Medical devices directive - Nexus 2.14 Documentation (2023)

1912

Declaration of Conformity

Medical Devices Directive 93/42/EEC as amended by
EU Council Directive 2007/47/EC of 5^th September 2007
Electromagnetic Compatibility to EMC Directive 2014/30/EU
Electrical Safety to Low Voltage Directive 2014/35/EU.

We, Vicon Motion Systems Limited
Unit 6, Oxford Industrial Park
Mead Road, Yarnton, Oxford, OX5 1QU
UNITED KINGDOM

declare that theoptical motion cameras as part of a Vero System manufactured by VICONMOTION SYSTEMS LIMITED contribute to meet ANNEX V and VII Section 5 of the Medical Devices Directive 93/42/EEC in that the Quality Management System has been approved by Dare!! Services B.V., a notified body of the European Union (Reg No. 1912) for the manufacture and support of the aforementioned CLASS 1(m) Medical device. Product configurations and software options (Vicon Vero cameras), detail the product configurations and software options that conform to the metrological requirements of the Directive.

This declaration of conformity is issued under the sole responsibility of the manufacturer.

VICON MOTION SYSTEMS LIMITED has tested and demonstrated that all products of its own manufacture meet 2014/30/EU:

Electromagnetic Compatibility to:
EN60601-1-2:2007

General Requirements for Safety to:
EN 60601-1:2006 + A12:2014

Software Development, Conformity and Support
EN ISO 13485:2016
EN ISO 14971:2019
BS EN 62304:2006 + A1:2015, IEC 62304:2006/A1:2015

Thomas Shannon, TD PhD FIE (Aust), CPEng (Biomed.)
Director of Compliance

4^th May 2021
Date Expiration 17^th August 2023 (Article 120, EU 2017/745), subject to meeting the continued surveillance obligations, Section 4, Annex V. Certificate Number 20M00097CRT05 8^th September, 2020.

Not for use in an operating theater, anesthetic gas environment, or oxygen-rich environments. Not for use where there is a risk of compromising the essential performance of medical electrical equipment. Not suitable for use in high magnetic flux, ionizing radiation, dust ingress, high vibration, sterile, or life- or safety-critical environments.

Note: The overall installed system classification is defined by the highest risk device connected, which may include the connection of approved third-party equipment such as electromyography apparatus by clients.

This topic provides information relating to the EU Declaration of Conformity (Vicon Vero) .

Conformity of the Metrological Performance of CLASS 1 Products Manufactured in Accordance with
Annex VII, Section5 of the Medical Devices Directive 93/42/EEC of the 14th June 1993.
As amended by EU Council Directive 2007/47/EC of 5th September 2007.

We, Vicon Motion Systems Limited
Unit 6, Oxford Industrial Park
Mead Road, Yarnton, Oxford, OX5 1QU
UNITED KINGDOM

declare that theoptical motion cameras within a VICON Vero System manufactured by VICON MOTION SYSTEMS LIMITED have been tested prior to shipment and meet the following metrological performance:

Measurement criteria

• Supporting software Nexus 2.10 or later, Tracker 3.8 or later, Shogun 1.4 or later.
• Using a minimum of four cameras, resolution of the distance between the centers of two static 14mm spherical markers located within a volume no less than 4mx4mx1.5m to within 1mm Mean; 1mm Standard Deviation; sample size no less than 1,000.

1912

Declaration of Conformity

Medical Devices Directive 93/42/EEC as amended by
EU Council Directive 2007/47/EC of 5th September 2007
Electromagnetic Compatibility to EMC Directive 2014/30/EU
Electrical Safety to Low Voltage Directive 2014/35/EU

We, Vicon Motion Systems Limited
Unit 6, Oxford Industrial Park
Mead Road, Yarnton, Oxford, OX5 1QU
UNITED KINGDOM

declare that the cameras as part of a Vantage system manufactured by VICON MOTION SYSTEMS LIMITED contribute to meet ANNEX V and VII, Section 5 of the Medical Devices Directive 93/42/EEC in that the Quality Management System has been approved by Dare!! Services B.V, a notified body of the European Union (Reg No. 1912) for the manufacture and support of the aforementioned CLASS 1(m) Medical device. Product configurations and software options (Vicon Vantage cameras) detail the product configurations and software options that conform to the metrological requirements of the Directive.

