QT Medical QTERD100 QT ECG User Manual Manual

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Document Title	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
– 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.
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
incorporated
technology
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.
“REFER TO MANUAL”:
operating​ ​instructions
Follow
“MR-unsafe”: Do not expose the device
to
magnetic resonance (MR)
environment.
The degree of protection provided by
the enclosure from particulate
matter​ ​and​ ​water.
2 represents 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.
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”:
catalogue​ ​number​ ​of​ ​product.
The
"BATCH CODE": The manufacturer's
batch​ ​code.
"SERIAL
NUMBER":
manufacturer's​ ​serial​ ​number.
The
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
CON
REC
The PWR LED indicates the power
and​ ​charging​ ​status.
The CON LED indicates the
connecting status of the QT ECG ECG
Recorder to the mobile computing
device.
The REC LED indicates the recording
status​ ​of​ ​the​ ​recorder.
Electrode​ ​Strip
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
Storage
and
Temperature​ ​Limit
transportation
Storage
and
transportation
conditions:​ ​humidity​ ​range
Storage
and
transportation
conditions:​ ​pressure​ ​range
Date​ ​of​ ​manufacture
“CATALOGUE
NUMBER”:
catalogue​ ​number​ ​of​ ​product.
The
"BATCH CODE": The manufacturer's
batch​ ​code.
2.​ ​SAFETY​ ​INFORMATION
Make​ ​sure​ ​you​ ​are​ ​familiar​ ​with​ ​the​ ​safety​ ​information​ ​in​ ​this​ ​section​ ​before​ ​using
the​ ​QT​ ​ECG.​ ​Pay​ ​attention​ ​to​ ​all​ ​warnings​ ​and​ ​cautions​ ​to​ ​avoid​ ​personal​ ​injury
and/or​ ​equipment​ ​damage.
WARNING
CAUTION
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 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
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
11
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
12
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
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
13
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.
14
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​ C
​ harger
16
The​ ​Electrode​ ​Strip​ ​is​ ​packaged​ ​and​ ​sold​ ​separately
17
18
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.
19
20
21
Fig​ ​3.1.1c
A. Power​ ​Button:​​ ​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.
B. Micro​ ​USB​ ​Port:​​ ​Used​ ​for​ ​charging​ ​the​ ​QT​ ​ECG​ ​Recorder​ ​with​ ​the​ ​wall
charger
C. Recorder​ ​Receptacle:​​ ​Used​ ​to​ ​connect​ ​with​ ​the​ ​Electrode​ ​Strip
D. LED​ ​Indicators
LED
Indicators
ON
OFF
Blink
Fast​ ​Blink
Table​ ​3.1.1a​ ​Specification​ ​of​ ​the​ ​QT​ ​ECG​ ​Recorder
PWR(RGB)
CON(BLUE)
REC(Amber)
Green:​ ​Power​ ​on​ ​or​ ​Charging
complete
Softe​ ​white:​ ​charging
BLE​ ​connected
No​ ​information
BLE
disconnected/Advertising
Record
ongoing
Power​ ​off
Green:​ ​Low​ ​Battery​ ​<​ ​10%
Red:​ ​System​ ​error
No​ ​information
No​ ​information
No​ ​information
No​ ​information
Table​ ​3.1.1b​ ​Specification​ ​of​ ​the​ ​QT​ ​ECG​ ​Recorder
Feature
22
Specification
Brand​ ​Name
QT​ ​ECG
Model​ ​Number
QTERD100
Dimension
72.00x68.02x18.60​ ​mm​ ​(2.83​ ​x​ ​2.68​ ​x
0.735​ ​in)
Weight
85​ ​g
Enclosure​ ​Material
Polycarbonate
Wireless​ ​Technology
Bluetooth​ ​4.0​ ​dual​ ​mode
Operation​ ​frequency​ ​range:​ ​2.402​ ​GHz
<->​ ​2.480​ ​GHz​ ​(BLE);​ ​2,402MHz​ ​to​ ​2,480
MHz​ ​(BT)
LED
PWR:​ ​Power/Status​ ​LED​ ​(RGB)
CON:​ ​Connection​ ​LED​ ​(Blue)
REC:​ ​Recording​ ​LED​ ​(Amber)
External​ ​Port
Micro​ ​USB​ ​port​ ​of​ ​the​ ​recorder
(charging​ ​port)
Recorder​ ​Receptacle​ ​(connect​ ​with​ ​the
Electrode​ ​Strip)
Physical​ ​Button
Power​ ​On/Off​ ​switch
Battery
Rechargeable​ ​lithium-ion​ ​polymer
battery,​ ​3.7​ ​V,​ ​700​ ​mAh
23
Battery​ ​Charge​ ​Time
1.5​ ​hours
Battery​ ​Operating​ ​Time
17​ ​hours​ ​of​ ​continuous​ ​use
24​ ​hours​ ​of​ ​normal​ ​use​ ​(use:​ ​standby​ ​=
1:5)
with​ ​new​ ​battery
Battery​ ​Charging​ ​Procedure
Connect​ ​the​ ​QT​ ​ECG​ ​Recorder​ ​to​ ​wall
charger​ ​through​ ​the​ ​Micro​ ​USB​ ​port​ ​of
the​ ​recorder
Battery​ ​Replacement
Irreplaceable
Charging​ ​Indicator
Solid​ ​white
Low​ ​Battery​ ​Indicator
Blinking​ ​green
Service​ ​Life
Battery:​ ​≥​ ​300​ ​cycle
The​ ​QT​ ​ECG​ ​Recorder:​ ​5​ ​years
Signal​ ​Sampling​ ​Rate
1000​ ​Hz
Channel​ ​Skew
Acquisition​ ​Mode
Simultaneous​ ​sampling​ ​approach​ ​for
each​ ​channel
A/D​ ​Resolution
24-bit
Quantization​ ​Error
0.047​ ​uV/LSB
Frequency​ ​Response
0.05​ ​to​ ​150​ ​Hz
24
Triangle​ ​Response
6%​ ​maximum​ ​reduction​ ​20​ ​ms​ ​vs​ ​200
ms​ ​triangle​ ​wave
Filters
Default​ ​off.
Input​ ​Impedance
6.875​ ​MΩ
DC-offset​ ​Voltage
+/-​ ​399​ ​mV
Multichannel​ ​Crosstalk
≤15​ ​uV
CMRR
97​ ​dB
Noise​ ​Level
≤10​ ​uV
Overload​ ​Tolerance
Up​ ​to​ ​1​ ​V
Wireless​ ​Distance
20-30​ ​m
Bluetooth​ ​Transmission​ ​Rate
3​ ​Mbps
Standard​ ​Leads​ ​Acquired
I,​ ​II,​ ​III,​ ​aVR,​ ​aVL,​ ​aVF,​ ​V1,​ ​V2,​ ​V3,​ ​V4,
V5,​ ​V6
Sensitivity
5,​ ​10,​ ​20​ ​mm/mV​ ​auto​ ​(I~aVF:​ ​10
mm/mV,​ ​V1~V6:​ ​5​ ​mm/mV)
Calibration
Automatic
Data​ ​Storage
In​ ​mobile​ ​device
Lead-off​ ​Detection
Yes
25
Pacemaker​ ​Detection
Yes
Operating​ ​Temperature
5~40°C;​ ​41~104ºF
Operating​ ​Relative​ ​Humidity
15%​ ​–​ ​93%,​ ​Non-condensing
Operating​ ​Atmospheric​ ​Pressure
700​ ​hPa​ ​–​ ​1060​ ​hPa
Storage​ ​and​ ​Transport​ ​Temperature
-25~70ºC;​ ​-13~158ºF
Storage​ ​and​ ​Transport​ ​Relative
10%​ ​–​ ​93%,​ ​Non-condensing
Humidity
Storage​ ​and​ ​Transport​ ​Atmospheric
700​ ​hPa​ ​–​ ​1060​ ​hPa
Pressure
Charge​ ​Temperature
3.1.2 QT​ ​ECG​ ​Electrode​ ​Strip
0~55ºC;​ ​32~131ºF
The​ ​Electrode​ ​Strip​ ​is​ ​a​ ​self-adhesive,​ ​one-piece​ ​integrated​ ​electrode
system.​ ​It​ ​attaches​ ​to​ ​the​ ​body​ ​and​ ​plugs​ ​into​ ​the​ ​QT​ ​ECG​ ​Recorder​ ​as
shown​ ​in​ ​figure​ ​3.1.2a.
