QT Medical QT ECG Recorder User manual
QT ECG RECORDER
USER’S MANUAL
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Table of content
Important Warnings 2
Introduction 3
1.1 System Description 3
1.2 Indication for Use 4
1.3 Intended Use 4
1.4 Contraindications 4
1.5 Environment 4
1.6 Symbols 5
Safety Information 10
2.1 Warnings 10
2.2 Cautions 11
2.3 Note 13
Prior to Operation 14
3.1 Know your Unit 14
3.2 Patient Preparation 25
Operating Procedures 26
4.1 Attaching the Electrode Strip 26
4.2 Connecting the QT ECG Recorder 27
4.3 Recording the ECG 29
Preventive Maintenance 29
5.1 QT ECG Recorder 29
5.2 QT ECG Electrode Strip 29
5.3 Wall Charger 29
Troubleshooting 30
6.1 QT ECG Recorder 30
6.2 QT ECG Electrode Strip 31
Customer Service Support 32
Warranty 33
Appendix A. FCC Statement 33
Appendix B. IC Statement 34
Appendix C. Advice for Electromagnetic Interference 34
Appendix D. Compliance for Emissions and Immunity Standard 38
Appendix E. WIRELESS TECHNOLOGY 39
2
Important Warnings
Caution: Federal law restricts this device to sale by or on the order of a
licensed medical practitioner.
This device is not defibrillator-proof.
environment.
Do not try to charge the QT ECG Recorder while it is connected to the
Electrode Strip.
Read this manual thoroughly before using the QT ECG system. 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
transmission of infection or disease, dispose of the Electrode Strip properly
after each use. Contact your local authorities for the proper disposal method
of potential bio-hazardous materials.
Always use the latest version of the QT ECG App.
If you have a history of sensitive skin or allergy, consult your doctor before
using Electrode Strip.
To avoid contact irritation, patients with large breasts should place a piece
of gauze or a soft cloth between the underside of the left breast and the top
edge of the Electrode Strip.
3
Introduction
1.1 System Description
This user’s manual provides information about the QT ECG system and
instructions on how to use it.
system with Bluetooth connectivity. The QT ECG system consists of 5 major
components:
The QT ECG Recorder
Compact device that records 12-lead, resting electrocardiograms and
transmits the recorded data to a mobile device (smartphone, tablet, etc.) via
Bluetooth. A Bluetooth-enabled mobile device (not included) is required in
order to operate the QT ECG Recorder.
The Electrode Strip
Disposable, patented electrodes that are prepositioned on a self-adhesive
strip.
The QT ECG App
Software that allows you to use your mobile device to operate the QT ECG
recorder. You can send the recorded data to the cloud for a certified medical
professional to review.
Analysis
The analysis module provides ECG measurement from the collected data.
Web Service
The web service provides an interface for communication.
Note : To use the QT ECG system, you need a Bluetooth-enabled mobile device.
Warning :
Use only manufacturer-approved accessories.
The QT ECG system is not intended for treatment or monitoring. It captures data
that reflects the patient’s physiological condition. The data must be reviewed and
analyzed by a cardiologist or trained physician before a diagnosis is made.
4
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
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 near real-time to enable review at a physician's office,
hospital or other medical centers.
1.3 Intended Use
The QT ECG System is intended to condition an electrocardiographic signal
so that it can be transmitted digitally via Bluetooth technology and cell-
phone or communication device to a remote location.. The QT ECG System is
designed to be used by a patient or another layperson or a healthcare worker
to transmit a 12-lead ECG and rhythm strip in near real-time to enable review
at a physician’s office, hospital, or other medical centers.
1.4 Contraindications
Sensitive skin, allergy, or open wound.
1.5 Environment
The QT ECG system is designed for home use and for use in non-acute
care clinical settings. No professional medical training is required to use this
system.
5
1.6 Symbols
The following symbols are used in this manual and on the product and/or
packaging:
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.
The degree of protection
provided by the enclosure from
particulate matter and water.
First Number: 2 indicates
protection against object sized
objects)
Second Number: 2 indicates the
enclosure has a protection level
of “water jet”. Vertically dripping
water shall have no harmful effect
when the enclosure is tilted at an
position.
operating instructions.
device to a magnetic resonance
The QT ECG Recorder
Symbol/Marking Description
6
The WEEE symbol, indicating
Waste of Electrical and Electronic
Equipment.
NCC Declaration of Conformity
mark. Certification mark
employed on electronic products
manufactured or sold in the
certifies that the electromagnetic
interference from the device is
under limits approved by the
NCC.
FCC ID is a unique identifier
assigned to a device registered
with the United States Federal
Communications Commission.
IC ID is the product ID assigned
by Industry Canada to identify
wireless products in the Canadian
market.
