Contents Important information Assembly About this document 3 Requirements 14 Warnings and symbols 3 Installation/setup room 14 Copyright information 4...
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Contents 14 Validation of the sealing process 22 141 Validation steps 22 142 Daily function assessment 23 143 Annual Performance Qualification 24 15 Disinfection and cleaning 24...
Important information About this document Other symbols These symbols are used in the document and These installation and operating instructions on or in the unit: represent part of the unit Note, eg specific instructions regarding If the instructions and information in efficient and cost-effective use of the unit these installation and operating instruc- tions are not followed, Dürr Dental will...
Important information Safety 1.2 Copyright information All circuits, processes, names, software pro- Dürr Dental has designed and constructed this grams and units mentioned in this document are unit so that when used properly and for the in- protected by copyright tended purpose it does not pose any danger to The Installation and Operating Instructions must people or property Nevertheless, residual risks...
Important information 2.5 Qualified personnel 2.8 Transport The original packaging provides optimum pro- Operation tection for the unit during transport Unit operating personnel must ensure safe and If required, original packaging for the unit can be correct handling based on their training and ordered from Dürr Dental knowledge Instruct or have every user instructed in han-...
Product description Technical data Electrical data Voltage 230, 1~ Frequency 50 - 60 Nominal current Power output, max Fuses 2 x T 50 AH / 250 V~ (IEC 60127-2) Type of protection IP 20 Protection class General data Sealing temperature °C 100 - 200 (adjustable in 5 °C steps) 100 - 210 (version 20 or higher)
Höpfigheimer Str 17 74321 Bietigheim-Bissingen Germany Name of product: Hygopac Plus We hereby declare that the above product meets all applicable requirements of the directives listed below: – Machinery directive 2006/42/EC in its current version Name of the person with responsibility for compiling all technical documentation:...
Product description Operation On / off switch Standby LED Button – "Cancel" or "No" Shift key – switching between display / menu Display Button – "Confirm" or "Yes" Arrows for navigation from version 20: Press arrow "right" to start the transport belt manually Infeed Adjustable stop 10 SD card slot...
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Product description The device is equipped with an operating panel with display Information is displayed here and set- tings are performed for the operation if the device Pressing the On/Off switch starts the device The device heats up, and both the target temperature and the current temperature are shown on the display The operator is reminded of the operational qualification every day This is done after the device reaches the target temperature for the first time at the start of working To do this, a seam sealing test...
Product description 5.1 Display overview Display window Context area (eg Ready, Heating, Note) Time Symbol area Content area for text Menu window Context area Menu items Scroll bar for more than three entries 9000-616-37/02 1807V004...
Product description 5.2 Tyscor Pulse (optional) The software is connected via the network to the devices from Dürr Dental and displays the current status as well as messages and errors All messages are logged and can be printed or sent The cockpit shows the devices with the current characteristic data and provides a quick overview of the functional status of the devices The software interface consists of the menu bar, the side bar and the contents area...
Assembly Requirements Installation 6.1 Installation/setup room The room chosen for set up must fulfil the fol- lowing requirements: – Closed, dry, well-ventilated room – Should not be a room made for another pur- pose (e g boiler room or wet cell) Ambient and environmental conditions must be taken into account Do not oper- ate the unit in damp or wet conditions...
Assembly Commissioning Requirements: – Unit switched on and connected to the network NOTICE – Administrator or service technician access Damage to the device level selected in the software For units with firmware version 20 or Working in the menu bar, click on Device higher, an older version may not be Manager...
Assembly Settings upon Requirements: – Administrator or Service Technician access commissioning level selected Click on the device in the device list with the NOTICE left mouse button and keep the mouse button Damage to the device pressed For units with firmware version 20 or With the mouse key pressed, drag the unit higher, an older version may not be onto the cockpit...
Assembly 9.3 Adjusting the temperature 9.5 Set the speed for the belt transport Press the button to switch from the dis- play screen to the menu screen Version 20 or higher Use the button to scroll to the menu item Press button to switch from the display Settings and press...