This declaration of conformity is issued under the sole responsibility of the manufacturer.

VICON MOTION SYSTEMS LIMITED has tested and demonstrated that all products of its own manufacture meet 2014/30/EU:

Electromagnetic Compatibility to:
EN60601-1-2:2007

General Requirements for Safety to:
EN60601-1:2006 + A12:2014

Software Development, Conformity and Support
EN ISO 13485:2016
EN ISO 14971:2019
BS EN 62304:2006 + A1:2015, IEC 62304:2006/A1:2015

Thomas Shannon, TD PhD FIE (Aust), CPEng (Biomed.)
Director of Compliance

4^th May 2021
Date of Expiration 17^th August 2023 (Article 120, EU 2017/745), subject to meeting the continued surveillance obligations, Section 4, Annex V. Certificate Number 20M00097CRT05 8^th September, 2020.

Not for use in an operating theater, anesthetic gas environment, or oxygen-rich environments. Not for use where there is a risk of compromising the essential performance of medical electrical equipment. Not suitable for use in high magnetic flux, ionizing radiation, sterile, or life- or safety-critical environments.

Note: The overall system classification is defined by the highest risk device installed, which may include the connection of approved third-party equipment such as electromyography apparatus by clients.

This topic provides information relating to the EU Declaration of Conformity (Vicon Vantage).

Conformity of the Metrological Performance of CLASS 1 Products Manufactured in Accordance with
Annex VII, Section5 of the Medical Devices Directive 93/42/EEC of 14th June 1993.
As amended by EU Council Directive 2007/47/EC of 5th September 2007.

We, Vicon Motion Systems Limited
Unit 6, Oxford Industrial Park
Mead Road, Yarnton, Oxford, OX5 1QU
UNITED KINGDOM

declare that the VICON Vantage System manufactured by VICON MOTION SYSTEMS LIMITED has been tested prior to shipment and meets the following metrological performance:

Measurement criteria

• Supporting software Nexus 2.10 or later, Tracker 3.8 or later, Shogun 1.4 or later.
• Using a minimum of four cameras, resolution of the distance between the centers of two static 14mm spherical markers located within a volume no less than 4mx4mx1.5m to within 1mm Mean; 1mm Standard Deviation; sample size no less than 1,000.

1912

Declaration of Conformity

Medical Devices Directive 93/42/EEC as amended by EU Council Directive
2007/47/EC of 5^th September 2007
Electromagnetic Compatibility to EMC Directive 2014/30/EU.
Electrical Safety to Low Voltage Directive 2014/35/EU.

We, Vicon Motion Systems Limited
Unit 6, Oxford Industrial Park
Mead Road, Yarnton, Oxford, OX5 1QU
UNITED KINGDOM

declare that the T-Series Cameras (including Bonita and Bonita 2), Active Wand and Giganet as a support part of a supplied T-Series Gait Analysis System manufactured by VICON MOTION SYSTEMS LIMITED in that the Quality Management System has been approved by BSI Assurance UK Ltd for the manufacture and support of the aforementioned products.

This declaration of conformity is issued under the sole responsibility of the manufacturer.

