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 24040 - 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 9170-1 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 90-116 Matériel médico-chirurgical - Prises murales et fiches correspondantes pour fluides médicaux. - DIN 13260-2:2013-09 Supply systems for medical gases - Part 2: Dimensions and allocation of probes and gas-specific connection points for terminal units. - SS 8752430:2004 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. 16655/2, 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. 10627). 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: 04/07/2017 - Ed. / Is.: 03/5 Updated 04/07/2017 Page 1/13
Code Attachment 01 List of models Updated 04/07/2017 Description 000023210 NIST outlet connected to a double Rs flowmeter, 15-30 with bracket (fluss Rs dpp O2+mors+presa NIST) 000023211 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) 000029510 AFNOR NF S 90-116 twin outlet for vacuum 000029515 AFNOR NF S 90-116 twin outlet for O2 000029520 AFNOR NF S 90-116 twin outlet for air 000029525 AFNOR NF S 90-116 twin outlet for N2O 000029526 AFNOR NF S 90-116 twin outlet CO2 000029530 000029535 AFNOR NF S 90-116 twin outlet for O2 with aluminum body, slide 25x5 m-f, 0.65m tubing and coupling AFNOR NF S 90-116 twin outlet for vacuum with aluminum body, slide 25x5 m-f, 0.65m tubing and coupling 000029600 UNI 9507 twin outlet for vacuum 000029610 UNI 9507 twin outlet for O2 000029620 UNI 9507 twin outlet for air 000029630 UNI 9507 twin outlet for N2O 000029700 Vacuum outlet duplicators DIN 13260 000029710 O2 outlet duplicators DIN 13260 000029720 Air outlet duplicators DIN 13260 000260965 Universal suction trolley for 2 jars complete with outlet AFNOR NF-S 90-116, support for 4 jars with slide 30x5 and 2 m. Hose EN 739 000260966 Universal suction trolley for 2 jars complete with outlets AFNOR NF-S 90-116 000260967 Universal suction trolley for 2 jars complete with outlets UNI 9507 000260968 Universal suction trolley with DIN 13260 outlets 000260971 Universal suction trolley with BS 5682 outlets 000340100 AFNOR NF S 90-116 outlet for O2 g. ¼ m. 000340150 AFNOR NF S 90-116 outlet for O2 m12x1.25 m for pressure regulator integrated in the cylinder valve type mercury 000340200 AFNOR NF S 90-116 outlet for air g. ¼ m. 000340300 AFNOR NF S 90-116 outlet for vacuum g. ¼ m. 000340400 AFNOR NF S 90-116 outlet for N2O g. ¼ m. 000340500 AFNOR NF S 90-116 outlet for O2 g. ¼ m. with lock nut for reverse panel 000340501 AFNOR NF S 90-116 outlet for air g. ¼ m. with lock nut for reverse panel 000340502 AFNOR NF S 90-116 outlet for N2O g. ¼ m. with lock nut for reverse panel 000340503 AFNOR NF S 90-116 outlet for vacuum g. ¼ m. with lock nut for reverse panel 000340510 AFNOR NF S 90-116 outlet for O2 hose connector Updated 04/07/2017 Page 2/13
Code Description 000340600 AFNOR NF S 90-116 outlet for air hose connector 000340700 AFNOR NF S 90-116 outlet for vacuum hose connector 000340800 AFNOR NF S 90-116 outlet for N2O hose connector 000340900 EN 739 outlet for air-800 m18x1.5 000345100 UNI 9507 outlet for O2 with parking position 000345200 UNI 9507 outlet for air with parking position 000345300 UNI 9507 outlet for vacuum with parking position 000345400 UNI 9507 outlet for N2O with parking position 000345500 UNI 9507 outlet for CO2 with parking position 000345600 UNI 9507 outlet