Safety And Warnings; Regulatory Info - Infinite sense Installation And Setup Manual

safety and
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warnings
Liquid damage warning: Sense is not waterproof. Please advise the user
to avoid submerging or spilling liquid on or into their prosthesis. This may
cause Sense to be permanently damaged. If the user will be wearing their
prosthesis in wet environments, ensure that Sense is sufficiently protected
from the external environment.
Battery use warning: Sense must be powered by a FlexCell battery system
from IBT. We have conducted safety testing to confirm compatibility
between Sense and FlexCell batteries.
Modification WARNING: Any unauthorized modification to Sense can pose
a safety risk to the user and will void the warranty. Changes or modifications
not expressly approved by Infinite Biomedical Technologies, LLC could void
the user's authority to operate the equipment.
WARNING: DO NOT USE harsh chemicals (such as bleach, kitchen cleaners,
etc.) to clean electrodes. This could permanently damage the electrode. If
you are not sure if a specific chemical is considered harsh, please call us
prior to cleaning the electrode.
WARNING: Do not use Sense during safety critical tasks.
WARNING: Do not drop Sense or the IBT Electrodes. This could cause
damage to the Sense electronics.
WARNING: IBT Electrodes are only to be used with the Sense signal
processing box or other compatible IBT systems.
Sense needs special precautions regarding EMC and needs to be installed
and put into service according to the EMC information provided in this
document.
Please note that portable and mobile RF communications equipment can
affect Sense.
WARNING: Use of accessories and prosthetic parts other than those
specified in the product order may result in malfunction of the Sense
system and can cause increased emissions and decreased immunity of
the Sense system.
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regulatory info

11
This device complies with Part 15 of the FCC Rules. Operation is subject
to the following 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.
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.
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.
This product has been tested and verified to ensure that there are no issues
or concerns regarding reciprocal interference. This includes EMI, EMC and
RF.
This product has been certified and tested by 3rd party testing facilities to
the following standards:
IEC 60601-1, 3rd Edition
IEC 60601-1-2, 3rd and 4th Edition
IEC 60601-1-11, 1st Edition
IEC 61000: See next page
Also compliant as per CISPR 11:2015
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