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Summary of Contents for Metasys BR System
- Page 1 BR System Instructions for use 200004303 | 2024-09 eIFU: www.metasys.com/downloads...
- Page 2 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 200004303 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.
- Page 4 > 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 >...
- Page 5 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 The BR System is used for introduction of the GREEN&CLEAN BR in the water-bearing pipes of treatment units. 2.1. Indication Not applicable. 2.2. Contraindication Not applicable. 2.3. Target group Trained technical staff.
- Page 7 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 The BR System is used to introduce the product GREEN&CLEAN BR into the water-bearing pipes of the dental unit. In combination with GREEN&CLEAN BR, the BR System is used to sanitise the water-bearing pipes in the event of biofilm infestation. Existing biofilm is removed in 30 minutes.
- Page 9 Functional description The BR System is connected to the water inlet of the treatment unit. The pump then pumps the GREEN&CLEAN BR into the water-bearing pipes of the treatment unit. After a maximum exposure time of 30 minutes, the water inlet of the treatment unit is reconnected to the water mains. The waterbearing pipes are rinsed with fresh water until the liquid and the loosened dirt have been removed.
- Page 10 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 11 Remove all water consumers from the dental unit (protection against clogging). Remove the sealing cap (black). Insert the tube into the new GREEN&CLEAN BR bottle and press on the push-in cap. Remove the sealing plug (red). Connect the water inlet hose of the dental unit to the BR System.
- Page 12 As soon as the purple liquid emerges at the consumers, switch the device off again. Close the inlet tap. Disconnect the water inlet hose of the dental unit from the BR System. Remove the push-in cap from the GREEN&CLEAN BR bottle, replace the sealing plug...
- Page 13 Error messages 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!
- Page 14 Care and maintenance Care and maintenance 7.1. Replacing consumables Remove the empty GREEN&CLEAN BR bottle from the device. Pull the push-in cap (incl. tube) out of the bottle Insert the tube into the new GREEN&CLEAN BR bottle and press on the push-in cap. Place the bottle back in the device.
- Page 15 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 16 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 17 The warranty period for installed replacement parts ends with that for the originally delivered device. The METASYS customer is obligated to make his customer aware of the conditions regarding the warranty processing. The statutory warranty rights of the customer remain unaffected.
- Page 18 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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