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User Manual
Vacuclave
Steam sterilizer
from software version 4.0.1
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.
®
550
Germany", we guarantee that these demands will be met. Our certified quality
"competence in
0197
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Summary of Contents for MELAG Vacuclave 550
- Page 1 4.0.1 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 ................................ 7 Symbols used .................................. 7 Formatting rules................................... 7 Disposal .................................... 7 2 Safety..................................... 8 3 Performance specifications .............................. 9 Intended use .................................. 9 Sterilization procedure ................................. 9 Type of the feed water supply.............................. 9 Program runs .................................. 10 Safety equipment................................ 10 Performance characteristics of reprocessing programs .................... 11 4 Description of the device.............................. 12 Scope of delivery ................................ 12 Views of the device................................ 13... - Page 4 Contents Connection to the wastewater ............................ 35 Direct connection to the wastewater .......................... 35 Aligning the device................................ 36 Turning the device ................................ 36 Mounting the loading slide .............................. 37 Checking the software version............................ 39 Checking water supply and disposal .......................... 39 Checking date and time .............................. 39 Display brightness and volume............................ 39 Test runs.................................... 39 Instructing the users ................................ 39 Record of installation and setup ............................ 39...
- Page 5 Contents 10 Logging ..................................... 57 Batch documentation ................................. 57 Label printer.................................. 57 Logs menu .................................. 58 Log list .................................... 58 Log output options................................ 59 Output media .................................. 60 Displaying logs on the computer .......................... 61 11 Function checks ................................ 62 Service programs................................ 62 Vacuum test.................................. 62 Bowie & Dick test................................ 64 12 Settings ..................................... 65 General settings................................. 65 Language .................................. 65 Date and time................................ 65...
- Page 6 Contents 14 Pause times .................................. 80 Duration of the operating pause ............................ 80 Decommissioning ................................ 80 Draining ..................................... 80 Transport ................................... 81 Symbols on the packaging ............................ 81 On-site transport ................................ 81 Off-site transport ................................ 81 Installing the carrying system............................ 82 15 Malfunctions .................................. 83 Malfunction logs................................. 83 Warning and malfunction messages.......................... 84 16 Technical data .................................. 93 17 Accessories and spare parts ............................ 95 18 Technical tables ................................ 97...
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Page 7: 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 8: Safety
Please note that all serious accidents which occur in connection with the medical device (e.g. death or serious deterioration in the state of health of a patient) which were presumably caused by the device, must be reported to the manufacturer (MELAG) and the relevant authority of the member state, in which the user and/or patient resides. -
Page 9: Performance Specifications
3 Performance specifications Intended use The Vacuclave 550 steam sterilizer is mainly intended for use in the medical sector, e.g. in medical and dental practices. The small steam sterilizer is designed according to 13060. It uses the fractionated vacuum process to ensure ... -
Page 10: Program Runs
3 Performance specifications Program runs A reprocessing program runs in three main phases: the air removal and heating up phase, the sterilization phase and the drying phase. After program start, you can follow the program run on the display. It shows the chamber temperature and pressure as well as the time until the end of drying. -
Page 11: Performance Characteristics Of Reprocessing Programs
3 Performance specifications Internal logic monitoring The electronics of the steam sterilizer monitor the successful program run by means of two separate test processes. When a program has been successfully completed, it is shown on the display as a successful program. In addition, the status LED below the display illuminates green. -
Page 12: Description Of The Device
• Drain hose • Power cable • Carrying system • Allen key for opening the door in an emergency • Test gauge TR20 for door lock nut • MELAG oil for door lock nut • Level increase, tank overflow • Installation material... -
Page 13: Views Of The Device
4 Description of the device Views of the device View from the front Access to the validation fitting Feed water tank cover Power switch Opening for door opening in an emer- gency Door Service hatch View from front, with open service hatch Overheat protection reset button Feed water tank drain valve USB connection... - Page 14 4 Description of the device View from the front, with open door Colour touch display Door lock nut Pressure release filter Sterile filter Locking spindle View from rear 19 20 21 22 23 USB connection Ethernet connection Overflow funnel Electrical connection, filling pump (op- tional) Feed water connection of the filling pump...
