Quanta Computer QUANTA User manual

“QUANTA”PORTABLE ECG MONITORING
DEVICE
User Manual

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TABLE OF CONTENTS
Safety Notes............................................................ 3
Product Overview................................................... 6
Indication for Use.....................................................................6
Package Contents ....................................................................7
Product Configurations.........................................................................................8
Components..............................................................................8
Sensor.....................................................................................................................8
Charger ...................................................................................................................9
Body Patch ...........................................................................................................10
Sensor Holder.......................................................................................................10
Product Requirements...........................................................12
Before You Start................................................... 13
Charging the Battery..............................................................13
Installing the App ...................................................................13
Enabling Bluetooth.................................................................13
Getting Started ..................................................... 14
Creating a Profile....................................................................14
Pairing .....................................................................................15
Wearing the ECG Sensor.......................................................15
Wearing the sensor holder....................................................16
Removing the ECG Sensor from the Holder........................17
Wearing the body patch.........................................................18
The Q-ecg App...................................................... 19

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Main Screen ............................................................................19
Menu........................................................................................20
History...................................................................................................................22
Profile....................................................................................................................24
Pairing...................................................................................................................24
Clear Data .............................................................................................................25
Quit........................................................................................................................25
Measuring ECG when Bluetooth is Disconnected..............25
Additional Information......................................... 26
LED Indicators........................................................................26
Sensor Status Indicator.......................................................................................26
Cleaning ..................................................................................26
ECG Electrode Information....................................................27
Specifications.........................................................................27
Sensor Specifications..........................................................................................27
Charger Specifications........................................................................................28
Troubleshooting .....................................................................28
Customer Support..................................................................29
EU Representative ...............................................................................................29
Regulatory Marks.................................................................................................30

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SAFETY NOTES
The “QUANTA” PORTABLE ECG MONITORING DEVICE is to be used for clinical
assessment and personal reference only.
The “QUANTA” PORTABLE ECG MONITORING DEVICE consists entirely of
sophisticated medical electrical parts. Maintenance can only be carried out by
professional technicians. Unauthorized disassembly of the device by the user is
not allowed.
The “QUANTA” PORTABLE ECG MONITORING DEVICE must be used with its
specified accessories and electrodes. The use of accessories and electrodes
from other brands can damage the device or cause inaccurate readings. For
more information, see Product Requirements.
Do not allow the connectors or contacts on the device’s 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” PORTABLE ECG MONITORING DEVICE is low on battery
power, it will automatically stop taking measurements and the corresponding
indicator lights will blink. Please charge the sensor’s battery as soon as it shows
a low battery state.
Avoid using devices that can affect the accuracy of the readings when the
“QUANTA” PORTABLE ECG MONITORING DEVICE is taking measurements (e.g.,
using a blood pressure monitor will affect the ECG’s pulse measurement).
Avoid using other electronic devices when the “QUANTA” PORTABLE ECG
MONITORING DEVICE is taking measurements. If using another other electronic
device is necessary, please check to ensure the ECG is continuing to take
measurements normally. See The Q-ECG App to see how to check if the device
taking measurements normally.
Do not use the “QUANTA” PORTABLE ECG MONITORING DEVICE near open
flames, in excessive heat, extreme temperatures, moist, dust, or direct sunlight.
When ambient temperature is 104°F –113°F (40 –45°C), do not use the
“QUANTA” PORTABLE ECG MONITORING DEVICE because it may cause low-
temperature burns.
Users must purchase Sensor Holder、ECG electrodes or Body Patch separately
when using the Sensor Holder or Body Patch. The specification can be found in
ECG Electrode Information.
Pay attention to ensure that the “QUANTA” PORTABLE ECG MONITORING DEVICE
is not swallowed by pets or children.
Cardiac pacemakers or other electrical stimulators may affect the accuracy of the
measurements of the “QUANTA” PORTABLE ECG MONITORING DEVICE.