26
Fig.​ ​3.1.2a
The​ ​Electrode​ ​Strip​ ​comes​ ​in​ ​4​ ​different​ ​sizes,​ ​depending​ ​on​ ​body​ ​size
and​ ​shape.​ ​Find​ ​the​ ​right​ ​size​ ​by​ ​using​ ​the​ ​sizing​ ​chart​ ​(Table​ ​3.1.2a).
Table​ ​3.1.2a
Size
Shoulder​ ​width​ ​(cm)
28-36
36-40
40-46
XL
>46
Warning:​ ​The​ ​Electrode​ ​Strip​ ​is​ ​not​ ​defibrillator-proof.​ ​Do​ ​not​ ​use​ ​high
27
voltage​ ​device​ ​such​ ​as​ ​AED​ ​while​ ​the​ ​Electrode​ ​Strip​ ​is​ ​still​ ​attached​ ​to
the​ ​body.
Caution:​ ​The​ ​Electrode​ ​Strip​ ​shelf​ ​life​ ​is​ ​one​ ​year.​ ​Do​ ​not​ ​use​ ​if​ ​past
expiration​ ​date.
3.1.3 Wall​ ​Charger
This​ ​medical​ ​grade​ ​AC-to-DC​ ​power​ ​adapter​ ​provides​ ​external​ ​isolation
from​ ​AC​ ​mains.​ ​Use​ ​the​ ​wall​ ​charger​ ​provided​ ​to​ ​charge​ ​your​ ​QT​ ​ECG
Recorder.​ ​Use​ ​only​ ​100-240v​ ​wall​ ​socket-outlet.
Warning:​ ​Do​ ​not​ ​use​ ​any​ ​external​ ​power​ ​supply​ ​such​ ​as​ ​portable
battery​ ​charger​ ​or​ ​PC​ ​to​ ​charge​ ​the​ ​QT​ ​ECG​ ​Recorder
Caution:​ ​Use​ ​only​ ​wall​ ​charger​ ​provide​ ​by​ ​QT​ ​Medical.​ ​If​ ​your​ ​wall
charger​ ​is​ ​lost,​ ​contact​ ​support@QTMedical.com​​ ​for​ ​replacement.
3.1.4 QT​ ​ECG​ ​App
The​ ​QT​ ​ECG​ ​App​ ​is​ ​an​ ​integral​ ​part​ ​of​ ​the​ ​QT​ ​ECG​ ​system.​ ​It​ ​works​ ​with
most​ ​Apple​ ​and​ ​Android-based​ ​mobile​ ​devices.​​ ​See​ ​Table#​ ​on​ ​page​ ​#​ ​for
a​ ​list​ ​of​ ​compatible​ ​devices.​ ​To​ ​see​ ​how​ ​this​ ​app​ ​works,​ ​watch​ ​our​ ​video
tutorial​ ​(URL).
Warning:​ ​Always​ ​use​ ​the​ ​latest​ ​version​ ​of​ ​the​ ​QT​ ​ECG​ ​App.
Warning:​ ​Run​ ​virus​ ​scan​ ​regularly​ ​on​ ​your​ ​mobile​ ​device.
3.2​ ​System​ ​Setup
A​ ​one-time​ ​setup​ ​is​ ​required​ ​before​ ​you​ ​can​ ​begin​ ​using​ ​the​ ​QT​ ​ECG​ ​system.​ ​Have​ ​your
28
Bluetooth-enabled​ ​mobile​ ​device​ ​and​ ​the​ ​QT​ ​ECG​ ​Recorder​ ​ready,​ ​then​ ​follow​ ​the
steps​ ​below:
1.​ ​New​ ​User​ ​Registration
Email​ ​the​ ​serial​ ​number​ ​of​ ​your​ ​QT​ ​ECG​ ​Recorder​ ​to​ ​service@QTMedical.com​.​ ​Your
username​ ​and​ ​password​ ​will​ ​be​ ​emailed​ ​to​ ​you​ ​after​ ​your​ ​unit​ ​is​ ​registered
2.​ ​Download​ ​the​ ​Mobile​ ​App
Download​ ​the​ ​QT​ ​ECG​ ​App​ ​from​ ​the​ ​Apple​ ​App​ ​store​ ​or​ ​Google​ ​Play
3.​​ ​Log-in
Open​ ​the​ ​QT​ ​ECG​ ​App​ ​on​ ​your​ ​mobile​ ​device​ ​and​ ​login​ ​using​ ​the​ ​username​ ​and
password​ ​provided​ ​in​ ​step​ ​1​ ​above.
4.​ ​Bluetooth​ ​Pairing
I. While​ ​the​ ​App​ ​is​ ​open​ ​on​ ​your​ ​mobile​ ​device​ ​and​ ​you​ ​are​ ​logged​ ​into​ ​your
account,​ ​turn​ ​on​ ​your​ ​QT​ ​ECG​ ​Recorder​ ​by​ ​pressing​ ​down​ ​on​ ​the​ ​power​ ​button
for​ ​5​ ​seconds​ ​until​ ​the​ ​PWR​ ​indicator​ ​light​ ​turns​ ​solid​ ​green.
II. Tap​ ​the​ ​“Connect”​ ​button​ ​shown​ ​in​ ​the​ ​QT​ ​ECG​ ​App​ ​on​ ​your​ ​mobile​ ​device,
which​ ​will​ ​begin​ ​scanning​ ​for​ ​the​ ​QT​ ​ECG​ ​Recorder.
III. When​ ​the​ ​CON​ ​indicator​ ​light​ ​turns​ ​solid​ ​blue,​ ​the​ ​units​ ​are​ ​paired.
5.​ ​Enter​ ​Patient​ ​Profile
3.3​ ​Equipment​ ​Preparation
Charge​ ​the​ ​QT​ ​ECG​ ​Recorder​ ​fully​ ​before​ ​the​ ​first​ ​use.
Warning:​ ​Visually​ ​inspect​ ​the​ ​QT​ ​ECG​ ​and​ ​all​ ​accessories​ ​before​ ​use.​ ​Do​ ​not
use​ ​if​ ​any​ ​component​ ​appears​ ​damaged.​ ​For​ ​support​ ​contact
service@QTmedical.com
3.4​ ​Patient​ ​Preparation
● Make​ ​sure​ ​the​ ​skin​ ​on​ ​the​ ​chest​ ​is​ ​clean​ ​and​​ ​dry,​ ​free​ ​of​ ​lotion​ ​or​ ​oil.​ ​For
males​ ​with​ ​lots​ ​of​​ ​hair​ ​on​ ​the​ ​chest,​ ​shave​ ​the​ ​chest​ ​along​ ​the​​ ​area
indicated
29
● The​ ​patient​ ​should​ ​rest​ ​(sit
still​ ​or​ ​lie​ ​down)​ ​for​ ​at​ ​least​ ​5​ ​minutes
before​ ​taking​ ​an​ ​ECG​ ​recording.
3.5​ ​Selecting​ ​Electrode​ ​Strip​ ​Size
The​ ​Electrode​ ​Strips​ ​come​ ​in​ ​4​ ​different​ ​sizes.​ ​Use​ ​the​ ​sizing​ ​chart​ ​below​ ​to​ ​find
the​ ​size​ ​that​ ​is​ ​right​ ​for​ ​you.
