Declaration of Conformity
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1 rllox [Tledicalr Declaration of Conformity - Medical Device Directive 93l42 EEC - Nox Medical Katrinaftuni 2, IS-105, Reykjavi[ Iceland 7 September 2016 confirms that the products listed below that bear the CE marking, conform to the Essential Requirements defined within Annex I of the European Council Directive 93l42lEEC of t4 June 1993, as amended by lec, concerning Medical Devices. Product Type Nox Eipolar Snap- On Electrode Cables - Packages Version 0100 Nox Unipolar Snap-On Electrode Cables - Packages Version 0100 Technical Names and Description Nox Snap on Double Lead Orange 50/100 cm - 1 unit (NOX- ESNAPlPACl) Nox Snap on Double Lead Grey L48lL50 cm - 1 unit (NOX- ESNAP2PACl) Nox Snap on Double Lead Black 148/150 cm - 1 unit (NOX- ESNAP3PACl) Nox Snap on Double Lead White 50/52 cm - 1 unit (NOX-ESNAP4PAC1) Nox Snap on Double Lead Beige/Orange 30/50 cm - 1 unit (NOX- PESNAPlPACl) Nox Snap on Double Lead Beige/Grey 98/100 cm - 1 unit (NOX- PESNAP2PACl) Nox Snap on Double Lead Beige/Black 98/100 cm - 1 unit (NOX- PESNAP3PACl) Nox Snap on Double Lead Beige/White 30/32 cm - 1 unit (NOX- PESNAP4PACl) Nox Snap on Lead White 50 cm - 2 units (NOX-ESNAPTPAC2) Nox Snap on Lead Green 100 cm - 1 unit (NOX-ESNAPSPACI) Nox Snap on Lead Grey 150 cm - 2 units (NOX-ESNAP9PAC2) Nox Snap on Lead Black 150 cm - 2 units (NOX-ESNAP1OPAC2) Nox Snap on Lead Orange 100 cm - 2 units (NOX-ESNAP11PAC2) Nox Snap on Lead Beige/White 30 cm - 2 units (NOX-PESNAPTPAC2) Nox Snap on Lead Beige/Green 50 cm - 1 unit (NOX-pESNAP8PAC1) Nox Snap on Lead Beige/Grey 100 cm - 2 units (NOX-PESNAP9PAC2) Nox Snap on Lead Beige/Black 100 cm - 2 units (NOX-PESNAP1OPAC2) Nox Gold Cup Electrode Leads - Version 101 Pack of Ten Different Colored Nox Gold Cup Electrode Leads (NOX- ECUPAUl0) l lpage
2 rilox ttledicalr ProductType Technical Names and Description Instructions for Nox Gold Cup Electrodes - Instructions for Use (ECUPAUILEA) - use version 0101, REV2 Nox Snap-on Electrode Cables - Instructions for Use, English (ESNAPLEA) - version 0100, REV3 Nox Snap-on Electrode Cables - Instructions for Use, French (ESNAPLEAFRENCH) - version 0100, REV1 The Nox electrodes and electrode cables listed above are categorized as Class I, according to Rule 7: IUon-invasive devies. The conformity assessment has been undertaken via Annex Wf of tlle Council Diredive 93l42lEEC. Furthermore, Nox Medical holds an ISO 13485:2003/CMDCAS certified Quality Management System (certificate no. FM ) for the following scope: The design and manuhcturc of pediatric and adult sleep diagnostic devices. 2lPage
3 rnox ftledicalr INTENDED USE The Nox gold cup electrodes leads are intended to enable recording of EEG/EOG signals during sleep studies. The Nox gold cup electrodes leads are not certified to be used for electrical stimulation purposes. The Nox snap-on electrode cables are intended to enable recording of EMG/ECG signals during sleep studies. The Nox gold cup electrodes leads and Nox snap-on electrode cables are intended for both pediatric and adult patients. The Nox gold cup electrodes leads and Nox snap-on electrode cables are not ceftifled to be used for continuous monitoring where failure to operate can cause injuries or death of the patient. The intended environments are hospitals, Institutions, sleep centers, sleep clinics, or other test environments, including the patient's home. 3lPage
4 rllox [Tledicalr LIST OF STANDARDS The Nox electrodes and electrode cables comply with the following standards: / EN :2006 Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance / EN ISO 14971:2012 Medical devices - Application of risk management to medical devices r' ISO L:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied Director of Q&R Nox Medical 4lPa9e
5 rnox ftledicalr STATEMENT All design changes to the original electrode cables and electrode leads and instructions for use have been controlled within a certified ISO 13485:2003 Quality Management System that strives to comply with all applicable requirements of Council Directive 93l42lEtc. The safety and effectiveness of the latest released electrode cables and electrode leads have been demonstrated by thorough testing, verification, risk analysis, validation and clinical evaluation, according to their specificatlons and intended use. Furthermore, the latest released electrode cables and electrode leads are found to be in compliance with all applicable standards. Based on all the verification testing, validation and clinical evaluation performed the latest released electrode cables and electrode leads are deemed safe and effective for their intended use. This statement applies to the newest release of the electrode cables and electrode leads controlled within the internal project: ( ) Ok Release. Director of Q&R Nox Medical 5lPa9e
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