Spencer spn01 - Intended Use (US); Intended Use (EU and CAN); Warning; Patent Information

spencer 2022A user guide spencerhealthsolutions.com 78
Intended use (US)
The spencer® SmartHub is an AC-powered,
countertop, in-home device intended to assist
users by providing alerts for pre-determined
medication dosing schedules and tracking
adherence. spencer uses wireless communication
along with spencerCare™, spencerAssist
®
and
spencerConnect
®
software to inform users,
caregivers, and healthcare professionals.
spencerConnect
®
is proprietary software installed on
the spencer SmartHub that enables users to connect
their spencer SmartHub to other medical devices
(e.g. glucometer, blood pressure cuff) for recording,
transferring, and storing readings.
spencerAssist® is proprietary software installed
on a mobile device (e.g., phone, tablet) and
spencerCare™ is proprietary web-based software
viewed at a pharmacy. This software is intended
to inform users, caregivers, and healthcare
professionals with medication alerts, medication
adherence information, and readings from
connected devices.
Intended use (EU and CAN)
The spencer
®
SmartHub is intended to assist
with monitoring disease treatments by tracking
medication adherence.
spencerCare™ is software intended to assist
healthcare professionals with monitoring disease
treatments by working with the spencer SmartHub
to calculate medication adherence and to lter and
graph adherence information.
spencerAssist
®
is software intended to assist
healthcare professionals with monitoring disease
treatments by working with spencerCare™ to lter
and graph medication adherence information.
Warning
spencer SmartHub, spencerAssist, spencerConnect,
and spencerCare are not intended to be used for
primary diagnosis, for treatment or therapeutic
purposes, for critical situations or conditions, to
trigger an immediate or near-term action, or for use
in lifesaving situations.
The spencer SmartHub is not intended for life-saving
or temperature-sensitive medications.
Patent information
Go to www.spencerhealthsolutions.com for patent
information regarding the spencer SmartHub.
Wireless compliance state-
ments
FCC Part 15 – spn01
This spencer SmartHub is compliant with Part 15 of
the FCC Rules and with Industry Canada license-
exempt RSS standard(s). Operation is subject to the
following 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, and (3) changes or
modications made to this equipment not expressly
approved by Spencer Health Solutions may void the
FCC authorization to operate this equipment.
Industry Canada RSS – spn02
Le présent appareil est conforme aux CNR
d’Industrie Canada applicables aux appareils radio
exempts de licence. L’exploitation est autorisée
aux 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) Les changements ou modications apportées
à cet équipement non expressément approuvée
par Spencer Health Solutions peuvent annuler
l’autorisation FCC d’utiliser cet équipement.
Radio Equipment Directive – spn03
This device complies with all applicable standards
and regulations related to radio equipment directive
2014/53/EU.
Device Warnings
A warning indicates the possibility of injury to the
user or operator.