4.​ ​OPERATING​ ​PROCEDURES
4.1​ ​Attaching​ ​the​ ​Electrode​ ​Strip
Warning:​ ​Do​ ​not​ ​attach​ ​the​ ​Electrode​ ​Strip​ ​onto​ ​yourself.​ ​Ask​ ​a​ ​trusted​ ​adult​ ​to​ ​help
you.
Caution:​ ​Do​ ​not​ ​tug​ ​at​ ​the​ ​cables​ ​attaching​ ​the​ ​electrodes​ ​(RA,​ ​LA,​ ​LL)​ ​to​ ​the
Electrode​ ​Strip.​ ​Keep​ ​the​ ​cables​ ​and​ ​the​ ​3​ ​external​ ​electrodes​ ​clear​ ​of​ ​the​ ​adhesive
side​ ​of​ ​the​ ​Electrode​ ​Strip.
30
1. Tear​ ​open​ ​the​ ​QT​ ​ECG​ ​Electrode​ ​Strip​ ​(Strip)​ ​package.​ ​Remove​ ​the​ ​plastic
cover​ ​to​ ​expose​ ​the​ ​sticky​ ​side​ ​of​ ​the​ ​Strip.
2. With​ ​the​ ​sticky​ ​side​ ​facing​ ​patient,​ ​place​ ​the​ ​strip​ ​on​ ​the​ ​patient’s​ ​chest.
First,​ ​position​ ​the​ ​Blue​ ​Box​ ​at​ ​the​ ​center​ ​of​ ​the​ ​chest,​ ​between​ ​the​ ​nipples.
Then,​ ​wrap​ ​the​ ​strip​ ​from​ ​the​ ​center​ ​of​ ​the​ ​chest​ ​around​ ​the​ ​left​ ​side​ ​of​ ​the
chest.​ ​The​ ​Red​ ​Arrow​ ​should​ ​be​ ​pointing​ ​to​ ​the​ ​left​ ​nipple.​ ​For​ ​females,​ ​the
Strip​ ​should​ ​go​ ​under​ ​the​ ​left​ ​breast.
If​ ​placement​ ​of​ ​the​ ​Electrode​ ​Strip​ ​needs​ ​adjustment,​ ​the​ ​Electrode​ ​Strip
31
can​ ​be​ ​lifted​ ​off​ ​for​ ​repositioning
3. Remove​ ​the​ ​adhesive​ ​backing​ ​of​ ​the​ ​other​ ​3​ ​electrodes​ ​(RA,​ ​LA,​ ​LL),​ ​one​ ​at
a​ ​time.
●
The​ ​Black​ ​electrode​ ​(LA)​ ​goes​ ​on​ ​the​ ​upper​ ​left​ ​arm​ ​of​ ​the​ ​patient
●
The​ ​White​ ​electrode​ ​(RA)​ ​goes​ ​on​ ​the​ ​upper​ ​right​ ​arm​ ​of​ ​the​ ​patient
●
The​ ​Red​ ​electrode​ ​LL​ ​goes​ ​on​ ​the​ ​left​ ​hip​ ​joint
4. Press​ ​firmly​ ​on​ ​the​ ​Electrode​ ​Strip​ ​and​ ​all​ ​electrodes​ ​to​ ​ensure​ ​the
attachments​ ​are​ ​secure
4.2​ ​Connecting​ ​the​ ​QT​ ​ECG​ ​Recorder
1. ​ ​Connect​ ​the​ ​Recorder​ ​to​ ​the​ ​Strip​ ​by​ ​inserting​ ​QT​ ​ECG​ ​into​ ​the​ ​connector
on​ ​the​ ​Electrode​ ​Strip.​ ​Insert​ ​the​ ​strip​ ​firmly​ ​until​ ​it​ ​is​ ​fully​ ​attached.
32
2. Do​ ​not​ ​directly​ ​place​ ​QT​ ​ECG​ ​on​ ​the​ ​body,​ ​use​ ​a​ ​gauze​ ​pad​ ​to​ ​separate​ ​the
device​ ​with​ ​the​ ​skin.
3. Press​ ​and​ ​hold​ ​the​ ​Power​ ​button​ ​for​ ​5​ ​seconds​ ​to​ ​turn​ ​on​ ​the​ ​QT​ ​ECG
Recorder.
4. The​ ​Recorder​ ​is​ ​recording​ ​when​ ​Power​ ​(PWR)​ ​is​ ​Green,​ ​Connection​ ​(CON)
is​ ​Blue,​ ​and​ ​Recording​ ​(REC)​ ​is​ ​blinking​ ​Amber.
33
4.3​ ​Taking​ ​an​ ​ECG​ ​Recording
For​ ​the​ ​QT​ ​ECG​ ​App​ ​software​ ​operation,​ ​please​ ​see​ ​the​ ​following
●
Tap​ ​the​ ​QT​ ​ECG​ ​App​ ​icon​ ​to​ ​activation​ ​of​ ​the​ ​app
●
Log​ ​in:​​ ​Input​ ​username​ ​and​ ​password,​ ​then​ ​press​ ​the​ ​login​ ​button.
34
35
●
圖示
36
Input​ ​patient’s​ ​profile:​​ ​Click​ ​the​ ​“Patient”,​ ​to​ ​input​ ​the​ ​patient’s​ ​medical​ ​record​ ​number
(MRN,​ ​if​ ​applicable),​ ​Name,​ ​DOB,​ ​Electrode​ ​Strip​ ​size.
37
●
38
Input​ ​patient’s​ ​symptoms:​​ ​Click​ ​the​ ​“Note”​ ​button​ ​to​ ​input​ ​patient’s​ ​symptoms.
39
●
圖示
40
Scan​ ​and​ ​connect​ ​QT​ ​ECG​ ​Recorder:​ ​Tap​ ​on​ ​the​ ​“Connect”​ ​button,​ ​device​ ​will
scan​ ​for​ ​the​ ​recorder.​ ​If​ ​found,​ ​the​ ​device​ ​will​ ​automatically​ ​connect​ ​and
start​ ​receiving​ ​signals​ ​from​ ​the​ ​QT​ ​ECG​ ​Recorder
41
●
圖示
42
Check​ ​lead-off:​ ​The​ ​screen​ ​displays​ ​the​ ​status​ ​of​ ​all​ ​leads​ ​on​ ​the​ ​user’s​ ​chest.​ ​ ​Check
the​ ​”Lead”​ ​button,​ ​make​ ​sure​ ​all​ ​the​ ​leads​ ​are​ ​in​ ​green​ ​color.​ ​If​ ​“Lead​ ​off”
alert​ ​is​ ​shown​ ​(amber),​ ​please​ ​trouble-​ ​shoot​ ​the​ ​electrode​ ​attachment.
Refer​ ​to​ ​the​ ​User​ ​Manual​ ​if​ ​needed.
● Record​ ​ECG​ ​Data​:​ ​An​ ​ECG​ ​tracing​ ​will​ ​be​ ​displayed​ ​on​ ​the​ ​screen.​ ​Tap​ ​on
the​ ​“Record”​ ​button.​ ​The​ ​ECG​ ​will​ ​be​ ​recorded.
圖示
43
● Upload​ ​ECG​ ​file:​ ​When​ ​record​ ​ECG​ ​complete,​ ​app​ ​will​ ​upload​ ​ECG​ ​file
automatically.
● ECG​ ​file​ ​list:​ ​If​ ​upload​ ​ECG​ ​file​ ​complete,​ ​you​ ​can​ ​tap​ ​”Open​ ​File”
button​ ​to​ ​get​ ​the​ ​file​ ​list.
44
45
● Detail​ ​view:​ ​Click​ ​the​ ​"Detail"​ ​button,​ ​you​ ​can​ ​get​ ​more​ ​than​ ​12​ ​ECG
details.​ ​And​ ​can​ ​use​ ​the​ ​caliper​ ​to​ ​measure​ ​the​ ​value​ ​of​ ​each​ ​point.
