Related Manuals for Metasys COMPACT Dynamic
Summary of Contents for Metasys COMPACT Dynamic
- Page 1 COMPACT Dynamic Instructions for use EN | 200004297 | 2023-09 eIFU: www.metasys.com/downloads...
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Page 2: Table Of Contents
Table of contents Table of contents Notes ..............................4 1.1. General instructions ..........................................4 1.2. Explanation of the symbols ......................................... 4 Intended use ............................6 2.1. Indication ............................................. 6 2.2. Contraindication ..........................................6 2.3. Target group ............................................6 Safety-related information .........................7 3.1. General safety-related information ...................................... - Page 3 200004297 If you would like to request a printed copy of the instructions for use, please contact us at ifu@metasys.com or use the order form at www.metasys.com/downloads A hardcopy of the instructions for use will be made available to you free of charge and within seven calendar days of receipt of the request.
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Page 4: Notes
Notes 1.1. General instructions METASYS can only guarantee the safety, reliability and performance of the dental device if the following instructions are adhered to: > The product is only to be used in accordance with the instructions for use. >... - Page 5 UDI marking with standard authorized representative‘s device compliant HIBC data content registered office in Switzerland 1.3. Copyright notice All names and contents are protected by copyright. Distribution, duplication or alternative use of this document is only permitted with the written consent of METASYS Medizintechnik.
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Page 6: Intended Use
Intended use Intended use The METASYS COMPACT Dynamic is a software-controlled two-step single-unit amalgam separator with integrated dynamic air/water separation, as well as a suction flow valve for separating amalgam from the waste water of dental treatment units. 2.1. Indication Not applicable. 2.2. Contraindication Not applicable. 2.3. Target group The device shall be used by trained and qualified personnel exclusively. -
Page 7: Safety-Related Information
Safety-related information Safety-related information 3.1. General safety-related information All serious incidents related to the device must be reported to the manufacturer and the competent authority of the Member State where the user and/or the patient is resident. 3.2. Safety instructions Assembly, modifications or repairs may only be carried out by authorised qualified personnel who guarantee compliance with the EN 60601-1 standard (international standard on Medical Electrical Equipment and Systems, in particular part 1: General requirements for basic safety). -
Page 8: Product Description
Product description Product description 4.1. Product description COMPACT Dynamic a two-stage single place amalgam separator with integrated dynamic air/water separation. 4.2. Technical data / performance data Height [H] Width [W] Depth [D] COMPACT Dynamic Power supply 24 V AC Frequency 50/60 Hz Max. -
Page 9: Construction
Product description 4.4. Construction Module 1 Module 2 Central fastening element: Air/water separation: > Air, water and electrical connections > Collection container > Wall mount > Centrifuge > Main board > Separation unit > Diagnostic board > Filter unit Cover Cover (optional) 4.5. -
Page 10: Diagram
Product description 4.6. Diagram Legend Suction flow (secretion) Negative pressure Waste water Amalgam Waste water with amalgam... -
Page 11: Preparation For Use
Preparation for use Preparation for use 5.1. Transport and storage The device is shipped in two polystyrene shells fixed together. This original packaging must be used for any onward and return transport. The device must always be transported and stored in an upright position. The device must be transported to the installation site in a completely packed state. After unpacking the device, check for completeness and possible transport damage. 70 °C Transport and storage temperature 0 °C... -
Page 12: Assembly Variants
The cover should be mounted on the connection box of the treatment unit. The external display and a transformer are already integrated in the cover. 5.2.2. Pipe and hose connections COMPACT Dynamic Built-in version COMPACT Dynamic with cover Connection for spittoon drain hose Ø 15 mm Connection for suction hose (for hose storage) Ø 26 mm Connection for suction hose (to suction machine) Ø... -
Page 13: Connection Dimensions
