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User manual
MELAseal
Sealing device
from software version 1.0.0
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.
®
300
Germany", we guarantee that these demands will be met. Our certified quality
"competence in
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Summary of Contents for MELAG MELAseal 300
- Page 1 1.0.0 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................................. 9 Touch display.................................. 10 LED display and acoustic signals.......................... 12 QR code .................................. 13 4 Commissioning................................... 14 Requirements of the installation location ........................... 14... - Page 4 11 Malfunctions .................................. 55 Warnings and malfunction messages.......................... 55 Malfunction logs................................. 57 12 Manufacturer's recommendation for routine operation .................... 58 Performing the peel test.............................. 58 MELAG seal seam stability test ............................ 58 13 Standard specifications .............................. 59 14 Technical Data .................................. 60 15 Accessories and spare parts ............................ 61 Glossary .................................... 62...
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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 download centre at www.melag.com. -
Page 6: Safety
2 Safety 2 Safety When operating the device, comply with the following safety instructions as well as those contained in sub- sequent 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 Only competent and trained personnel may use the device. -
Page 7: Description Of The Device
EN ISO 11607-2 DIN 58953-7. The Rotary sealing device MELAseal 300 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 ... -
Page 8: Views Of The Device
3 Description of the device Views of the device View from the front Colour touch display In-feed Depth adjustment View from rear Power switch (On/Off) USB connection Ethernet interface Power cable connection... -
Page 9: Symbols On The Device
3 Description of the device Symbols on the device Type plate Manufacturer of the product Date of manufacture of the product 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... -
Page 10: Touch Display
3 Description of the device Touch display The user interface consists of a colour 4.3-inch touch display. USB connections for data export (e.g. log output) and data import (e.g. software update) are located on the rear of the device. PLEASE NOTE: The USB connection on the back of the display is exclusively for USB flash drives. Do not connect any other output media to this connection. - Page 11 3 Description of the device Symbol Description User role service technician User role practice employee Computer connected MELAtrace connected Printer connected USB flash drive connected Sealing successful Sealing not successful Malfunction log Main area The device settings for activating/deactivating functions are made in the main area. Messages and/or user instructions are displayed depending on the status of the device.
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Page 12: Led Display And Acoustic Signals
3 Description of the device Start screen structure Open main menu Display of TARGET temperature, TAR- GET speed, film type Display of device status Display of ACTUAL temperature/pro- gress indicator Display of user ID, batch number, num- ber of seals in the batch Open Seal Check Start new batch Start return... -
Page 13: Qr Code
3 Description of the device QR code Further information on function tests, notifications, warnings and malfunction messages can be found on the MELAG website. A corresponding QR code will take you directly to the MELAG website. Press Example view of the Seal Check reminder notification Ê... -
Page 14: Commissioning
4 Commissioning 4 Commissioning Requirements of the installation location CAUTION Failure to comply with the setup 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 15: Switching On The Device
4 Commissioning The following must be fulfilled or present: ü The sealing device has been switched off. ü The power cable, delivered in the scope of delivery, is present. Connect the power cable to the back of the device. Plug the power plug of the device into the power socket of the practice. -
Page 16: Configuring The Device
4 Commissioning Configuring the device The configuration wizard appears automatically when the device is started for the first time and helps you with the setting. To ensure that the configuration wizard does not appear every time the device is started, it must be run through once completely. -
Page 17: Authenticate User
4 Commissioning Authenticate user You have the option of activating or deactivating the user authentication, see Authentication [} Page 44]. If authentication is activated, the user is prompted to authenticate themselves with their ID or user name and PIN when the device starts. The user ID is documented in the sealing log. Log in user ü... -
Page 18: Checking Date And Time
