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Summary of Contents for Metasys WEK
- Page 1 Instructions for use EN | 200004301 | 2024-04 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 1.3. Copyright notice ..........................................5 Intended use ............................6 2.1. Indication ............................................. 6 2.2. Contraindication ..........................................6 2.3. Target group ............................................6 Safety-related information .........................7 3.1. - Page 3 DE, EN, IT, DA, FI, NL e-mail ifu@metasys.com Order number 200004301 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. Translations Translation of the original instructions for use Tetras GmbH Sirius Business Park, Rupert-Mayer-Str. 44, 81379 Munich, Germany Images The images contained in these instructions for use are for reference and may differ from the actual appearance of the product.
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Page 4: Notes
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. > During maintenance and service work (inspection, service, repair, replacement), only use original replacement parts. > All manufacturer specifications for the treatment units to which the device is connected must be observed. > After commissioning, complete the proof of installation and send this to METASYS in order to define the warranty period. > All maintenance and service work must be entered into the device logbook. > On request by an authorised technician, METASYS will provide all documentation that may be of use to technically qualified personnel during maintenance and service works > METASYS accepts no responsibility for damage that may arise due to external influences (defective installation), using incorrect information, improper use of the dental device, or maintenance and service works being carried out improperly. > The user must familiarise himself/herself with how to operate the dental device and ensure that the dental device is in good condition each time before operating it. Important: Read the accompanying documents of the device carefully before installation, commissioning and use and keep them for the entire service life of the product! 1.2. Explanation of the symbols CE mark End device ready for operation... -
Page 5: Copyright Notice
Name and address of the Unique identifier of a medical 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. -
Page 6: Intended Use
Intended use Intended use The water decontamination system WEK is used for software-controlled dosing of GREEN&CLEAN WK into the water supply of medical treatment units and for separating the treatment water from the supplying pipe. 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). The electrical installation must comply with the regulations of the IEC (International Electrotechnical Commission). Medical devices should be handled with care with regard to electromagnetic compatibility. Special safety measures must therefore be taken. The device is not suitable for operation in explosive areas or in flammable atmospheres. 3.3. Warnings Danger Warning of a danger that will directly result in serious injury or death Warning of a danger that can result in serious injury or death Warning Caution Warning of a danger that can result in minor injury Attention Warning of a danger that can result in extensive damage to property... -
Page 8: Product Description
Water consumption - turbines, straight 50 – 70 ml/min 50 – 70 ml/min and contra-angle handpieces Water consumption - mouth rinsing 150 ml/filling of mouth rinsing cup 150 ml/filling of mouth rinsing cup Class MD class 1 MD class 1 4.3. Type plate WEK Built-in version For versions without a mounting plate, the type plate is located on module 4 (mixing container). For versions with a mounting plate, the type plate is located on the mounting plate. WEK with cover The type plate is located on the housing (next to the external display - push the lid of the cover upwards). -
Page 9: Construction
Product description Device description Item number Serial number Connection data Date of manufacture Manufacturer Follow instructions for use Protection class II CE mark Name and address of the authorized representative‘s registered office in Switzerland Example picture Separate collection of electrical/electronic equipment (WEEE) Medical device Unique identifier of a medical device, UDI marking with standard compliant HIBC data content 4.4. Construction Module 1 Control electronics BATT 2x LR44 1,5 V LED1 LED3 LED2 LED4 SIC1... - Page 10 Product description Module 4 Mixing tank; this is where the water (after the free-fall section) is mixed with the disinfectant. This module contains the tank, level and outlet probe, as well as 2 magnetic valves and a disinfectant sensor. Module 5 Double membrane pump and membrane rupture sensor Module 5 Module 6 Water unit; consisting of a flow rate limiter and dosing valves Module 7 Compressed air unit; this is a pressure regulator. Additional housing (optional); consisting of housing, mounting plate, main Module 8 water tap with pre-filter (80 µm), transformer and main switch.