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Page 15: Symbols On The Device
4 Description of the device Symbols on the device Type plate Manufacturer of the product Date of manufacture of the product Label as medical 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 Identification number of the notified body responsible for conformity assessment according to Pres-... -
Page 16: Service Hatch
4 Description of the device Device symbols - front Symbol Description Symbol Description Feed water drain connec- Overheat protection reset tion button USB connection Service connection Device symbols - rear Symbol Description Symbol Description Aqua dem Feed water connection, Osmosis drain Wastewater connection, water treatment unit... -
Page 17: Colour Touch Display
4 Description of the device Colour touch display The user interface consists of a colour 7-inch touch display. The selected menu item is highlighted in colour. The display of the areas (A, B, C) is dynamic and can change depending on the device status. Due to the dynamic display, the display and position of the buttons on the device may differ from the illustrations shown. -
Page 18: Led Status Bar
4 Description of the device Buttons in the information area Button Description Show or hide Device status Open or close Device status Malfunction message present Show or hide malfunction message Warning message present Show or hide warning message Energy-saving activated Show or hide energy-saving dialog Buttons in the program selection Button... -
Page 19: Program Run
The device is delivered without a mount for holding trays or cassettes. No mount is necessary for the sterilization of sterilization containers or MELAstore Box, but MELAG recommends use of the loading slide. Depending on the typical load, different accessories can be combined with the device. -
Page 20: Installation Requirements
Failure to comply with the setup conditions can result in injuries and/or damage to the device. The steam sterilizer should only be setup, installed and commissioned by persons authorised by MELAG. The steam sterilizer is not suitable for operation in explosive atmospheres. -
Page 21: Space Requirements
5 Installation requirements Space requirements Dimensions Vacuclave 550 Width 63.6 cm Height 65 cm Chamber depth 45 cm Clearance between the device feet 37.1 cm Clearance from rear device foot up to the rear panel 17.3 cm Max. swivel distance with open door 48.2 cm... -
Page 22: Mains Connection
5 Installation requirements Additional space requirement for the feed water supply If the device is operated with a water treatment unit or filling pump with storage tank, additional space is required. It is necessary to ensure free access to the hoses and cables of the device leading to the water treatment unit. Dimensions MELAdem 47 Osmosis module... -
Page 23: Water Connection
The steam sterilizer has an internal air gap (type AB) to protect the drinking water water. To protect the MELAdem 47, MELAdem 53 and MELAdem 53 C water treat- ment units, MELAG recommends the installation of a safety combination ac- cording to EN 1717. Further country specific measures may be required for protecting the drink- ing water. -
Page 24: Operating The Device With Memory Media
5 Installation requirements NOTICE When performing a device software update, use only the update data authorised by MELAG for the corresponding device type. Operating the device with memory media To prevent data loss, only use memory media to save the log data with the following characteristics: functional (without malware, etc.) -
Page 25: Network Bandwidth / Quality Of Service (Qos)
5 Installation requirements Network bandwidth / Quality of Service (QoS) The device does not place any requirements on the LAN bandwidth for data transfer, that exceed the standard time-out times of the respective logs. Process Volume max. Volume normal Program log 1 MB 200 kB Malfunction log... -
Page 26: Setup And Installation
Improper installation may lead to a short-circuit, fire, water damage or electrical shock. This could result in serious injury. Only have the device set up, installed and commissioned by people authorised by MELAG. Comply with the following for safe handling: The connections for electrical provision and water supply and discharge must be setup by trained personnel. -
Page 27: Connecting The Power Cable And Removing Accessories
6 Setup and installation Tighten the housing screws again. Keep the carrying system. Connecting the power cable and removing accessories NOTICE Before switching on for the first time, the device must have acclimatised to the required ambient temperature (5-40 °C). PLEASE NOTE In the case of automatic feed water supply, the device attempts to supply feed water after start-up. -
Page 28: Installation Examples
6 Setup and installation Installation examples On the following pages you will find examples for the recommended types of installation for the supply of feed water and the disposal of wastewater. PLEASE NOTE For detailed information on the cold water connection of the water treatment unit, see the user manual of the unit. - Page 29 6 Setup and installation Item Description Art. no. Contained in on-site protection (air gap to EN 1717)* Double hose nozzle connection Cu seal 13.5x20 ME32050 Scope of delivery QSS-E straight ME38710 Scope of delivery Wastewater adapter (G1/4” internal thread) ME56930 Scope of delivery Wall outlet NW40*...
