User's Manual

ABOUT THIS MANUAL
Your doctor should be your first source of
information regarding your health.
This manual addresses many of the questions you
or your family may have about your Smart Spot and
its use. In this manual the patient can be considered
as an intended operator.
If you have technical or usage questions that are not
covered in this manual or you want more in-depth
information, please contact MicroPort technical
assistance.
1. INTRODUCTION
The Smart Spot you received is part of the
SMARTVIEW Remote Monitoring System. This
system has been specially designed to transmit
information stored in your MicroPort implanted
cardiac device to your doctor on demand. Your
MicroPort cardiac device is equipped with a
transmitter which sends clinical information and
device parameters to your doctor through the Smart
Spot using a telemetry head. The data retrieved by
your Smart Spot is routed through the mobile phone
network, converted to a format that can be reported
to your doctor.
The SMARTVIEW Remote Monitoring System
designed by MicroPort can be used only on a
doctor’s instruction.
The Smart Spot sends data to a back office
managed and controlled by MicroPort.
2. INDICATION
The Smart Spot is indicated for the remote follow
up of patients who are implanted with a MicroPort
implanted cardiac device only according to the
applicable Medical Guidelines (2018
ACC/AHA/HRS Guideline on the Evaluation and
Management of Patients With Bradycardia and
Cardiac Conduction Delay, Journal of the American
College of Cardiology (2018)).
3. USER PROFILE
Any person who was prescribed for remote
monitoring by and under supervision of a physician.
4. WARNINGS AND PRECAUTIONS
4.1. WARNINGS
The SMARTVIEW Remote Monitoring
System is not intended as an emergency
response system.
If at any time you feel that you need a fast
response, CALL YOUR LOCAL EMERGENCY
SERVICE IMMEDIATELY.
4.2. SAFETY PRECAUTIONS
Alteration – Your Smart Spot and supplied parts
shall not be modified, altered, or changed in any
way without signed written permission from
MicroPort. Unauthorized modification may void the
equipment authorization from the FCC and will void
the MicroPort warranty. Use only MicroPort supplied
parts.
Keep out of the reach of children – Do not let
children touch the Smart Spot.
Environmental factors – To reduce the risk of fire,
electric shock and personal injury, do not expose
this appliance to rain, moisture or extreme
temperatures and avoid any installation or Patient
Initiated Transfer operation during an electrical
storm. If the Smart Spot is damaged due to a shock
or liquid exposure, do not plug it in again and call
our MicroPort technical assistance.
Keep the device dry – Keep it away from moisture
and do not spill or drip liquids on it.
Keep the cables free – Do not use the cables
for any purpose other than for performing a
transmission.
Mobile communication – Keep the Smart Spot
more than 20 cm (8 inches) away from your body
while it is transferring the data to your doctor (Step
7 of §6.1 Normal functioning).
For continued IP21 protection (from solid and
liquid body intrusions) - Do not remove the silicon
sleeve from the USB connector.
4.3. PRECAUTIONS FOR SAFE
OPERATION
Location – The Smart Spot should be placed in
a stable position during its normal utilisation. It is
recommended that the Smart Spot not be used
adjacent to or stacked with other equipment but
if adjacent or stacked use is unavoidable, verify
that the equipment operates normally in the
configuration in which it is intended.
Power supply – The Smart Spot should be
connected exclusively to a MicroPort power
adaptor.
Power supply protection – Power adaptors should
be routed so they are not likely to be walked on or
pinched by items placed on or against them.
Power supply disconnection – The power socket
must be near the Smart Spot and easily accessible.
The power socket isolates the Smart Spot circuits
from the supply mains. You can only remove power
from the Smart Spot by disconnecting the power
adaptor from the outlet. Always carefully disconnect
all plugs by pulling on the plug and not on the cord.
Smart Spot – UA10275A 3