Infinity delta series patient monitoring device (614 pages)
Summary of Contents for Dräger Fabius Tiro SW 3.n
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Reprocessing Fabius family Anesthesia workstation WARNING To properly use this medical device, Software 3.n read and comply with the instructions for use and this supplement.
Contents Contents Supplement to the instructions for use ..Information about this document ..Trademarks ......Reprocessing .
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English Reprocessing Fabius family en Supplement to the instructions for use Instructions for use Part number Edition Fabius Tiro SW 3.n 9054601 1 – 2014-06 and higher Fabius GS premium SW 3.n 9054626 1 – 2014-06 and higher Fabius MRI SW 3.n 9054649 1 –...
English Reprocessing Safety information Correct reprocessing WARNING WARNING Risk of failure of flow measurement Risk due to improperly reprocessed products Improper reprocessing and soiling, such as Reusable products must be reprocessed, oth- deposits or particles, can damage the flow erwise there is an increased risk of infection. sensor: –...
English CAUTION Risk of patient injury due to failure of accessories Disposable products have been designed, tested and manufactured exclusively for single use. Re- use, reprocessing or sterilization can result in fail- ure of accessories and injury to the patient. Do not reuse, reprocess, or sterilize disposable products.
English Classifications for reprocessing Classification of medical devices The classification depends on the intended use of the medical device. The risk of infection transmission through the application of the product to the patient without proper reprocessing is the basis of the Spaulding classification. Classification Explanation Non-critical...
English Before reprocessing Observe before disassembly 1 Switch off the device and all devices connected to it. 2 Disconnect all power plugs. Disassembling and removing patient-specific accessories and consumables The patient-specific accessories and consumables must be removed from the device and, if necessary, disassembled.
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English Removing the breathing hoses WARNING Risk of infection Breathing gas which may contain infectious agents flows through the sample line. – If no bacteria filter is used between the sample line and the patient, the sample lines must not be reused and must be re- placed after each patient.
English Disassembling and removing device-specific components The device-specific components must be removed 5 Disconnect the O sensor cable with the O from the device and, if necessary, disassembled. sensor (E). Remove the following accessories: – Hoses and cables – O sensor –...
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English Removing the CO absorber Reusable absorber 1 Remove the CO absorber: – CLIC absorber (disposable absorber) – Reusable absorber CLIC absorber (disposable absorber) Observe the instructions for use of the CLIC absorber. 1 Unscrew the CO absorber (A) from the compact breathing system.
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English Removing the CLIC adapter (option) Removing the rigid breathing bag arm (option) Observe the instructions for use of the CLIC Observe the instructions for use of the rigid adapter. breathing bag arm. Unscrew the CLIC adapter (A) from the compact breathing system in the direction of the 1 Loosen the two knurled screws (A) on the arrow.
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English Removing the flow sensor Removing the compact breathing system Observe the instructions for use of the flow sensor. CAUTION Risk of injury due to breathing system heating When the breathing system heating is switched on, the bottom side of the compact breathing sys- tem and the heating plate beneath it can become hot.
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English Preparing the inspiratory valve and the Removing the APL valve expiratory valve WARNING Risk of damage to the compact breathing sys- If the APL valve is not disassembled before the compact breathing system is reprocessed, this can lead to leakages in the compact breathing system.
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English Removing the ventilator parts Removing the anesthetic gas receiving system Observe the instructions for use of the anesthetic gas receiving system. Before removing the anesthetic gas receiving system from the device, make sure all connection hoses to the compact breathing system and to the terminal unit are disconnected.
English Validated reprocessing procedures Overview of the reprocessing procedures of the components Components Surface disinfection Machine cleaning with Description of the pro- with cleaning thermal disinfection cedure Device surface including screen Trolley and holders See page 17 Removable parts of the main device Compact breathing sys- See pages 18 and 23...
English Surface disinfection with cleaning Components: – Device surface including screen – Trolley and holders – Removable parts of the main device Components Surface disinfectant Manufacturer Concentration Contact time – Device surface includ- Dismozon plus Bode 1.6 % 15 min ing screen Chemie –...
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English Machine cleaning with thermal disinfection Use a washer-disinfector that meets the requirements of the standard ISO 15883. Dräger recommends the use of a load carrier for anesthesia accessories and ventilation accessories. Follow the manufacturer's instructions for the washer-disinfector. Components: –...
