guidelines ................................ 5 Symbols used .................................. 5 Formatting rules................................... 5 Disposal .................................... 5 2 Safety..................................... 6 3 Description of the device.............................. 7 Intended use .................................. 7 Scope of delivery ................................. 7 Views of the device................................ 8 Symbols on the device................................. 8 Operating and display field .............................. 9 4 Commissioning................................... 10 Requirements of the installation location ........................... 10 Connecting the sealing device............................ 10... - Page 4 Contents 11 Malfunctions .................................. 22 12 Manufacturer's recommendation for routine operation .................... 24 Performing the peel test.............................. 24 MELAG seal seam stability test ............................ 24 13 Standard specifications .............................. 25 14 Technical Data .................................. 26 15 Accessories and spare parts ............................ 27...
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Page 5: General Guidelines
Make sure that you always have access to digital or printed version of the user manual. Should the manual no longer be legible, is damaged or has been lost, you can download a new copy from MELAG down- load centre at www.melag.com. -
Page 6: Safety
Never 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- authorised technician. -
Page 7: Description Of The Device
German standard DIN 58953-7. The rotary sealing device MELAseal Pro is not a medical device as defined by the Medical Device Regulation. Suitable materials For the heat sealing of transparent sterilization packages in accordance with EN 868-5 e.g. MELAfol reels and pouches are suitable. -
Page 8: Views Of The Device
3 Description of the device Views of the device View from front Operating and display panel Conveyor belt View from left Adjustment wheel for adjusting the clearance between the seal seam to the packaging cutting edge Guide rails View from rear Type plate Serial interface (RS232) Power cable connection... -
Page 9: Operating And Display Field
3 Description of the device Article number of the product Serial number of the product Observe user manual or electronic user manual Do not dispose of product in household waste CE marking Electrical connection of the product: Alternating current (AC) Symbols on the power switch Switching on device Switching off device... -
Page 10: Commissioning
4 Commissioning 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. Comply with all the specifications of this chapter for initial commissioning. The device is not suitable for operation in explosive atmospheres. The device is only intended for use in interior spaces. -
Page 11: Switching On The Sealing Device
4 Commissioning Switching on the sealing device ü The sealing device is connected to the power supply. Switch on the sealing device at the power switch. Ê After switching on the sealing device, the display shows the message Heating up. It takes approx. 3-5 min before the pre-set sealing temperature of 180 °C is reached. -
Page 12: Sealing
5 Sealing 5 Sealing Sealing procedure NOTICE Inserting the packaging incorrectly can result in the adhesion of film residue to the sealing rail. Always guide the packaging into the device with the film side pointing upwards. PLEASE NOTE When sealing MELAfol pouches with a side gusset, ensure compliance with the manufacturer’s specifications (e.g. -
Page 13: Display Of The Daily Batches
5 Sealing Display of the daily batches The daily batch counter #: 000 is displayed in the upper right-hand corner of the display: It counts the number of seals performed in the course of one day. If the sealing device is switched off, the counter is reset to 000. PLEASE NOTE This does not reset the total batch counter. -
Page 14: Logging
6 Logging 6 Logging Documenting the sealing process EN ISO 11607-2 requires that the sealing process is monitored and documented in order to satisfy the requirement for compliance with the specifications contained in part 2 of the standard. As a result, you are able to record the logs of the sealing procedures, to output and archive them on the following output media: ▪... -
Page 15: Storage Structure Of The Log Files
The daily logs are saved in English. Example of a log with several sealing procedures: -------------------- MELAG MEDIZINTECHNIK -------------------- 10 MELAG MELAseal Pro 25 Date: 06.01.2010 80 SerNr: 2009SPF0001 | |Time |Charge|Tmp|Prs|Vel|Limits |CRC |--|-----|------|---|---|---|-----------------------|---- |OK|09:19| 00012|180|098|087|185-175 120-090 120-078|F228(PC) - Page 16 6 Logging Key: Row 10 - Designation of the sealing device Row 25 - Date of sealing procedures (dd.mm.yyyy) Row 80 - Serial number of the sealing device OK / !! - Sealing procedure successful / sealing procedure unsuccessful Time - Time of the sealing procedure Batch - Total number of charges...
