Dossier de candidature Société ResMed SAS

Transcription

1 Dossier de candidature Société ResMed SAS Marquages CE Nox Medical ResMed SAS, Parc Technologique de Lyon, 292 allée Jacques Monod, Saint Priest Cedex Tél : Fax : Fax commandes :

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7 30 April 2013 Declaration of Conformity -Medical Device Directive 93/42/EEC- Nox Medical Katrinartuni 2, IS-105, Reykjavik, Iceland confirm that the products listed below that bear the CE marking, conform to the Essential Requirements defined within Annex I of the European Council Directive 93/42/EEC, 14 June 1993, as amended by 2007/47/EC, concerning Medical Devices. Product Type NOX-T3 System (Nox-T3_EUF) with WristOX 2 Version 0210 Technical Names and Description T3 Recorder (ASDB1) 1 unit Abdomen Cable (ATC1) 1 unit USB Cable (USBC) 1 unit RIP Belts Disposable (RIPDM) 2 sets NOX Cannula with filter (CANAF) 2 units Hookup Card (HOOKUP) 1 unit Carry Case (SDBECC) 1 unit AA Battery (NOXBAT) 2 units Noxturnal CD (NOXT_CD) 1 unit WristOx 2 Pulse Oximeter (Model 3150) 1 unit WristOx 2 Soft Sensor (Medium) 1 unit Wristband 1 unit CD-ROM of the Operators Manual 1 unit AAA Battery 2 units NOX-T3 Demo System (Nox- T3D_EUF) with WristOX 2 Version 0210 T3 Recorder (ASDB1D) 1 unit Abdomen Cable (ATC1) 1 unit USB Cable (USBC) 1 unit RIP Belts Disposable (RIPDM) 2 sets NOX Cannula with filter (CANAF) 2 units Hookup Card (HOOKUP) 1 unit Carry Case (SDBECC) 1 unit AA Battery (NOXBAT) 2 units Noxturnal CD (NOXT_CD) 1 unit WristOx 2 Pulse Oximeter (Model 3150) 1 unit WristOx 2 Soft Sensor (Medium) 1 unit Wristband 1 unit CD-ROM of the Operators Manual 1 unit AAA Battery 2 units 1 P a g e

8 SPARE PARTS FOR THE T3 SYSTEM: Product Type NOX-T3 Service Kit Version 0130 NOX-T3 Abdomen Cable Version 0140 NOX-T3 USB Cable Version 0102 NOX-T3 Carry Case Version 0300 NOX-T3 Hook-up Card Version 0120 NOX-T3 Battery Lid Version 0100 NOX-T3 Clip Strap Version 0100 Technical Names and Description NOX-T3_SERVICEKIT includes spare parts for the NOX-T3 System: Battery Lid (NOX- NOXLID), Hold Clips (NOX-CLIP1) and Abdomen Cable (NOX-ATC1) NOX-ATC1 1 unit NOX-USBC 1 unit NOX-T3_CC 1 unit NOX-HOOKUP 1 unit NOX-NOXLID 1 unit NOX-CLIP1 1 unit ACCESSORIES FOR THE T3 SYSTEMS: Product Type NOX Oximeter Strap Kit Version 0100 NOX EtCO2 Interface with RespSense Version 0100 Technical Names and Description NOX-OXSTR5 pack of five oximeter straps NOX-CO2KIT1 including Bluetooth Dongle (BTCO2DON), Adapter (BTCO2ADA) and Leaflet (BTCO2LEA) 2 P a g e

9 The NOX T3 Systems and the Noxturnal application listed above are categorized as Class IIa, according to: Rule 10: Active device intended for diagnosis. The conformity assessment has been undertaken via Annex II of the Council Directive 93/42/EEC. The components listed under SPARE PARTS and ACCESSORIES above are categorized as Class I, according to: Rule 1: Non-invasive devices. The conformity assessment has been undertaken via Annex VII of the Council Directive 93/42/EEC. Nox Medical is certified to Full Quality Assurance by BSI (Certificate No. CE ), i.e. to fully comply with the requirements of Council Directive 93/42/EEC, Annex II, section 3.2 in respect of Design and manufacture of sleep diagnostic devices. Furthermore Nox Medical holds an ISO 13485:2003/CMDCAS certified Quality Management System (Certificate No. FM540789) for the following scope: The design and manufacture of pediatric and adult sleep diagnostic devices. 3 P a g e

