Safety and regulatory info

FCC ID: DMR-IMUAP1

Users Manual

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FCCID_3704927

                            Safety and Regulatory Information


IMeasureU Sensor V1 Safety and Regulatory Information

The terms “device” or “wireless device” used in this section refers to your IMeasureU
Sensor V1 wearable product. Read this information before using your device.

Federal Communications Commission (FCC) Part 15 Information to User
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:

      Reorient or relocate the receiving antenna.
      Increase the separation between the equipment and receiver.
      Consult the dealer or an experienced radio/TV technician for help.

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
Motions 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-IMUAP1.




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                              Safety and Regulatory Information

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 licence-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.

Conformément à la réglementation d'Industrie Canada, le présent émetteur radio peut
fonctionner avec une antenne d'un type et d'un gain maximal (ou inférieur) approuvé pour
l'émetteur par Industrie Canada.
Dans le but de réduire les risques de brouillage radioélectrique à l'intention des autres
utilisateurs, il faut choisir le type d'antenne et son gain de sorte que la puissance isotrope
rayonnée équivalente (p.i.r.e.) ne dépasse pas l'intensité nécessaire à l'établissement
d'une communication satisfaisante.


Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils
radio exempts de licence. L'exploitation est autorisée aux deux conditions suivantes : (1)
l'appareil ne doit pas produire de brouillage, et (2) l'utilisateur de l'appareil doit accepter
tout brouillage radioélectrique subi, même si le brouillage est susceptible d'en
compromettre le fonctionnement.

The published COMPANY NUMBER and UPN NUMBER is 11323A-IMUAP1.



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:
      Radiocommunications (Compliance Labelling - Devices) Notice 2014 made
       under section 182 of the Radiocommunications Act 1992;
      Radiocommunications Labelling (Electromagnetic Compatibility) Notice 2008
       made under section 182 of the Radiocommunications Act 1992;
      Radiocommunications (Compliance Labelling – Electromagnetic Radiation)
       Notice 2014 made under section 182 of the Radiocommunications Act 1992.


Supplier’s declaration of conformity available upon request.




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                             Safety and Regulatory Information

Other Important Safety Information

      Only qualified personnel should service the device. Faulty service may be
       dangerous and may invalidate any warranty applicable to the device.
      Do not store or carry flammable liquids, gases, or explosive materials in the same
       compartments as the device, its parts, or accessories.
      For vehicles equipped with an air bag, remember that an airbag inflates with great
       force. Do not place objects, including portable wireless equipment near or in the
       area over the air bag or in the airbag deployment area. If the wireless device is
       within the deployment area as an air bag inflates, serious injury could result.
      Switch off the device off before boarding an aircraft. The use of wireless devices in
       aircraft is illegal and may be dangerous to the aircraft’s operation. Check with
       appropriate authorities before using any function of the device while on an aircraft.
      The primary responsibility of every driver is the safe operation of his or her vehicle.
       Do not engage in any activity while driving a moving vehicle which may take your
       eyes off the road or become absorbed in any activity that your ability to concentrate
       on the act of driving becomes impaired.
      Failure to observe these instructions may lead to the suspension or denial of
       network services, or legal action, or both.

Battery Use and Safety

      The battery in this device is not intended to be replaced by the consumer. If you
       believe the battery is damaged or needs to be replaced, return the device for
       inspection and replacement.
      Do not let the device or battery come in contact with liquids. Liquids can get into
       the device’s circuits, leading to corrosion. Even when the device appears dry and
       appears to operate normally, the circuit could slowly corrode and pose a safety
       hazard.
      Do not place the device in or near a heat source. Excessive heating can damage
       the device and battery and could cause the device or the battery to explode. Do
       not dry a wet or damp device with an appliance or heat source such as a microwave
       oven, hair dryer, iron, or radiator. Avoid leaving your device in your vehicle in high
       temperatures.
      Do not dispose of the device or battery in a fire. The device or battery may explode
       when overheated.
      Avoid dropping the device. Dropping the device, especially on a hard surface, can
       potentially cause damage. If you suspect damage to the device or battery, return
       it for inspection.
      Never use any battery that is damaged in any way.
      Warning. Use of a non-manufacturer approved batteries may present a risk of fire,
       leakage, or other hazard. Manufacturer warranty does not cover damage to the
       device caused by non approved batteries.
      Do not use incompatible batteries and chargers. If using a powered USB Hub always
       ensure that you use the manufacturer’s approved or recommended power source.
       Some websites and second-hand dealers not associated with reputable
       manufacturers and carriers, might be selling incompatible or even counterfeit
       batteries and chargers. Please refer to Vicon Motion Systems Ltd for advice. Misuse
       or use of incompatible batteries and chargers could result in damage to the device
       and a possible risk of fire, explosion, or leakage, leading to serious injuries, damage
       to your device, or other serious hazard.

Operating Environment

      Avoid temperature below 0oC/ 32oF or above 37oC/99oF.

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                          Safety and Regulatory Information

   Do not expose your device to dust, dirt, or sand.
   Remember to follow any special regulations in force in any area, and always switch
    your device off whenever it is forbidden to use it, or when it may cause interference
    or danger. When connecting the device or any accessory to another device, read
    its user’s guide for detailed safety instructions. Do not connect incompatible
    products.


   Implantable Medical Devices. A minimum separation of 6 inches (15.3 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:
        o Should ALWAYS keep the device more than 6 inches (15.3 mm) from their
           implantable medical device when the device is turned ON;
        o Should not carry the device in a breast pocket;
        o Should immediately turn the device OFF if there is any reason to suspect
           that interference is taking place;

    Should read and follow the directions from the manufacturer of your implantable
    medical device. If you have any questions about using your wireless device with an
    implantable medical device, consult your health care provider.

