DECLARATION OF CONFORMITY FOR THE MEDICAL DEVICE FAMILY OUTLETS FOR COMPRESSED MEDICAL GASES AND VACUUM AND FOR ANAESTHETIC GAS SCAVENGING SYSTEMS

Transcription

1 DECLARATION OF CONFORMITY FOR THE MEDICAL DEVICE FAMILY OUTLETS FOR COMPRESSED MEDICAL GASES AND VACUUM AND FOR ANAESTHETIC GAS SCAVENGING SYSTEMS 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 OUTLETS FOR COMPRESSED MEDICAL GASES AND VACUUM, 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 9 and 11 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 Terminal units for medical gas pipeline systems Part 1: Terminal units for use with compressed medical gases and vacuum. - EN ISO 5359 Low pressure hose assemblies for use with medical gases. - UNI 9507 Impianti di distribuzione di gas per uso medico Unità terminali. - NF S Matériel médico-chirurgical - Prises murales et fiches correspondantes pour fluides médicaux. - DIN : Supply systems for medical gases - Part 2: Dimensions and allocation of probes and gas-specific connection points for terminal units. - SS :2004 Medical gas pipeline systems - Connectors for medical gases. - BS 5682:1998 Specification for probes (quick connectors) for use with medical gas pipeline systems. 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 postmarketing 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 04/07/2017. 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: 04/07/ Ed. / Is.: 03/5 Updated 04/07/2017 Page 1/13

2 Code Attachment 01 List of models Updated 04/07/2017 Description NIST outlet connected to a double Rs flowmeter, with bracket (fluss Rs dpp O2+mors+presa NIST) NIST outlet connected to a double Rs flowmeter, 30l g1/4-30l hose connector + bracket (fluss Rs dpp O2 30l g1/4-30lpg+mors+nist) AFNOR NF S twin outlet for vacuum AFNOR NF S twin outlet for O AFNOR NF S twin outlet for air AFNOR NF S twin outlet for N2O AFNOR NF S twin outlet CO AFNOR NF S twin outlet for O2 with aluminum body, slide 25x5 m-f, 0.65m tubing and coupling AFNOR NF S twin outlet for vacuum with aluminum body, slide 25x5 m-f, 0.65m tubing and coupling UNI 9507 twin outlet for vacuum UNI 9507 twin outlet for O UNI 9507 twin outlet for air UNI 9507 twin outlet for N2O Vacuum outlet duplicators DIN O2 outlet duplicators DIN Air outlet duplicators DIN Universal suction trolley for 2 jars complete with outlet AFNOR NF-S , support for 4 jars with slide 30x5 and 2 m. Hose EN Universal suction trolley for 2 jars complete with outlets AFNOR NF-S Universal suction trolley for 2 jars complete with outlets UNI Universal suction trolley with DIN outlets Universal suction trolley with BS 5682 outlets AFNOR NF S outlet for O2 g. ¼ m AFNOR NF S outlet for O2 m12x1.25 m for pressure regulator integrated in the cylinder valve type mercury AFNOR NF S outlet for air g. ¼ m AFNOR NF S outlet for vacuum g. ¼ m AFNOR NF S outlet for N2O g. ¼ m AFNOR NF S outlet for O2 g. ¼ m. with lock nut for reverse panel AFNOR NF S outlet for air g. ¼ m. with lock nut for reverse panel AFNOR NF S outlet for N2O g. ¼ m. with lock nut for reverse panel AFNOR NF S outlet for vacuum g. ¼ m. with lock nut for reverse panel AFNOR NF S outlet for O2 hose connector Updated 04/07/2017 Page 2/13

3 Code Description AFNOR NF S outlet for air hose connector AFNOR NF S outlet for vacuum hose connector AFNOR NF S outlet for N2O hose connector EN 739 outlet for air-800 m18x UNI 9507 outlet for O2 with parking position UNI 9507 outlet for air with parking position UNI 9507 outlet for vacuum with parking position UNI 9507 outlet for N2O with parking position UNI 9507 outlet for CO2 with parking position UNI 9507 outlet for O2 + N2O with parking position UNI 9507 outlet for air 800 with parking position UNI 9507 outlet for air 800 kpa with hose connector parking position UNI 9507 outlet for N2-800 with parking position UNI 9507 outlet for N2 with parking position UNI 9507 outlet NEO for O UNI 9507 outlet NEO for air UNI 9507 outlet NEO for vacuum UNI 9507 outlet NEO for N2O UNI 9507 outlet NEO for CO UNI 9507 outlet for O UNI 9507 outlet for O2 m12x1.25 m for pressure regulator integrated in the cylinder valve type Mercury UNI 9507 outlet for air UNI 9507 outlet for vacuum UNI 9507 outlet for N2O UNI 9507 outlet for CO UNI 9507 outlet for O2 hose coupling UNI 9507 outlet for air hose connector UNI 9507 outlet for N2O hose connector UNI 9507 outlet for vacuum hose connector AFNOR NF S outlet for O2 m22x AFNOR NF S outlet for N2O m16x AFNOR NF S outlet for vacuum m24x AFNOR NF S outlet for air m20x1.5s EN 739 outlet for air-800 with socket AFNOR NF S outlet for CO2 m20x EN 739 outlet for AIR-800 hose connector Updated 04/07/2017 Page 3/13

