Regulatory Marks ................................................................................................. 36
SAFETY NOTES
• The Quanta Smart Wearable ECG Monitoring Device is to be used for clinical
assessment and personal reference only. The Quanta Smart Wearable ECG
Monitoring Device is not intended for diagnostic use.
• The Quanta Smart Wearable ECG Monitoring Device consists entirely of
sophisticated medical electrical parts so maintenance can only be carried out by
professional technicians. Unauthorized disassembly of the device by the user is not
allowed.
• The Quanta Smart Wearable ECG Monitoring Device must be used with the
specified “accessories” and “electrodes”. The use of accessories and electrodes
from other brands may lead to faulty readings. For more information, see Product Requirements.
• Do not allow the metal connectors to come into contact with any kind of power
source during use.
• Damaged or faulty accessories and electrodes should not be used.
• When the Quanta Smart Wearable ECG Monitoring Device is low on power, it will
automatically stop taking measurements and the corresponding indicator lights will
blink. Please charge the sensor as soon as it shows a low battery state.
• When the Quanta Smart Wearable ECG Monitoring Device is taking measurements,
please try and avoid using any instruments or devices that may affect the accuracy
of the readings (e.g. the use of a blood pressure meter will affect the measurement
of the pulse).
• When the Quanta Smart Wearable ECG Monitoring Device is taking measurements,
please try and avoid using other electronic devices nearby. If it must be used with
other electronic devices simultaneously, please check to make sure that the Quanta
Smart Wearable ECG Monitoring Device is continuing to take measurements
normally.
• The Quanta Smart Wearable ECG Monitoring Device-specific accessories are
defined in this user guide. The use of accessories from other brands may damage
the device.
• Do not use the Quanta Smart Wearable ECG Monitoring Device in a flammable
environment.
• When the environment temperature is 45degC, the surface temperature of Quanta
Smart Wearable ECG Monitoring Device will be 46degC.
• When ambient temperature is 40~45degC, do not use the Quanta Smart Wearable
ECG Monitoring Device for more than 4 hours to avoid low-temperature burns.
• Users have to buy ECG electrodes themselves when using the direct wear patch.
The specification for ECG electrodes can be found in ECG Electrode Information.
• Pay attention to ensure that the Quanta Smart Wearable ECG Monitoring Device is
not swallowed by pets or children.
• Cardiac pacemakers or other electrical stimulators may affect the accuracy of the
measurements for the Quanta Smart Wearable ECG Monitoring Device.
• The conductive parts of the electrodes and associated connectors for type CF
applied parts, including the neutral electrode, should not make contact with other
conductive parts including the ground.
• Please read through this user guide carefully before using the Quanta Smart
Wearable ECG Monitoring Device.
• If the Quanta Smart Wearable ECG Monitoring Device must be used to take
measurements over an extended period of time, please inspect the contact point of
the electrodes at least once every 8 hours to make sure that the electrodes are in
the right position and there is no allergic skin reaction on the user.
• Do not use high-frequency instruments or electrical medical equipment such as
“defibrillators” when using the Quanta Smart Wearable ECG Monitoring Device.
• When the Quanta Smart Wearable ECG Monitoring Device is taking measurements
and a stable reading cannot be taken then stop taking measurements right away as
not everyone is suitable to sensor using the Quanta Smart Wearable ECG
Monitoring Device.
• The Quanta Smart Wearable ECG Monitoring Device can only take measurements
when the subject is stationary (e.g. while sitting or lying down) or engaging in
ordinary activity. Any activities not permitted by the attending physician may affect
the accuracy of the measurements.
• Do not use the Quanta Smart Wearable ECG Monitoring Device in an excessively
humid environment and never submerge it directly under water.
• Do not expose the Quanta Wearable ECG Monitoring Device to extremely
temperature, moist environment, dust or direct sun light.
• Do not clean or wipe the Quanta Smart Wearable ECG Monitoring Device with
corrosive and abrasive cleaning agents.
• The disposal of the Quanta Smart Wearable ECG Monitoring Device and its
accessories should comply with the relevant local regulations.
• The Quanta Smart Wearable ECG Monitoring Device has been tested and certified
to international electro-magnetic compatibility (EMC) standards for medical
equipment (EN 60601-1 and EN 60601-1-2).
• The Quanta Smart Wearable ECG Monitoring Device and its accessories should be
disposed of properly.
• Battery Caution: There is a risk of explosion if the battery for the Quanta Smart
Wearable ECG Monitoring Device is replaced by an incorrect type.
• The Quanta Smart Wearable ECG Monitoring Device’s use is not intended for
infants weighing less than 10 kg.
• The expected service life of Quanta Smart Wearable ECG Monitoring Device is 3
years.
PRODUCT OVERVIEW
Indication for Use
The Quanta Smart Wearable ECG Monitoring Device is intended for use in the noninvasive measurement of a functional Electrocardiography (ECG) and heart rate (HR) in
hospital, healthcare institute, and home environments by trained medical professionals
and trained-adults. The Smart Wearable ECG Monitoring Device will process ECG
signals and calculate HR. ECG and HR data will be transferred to a smartphone via
Bluetooth, and further displayed on the smartphone screen via a dedicated app called
Q-COR. The device should be worn on the human body along with a belt or a patch
with gel electrodes. The Quanta Smart Wearable ECG Monitoring Device is sold to
professional organizations such as home care givers, clinics, or hospitals rather than to
the general public. It can only be installed by trained adults or medical personnel.
Unauthorized installation by users is not allowed.
Direct Wear
Patch x 1
Body Strap
Patch x 1
Body Strap
B1
x 1
Body Strap
B2
x 1
User Manual
Pin x 1
User Manual x 1
Package Contents
After purchasing the Smart Wearable ECG Monitoring Device please check the product
package to ensure that the following items are included:
ECG Sensor x 1 Charger x 1
USB Charging Cable x 1 5V/2A Adapter x 1
(For Select Models)
(For Select Models)
(For Select Models)
(For Select Models)
Product Configurations
Part Name
Model Number
CI3SKU1
CI3SKU2
CI3SKU3
Body Strap Patch
CI3-P2 V
V
The following is a table that lists the various product configurations for the Quanta
Smart Wearable ECG Monitoring Device and the components included for each
configuration.
Product Configuration
Smart Wearable ECG Sensor
Charger CI3-C V V V
Direct Wear Patch CI3-P1 V
Body Strap B1 CI3-B1 V
Body Strap B2 CI3-B2
CI3 V V V
Components
Sensor
Front
1
Status Indicator (see LED Indicators for more information)
1 Patch Connectors
3
LED Indicators
3
3
Back
2 Charging Contacts
3 Bluetooth Pairing Button
Charger
1 Charging Contacts
2 USB Charging Port
Charging Indicator (see
for more information)
Body Strap Patch
Front
1 Sensor Connectors
Back
1 Electrode Connectors
IMPORTANT: If any wear or damage to the wire shielding is found on the patch during use,
replace immediately.
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