   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. Switch your wireless device off when in
    any area with a potential explosive atmosphere and obey all signs and instructions.
    Sparks in such areas could cause an explosion or fire resulting in bodily injury or
    even death. Users are advised to switch the wireless device off while at a refueling
    point (service station).

    Users are reminded of the need to observe restrictions on the use of radio
    equipment in fuel depots (fuel storage and distribution areas), chemical plants or
    where blasting operations are in progress. Areas with a potentially explosive
    atmosphere are often but not always, clearly marked. They include below deck on
    boats, chemical transfer or storage facilities, vehicles using liquefied petroleum gas
    (such as propane or butane), areas where the air contains chemicals or particles,
    such as grain, dust, metal powders or anesthetic gases, and other areas where you

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                             Safety and Regulatory Information

       would normally be advised to turn off your vehicle engine. Vehicles using liquefied
       petroleum gas (such as propane or butane) must comply with the National Fire
       Protection Standard (NFPA-58). For a copy of this standard, contact the National
       Fire Protection Association.

      High Magnetic Flux Environments. The device contains ferrous components so
       may constitute a physical projectile hazard if brought into high magnetic flux
       environments such as found within Magnetic Resonance Imaging (MRI) facilities.




      Securing Straps. Securing straps are Latex Free, manufactured using Neoprene
       or polychloroprene. Allergic reaction to neoprene is generally ascribed to the
       accelerants used to manufacture the man-made rubber, specifically thiourea
       compounds and mercaptobenzothiazole (MBT). Symptoms of neoprene-related
       allergic contact dermatitis (ACD) include itching, skin eruptions, swelling, and
       hemorrhages into the skin. If you experience an ACD, please immediately desist
       from using the straps.

Restricting Children’s Access to Your Device

      Your device is not a toy. Do not allow children to play with it because they could
       hurt themselves and others or damage the device.
      Keep the device and all its parts and accessories out of reach of small children.

Restriction of the Use of certain Hazardous Substances in Electrical and Electronic
Equipment –RoHS and Recast (RoHS 2)
This device is fully RoHS (2002/95/EC provides that new electrical and electronic
equipment put on the market for the first time from 1 July 2006) 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 3 rd 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 the continual supply reliable and safe products, we
ensure that our suppliers fulfill all requirements regarding chemical substances and
prepared materials.




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                            Safety and Regulatory Information

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.




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                             Safety and Regulatory Information

Specific Absorption Rate (SAR) Certification

For United States of American Customers (FCC)

For Standalone SAR exclusion consideration, when SAR Exclusion Threshold requirement
in KDB 447498 is satisfied, standalone SAR evaluation for general population exposure
conditions by measurement or numerical simulation is not required. At 2480 MHz,
equivalent isotropically radiated power of the device is 0.360mW, which will be less than
the SAR Exclusion Threshold (9.53mW). For further information, please see clause 4.3 of
KDB 447498 D01 General RF Exposure Guidance.”

This device has been granted authorisation to be used in the United States for all
equipment exhibiting DMR-IMUAP1.

For Canadian Customers (ISED)

SAR evaluation is required if the separation distance between the user and/or bystander
and the antenna and/or radiating element of the device is less than or equal to 20 cm,
except when the device operates at or below the applicable output power level (adjusted
for tune-up tolerance) for the specified separation distance. At 2480 MHz, equivalent
isotropically radiated power of the device is 0.360mW, which will be less than the SAR
Exclusion Threshold at distance of ≤ 5 mm (3.94mW). For further information, please see
clause 2.5.1 of RSS-102 Issue 5 March 2015.

This device has been granted authorisation to be used in Canada for all equipment
exhibiting 11323A-IMUAP1.

For European Union 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:

Frequency (MHz)       EIRP (dBm)             Limit (W/m2)          Minimum safe
                                                                   distance (m)
2480                  -8.2                   10                    0.001096




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                             Safety and Regulatory Information

CE Declaration of Conformity




                            Declaration of Conformity
                  (Radio Equipment Directive 2014/53/EU)
We, Vicon Motion Systems Ltd
Unit 6, Oxford Industrial Park
Yarnton, Oxfordshire, OX5 1QU
UNITED KINGDOM

declare under our sole responsibility that the product

IMEASUREU SENSOR V1
to which the declaration relates, is in conformity with the following standards and/or other
normative documents.

 SAFETY(1)    EN 60601-1:2006/A12: 2014
              Latex Free
              RF Exposure Evaluation RED 2014/53/EU Article 3(1)(a).

 EMC          EN 60601-1-2:2015 with reference to
              ETSI EN 301489-17v3.2.2 (Draft) (ETSI 301 489-1 v2.2.0 (Draft)).

 RADIO        EN300 328 V2.1.1
              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 product is 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, Yarnton, Oxfordshire, OX5 1QU, UNITED KINGDOM that will be
made available on request.




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

Director

6th November 2017




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                         Safety and Regulatory Information


(1) Risk analysis performed under ISO14971:2012 in compliance with Medical
    Devices Directive 93/42/EEC applied as amended by EU Council Directive
    2007/47/EC of 5th September 2007 as the product is wearable.

(2) For research purposes only, not a medical device. Not for use in an operating
    theatre, anaesthetic 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.




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Document Created: 2018-01-05 16:17:44
Document Modified: 2018-01-05 16:17:44

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