QT Medical QT ECG QTERD100 User manual

QT ECG USER’S MANUAL
IMPORTANT WARNINGS
●Federal law restricts sale of this device by or on the order of a physician.
●This device is not defibrillator-proof.
●MR Unsafe! Do not expose the device to a magnetic resonance (MR)
environment.
●Do not try to charge the QT ECG Recorder while it is connected to the Electrode
Strip.
●Do not place the Electrode Strip on yourself. Ask someone else to help you.
●Both you and the person helping you need to read this manual thoroughly
before using the QT ECG. For your safety, follow the operating instructions and
all safety measures, including warnings and cautions, listed in this manual to
ensure safe and reliable performance of the system.
●The Electrode Strip is for one-time use only. Do not reuse. To prevent potential
transmission of infection or disease, dispose the Electrode Strip properly after
each use. Contact local authorities for proper disposal method of potentially
bio-hazardous materials.
●Always use the latest version of the QT ECG App.

1. INTRODUCTION
This user manual provides information on the QT ECG system and instructions on
how to use it.
1.1 System Description
The QT ECG system is a hand-held, cordless 12-lead electrocardiograph (ECG)
system with Bluetooth connectivity. The QT ECG system consists of 3 major
components:
●The QT ECG Recorder – Compact device that records 12-lead, resting
electrocardiograms, then transmits the recorded data to a mobile device
(smartphone, tablet, etc.) paired via Bluetooth. A Bluetooth-enabled mobile
device (not included) is needed to operate the QT ECG Recorder, and to send
the recoded rhythm strip to a cardiologist or licensed physician for review.
●The QT Electrode Strip – Disposable, patented electrodes that are
prepositioned on a self-adhesive strip
●The QT ECG App – Software that lets you use your mobile device to operate the
QT ECG recorder, then send the recorded data via email to a certified medical
professional for review.
Note: To use the QT ECG system, you will need to have a Bluetooth- enabled
mobile device.
Warning: Use only manufacturer-approved accessories with the QT ECG.
Warning: The QT ECG is not intended for treatment or monitoring. It captures
data that reflect the patient’s physiological condition. The data must be reviewed
and analyzed by a cardiologist or trained physician before a diagnosis is made.
1.2 Indication for Use
The QT ECG System is intended to acquire, record and process an
electrocardiographic signal so that it can be transmitted digitally via Bluetooth
technology to a cell-phone or mobile device, then to a remote location. The QT
ECG System is indicated for use on adult patients and pediatric patients age 18
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– 22 years. It is designed to be used by a patient or other layperson in the
home, or by healthcare workers in non-acute care clinical facilities (such as
nursing homes, skilled nursing facilities), to record and transmit a 12-lead ECG
and rhythm strip in real-time to enable review at a physician's office, hospital
or other medical receiving centers.
1.3 Intended Use
The QT ECG System is intended for use on adult patients and pediatric patients
age 18 – 22 years to acquire ECG signals so that it can be transmitted wirelessly
via Bluetooth to a cell-phone or mobile device, then to a remote location. The
QT ECG System is designed to be used by a patient to record ECG data and
transmit to a physician’s office, hospital or other medical receiving center for
review
1.4 Contraindications
There are no known contraindications.
1.5 Environment
The QT ECG system is designed for home use and for use in non-clinical settings. No
professional medical training is required to use this system.
1.6 Symbols
The following symbols are used in this manual and in the product:
The QT ECG Recorder
Symbol/Marking
Description
FCC Declaration of Conformity mark.
Certification mark employed on
electronic products manufactured or
sold in the United States which
certifies that the electromagnetic
interference from the device is under
limits approved by the Federal
Communications Commission.
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NCC Declaration of Conformity mark.
Certification mark employed on
electronic products manufactured or
sold in the Republic of China (Taiwan)
which certifies that the
electromagnetic interference from
the device is under limits approved
by the NCC.
The WEEE symbol, indicating
separate collection for WEEE- Waste
of Electrical and Electronic
Equipment, consists of the
crossed-out wheeled bin.
Bluetooth wireless technology
incorporated
Non-ionizing radiation
Model Number: QTERD100
The QT ECG Recorder reference
number.
FCC ID: 2AIBAQTERD100
Contains FCC ID: SSSBC127-X
FCC ID is a unique identifier assigned
to a device registered with the
United States Federal
Communications Commission.
IC: 21780-QTERD100
Contains IC: 11012A-BC127
IC ID is the product ID assigned by
Industry Canada to identify wireless
products in the Canadian market.
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“REFER TO MANUAL”: Follow
operating instructions
“MR-unsafe”: Do not expose the device
to a magnetic resonance (MR)
environment.
The degree of protection provided by
the enclosure from particulate
matter and water.
2represents that protection against
object sized >12.5mm (Fingers or
similar objects)
2represents that the enclosure has a
protection level of “water jet;”.
Vertically dripping water shall have
no harmful effect when the enclosure
is tilted at an angle up to 15° from its
normal position.
“MANUFACTURER”: The name and
the address of the manufacturer.