10 INTENDED USE The NOX-T3 device is intended for ambulatory recording of physiological signals during sleep. The Noxturnal software is intended for configuring the NOX-T3 device for a study as well as downloading and archiving studies from the T3 device. The Noxturnal software is intended for review and analysing of physiological signals and presenting the analysis result in reports. The NOX T3 system is intended for patients greater than 2 years of age. The NOX T3 system is NOT intended for any patient monitoring or automatic diagnosis. The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments, including the patient s home. SUMMARY TESTING, VERIFICATION AND VALIDATON The following summary applies to Nox Medical components only: The overall design and development process of the NOX T3 System and NOX T3 accessories was according to internal quality management processes compliant with ISO 13485:2003 Medical Device Directive (MDD) FDA Quality System Regulation (QSR) Canada Medical Device Regulations (CMDR) The NOX T3 System and NOX T3 accessories have been tested and verified in various phases to include internal testing, verification and validation as well as external testing to assure product safety, effectiveness and reliability. The design was verified and validated, including clinical evaluation, throughout the design process according to requirement specifications and intended use. Simulated use testing of the Nox T3 System has been conducted in a simulated clinical environment. The purpose of the validation was to make sure no unexpected difficulties arise and that the performance is as expected in the clinical environment. Cons and pros were reported and issues feed into formal process. The signals recorded with the Nox T3 system were compared to signals recorded with the Embla N7000 recording device. The result demonstrates the reliability and usability of all signals recorded with the Nox T3 system. Analysis comparison was performed to validate the quality of the automatic scoring performed by the Noxturnal application compared to manual scoring of full PSG data. The validation study focused on the comparison of the Apnea Hypopnea Index (AHI) values and the Oxygen Desaturation Index (ODI) values. The recordings used consisted of 1057 Embla N7000 recordings which had all gone through the process of being manually scored by sleep technicians with RPSGT certification, and then reviewed by a physician. 4 P a g e

11 The analysis comparison result demonstrates that the Noxturnal application scores AHI and ODI events in a substantially equivalent manner to the manual scoring on full PSG recordings obtained using Embla N7000 recording devices. Clinical evaluation has been performed for the Nox T3 system. This evaluation included comparison for Apnea/Hypopnea scoring of Noxturnal as reflected by the Apnea/Hypopnea Index (AHI) compared to manual scoring of full Embla N70000 PSG data, published literature and post marketing feedback. The conclusion from the clinical evaluation for the T3 System is as follow: This clinical evaluation shows that all of the signals, analyses and parameters used in the current Nox T3 and Noxturnal products have roots in widely approved standards for sleep diagnostics supported by relevant scientific literature. Usability testing according to IEC 62366:2007: Medical devices Application of usability engineering to medical devices was performed to ensure reasonable usability of the NOX T3 System along with its accessories, to minimize use errors and use-associated risks and to provide safety for the patient, user and others related to usability. The output of the usability process is fed back into the design process as needed to receive the usability goals for the product. Usability testing has been completed for the Nox T3 System including the NOX T3 accessories with all usability goals passed. The NOX T3 components are intended to be worn over clothing and are thus in no direct contact to the patient's skin. The only exemption from this is the oximeter strap that is intended to be worn in direct contact to skin and is made of similar materials as commonly used in clothing/sport/support articles. Only standard materials used for products components. No parts contain latex. No parts are sterilized or need sterilization before use. The NOX T3 components are designed and manufactured with predefined stipulation for cleanliness. The Nox T3 components are categorized as surface products in indirect contact to skin with a limited duration of contact, i.e. less than 24 hours (oximeter strap in direct contact though). Result of biocompatibility evaluation (type of product and materials used) requires no additional biocompatibility tests to be performed on the products. The NOX T3 System components are thus deemed safe regarding biocompatibility and biology. Risk analysis was performed for the NOX T3 System according to ISO14971:2009 Medical devices Application of risk management to medical devices. As a result appropriate measures were implemented and their effectiveness verified and validated. Appropriate methods are in place to obtain relevant production and post-production information The overall residual risk posed by the medical device has been evaluated, after all risk control measures have been implemented and verified. The remaining risk is found to be acceptable and out weighted by the benefits of using the NOX T3 system along with its NOX accessories and is in compliance with the company s criteria for risk acceptability. The NOX T3 system and NOX T3 accessories are thus considered safe and effective for its intended use. 5 P a g e