46
47
● Add​ ​comment:​ ​Click​ ​the​ ​“New​ ​Comment”​ ​button,​ ​you​ ​can​ ​add​ ​new
comment.
48
● Serial​ ​comparison:​ ​Choose​ ​any​ ​two​ ​ECG​ ​files​ ​of​ ​the​ ​same​ ​person,​ ​and
click​ ​the​ ​"Serial​ ​comparison"​ ​button​ ​to​ ​conduct​ ​ECG​ ​comparison.
49
50
4.4​ ​Detaching​ ​the​ ​Device
After​ ​finish​ ​record​ ​ECG,​ ​disconnect​ ​the​ ​bluetooth​ ​and​ ​turn​ ​off​ ​QT​ ​ECG​ ​recorder.
5.​ ​TROUBLESHOOTING
5.1​ ​QT​ ​ECG​ ​Recorder
● Problem:​ ​PWR​ ​LED​ ​indicator​ ​does​ ​not​ ​light​ ​up​ ​during​ ​charging
○
Solution:​ ​PWR​ ​LED​ ​indicator​ ​will​ ​turn​ ​off​ ​after​ ​it​ ​is​ ​fully​ ​charged,
If​ ​the​ ​PWR​ ​LED​ ​does​ ​not​ ​light​ ​up​ ​with​ ​charging,​ ​this​ ​may​ ​indicate​ ​that
battery​ ​is​ ​fully​ ​charged.
● Problem:​ ​Unable​ ​to​ ​turn​ ​on​ ​the​ ​QT​ ​ECG​ ​Recorder
○
51
Solution:​ ​Press​ ​and​ ​hold​ ​the​ ​power​ ​button​ ​for​ ​30​ ​seconds.​ ​If
Power​ ​LED​ ​indicator​ ​still​ ​does​ ​not​ ​light​ ​up,​ ​please​ ​try​ ​again​ ​after
charging​ ​the​ ​device​ ​for​ ​1​ ​hour.
○
Solution:​ ​If​ ​above​ ​solution​ ​does​ ​not​ ​work,​ ​please​ ​contact​ ​our
customer​ ​service.
● Problem:​ ​Unable​ ​to​ ​turn​ ​off​ ​the​ ​QT​ ​ECG​ ​Recorder
○
Solution:​ ​Make​ ​sure​ ​the​ ​micro-USB​ ​cable​ ​is​ ​not​ ​connected
○
Solution:​ ​Press​ ​and​ ​hold​ ​power​ ​button​ ​for​ ​30​ ​seconds.​ ​ ​If​ ​still
unable​ ​to​ ​turn​ ​off​ ​the​ ​QT​ ​ECG​ ​Recorder,​ ​please​ ​contact​ ​our​ ​customer
service.
● Problem:​ ​Unable​ ​to​ ​connect​ ​the​ ​QT​ ​ECG​ ​Recorder​ ​to​ ​the​ ​mobile​ ​device
via​ ​Bluetooth
○
Solution:​ ​If​ ​Bluetooth​ ​is​ ​not​ ​connected​ ​when​ ​it​ ​is​ ​on,​ ​please​ ​turn
off​ ​the​ ​recorder​ ​then​ ​turn​ ​on​ ​the​ ​recorder​ ​again.
5.2​ ​QT​ ​Electrode​ ​Strip
● Problem:​ ​Package​ ​opened​ ​or​ ​damaged​ ​before​ ​use
○
Solution:​ ​Do​ ​not​ ​use​ ​the​ ​Electrode​ ​Strip,​ ​contact​ ​our​ ​customer
service​ ​for​ ​replacement.
● Problem:​ ​7​ ​chest​ ​lead​ ​electrodes​ ​or​ ​3​ ​limb​ ​lead​ ​electrodes​ ​are​ ​damaged
or​ ​missing
○
Solution:​ ​Do​ ​not​ ​use​ ​the​ ​Electrode​ ​Strip​ ​and​ ​contact​ ​our
customer​ ​service.
● Problem:​ ​Size​ ​of​ ​Electrode​ ​Strip​ ​enclosed​ ​does​ ​not​ ​match​ ​with​ ​package
labels
○
Solution:​ ​Do​ ​not​ ​use​ ​the​ ​Electrode​ ​Strip​ ​and​ ​contact​ ​our
customer​ ​service.
52
5.3​ ​QT​ ​ECG​ ​App
● Problem:​ ​Crashed​ ​during​ ​use
○
Solution:​ ​Reboot​ ​and​ ​restart,​ ​if​ ​problem​ ​persists,​ ​please​ ​contact
our​ ​customer​ ​service.
● Problem:​ ​Cannot​ ​boot​ ​up​ ​application​ ​or​ ​the​ ​app​ ​quits​ ​unexpectedly
○
Solution:​ ​Please​ ​contact​ ​our​ ​customer​ ​service.
● Problem:​ ​Application​ ​is​ ​not​ ​performing​ ​smoothly
○
Solution:​ ​Too​ ​many​ ​apps​ ​may​ ​be​ ​open​ ​and​ ​running​ ​at​ ​the​ ​same
time.​ ​Please​ ​reboot​ ​the​ ​mobile​ ​device​ ​and​ ​try​ ​again.
● Problem:​ ​All​ ​ECG​ ​tracings​ ​disappear​ ​on​ ​the​ ​display.​ ​The​ ​screen​ ​display
looks​ ​like​ ​the​ ​following:
○
Solution:​ ​The​ ​problem​ ​may​ ​be​ ​caused​ ​by​ ​system​ ​overload​ ​or
saturation.​ ​ ​Please​ ​carefully​ ​remove​ ​the​ ​Electrode​ ​Strip​ ​from​ ​the
patient’s​ ​chest​ ​and​ ​disconnect​ ​the​ ​QT​ ​ECG​ ​ECG​ ​Recorder.​ ​ ​Please​ ​restart
the​ ​entire​ ​process.​ ​If​ ​the​ ​problem​ ​persists,​ ​please​ ​contact​ ​our​ ​customer
service.
● Problem:​ ​Lead-off​ ​warning.​ ​The​ ​screen​ ​display​ ​is​ ​as​ ​follows:
○
Solution:​ ​Check​ ​the​ ​corresponding​ ​chest​ ​electrode.​ ​Make​ ​sure
the​ ​electrode​ ​is​ ​attached​ ​properly​ ​to​ ​the​ ​skin​ ​and​ ​making​ ​a​ ​good
contact.
● Problem:​ ​Low​ ​battery​ ​warning.​ ​The​ ​screen​ ​displays​ ​the​ ​following:
○
Solution:​ ​Disconnect​ ​the​ ​Recorder​ ​from​ ​the​ ​Electrode​ ​Strip,​ ​and
remove​ ​electrode​ ​from​ ​the​ ​user.​ ​Charge​ ​the​ ​QT​ ​ECG​ ​Recorder​ ​using​ ​the
wall​ ​charger​ ​with​ ​the​ ​micro-USB​ ​cable.​ ​Do​ ​not​ ​record​ ​and​ ​charge​ ​at​ ​the
same​ ​time.
5.4​ ​Others
● Problem:​ ​Cannot​ ​record​ ​ECG​ ​signals
○
53
Solution:​ ​Review​ ​the​ ​user​ ​manual​ ​to​ ​ensure​ ​all​ ​steps​ ​and
instructions​ ​are​ ​properly​ ​followed.
○
Solution:​ ​If​ ​the​ ​instructions​ ​are​ ​properly​ ​followed​ ​but​ ​the​ ​app
problem​ ​persists,​ ​please​ ​shut​ ​down​ ​the​ ​application,​ ​reboot,​ ​and​ ​try
again.
