Related Manuals for Creo Medical AIR:MASTER
Summary of Contents for Creo Medical AIR:MASTER
- Page 1 Operating Instructions AIR:MASTER For blowing out and drying waterproof flexible endoscopes Updated 18.03.2024 Rev.3 Page TD-04 AIR:MASTER Revision 1 of 27 IFU-TD04-002...
- Page 2 Page TD-04 AIR:MASTER Revision 2 of 27 IFU-TD04-002...
- Page 3 These Operating Instructions apply to the following products: AIR:MASTER REF: 7000-K01 The AIR:MASTER is a Class I / Rule 13 active medical device as defined in Annex VIII Council Regulation (EU) 2017/745. A Declaration of Conformity can be provided on request.
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Page 4: Table Of Contents
Delivery ........................9 Parts supplied ...................... 9 Returning the device ....................10 Device overview ......................11 Instructions attached to the device ..............12 Electrical connection ....................12 Operating the AIR:MASTER ...................12 Functional check ....................13 Drying endoscopes....................14 6.2.1 Preparation ......................14 6.2.2 Connecting up the endoscope (clean side) ............14 After using the device ....................15... - Page 5 Processing ......................15 7.1.1 AIR:MASTER on the clean side of the reprocessing room ........15 Maintenance activities every four weeks ..............15 Maintenance activities once a year ...............16 7.3.1 Tube connections ....................16 7.3.2 Maintenance ......................16 Disinfecting and cleaning the device ................16 AIR:MASTER ......................16 8.1.1...
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Page 6: Instructions For Use
(jet channel, air/water channel, biopsy channel, suction channel). The AIR:MASTER can be used on either the clean side or the contaminated side of the reprocessing room but not at the same time, i.e. not during the same reprocessing operation. -
Page 7: Hazards And Risks Arising During Use
1.2.1 Hazards and risks arising during use Infections can be transmitted when using the AIR:MASTER. The AIR:MASTER must not be used in rooms with flammable or explosive gases (within flash distance of potentially explosive anaesthetics or other potentially explosive substances). -
Page 8: General Remarks On Dangers And Risks
The use of inappropriate accessories can cause the device to operate incorrectly, which may result in injury to patients, users, third parties and service technicians. Use only accessories specified for operation with the AIR:MASTER device (see Appendix II). 2.5.5 Faulty fuses When replacing a faulty fuse, please ensure the new fuse corresponds with the specifications displayed on the device or set out in these Operating Instructions. -
Page 9: Instructions On Operation
Maintenance and service life Regular preventive maintenance is the basic prerequisite to ensure the functionality and operational safety of the AIR:MASTER over the entire expected service life. For this reason, the AIR:MASTER must be serviced every 12 months by the manufacturer, Creo Medical GmbH or a company authorised by the manufacturer. -
Page 10: Returning The Device
Operating Instructions Returning the device If you need to return the device, please use the original packaging. We will not accept responsibility for damage incurred during transport as a result of inappropriate packaging. Page TD-04 AIR:MASTER Revision 10 of 27 IFU-TD04-002... -
Page 11: Device Overview
Socket for shrouded 3-pin plug: the device must only be operated with the voltage given on the rating plate Fan: for forced-air cooling of the compressor pumps Page TD-04 AIR:MASTER Revision 11 of 27 IFU-TD04-002... -
Page 12: Instructions Attached To The Device
If the mains voltage is incorrect, the device may not function properly or could be damaged. The AIR:MASTER will be ready for use as soon as it has been properly installed. Operating the AIR:MASTER The procedures outlined below should be carried out the first time the device is used and then at regular intervals during normal operation. -
Page 13: Functional Check
AIR:MASTER pumps will continue to run. Switch the AIR:MASTER ‘OFF’ via the mains switch and remove the LL plug from the compressed air outlet. Once the device has completed all the functions without error messages, the functional test has been passed. -
Page 14: Drying Endoscopes