Preparation for use > The device must be connected to the sewage pipe via an odour trap. > The waste water must be able to flow freely, as the separation efficiency is not guaranteed in the event of backwater. > Water jet operated saliva ejectors must be shut down due to high water consumption. > The flushing of the spittoon must be limited by means of a timer or button to max. 30 seconds at a max. water flow of 3 l/min to enable the centrifuge to stop. > For matching hose adapters and fittings see 9.1.1. Accessories, service kits, collection containers and spare parts. 5.2.3. Connection dimensions ø... -
Page 14: Installation, Assembly And Commissioning
Read the instructions carefully before installation and commissioning! Meet spatial requirements see 5.2. Installation requirements Check the coarse filter in the spittoon Install the pre-filter (if not present in the hose storage) COMPACT Dynamic Built-in version Fit a contact protection plate behind module 1 (if the subsurface is electrically conductive) Connect the spittoon drain hose (Mesh size of the coarse filter max. 3 mm) Connect the drain hose... -
Page 15: Installation And Assembly Of Optional Accessories, Retrofit Parts And Spare Parts
Installation and assembly of optional accessories, retrofit parts and spare parts Assembly, modifications and repairs may only be carried out exclusively by authorised specialist personnel (see 3.2. Safety instructions)! The METASYS technical customer service is also available for further information and assistance in carrying out repairs, retrofitting, fault analyses, etc. 5.3.2. Connecting to other devices When connecting the METASYS device to other devices or systems, hazards can arise. It must therefore be ensured that no hazards arise for the user or the patient and that the environment is not affected. The specifications of the manufacturer of the device or system to be connected must be observed. -
Page 16: Electronics
Preparation for use 5.4. Electronics The mains connection may only be carried out by a qualified electrician. The electrical installation must be carried out in accordance with the applicable local regulations. Before connecting to the mains, compare the rated voltage on the device type plate with the mains voltage. 5.4.1. Electrical connections LED 1 LED fill level LED 2 LED suction hose X1 (fill level / water level) Filling level Motor connection X3 (main power) Power supply 24 V AC The supply voltage must be taken from a safety transformer that complies with the requirements of IEC 601-1 / VDE... -
Page 17: Use
Error messages Assembly, modifications and repairs may only be carried out exclusively by authorised specialist personnel (see 3.2. Safety LEUCHTEN instructions)! The METASYS technical customer service is also available for further information and assistance in carrying out repairs, retrofitting, fault analyses, etc. BLINKEN... - Page 18 BLINKEN RESET RESET RESET RESET LEUCHTEN BLINKEN RESET RESET RESET RESET LEUCHTEN Error message Externe Anzeige Possible cause Countermeasures BLINKEN LED 1 flashes green RESET RESET LED 3 flashes yellow Motor overtemperature Notify your service technician. RESET RESET RESET RESET RESET RESET Buzzer tone can be switched off via RESET collection container replacement RESET...
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Page 19: Care And Maintenance
For information on use and safety instructions, see the GREEN&CLEAN M2 instructions for use. 7.1.2. Cleaning and emptying the prefilter Collect the residues containing amalgam from the filter drawer in a suitable container. 7.2. Maintenance and service Assembly, modifications and repairs may only be carried out exclusively by authorised specialist personnel (see 3.2. Safety instructions)! For further information and assistance in carrying out repairs, retrofitting, fault analyses, etc., the METASYS technical customer service is also available! Warning: Switch off the main switch of the treatment unit! -
Page 20: Replacement Of The Collection Container
Care and maintenance Warning: Avoid contact with the contents of the amalgam separator! Warning: Risk of contamination: To avoid infection, wear personal protective equipment (hand, eye, mouth-nose protection) and disinfect and clean the device! 7.2.1. Replacement of the collection container Provide a new collection container and disinfectant. - Page 21 Care and maintenance Place the upper section on the new collection container. Hold the collection container and turn the upper part clockwise as far as it will go; carry out a visual inspection (all retaining lugs of the container must be properly engaged). Grease the sealing surfaces in the retaining element with Vaseline.
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Page 22: Disposal Of The Collection Container
7.2.2. Disposal of the collection container The full collection container can be returned to the company‘s own disposal organisation, METASYS logistics & collection GmbH GmbH. Retain the confirmation of disposal in accordance with state law. When the complete device is disassembled at the end of its service life, it can be returned to the manufacturer for correct disposal (see 8.2. Recycling and disposal). -
Page 23: Service Mode
