User's Manual

User Manual – FloPatch FP120 Rev 1.0
CONFIDENTIAL UNCONTROLLED UNLESS OTHERWISE SIGNED AND/OR STAMPED. Page 5 / 33
1.4 Industry Canada Compliance
IC: 25612-FP120
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.
CAN ICES-3 (B)/NMB-3(B)
RF Exposure Statement:
This equipment complies with ISED RSS-102 radiation exposure limits set forth for an uncontrolled
environment.
Cet équipement est conforme avec ISED RSS-102 des limites d'exposition aux rayonnements définies pour
un environnement non contrôlé.
2. FLOPATCH INTENDED USE/INDICATIONS FOR USE
2.1 Intended Use
The FloPatch (FP120) is intended for the detection and analysis of blood flow in peripheral vasculature.
The device is intended to be used by medical professionals, such as physicians and nurses, in hospitals and
professional environments. The device is intended for prescription use only.
2.2 Intended Users
The device is intended to be used by trained medical professionals, such as physicians and nurses.
2.3 Intended Patient Population
Adults (individuals over the age of 18 years).
2.4 Intended Use Environment
Hospitals and professional environments.
2.5 Contraindications
There are no known contraindications for this device.