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
2

– 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.
3

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.
4

“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.
5

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.
6

"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
7

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
8

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
9

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.
10