4 Commissioning Confirm the notification with YES. Ê The start screen appears. Ê No user ID appears on the logs. Log out user ü A user is logged in. In the main menu, press Press LOGOUT. Ê No more users are logged in. Ê... -
Page 19: Sealing
ü The sealing temperature has been reached. Insert the transparent sterilization package in the in-feed on the left-hand side of the device. PLEASE NOTE: MELAG recommends guiding the packaging through the device with the film side pointing upwards. Ê As soon as the device detects the wrapping, the wrapping is carried out automatically. -
Page 20: Batch Counter
5 Sealing Batch counter You can combine several seals in one batch. This can be, for example, seals that are reprocessed together in one operating cycle. The display shows the number of seals. Press on the start screen to start a new batch. Confirm with OK. -
Page 21: Logging
USB flash drive at any time. The automatic logging of sealing procedures is deactivated by default. MELAG recommends activating the automatic logging function. For direct output, activate the log output for the respective output medium, see Log output. -
Page 22: Using The Usb Flash Drive As An Output Medium
6 Logging Example log Using the USB flash drive as an output medium NOTICE Danger of data loss through damage of the USB flash drive following improper use. Do not exert any force on the USB flash drive whilst inserting it. Should you wish to save the log of a sealing procedure on the USB flash drive automatically, connect it as follows: Switch off the sealing device. -
Page 23: Logs Menu
6 Logging Logs menu The Logs menu provides you with the following options: • Display and output of sealing logs • Display and output of malfunction logs • Output of status logs Log types Log type Description Sealing logs Log of a sealing procedure Malfunction log Log with malfunctions that occurred outside a program run Status log... - Page 24 6 Logging Select the log type to be output. Ê A list of the selected log type appears. Select a log from the list. Example view of sealing log list. Ê The log is displayed. Press to output the log. Example view of a sealing log.
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Page 25: Function Checks
7 Function checks Function check with MELAcontrol Seal Check The MELAcontrol Seal Check serves to check the function of the seal seam produced by your sealing device. MELAG recommends performing this function check once a day during operation. The device is fitted with a reminder function which reminds e.g. at the daily seal check. -
Page 26: Performing A Melacontrol Inktest
7 Function checks The option for seal seam evaluation is displayed: Press YES if the seal seam meets the criteria. Press NO if the seal seam does not meet the criteria and repeat the test seal. Ê The result of the Seal Check is recorded. Performing a MELAcontrol InkTest The MELAcontrol Ink Test is a reliable test for routine control of the seal seam for leaks. -
Page 27: Settings
8 Settings 8 Settings Parameters such as language, date, etc. can be set in the submenus of the Settings menu. In the main menu, press Settings. Make settings in the corresponding submenus. Ê After saving, settings are immediately applied and the view changes from the respective submenu back to the Settings menu. -
Page 28: General Settings
8 Settings General settings General settings can be changed by any user. Language You can switch between the enabled languages in the Language submenu. Press Language in the Settings menu. Select the desired language using or Ê After a setting has been changed, the SAVE button is active. Confirm with SAVE. -
Page 29: Time
8 Settings Select the correct date in the calendar. Press (past) or (future) to select the month. TIP: Long press = 1-year increments Ê After a setting has been changed, the SAVE button is active. Press SAVE. Ê The view switches back to the Settings menu. Time The time of the device must be correctly set for proper batch documentation. -
Page 30: Display
8 Settings Press SAVE. Ê The view switches back to the Settings menu. Display Individualise the display brightness. Press Display in the Settings menu. Press Press one of the buttons to change the brightness of the display. The display brightness can be adjusted in several steps. Set the display darker Set the display brighter The colour bar below the value display gives you an impression of... -
Page 31: Audio
8 Settings Audio You can activate (ON) or deactivate (OFF) the signal tones in the Audio submenu. The signal tones are activated by default. Press Audio in the Settings menu. Select the desired setting by pressing OFF/ON. Ê After a setting has been changed, the SAVE button is active. Press SAVE. -
Page 32: Film Type
8 Settings Press or to shorten or lengthen the time until energy-saving mode is activated. TIP: short press = increments of 1 long press = increments of 5 Example view of Level 1 Press OK to confirm the setting. Ê After a setting has been changed, the SAVE button is active. - Page 33 8 Settings Enter a name for the new film type and press OK to confirm. Select the desired sealing temperature by pressing Press OK to confirm the setting. Select the desired conveying speed by pressing Press OK to confirm the setting. Press SAVE.