○
Solution:​ ​If​ ​instructions​ ​are​ ​followed​ ​but​ ​the​ ​problem​ ​persists,
press​ ​the​ ​power​ ​button​ ​to​ ​shut​ ​down​ ​and​ ​reboot​ ​the​ ​QT​ ​ECG​ ​Recorder
and​ ​try​ ​again.
○
Solution:​ ​If​ ​all​ ​steps​ ​are​ ​followed,​ ​but​ ​the​ ​recorder​ ​still​ ​cannot
record​ ​ECG,​ ​please​ ​contact​ ​our​ ​customer​ ​service.
● Problem:​ ​ ​Cannot​ ​find​ ​the​ ​recorder​ ​while​ ​connection
○ Solution:​ ​Check​ ​the​ ​recorder​ ​is​ ​on.
6.​ ​PREVENTIVE​ ​AND​ ​MAINTENENACE
The following sections describe how to clean and/or disinfect the QT ECG system, including
recommended cleaning and disinfecting solutions and methods. It also covers the routine
preventive​ ​maintenance​ ​for​ ​the​ ​QT​ ​ECG​ ​Recorder.
6.1​ ​QT​ ​ECG​ ​Recorder
To clean the QT ECG Recorder, dampen a soft cloth with lukewarm soapy water or natural
cleaner and gently wipe down the recorder. The QT ECG Recorder should never be
immersed in water under any circumstances. Take care not to scratch the device with
abrasive cleaners or excessively wipes on the label. The QT ECG ECG Recorder should be
gently cleansed before every use. To disinfect the QT ECG Recorder, dampen a soft cloth
with isopropyl alcohol. Regularly inspect the QT ECG Recorder for damage such as warping
or​ ​cracking.​ ​If​ ​there​ ​is​ ​any​ ​damage,​ ​please​ ​do​ ​not​ ​use​ ​it​ ​and​ ​contact​ ​the​ ​customer​ ​service.
6.2​ ​QT​ ​Electrode​ ​Strip
The​ ​Electrode​ ​Strip​ ​is​ ​for​ ​one-time​ ​use​ ​only.​ ​ ​There​ ​is​ ​no​ ​need​ ​to​ ​clean.
6.3​ ​Wall​ ​Charger
The cleaning procedure for the wall charger is the same as the QT ECG Recorder. Please
disconnect​ ​the​ ​wall​ ​charger​ ​from​ ​power​ ​sources​ ​before​ ​beginning​ ​any​ ​cleaning​ ​procedure.
54
7.​ ​TROUBLESHOOTING
7.1​ ​QT​ ​ECG​ ​Recorder
●
Problem:​ ​PWR​ ​LED​ ​indicator​ ​does​ ​not​ ​light​ ​up​ ​during​ ​charging
Solution:​ ​PWR​ ​LED​ ​indicator​ ​will​ ​turn​ ​off​ ​after​ ​it​ ​is​ ​fully​ ​charged,​ ​If​ ​the​ ​PWR​ ​LED
does​ ​not​ ​light​ ​up​ ​with​ ​charging,​ ​this​ ​may​ ​indicate​ ​that​ ​battery​ ​is​ ​fully​ ​charged.
●
Problem:​ ​Unable​ ​to​ ​turn​ ​on​ ​the​ ​QT​ ​ECG​ ​Recorder
Solution:​ ​Press​ ​and​ ​hold​ ​the​ ​power​ ​button​ ​for​ ​30​ ​seconds.​ ​If​ ​Power​ ​LED
indicator​ ​still​ ​does​ ​not​ ​light​ ​up,​ ​please​ ​try​ ​again​ ​after​ ​charging​ ​the​ ​device​ ​for​ ​1
hour.
●
Solution:​ ​If​ ​above​ ​solution​ ​does​ ​not​ ​work,​ ​please​ ​contact​ ​our​ ​customer​ ​service.
Problem:​ ​Unable​ ​to​ ​turn​ ​off​ ​the​ ​QT​ ​ECG​ ​Recorder
Solution:​ ​Make​ ​sure​ ​the​ ​micro-USB​ ​cable​ ​is​ ​not​ ​connected
Solution:​ ​Press​ ​and​ ​hold​ ​power​ ​button​ ​for​ ​30​ ​seconds.​ ​ ​If​ ​still​ ​unable​ ​to​ ​turn​ ​off
the​ ​QT​ ​ECG​ ​Recorder,​ ​please​ ​contact​ ​our​ ​customer​ ​service.
●
Problem:​ ​Unable​ ​to​ ​connect​ ​the​ ​QT​ ​ECG​ ​Recorder​ ​to​ ​the​ ​mobile​ ​device​ ​via​ ​Bluetooth
Solution:​ ​If​ ​Bluetooth​ ​is​ ​not​ ​connected​ ​when​ ​it​ ​is​ ​on,​ ​the​ ​blue​ ​CON​ ​LED​ ​indicator
will​ ​blink.​ ​When​ ​properly​ ​connected,​ ​CON​ ​LED​ ​indicator​ ​will​ ​be​ ​a​ ​solid​ ​light.​ ​If
CON​ ​LED​ ​indicator​ ​is​ ​off​ ​or​ ​blinking​ ​when​ ​turned​ ​on,​ ​please​ ​contact​ ​our
customer​ ​service.
7.2​ ​QT​ ​Electrode​ ​Strip
●
Problem:​ ​Package​ ​opened​ ​or​ ​damaged​ ​before​ ​use
Solution:​ ​Do​ ​not​ ​use​ ​the​ ​Electrode​ ​Strip,​ ​contact​ ​our​ ​customer​ ​service​ ​for
replacement.
●
Problem:​ ​7​ ​chest​ ​lead​ ​electrodes​ ​or​ ​3​ ​limb​ ​lead​ ​electrodes​ ​are​ ​damaged​ ​or​ ​missing
●
55
Solution:​ ​Do​ ​not​ ​use​ ​the​ ​Electrode​ ​Strip​ ​and​ ​contact​ ​our​ ​customer​ ​service.
Problem:​ ​Size​ ​of​ ​Electrode​ ​Strip​ ​enclosed​ ​does​ ​not​ ​match​ ​with​ ​package​ ​labels
o
Solution:​ ​Do​ ​not​ ​use​ ​the​ ​Electrode​ ​Strip​ ​and​ ​contact​ ​our​ ​customer​ ​service.
7.3​ ​QT​ ​ECG​ ​App
●
Problem:​ ​Crashed​ ​during​ ​use
Solution:​ ​Reboot​ ​and​ ​restart,​ ​if​ ​problem​ ​persists,​ ​please​ ​contact​ ​our​ ​customer
service.
●
Problem:​ ​Cannot​ ​boot​ ​up​ ​application​ ​or​ ​the​ ​app​ ​quits​ ​unexpectedly
●
Solution:​ ​Please​ ​contact​ ​our​ ​customer​ ​service.
Problem:​ ​Application​ ​is​ ​not​ ​performing​ ​smoothly
Solution:​ ​Too​ ​many​ ​apps​ ​may​ ​be​ ​open​ ​and​ ​running​ ​at​ ​the​ ​same​ ​time.​ ​Please
reboot​ ​the​ ​mobile​ ​device​ ​and​ ​try​ ​again.
56
●
Problem:​ ​All​ ​ECG​ ​tracings​ ​disappear​ ​on​ ​the​ ​display.​ ​The​ ​screen​ ​display​ ​looks​ ​like​ ​the
following:
Solution: The problem may be caused by system overload or saturation. Please
carefully remove the Electrode Strip from the patient’s chest and disconnect the
QT ECG ECG Recorder. Please restart the entire process. If the problem persists,
please​ ​contact​ ​our​ ​customer​ ​service.
57
●
Problem:​ ​Lead-off​ ​warning.​ ​The​ ​screen​ ​display​ ​is​ ​as​ ​follows:
Solution:​ ​Check​ ​the​ ​corresponding​ ​chest​ ​electrode.​ ​Make​ ​sure​ ​the​ ​electrode​ ​is
attached​ ​properly​ ​to​ ​the​ ​skin​ ​and​ ​making​ ​a​ ​good​ ​contact.
