Vicon Blue Trident Model V2 Safety and Regulatory Information

This information is also available as a PDF.

The terms "device" or "wireless device" used in this section refer to your Vicon Blue Trident Model V2 wearable product. Read this information before using your device.

Radio and television interference regulatory information

These sections contain information concerning compliance of Vicon Blue Trident Model V2 devices with regulations about radio and television interference.

For United States of America customers

Federal Communications Commission (FCC) Part 15 information

Pursuant to part 15.21 of the FCC Rules, you are cautioned that changes or modifications not expressly approved by Vicon Motion Systems Ltd could void your authority to operate the device. This device complies with part 15 of the FCC Rules. Operation is subject to the two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.

Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15(c) of the FCC CFR47 rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency (RF) energy and, if not used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular application. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

FCC Notice and Cautions

The device may cause TV or radio interference if used in close proximity to receiving equipment. The FCC can require you to stop using the equipment if such interference cannot be eliminated.

Cautions: Any changes or modifications to your device not expressly approved by Vicon Motion Systems Ltd could void your warranty for this equipment and void your authority to operate this equipment. Only use approved batteries. The use of any unauthorized accessories may be dangerous and void the device warranty if said accessories cause damage or a defect to the device. Although your device is quite sturdy, it is a complex piece of equipment and can be broken. Avoid dropping, hitting, bending or sitting on it.

This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. End users must follow the specific operating instructions for satisfying RF exposure compliance. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter.

The published FCC ID is DMR-IMUAP2.

For Canadian customers

Under Industry Canada regulations, this radio transmitter may only operate using an antenna of a type and maximum (or lesser) gain approved for the transmitter by Industry Canada.

To reduce potential radio interference to other users, the antenna type and its gain should be so chosen that the equivalent isotropically radiated power (e.i.r.p.) is not more than that necessary for successful communication.

This device complies with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device.

The published COMPANY NUMBER and UPN NUMBER is 11323A-IMUAP2.

For the Canadian-French translation of the relevant safety & regulatory information, see Vicon Blue Trident Model V2 Safety & Regulatory Info_CaFr.pdf.

For Australian and New Zealand customers

The product complies with the requirements of the relevant Australian Communications and Media Authority Standards made under the following Notices:

Supplier’s declaration of conformity available upon request.

For Japanese customers

Conformity Assessment Body (CAB ID 205) with respect to the Japan/EU MRA, declares that the Vicon® Blue Trident Sensor Model V2 complies with the Certification by Type of the Ordinance Concerning Technical Regulations Conformity Certification, etc. of Specified Radio Equipment (MPT Ordinance No. 37 of 1981).

Category of the Specified Radio Equipment Article 2, Paragraph 1, Item (19).
Class of Emission F1D
Frequency 2402 MHz-2480 MHz
Antenna Power 4.9 mW/MHz
Antenna Gain 0.8 dBi

For the Japanese translation of the relevant safety & regulatory information, see Vicon Blue Trident Model V2 Safety & Regulatory Info_J.pdf.

For The People's Republic of China Customers

The wireless device is classified as F Type General Micro power (short range) radio transmission equipment in that:

The State Radio Regulation Committee (SRRC) is administered by the Ministry of Industry and Information Technology of the PRC (MIIT)'s Radio Administration Bureau. As of 1st December 2016, the SRRC no longer requires Type Approval for specific Low Power Short Range devices including F Type not employing Bluetooth® radio protocols.

For United Kingdom and European Union customers

Declaration of Conformity

(Radio Equipment Directive 2014/53/EU)

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

declare under our sole responsibility that the products to which the declaration relates, are in conformity with the following standards and/or other normative documents.

VICON Blue Trident Model V2

SAFETY(1) EN 60601-1:2006/A12: 2014
Latex Free
RF Exposure Evaluation RED 2014/53/EU Article 3(1)(a).
Low Power Exemption limit calculated to EN 62479:2010.
IEC 62133:2012 LiPo Battery
EMCEN 60601-1-2:2015 & ETSI EN 301 489-17 v3.1.1 (ETSI EN 301 489-1 v2.1.1)
RADIOETSI EN300 328 V2.1.1 (2016-11)
Covering wide band transmission systems; data transmission equipment operating in the 2.4 GHz ISM band.

VICON Beacon Model MSU1

SAFETY(1) IEC 60950-1:2005/A2:2013
EMCEN61326:2013; ETSI EN301 489-17 V2.2.1:2012 using the common technical requirements of ETSI EN301 489-1 V2.1.1
RADIOETSI EN300 328 V2.1.1 (2016-11)
Covering wide band transmission systems; data transmission equipment operating in the 2.4 GHz ISM band.

We hereby declare that all essential radio test suites have been carried out and that the above named products are in conformity to all the essential requirements of Directive 1999/5/EC. The technical documentation is kept at Vicon Motion Systems Ltd, Unit 6, Oxford Industrial Park, Mead Road, Yarnton, Oxford, OX5 1QU, UNITED KINGDOM and will be made available on request.

Please refer to the Vicon Blue Trident Model V2 Safety and Regulatory Information for further guidance.

T.M.L. Shannon, TD, PhD, FIE (Aust.), CPEng (Biomed.)
Director

15th January 2020

1. Not a medical device. Not for use in an operating theater, anesthetic gas 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. For placement onto body extremities only.

Environmental regulations - United Kingdom and European Union customers

Restriction of the Use of certain Hazardous Substances in Electrical and Electronic Equipment – RoHS and Recast (RoHS 2)

This device is fully RoHS- and RoHS 2-compliant. The European Union Directive 2011/65/EU provides that new electrical and electronic equipment put on the market for the first time from 3rd January 2014 shall not contain more than permitted levels of lead, cadmium, mercury, hexavalent chromium, polybrominated biphenyls (PBB), or polybrominated diphenyl ethers (PBDE; PentaBDE, OctaBDE; DecaBDE), Mercury (Hg).