- Page 34 8 Settings Editing a slide type Press Film type in the Settings menu. Press to edit the selected film type. Press to scroll through the list. Press to adjust the sealing temperature /conveying speed Select the desired film type/conveying speed by pressing Example view of the sealing temperature Press OK to confirm the setting.
- Page 35 8 Settings Deleting a slide type Press Film type in the Settings menu. Press to delete an entry. The MELAfol film type cannot be deleted. Press to scroll through the list. Press DELETE. Confirm the query with YES.
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Page 36: Log Output
8 Settings Log output In the Log output submenu, you can set how the log should be output by default for each output medium. Log output is deactivated by default. ON: The log is output automatically at the end of the sealing procedure. OFF: No log output is possible, even with output medium connected. - Page 37 8 Settings Press MELAprint. Press ON or OFF to activate or deactivate the immediate output. Press SAVE. Ê The selection has been set as default. The view switches back to the Log output submenu. Set up the printer, see Configuring the log printer [} Page 37]. Configuring the log printer Printer via USB Configure the printer by pressing...
- Page 38 8 Settings Press SAVE. Example view of a selected configuration. Ê The selection has been set as default and the view changes back to the Log output submenu. Printer via network Configure the printer by pressing in the bottom row. Select Network by pressing or ...
- Page 39 8 Settings Press SAVE. Example view of a selected configuration. Ê The selection has been set as default and the view changes back to the Log output submenu. Log output on a FTP server Press Log output in the Settings menu. Press FTP server. Press ON or OFF to activate or deactivate the immediate output. Press SAVE.
- Page 40 8 Settings Configure a FTP server Configure the FTP server by pressing in the bottom row. Enter the IP address and accept the changes by confirming with . Ê The view for changing the user name is displayed. Enter the user name of the FTP server and accept the changes by confirming with .
- Page 41 8 Settings Confirm with OK. If the connection test fails, check your entries and test again. Press SAVE. Ê The selection has been set as default and the view changes back to the Log output submenu. Log output with MELAtrace Press Log output in the Settings menu. Press MELAtrace.
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Page 42: Administrative Settings
8 Settings Administrative settings To make administrative settings, such as changes in user administration, you must log in as an administrator. In the main menu, press Administration. Enter the associated PIN. PLEASE NOTE: The PIN must be re-entered each time the menu is opened. -
Page 43: Admin Pin
8 Settings Admin PIN When the device is delivered, the admin PIN is set to 1000 by default. MELAG recommends that you change the admin PIN upon commissioning. PLEASE NOTE If the changed Admin PIN is lost, contact an authorised technician. -
Page 44: Authentication
8 Settings Authentication Authentication is deactivated by default. The following must be fulfilled or present: ü You are logged in as an administrator or service technician, see Logging in and out of the user role [} Page 42]. ü Users have been created, see Users [} Page 45]. -
Page 45: Users
8 Settings Users An individual ID and user PIN can be issued to every user to facilitate reliable traceability. The user can authenticate himself with the user PIN, see Authentication [} Page 44]. Adding a user The following must be fulfilled or present: ü... -
Page 46: Reminders
8 Settings A user ID is assigned and displayed in the title. All components of the user entry can be via edited again by pressing Press SAVE to accept the user entry. Ê The user list view is displayed. Editing a user The following must be fulfilled or present: ü... - Page 47 8 Settings Press of the respective reminder to edit it. Ê The view of the current reminder settings is displayed. Press next to Interval. Example view of the menu Seal Check. Ê The view for setting the interval is displayed. The device-specific recommendation for the selected reminder is displayed as a note above the selection.
