Dräger...Dräger ^ ^ 00 EC Declaration of Conformity EG Konformitätserklärung Date / Datum...
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Dräger ^ ^ 00 EC Declaration of Conformity EG Konformitätserklärung Date / Datum 2018-07-12 Cr- European Directive 93/42/EEC, Annex II Document ID / Dokument Nr. European Directive 2011/65/EU Europäische Richtlinie 93/42/EWG, Anhang II MD101-004-1807-205-0 Europäische Richtlinie 2011/65/EU Drägerwerk AG & Co. KGaA Moislinger Allee 53-55 23542 Lübeck Germany hereby declares under its sole responsibility that the / erklärt hiermit in alleiniger Verantwortung, dass Product Name / Produktbezeichnung Medical Device / Medizinprodukt Device Class UMDNS Code/ GMDN Code Fabius GS Premium Fabius Tiro Fabius Tiro D-M Fabius MRI Anesthesia Workstation llb 10-134/ 37710 meets the provisions of the European Directive 93/42/EEC on medical devices. An examination of the quality management System has been carried out following Annex 11.3 of the directive by the Notified Body TÜV Süd Product Service GmbH, Ridlerstraße 65, 80339 Munich, Germany, EC No. 0123. The quality management System also complies to EN ISO 9001 and EN ISO 13485. This declaration is effective for products placed on the market as of the date of issue. Any modifications of the medical device not authorized by Dräger will invalidate this declaration. mit den Bestimmungen der europäischen Richtlinie 93/42/EWG (Medizinprodukte) übereinstimmt. Eine Überprüfung des Qualitätsmanagementsystems, nach den Regeln wie in Anhang 11.3 der Richtlinie beschrieben, wurde durch die Benannte Stelle TÜV Süd Product Service GmbH, Ridlerstraße 65, 80339 München, EU Kennnummer 0123, vorgenommen. Das Qualitätsmanagementsystem erfüllt weiterhin die Anforderungen gemäß EN ISO 9001 und EN ISO 13485. Diese Erklärung ist gültig für ab dem Ausstellungsdatum in Verkehr gebrachte Produkte. Jede nicht durch Dräger autorisierte Modifikation an dem Medizinprodukt führt zur Ungültigkeit dieser Erklärung. Drägerwerk AG & Co. KGaA Moislinger Allee 53-55 23558 Lübeck, Germany Postal address: 23542 Lübeck, Germany Tel +49 451 882-0 Fax +49 451 882-2080 [email protected] www.draeger.com VATno. DE135082211 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 Registered Office: Lübeck Commercial register: Local court Lübeck HRB 7395 HL Chairman of the Supervisory Board for Drägerwerk AG & Co. KGaA and Drägerwerk Verwaltungs AG: AG Stefan Lauer Executive Board: Stefan Dräger (chairman) Rainer Klug Gert-Hartwig Lescow Dr. Reiner Piske Anton Schrofner
Transcript of Dräger...Dräger ^ ^ 00 EC Declaration of Conformity EG Konformitätserklärung Date / Datum...
Dräger
^ ^ 00
EC Declaration of ConformityEG Konformitätserklärung
Date / Datum2018-07-12
Cr- European Directive 93/42/EEC, Annex II Document ID / Dokument Nr.European Directive 2011/65/EUEuropäische Richtlinie 93/42/EWG, Anhang II MD101-004-1807-205-0Europäische Richtlinie 2011/65/EU
Drägerwerk AG & Co. KGaA Moislinger Allee 53-55 23542 Lübeck Germany
hereby declares under its sole responsibility that the / erklärt hiermit in alleiniger Verantwortung, dass
Product Name / Produktbezeichnung
Medical Device / Medizinprodukt DeviceClass
UMDNS Code/ GMDN Code
Fabius GS Premium
Fabius Tiro
Fabius Tiro D-M
Fabius MRI
Anesthesia Workstation llb10-134/
37710
meets the provisions of the European Directive 93/42/EEC on medical devices. An examination of the quality management System has been carried out following Annex 11.3 of the directive by the Notified Body TÜV Süd Product Service GmbH, Ridlerstraße 65, 80339 Munich, Germany, EC No. 0123. The quality management System also complies to EN ISO 9001 and EN ISO 13485.This declaration is effective for products placed on the market as of the date of issue. Any modifications of the medical device not authorized by Dräger will invalidate this declaration.