REACH Declaration of Conformity

Vicon Motion Systems Ltd is a manufacturer of electronic hardware. We are therefore considered a "downstream user" as far as the REACH document is concerned. Vicon Motion Systems Ltd is therefore not obligated to register with the European Agency for Chemicals 'ECHA'.

Products sold by Vicon Motion Systems Ltd are "articles" as defined in REACH (Article 3 Definitions). Moreover and under normal and reasonably foreseeable circumstances of application, the articles supplied shall not release any substance. For that, Vicon Motion Systems Ltd is neither obligatory for registration nor for the creation of material safety data sheets.

In order to assure our customers of the continual supply reliable and safe products, we ensure that our suppliers fulfill all requirements regarding chemical substances and prepared materials.

Waste Electrical and Electronic Equipment (WEEE)

(Applicable in the European Union and other European countries with separate collection systems)

The use of the symbol as a marking on the equipment, accessories or literature indicates that this product and its electronic accessories (e.g. USB cable) may not be treated as household waste. By ensuring this product is disposed of correctly, you will help prevent potential negative consequences for the environment and human health, which could otherwise be caused by inappropriate waste handling of this product.

Household users should contact either their retailer where they purchased this device, or their local government office, for details of where and how they can take these items for environmentally safe recycling. Business users should contact their supplier and check the terms and conditions of the purchasing contract. This device and its electronic accessories should not be mixed with other commercial waste for disposal.

Correct disposal of batteries in this device

(Applicable in the European Union and other European countries with separate battery systems)

The use of the symbol as a marking on the battery, manual or packaging indicates that the battery in this device should not be disposed of with other household waste at the end of their working life. Where marked, the chemical symbols Hg, Cd or Pb indicate that the battery contains mercury, cadmium or lead above the reference levels in EC Directive 2006/66. If batteries are not properly disposed of, these substances can cause harm to human health or the environment.

To protect natural resources, and to promote material reuse, please separate batteries form other types of waste and recycle them through your local, free battery return system.

The rechargeable battery incorporated in this device is not user replaceable. For information on its replacement please contact Vicon Motion Systems Ltd.

Specific Absorption Rate (SAR) certification

RF exposure was evaluated to ensure compliance with EU, FCC rules and RSS standards for a wearable device only applied to the extremities, where the distance from the center of the antenna to the skin surface was measured to be 4 mm minimum.

For European Union and Australian/New Zealand customers (RED)

Minimum Safe distance for RF exposure, based on the Reference Levels for General Public exposure of EU Council Recommendation (1999/519/EC) of 12 July 1999 on the limitation of exposure of the general public to electromagnetic fields (0 Hz to 300 GHz) was calculated against the requirements with Standard EN62479:2010.

For United States of America customers (FCC)

SAR Threshold requirement in KDB 447498 was evaluated (47 CFR §§1.1307 and 2.1091).

This device has been granted authorization to be used in the United States for all equipment exhibiting DMR-IMUAP2.

For Canadian customers (ISED)

Devices that have a radiating element normally operating at or below 6 GHz, with a separation distance of up to 20 cm between the user and/or bystander and the device, shall undergo a SAR evaluation. For further information, please see clause 2.5.1 of RSS-102 Issue 5 March 2015.

This device has been granted authorization to be used in Canada for all equipment exhibiting 11323A-IMUAP2.

RF exposure analysis for a wearable device applied to the extremities

RegionReference for LimitLimitMeasured/Derived valuesUnits
EUEN 62479:201019.416.8mW
USKDB 447498 D017.522.9N/A
CanadaRSS-102 issue 5 (2015)1036.8mW
  1. EN 62479:2010 PMax' Equations (B.1) – (B.5) at 4 mm from center of antenna to skin surface.
  2. 10-g SAR test exclusion thresholds for extremity wearing; 100 MHz to 6 GHz at test separation distances ≤ 50 mm are determined by: [(max. power of channel, including tune-up tolerance, mW)/(min. test separation distance, mm)] ·[√f(GHz)] ≤ 7.5. Test separation distance is taken as 4 mm and maximum power is 7.5 mW at 2.480 GHz.
  3. Section 2.5.1, table 1, based on a separation distance of ≤5 mm and frequency of 2450 MHz, limb-worn device evaluation maximum permissible exposure limits are multiplied by 2.5.

Other important safety information

Battery use and safety

Operating environment

Implantable medical devices

A minimum separation of 6 inches (153 mm) should be maintained between the device and an implantable medical device, such as a pacemaker or implantable defibrillator, to avoid potential interference by the device. Persons who have such implantable medical devices:

Other Medical Devices

If you use any other personal medical devices, consult the manufacturer of your device to determine if it is adequately shielded from external RF energy. Your physician may be able to assist you in obtaining this information. Immediately turn the device OFF if there is any reason to suspect that interference is taking place.

Switch your wireless device off in health care facilities when any regulation posted in these areas instructs you to do so. Hospitals or health care facilities may be using equipment that could be sensitive to external RF energy.

Vehicles

RF signals may affect improperly installed or inadequately shielded electronic systems in motor vehicles. Check with the manufacturer or its representative regarding using your wireless device in a motor vehicle. You should also consult the manufacturer of any equipment that has been added to your vehicle. Immediately turn the device OFF if there is any reason to suspect that interference is taking place.

Posted facilities

Switch your device off in any facility where posted notices require you to do so.

Potentially explosive environments

High magnetic flux environments

Securing straps

Restricting children's access to your device

Bluetooth

Declaration ID DO43233

Company ID Decimal: 1467; Hexadecimal: 0x05BB