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Page 17: Settings
7 Settings 7 Settings Date and time The date and time must be set correctly so that the time of the sealing procedure can be logged correctly and a clear al- location to the time of sealing can be established. Date To set the current date, proceed as follows: Switch on the sealing device at the power switch. -
Page 18: Sealing Temperature
The sealing temperature is determined by the type of sterilization packaging. The sealing temperature for MELAfol reels and pouches is 170-190 °C. MELAG recommends a sealing temperature of 180 °C. When using MELAfol transparent sterilization package retain the works setting sealing temperature of 180 °C. When using sterilization packages from oth- er manufacturers, comply with their specifications. -
Page 19: Maintenance
Continuing operation beyond the maintenance interval can result in malfunctions in the device! Maintenance should only be performed by trained and authorised technicians. Maintain the specified maintenance intervals. Carry out maintenance with an original maintenance set prepared by MELAG. Only original MELAG spare parts may be used. Validation Your sealing device complies with all standard requirements for the validation of the sealing procedure in accordance with EN ISO 11607-2. -
Page 20: Pause Times
9 Pause times 9 Pause times Pause times The sealing device can remain switched on over longer operating pauses of many hours. MELAG recommends 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. -
Page 21: Optional Accessories
10 Optional accessories 10 Optional accessories Work table Standard The work table Standard is placed directly in front of the sealing device. The work table makes it easier to seal light packaging. Work table Comfort The work table Comfort is placed directly in front of the sealing device. -
Page 22: Malfunctions
11 Malfunctions Troubleshooting online All messages with current descriptions can be found in the Troubleshooting portal on the MELAG website (https://www.melag.com/en/service/troubleshooting). WARNING Improper opening of the housing cover brings the danger of an electric shock. Never open the sealing device housing cover without authorisation. - Page 23 11 Malfunctions Malfunction messages The warning and malfunction messages are confirmed with Event Possible causes What you can do TEMP 1 The temperature does not increase fast Switch off the sealing device and then on again. enough after switching on the sealing device.
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Page 24: Manufacturer's Recommendation For Routine Operation
MELAG offers a seal seam stability test for the validation of your sealing processes. After testing the film test strips, you will receive a certificate from MELAG stating the conformity of the seal seams with the EN 868-5 standard, Appendix D, if the seal seam stability test is successful. -
Page 25: Standard Specifications
Maintain the clearance between seal seam and cutting edge as prescribed in the standard: DIN 58953-7 requires the maintenance of a sufficient overhang between the seal seam and the cutting edge when working with film pouches on the removal side. This ensures aseptic removal. MELAG recommends a minimum overhang of 10 mm. -
Page 26: Technical Data
14 Technical Data 14 Technical Data Device type MELAseal Pro Device dimensions (W x D x H) 46 x 29.5 x 15.5 cm Weight 11.4 kg Electrical connection Power supply 220-240 V, 50/60 Hz Electrical power max. 365 W, average 180 W Device fuse 2x 3.15 A T, 1x 1.6 A T, 1x 250 mA T... -
Page 27: Accessories And Spare Parts
ME01048 USB serial adapter ME80270 MELAcontrol Seal Check ME01079 MELAcontrol Ink Test ME01089 Spare parts Separating plate for reel dispenser MELAseal Pro ME71200 Angled adapter, interface (RS232) for MELAseal Pro ME80210 Mains fuse for MELAseal Pro ( 3.15 A) ME74320... - Page 28 MELAG Medizintechnik GmbH & Co. KG Geneststraße 6-10 10829 Berlin Germany Email: info@melag.com Web: www.melag.com Original instructions Responsible for content: MELAG Medizintechnik GmbH & Co. KG We reserve the right to technical alterations Your stockist...
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