mit den Bestimmungen der europäischen Richtlinie 93/42/EWG (Medizinprodukte) übereinstimmt. Eine Überprüfung des Qualitätsmanagementsystems, nach den Regeln wie in Anhang 11.3 der Richtlinie beschrieben, wurde durch die Benannte Stelle TÜV Süd Product Service GmbH, Ridlerstraße 65, 80339 München, EU Kennnummer 0123, vorgenommen. Das Qualitätsmanagementsystem erfüllt weiterhin die Anforderungen gemäß EN ISO 9001 und EN ISO 13485.Diese Erklärung ist gültig für ab dem Ausstellungsdatum in Verkehr gebrachte Produkte. Jede nicht durch Dräger autorisierte Modifikation an dem Medizinprodukt führt zur Ungültigkeit dieser Erklärung.
Drägerwerk AG & Co. KGaA Moislinger Allee 53-55 23558 Lübeck, Germany Postal address:23542 Lübeck, Germany Tel +49 451 882-0 Fax +49 451 882-2080 [email protected] www.draeger.com VATno. DE135082211
Bank details:Commerzbank AG, LübeckIBAN: DE95 2304 0022 0014 6795 00Swift-Code: COBA DE FF 230Sparkasse zu LübeckIBAN: DE15 2305 0101 0001 0711 17Swift-Code: NOLADE21SPL
Registered Office: Lübeck Commercial register:Local court Lübeck HRB 7903 HL General partner: Drägerwerk Verwaltungs Registered Office: Lübeck Commercial register:Local court Lübeck HRB 7395 HL
Chairman of the Supervisory Board for Drägerwerk AG & Co. KGaA and Drägerwerk Verwaltungs AG:
AG Stefan LauerExecutive Board:Stefan Dräger (chairman)Rainer Klug Gert-Hartwig Lescow Dr. Reiner Piske Anton Schrofner
Dräger
Appendix I to EC Declaration of ConformityAnlage 1 zur EG Konformitätserklärung
Date / Datum2018-07-12Cf- European Directive 93/42/EEC Document ID / Dokument Nr.
^ ^ o European Directive 2011/65/EUEuropäische Richtlinie 93/42/EWG MD101-004-1807-205-0-00Europäische Richtlinie 2011/65/EU
Drägerwerk AG & Co. KGaA Moislinger Allee 53-55 23542 Lübeck Germany
Product name / Produktbezeichnung Medical device / Medizinprodukt
Fabius GS Premium Anesthesia Workstation
Fabius Tiro
Fabius Tiro D-M
Fabius MRI
Applied Standards in full or in part / Vollständig oder teilweise angewendete Normen:
EN 60601-1: 1990+A1:1993 +A2:1995 + AC:1994(IEC 60601-1:1998+ A1:1991 + A2.1995)
Medical electrical equipment - Part 1: General requirements for safety
EN 60601-1: 2006 + A1:2013 (IEC 60601-1:2012)
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
EN 60601-1-2: 2007 (IEC 60601-1-2:2007)
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard:Electromagnetic compatibility - Requirements and tests
EN 60601-1-4: 1996 + A1:1999 (IEC 60601-1-4:1996 + AMD: 1999)
Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical System
EN 60601-1-6: 2010 + AMD1:2015 (IEC 60601-1-6: 2010 + A1.2013)
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability
EN 60601-1-8: 2007+ AC:2010 + COR:2014(IEC 60601-1-8:2006 + AMD1:2012)
Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm Systems in medical electrical equipment and medical electrical Systems
EN 60601-2-13: 2006 + A1: 2007 (IEC 60601-2-13: 2003 + A1: 2006)