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Page 30: Example 2 - Automatic Water Supply And Disposal With Ion Exchanger Meladem 53/53 C (Hd)
6 Setup and installation Example 2 - Automatic water supply and disposal with ion exchanger MELAdem 53/53 C (HD) Automatic water disposal should always be installed in case of automatic water supply. In addition, it is necessary to install a water stop. The MELAdem 53/53 C water treatment unit is either connected to the device’s feed water connection either via a water branch or by means of a water distributor. - Page 31 6 Setup and installation Item Description Art. no. Contained in 10.3 Wastewater adapter (G1/4” internal thread) ME56930 Scope of delivery Water distributor for MELAdem 53 for connecting several devices ME69005 MELAdem 53/53 C ME01038/ ME01036 12.1 Safety combination HD according to EN 1717 for wall mouting ME70685 ME01038/ ME01036...
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Page 32: Example 3 - Automatic Water Supply And Disposal With Ion Exchanger Meladem 53/ 53 C (Ea)
6 Setup and installation Example 3 - Automatic water supply and disposal with ion exchanger MELAdem 53/ 53 C (EA) Automatic water disposal should always be installed in case of automatic water supply. In addition, it is necessary to install a water stop. The MELAdem 53/ 53 C water treatment unit is either connected to the device’s feed water connection either via a water branch or by means of a water distributor. - Page 33 6 Setup and installation Item Description Art. no. Contained in Water distributor for MELAdem 53 for connecting several devices ME69005 MELAdem 53/53 C ME01038/ ME01036 11.1 Water inlet hose (2.5 m, complies with EN 1717) ME24930 ME01038/ ME01036 11.2 Pipe elbow with drain valve ME70405 ME01038/ ME01036...
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Page 34: Example 4 - Use Of The Filling Pump With External Storage And Wastewater Container
6 Setup and installation Example 4 - Use of the filling pump with external storage and wastewater container The device is supplied with feed water from the storage container via the filling pump. The maximum suction lift is 1.2 m. The wastewater is fed into the wastewater container via the drain hose. The filling level of the wastewater container is monitored by the device with a level sensor. -
Page 35: Connection To The Wastewater
6 Setup and installation NOTICE Improper installation There is a risk of water damage if the water connection is installed improperly. Check all water connections and joints. Connect the outlet hose to the external wastewater container (doc. ZBA_ABW). Install the filling pump as described in the separate installation instructions (doc. ZBA_P10). In the Settings > Water management menu, set the wastewater disposal to Manual, see Water management... -
Page 36: Aligning The Device
6 Setup and installation Undo the screws (TX20) in the rear device cover and remove the cover. Connect the overflow funnel to the wastewater, see Connection to the wastewater [} Page 35]. Dismantle the wastewater hose (pos. a) from the overflow funnel. Shorten the wastewater hose and connect it to the internal connection socket of the direct outlet (pos. -
Page 37: Mounting The Loading Slide
6 Setup and installation Screw in the device feet completely. Turn the device on the worktop in the desired direction. Ê The device does not need to be lifted. Carry out the necessary work on the device. Turn back the device. Unscrew the two device feet (approx. - Page 38 6 Setup and installation Pull the loading slide out slightly to better access the pressure release filter (pos. c). Mount the loading slide to the rear of the pressure release filter using a locking edge washer and the hex nut. Slide the loading slide fully into the device. Mount the loading slide at the front with a locking edge washer and the flat-head screw.