VICON MOTION SYSTEMS LIMITED has tested and demonstrated that all products of its own manufacture meet 2014/30/EU:

Electromagnetic Compatibility to:
EN60601-1-2:2007

General Requirements for Safety to:
T-Series Cameras (including Bonita and Bonita 2), Active Wand and Giganet
EN60601-1:2006 + A12:2014

Software Development, Conformity and Support
EN ISO 13485:2016
EN ISO 14971:2019
BS EN 62304:2006 + A1:2015, IEC 62304:2006/A1:2015

T.M.L. Shannon, TD, FIE (Aust), CPEng (Biomedical)
Director of Regulatory Compliance

17^th March 2021
Date of Expiration Validity of the MD727611 Certificate

Not for use in an operating theatre, anaesthetic gas environment, or oxygen-rich environments. Not for use where there is a risk of compromising the essential performance of medical electrical equipment. Not suitable for use in high magnetic flux, ionizing radiation, sterile, or life- or safety-critical environments.

This topic provides information relating to the EU Declaration of Conformity (Vicon MX T-Series).

Conformity of the Metrological Performance of CLASS 1 Products in accordance with
Annex VII, Section 5 of the Medical Devices Directive 93/42/EEC of 14th June 1993.
Aas amended by EU Council Directive 2007/47/EC of 5th September 2007.

We, Vicon Motion Systems Limited
Unit 6, Oxford Industrial Park
Mead Road, Yarnton, Oxford, OX5 1QU
UNITED KINGDOM

declare that the T-Series Cameras (including Bonita and Bonita 2), Active Wand and Giganet as a support part of a supplied T-Series Gait Analysis System manufactured by VICON MOTION SYSTEMS LIMITED has been tested prior to shipment and meets the following metrological performance:

Measurement Criteria

• Supporting software Nexus 2.10 or later, Shogun 1.4 or later, Tracker 3.8 or later.
• Using a minimum of four cameras, resolution of the distance between the centers of two static 14 mm spherical markers located within a volume no less than 4 m x 4 m x 1.5 m to within 1 mm Mean; 1 mm Standard Deviation; sample size no less than 1,000.

Analogue Digital Conversion

Resolution to ± 10 mV mean and ± 10 mV (1 Standard Deviation).

Synchronization

Difference within one video frame.

1912

Declaration of Conformity

Medical Devices Directive 93/42/EEC as amended by
EU Council Directive 2007/47/EC of 5^thSeptember 2007

We, Vicon Motion Systems Limited
Unit 6, Oxford Industrial Park
Mead Road, Yarnton, Oxford, OX5 1QU

declare that VICON NEXUS Software utilized within the Vantage or Vero Gait Analysis Systems and manufactured by VICON MOTION SYSTEMS LIMITED meets ANNEX V of the Medical Devices Directive 93/42/EEC in that the Quality Management System has been approved by Dare!! Services B.V., a notified body of the European Union (Reg No. 1912) for the manufacture and support of the aforementioned CLASS 1(m) medical device.

declare that the medical devices listed below and bearing the CE marking, conform with the essential requirements of the Directive 93/42/EEC as amended by Directive 2007/47/EEC. Applicable harmonized standards have been used to demonstrate the safety and efficacy of the device when used in accordance to the Software Instructions for Use. The following standards were applied:

EN ISO 9001:2015
EN ISO 13485:2016
EN ISO 14971:2012
BS EN 62304:2006 + A1:2015, IEC 62304:2006/A1:2015

NEXUS Data capture software for clinical gait, biomechanics, and sports sciences. Incorporates implementation of independently validated biomechanical Models. CLASS I(m).

Polygon Tool for reporting and presentation, enabling communication and sharing of data. Legacy Supported CLASS I.

Each version of software is released in accordance with records certifying compliance with the specifications.

This declaration of conformity is issued under the sole responsibility of the manufacturer.

Thomas Shannon TD PhD FIE (Aust) CPEng (Biomed.)
Director of Compliance

The Declaration is valid from 4^th May 2021
Date of Expiration 17^th August 2023 (Article 120, EU 2017/745), subject to meeting the continued surveillance obligations, Section 4, Annex V. Certificate Number 20M00097CRT05 8^th September, 2020.

View/download a PDF of this certificate and its annex