Medical electrical equipment - Part 2-13: Particular requirements for the safety and essential performance of anaesthetic Systems
EN ISO 8835-2: 2009 (ISO 8835-2: 2007)
Inhalational anaesthesia Systems - Part 2: Anaesthetic breathingSystems
EN ISO 8835-5: 2009 (ISO 8835-5: 2004)
Inhalational anaesthesia Systems - Part 5: Anaesthetic Ventilators
Drägerwerk AG & Co. KGaA Moislinger Allee 53-55 23558 Lübeck, Germany Postal address:23542 Lübeck, Germany Tel +49 451 882-0 Fax +49 451 882-2080 [email protected] www.draeger.com VATno. DE135082211
Bank details:Commerzbank AG, LübeckIBAN: DE95 2304 0022 0014 6795 00Swift-Code: COBA DE FF 230Sparkasse zu LübeckIBAN: DE15 2305 0101 0001 0711 17Swift-Code: NOLADE21SPL
Registered Office: Lübeck Commercial register:Local court Lübeck HRB 7903 HL General partner: Drägerwerk Verw Registered Office: Lübeck Commercial register:Local court Lübeck HRB 7395 HL
Chairman of the Supervisory Board for Drägerwerk AG & Co. KGaA and Drägerwerk Verwaltungs AG:
AG Stefan Lauer Executive Board:Stefan Dräger (chairman)Rainer Klug Gert-Hartwig Lescow Dr. Reiner Piske Anton Schrofner
Page 1 of 2
Dräger
Product name / Produktbezeichnung Medical device / Medizinprodukt
Fabius GS Premium Anesthesia Workstation
Fabius Tiro
Fabius Tiro D-M
Fabius MRI
Applied Standards in full or in part / Vollständig oder teilweise angewendete Normen:
EN ISO 80601-2-13: 2012 (ISO 80601-2-13: 2011)
Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic Workstation
EN ISO 80601-2-55: 2011 + COR:2012 (ISO 80601-2-55: 2011)
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
EN ISO 21647: 2009(ISO 21647: 2004 + COR: 2005)
Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors
EN ISO 14971: 2012 (ISO 14971: 2007 COR)
Medical devices - Application of risk management to medical devices
EN ISO 10993-1: 2009 + AC:2010 (ISO 10993: 2009 + COR.2010)
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
EN 1041: 2008 + A1:2013 Information supplied by the manufacturer of medical devices
EN ISO 15223-1: 2016 (ISO 15223-1: 2016)
Medical devices - Symbols to be used with medical device labels, labelling and Information to be supplied - Part 1: General requirements
IEC 62304:2006 +A1:2015 Medical device Software - Software life-cycle processes
Drägerwerk AG & Co. KGaA Moislinger Allee 53-55 23558 Lübeck, Germany Postal address:23542 Lübeck, Germany Tel +49 451 882-0 Fax +49 451 882-2080 [email protected] www.draeger.com VATno. DE135082211
Bank details:Commerzbank AG, LübeckIBAN: DE95 2304 0022 0014 6795 00Swift-Code: COBA DE FF 230Sparkasse zu LübeckIBAN: DE15 2305 0101 0001 0711 17Swift-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. KGaA and Drägerwerk Verwaltungs AG: Stefan Lauer Executive Board:Stefan Dräger (chairman)Rainer Klug Gert-Hartwig Lescow Dr. Reiner Piske Anton Schrofner
Page 2 of 2
Dräger