12 LIST OF STANDARDS The NOX T3 systems comply with the following standards (are licensed according to): EN :2006 Medical electrical equipment Part 1: General requirements for basic safety and essential performance CAN/CSA C22.2 NO M90 Medical Electrical Equipment Part 1: General Requirements for Safety (Canada) UL Medical Electrical Equipment Part 1: General Requirements for Safety (USA) IEC :1993 (First Edition) & A1:1999 Particular requirements for the safety of electrocardiographs IEC : 2002 (Second Edition) Particular requirements for the safety of electroencephalographs IEC : 1998 (First Edition) Particular requirements for the safety of electromyographs and evoked response equipment IEC : Corr.1:2006: Information technology equipment Safety General requirements (EN : A11:2009) 21CFR898 FDA PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT CABLES:2007 IEC :2007:Medical electrical equipment Part 1-2: General requirements for safety Collateral standard: Electromagnetic compatibility Requirements and tests ETSI EN v Electromagnetic compatibility and Radio Spectrum Matters (ERM); Wideband Transmission systems; Data transmission equipment operating in the 2,4 GHz ISM band and using spread spectrum modulation techniques EN V1.8.1 (2008) & Electromagnetic compatibility and radio spectrum matters (ERM); Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 1: Common technical requirements EN V2.1.1 (2009) Electromagnetic compatibility and radio spectrum matters (ERM) Electromagnetic compatibility (EMC) standard for radio equipment Part 17: Specific conditions for broadband data and Transmission systems EN Generic Standard to Demonstrate the Compliance of Low-Power Electronic and Electrical Apparatus with the Basic Restrictions Related to Human Exposure to Electromagnetic Fields (10 MHz 300 GHz) General Public The NOX-T3 device has been tested and found to comply with FCC Rules and Regulations 47 CFR Part , , , and Part 18, the limits for a Class B digital device Canada RSS-210 (RSS-GEN Issue 1 of Industry Canada (IC)) Bluetooth EPL (End Product Listing) Federal Communication Commission (FCC) Grant of Equipment Authorization ISO 14971:2009 Medical Devices Application of risk management to medical devices IEC62304 Medical Device Software Software Life Cycle Processes EN 62366:2008 Medical devices - Application of usability engineering to medical devices ISO :2007 and A1:2008 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied 6 P a g e

13 STATEMENT All design changes to the original NOX T3 System and NOX T3 accessories have been controlled within an ISO 13485:2003 Quality Management System that strives to comply with all applicable requirements of MDD, FDA QSR and CMDR. The safety and effectiveness of the latest released NOX T3 Systems and NOX T3 accessories has been demonstrated by thorough internal and external testing, verification, risk analysis, validation and clinical evaluation, according to its specification and intended use. Furthermore the latest released NOX T3 Systems are found to be in compliance with all applicable standards. Based on all the verification testing, validation and clinical evaluation performed the latest released NOX T3 Systems is deemed safe and effective for its intended use. This statement applies to the newest release of the NOX T3 Systems controlled within the internal project: ( ) - Katrinartun Release. 7 P a g e

14 STATEMENT NOX T3 SYSTEM PACKS INCLUDING CE MARKED THIRD PARTY COMPONENTS The NOX T3 System (NOX-T3_EUF and NOX-T3D-EUF) with WristOX 2 includes a CE marked Pulse Oximeter and Soft Sensor along with user instruction and other accessories from Nonin Medical Inc. as well as CE marked components from Nox Medical. The following is hereby stated for the system packs Nox-T3_EUF and NOX-T3D-EUF : The devices included in the system pack are put together within their intended purposes and within the limits of use specified by the manufacturers listed above. Nox Medical has verified the mutual compatibility of the devices in the system pack. Nox Medical has packed the system pack and supplied relevant information to users including relevant instruction from Nonin Medical accompanying the WristOX 2. The whole activity of generating the system pack is subjected to Nox Medical s internal control and inspection system/quality Management System; certified according to ISO 13485: P a g e