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Page 11: Functional Description
Product description 4.5. Functional description After opening the tap and switching on the device, the dosing valve is opened and 150 ml of water is added to the mixing container. The water level in the mixing container is monitored by an electronic level probe A. If the contact on this probe is triggered, magnetic valves 2 (compressed air) and 1 (GREEN&CLEAN WK) open. As a result, the compressed air-operated double membrane pump draws approx. 1.75 ml of hydrogen peroxide from the GREEN&CLEAN WK bottle and adds it to the mixing container. If the water level drops below level probe A, the dosing valve opens again until overflow probe B is reached. When this probe is reached, 300 ml of water has now been added to the mixing container. Magnetic valves 2 and 1 now open again and add additional 1.75 ml of GREEN&CLEAN WK to the mixing container. This ensures that the required concentration of disinfectant solution is continuously maintained. The water inlet in the mixing tank is designed as a free fall section, which ensures that the WEK is separated from the water supply network as required by DVGW (DIN 1988, Part 4). A backflow of contaminated water or water mixed with GREEN&CLEAN WK to the supply network is therefore no longer possible. If a consumer is activated, the consumption medium flows from the mixing tank via the pressure tank to the corresponding consumers. This lowers the water level in the pressure tank and consequently the water pressure. The membrane pump is started by means of a pressure switch attached to the pressure tank and set to 2.5 bar. This membrane pump is responsible for emptying the mixing tank or filling the pressure tank and for maintaining the necessary flow pressure. An air cushion in the pressure tank compensates for the water level. If necessary, the air cushion is balanced with compressed air (magnetic valve 3) - all this to ensure a stable water jet for the consumers. The air cushion probe ensures that the air pressure remains constant. The disinfectant is drawn from the GREEN&CLEAN WK bottle. A disinfectant sensor monitors the presence of GREEN&CLEAN WK. If no more disinfectant can be delivered (e.g. because the disinfectant bottle is empty), an error message is shown. -
Page 12: Preparation For Use
Preparation for use Preparation for use 5.1. Transport and storage Device with cover: The device is shipped in two polystyrene trays fastened together in a cardboard box. Built-in version: The device is shipped in a cardboard box with bubble wrap. 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. Transport and storage temperature 0 °C –... -
Page 13: Pipe And Hose Connections
GREEN&CLEAN WK bottle connection PVC hose Inner diameter = 2 mm / outer diameter = 4 mm Water outlet connection (to the consumers) PUR hose Inner diameter = 4 mm / outer diameter = 6 mm 5.2.3. Filter / pre-filter If not already integrated in the treatment unit, a pre-filter with a maximum mesh size of 80 µm must be fitted upstream of the water connection of the WEK. -
Page 14: Installation, Assembly And Commissioning
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. Please note that the transformer is still live when the device is switched off (main switch WEK set to OFF)! Before carrying out any installations or repairs, disconnect the device from the mains using the device/practice main switch! 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 15: Electronics
Fuses may only be replaced by the same type! 5.4.1. Electrical connections / circuit diagram X1 - Power supply 24 V AC (orange) METASYS WEK The supply voltage must be taken from a safety transformer that 200003193v03 | 2024-01 meets the requirements of EN 60601-1 and EN 61558-2-6. -
Page 16: Use
To increase the concentration of GREEN&CLEAN WK if necessary, intensive decontamination can be activated by pressing the RESET button for 4 seconds (LED 1 flashes) until the first beep. During this process, LED 1 lights up constantly and LED 3 flashes. For the next chemical dosing, 3 cycles of GREEN&CLEAN WK are added first, followed by 2 cycles for each of the next 4 doses. No more chemicals are added during the final dosing, so that the normal concentration of the working solution is restored once intensive decontamination is complete. After decontamination, LED 3 goes out and a short buzzer signal sounds - the WEK is back in normal operation. -
Page 17: Error Messages
Level probe in the mixing container is First check whether the main water All valves and the pump are switched dirty, or no water supply! tap or the water supply line is off. The buzzer can be switched off LED 2 flashes red open. Clean or replace the mixing with the RESET button. Once the Buzzer sound container probe (see 7.2.2). cause has been rectified, the WEK can only be reactivated by switching it off and on again. LEUCHTEN BLINKEN RESET RESET LED 1 lights up green Defective double membrane pump, Clean the overflow sensor. Check All valves and the pump are switched... -