●
58
Problem:​ ​Low​ ​battery​ ​warning.​ ​The​ ​screen​ ​displays​ ​the​ ​following:
o
Solution:​ ​Disconnect​ ​the​ ​Recorder​ ​from​ ​the​ ​Electrode​ ​Strip,​ ​and​ ​remove
electrode​ ​from​ ​the​ ​user.​ ​Charge​ ​the​ ​QT​ ​ECG​ ​Recorder​ ​using​ ​the​ ​wall​ ​charger
with​ ​the​ ​micro-USB​ ​cable.​ ​Do​ ​not​ ​record​ ​and​ ​charge​ ​at​ ​the​ ​same​ ​time.
7.4​ ​Other
●
Problem:​ ​Cannot​ ​record​ ​ECG​ ​signals
Solution: Review the user manual to ensure all steps and instructions are
properly​ ​followed.
Solution: If the instructions are properly followed but the app problem persists,
please​ ​shut​ ​down​ ​the​ ​application,​ ​reboot,​ ​and​ ​try​ ​again.
Solution: If instructions are followed but the problem persists, press the power
button​ ​to​ ​shut​ ​down​ ​and​ ​reboot​ ​the​ ​QT​ ​ECG​ ​Recorder​ ​and​ ​try​ ​again.
Solution: If all steps are followed, but the recorder still cannot record ECG,
please​ ​contact​ ​our​ ​customer​ ​service.
8.​ ​CUSTOMER​ ​SERVICE​ ​SUPPORT
For​ ​customer​ ​service​ ​support,​ ​please​ ​contact:
QT​ ​Medical,​ ​Inc.
1001​ ​W​ ​Carson​ ​Street,​ ​Suite​ ​U,​ ​Torrance,​ ​CA90502,​ ​U.S.A.
TEL​ ​(424)​ ​558-3500
FAX​ ​(310)​ ​755-3108
service@qtmedical.com
Manufactured​ ​for:​ ​QT​ ​Medical,​ ​Inc.
1001​ ​W​ ​Carson​ ​Street,​ ​Suite​ ​U,​ ​Torrance,​ ​CA90502,​ ​U.S.A.
59
http://www.qtmedical.com
9.​ ​WARRANTY
The Company warrants the QT ECG against defects in materials and workmanship under
ordinary clinical use for one year from the delivery date. During this warranty period, if a
defect arises in the QT ECG, the Company will at its option, to the extent permitted by law,
either (i) repair the QT ECG ECG Screen using either new or refurbished parts, (ii) replace QT
ECG with a new or refurbished device that is equivalent to the device to be replaced, or (iii)
if (i) or (ii) are not reasonably possible, refund you all or part of the purchase price of QT
ECG, as deemed appropriate by the Company. This limited warranty applies, to the extent
permitted by law, to any repair, replacement part or replacement device for the remainder
of the original warranty period or for ninety days, whichever period is longer. All replaced
parts and devices for which a refund is given shall become the Company’s property. This
limited warranty applies only to hardware components of the QT ECG that are not subject to
accident, misuse, neglect, fire or other external causes, alterations, or repair. Should a
warranty
repair
be
required,
please
contact
customer
service
at
service@qtmedical.com​. In general, the Company will send you packaging that you
can use to return the device to the appropriate customer service location. Third party
tablets or computer devices are not covered under the Company’s warranty. Warranty
claims for tablets or other mobile computing devices should be directed to the original
manufacturer​ ​of​ ​those​ ​devices.
APPENDIX
60
A. FCC​ ​Statement
B. IC​ ​Statement
C. Advice​ ​for​ ​Electromagnetic​ ​interference
61
APPENDIX​ ​A
FCC​ ​Statement
This device complies with part 15 of the FCC Rules. Operation is subject to the following
two​ ​conditions:
(1)​​ ​ ​ ​ ​ ​ ​ ​This​ ​device​ ​may​ ​not​ ​cause​ ​harmful​ ​interference,​ ​and
(2)
This device must accept any interference received, including interference that may
​
cause​ ​undesired​ ​operation.
NOTE: This equipment has been tested and found to comply with the limits for a
Class B digital device, pursuant to part 15 of the FCC Rules. These limits are
designed to provide reasonable protection against harmful interference in a
residential​ ​installation.
This equipment generates, uses and can radiate radio frequency energy and, if
not installed and used in accordance with the instructions, may cause harmful
interference to radio communications. However, there is no guarantee that
interference​ ​will​ ​not​ ​occur​ ​in​ ​a​ ​particular​ ​installation.
If this equipment does cause harmful interference to radio or television
reception, which can be determined by turning the equipment off and on, the
user is encouraged to try to correct the interference by one or more of the
following​ ​measures:
—Reorient​ ​or​ ​relocate​ ​the​ ​receiving​ ​antenna.
—Increase​ ​the​ ​separation​ ​between​ ​the​ ​equipment​ ​and​ ​receiver.
—Connect the equipment into an outlet on a circuit different from that to which
the​ ​receiver​ ​is​ ​connected.
—Consult​ ​the​ ​dealer​ ​or​ ​an​ ​experienced​ ​radio/TV​ ​technician​ ​for​ ​help.
62
Changes or modifications not expressly approved by the party responsible for compliance could
void​ ​the​ ​user’s​ ​authority​ ​to​ ​operate​ ​the​ ​equipment​.
63
APPENDIX​ ​B
IC​ ​Statement
64
APPENDIX​ ​B
IC​ ​Statement
This device complies with Industry Canada license-exempt RSS standard(s). Operation is
subject to the following two conditions: (1) this device may not cause interference, and
(2) this device must accept any interference, including interference that may cause
undesired​ ​operation​ ​of​ ​the​ ​device.
Le​ ​present​ ​appareil​ ​est​ ​conforme​ ​aux​ ​CNR​ ​d’Industrie​ ​Canada​ ​applicables​ ​aux​ ​appareils
radio​ ​exempts​ ​de​ ​licence.​ ​L’exploitation​ ​est​ ​autorisee​ ​aux​ ​deux​ ​conditions​ ​suivantes​ ​:​ ​(1)
l’appareil​ ​ne​ ​doit​ ​pas​ ​produire​ ​de​ ​brouillage,​ ​et​ ​(2)​ ​l’utilisateur​ ​de​ ​l’appareil​ ​doit
accepter​ ​tout​ ​brouillage​ ​radioelectrique​ ​subi,​ ​meme​ ​si​ ​le​ ​brouillage​ ​est​ ​susceptible​ ​d’en
compromettre​ ​le​ ​fonctionnement.
65
APPENDIX​ ​C
Taiwan​ ​requlatory​ ​information(NCC)
低功率電波輻射性電機管理辦法
第十二條
​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​經型式認證合格之低功率射頻電機，非經許可，
公司、商號或使用者均不得擅自變更頻率、加大功率
或變更原設計之特性及功能。
第十四條
​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​低功率射頻電機之使用不得影響飛航安全及干擾
合法通信；經發現有干擾現象時，應立即停用，並改
善至無干擾時方得繼續使用。
​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​前項合法通信，指依電信法規定作業之無線電通
信。低功率射頻電機須忍受合法通信或工業、科學及
醫療用電波輻射性電機設備之干擾。
66
APPENDIX​ ​D
Advice​ ​for​ ​Electromagnetic​ ​interference
The​ ​following​ ​is​ ​information​ ​on​ ​potential​ ​electromagnetic​ ​interference
and​ ​advice​ ​on​ ​how​ ​to​ ​avoid​ ​or​ ​minimize​ ​such​ ​interference.
