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7
S a fe ty a n d
Wa rn i n g s
Liquid damage warning: Element is not waterproof. Please advise the
user to avoid submerging or spilling liquid on or into their prosthesis.
This may cause Element to be permanently damaged. If the user will
be wearing their prosthesis in wet environments, ensure that Element
is sufficiently protected from the external environment.
Battery use warning: Element must be powered by a FlexCell battery
system from IBT. We have conducted safety testing to confirm
compatibility between Element and FlexCell batteries.
Modification WARNING: Any unauthorized modification to Element 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 Element during safety critical tasks.
WARNING: IBT Electrodes are only to be used with the Element signal
processing box or other compatible IBT systems.
Element 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 Element.
WARNING: Use of accessories and prosthetic parts other than those
specified in the product order may result in malfunction of the Element
system and can cause increased emissions and decreased immunity
of the Element system.
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I N C I D E N T R E P O R T I N G
Any serious incident needs to be reported to Infinite Biomedical Technologies
and to the competent authority of the EU member state in which you and that
patient are established.
IBT can be reached at:
Infinite Biomedical Technologies, LLC.
8 Market Place, Suite 500
Baltimore, MD 21202, USA
Phone: +1 (443) 451-7175
E-mail: info@i-biomed.com
Website:
www.i-biomed.com
Contact information for competent authorities can be found at:
https://ec.europa.eu/growth/sectors/medical-devices/contacts�en
8
Regul a to r y I nfo
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. (Continued on
next page).
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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