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UDI data matrix barcode is intended
to assign a unique identifier to
medical devices within the United
States.
Caution: Federal law restricts this
device to sale by or on the order of a
licensed medical practitioner.
Type CF is the most stringent
classification, being required for
those applications where the applied
part is in direct conductive contact
with the heart or other applications
as considered necessary.
Storage and transportation
conditions: humidity range
Storage and transportation
conditions: pressure range
Storage and transportation
conditions: temperature range
“CATALOGUE NUMBER”: The
catalogue number of product.
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"BATCH CODE": The manufacturer's
batch code.
"SERIAL NUMBER": The
manufacturer's serial number.
The packing date of QT ECG ECG
Recorder.
Rated direct current input supply
voltage and current.
Press and hold for 5 second to on/off
the QT ECG Recorder.
PWR
The PWR LED indicates the power
and charging status.
CON
The CON LED indicates the
connecting status of the QT ECG ECG
Recorder to the mobile computing
device.
REC
The REC LED indicates the recording
status of the recorder.
Electrode Strip
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Do not reuse
Do not use if package is damaged
General warning sign
Type CF is the most stringent
classification, being required for
those applications where the applied
part is in direct conductive contact
with the heart or other applications
as considered necessary.
Keep away from sunlight
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Storage and transportation
Temperature Limit
Storage and transportation
conditions: humidity range
Storage and transportation
conditions: pressure range
Date of manufacture
“CATALOGUE NUMBER”: The
catalogue number of product.
"BATCH CODE": The manufacturer's
batch code.
2. SAFETY INFORMATION
Make sure you are familiar with the safety information in this section before using
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the QT ECG. Pay attention to all warnings and cautions to avoid personal injury
and/or equipment damage.
WARNING
Indicates a potentially hazardous situation which, if not
avoided, could result in personal injury.
CAUTION
Indicates a potentially hazardous situation which, if not
avoided, may result in damage to the equipment or other
property.
2.1 Operating the Device
2.1.1 Warnings
2.1.1.1 Inspection: Visually inspect the QT ECG and all accessories prior to
use. Do not use if any components are damaged.
2.1.1.2 Do not use high voltage device such as AED (Automated External
Defibrillator) when using Electrode Strip. Please remove the QT
ECG before using high voltage device on the individual. High
voltage device will damage the Electrode Strip and the QT ECG
Recorder if they are used at the same time.
2.1.1.3 No modification of this equipment is allowed.
2.1.1.4 Never attempt to connect the QT ECG Recorder and its
accessories to any other device. Always follow the User Manual
instructions for safe and reliable performance. Only connect the
QT ECG Recorder with approved accessories to the device.
2.1.1.5 Never use the conductive parts of the Electrode Strip to contact
any other conductive objects, including the earth.
2.1.1.6 Keep the device away from flammables, such as, nitrous oxide and
anesthetic mixtures with oxygen and air.
2.1.1.7 To prevent potential transmission of infection or disease, the
one-time use Electrode Strip must be properly disposed of after
each use. The QT ECG Recorder may be cleaned before usage.
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Please refer to the section “Preventive Maintenance” to find
information about cleaning methods.
2.1.1.8 The QT ECG is not designed for use with high voltages or surgical
equipment. To ensure the safety of the operator and the
individual having the test, disconnect the device and all
components prior to any procedure.
2.1.1.9 The Electrode Strip may damage the skin if removed too quickly or
carelessly.
2.1.1.10 The Electrode Strip is for one-time use only. Do not reuse.
2.1.1.11 Do not place the Electrode Strip yourself. Ask someone else for
help when applying the Electrode Strip.
2.1.1.12 Once the data has been collected, remove the Electrode Strip
right away. Prolonged use of the Electrode Strip could cause
allergic reaction or skin irritation. Contact your doctor if skin
reaction persists.
2.1.1.13 To avoid strangulation and suffocation, use under adult
supervision.
2.1.1.14 The summation of electrical current leakage when a QT ECG
Recorder and a Electrode Strip are in use and interconnected is at
most 50 uA.
2.1.1.15 Remove the device if it causes discomfort.
2.1.1.16 The use of applied part (Electrode Strip) is not intended for
intracardiac use or direct cardiac application. It should not come
in direct contact with the heart.
2.1.1.17 Use of the QT ECG adjacent to or stacked with other equipment
should be avoided because it could result in improper operation
or high current leakage. If such use is necessary, the QT ECG and
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the other equipment should be observed to verify that they are
operating normally.
2.1.1.18 Use of accessories or Electrode Strip other than those specified or
provided by QT Medical of the QT ECG could result in increased
electromagnetic emissions or decreased electromagnetic
protection of the QT ECG and lead to improper functions.
2.1.1.19 Portable RF communication equipment (including peripherals
such as antenna cables and external antennas) should be used no
closer than 30 cm (12 inches) to any part of the QT ECG including
Electrode Strip. Otherwise, degradation of the performance of the
QT ECG could result.