Assembly 9.7 Configuring the network Syslog settings If the unit is monitored using third-party docu- Restart the device after performing a mentation software for documentation of the menu change sealing processes, Syslog settings will still need to be adjusted for it Press the button to switch from the dis- The network integration of the unit can be car-...
Usage 10 Use of suitable sterile 10.1 Recommendations for the sterile product packaging product packaging Here are various recommendations for working The following may be used: with sterile product packaging: Sterile product packaging in accordance with – Select sufficiently large packaging DIN EN ISO 11607-1 and the applicable parts of –...
Usage 11 Operation 11.1 Start the transport belt manually Switch on the unit with button Version 20 or higher The display will show the setpoint temperature In standby mode, the transport belt can be and the actual temperature started manually by pressing the arrow (right) The blue indicator light flashes during the This ca be used to remove packaging that has heat-up phase (version 20 or higher)...
The following is shown in the unit block of the If several messages occur, the symbol of the Hygopac Plus: highest message level in each case is displayed – Sequential number of the last sealing process As soon as a message concerning a de- –...
Usage 13 Adjustment of the 14 Validation of the sealing adjustable stop process With the aid of the adjustable stop, the distance 14.1 Validation steps between the sealing seam and the edge can be The validation of the sealing process consists of adjusted to one of three different distances (2 , the following steps: 25 or 3 mm)...
Usage 14.2 Daily function assessment Starting further operational qualifications Version 20 or higher If the menu item Operational qualification (OQ) A further operational qualification can be started is activated in the menu of the unit, then a re- independently of the initial work day request quest to perform an operational qualification of the sealing process will appear every day after The operational qualification is also recorded in...
Usage 15 Disinfection and cleaning 14.3 Annual Performance Qualification Switch off and de-energise the unit If, in the menu of the unit, the menu item Per- (eg unplug from mains) formance Qualification (PQ = Performance Qualification) is activated, a request will appear Only damp-wipe the unit when it is cold once a year to carry out a performance qualifi- cation of the sealing process...
Troubleshooting 16 Tips for operators and service technicians Any repairs exceeding routine maintenance may only be carried out by qualified personnel or our service Prior to working on the device or in case of danger, disconnect it from the mains (e g pull the mains plug) Error messages with a Note must be acknowledged by pressing to get the unit ready for...
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Troubleshooting Fault Probable cause Solution Note Inadequate ventilation of the unit Acknowledge the message Provide sufficient ventilation Unit overheating! Defective heating system Wait until the temperature has settled within the required range In the event of a persistent fault, contact a Service Technician Note Temperature control is defective Inform your Service Technician...
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Troubleshooting Fault Probable cause Solution Note Foil held back in the unit during Acknowledge the message Car- transport ry the foil along with the same Notice speed that is specified by the Speed too low Transport system dirty unit, or use an instrument table Speed measuring system defec- Check the transport system tive...
Appendix 17 Menu structure Level 1 Level 2 Level 3 Level 4 Level 5 Language [X] German (DE) [ ] English (EN) Access level [X] Operator [ ] Administrator [ ] Service techni- cian Device Informa- REF: tion Firmware: Operational qualifi- Supply test foil cation Settings...
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Appendix Level 1 Level 2 Level 3 Level 4 Level 5 Sealing parame- Temperature: ters xxx °C Pressing force: xx N Speed: Up to version 20: xx mm/s From version 20: xx m/min Statistics Batch counter xxx foils Visible from access level Operator or higher Visible from access level Administrator or higher Visible from access level Service Technician or higher 9000-616-37/02 1807V004...
SD card in the unit or to a connected PC via a documentation program The individual fields are sepa- rated by a semicolon Example up to version 2.0 Example from version 2.0 Explanation Hygopac Plus; item designation 6022-80; order number EX00112; serial number 1423677; firmware version Time; comprising the date, time and **time zone** LOT;...
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Hersteller/Manufacturer: DÜRR DENTAL SE Höpfigheimer Str. 17 74321 Bietigheim-Bissingen Germany Fon: +49 7142 705-0 www.duerrdental.com info@duerrdental.com...
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