DECLARATION OF CONFORMITY FOR THE MEDICAL DEVICE FAMILY LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES

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1 FLOW METER S.p.A. Capitale Sociale: int. versato Sede legale: Via del Lino, LEVATE (Bg) Amministrazione e Stabilimenti: Via del Lino, LEVATE (Bg) Tel. +39/035/ Telefax +39/035/ info@flowmeter.it Codice fiscale e Partita IVA: C.C.I.A.A. Bergamo Iscritta al Tribunale di Bergamo - Volume Reg. Società DECLARATION OF CONFORMITY FOR THE MEDICAL DEVICE FAMILY LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES whose codes are specified in the attachment, to the essential requirements described in Annex I of Directive 93/42/EEC, as amended by Directive 2007/47/EC and as prescribed by Annex II of Directive 93/42/EEC and following amendments. FLOW METER S.p.A., with registered office and operation site in Via del Lino, 6, zip code Levate (BG) - I, manufacturer of the medical devices named LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES, whose codes are reported in the attachment, declares under its own responsibility that the devices in question satisfy all the essential requirements of Annex I of Directive on Medical Devices 93/42/EEC, amended by Directive 2007/47/EC. For this purpose it hereby guarantees and declares under its own responsibility that: 1. The devices in question satisfy the dispositions applicable under Directive 93/42/EEC, amended by Directive 2007/47/EC. 2. The devices in question should be considered as belonging to Class II B, following rules 2 and 9 of Annex IX of the above mentioned Directives. 3. The devices in question are sold in NON STERILE packaging. 4. The devices in question are manufactured in different versions as stated in the list of product codes in the attachment. 5. The design and manufacturing procedures comply with the requirements of the Company Quality System, as prescribed in the Annex II of the a.m. Directive. 6. The Product Technical File will be filed and available to the Notified Body, as specified by Annex II of Directive 93/42/EEC of reference, amended by Directive 2007/47/EC, for a period of at least ten years from the last placing on the market of the product with the last product batch record, under the responsibility of the Technical Director and Legal Representative below mentioned. 7. The a.m. medical devices comply with all the requirements of the following standards: - EN ISO 5359 Anaesthetic and respiratory equipment - Low-pressure hose assemblies for use with medical gases. - EN ISO Terminal units for medical gas pipeline systems - Part 1: Terminal units for use with compressed medical gases and vacuum. - EN ISO Medical supply units. - EN ISO Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation. - EN ISO Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators + EN ISO /AC - EN ISO Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum. - UNI ENV Medical gas pipeline systems Part 6: Dimensions and allocation of s for terminal units for compressed medical gases and vacuum. + EC UNI ENV UNI 9507 Impianti di distribuzione dei gas per uso medico Unità terminali. - BS 5682 Specification for s (quick connectors) for use with medical pipeline systems. - DIN Versorgungsanlagen für medizinische Gase - Teil 2: Maße und Zuordnung von Steckern und gasartspezifischen Verbindungsstellen für Entnahmestellen. - NF-S Matériel médico-chirurgical - Prises murales et fiches correspondantes pour fluides médicaux. - ISO 1402 Rubber and plastics hoses and hose assemblies Hydrostatic testing. - ISO 554 Standard atmospheres for conditioning and/or testing Specifications. - ISO 1307 Rubber and plastics - Hose sizes, minimum and maximum inside diameters, and tolerance on cut-to-length hoses. - ISO 8033 Rubber and plastic hoses Determination of adhesion between components. 8. The devices in question have been manufactured and placed on the market as indicated in the Product Technical File and according to the company Quality System declared to be compliant by CERTIQUALITY, Notified Body number 0546 according to Directive 93/42/EEC, as prescribed in annex II of the aforementioned Directive amended by Directive 2007/47/EC (certificate no /2, first issue of 04/07/2017, current issue of 04/07/2017 and valid up to 03/07/2022). This system, adopted for the design and manufacturing of all devices, is declared as conforming to standards ISO 9001:2008 (ref. certificate no. 421) and EN ISO 13485:2012 (ref. certificate no ). 9. The placing on the market of the above mentioned devices has already been notified to the Italian Competent Authority by FLOW METER S.p.A.. A suitable procedure has been established and is maintained in order to guarantee the post-marketing surveillance required by Directive 93/42/EEC, amended by Directive 2007/47/EC. This declaration of conformity content is confirmed at every placing on the market of a new device batch, manufactured since 28/02/2018. This declaration of conformity is valid until the expiry date of the certificate. Attachments: List of models with codes to which this declaration refers; Copy of EC marking certificate. Witnessed Flow Meter S.p.A. The legal representative Roberto Paratico Date of issue of the declaration: 28/02/ Ed. / Is.: 03/5 Updated 28/02/2018 Page 1/10