Bluetooth wireless technology
incorporated.
Non-ionizing radiation.
number.
Model Number: QTERD100
The QT ECG Recorder
Symbol/Marking Description
7
name and the address of the
manufacturer.
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: temperature range.
reference number of product,
same as model number.
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.
Storage and transportation
conditions: pressure range.
Storage and transportation
conditions: humidity range.
The QT ECG Recorder
Symbol/Marking Description
93%
10%
8
manufacturer's serial number.
and charging status.
Bluetooth connection status
mobile computing device.
voltage and current.
Power Button: Press and hold for
5 seconds to turn on/off the QT
recording status of the QT ECG
The QT ECG Recorder
Symbol/Marking Description
9
Do not use if package is
damaged.
Date of manufacture.
General warning sign.
Keep away from sunlight.
The QT ECG Electrode Strip
Symbol/Marking Description
number or batch code.
Do not reuse.
Safety Information
2.1 Warnings
Make sure you are familiar with the safety information in this section before
using the QT ECG system. Pay attention to all warnings and cautions to avoid
personal injury and/or equipment damage.
2.1.1. Inspection: Visually inspect the QT ECG system and all accessories to
use. Do not use if any COMPONENTS ARE DAMAGED.
2.1.2. The QT ECG system is not defibrillator-proof. Remove the QT ECG
system from the patient’s body before using any high voltage device
2.1.3. No modification of this equipment is allowed.
2.1.4. Never attempt to connect the QT ECG Recorder and its accessories
to any other device. Only use manufacturer-approved accessories to
connect with the QT ECG recorder.
2.1.5. Never use the conductive parts of the QT ECG Electrode Strip to contact
any other conductive objects, including the earth.
2.1.6. Keep the device away from flammables, such as nitrous oxide and
anesthetic mixtures with oxygen and air.
2.1.7. To prevent potential transmission of infection or disease, the one-time
use QT ECG Electrode Strip must be properly disposed of after each use.
The QT ECG Recorder may be cleaned before usage. refer to the section
“Preventive Maintenance” to find information about cleaning methods.
2.1.8. The QT ECG system is not designed for use with high voltages or
surgical equipment. To ensure the safety of the operator and the
Patient, disconnect the device and all components prior to any medical
procedure.
2.1.9. The QT ECG Electrode Strip may damage the skin if removed abruptly or
carelessly.
Indicates a potentially hazardous situation which, if
not avoided, could result in personal injury.
Indicates a potentially hazardous situation which, if
not avoided, may result in damage to the equipment
or other property.
2.1.10. The QT ECG Electrode Strip is for one-time use only. Do not reuse.
2.1.11. Once the data has been collected, remove the QT ECG Electrode Strip
right away. Prolonged use of the QT ECG Electrode Strip may cause
allergic reaction or skin irritation. Contact your doctor if you have an
allergic reaction or if skin irritation persists.
2.1.12. To avoid strangulation and suffocation, use under adult supervision.
2.1.13. The summation of electrical current leakage when a QT ECG Recorder
and a QT ECG Electrode Strip are in use and interconnected is at most 50
uA.
2.1.14. Remove the device if it causes any physical discomfort.
2.1.15. The QT ECG Electrode Strip is not intended for intracardiac use or direct
cardiac application. It should not come in direct contact with the heart.
2.1.16. Use of the QT ECG system 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 system and the other
equipment should be monitored to verify that they are operating normally.
2.1.17. Use of accessories or the QT ECG Electrode Strip other than those specified
or provided by QT Medical could result in increased electromagnetic
emissions or decreased electromagnetic protection of the QT ECG system
and lead to improper functions.
2.1.18. Do not use Portable RF communication equipment (including peripherals
such as antenna cables and external antennas) within 30 cm (12 inches) of
any part of the QT ECG system including the QT ECG Electrode Strip. Radio
Frequencies may degrade the performance of the QT ECG system.
2.1.19. If you have any service or maintenance issue when in use, please contact QT
Medical customer service support.
2.2 Cautions
2.2.1. Only use the device in environments described in the User’s Manual.
Do not use the QT ECG system in close proximity of equipment with
electromagnetic interference such as microwave ovens, radios,
televisions, etc. The electromagnetic interference can degrade the
performance of the device.
2.2.2.
Discharge), the ESD signal may interfere with ECG signals. Try to avoid
this kind of environment. No modification of this equipment is allowed.
2.2.3. Do not take apart the device or alter any component. For technical
assistance please contact QT Medical.
2.2.4. For cybersecurity purposes, users should run regular virus checks on the
mobile device.
2.2.5. Only use the QT ECG Recorder with compatible firmware as specified
in the User’s Manual.
2.2.6. Follow the User’s Manual when connecting the device to its
components. Ensure all accessories and the device are properly
connected.