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Page 48: Network
8 Settings Select the desired date in the calendar. Press (past) or (future) to select the month. TIP: press and hold = 1-year increments Ê The current settings view is displayed. Press SAVE. Ê The view switches back to the Administration menu. Network You can select an automatic configuration via DHCP or enter the required address details manually. - Page 49 8 Settings or to select the setting Manual (static) and confirm the selection with OK. Ê The view for editing the IP address is displayed. Enter the IP address of your network and confirm the selection with . Ê The view for editing the subnet mask is displayed. Enter the address of the subnet mask of your network and confirm the selection with .
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Page 50: Software Update
Check whether all required logs have been output to an output medium. Please observe the further information in the separate instruction “Information regarding software update and re-installation”. You can find the document in the download centre on our website at www.melag.com/ en/service/downloadcenter. The following must be fulfilled or present: ü... -
Page 51: Configuring The Device
8 Settings Confim the notification for log backup with YES. Press NEXT to perform the software update. Ê During the software update, the device independently performs one or more restarts. Configuring the device Settings on the device can also be adjusted using the configuration wizard. ü... -
Page 52: Factory Setting
8 Settings Check your settings in the displayed overview. Example view of device settings Press END to end the configuration wizard and restart the device. Factory setting You have the option of resetting the device to the factory settings. All settings and saved values will be lost. ü... -
Page 53: Maintenance
Maintain the specified maintenance intervals. Continuing operation beyond the maintenance interval can result in malfunctions in the device. Have maintenance performed only by trained and authorised technicians using the original MELAG maintenance set. If components that are not included in the maintenance set have to be replaced during maintenance, only original spare parts from MELAG may be used for the replacement. -
Page 54: Pause Times
The sealing device can remain switched on over longer operating pauses of many hours. The sealing device automatically switches to energy-saving mode after a user-defined time, see Energy saving [} Page 31]. MELAG recommends switching off the device during long operating pauses to save energy and for safety reasons. Transport and storage NOTICE Damage to the housing and the device interior as a result of using unsuitable transport packaging. -
Page 55: Malfunctions
Should you be unable to find the relevant event, or your efforts do not redress the problem, you can contact your nearest stockist or authorised MELAG customer service provider. Have the following information ready: • The serial number of your device (see type plate or device status info) •... - Page 56 11 Malfunctions Event Possible causes What you can do 36512 There is no paper in the printer. Replace the empty paper roll with a new one. 36731 No USB flash drive is connected. For logging: 1. Connect a functional USB flash drive. 2.
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Page 57: Malfunction Logs
11 Malfunctions Malfunction logs In the Logs > Malfunctions menu, you can view malfunction logs and output them to a USB flash drive, see Subsequent log output [} Page 23]. -
Page 58: Manufacturer's Recommendation For Routine Operation
MELAG offers a seal seam stability test for the validation of your sealing procedures. 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... -
Page 59: 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 60: Technical Data
14 Technical Data 14 Technical Data Device type MELAseal 300 Device dimensions (W x D x H) 36 x 16 x 17.5 cm Weight 5.6 kg Electrical connection Power supply 220-230 V, 50/60 Hz Electrical power max. 650 W Device fuse 1x 8 A Overheat protection >... -
Page 61: Accessories And Spare Parts
15 Accessories and spare parts 15 Accessories and spare parts All specified articles are available through specialist dealers. Article Art. no. Accessories Work table Comfort ME00141 Work table Standard ME77750 Wall mounted reel dispenser with cutting device ME00116 Flex roll holder (available from the end of 2024) ME00142 MELAcontrol Seal Check ME01079... -
Page 62: Glossary
An authorised technician is a person intensively trained and authorised by MELAG who has sufficient specific device and technical knowledge. to perform maintenance and installation work on MELAG devices. Only they may carry out this work. Batch The batch is the summary of seals that, for example, run through the same reprocessing procedure together or belong to the same instrument set. - Page 64 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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