15 29 April 2013 Declaration of Conformity -Medical Device Directive 93/42/EEC- Nox Medical Katrinartuni 2 IS-105, Reykjavik, Iceland 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 93/42/EEC of 14 June 1993, as amended by 2007/47/EC, concerning medical devices. Product Type NOX Semi-disposable RIP Belts Version 0120 NOX Disposable RIP Belts Version 0110 Technical Names and Description Packages of 10 sets of belts: NOX Semi-disposable RIP Belt - Size Small - 10 sets (NOX-RIPS10) NOX Semi-disposable RIP Belt - Size Medium - 10 sets (NOX-RIPM10) NOX Semi-disposable RIP Belt - Size Large - 10 sets (NOX-RIPL10) Single belts: NOX Disposable RIP Belt - Size Pediatric (NOX-RIPDP) NOX Disposable RIP Belt - Size Small (NOX-RIPDS) NOX Disposable RIP Belt - Size Medium (NOX-RIPDM) NOX Disposable RIP Belt - Size Large (NOX-RIPDL) Packages of 20 sets of belts: NOX Disposable RIP Belt - Size Pediatric - 20 sets (NOX-RIPDP20) NOX Disposable RIP Belt - Size Small - 20 sets (NOX-RIPDS20) NOX Disposable RIP Belt - Size Medium - 20 sets (NOX-RIPDM20) NOX Disposable RIP Belt - Size Large - 20 sets (NOX-RIPDL20) 1 P a g e

16 Nox Medical is certified to Full Quality Assurance by BSI (Certificate No. CE ), i.e. to fully comply with the requirements of Council Directive 93/42/EEC, Annex II, section 3.2 in respect of Design and manufacture of sleep diagnostic devices. Furthermore Nox Medical holds an ISO 13485:2003/CMDCAS certified Quality Management System (Certificate No. FM540789) for the following scope: The design and manufacture of pediatric and adult sleep diagnostic devices. The products listed above are categorized as Class I, according to: Rule 12: All other active devices are in Class I. The conformity assessment has been undertaken via Annex VII of the Council Directive 93/42/EEC. 2 P a g e

17 SUMMARY TESTING, VERIFICATION AND VALIDATON The overall design and development process of the NOX RIP belts was according to internal quality management processes compliant with ISO 13485:2003 Medical Device Directive (MDD) FDA Quality System Regulation (QSR) Canada Medical Device Regulation (CMDR) The Nox RIP belts have been tested and verified in various phases to include internal testing, verification and validation as well as external testing to assure product safety, effectiveness and reliability. The design was verified and validated, including clinical evaluation, throughout the design process according to requirement specifications and intended use. Simulated use testing of the RIP belts has been conducted in a simulated clinical environment. The purpose with the validation was to make sure no unexpected difficulties arise and that the performance is as expected in the clinical environment. Cons and pros were reported and issues feed into formal process. Signal comparison studies results demonstrate the reliability and usability of the respiratory effort signals recorded with the NOX RIP belts in combination with the Nox T3 system. Clinical evaluation has been performed for the NOX RIP belts as part of the Nox T3 system. This evaluation included comparison for Apnea/Hypopnea scoring of Noxturnal as reflected by the Apnea/Hypopnea Index (AHI) compared to manual scoring of full Embla N70000 PSG data, published literature and post marketing feedback. The conclusion from the clinical evaluation for the T3 System is as follow: This clinical evaluation shows that all of the signals, analyses and parameters used in the current Nox T3 and Noxturnal products have roots in widely approved standards for sleep diagnostics supported by relevant scientific literature. Usability testing according to IEC 62366:2007: Medical devices Application of usability engineering to medical devices was performed to ensure reasonable usability of the NOX RIP belts, to minimize use errors and use-associated risks and to provide safety for the patient, user and others related to usability. The output of the usability process was fed back into the design process as needed to receive the usability goals for the product. Usability testing has been completed for the RIP belts with all usability goals passed. The NOX RIP belts are intended to be worn over clothing and are thus in no direct contact to the patient s skin. Only standard materials are used for products components. No part contains latex. No parts sterilized or need sterilization before use. The NOX RIP belts are designed and manufactured with predefined stipulation for cleanliness. The Nox RIP belts are categorized as surface products in indirect contact to skin with a limited duration of contact, i.e. less than 24 hours. Result of biocompatibility evaluation (type of product and materials used) requires no additional biocompatibility tests to be performed on the products. The NOX RIP belts are thus deemed safe regarding biocompatibility and biology. Risk analysis was performed for the NOX RIP belts according to ISO14971:2009 Medical devices Application of risk management to medical devices. As a result appropriate measures were implemented and their effectiveness verified and validated. Appropriate methods are in place to obtain relevant production and post-production information. 3 P a g e

