Use Instructions

PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 31 of 101
The Eagle V1.2 Imaging System complies with Part 15 of the FCC Rules (USA) and ICES-3(B)/NMB-3(B)
(Canada).
Handheld Fluorescence Camera has an operational duty cycle of 5 minutes on, 15 minutes off.
3.2.1. Federal Communication Interference Statement
We SBI ALApharma, 305-123 Edward St, Toronto, ON, M5G 1E2, Canada, 289-800-9455, declare under
our sole responsibility that the Handheld Fluorescence Camera complies with complies with Part 15 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 product does not contain any user serviceable components. Any unauthorized product changes or
modifications will invalidate warranty and all applicable regulatory certification and approvals, including
authority to operate this device.
WARNING: This equipment has been tested and found to comply with the limits for a Class B digital device,
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 and radiates radio frequency
energy and, if not installed and used in accordance with the instructions, may cause harmful interference
to radio communications.
3.2.2. Industry Canada Statements
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 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.
3.2.3. Electromagnetic Compatibility
The Handheld Fluorescence Camera meets the requirements of Safety EMC Testing per IEC 60601-1-
2:2014 4th Edition / EN 60601-1-2:2015. Medical electrical equipment requires special precautions
regarding electromagnetic compatibility (EMC) and must be used according to the instructions in this User
Manual.
While unlikely, it is possible that high levels of emitted radio-frequency (RF) electromagnetic interference
(EMI) from other portable and mobile RF communications equipment or nearby radio-frequency sources
could result in performance disruption of the Handheld Fluorescence Camera.
Warning
The device is equipped with sensitive electronic components. While imaging, avoid strong
electrical or electromagnetic fields, e.g. mobile phones, microwave ovens, etc.; or it may
lead to temporary imaging error or inaccuracy.