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Page 39: Checking The Software Version
Record of installation and setup The record of installation is to be completed by the responsible stockist and a copy sent to MELAG as proof of the correct setup, installation and initial commissioning. This is a constituent part of any guarantee claim. -
Page 40: Service Connection
6 Setup and installation Service connection PLEASE NOTE While using the service connection with MELAtrace, no other activities may be carried out at the device. The service connection enables the diagnosis of the device and the control of valves via the MELAtrace software. Service settings To make service settings, such as a Software reinstallation, you must log in as a service technician, see Logging on user role... -
Page 41: First Steps
7 First steps 7 First steps Switching on the device The following must be fulfilled or present: ü The device is connected to the power supply. ü The feed water supply is secure. ü The wastewater disposal is connected. Switch on the device at the power switch, see Device views [} Page 13]. -
Page 42: Closing The Door
7 First steps The following must be fulfilled or present: ü The device is switched on and booted up. Open the door by pressing OPEN DOOR. The button is displayed when the menu area is minimised. Ê The door unlocks automatically. Closing the door When closing the door, comply with the following instructions to guarantee faultless operation of the door locking mechanism:... -
Page 43: Feed Water Supply
PLEASE NOTE Should you wish to use a water treatment unit from another manufacturer, please consult MELAG. Using an external storage container For the feed water supply via an external storage container, the feed water is pumped into the device via a filling pump. -
Page 44: Using The Feed Water Tank (Emergency Operation)
Switch the water supply to Manual, see Water management [} Page 67]. Disposal of the wastewater The Vacuclave 550 has no internal wastewater tank. The wastewater is either drained automatically via the overflow funnel or it is collected in an external wastewater container and is drained manually. NOTICE Water damage due to overflowing wastewater container When draining manually, check the level in the wastewater occasionally. -
Page 45: Important Information For Routine Operation
The use of another test system in accordance with EN 867-5 is possi- ble. The number of the available test systems means that MELAG is not able to provide technical support when using a different system. PLEASE NOTE Document the results of the tests. -
Page 46: Sterilization
Only ever use packaging material and systems which have been cleared by their manufacturer for steam sterilization. Use only original MELAG accessories or those from other suppliers authorised for use by MELAG. Reprocessing instruments Unwrapped sterile material loses its sterility on contact with ambient air. If you intend to store your instruments sterilely, wrap them in suitable packaging before sterilization. -
Page 47: Loading The Steam Sterilizer
Use aluminium sterile containers. Aluminium retains and conducts heat and thus accelerates drying. Closed sterile containers must be either perforated or have a valve on at least one side. MELAG sterile containers, e.g. MELAstore Box, fulfil the requirements for successful sterilization and drying. -
Page 48: Soft Sterilization Packaging
9 Sterilization Soft sterilization packaging WARNING Risk of contamination due to insufficient drying To improve the drying results for full loads of soft sterilization packages, the setting Drying: Intelligent must be activated. Soft sterilization packages can be used in both sterile containers and on trays. Please comply with the following when ... -
Page 49: Load Quantities And Versions
Max. weight per component 2 kg For MELAG mounts, trays, sterile containers, see Accessories and spare parts. Maximum load quantities for instruments and textiles The total weight is the sum of the mass of the load to be sterilized, the packaging materials, the containers and the mount. -
Page 50: Selecting The Program
9 Sterilization Loading slide The loading slide allows convenient loading and unloading. The slide can be pulled out of the chamber with a tray lifter or heat protection gloves. Start loading containers or MELAstore Box at the rear end of the slide. You can stack the MELAstore Box 100 cross-wise on top of each other up to four times. -