18 The overall residual risk posed by the medical device has been evaluated, after all risk control measures have been implemented and verified. The remaining risk is found to be acceptable and out weighted by the benefits of using the NOX RIP belts and is in compliance with the company s criteria for risk acceptability. The NOX RIP belts are thus considered safe and effective for its intended use. LIST OF STANDARDS The NOX RIP belts comply with the following standards: EN :2006 Medical electrical equipment Part 1: General requirements for basic safety and essential performance IEC :2007:Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests 21CFR898:2007 FDA Performance standard for electrode lead wires and patient cables ISO 14971:2009 Medical Devices - Application of risk management to medical devices ISO :2007 and A1:2008- Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied EN 62366:2008 Medical devices - Application of usability engineering to medical devices STATEMENT All design changes to the original NOX RIP belts have been controlled within an ISO 13485:2003 Quality Management System that strives to comply with all applicable requirements of MDD, FDA QSR and CMDR. The safety and effectiveness of the latest released NOX RIP Belts has been demonstrated by thorough internal and external testing, verification, risk analysis, validation and clinical evaluation, according to its specification and intended use. Furthermore the latest released NOX RIP belts are found to be in compliance with all applicable standards. Based on all the verification testing, validation and clinical evaluation performed the latest released NOX RIP belts is deemed safe and effective for its intended use. This statement applies to the newest release of the NOX RIP belts controlled within the internal project: Watermark ( ). 4 P a g e

19 29 April 2013 Declaration of Conformity -Medical Device Directive 93/42/EEC- Nox Medical Katrinartuni 2 IS-105, Reykjavik, Iceland 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 93/42/EEC of 14 June 1993, and as amended by 2007/47/EC, concerning medical devices. Product Type NOX Semi-disposable RIP Belts Version 0120 NOX Disposable RIP Belts Version 0110 NOX RIP Abdomen Cable E Version 0100 NOX RIP Thorax Cable E Version 0100 Technical Names and Description Packages of 10 sets of belts: NOX Semi-disposable RIP Belt - Size Small - 10 sets (NOX-RIPS10) NOX Semi-disposable RIP Belt - Size Medium - 10 sets (NOX-RIPM10) NOX Semi-disposable RIP Belt - Size Large - 10 sets (NOX-RIPL10) Single belts: NOX Disposable RIP Belt - Size Pediatric (NOX-RIPDP) NOX Disposable RIP Belt - Size Small (NOX- RIPDS) NOX Disposable RIP Belt - Size Medium (NOX-RIPDM) NOX Disposable RIP Belt - Size Large (NOX- RIPDL) Packages of 20 sets of belts: NOX Disposable RIP Belt - Size Pediatric - 20 sets (NOX-RIPDP20) NOX Disposable RIP Belt - Size Small - 20 sets (NOX-RIPDS20) NOX Disposable RIP Belt - Size Medium - 20 sets (NOX-RIPDM20) NOX Disposable RIP Belt - Size Large - 20 sets (NOX-RIPDL20) NOX-EMBA1A NOX-EMBA1T 1 P a g e

20 Product Type NOX RIP Cable Kit E Version 0100 NOX RIP Starter Kit E S/M/L Version 0100 NOX RIP Starter Kit E M Version 0100 NOX RIP Belts and Cannula Kit S/M/L Version 0100 Technical Names and Description NOX-EMBA1 NOX RIP Cable Kit E (NOX-EMBA1): - NOX RIP Abdomen Cable E (NOX-EMBA1A) 1 unit - NOX RIP Thorax Cable E (NOX-EMBA1T) 1 unit - Instruction for Use Leaflet (NOX-EMBA1LEA) 1 unit NOX-EMBA1KIT1 NOX RIP Starter Kit E S/M/L (NOX-EMBA1KIT1): - NOX RIP Abdomen Cable E (NOX-EMBA1A) 1 unit - NOX RIP Thorax Cable E (NOX-EMBA1T) 1 unit - Instruction for Use Leaflet (NOX-EMBA1LEA) 1 unit - NOX Disposable RIP Belt Size Small (NOX- RIPDS20) 1 pack (20 sets) - NOX Disposable RIP Belt Size Medium (NOX- RIPDM20) 3 packs (60 sets) - NOX Disposable RIP Belt Size Large (NOX- RIPDL20) 1 pack (20 sets) - NOX Cannula with Luer-Lock Size Adult (NOX- CANA50) 2 packs (100 units) NOX-EMBA1KIT2 NOX RIP Starter Kit E M (NOX-EMBA1KIT2): - NOX RIP Abdomen Cable E (NOX-EMBA1A) 1 unit - NOX RIP Thorax Cable E (NOX-EMBA1T) 1 unit - Instruction for Use Leaflet (NOX-EMBA1LEA) 1 unit - NOX Disposable RIP Belt Size Medium (NOX- RIPDM20) 5 packs (100 sets) - NOX Cannula with Luer-Lock Size Adult (NOX- CANA50) 2 packs (100 units) NOX-ATC1KIT1 NOX RIP Belts and Cannula Kit S/M/L (NOX- ATC1KIT1): - NOX Abdomen Cable (NOX-ATC1) 1 unit - NOX Disposable RIP Belt Size Small (NOX- RIPDS20) 1 pack (20 sets) - NOX Disposable RIP Belt Size Medium (NOX- RIPDM20) 3 packs (60 sets) - NOX Disposable RIP Belt Size Large (NOX- RIPDL20) 1 pack (20 sets) - NOX Cannula with Filter Size Adult (CANAF40) 2 packs (80 units) 2 P a g e