Guidance​ ​for​ ​Electromagnetic​ ​Emissions:
QT​ ​ECG​ ​is​ ​intended​ ​for​ ​use​ ​in​ ​the​ ​electromagnetic​ ​environment​ ​specified​ ​below.
The​ ​customer​ ​or​ ​the​ ​user​ ​of​ ​QT​ ​ECG​ ​should​ ​assure​ ​that​ ​it​ ​is​ ​used​ ​in​ ​such​ ​an
environment.
Emissions​ ​test
Compliance
RF​ ​emissions
Group​ ​2
RF​ ​emissions
Class​ ​B
Harmonic​ ​emissions
Class​ ​A
Voltage​ ​fluctuations/
Complies
CISPR​ ​11
CISPR​ ​11
IEC​ ​61000-3-2
Flicker​ ​emissions
Electromagnetic​ ​environment​ ​–
guidance
QT​ ​ECG​ ​must​ ​emit​ ​electromagnetic
energy​ ​in​ ​order​ ​to​ ​perform​ ​its
intended​ ​function.​ ​Nearby​ ​electronic
equipment​ ​may​ ​be​ ​affected.
QT​ ​ECG​ ​is​ ​suitable​ ​for​ ​use​ ​in​ ​all
establishments,​ ​including​ ​domestic
establishments​ ​and​ ​those​ ​directly
connected​ ​to​ ​the​ ​public​ ​low-voltage
power​ ​supply​ ​network​ ​that​ ​supplies
buildings​ ​used​ ​for​ ​domestic​ ​purposes.
IEC​ ​61000-3-3
Guidance​ ​for​ ​Electromagnetic​ ​Immunity:
QT​ ​ECG​ ​is​ ​intended​ ​for​ ​use​ ​in​ ​the​ ​electromagnetic​ ​environment​ ​specified​ ​below.
The​ ​customer​ ​or​ ​the​ ​user​ ​of​ ​QT​ ​ECG​ ​should​ ​assure​ ​that​ ​it​ ​is​ ​used​ ​in​ ​such​ ​an
environment.
Immunity
test
Electrostatic
discharge​ ​(ESD)
IEC
61000-4-2
67
IEC​ ​60601​ ​test
level
Compliance
level
±​6​ ​kV​ ​contact
±​6​ ​kV​ ​contact
±​8​ ​kV​ ​air
±​8​ ​kV​ ​air
Electromagnetic​ ​environment
–​guidance
Floors​ ​should​ ​be​ ​wood,​ ​concrete​ ​or
ceramic​ ​tile.​ ​If​ ​floors​ ​are​ ​covered​ ​with
synthetic​ ​material,​ ​the​ ​relative
humidity​ ​should​ ​be​ ​at​ ​least​ ​30​ ​%.
Electrical​ ​fast
transient/burst
±​2​ ​kV​ ​for​ ​power
supply​ ​lines
±​2​ ​kV​ ​for​ ​power
supply​ ​lines
±​1​ ​kV​ ​for
input/output
lines
±​1​ ​kV​ ​for
input/output
lines
±​1​ ​kV​ ​line(s)​ ​to
line(s)
±​1​ ​kV​ ​line(s)​ ​to
line(s)
±​2​ ​kV​ ​line(s)​ ​to
earth
±​2​ ​kV​ ​line(s)​ ​to
earth
Interruptions
and​ ​voltage
variations​ ​on
power​ ​supply
input​ ​lines
<5​ ​%​ ​U​T
<5​ ​%​ ​U​T
IEC​ ​61000-4-11
40​ ​%​ ​U​T
(60​ ​%​ ​dip​ ​in​ ​U​T)
for​ ​5​ ​cycles
40​ ​%​ ​U​T
70​ ​%​ ​U​T
70​ ​%​ ​U​T
<5​ ​%​ ​U​T
<5​ ​%​ ​U​T
3​ ​A/m
3​ ​A/m
IEC​ ​61000-4-4
Surge
IEC​ ​61000-4-5
(>95​ ​%​ ​dip​ ​in
U​T)​ ​for​ ​0.5​ ​cycle
(30​ ​%​ ​dip​ ​in​ ​U​T)
for​ ​25​ ​cycles
(>95​ ​%​ ​dip​ ​in
U​T)​ ​for​ ​5​ ​sec
Power
frequency
(50/60​ ​Hz)
magnetic​ ​field
(>95​ ​%​ ​dip​ ​in
U​T)​ ​for​ ​0.5​ ​cycle
(60​ ​%​ ​dip​ ​in​ ​U​T)
for​ ​5​ ​cycles
Mains​ ​power​ ​quality​ ​should​ ​be​ ​that​ ​of
a​ ​typical​ ​commercial​ ​or​ ​hospital
environment.
Mains​ ​power​ ​quality​ ​should​ ​be​ ​that​ ​of
a​ ​typical​ ​commercial​ ​or​ ​hospital
environment.
Mains​ ​power​ ​quality​ ​should​ ​be​ ​that​ ​of
a​ ​typical​ ​commercial​ ​or​ ​hospital
environment.​ ​If​ ​the​ ​user​ ​of​ ​QT​ ​ECG
requires​ ​continued​ ​operation​ ​during
power​ ​mains​ ​interruptions,​ ​it​ ​is
recommended​ ​that​ ​QT​ ​ECG​ ​be
powered​ ​from​ ​an​ ​uninterruptible
power​ ​supply​ ​or​ ​a​ ​battery.
(30​ ​%​ ​dip​ ​in​ ​U​T)
for​ ​25​ ​cycles
(>95​ ​%​ ​dip​ ​in
U​T)​ ​for​ ​5​ ​sec
Power​ ​frequency​ ​magnetic​ ​fields
should​ ​be​ ​at​ ​levels​ ​characteristic​ ​of​ ​a
typical​ ​location​ ​in​ ​a​ ​typical​ ​commercial
or​ ​hospital​ ​environment.
IEC​ ​61000-4-8
NOTE​ ​U​T​ ​is​ ​the​ ​a.c.​ ​mains​ ​voltage​ ​prior​ ​to​ ​application​ ​of​ ​the​ ​test​ ​level.
QT​ ​ECG​ ​is​ ​intended​ ​for​ ​use​ ​in​ ​the​ ​electromagnetic​ ​environment​ ​specified​ ​below.
The​ ​customer​ ​or​ ​the​ ​user​ ​of​ ​QT​ ​ECG​ ​should​ ​assure​ ​that​ ​it​ ​is​ ​used​ ​in​ ​such​ ​an
environment.
Immunity
test
IEC​ ​60601​ ​test
level
Compliance
level
Electromagnetic​ ​environment​ ​–
guidance
Portable​ ​and​ ​mobile​ ​RF
communications​ ​equipment​ ​should​ ​be
used​ ​no​ ​closer​ ​to​ ​any​ ​part​ ​of​ ​QT​ ​ECG,
including​ ​cables,​ ​than​ ​the
recommended​ ​separation​ ​distance
calculated​ ​from​ ​the​ ​equation​ ​applicable
to​ ​the​ ​frequency​ ​of​ ​the​ ​transmitter.
68
Conducted
RF
IEC
61000-4-6
Radiated​ ​RF
IEC
61000-4-3
3​ ​Vrms
150​ ​kHz​ ​to​ ​80
MHz
3​ ​V/m
3​ ​Vrms
Recommended​ ​separation​ ​distance
d​ ​=​ ​1.2
3​ ​V/m
80 MHz to 2,5
GHz
d​ ​=​ ​1.2
​ ​80​ ​MHz​ ​to​ ​800​ ​MHz
d​ ​=​ ​2.3
​ ​800​ ​MHz​ ​to​ ​2,5​ ​GHz
where​ ​P​ ​is​ ​the​ ​maximum​ ​output​ ​power
rating​ ​of​ ​the​ ​transmitter​ ​in​ ​watts​ ​(W)
according​ ​to​ ​the​ ​transmitter
manufacturer​ ​and​ ​d​ ​is​ ​the
recommended​ ​separation​ ​distance​ ​in
meters​ ​(m).