Page 18: Care And Maintenance
7.3 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! Please note that the transformer is still live when the device is switched off (main switch WEK set to OFF)! Before carrying out any installations or repairs, disconnect the device from the mains using the device/practice main switch! 7.2.1. Function test The GREEN&CLEAN WK test strips can be used to check whether the correct amount of hydrogen peroxide is being mixed with the process water. It is recommended that this check is carried out weekly. For information on use and safety instructions, see the GREEN&CLEAN WK instructions for use. -
Page 19: Checking The Overflow Probe
Clean or dry the overflow probe, check the circuit board connections (see 5.4 Electronics) Check the double membrane pump and circuit board Reconnect the device to the power supply 7.2.4. 1-year maintenance kit An annual service of the WEK water decontamination system (service kit order no. 120000042) is mandatory. This service includes a complete functional check of the device, as well as checking or replacing the following parts: 2 x magnetic valve (one of which must be replaced alternately) Non-return valve for membrane pump 3 x PVC hoses 4x6 mm Pre-filter insert Checking and cleaning the mixing container and the probes in it Bottle connector (not shown) 7.2.5. -
Page 20: Decommissioning
Warning: 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. 8.2. Recycling and disposal The device may be contaminated! Advise the disposal company of this so that appropriate precautions can be taken. -
Page 21: Annex
05020011 WEK Water decontamination system, Novadent Device, Novadent version, with instructions for use 108000023 05020045 WEK Water decontamination system, OMS Device, OMS version, with instructions for use 108000024 05020033 WEK Water decontamination system, Planmeca Device, Planmeca version, with instructions for use 108000025 05020043 WEK Water decontamination system, Ritter Device, Ritter Concept R400 version, with instructions for Concept R400 108000026 05020017 WEK Water decontamination system, Ritter... -
Page 22: Accessories, Service Kits, Collection Containers And Spare Parts
ET WEK, non-return valve, air, 4 mm 120000014 50050112 ET WEK, pump head 120000015 50050007 ET WEK, Planmeca, membrane pump 120000016 50050128 ET WEK, Planmeca, 1-year maintenance kit, hygiene set 120000017 50050004 ET WEK, mixing container, double membrane pump 120000018 50050119 ET WEK, mixing container without lid 120000019 50050003... - Page 23 120000036 50050120 ET WEK, ATMOS, condensate separator 120000037 50050127 ET WEK, ATMOS, main circuit board 120000038 50050125 ET WEK, ATMOS, compressed air generator/compressor 120000039 50050122 ET WEK, ATMOS Aqua clean, 1-year maintenance kit 120000040 50050101 ET WEK, cover for device...
- Page 24 120000012 Module 4 Bestellnr. | Order no. Bezeichnung | Designation 120000042 WEK, 1-Jahres-Wartungs-Kit | Annual inspection kit 120000016 WEK, Planmeca, 1-Jahres-Wartungs-Kit | Annual inspection kit 120000033 WEK, Belmont/Galbiati/Ritter, 1-Jahres-Wartungs-Kit | Annual inspection kit 120000041 WEK, 3-Jahres-Wartungs-Kit | 3-year inspection kit...
- Page 25 Annex Wasserentkeimung WEK Water decontamination system WEK 120000149 120000026 120000010 120000027 120000035 120000007 120000040 120000009 120000437 120000008 120000023 PVC 2 x4 mm 120000100 PA4 x 6 mm 120000104 120000003 120000002 PUR 2,5 x4 mm 120000103 PUR 2 x4 mm 120000102...
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Page 26: Warranty Conditions
Failure to provide visual images (photos, video clips ...) of the METASYS item complained about, as well as of its installation situation and ambient conditions. METASYS reserves the right to demand the documentation supplied with the device to check the maintenance intervals for the assertion of warranty claims. The processing of warranty claims takes place exclusively according to the following method: In the event of malfunctions, the device must be opened by an authorized technician, the relevant component taken out and sent to METASYS unopened and cleaned. 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. The consignment of the device or component to METASYS always represents a repair order for METASYS. For cost estimates for the repair of returned devices, a processing fee* is charged if the warranty period has expired or no warranty case exists. For products inspections only without any cost... - Page 27 Annex...
- Page 28 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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