Page 51: Program Options
9 Sterilization Program loading Program Packaging Especially suitable for Universal-B Single and multiple wrapped • Mixed loads • Products with narrow lumen Quick-S Only unwrapped • Simple solid instruments (no textiles) • Simple hollow bodies Gentle-B Single and multiple wrapped •... -
Page 52: Starting The Program
9 Sterilization Start the program with START PROGRAM. If Authentication at Reprocessing program start is activated, enter the PIN, see Authentication [} Page 72]. Confirm the subsequent dialogue window with START PROGRAM. Starting the program The following must be fulfilled or present: ü The sterile filter is screwed into the device. ü... -
Page 53: Manual Program Abort
9 Sterilization Manual program abort You can abort the program at any time. If you abort the program before the end of the sterilization phase, the load is not sterile. WARNING Danger of infection from early program abort Aborting a program before the drying phase begins means that the load is unsterile. This endangers the health of your patients and practice team. -
Page 54: Ending The Program Prematurely
9 Sterilization Ending the program prematurely You can exit the program prematurely after the drying starts. If you exit the program before the drying has finished, the load is not completely dried and should be used immediately. The following must be fulfilled or present: ü... -
Page 55: Approval Process
9 Sterilization If automatic log output after the end of the program is activated in the Settings > Log output menu, the log of the run program is output to the activated output media after the door is opened. Approval process According to “Hygiene requirements for the reprocessing of medical devices”, instrument reprocessing ends with ... -
Page 56: Storing Sterile Material
9 Sterilization Storing sterile material The maximum storage time is dependent on the packaging and the storage conditions. Please observe the regulatory requirements for the storage period of sterile materials (in Germany e.g. 58953, Part 8 or the DGSV guidelines) ... -
Page 57: Logging
[} Page 60]. If you continue the program without outputting the logs, the oldest log is overwritten automatically. The number of free log memory locations can be viewed under Device status > Device. MELAG recommends outputting logs automatically, see Log output [} Page 69]. Label printer The use of a label printer facilitates batch traceability. -
Page 58: Logs Menu
10 Logging Logs menu The Logs menu provides you with the following options: • Display and output of program logs, see Log output [} Page 69] • Display and output of malfunction logs • Display and output of status log • Display and output of system log •... -
Page 59: Log Output Options
10 Logging Press the button with the arrow to view and output a log. Press OUTPUT LOG to enter the Log output options and output the displayed log. Press PRINT LABELS to open the label printing dialog. Press the button with the arrow to change the Quantity or the Storage duration. -
Page 60: Output Media
10 Logging The following settings are possible: Output status Description Not output All logs that are not output will be output. Last The log of the last successful completed program is outputted. All logs of the selected log type are output. Output media The following output media can be activated and configured in the menu Settings > Log output: •... -
Page 61: Displaying Logs On The Computer
10 Logging Displaying logs on the computer The log files are generated in html format and can be displayed and printed on the computer with a web browser or in MELAtrace. The program, malfunction and status protocols contain a legend entry for each line. The program logs contain graphic data and can be displayed as graphic logs in MELAtrace. -
Page 62: Function Checks
11 Function checks 11 Function checks Service programs Program name Program Operating Use/function time Vacuum test 25 min For measuring the leakage rate, test with a dry and cold device (test without load) Bowie & Dick test 20 min Steam penetration test with special test package (available from specialist stockists) Draining 3 min... - Page 63 11 Function checks Options for the vacuum test Under Options, you can extend the vacuum test to areas that are connected to the sterilization chamber. In this way, you can also evaluate their leak tightness. Working in the Service programs menu, select Vacuum test and press Options.