21 Product Type NOX RIP Belts and Cannula Kit M Version 0100 Technical Names and Description NOX-ATC1KIT2 NOX RIP Belts and Cannula Kit M (NOX- ATC1KIT2): - NOX Abdomen Cable (NOX-ATC1) 1 unit - NOX Disposable RIP Belt Size Medium (NOX- RIPDM20) 4 packs (80 sets) - NOX Cannula with Filter Size Adult (CANAF40) 2 packs (80 units) 3 P a g e

22 Nox Medical is certified to Full Quality Assurance by BSI (Certificate No. CE ), i.e. to fully comply with the requirements of the Council Directive 93/42/EEC, Annex II, section 3.2 in respect of Design and manufacture of sleep diagnostic devices. Furthermore Nox Medical holds an ISO 13485:2003/CMDCAS certified Quality Management System (Certificate No. FM540789) for the following scope: The design and manufacture of pediatric and adult sleep diagnostic devices. The semi-disposable and disposable RIP belts, the RIP abdomen and thorax cables E, the cable Kit E, starter kits E S/M/L and M, and Nox RIP belts and cannula kits S/M/L and M listed above are categorized as Class I, according to: Rule 12: All other active devices are in Class I. The cannulas included in the starter kit E are categorized as Class I, according to: Rule 1: Non-invasive devices. The cannulas and the abdomen cable included in the RIP belts and cannula kit are categorized as Class I, according to: Rule 1: Non-invasive devices. The conformity assessment has been undertaken via Annex VII of the Council Directive 93/42/EEC. 4 P a g e

23 29 April 2013 Declaration of Conformity -Medical Device Directive 93/42/EEC- Nox Medical Katrinartuni 2 IS-105, Reykjavik, Iceland 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 93/42/EEC of 14 June 1993, as amended by 2007/47/EC, concerning medical devices. Product Type NOX QDC Adapter Kit Version 0200 NOX RIP Disposable Belts Version 0110 Technical Names and Description NOX- QDCA1 NOX QDC Adapter Kit (NOX- QDCA1): - QDC Adapter (NOX-QDCA1A) 2 units - Instructions for Use (NOX-QDCA1LEAF) Single belts: NOX Disposable RIP Belt - Size Pediatric (NOX- RIPDP) NOX Disposable RIP Belt - Size Small (NOX- RIPDS) NOX Disposable RIP Belt - Size Medium (NOX- RIPDM) NOX Disposable RIP Belt - Size Large (NOX- RIPDL) Packages of 20 sets of belts: NOX Disposable RIP Belt - Size Pediatric - 20 sets (NOX-RIPDP20) NOX Disposable RIP Belt - Size Small - 20 sets (NOX-RIPDS20) NOX Disposable RIP Belt - Size Medium - 20 sets (NOX-RIPDM20) NOX Disposable RIP Belt - Size Large - 20 sets (NOX-RIPDL20) 1 P a g e

24 Nox Medical is certified to Full Quality Assurance by BSI (Certificate No. CE ), i.e. to fully comply with the requirements of Council Directive 93/42/EEC, Annex II, section 3.2 in respect of Design and manufacture of sleep diagnostic devices. Furthermore Nox Medical holds an ISO 13485:2003/CMDCAS certified Quality Management System (Certificate No. FM540789) for the following scope: The design and manufacture of pediatric and adult sleep diagnostic devices. The products listed above are categorized as Class I, according to: Rule 12: All other active devices are in Class I. The conformity assessment has been undertaken via Annex VII of the Council Directive 93/42/EEC. 2 P a g e