Field​ ​strengths​ ​from​ ​fixed​ ​RF
transmitters,​ ​as​ ​determined​ ​by​ ​an
electromagnetic​ ​site​ ​survey,​ a​​ ​ ​should​ ​be
less​ ​than​ ​the​ ​compliance​ ​level​ ​in​ ​each
frequency​ ​range.​ ​b
Interference​ ​may​ ​occur​ ​in​ ​the​ ​vicinity​ ​of
equipment​ ​marked​ ​with​ ​the​ ​following
symbol:
NOTE​ ​1​ ​At​ ​80​ ​MHz​ ​and​ ​800​ ​MHz,​ ​the​ ​higher​ ​frequency​ ​range​ ​applies.
NOTE​ ​2​ ​These​ ​guidelines​ ​may​ ​not​ ​apply​ ​in​ ​all​ ​situations.​ ​Electromagnetic​ ​propagation​ ​is​ ​affected​ ​by​ ​absorption
and​ ​reflection​ ​from​ ​structures,​ ​objects​ ​and​ ​people.
​ ​ ​Field​ ​strengths​ ​from​ ​fixed​ ​transmitters,​ ​such​ ​as​ ​base​ ​stations​ ​for​ ​radio​ ​(cellular/cordless)​ ​telephones​ ​and​ ​land
mobile​ ​radios,​ ​amateur​ ​radio,​ ​AM​ ​and​ ​FM​ ​radio​ ​broadcast​ ​and​ ​TV​ ​broadcast​ ​cannot​ ​be​ ​predicted​ ​theoretically
with​ ​accuracy.​ ​To​ ​assess​ ​the​ ​electromagnetic​ ​environment​ ​due​ ​to​ ​fixed​ ​RF​ ​transmitters,​ ​an​ ​electromagnetic​ ​site
survey​ ​should​ ​be​ ​considered.​ ​If​ ​the​ ​measured​ ​field​ ​strength​ ​in​ ​the​ ​location​ ​in​ ​which​ ​QT​ ​ECG​ ​is​ ​used​ ​exceeds​ ​the
applicable​ ​RF​ ​compliance​ ​level​ ​above,​ ​QT​ ​ECG​ ​should​ ​be​ ​observed​ ​to​ ​verify​ ​normal​ ​operation.​ ​If​ ​abnormal
performance​ ​is​ ​observed,​ ​additional​ ​measures​ ​may​ ​be​ ​necessary,​ ​such​ ​as​ ​reorienting​ ​or​ ​relocating​ ​QT​ ​ECG.
a​
​ ​ ​Over​ ​the​ ​frequency​ ​range​ ​150​ ​kHz​ ​to​ ​80​ ​MHz,​ ​field​ ​strengths​ ​should​ ​be​ ​less​ ​than​ ​3​ ​V/m.
b​
Recommended​ ​Separation​ ​Distances​ ​between​ ​Mobile​ ​RF
69
Communications​ ​Equipment​ ​and​ ​QT​ ​ECG:
QT​ ​ECG​ ​is​ ​intended​ ​for​ ​use​ ​in​ ​an​ ​electromagnetic​ ​environment​ ​in​ ​which​ ​radiated
RF​ ​disturbances​ ​are​ ​controlled.​ ​The​ ​customer​ ​or​ ​the​ ​user​ ​of​ ​QT​ ​ECG​ ​can​ ​help
prevent​ ​electromagnetic​ ​interference​ ​by​ ​maintaining​ ​a​ ​minimum​ ​distance
between​ ​portable​ ​and​ ​mobile​ ​RF​ ​communications​ ​equipment​ ​(transmitters).
According​ ​to​ ​the​ ​maximum​ ​output​ ​power​ ​of​ ​the​ ​communications​ ​equipment,
recommended​ ​environment​ ​for​ ​QT​ ​ECG​ ​is​ ​described​ ​below,
Rated​ ​maximum
output​ ​power​ ​of
transmitter
Separation​ ​distance​ ​according​ ​to​ ​frequency​ ​of​ ​transmitter
150​ ​kHz​ ​to​ ​80​ ​MHz
d​ ​=​ ​1.2
80​ ​MHz​ ​to​ ​800​ ​MHz
d​ ​=​ ​1.2
800​ ​MHz​ ​to​ ​2.5​ ​GHz
d​ ​=​ ​2.3
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For​ ​transmitters​ ​rated​ ​at​ ​a​ ​maximum​ ​output​ ​power​ ​not​ ​listed​ ​above,​ ​the​ ​recommended​ ​separation​ ​distance​ ​d
in​ ​meters​ ​(m)​ ​can​ ​be​ ​estimated​ ​using​ ​the​ ​equation​ ​applicable​ ​to​ ​the​ ​frequency​ ​of​ ​the​ ​transmitter,​ ​where​ ​P​ ​is
the​ ​maximum​ ​output​ ​power​ ​rating​ ​of​ ​the​ ​transmitter​ ​in​ ​watts​ ​(W)​ ​according​ ​to​ ​the​ ​transmitter​ ​manufacturer.
NOTE​ ​1​ ​At​ ​80​ ​MHz​ ​and​ ​800​ ​MHz,​ ​the​ ​separation​ ​distance​ ​for​ ​the​ ​higher​ ​frequency​ ​range​ ​applies.
NOTE​ ​2​ ​These​ ​guidelines​ ​may​ ​not​ ​apply​ ​in​ ​all​ ​situations.​ ​Electromagnetic​ ​propagation​ ​is​ ​affected​ ​by​ ​absorption
and​ ​reflection​ ​from​ ​structures,​ ​objects​ ​and​ ​people.
Appendix​ ​E.​ ​Compliance​ ​for​ ​Emissions​ ​and​ ​Immunity​ ​Standard
Standard
Biocompatibility
70
Edition
ISO​ ​10993-10:2002/Amd​ ​1:2006,​ ​Biological
evaluation​ ​of​ ​medical​ ​devices​ ​-​ ​Part​ ​10:​ ​Tests​ ​for
irritation​ ​and​ ​skin​ ​sensitization;
ISO​ ​10993-5:1999,​ ​Biological​ ​evaluation​ ​of​ ​medical
devices​ ​-​ ​Part​ ​5:​ ​Tests​ ​for​ ​in​ ​vitro​ ​cytotoxicity.
Electrical​ ​Safety
IEC​ ​60601-1:2005+AMD1:2012​ ​CSV/COR1:2012,
IEC​ ​60601-1-11:2015,
EN​ ​60601-1:2006+A1:2013+A12:2014+US​ ​DEVIATION,
Electromagnetic
Compatibility
(EMC​ ​Safety)
Electrode
Battery
Wall-Charger
IEC​ ​60601-2-25:2011
IEC​ ​60601-1-2:2014
ANSI/AAMI​ ​EC12:2000/(R)2010,
IEC​ ​62133:2012
EN60601-1-2:2014_GROUP​ ​1
Electrocardiograph
Performance
Class​ ​B​ ​FCC​ ​PART​ ​15​ ​&​ ​PART​ ​18​ ​CLASS​ ​B
UL​ ​ES60601-1:2005
CSA​ ​C22.2​ ​NO.60601-1:2008
EN60601-1:2006
IEC​ ​60601-1:2005
EN60601-1-11
BSMI​ ​CNS​ ​14336-1
IEC​ ​60601-2-25:2011
Meet​ ​FCC,​ ​IC,​ ​CE,​ ​NCC
CE​ ​R&TTE​ ​EN​ ​301489-1V1.9.2
CE​ ​R&TTE​ ​EN​ ​301489-17v2.1.1
CE​ ​R&TTE​ ​EN​ ​300328​ ​V2.1.1
FCC​ ​Part​ ​15B
RF
71
FCC​ ​Part​ ​15C
72

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