4 Code Description EN 739 outlet for N2-800 m22x1.5s EN 739 outlet for O2 m22x EN 739 outlet for air m20x1.5s Outlet AFNOR NF-S thread UNI AIR ABS AFNOR NF S outlet for O2 M22x ABS AFNOR NF S outlet for AIR M20x1.5S ABS AFNOR NF S outlet for VACUUM M24x ABC AFNOR NF S outlet for N2O M16x ABS AFNOR NF S outlet for CO2 M20x ABS AFNOR NF S outlet for AIR 800 M18X BS 5682 terminal unit for air BS 5682 terminal unit for air BS 5682 terminal unit for O BS 5682 terminal unit for N2O BS 5682 terminal unit for vacuum Outlet BS 5682 O2 m12x1,25 for Easycare Outlet BS 5682 AIR m12x1,25 for Easycare DIN terminal unit air DIN terminal unit for CO DIN terminal unit for N DIN terminal unit for O DIN terminal unit for N2O DIN terminal unit for vacuum Outlet DIN O2 m12x1,25 for Easycare Outlet DIN AIR m12x1,25 for Easycare Outlet DIN vacuum m13x1,25 for duplicators SS terminal unit for air SS terminal unit for air SS terminal unit for CO SS terminal for O SS terminal for N2O SS terminal unit for vacuum Socket for UNI 9507 outlet for O Socket for UNI 9507 outlet for N2O Socket for UNI 9507 outlet for vacuum Socket for UNI 9507 outlet for air Updated 04/07/2017 Page 4/13

5 Code Description Socket for UNI 9507 outlet for CO Socket for UNI 9507 outlet for N Socket for UNI 9507 outlet for AIR Panel socket for UNI 9507 outlet for O Panel socket for UNI 9507 outlet for air Panel socket for UNI 9507 outlet for vacuum Panel socket for UNI 9507 outlet for N2O Panel socket for UNI 9507 outlet for AIR Socket for BS-DIN-SS for modular flush-mounted case O2 OX Socket for BS-DIN-SS for modular flush-mounted case AIR OX Socket for BS-DIN-SS for modular flush-mounted case AIR-800 OX Socket for BS-DIN-SS for modular flush-mounted case N2O OX Socket for BS-DIN-SS for modular flush-mounted case CO2 OX Socket for BS-DIN-SS for modular flush-mounted case N2 OX Socket for BS-DIN-SS for modular flush-mounted case VAC OX Socket for BS-DIN-SS for bed head unit with hose shape at O oxygen OX Socket for BS-DIN-SS for bed head unit with hose shape at O AIR OX Socket for BS-DIN-SS for bed head unit with hose shape at O AIR-800 OX Socket for BS-DIN-SS for bed head unit with hose shape at O N2O OX Socket for BS-DIN-SS for bed head unit with hose shape at O CO2 OX Socket for BS-DIN-SS for bed head unit with hose shape at O N2 OX Socket for BS-DIN-SS for bed head unit with hose shape at O VAC OX Socket for BS-DIN-SS for bed head unit with hose shape at 225 O2 OX Socket for BS-DIN-SS for bed head unit with hose shape at 225 AIR OX Socket for BS-DIN-SS for bed head unit with hose shape at 225 AIR-800 OX Socket for BS-DIN-SS for bed head unit with hose shape at 225 N2O OX Socket for BS-DIN-SS for bed head unit with hose shape at 225 CO2 OX Socket for BS-DIN-SS for bed head unit with hose shape at 225 N2 OX Socket for BS-DIN-SS for bed head unit with hose shape at 225 VAC OX Socket for BS-DIN-SS for bed head unit with hose shape at 135 OSSIGENO OX Socket for BS-DIN-SS for bed head unit with hose shape at 135 AIR OX Socket for BS-DIN-SS for bed head unit with hose shape at 135 AIR-800 OX Socket for BS-DIN-SS for bed head unit with hose shape at 135 N2O OX Socket for BS-DIN-SS for bed head unit with hose shape at 135 CO2 OX Socket for BS-DIN-SS for bed head unit with hose shape at 135 N2 OX Socket for BS-DIN-SS for bed head unit with hose shape at 135 VAC OX Updated 04/07/2017 Page 5/13

