Dräger Medical

Aneasthesia Machines

Draeger Fabius Gas Outlet MHRA Supplement to the Instructions for Use

Alert

Supplement

2 Pages

Drägerwerk AG & Co... GaA, 23542 Lübeck To our customers and users of the Fabius with Auxiliary Common Gas Outlet (ACGO) Add... evice label – ext... resh-gas outlet / aux... ommon gas outlet September 2018 Dear Madam/Sir, We would like to follow up on the Safety Notice issued by Dräger in October 2017, which addressed that the external fresh-gas outlet / auxiliary common gas outlet on anesthesia workstations had – in some cases – not been used in accordance to the instructions for use... herefore, Dräger illustrated the functional principle of rebreathing systems and again highlighted guidelines for the safe use of the external fresh-gas outlet / auxiliary common gas outlet of Fabius anesthesia machines which are already given in the instructions for use... oreover, we already indicated our intention to create a separate device label as an additional reminder to check the setting of the fresh-gas path when starting a mechanical ventilation or ManSpont, (i... when using the COSY rebreathing system) in our initial writing... ou will find this new label and a supplement to the Instruction for Use enclosed to this letter... he label consists of a graphical and a textual part/description and it is designed to fit to the ventilator control panel next to the keys for selecting the ventilation modes... here is one label for each variant of the external fresh-gas outlet: Drägerwerk AG & Co... GaA Moislinger Allee 53-55 23558 Lübeck, Germany Postal address: 23542 Lübeck, Germany Tel +49 451 882-0 Fax +49 451 882-2080 info@draeger... m www... aeger... m VAT no... E135082211 Bank details: Commerzbank AG, Lübeck IBAN: DE95 2304 0022 0014 6795 00 Swift-Code: COBA DE FF 230 Sparkasse zu Lübeck IBAN: DE15 2305 0101 0001 0711 17 Swift-Code: NOLADE21SPL Registered office: Lübeck Commercial register: Local court Lübeck HRB 7903 HL General partner: Drägerwerk Verwaltungs AG Registered office: Lübeck Commercial register: Local court Lübeck HRB 7395 HL Chairman of the Supervisory Board for Drägerwerk AG & Co... GaA and Drägerwerk Verwaltungs AG: Stefan Lauer Executive Board: Stefan Dräger (chairman) Rainer Klug Gert-Hartwig Lescow Dr... einer Piske Anton Schrofner Page 2 / 2 Variant External fresh-gas outlet External fresh-gas outlet with an additional switch Description in the IfU When an automatic ventilation mode (Volume Control, Pressure Control, Pressure Support, SIMV/PS) or the ManSpont ventilation mode is used, … …connect the short fresh-gas …set the switch on the external hose to the external fresh-gas fresh-gas outlet to the COSY outlet... position... Label Please select the label that fits your device configuration and the correct language and stick both onto the ventilator control panel as per the instructions on the sticker board... n case of questions, please do not hesitate to contact your local Dräger contact... Kind regards, Alexander Herden Product Management Life Support Systems Anesthesiology Attachment - Labels for both variants of the ext... resh-gas outlet - Supplement to the Instructions for Use
File Type: PDF
File Size: 224KB
File Name: draeger_fabius_gas_outlet_mhra_supplement_to_the_in.pdf
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