for O2 + N2O with parking position 000345700 UNI 9507 outlet for air 800 with parking position 000345710 UNI 9507 outlet for air 800 kpa with hose connector parking position 000345800 UNI 9507 outlet for N2-800 with parking position 000345900 UNI 9507 outlet for N2 with parking position 000346000 UNI 9507 outlet NEO for O2 000346001 UNI 9507 outlet NEO for air 000346002 UNI 9507 outlet NEO for vacuum 000346003 UNI 9507 outlet NEO for N2O 000346004 UNI 9507 outlet NEO for CO2 000346100 UNI 9507 outlet for O2 000346150 UNI 9507 outlet for O2 m12x1.25 m for pressure regulator integrated in the cylinder valve type Mercury 000346200 UNI 9507 outlet for air 000346300 UNI 9507 outlet for vacuum 000346400 UNI 9507 outlet for N2O 000346500 UNI 9507 outlet for CO2 000346600 UNI 9507 outlet for O2 hose coupling 000346650 UNI 9507 outlet for air hose connector 000346800 UNI 9507 outlet for N2O hose connector 000346850 UNI 9507 outlet for vacuum hose connector 000348000 AFNOR NF S 90-116 outlet for O2 m22x1.5 000348001 AFNOR NF S 90-116 outlet for N2O m16x1.5 000348002 AFNOR NF S 90-116 outlet for vacuum m24x1.5 000348003 AFNOR NF S 90-116 outlet for air m20x1.5s 000348004 EN 739 outlet for air-800 with socket 000348005 AFNOR NF S 90-116 outlet for CO2 m20x1.5 000348007 EN 739 outlet for AIR-800 hose connector Updated 04/07/2017 Page 3/13
Code Description 000348008 EN 739 outlet for N2-800 m22x1.5s 000348009 EN 739 outlet for O2 m22x1.5 000348010 EN 739 outlet for air m20x1.5s 000348011 Outlet AFNOR NF-S 90-116 thread UNI AIR-800 000348100 ABS AFNOR NF S 90-116 outlet for O2 M22x1.5 000348110 ABS AFNOR NF S 90-116 outlet for AIR M20x1.5S 000348120 ABS AFNOR NF S 90-116 outlet for VACUUM M24x1.5 000348130 ABC AFNOR NF S 90-116 outlet for N2O M16x1.5 000348140 ABS AFNOR NF S 90-116 outlet for CO2 M20x1.5 000348150 ABS AFNOR NF S 90-116 outlet for AIR 800 M18X1.5 000348201 BS 5682 terminal unit for air 000348202 BS 5682 terminal unit for air-800 000348200 BS 5682 terminal unit for O2 000348203 BS 5682 terminal unit for N2O 000348204 BS 5682 terminal unit for vacuum 000348210 Outlet BS 5682 O2 m12x1,25 for Easycare 000348211 Outlet BS 5682 AIR m12x1,25 for Easycare 000348251 DIN 13260-2 terminal unit air 000348252 DIN 13260-2 terminal unit for CO2 000348253 DIN 13260-2 terminal unit for N2 000348250 DIN 13260-2 terminal unit for O2 000348254 DIN 13260-2 terminal unit for N2O 000348255 DIN 13260-2 terminal unit for vacuum 000348270 Outlet DIN 13260-2 O2 m12x1,25 for Easycare 000348271 Outlet DIN 13260-2 AIR m12x1,25 for Easycare 000348272 Outlet DIN 13260-2 vacuum m13x1,25 for duplicators 000348301 SS 875 24 30 terminal unit for air 000348302 SS 875 24 30 terminal unit for air-800 000348303 SS 875 24 30 terminal unit for CO2 000348300 SS 875 24 30 terminal for O2 000348304 SS 875 24 30 terminal for N2O 000348305 SS 875 24 30 terminal unit for vacuum 000351000 Socket for UNI 9507 outlet for O2 000351004 Socket for UNI 9507 outlet for N2O 000351005 Socket for UNI 9507 outlet for vacuum 000351008 Socket for UNI 9507 outlet for air Updated 04/07/2017 Page 4/13
