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Dräger
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EC Declaration of ConformityEG Konformitätserklärung
Date / Datum2019-08-16
Cr™ European Directive 93/42/EEC, Annex II Document ID / Dokument Nr.European Directive 2011/65/EUEuropäische Richtlinie 93/42/EWG, Anhang II MD106-011-1908-049-0Europäische Richtlinie 2011/65/EU
Drägerwerk AG & Co. KGaA Moislinger Allee 53-55 23542 Lübeck Germany
hereby declares that the / erklärt hiermit, dass
Product name /Produktbezeichnung
Medical device /Medizinprodukt
DeviceClass
UMDNS Code/ GMDN Code
Babyleo TN500 Infant Incubator llb 12-113/36025
meets the provisions of the following European Directives:- 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.- 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment. 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 Draeger will invalidate this declaration.
mit den Bestimmungen der folgenden europäischen Richtlinien übereinstimmt:-93/42/EWG über Medizinprodukte 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.-2011/65/EU zur Beschränkung der Verwendung bestimmter gefährlicher Stoffe in Elektro- und Elektronikgeräten. Diese Erklärung ist gültig für ab dem Ausstellungsdatum in Verkehr gebrachte Produkte. Jede nicht durch Draeger autorisierte Modifikation an dem Medizinprodukt führt zur Ungültigkeit dieser Erklärung.
Head of Regulatory Affairs Director of Regulatory Affairs
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 info@draeger.com www.draeger.com
Bank details:Commerzbank AG, LübeckIBAN DE33 2304 0022 0014 6779 00BIC COBADEFF230Deutsche Bank AG, LübeckIBAN DE85 2307 0710 0031 0003 00BIC DEUTDEHH222
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)Dr. Herbert Fehrecke Gert-Hartwig Lescow Anton Schrofner
Dräger
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Appendix I to EC Declaration of ConformityAnlage zur 1 zur EG Konformitätserklärung
Date / Datum2019-08-16
fr- European Directive 93/42/EEC, Annex II Document ID / Dokument NrEuropean Directive 2011/65/EUEuropäische Richtlinie 93/42/EWG, Anhang II MD106-011-1908-049-0-00Europäische Richtlinie 2011/65/EU
Drägerwerk AG & Co. KGaA Moislinger Allee 53-55 23542 Lübeck Germany
Product name / Produktbezeichnung Medical device / Medizinprodukt
Babyleo TN500 Incubator, Neonatal, Incuwarmer
Applied Standards in full or in part / Vollständig oder teilweise angewendete Normern.
EN 60601-1:2006/AC:2010 AMD11:2011 AMD 1:2013 AMD 12 2014 (IEC 60601-1:2012 (CON ED) 3.1 COR1 2014)
EN 60601-1-2:2015 (IEC 60601-1-2:2014)
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
Medical electrical equipment --Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC TR 60601-4-2: 2016 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: Performance of medical electrical equipment and medical electrical Systems
EN 60601 -1 -8:2007/AC:2010 AMD 112017(IEC 60601-1-8:2006 AMD 1 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 62304:2006 AMD 1 2015 (IEC 62304:2006 AMD 1 2015)
Medical device Software - Software life-cycle processes
EN 60601-1-6:2010 AMD 1 2015 (IEC 60601-1-6: 3rd ed. 2010 AMD 12013)
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral Standard:Usability
EN 62366:2008 AMD 1 2015 (IEC 62366: 2007 AMD 1 2014)
Medical devices - Application of usability engineering to medical devices
EN ISO 15223-1:2016 COR 2017 (ISO 15223-1:3ED 2016 CORRECTED)
Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements (ISO 15223-1:2016, Corrected Version 2017-03)
Page 1 of 2
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 info@draeger.com www.draeger.com
Bank details:Commerzbank AG, LübeckIBAN DE33 2304 0022 0014 6779 00BIC COBADEFF230Deutsche Bank AG, LübeckIBAN DE85 2307 0710 0031 0003 00BIC DEUTDEHH222
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)Dr. Herbert Fehrecke Gert-Hartwig Lescow Anton Schrofner
Dräger
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Appendix I to EC Declaration of ConformityAnlage zur 1 zur EG Konformitätserklärung