6.2.2 Connecting up the endoscope (clean side) When using the AIR:MASTER on the clean side of the reprocessing room, please follow these instructions: Remove the valves from the endoscope and close off the valve shafts with the correct adapters for that endoscope. -
Page 15: After Using The Device
Note The endoscope should be hung up before it is dried. Creo Medical GmbH provides suitable endoscope hangers for wall-mounting (further details available from our current catalogue). After using the device 1. -
Page 16: Maintenance Activities Once A Year
Notice Use only strainers approved by Creo Medical GmbH as these are calibrated specifically to the AIR:MASTER pump capacity. Maintenance activities once a year 7.3.1 Tube connections Both the tubes inside the device and the connection tubes must be replaced once a year as part of the annual service. -
Page 17: Maintenance, Inspection And Testing
(e.g. Beta Guard RFU wipes require five minutes). 9) Allow the device to dry off. 8.1.5 Maintenance, inspection and testing We recommend annual maintenance of such devices by Creo Medical GmbH or a person authorised by us. 8.1.6 Packaging No special requirements. -
Page 18: At The Place Of Use
8.2.6 Manual disinfection Equipment required: non-protein-fixing VAH-listed (VAH = Association for Applied Hygiene) instrument disinfectant based on quaternary compounds, acetals and aldehydes (e.g. InstruPlus viruguard, Dr Deppe GmbH #600052) preferably demineralised water (deionised Page TD-04 AIR:MASTER Revision 18 of 27 IFU-TD04-002... -
Page 19: Automated Cleaning And Disinfection (Aer)
¹ Within the range of their authorisation, local authorities may adopt other rules (parameters for effective disinfection). 4) At the end of the programme, remove the tube set. 5) Check that the set is dry and, if necessary, dry using medical-grade compressed air Page TD-04 AIR:MASTER Revision 19 of 27 IFU-TD04-002... -
Page 20: Maintenance, Inspection And Testing
Device is not working: Green light on the power switch is not lit. Ensure the plug is inserted firmly into the power socket. Check the mains power supply and socket. Check the fuse on the device. Page TD-04 AIR:MASTER Revision 20 of 27 IFU-TD04-002... -
Page 21: Final Disposal
If the problem persists: contact an authorised service technician. Final disposal At the end of its useful service life, the AIR:MASTER and its detachable components have to be disposed of in accordance with applicable local regulations. Technical specifications Mains supply, rated... -
Page 22: Emc Conditions
DC voltage connections between parts of equipment or systems not connected to a DC voltage network are treated as input/output connections. For example, ‘25/30 cycles’ means ‘25 cycles for 50 Hz mains frequency tests’ or ‘30 cycles for 60 Hz mains frequency tests’. Page TD-04 AIR:MASTER Revision 22 of 27 IFU-TD04-002... -
Page 23: Appendix I Connecting Up An Endoscope
Attach suction channel tube Connection tube for CO2 connection Order no.: 7522-A00 (CF models only) For Olympus Series 40 endoscopes, use the air/water channel cap supplied with the endoscope. (Supplied by Olympus) Page TD-04 AIR:MASTER Revision 23 of 27 IFU-TD04-002... - Page 24 Order no.: 7531-000 Connecting Fuji Video Endoscope Series 300 Unscrew valves and screw in valve plugs Supplied by Fuji Attach channel adapter WA-7 - Supplied by Fuji - Attach biopsy channel tube Page TD-04 AIR:MASTER Revision 24 of 27 IFU-TD04-002...
- Page 25 1. Screw in suction valve connector 2. Close air/water valve Supplied by Pentax OF-B65 OF-B64 LL-M LL-M Attach biopsy channel tube Attach air/water channel cap and Attach suction channel tube connect the air/water channel tube Page TD-04 AIR:MASTER Revision 25 of 27 IFU-TD04-002...
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Page 26: Appendix Ii Accessories
Member State in which the user and/or patient is established. For the Federal Republic of Germany, this is: Federal Institute for Drugs and Medical Devices (BfArM) Kurt-Georg-Kiesinger-Allee 3, 53175 Bonn, Germany www.bfarm.de Page TD-04 AIR:MASTER Revision 26 of 27 IFU-TD04-002... - Page 27 CREO MEDICAL GmbH Hans-Böckler-Straße 29 40764 Langenfeld – Germany Tel. +49 (0) 2173 20047-0 Fax. +49 (0) 2173 20047-40 E-Mail info.de@creomedical.de www.creomedical.com Page TD-04 AIR:MASTER Revision 27 of 27 IFU-TD04-002...
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