ff « Appendix II to EC Declaration of ConformityAnlage II zur EG Konformitätserklärung
Date / Datum2018-07-12
European Directive 93/42/EEC Document ID / Dokument Nr.^ ^ o European Directive 2011/65/EU
Europäische Richtlinie 93/42/EWG M D101 -004-1807-205-0-ECAEuropäische Richtlinie 2011/65/EU
Drägerwerk AG & Co. KGaA Moislinger Allee 53-55 23542 Lübeck Germany
Extent of conformity assessment / Umfang der KonformitätsbewertungPart No. / Product name /Sach Nr. Produktbezeichnung
8606000 Fabius Tiro8607000 Fabius GS premium8607300 Fabius MRI8608400 Fabius Tiro D-M8608841 Software 3.35a Fabius8608842 Software 3.35b Fabius8620188 Software 3.36a Fabius8620189 Software 3.36b Fabius2600650 Diaphragm, cup4115837 Vapor Parking ASM variable4116230 Adapter ASM - 3-way DISS4117391 Adapter asm 3 way 02 NIST4117441 KIT-COVER- GCX RAIL4117509 KIT - HANDLE MTG - FABIUS GS4117510 Shelf-Right Side MTG-Fab GS4117513 Kit-Plate-Top4117515 Scavenger mount FAB GS4117519 KIT-IV POLE MTG-FAB GS4117636 Kit-Adapter Arm Asm Vamos4117638 Kit Mounting Arm Universal4117642 Kit-Mount Adapter GCX4118306 KIT-FLIP UP TRAY-TIRO4118453 Kit-pivot rail asm-GCX4118454 Kit Suction Mount DOM4118555 Kit-euro rail-short-GCX4199763 Cyl brkt-trolley MT4199905 Adapter asm 3-way 02 NIST UK4720095 Rail Mount CPS/IDS Pwr Supply4720129 Wall Bracket CPS/IDS Pwr Spl6850645 02-Sensor (capsule)6870776 Adapter plate GCX6870841 Power supply mount8301348 Earthing cable, 0,8 M8301349 Earthing cable, 3,2 M
Drägerwerk AG & Co. KGaA Bank details: Registered Office: Lübeck Chairman of the Supervisor^ BoardMoislinger Allee 53-55 Commerzbank AG, Lübeck Commercial register: for Drägerwerk AG & Co. KGaA23558 Lübeck, Germany IBAN: DE95 2304 0022 0014 6795 00 Local court Lübeck HRB 7903 HL and Drägerwerk Verwaltungs AG:Postal address: Swift-Code: COBA DE FF 230 General partner: Drägerwerk Verwaltungs AG Stefan Lauer23542 Lübeck, Germany Sparkasse zu Lübeck Registered Office: Lübeck Executive Board:Tel +49 451 882-0 Fax +49 451 882-2080
IBAN: DE15 2305 0101 0001 0711 17 Commercial register: Stefan Dräger (chairman)Swift-Code: NOLADE21SPL Local court Lübeck HRB 7395 HL Rainer Klug
[email protected] Gert-Hartwig Lescowwww.draeger.com Dr. Reiner PiskeVATno. DE135082211 Anton Schrofner Page 1 of 3
Dräger
Extent of conformity assessment / Umfang der KonformitätsbewertungPart No. / Product name /Sach Nr. Produktbezeichnung
8604310 Hose-ventiiator 110cm8604718 Cover ASM-Side-LF Cosy Fab GS8604720 Cover ASM-Side-RH Cosy Fab GS8604800 Conversion Kit-Cyl8604919 Moisture Reduction Kit f. Cosy8605088 Flexible Bag Arm Assembly8605433 Passive scavenger asm8605491 Double Vapor Mount Assy8605627 Kit watertrap Cosy right8605796 Cosy2.6 with heating8605797 Cosy 2.68605828 Ventilator lid8605897 Conversion Kit Cosy 2.6 Fleater8605898 Advanced Low Flow Kit Cosy 2.68606055 housing asm 02 sensor8606063 Kit-mounting-arm-universal, 12"8606137 Conversion kit SCIO Mount8606246 