Quanta Computer ecg103-K1 User manual

QOCA PORTABLE ECG MONITORING DEVICE
User Manual
CIH418-01 Ver.: 2B

CIH418-01 1
TABLE OF CONTENTS
Safety Notes.........................................................4
Product Overview ..............................................10
Indication for Use......................................................10
Package Contents.....................................................11
Product Configurations......................................12
Components ..............................................................13
Sensor..................................................................13
Charger ................................................................15
Body Patch..........................................................17
Sensor Holder & Cable.......................................18
12-unit Charger (Charging 12 sensors at the
same time) ...........................................................20
Product Requirements .............................................21
Before You Start ................................................22
Charging the Battery.................................................22
Installing the App......................................................23
Enabling Bluetooth ...................................................23

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Getting Started...................................................24
Pairing ........................................................................24
Wearing the ECG Sensor .........................................25
Wearing the sensor holder.......................................26
Removing the ECG Sensor from the Holder..........29
Wearing the body patch ...........................................30
The QOCA ecg APP...........................................33
Main Screen...............................................................33
Take a Measurement.................................................34
Check the Device and User Information.................36
Measuring ECG when Bluetooth is Disconnected 37
Additional Information.......................................39
LED Indicators...........................................................39
Sensor Status Indicator .....................................39
Cleaning .....................................................................41
ECG Electrode Information......................................42
Specifications............................................................43
Sensor Specifications ........................................43

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Charger Specifications.......................................45
Troubleshooting........................................................45
Gateway mode information......................................45
Gateway Compatible Specifications.................46
Customer Support.....................................................47
EU Representative..............................................47
Label Information: ..............................................47
Federal Communications Commission (FCC)
Statement...................................................................48
Regulatory Marks................................................50
Supplier’s Declaration..............................................53

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SAFETY NOTES
•The QOCA PORTABLE ECG MONITORING
DEVICE is to be used for clinical assessment and
personal reference only.
•The QOCA 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 QOCA 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
devices to come into contact with any kind of power
source during use.
•Damaged or faulty accessories and electrodes
should not be used.
•When the QOCA 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.

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•Avoid using devices that can affect the accuracy of
the readings when the QOCA 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 QOCA
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 QOCA ecg APP to see how to check if the
device taking measurements normally.
•Do not use the QOCA PORTABLE ECG
MONITORING DEVICE near open flames or in
excessive heat.
•When ambient temperature is 104°F –113°F (40 –
45°C), do not use the QOCA 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.

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•Pay attention to ensure that the QOCA 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
QOCA PORTABLE ECG MONITORING DEVICE.
•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 QOCA PORTABLE ECG MONITORING
DEVICE.
•If QOCA 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.

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•Do not use high-frequency instruments or electrical
medical equipment such as defibrillators when using
the QOCA PORTABLE ECG MONITORING DEVICE.
•The QOCA PORTABLE ECG MONITORING
DEVICE can only take measurements while the
subject is at rest (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 expose QOCA PORTABLE ECG
MONITORING DEVICE to extreme temperatures,
extremely moist environments, dust, or direct
sunlight.
•Do not clean the QOCA PORTABLE ECG
MONITORING DEVICE with corrosive or abrasive
cleaning agents.
•The QOCA 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 QOCA 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).

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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 QOCA PORTABLE ECG
MONITORING DEVICE is replaced by an incorrect
battery type.
•The QOCA 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 QOCA PORTABLE
ECG MONITORING DEVICE is 2 years.
•People with sensitive skin or with known skin
conditions should use the QOCA PORTABLE ECG
MONITORING DEVICE with caution. If irritation such
as redness, severe itching or allergic symptoms (i.e.
hives) develop, instruct patients to remove the QOCA
PORTABLE ECG MONITORING DEVICE
immediately and have them contact their physician.
•Do not use ECG sensor on patients with known skin
allergies or family history of skin allergies.
•Do not use QOCA PORTABLE ECG MONITORING
DEVICE in MRI or X-ray room.
•This device should not be used adjacent to or
stacked with other equipment.

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•Please do not use any other cables or accessories
not approved by the manufacturer in this manual to
avoid negative influence on electromagnetic
compatibility.
•Due to electrostatic discharge (ESD) sparks may
cause sparks. QOCA PORTABLE ECG
MONITORING DEVICE is not suitable for use in an
explosive environment.
•QOCA 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, QOCA
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 QOCA 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 QOCA WEARABLE ECG MONITORING DEVICE is
intended for non-invasive measurement of
Electrocardiogram (ECG) and heart rate (HR) of patients at
rest in hospitals, healthcare institutes, and home
environments. The QOCA WEARABLE ECG
MONITORING DEVICE will process ECG signals and
calculate HR on continuous, spot check, or event record
mode. ECG and HR data will be transferred to a
smartphone via Bluetooth and displayed on the
smartphone screen via a dedicated application called
QOCA 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
QOCA WEARABLE 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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The device is intended for use on patients 20 years of age
and older. The QOCA WEARABLE ECG MONITORING
DEVICE is only available by prescription and be used by or
under the instruction of medical personnel.
Package Contents
After purchasing the QOCA PORTABLE ECG
MONITORING DEVICE , please check the product
package to ensure that the following items are included:
ecg103 product package
ecg103
ECG Sensor x 1
Charger x 1
Protection bag x 1

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USB Charging
Cable x 1
User Manual x 1
Product Configurations
The following table lists the sensor related items included
in the various packages available for the QOCA Portable
ECG Monitoring Device.
Product Package
Part Name
Model Number
ecg103-K1
ecg103-K2
QOCA PORTABLE
ECG MONITORING
DEVICE
ecg103
✓
✓
Charger
ecg103-C1
✓
✓
USB Charging
Cable
NA
✓
✓
Sensor Holder*
ecg103-P5
✓

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Body Patch*
ecg103-P1
✓
Components
Sensor
Front
1
2
3

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1
Power Button
2
Battery LED (see LED Indicators for more
information)
3
Indicator LED (see LED Indicators for more
information)
Back
1
Charging Contacts
2
Holder Connectors
1
2
3

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3
Laser Printing Area
NOTE: Electrode button connector will support plug in/off
test under 1000 times.
Charger
1
2

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1
Charging Contacts
2
USB Charging Port

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Body Patch
Front Exterior (with pocket closed)
1
Gel
2
Contact Point
Material
Made from Nonwoven
1
2

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Sensor Holder & Cable
Front
1
Sensor Connectors
Material
Made from Polydefin Foam
2
Cable Connector
1
2

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Back
1
Electrode Connectors
IMPORTANT: If any damage to the wire shielding is found
on the holder, replace immediately.
1
1