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Page 64: Bowie & Dick Test
11 Function checks Bowie & Dick test Bowie & Dick test serves as proof of steam penetration of porous materials such as e.g. textiles. You can perform a routine function check for proof of steam penetration. To do so, use the Bowie & Dick Test service program. Specialist stockists provide various test systems for the Bowie &... -
Page 65: Settings
12 Settings 12 Settings General settings General settings can be changed by any user. Language In the Settings > Language menu, you can switch between the enabled languages. Set the desired language. Press CONFIRM to accept the changes. Ê The dialogues on the display and the log texts are changed to the selected language. Date and time Date and time of the device must be correctly set for proper batch documentation. -
Page 66: Display Brightness
12 Settings Set the time. Press SAVE to accept the changes. Display brightness In the Settings > Brightness menu, you can set the brightness of the display. The display brightness is adjusted immediately. The colour bar (pos. a) gives you an impression of the colour contrast. Move the slider to the left or right or press the plus (pos. -
Page 67: Energy-Saving
The wastewater is disposed of via the overflow funnel into an external wastewater container. The container is monitored by a level sensor and must be emptied regularly. MELAG recommends daily emptying. The capacity of the wastewater container is at least 10 cycles. -
Page 68: Program Options
12 Settings Program options In the Settings > Program options menu, you can make default settings for program options. Press the button with the arrow to make changes. Activate or deactivate the desired setting by selecting or deselecting it. Confirm the changes with OK. Press SAVE to accept the changes. -
Page 69: Log Output
12 Settings Log output In the Settings > Log output menu, you can set how the log should be output by default for each output medium [} Page 60]. The following settings are possible: Option Description Deactivated No log output possible, even with output medium connected Manual Manual log output possible via the log list Automatic (immediately... -
Page 70: Administrative Settings
12 Settings The following settings are possible: Option Description Deactivated No label print possible, even with label printer connected Manual Manual label print possible via the log list Automatic (immediately Label printing dialogue is displayed for the specified programs after each program after program run) run. -
Page 71: Logging On User Role
12 Settings Press the buttons with the arrow to change the ID (pos. d), the user name (pos. e) or the PIN (pos. f). Confirm the changes with OK and accept the changes with SAVE. PLEASE NOTE You can determine the necessity of user authentication via a PIN in the Authentication menu. Logging on user role To log on a user role, proceed as follows: Press the user role button. -
Page 72: Logging Off A User Role
12 Settings Logging off a user role In order to log off a user role, proceed as follows: Press the user role button. Press LOGOUT. Ê The symbol of the user role button changes. Authentication In the Settings > Administration menu, you can activate authentication (PIN entry) for the start or end of the program. -
Page 73: Batch Approval
12 Settings The following settings are possible: Designation Description Reprocessing program PIN entry required to start a program start Reprocessing program end PIN entry required to open a door Service program start PIN entry required to start a service program Service program end PIN entry required to open door after a service program PLEASE NOTE... -
Page 74: Software Update
12 Settings Software update In the Settings > Administration menu, you can perform a software version update. NOTICE During a software update, all program logs are deleted. Check whether all required logs have been output to an output medium. The following must be fulfilled or present: ü... -
Page 75: Maintenance
Checking and oiling the door lock NOTICE Wear of the door lock Only use MELAG oil. Check and oil the door lock every two months as follows: Clean the locking spindle and nut with a non-fuzzing cloth. Insert the check gauge into the door lock nut as far as it will go and turn it 180°. -
Page 76: Changing The Dust Filter
Do not use any hard objects for cleaning such as a metal saucepan cleaner or a steel brush. Sterilization chamber, door seal, mount, trays To maintain the value of your device and to avoid persistent contamination and deposits, MELAG recommends weekly cleaning of the surfaces. -
Page 77: Housing Parts
13 Maintenance Housing parts Where necessary, clean the housing parts with a neutral fluid cleaner or spirit. Comply with the following specifications when disinfecting the housing parts: Use wipe disinfectants and not spray disinfectants. This prevents disinfectant from getting into inaccessible places or ventilation slots. - Page 78 13 Maintenance Open the cover cap on the top of the device. If the cover is difficult to open, let the device cool down. Check the tank for contamination and, if necessary, clean it with a sponge and solvent-free, non-alkaline cleaner (e.g. washing-up liquid).
