Warning
K-Sensors is a medical sensor. K-Sensors must be used according to the present User's
Manual and its recommendations. Failure to do so may result in personal injury.
Users are responsible for their exercise manner and the manner in which they use
K-Sensors. Movement promoted by K-Sensors can be associated with risks of injury.
Consult on a regular basis KINVENT's website for available information on
contraindications, risks or side effects concerning K-Sensors. Kinvent doesn't offer
treatment advice or any medical diagnosis.
In case you are currently under medication, injured or in delicate medical condition,
consult a quali
fied professional prior to the use of any K-Sensors product. .
KINVENT doesn't guarantee any therapeutic result when using K-Sensors.
Declaration of Conformity
KINVENT Sensors are:
Class I measuring medical devices per Annex IX of Council Directive 93/42/EEC
K Plates, K Deltas are
Class I medical devices per CFR Title 21 Part 890 Subpart B, Sec. 890.1575
K Push, K Pull, K Grip, K Bubble are
Class II medical devices per CFR Title 21 Part 890 Subpart B, Sec. 890.1925
K Sens is
Class I medical devices per CFR Title 21 Part 888 Subpart B, Sec. 888.1500
KINVENT Sensors are:
Class II medical devices per Rule 10 of the Canadian Medical Devices Regulations
KINVENT Sensors also meet the following Technical Standards, to which Conformity is
declared:
IEC 60601-1
IEC 60601-1-2
KINVENT Sensors are designed and manufactured in a facility certi
fied to the following
international standards:
ISO 9001:2015
ISO 13485:2016
FCC information
K-Sensors is a product using certain radio-frequencies during functioning. All K-Sensors
equipment has been tested and found to comply with the limits for a Class B digital
sensor, pursuant to part 15 of the FCC 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 energy, and if not installed
and 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 installation. 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.
31 © 2022 KINVENT Biomecanique E2022C_EN
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