2.1.2 Cautions
2.1.2.1 Only use the device in environments described in the User
Manual. Avoid presence of equipment with electromagnetic
interference such as microwave ovens, radios, televisions, etc.
The electromagnetic interference can degrade the performance of
the device.
2.1.2.2 If the QT ECG is used in an environment with ESD (ElectroStatic
Discharge), the ESD signal may interfere with ECG signals. Try to
avoid this kind of environment.
2.1.2.3 Do not take apart the device or alter any component. For
technical assistance please contact QT Medical.
2.1.2.4 For cybersecurity purposes, user should run regular virus checks
on the mobile device.
2.1.2.5 Only use the QT ECG with compatible firmware as specified in the
User Manual.
2.1.2.6 Follow the User Manual when connecting the device to its
components. Assure all accessories and device are properly
connected.
2.1.2.7 Cleaning the device incorrectly or exposure to cleanser and
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disinfectant can damage the device. Please follow the cleaning
instructions carefully.
2.1.2.8 Do not use non-recommended cleaning or disinfection solutions
with the QT ECG Recorder and its accessories. Please follow the
cleaning instructions carefully.
2.1.2.9 Do not attempt to autoclave or sterilize the QT ECG Recorder and
its accessories.
2.1.2.10 Do not attempt to charge the QT ECG Recorder when it is
connected to the Electrode Strip.
2.1.2.11 The Electrode Strip should be applied only to intact, clean skin
(e.g., not over open wounds, lesions, infected, or inflamed areas).
2.1.2.12 Avoid using the QT ECG when it is in the presence of equipment
with known electromagnetic interference, such as MRI, CT, and
ultrasound machines. Such equipment may affect the quality of
signals recorded by the QT ECG. A list of advice to avoid or
minimize the interference is noted in the Appendix.
2.1.2.13 Do not open the Electrode Strip package until time of use. If not
stored properly, the Electrode Strip might dry out, which can
result in poor conductivity and poor quality data.
2.1.2.14 Once the Electrode Strip package is opened, use it as soon as
possible. Keep it away from lint and dust, which may result in
poor conductivity and poor quality data. Keep it away from
children and pets to avoid damage.
2.1.2.15 Keep the device away from exposure to direct sunlight.
2.1.2.16 Follow storage condition instructions as described in the User
Manual. Make sure the storage environment is appropriate.
2.1.2.17 If necessary, contact local authorities to determine the proper
method of disposal for potentially biohazardous parts and
accessories.
2.2 Note
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2.2.1 Federal law restricts sale of this device by or on the order of a physician.
2.2.2 The device does not require calibration.
2.2.3 The QT ECG is not intended for treatment or monitoring. It captures data
that reflect the patient’s physiological condition. The data can be shared
with the patient after it has been reviewed and analyzed by a cardiologist
or trained physician.
2.2.4 Always use the latest version of the QT ECG App
2.2.5 Before placing the Electrode Strip on the patient’s chest, locate the
landmarks on the chest as described in the User Manual or quick guide. A
misplaced Electrode Strip can lead to inaccurate results.
2.2.6 When necessary, properly dispose of the Electrode Strip after use in
compliance with local regulations.
2.2.7 The ECG data displayed on the mobile device is 500 Hz. A computer or
server based diagnostic report, can display up to 1000 Hz should the
physician need higher resolution data.
2.2.8 Patients should remain as still as possible when collecting ECG data.
Excessive patient movement can lead to poor quality data.
2.2.9 For optimal data collection, the patient’s skin should be free of oil and/or
lotions before placing the Electrode Strip on the chest.
2.2.10 Please charge the device fully before the first use.
2.2.11 The Electrode Strip should only be used in consultation with QT Medical,
Inc. or a health care provider familiar with its proper placement and use.
2.2.12 The Electrode Strip should be replaced if the adhesive patches can no
longer attach firmly to the skin.
2.2.13 Please consult your healthcare provider for assistance with choosing the
proper Electrode Strip size and fit. The Electrode Strip is designed to fit
adult, pediatric and newborn patients.
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15

3. PRIOR TO OPERATION
3.1 Know your Unit
Your package contains the following items:
A. QT ECG Recorder
B. Quick Guide
C. Wall Charger
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The Electrode Strip is packaged and sold separately
17

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3.1.1 QT ECG Recorder (Main Device)
The three-view diagram of the QT ECG Recorder is shown in Fig 3.1.1a To
turn on/off the QT ECG Recorder, press and hold the power button for 5
seconds. The Power (PWR) LED indicator will turn solid green when the
power is on. The QT ECG Recorder has two ports; one is used to connect
with the Electrode Strip, and the other is used for charging with a Micro
USB wall charger (Fig 3.1.1b & Fig 3.1.1c). Do not attempt to charge and
plug-in the Electrode Strip at the same time. Do not use any charger
other than the one provided in the original case. Do not attempt to
connect the QT ECG Recorder with any other cable, connector or power
cord because such practice can damage the QT ECG Recorder.
There are three LED indicators; PWR, CON and REC which indicate the
device status.
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