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Page 79: Maintenance
Maintenance work is to be performed regularly after 4000 program cycles but must be performed after 24 months. The steam sterilizer will issue a maintenance message at the relevant time. Carry out maintenance with an original maintenance set prepared by MELAG. Only original MELAG spare parts may be used. -
Page 80: Pause Times
14 Pause times 14 Pause times Duration of the operating pause Duration of the operating pause Measure Short pauses between two sterilization pro- • Keep the door closed to save energy cesses • Set Energy-saving as required, see Energy-saving [} Page 67] Pauses which last longer than an hour •... -
Page 81: Transport
14 Pause times Transport CAUTION Danger of injury from incorrect carrying. Lifting and carrying too heavy a load can result in spinal injury. Failure to comply with these provisions can result in crushing. The device should always be carried by two people. Use the carrying system to carry the device. -
Page 82: Installing The Carrying System
14 Pause times Installing the carrying system Undo the three bottom housing screws. Hook the carrying system up into the baseplate. Secure the carrying system on the device with the three screws. -
Page 83: Malfunctions
Should you be unable to find the relevant event, or your efforts do not redress the problem, you can contact your stockist or the MELAG customer service. Have the number of your device, the event number and a detailed description of the malfunction to hand so that we can help you. -
Page 84: Warning And Malfunction Messages
15 Malfunctions Warning and malfunction messages Event Possible cause What you can do 10059 The external wastewater container is full. Empty the external wastewater container be- fore the next program start. 10062 The lack of water in the feed water tank Secure the water supply (main tap) or fill the could not be remedied within the monitoring external storage container if using the filling... - Page 85 15 Malfunctions Event Possible cause What you can do 10101 Short-term wastewater blockage. The float Check whether the outlet hose is bent or the switch (S13) in the overflow funnel detected shut-off valve is possibly closed. a short-term impermissible water level, which indicates a blockage in the wastewa- This is only a warning.
- Page 86 15 Malfunctions Event Possible cause What you can do 10145 Monitoring time only runs when evacuation Check the dust filter for contamination and in negative pressure is started. The malfunc- replace it if necessary. tion is triggered if evacuation cannot be com- The intake area of the cooling system under pleted within the monitoring time.
- Page 87 15 Malfunctions Event Possible cause What you can do 10226 There is not enough feed water in the tank. Fill the feed water tank up to the maximum mark (MAX) of the level increase. 10241 Pressure-controlled evacuation. This is trig- Check the dust filter for contamination and gered when, in a gradient-monitored pro- replace it if necessary.
- Page 88 15 Malfunctions Event Possible cause What you can do 10257 Monitor pressure gradient during evacuation Check the dust filter for contamination and in the vacuum test. The pressure change at replace it if necessary. pressure sensor S1 is too low during evacu- The intake area of the cooling system under ation.
- Page 89 15 Malfunctions Event Possible cause What you can do 10267 Clock-controlled evacuation. The pressure Check the dust filter for contamination and change is less than expected; the vacuum replace it if necessary. performance is decreasing. The intake area of the cooling system under the device must be free.
- Page 90 15 Malfunctions Event Possible cause What you can do 10271 Conductivity monitoring. The warning value Have a regenerated cartridge ready for your for poor conductivity was exceeded. A pro- water treatment unit. gram start is still possible. This is only a warning. The reprocessing re- sult is not affected.
- Page 91 15 Malfunctions Event Possible cause What you can do 11001 Several USB sticks are directly connected to Please connect only one USB stick to the the device device. This is only a warning. The reprocessing re- sult is not affected. You can continue to use the device.
- Page 92 15 Malfunctions Event Possible cause What you can do 11011 Several printers are directly connected to the Please connect only one printer to the de- device. vice. Please restart the printer. First start the device and then the printer. This is only a warning. The reprocessing re- sult is not affected.
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Page 93: Technical Data
16 Technical data 16 Technical data Device type Vacuclave 550 Device dimensions (H x W x D) 65.0 x 63.6 x 71.5 cm Empty weight 98 kg Operating weight 127 kg Floor loading (normal operation) 2.71 kN/m² Floor load (hydraulic pressure test) 3.53 kN/m²... - Page 94 16 Technical data Wastewater Max. throughflow volume 2 l/min Max water temperature 90 °C for 30 s, max. 98 °C for 1 s Working and operating pressures Permissible operating pressure chamber -1 bar to + 3 bar relative Permissible operating pressure jacket -1 bar to + 3 bar relative Working pressure chamber/jacket 2.2 bar relative...