2.2.7. Cleaning the device incorrectly or exposure to harsh or abrasive
cleanser and disinfectant can damage the device. Please follow the
cleaning instructions carefully.
2.2.8. Do not use non-recommended cleaning or disinfection solutions with
the QT ECG Recorder and its accessories. Please follow the cleaning
instructions carefully.
2.2.9. Do not attempt to autoclave or sterilize the QT ECG Recorder and its
accessories.
2.2.10. Do not attempt to charge the QT ECG Recorder when it is connected to
the QT ECG Electrode Strip.
2.2.11. The QT ECG Electrode Strip should be applied only to intact, clean skin (i.e.,
not over open wounds, lesions, infected, or inflamed areas).
2.2.12. Avoid using the QT ECG system 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 system.
2.2.13. Do not open the QT ECG Electrode Strip package until time of use. If not
stored properly, the QT ECG Electrode Strip might dry out, which can
result in poor conductivity and poor data quality.
2.2.14. Once the QT ECG 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 data quality. Keep it away from children and pets to
avoid damage.
2.2.15. Keep the device away from prolonged exposure to direct sunlight.
2.2.16. Follow storage condition instructions as described in the User’s Manual.
Make sure the storage environment is appropriate.
2.2.17. If necessary, contact local authorities to determine the proper method of
disposal for potentially biohazardous parts and accessories.
2.2.18. Charge the QT ECG Recorder fully (approximately 1.5 hours) before first use.
2.2.19. Charge the QT ECG Recorder regularly, before the battery is depleted of
power. Keeping the battery at a low charge for a prolonged period of time
will damage the battery.
2.2.20. The battery in the QT ECG Recorder may be charged approximately 300
times. If you have questions or concerns about the battery, please contact
QT Medical customer support.
2.3 Note
2.3.1. Caution: Federal law restricts this device to sale by or on the order of a
licensed medical practitioner.
2.3.2. The device does not require calibration.
2.3.3. Always use the latest version of the QT ECG App.
2.3.4. Before placing the QT ECG Electrode Strip on the patient’s chest, locate the
landmarks on the chest as described in the User’s Manual or Quick Guide. A
misplaced QT ECG Electrode Strip can lead to inaccurate results.
2.3.5. The diagnostic report renders ECG data in 1000-hz temporal resolution.
2.3.6. Patients should remain as still as possible when performing an ecg test.
Excessive patient movement can lead to poor quality data.
2.3.7. For optimal data collection, the patient’s skin should be free of oil and/or
lotions before placing the QT ECG Electrode Strip on the chest.
2.3.8. When the battery level drops below 20%, charge the unit immediately.
Depleting the charge will damage the battery.
2.3.9. The QT ECG Electrode Strip should only be used in consultation with QT
Medical, Inc. or a healthcare provider familiar with its proper placement and
use.
2.3.10. The QT ECG Electrode Strip should be replaced if the adhesive patches can
no longer attach firmly to the skin.
2.3.11. Consult your healthcare provider for assistance with choosing the proper QT
ECG Electrode Strip size and fit. The QT ECG Electrode Strip is designed to
3.1 Know your Unit
Your package contains the following items:
Quick Guide
PCA500
D.
C.
Fig. 3.1 a
The QT ECG Recorder can be used with the following:
a. Electrode Strip (packaged and sold separately)
a.
Fig. 3.1 b
The three-view diagram of the QT ECG Recorder is shown in Fig 3.1.1a.
Fig. 3.1.1a
Warning :
the same time.
Do not use any charger other than the one provided in the original case.
To avoid risk of product damage, do not attempt to connect the QT ECG
Fig. 3.1.1b
Power Button : To turn on/off the QT ECG Recorder, press and hold the
green when the power is on.
Micro USB Port : Used for charging the QT ECG Recorder with the wall charger
(included) (Fig. 3.1.1b)
C. Recorder Receptacle : Used to connect with the QT ECG Electrode Strip
Connector (Fig. 3.1.2b)
D. LED Indicators :
indicate the device status.
LED Indicators PWR LED CON LED REC LED
Green: Powered on
or the battery is
fully charged
Soft white: battery
charging
Blue: Connected
Power off
Blink
Battery
Blue: Bluetooth
is not connected,
ready to connect
Blink Fast
Feature Specification
Brand Name QT ECG
Dimension
Weight 67 g
Polycarbonate
Wireless Technology
the QT ECG Electrode Strip)
Physical Button
Battery
Battery Charge Time
Feature Specification
Battery Charging Procedure
the recorder
Not user-replaceable
Charging Indicator Soft white
Blinking green
6 months
Note: It is recommended to charge the
5 years
Channel Skew
Simultaneous sampling on all channels
24-bit
Quantization Error
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