Code Description 000351010 Socket for UNI 9507 outlet for CO2 000351011 Socket for UNI 9507 outlet for N2-800 000351012 Socket for UNI 9507 outlet for AIR-800 000351020 Panel socket for UNI 9507 outlet for O2 000351030 Panel socket for UNI 9507 outlet for air 000351040 Panel socket for UNI 9507 outlet for vacuum 000351050 Panel socket for UNI 9507 outlet for N2O 000351060 Panel socket for UNI 9507 outlet for AIR-800 000353000 Socket for BS-DIN-SS for modular flush-mounted case O2 OX 617 000353001 Socket for BS-DIN-SS for modular flush-mounted case AIR OX 617 000353002 Socket for BS-DIN-SS for modular flush-mounted case AIR-800 OX 617 000353003 Socket for BS-DIN-SS for modular flush-mounted case N2O OX 617 000353004 Socket for BS-DIN-SS for modular flush-mounted case CO2 OX 617 000353005 Socket for BS-DIN-SS for modular flush-mounted case N2 OX 617 000353006 Socket for BS-DIN-SS for modular flush-mounted case VAC OX 617 000353010 Socket for BS-DIN-SS for bed head unit with hose shape at O oxygen OX 617-2 000353011 Socket for BS-DIN-SS for bed head unit with hose shape at O AIR OX 617-2 000353012 Socket for BS-DIN-SS for bed head unit with hose shape at O AIR-800 OX 617-2 000353013 Socket for BS-DIN-SS for bed head unit with hose shape at O N2O OX 617-2 000353014 Socket for BS-DIN-SS for bed head unit with hose shape at O CO2 OX 617-2 000353015 Socket for BS-DIN-SS for bed head unit with hose shape at O N2 OX 617-2 000353016 Socket for BS-DIN-SS for bed head unit with hose shape at O VAC OX 617-2 000353020 Socket for BS-DIN-SS for bed head unit with hose shape at 225 O2 OX 617-3 000353021 Socket for BS-DIN-SS for bed head unit with hose shape at 225 AIR OX 617-3 000353022 Socket for BS-DIN-SS for bed head unit with hose shape at 225 AIR-800 OX 617-3 000353023 Socket for BS-DIN-SS for bed head unit with hose shape at 225 N2O OX 617-3 000353024 Socket for BS-DIN-SS for bed head unit with hose shape at 225 CO2 OX 617-3 000353025 Socket for BS-DIN-SS for bed head unit with hose shape at 225 N2 OX 617-3 000353026 Socket for BS-DIN-SS for bed head unit with hose shape at 225 VAC OX 617-3 000353030 Socket for BS-DIN-SS for bed head unit with hose shape at 135 OSSIGENO OX 617-4 000353031 Socket for BS-DIN-SS for bed head unit with hose shape at 135 AIR OX 617-4 000353032 Socket for BS-DIN-SS for bed head unit with hose shape at 135 AIR-800 OX 617-4 000353033 Socket for BS-DIN-SS for bed head unit with hose shape at 135 N2O OX 617-4 000353034 Socket for BS-DIN-SS for bed head unit with hose shape at 135 CO2 OX 617-4 000353035 Socket for BS-DIN-SS for bed head unit with hose shape at 135 N2 OX 617-4 000353036 Socket for BS-DIN-SS for bed head unit with hose shape at 135 VAC OX 617-4 Updated 04/07/2017 Page 5/13
Code Description 000353040 Socket for BS-DIN-SS for bed head unit with hose shape at 135 with fold at 0 oxygen 000353041 Socket for BS-DIN-SS for bed head unit with hose shape at 135 with fold at 0 AIR 000353042 Socket for BS-DIN-SS for bed head unit with hose shape at 135 with fold at 0 AIR-800 000353043 Socket for BS-DIN-SS for bed head unit with hose shape at 135 with fold at 0 N2O 000353044 Socket for BS-DIN-SS for bed head unit with hose shape at 135 with fold at 0 CO2 000353045 Socket for BS-DIN-SS for bed head unit with hose shape at 135 with fold at 0 N2 000353046 Socket for BS-DIN-SS for bed head unit with hose shape at 135 with fold at 0 VAC 000353050 Socket for BS-DIN-SS for bed head unit with hose shape at 225 with fold at 0 oxygen 000353051 Socket for BS-DIN-SS for bed head unit with hose shape at 225 with fold at 0 AIR 000353052 Socket for BS-DIN-SS for bed head unit with hose shape at 225 with fold at 0 AIR-800 000353053 Socket