6 Code Description Socket for BS-DIN-SS for bed head unit with hose shape at 135 with fold at 0 oxygen Socket for BS-DIN-SS for bed head unit with hose shape at 135 with fold at 0 AIR Socket for BS-DIN-SS for bed head unit with hose shape at 135 with fold at 0 AIR Socket for BS-DIN-SS for bed head unit with hose shape at 135 with fold at 0 N2O Socket for BS-DIN-SS for bed head unit with hose shape at 135 with fold at 0 CO Socket for BS-DIN-SS for bed head unit with hose shape at 135 with fold at 0 N Socket for BS-DIN-SS for bed head unit with hose shape at 135 with fold at 0 VAC Socket for BS-DIN-SS for bed head unit with hose shape at 225 with fold at 0 oxygen Socket for BS-DIN-SS for bed head unit with hose shape at 225 with fold at 0 AIR Socket for BS-DIN-SS for bed head unit with hose shape at 225 with fold at 0 AIR Socket for BS-DIN-SS for bed head unit with hose shape at 225 with fold at 0 N2O Socket for BS-DIN-SS for bed head unit with hose shape at 225 with fold at 0 CO Socket for BS-DIN-SS for bed head unit with hose shape at 225 with fold at 0 N Socket for BS-DIN-SS for bed head unit with hose shape at 225 with fold at 0 VAC Socket for BS-DIN-SS for bed head unit with hose shape back oxygen OX Socket for BS-DIN-SS for bed head unit with hose shape back AIR OX Socket for BS-DIN-SS for bed head unit with hose shape back AIR-800 OX Socket for BS-DIN-SS for bed head unit with hose shape back N2O OX Socket for BS-DIN-SS for bed head unit with hose shape back CO2 OX Socket for BS-DIN-SS for bed head unit with hose shape back N2 OX Socket for BS-DIN-SS for bed head unit with hose shape back VAC OX Socket for BS-DIN-SS for bed head unit with hose connector at 0 oxygen OX Socket for BS-DIN-SS for bed head unit with hose connector at 0 AIR OX Socket for BS-DIN-SS for bed head unit with hose connector at 0 AIR-800 OX Socket for BS-DIN-SS for bed head unit with hose connector at 0 N2O OX Socket for BS-DIN-SS for bed head unit with hose connector at 0 CO2 OX Socket for BS-DIN-SS for bed head unit with hose connector at 0 N2 OX Socket for BS-DIN-SS for bed head unit with hose connector at 0 VAC OX Socket for BS-DIN-SS for bed head unit with hose connector at 135 O2 OX Socket for BS-DIN-SS for bed head unit with hose connector at 135 AIR OX Socket for BS-DIN-SS for bed head unit with hose connector at 135 AIR-800 OX Socket for BS-DIN-SS for bed head unit with hose connector at 135 N2O OX Socket for BS-DIN-SS for bed head unit with hose connector at 135 CO2 OX Socket for BS-DIN-SS for bed head unit with hose connector at 135 N2 OX Socket for BS-DIN-SS for bed head unit with hose connector at 135 VAC OX Socket for BS-DIN-SS for bed head unit with back hose connector O2 OX Updated 04/07/2017 Page 6/13

7 Code Description Socket for BS-DIN-SS for bed head unit with back hose connector AIR OX Socket for BS-DIN-SS for bed head unit with back hose connector AIR-800 OX Socket for BS-DIN-SS for bed head unit with back hose connector N2O OX Socket for BS-DIN-SS for bed head unit with back hose connector CO2 OX Socket for BS-DIN-SS for bed head unit with back hose connector N2 OX Socket for BS-DIN-SS for bed head unit with back hose connector VAC OX Updated 04/07/2017 Page 7/13

8 Attachment 02 EC marking certificate issued by Notified Body Updated 04/07/2017 Page 8/13

9 Attachment 02 EC marking certificate issued by Notified Body Updated 04/07/2017 Page 9/13

10 Attachment 02 EC marking certificate issued by Notified Body Updated 04/07/2017 Page 10/13

11 Attachment 02 EC marking certificate issued by Notified Body Updated 04/07/2017 Page 11/13

12 Attachment 02 EC marking certificate issued by Notified Body Updated 04/07/2017 Page 12/13

13 Attachment 02 EC marking certificate issued by Notified Body Updated 04/07/2017 Page 13/13