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English Preliminary cleaning Preliminary cleaning has been performed for selected components according to the following table. Step Component Agent Manufactur- Concentra- Tempera- Contact tion ture time Preliminary Compact Sekusept ak- Ecolab – 5 min in an cleaning breathing ultrasonic system (pre- bath at pared) 35 kHz +...
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English 1 Place the compact breathing system (prepared) with the absorber opening (A) facing upwards in the ultrasonic bath. 2 Gently move the compact breathing system back and forth in the ultrasonic bath for 5 minutes. Make sure that all trapped air bubbles can escape from the interior.
English Positioning the components in the load carrier Depending on the equipment level of the device, Absorber insert not all components may be present. Required aids: All components must be positioned securely in the – Hose (outer diameter: 22 mm) for connecting load carrier.
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English Piston diaphragm Ventilator lid 1 Connect the ventilator lid (A) to the hose (B). Place the piston diaphragm with the opening 2 Connect the other end of the hose to a suitable facing downwards on an injector nozzle. nozzle (C) on the load carrier.
English Performing reprocessing Compact breathing system Required aids: 1 Select a cycle. – 2 hoses (outer diameter: 22 mm) for connecting the compact breathing system 2 When the cycle has ended, check the components for visible soiling and repeat the cycle if necessary.
English Other agents and reprocessing procedures Disinfectants Use nationally approved disinfectants suitable for the respective reprocessing process and the intended application. Surface disinfectants The manufacturers of the surface disinfectants have verified at least the following spectra of activity: – Bactericidal –...
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English The following surface disinfectants were compatible with the material at the time of testing: Class of active ingre- Surface disinfectant Manufacturer Listing dient Chlorine-releasing BruTab 6S Brulin agents Clorox Professional Disinfecting Clorox Bleach Cleaner Dispatch Hospital Cleaner Disin- fectant Towels with Bleach Klorsept 17 Medentech Actichlor plus...
English After reprocessing Assembling and fitting device-specific components The device-specific components must be attached 1 Open the ventilator door (A) with the attached to the device and assembled if necessary. ventilator unit. Install and fit the following components: 2 Insert the piston diaphragm (B) into the –...
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English Assembling the inspiratory valve and the Connecting the compact breathing system expiratory valve 1 Completely pull out the locking pin (A) and hold it in that position. Inspiratory valve: 2 Insert the compact breathing system in the 1 Screw off the union nut (A). provided holder (B).
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English Fitting the flexible breathing bag arm (option) 1 Unscrew the expiratory port (A) from the compact breathing system. 2 Insert the flow sensor (B) into the compact breathing system. 1 Position and align the connection adapter (A) of 3 Attach the flow-sensor guard (C) (option). the flexible breathing bag arm on the connection of the compact breathing system.
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English Fitting the CLIC adapter (option) CLIC absorber (disposable absorber) 1 Screw the CLIC adapter (A) onto the bottom WARNING side of the compact breathing system in the Risk of insufficient ventilation direction of the arrow. If the CLIC absorber is not correctly locked into place, system leakage may occur.
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English Reusable absorber Fitting the fresh-gas hose WARNING Risk of hypoventilation Reuse of the soda lime dust filter can increase filter resistance and impair the ventilation function of Fabius. Replace the soda lime dust filter each time the soda lime is replaced. 1 Connect the fresh-gas hose (A) to the corresponding connection of the compact breathing system.
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English Assembling the O sensor Connecting the sensors and the measuring lines The sensors and measuring lines must be connected in accordance with the descriptions in the instructions for use. 1 Attach the following cables and lines to the corresponding connectors on the compact breathing system: –...
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English Fitting the anesthetic gas receiving system The anesthetic gas scavenging system (AGSS) must conform to ISO 8835-3 and ISO 80601-2-13. WARNING Risk of patient injury If the side openings of the receiving system are covered, this may cause a negative pres- sure in the breathing system and in the pa- tient's lungs.
English Preparation before next use of device Assembling and fitting patient-specific accessories and consumables WARNING WARNING Risk due to particles and dust Risk of insufficient ventilation due to stuck valves In order to protect the patient from particles and dust, a filter must be used between the in- Silicone spray can get into the breathing sys- spiratory limb of the compact breathing sys- tem and cause the valves to stick.
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English Connecting the sample line 1 Connect the sample line (D) to the connector of the Y-piece and to the connector of the water trap (E) on the patient-gas measurement module. Checking the operational readiness Prerequisites: – The device has been assembled and prepared so that it is ready for operation.
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