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The conductive parts of the electrodes and associated connectors for type BF
applied parts, which are parts that make conductive contact with the heart,
including the neutral electrode, should not make contact with other conductive
parts including the ground. Direct contact with other conductive parts may result
in electric shock.
Please read through this user guide carefully before using “QUANTA” PORTABLE
ECG MONITORING DEVICE.
If “QUANTA” PORTABLE 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 24 hours to make sure that the electrodes
are in the right position and that there is no allergic reaction on the user’s skin.
Do not use high-frequency instruments or electrical medical equipment such as
defibrillators when using the “QUANTA” PORTABLE ECG MONITORING DEVICE.
The “QUANTA” PORTABLE ECG MONITORING DEVICE can only take
measurements while 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 “QUANTA” PORTABLE ECG MONITORING DEVICE in MRI or X-ray
room.
Do not clean the “QUANTA” PORTABLE ECG MONITORING DEVICE with corrosive
or abrasive cleaning agents.
The “QUANTA” PORTABLE ECG MONITORING DEVICE and its accessories should
be disposed of properly. Disposal of the device and its accessories should
comply with the relevant local regulations.
The “QUANTA” PORTABLE 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). If abnormal behavior is
observed due to EMC disturbances, please relocate the device accordingly
Battery Caution: There is a risk of explosion if the battery for the “QUANTA”
PORTABLE ECG MONITORING DEVICE is replaced by an incorrect battery type.
The “QUANTA” PORTABLE ECG MONITORING DEVICE ’s use is not intended for
use with infants weighing less than 45lbs. (20 kg).
The expected service life of the “QUANTA” PORTABLE ECG MONITORING DEVICE
is 2 years.
If you feel very itching or find redness when wearing the body patch, remove the
body patch immediately.
This device should not be used adjacent to or stacked with other equipment.
Please do not use any other cables or accessories not approved by the
manufacturer in this manual to avoid negative influence on electromagnetic
compatibility.

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Due to electrostatic discharge (ESD) sparks may cause sparks. “QUANTA”
PORTABLE ECG MONITORING DEVICE is not suitable for use in an explosive
environment.
“QUANTA” PORTABLE ECG MONITORING DEVICE does not support with the
devices that apply high-frequency voltage to patients (such as electrosurgical
equipment and some respiratory sensors); if such devices are used at the same
time, it may cause adverse consequences. For procedures that require the use of
high-frequency surgical equipment, “QUANTA” PORTABLE ECG MONITORING
DEVICE should be removed beforehand.
Avoid using heavy electronic equipment or other sources of electromagnetic
interference (such as electric blankets) when using the “QUANTA” PORTABLE
ECG MONITORING DEVICE.
When the ECG signal is always unstable, please contact the manufacturer.

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PRODUCT OVERVIEW
Indication for Use
The “QUANTA”PORTABLE ECG MONITORING DEVICE is intended for non-
invasive measurement of a functional Electrocardiogram (ECG) and heart rate (HR) in
hospitals, healthcare institutes, and home environments by trained medical
professionals and trained adult. The “QUANTA”PORTABLE ECG MONITORING
DEVICE will process ECG signals and calculate HR on continuous, spot check, or event
record mode. Users can also add time tags to the ECG signals by pressing the
button. ECG and HR data will be transferred to a smartphone via Bluetooth and
displayed on the smartphone screen via a dedicated application called Q-ecg. The data
can be further transferred to cloud server for storage.
The device should be worn on the human body along with a body patch or a sensor
holder with gel electrodes. The “QUANTA”PORTABLE ECG MONITORING DEVICE
is available to professional organizations such as home caregivers, clinics, or hospitals.
It is not available to the general public. It should only be used by medical personnel or
trained adult patients. Use by unauthorized users is not allowed.

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Package Contents
After purchasing the “QUANTA”PORTABLE 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
User Manual x 1

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Product Configurations
The following table lists the sensor related items included in the various packages
available for the “QUANTA” PORTABLE ECG MONITORING DEVICE .
Product Package
Part Name
Model Number
Q-ecg-wu2-K1
Q-ecg-wu2-K2
“QUANTA”PORTABLE
ECG MONITORING DEVICE
Q-ecg-wu2


Charger
Q-ecg-wu2-C1


USB Charging Cable
NA


Sensor Holder*
Q-ecg-wu2-P5

Body Patch*
Q-ecg-wu2-P3

Components
Sensor
Front
1
Power Button
2
Battery LED (see LED Indicators for more information)
3
Indicator LED (see LED Indicators for more information)
1
2
3

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Back
1
Charging Contacts
2
Holder Connectors
3
Label Area
Charger
1
Charging Contacts
2
USB Charging Port
1
1
2
2
3