7.2.3. Service mode The electronics of the COMPACT Dynamic amalgam separator allows the device functions to be checked in a service mode. Attention: In order to return to normal operation or service mode after switching off the unit, it is essential to wait 5 seconds before switching it... -
Page 24: 5-Year Service Kit
Care and maintenance Start service mode Call up service mode (see 7.2.3 Service mode) Perform motor and valve test run at least once End service mode by switching off the supply voltage 7.2.5. 5-year service kit According to the German Waste Water Ordinance, Annex 50, amalgam separators must be inspected for proper condition at intervals of no longer than 5 years in accordance with state law! The 5-year inspection must be entered in the device document! Carry out a 1-year inspection... -
Page 25: 7.2.5.1. Visual Check Of The Centrifuge
Care and maintenance 7.2.5.1. Visual check of the centrifuge Remove separator from wall bracket Remove the four screws on the top of the unit using a suitable tool (Torx 20). Remove the lid of the separation (use the screwdriver support on the back). Do not remove the separation inlet seal! Remove the separation rotor by removing the plug in the center of the rotor using needle-nose pliers, loosen the hexagon socket screw and pull the rotor out upwards. -
Page 26: Decommissioning
Risk of contamination: To avoid infection, wear personal protective equipment (hand, eye, nose and mouth protection) and disinfect and clean the device! If it is necessary to return the device to the depot or to METASYS, the original METASYS packaging must be used. Before packing the METASYS device to be transported, clean and disinfect it. Possible openings where residual fluids could escape must be closed. -
Page 27: Annex
ET COMPACT Dynamic, adapter kit 120000574 ET COMPACT Dynamic, safety clip 120000575 ET COMPACT Dynamic, fuse T 6.3 A, 5 pcs. 120000576 ET COMPACT Dynamic, hose clamp set, 2x small, 2x large 120000577 ET COMPACT Dynamic, pump housing 120000578 ET COMPACT Dynamic, pump filter, 5 pcs. 120000579... - Page 28 ET COMPACT Dynamic, power unit 120000592 ET COMPACT Dynamic, a-dec, mounting plate 120000619 ET COMPACT Dynamic, siphon floor model 120000620 ET COMPACT Dynamic, Planmeca, CD4 circuit board adapter plug 120000621 ET COMPACT Dynamic, power unit, Nov. Service kits 120000598 ET COMPACT Dynamic, annual inspection kit...
- Page 29 Annex 122000028 GREEN&CLEAN M2 - refill kit 2, 2 x bottle 500 ml 122000031 GREEN&CLEAN M2 red, 25 x bottle 500 ml 122000030 GREEN&CLEAN M2 green, 25 x bottle 500 ml 121000009 GREEN&CLEAN M2 dispenser Nozzles and adapters 120000057 ET fittings, angle piece clean water outlet 15 mm 120000058 ET fittings, VITALI, connection parts set 120000059 ET fittings, T-distributor for 2 suction hoses 120000060 ET fittings, transport plug Ø 26, 2 pcs. 120000061 ET fittings, Siemens, reducer 15/21 mm, 5 pcs. 120000062 ET fittings, hose adapter 90°, 15 mm, 5 pcs. 120000063 ET fittings, hose adapter 24-25 mm, 5 pcs.
- Page 30 Annex 120000263 ET META Connect, extension 64.5 mm 120000264 ET META Connect, extension 56.5 mm 120000265 ET META Connect, extension 49.5 mm 120000266 ET META Connect, extension 27 mm 120000267 ET META Connect, connecting piece hose adapter 26 mm, 5 pcs 120000268 ET META Connect, connection adapter with mini-nozzle, 26 mm 120000269...
- Page 31 Annex Spare parts - COMPACT Dynamic 120000561 120000591 120000558 120000566 120000560 120000562 120000589 120000570 120000564 120000572 120000567 120000574 120000568 120000569 120000567 120000583 120000587 120000576 120000134 120000575 CD 3 = 120000590 120000585 120000577 120000565 120000563 120000578...
- Page 32 Annex External display - COMPACT Dynamic 120000438 120000165 120000215 120000209 120000208 Connection dimensions ø 15 ø 26 ø 26 ø 15...
- Page 33 Annex META Connect - hose adapters and adapters ø ø 26 ø 26 ø 26 ø 26 ø 21 ø 21 ø 21 ø 21 ø 21 120000262 120000263 120000264 120000265 120000266 ø 22 ø 26 ø 22 ø 26 ø...
- Page 34 Annex ø 21 ø 26 ø 21 ø 21 ø 26 ø 24 ø 31 ø ø 32 ø 25 ø ø 26 ø 26 ø 26 ø 26 ø 15 120000269 120000295 120000275 120000277 120000278 ø 10 ø 16 ø...
- Page 35 Annex hose adapters and adapters not combinable with META Connect 120000067 120000066 120000065 120000064 120000063 ø 10 ø 15 120000070 120000069 120000068 120000062 120000091 ø 17 ø 18 ø 19 ø 16 ø 15 120000057 120000061 120000088 120000074 Adapter for Dürr ø...
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Page 36: Warranty Conditions
The customer sends the device or component in question to METASYS at his own expense. METASYS checks whether there is a warranty claim. METASYS will repair the device or component if it is cost-effective. The customer is charged for the costs incurred for the repair, but not the replacement parts covered by the guarantee. - Page 38 METASYS Medizintechnik GmbH Florianistraße 3 | 6063 Rum bei Innsbruck | Austria Subject to printing and setting errors! T +43 512 205420 | info@metasys.com | metasys.com...
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