2 FLOW METER S.p.A. Capitale Sociale: int. versato Sede legale: Via del Lino, LEVATE (Bg) Amministrazione e Stabilimenti: Via del Lino, LEVATE (Bg) Tel. +39/035/ Telefax +39/035/ info@flowmeter.it Codice fiscale e Partita IVA: C.C.I.A.A. Bergamo Iscritta al Tribunale di Bergamo - Volume Reg. Società Attachment 01 List of models Updated 28/02/2018 Code Description Side 1 Side AFNOR NF-S terminal AFNOR NF-S unit AFNOR NF-S UNI length =1,5 m. for O2 BS 5682 BS Low pressure hose O2 assembly length 1,5 m. Probe AFNOR NF-S Outlet UNI AFNOR NF-S Low pressure hose O2 assembly length 1,5 m. Probe UNI 9507 Outlet UNI UNI DIN BS UNI 9507 UNI AFNOR NF-S AFNOR NF-S outlet AFNOR NF-S UNI 9507 outlet UNI 9507 AFNOR NF-S outlet AFNOR NF-S AFNOR NF-S AFNOR NF-S UNI UNI 9507 outlet Low pressure hose O2 assembly length 2,5 m. length =4,5 m. for O2 length =4,5 m. for O2 length =4,5 m. O2 length =4,5 m. for O2 length =4,5 m. for O2 length =1,5 m. for AIR UNI UNI 9507 UNI 9507 Probe DIN Probe EN ISO 5359 AFNOR NF-S outlet BS 5682 AFNOR NF-S UNI EN ISO 5359 outlet BS 5682 AFNOR NF-S EN ISO 5359 NIST UNI 9507 outlet EN ISO 5359 BS 5682 Updated 28/02/2018 Page 2/10

3 FLOW METER S.p.A. Capitale Sociale: int. versato Sede legale: Via del Lino, LEVATE (Bg) Amministrazione e Stabilimenti: Via del Lino, LEVATE (Bg) Tel. +39/035/ Telefax +39/035/ info@flowmeter.it Codice fiscale e Partita IVA: C.C.I.A.A. Bergamo Iscritta al Tribunale di Bergamo - Volume Reg. Società length=1,5 m. for air 4 bar Low pressure hose air assembly length 1,5 m length =1,5 M. AIR length =1,5 M. AIR length =2,5 M. AIR length=2,5 m. for air 4 bar length=2,5 m. for air 4 bar length=2,5 m. for air 4 bar Low pressure hose air assembly length 2,5 m length =1,5 m. for vacuum length=1,5 m. for N2O length=2,5 m. for N2O length=2.5 m - N2O length =4,5 m. for N2O length=4,5 m. - N2O length=3 m. for O length =1,5 m. for N2O length=1.5 m for vacuum length =2,5 M. vacuum length =2,5 M. vacuum length =2,5 M. vacuum AFNOR NF-S Probe UNI 9507 Outlet UNI 9507 UNI 9507 DIN AFNOR NF-S AFNOR NF-S AFNOR NF-S UNI 9507 UNI 9507 NIST AFNOR NF-S outlet AFNOR NF-S Probe DIN Probe EN ISO 5359 BS5682 AFNOR NF-S AFNOR NF-S BS 5682 AFNOR NF-S Probe AFNOR NF-S EN ISO 5359 AFNOR NF-S outlet AFNOR NF-S Probe AFNOR NF-S EN ISO 5359 DIN BS 5682 AFNOR NF-S BS 5682 Probe UNI Outlet UNI 9507 AFNOR NF-S UNI 9507 DIN EN ISO 5359 EN ISO 5359 EN ISO length =2,5 M. vacuum AFNOR NF-S AFNOR NF-S outlet length=2,5 m. for VACUUM AFNOR NF-S AFNOR NF-S length =2,5 m. for AIR 800 EN ISO 5359 outlet EN ISO length =4,5 m. for AIR AFNOR NF-S outlet AFNOR NF-S AFNOR NF-S length=4,5 m. for air 4 bar length UNI UNI 9507 outlet Updated 28/02/2018 Page 3/10

4 FLOW METER S.p.A. Capitale Sociale: int. versato Sede legale: Via del Lino, LEVATE (Bg) Amministrazione e Stabilimenti: Via del Lino, LEVATE (Bg) Tel. +39/035/ Telefax +39/035/ info@flowmeter.it Codice fiscale e Partita IVA: C.C.I.A.A. Bergamo Iscritta al Tribunale di Bergamo - Volume Reg. Società =4,5 m. for AIR length=4,5 m. for air 4 bar UNI 9507 Updated 28/02/2018 Page 4/10

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Updated 04/07/2017 Page 1/8

Updated 04/07/2017 Page 1/8 FLOW METER S.p.A. Capitale Sociale: 234.000 int. versato Sede legale: Via del Lino, 6 24040 LEVATE (Bg) Amministrazione e Stabilimenti: Via del Lino, 6-24040 LEVATE (Bg) Tel. +39/035/594047 - Telefax +39/035/594821