Date / Datum2019-08-16
i r -European Directive 93/42/EEC, Annex II Document ID / Dokument Nr.European Directive 2011/65/EUEuropäische Richtlinie 93/42/EWG, Anhang II MD106-011-1908-049-0-00Europäische Richtlinie 2011/65/EU
EN 1041:2008 A1:2013 Information supplied by the manufacturer of medical devices
EN ISO 14971:2012(ISO 14971: 2ED 2007 CORRECTED)
Medical devices - Application of risk management to medical devices
EN 50581:2012 Technical documentation for the assessment of electrical and electronic products with respect to the restriction of hazardous substances
EN ISO 10993-1:2009 AC 2010 (ISO 10993-1:2009 COR 1 2010)
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
EN ISO 17664:2017 (ISO 17664:2017)
Sterilization of medical devices - Information to be provided by the manufacturer for the Processing of resterilizable medical devices
ISO 18562-1:2017-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management Process
EN 60601-2-19:2009 (IEC 60601-2-19: 2009)
Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
EN 60601-2-21: 2009 (IEC 60601-2-21:2009)
Medical electrical equipment — Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
Head of Regulatory Affairs
<SoUnMFrank Clanzett
Page 2 of 2
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 info@draeger.com www.draeger.com
Bank details:Commerzbank AG, LübeckIBAN DE33 2304 0022 0014 6779 00BIC COBADEFF230Deutsche Bank AG, LübeckIBAN DE85 2307 0710 0031 0003 00BIC DEUTDEHH222
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)Dr. Herbert Fehrecke Gert-Hartwig Lescow Anton Schrofner
Dräger
^ ^ 00
Appendix II to EC Declaration of ConformityAnlage II zur EG Konformitätserklärung
Date / Datum2019-08-16
C f 2 European Directive 93/42/EEC, Annex II Document ID / Dokument Nr.European Directive 2011/65/EUEuropäische Richtlinie 93/42/EWG, Anhang II MD106-011-1908-049-0-ECAEuropäische Richtlinie 2011/65/EU
Drägerwerk AG & Co. KGaA Moislinger Allee 53-55 23542 Lübeck Germany
Extent of conformity assessment / Umfang der Konformitätsbewertung
Part No. / Sach Nr.
Product name /Produktbezeichnung
Description
2M60001 Babyleo TN500 basic Basicdevice device
2M60136 SWTN500 1.05 SW TN500 1.05
2M60105 Auto Thermo Package Auto Thermo Package
2M60905 Developmental Care Developmental CarePackage Package
2M60130 Scale TN500, NAWI compliant NAWI scale
2M60139 Scale TN500, Standard 10g Scale
2M60111 Bed support, complete Bed support
2M60590 Gas cylinder holder Gas cylinder holder
2M60570 Drawer for TN500 Drawer for TN500
8411075 Hose holder Hose holder
2M60170 Heated mattress for Heated mattress forTN500 TN500
2M60180 Multi-purpose holder Multi-purpose holder
2M60401 Clamp for GCX rail Clamp for GCX rail
2M60773 Cable for nurse call Cable for nurse call
MX17015 Air Filter (20 pcs.) Air Filter (20 pcs.)
Page 1 of 2
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 info@draeger.com 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
Dräger
^ ^ co
Appendix II to EC Declaration of ConformityAnlage II zur EG Konformitätserklärung
Date / Datum2019-08-16
Cr-European Directive 93/42/EEC, Annex II Document ID / Dokument Nr.European Directive 2011/65/EUEuropäische Richtlinie 93/42/EWG, Anhang II MD106-011-1908-049-0-ECAEuropäische Richtlinie 2011/65/EU
Extent of conformity assessment / Umfang der Konformitätsbewertung
Part No. / Sach Nr.
Product name /Produktbezeichnung
Description
MK08493 Additional shelf Additional shelf
MK08876 IV pole, 760 mm IV pole, 760 mm
4118555 Rail, 100 mm for Rail, 100 mm forGCX profile GCX profile
2M85446 Connection hose Connection hoseholder holder
2M21293 Hook Hook
4118453 Holder for cylinder Holder for cylinderpacket for GCX packet for GCXprofile profile
2M60458 02 Option small parts T500 02 Option small parts T500
Head of Regulatory Affairs
Frank Clanzett
Page 2 of 2Chairman 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
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 info@draeger.com 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
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