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Page 95: Accessories And Spare Parts
17 Accessories and spare parts 17 Accessories and spare parts You can obtain the specified articles and an overview of further accessories from your stockist. Accessories for the device Category Article Art. no. Mounts Basic mount ME22486 for 9 tray levels Loading slide ME22606 for up to 10 MELAstore Box 100... - Page 96 Surface-mounted siphon ME37410 Chamber Protect chamber cleaning set ME01081 Spare parts Category Article Art. no. Device MELAG oil for door lock nut ME27515 Test gauge TR20 for door lock nut ME27521 Sterile filter ME20160 Tank filter ME21358 Dust filter ME82260...
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Page 97: Technical Tables
18 Technical tables 18 Technical tables Feed water quality Minimum requirements to the feed water following 13060, Appendix C Substance/property Feed water Evaporation residue ≤ 10 mg/l Silicon oxide, SiO ≤ 1 mg/l Iron ≤ 0.2 mg/l Cadmium ≤ 0.005 mg/l Lead ≤ 0.05 mg/l Traces of heavy metal apart from ≤ 0.1 mg/l iron, cadmium, lead Chloride... -
Page 98: Precision And Drift Behaviour
18 Technical tables Step Universal-B Prion-B Gentle-B Quick-S Program phase P [mbar ] T [°C] Pressure (P) / Temperature (T) tolerance SF33 c 2000 +100/-20 +100/-20 c 1500 ◄ Fractionation steam intake c 2950 +60/-60 +60/-60 c 1850 ◄ Hold steam intake c 2950 +60/-60 +60/-60... -
Page 99: Measuring Chains
18 Technical tables Measuring chains Measuring chain for the temperature measurement on the electronics (without sensor) Precision (at 135 °C) ± 0.2 K Drift per year ± 0.005 K Drift in 5 years ± 0.025 K Measuring chain for the pressure measurement on the electronics (without sensor) Precision ± 0.2 % corresponds to ± 8.0 mbar corresponds to approx. -
Page 100: Pressure-Time Chart
18 Technical tables Pressure-time chart Pressure-time diagram for Universal-B, 134 °C and 2.1 bar Pressure-time diagram for Quick-S, 134 °C and 2.1 bar... -
Page 101: Empty Chamber Test
18 Technical tables Pressure-time diagram for Prion-B, 134 °C and 2.1 bar Pressure-time diagram for Gentle-B, 121 °C and 1.1 bar Empty chamber test The coldest point in the sterilization chamber during the empty chamber test lies directly on the temperature sensor (see blue dot in the following figure). -
Page 102: Glossary
MELAG who has sufficient specific prevention. device and technical knowledge. to perform maintenance and installation work on MELAG devices. Only they may DIN 58946-7 carry out this work. Standard – sterilization - steam steam sterilizers - part 7:... - Page 103 Glossary EN ISO 11607-1 opening on both sides which is: 2 ≤ L/D ≤ 1500 and L ≤ Standard - packaging for medical devices to be sterilized in 3000 mm and which does not correspond to the hollow the final packaging - Part 1: Requirements placed on body B L…hollow body length D…hollow body diameter materials, sterile barrier systems and packaging systems [see EN 13060]...
- Page 104 Certificate of Suitability According to the recommendations of the Commission for Hospital Hygiene and Infection Prevention at the Robert Koch Institute. Manufacturer: MELAG Medizintechnik GmbH & Co. KG Address: Geneststraße 6-10 10829 Berlin Country: Germany Product: Vacuclave ® Type of device:...
- Page 106 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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Questions and answers
We took delivery of a new 118 today. First universal run produces an error message of 30660.. water connectivity error Pls asisit?