Ergo Bracket for flat Panel8606247 Keyboard Tray w.sli.Mouse Tray8606259 conversion kit rail (GCX like)8606266 Conversion kit pcb Aux RS2328606357 Coupler asm - female 02 DISS8606358 Coupler asm - female AIR DISS8606359 Coupler asm - female N20 DISS8606434 Kit-Top Mon tilt/swivel/rail8606438 Supply Basket- FABIUS8606439 Top Plate 0 degree8606443 Top Plate tilt/swivel/mount8606533 Cylinder support asm8607040 Common gas outlet switch8607054 Hose, PEEP APL.Cosy, right8607055 Hose Asm PEEP-Pmax-APL Byp LH8607178 Vapor parking asm selectatec double8607218 KIT - ramming protection (COSY 2.6)8607383 Kit - airway pressure - Fabius8607385 cosy mt asm-8IN gcx arm8607511 Mounting parts gas outlet RH8607514 cosy mt asm-8IN gcx arm8607593 Adhesive tape 40mT/400 gauss8607596 set handholdes8607694 Kit auxiliary 02-flowmeter8607987 Upgrade kit acone switch-left8607988 Upgrade kit acone switch-right8608029 Adaption of suction holder8608056 kit pull-out writing tray8608129 Upgrade kit a-cone LH8608130 Upgrade kit a-cone RH2M85381 Carrying rack bronchial aspira
Drägerwerk AG & Co. KGaA Moislinger Allee 53-55 23558 Lübeck, Germany Postal address:23542 Lübeck, Germany Tel +49 451 882-0 Fax +49 451 882-2080 [email protected] www.draeger.com VATno. DE135082211
Bank details:Commerzbank AG, LübeckIBAN: DE95 2304 0022 0014 6795 00Swift-Code: COBA DE FF 230Sparkasse zu LübeckIBAN: DE15 2305 0101 0001 0711 17Swift-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. KGaA and Drägerwerk Verwaltungs AG: Stefan Lauer Executive Board:Stefan Dräger (chairman)Rainer Klug Gert-Hartwig Lescow Dr. Reiner Piske Anton Schrofner Page 2 of 3
Dräger
Extent of conformity assessment / Umfang der KonformitätsbewertungPart No. / Product name /Sach Nr. Produktbezeichnung
2M86296 Oxidem 3000M14737 VENTPLUGM27769 EARTH CABLE 6MM29430 transition fittingM32967 Conversion kit AGS rail clawM33145 hose asm AIR/02 1,5mM34333 Double plug-in connectorM34446 Adapter-hose asm 02M34447 Adapter-hose asm N20M34448 Adapter-hose asm AIRM34949 Hose NI ST VAC 1mMM15278 12z cast arm f. Dash/flatpanelMM15287 Power supply mount for channelMM15288 Vamos suspens. f. M-series armMM15693 Horiz. chan. low prof.tilt/sw.MM15741 Low prof. 0 dgr horiz. channelMM15748 10z Channel for MM 15742MM15753 Siemens power supply mountMM15886 SCIO hanger for arm mount
Drägerwerk AG & Co. KGaA Moislinger Allee 53-55 23558 Lübeck, Germany Postal address:23542 Lübeck, Germany Tel +49 451 882-0 Fax +49 451 882-2080 [email protected] www.draeger.com VATno. DE135082211
Bank details:Commerzbank AG, LübeckIBAN: DE95 2304 0022 0014 6795 00Swift-Code: COBA DE FF 230Sparkasse zu LübeckIBAN: DE15 2305 0101 0001 0711 17Swift-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. KGaA and Drägerwerk Verwaltungs AG: Stefan Lauer Executive Board:Stefan Dräger (chairman)Rainer Klug Gert-Hartwig Lescow Dr. Reiner Piske Anton Schrofner Page 3 of 3