for BS-DIN-SS for bed head unit with hose shape at 225 with fold at 0 N2O 000353054 Socket for BS-DIN-SS for bed head unit with hose shape at 225 with fold at 0 CO2 000353055 Socket for BS-DIN-SS for bed head unit with hose shape at 225 with fold at 0 N2 000353056 Socket for BS-DIN-SS for bed head unit with hose shape at 225 with fold at 0 VAC 000353060 Socket for BS-DIN-SS for bed head unit with hose shape back oxygen OX 617-7 000353061 Socket for BS-DIN-SS for bed head unit with hose shape back AIR OX 617-7 000353062 Socket for BS-DIN-SS for bed head unit with hose shape back AIR-800 OX 617-7 000353063 Socket for BS-DIN-SS for bed head unit with hose shape back N2O OX 617-7 000353064 Socket for BS-DIN-SS for bed head unit with hose shape back CO2 OX 617-7 000353065 Socket for BS-DIN-SS for bed head unit with hose shape back N2 OX 617-7 000353066 Socket for BS-DIN-SS for bed head unit with hose shape back VAC OX 617-7 000353070 Socket for BS-DIN-SS for bed head unit with hose connector at 0 oxygen OX617-8 000353071 Socket for BS-DIN-SS for bed head unit with hose connector at 0 AIR OX 617-8 000353072 Socket for BS-DIN-SS for bed head unit with hose connector at 0 AIR-800 OX617-8 000353073 Socket for BS-DIN-SS for bed head unit with hose connector at 0 N2O OX 617-8 000353074 Socket for BS-DIN-SS for bed head unit with hose connector at 0 CO2 OX 617-8 000353075 Socket for BS-DIN-SS for bed head unit with hose connector at 0 N2 OX 617-8 000353076 Socket for BS-DIN-SS for bed head unit with hose connector at 0 VAC OX 617-8 000353080 Socket for BS-DIN-SS for bed head unit with hose connector at 135 O2 OX 617-9 000353081 Socket for BS-DIN-SS for bed head unit with hose connector at 135 AIR OX617-9 000353082 Socket for BS-DIN-SS for bed head unit with hose connector at 135 AIR-800 OX617-9 000353083 Socket for BS-DIN-SS for bed head unit with hose connector at 135 N2O OX 617-9 000353084 Socket for BS-DIN-SS for bed head unit with hose connector at 135 CO2 OX617-9 000353085 Socket for BS-DIN-SS for bed head unit with hose connector at 135 N2 OX 617-9 000353086 Socket for BS-DIN-SS for bed head unit with hose connector at 135 VAC OX 617-9 000353090 Socket for BS-DIN-SS for bed head unit with back hose connector O2 OX 617-10 Updated 04/07/2017 Page 6/13
Code Description 000353091 Socket for BS-DIN-SS for bed head unit with back hose connector AIR OX 617-10 000353092 Socket for BS-DIN-SS for bed head unit with back hose connector AIR-800 OX617-10 000353093 Socket for BS-DIN-SS for bed head unit with back hose connector N2O OX 617-10 000353094 Socket for BS-DIN-SS for bed head unit with back hose connector CO2 OX 617-10 000353095 Socket for BS-DIN-SS for bed head unit with back hose connector N2 OX 617-10 000353096 Socket for BS-DIN-SS for bed head unit with back hose connector VAC OX 617-10 Updated 04/07/2017 Page 7/13
Attachment 02 EC marking certificate issued by Notified Body Updated 04/07/2017 Page 8/13
Attachment 02 EC marking certificate issued by Notified Body Updated 04/07/2017 Page 9/13
Attachment 02 EC marking certificate issued by Notified Body Updated 04/07/2017 Page 10/13
Attachment 02 EC marking certificate issued by Notified Body Updated 04/07/2017 Page 11/13
Attachment 02 EC marking certificate issued by Notified Body Updated 04/07/2017 Page 12/13
Attachment 02 EC marking certificate issued by Notified Body Updated 04/07/2017 Page 13/13