LifeWatch ECG Mini User manual

ECG Mini User Guide
ECG Mini
User Guide
PLEASE CALL
1.800.517.6330
FOR 24/7 CUSTOMER SUPPORT

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ECG Mini User Guide
This user guide includes information and instructions about the
ECG Mini (Continuous ECG Monitor and Arrhythmia Detector) monitoring
system. Please read it carefully before you begin testing.
If you have any questions regarding the ECG Mini please contact
LifeWatch at 1-800-517-6330.
Federal Law (USA) restricts this device to sale by
or on the order of a practitioner licensed by the
law of the State in which he/she practices to use
or order the use of the device.
CAUTION:
This manual should always accompany the unit.
All personnel utilizing the ECG Mini system must
have read and be familiar with the contents of this
manual.
First time use –You must call LifeWatch to
receive instructions on how to proceed for the first
time use.
The first time the ECG Mini is activated and is
attached to you, it will display screens that are not
seen in regular use. These screens are calibration
procedures the ECG Mini needs to perform to
adjust its operation for first time use.

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Authorized representatives:
USA
LifeWatch, Inc.
O’Hare International Center
10255 West Higgins Road
Suite 120
Rosemont, IL 60018
Tel: [phone]
Fax: [phone]
Toll Free: 800-633-3361
Fax: [phone]
Email:
[email protected]
Israel
LifeWatch
Technologies Ltd.
2 Pekeris Street.
Rehovot 7670202
Israel
Tel: [phone]
Fax: [phone]
Email:
[email protected]
Copyright Declaration
Copyright © 2015 LifeWatch Services, Inc. All rights reserved. LifeWatch,
Watching Life, LifeStar and ECG Mini are trademarks of LifeWatch
Services, Inc. LifeWatch reserves the right to change specifications at any
time without notice.
LifeWatch Technologies, LifeWatch Technologies logo and ECG Mini are
trademarks or registered trademarks of the LifeWatch® Group of
Companies.

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All other brand names and product names used in this document are trade
names, service marks, trademarks, or registered trademarks of their
respective owners.
The information and screens provided in this manual are subject to change
without notice.
LifeWatch Technologies Ltd. SHALL NOT BE LIABLE FOR TECHNICAL
OR EDITORIAL ERRORS OR OMISSIONS CONTAINED HEREIN; NOR
FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES RESULTING
FROM THE FURNISHING, PERFORMANCE, OR USE OF THIS
MATERIAL.
Illustrations included in this manual are general
representations only and are not meant to comply
with specific regulatory requirements.
ATTENTION: The ECG Mini is a near diagnostic tool only and is not
part of an emergency service. Heart strips transmitted by the device
are not viewed immediately by technicians. If when viewed, the
technician sees an arrhythmia that is potentially harmful or life
threatening, LifeWatch will attempt to facilitate care for the patient
through either their doctor or an emergency medical service,
although this care may be delayed.

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Table of Contents
1Introduction...............................................................8
1.1 INTENDED USE ...................................................8
1.2 GENERAL DESCRIPTION ......................................9
1.3 SYMBOLS ON EQUIPMENT AND LABELING ............11
1.4 WARNINGS AND CAUTIONS ................................13
1.5 GLOSSARY .......................................................19
2General Description...............................................20
3The ECG Mini Kit ....................................................22
3.1 GATEWAY PHYSICAL DESCRIPTION.....................23
HOW MUCH CHARGE IS IN THE BATTERY?......................24
4Important Information Before Use .......................26
4.1 GENERAL .........................................................26
4.2 NO CONNECTION WITH GATEWAY
CELLULAR DEVICE.......................................................26
5Using the ECG Mini................................................27
5.1 BEFORE STARTING............................................27
5.2 RECHARGING THE GATEWAY
CELLULAR DEVICE.......................................................29
6Using the ECG Mini System..................................30
6.1 GENERAL .........................................................30
6.2 INITIALIZING THE ECG MINI KIT ..........................30
6.3 PLACING THE PATCH.........................................30
6.4 INSTALLING THE ECG MINI TRANSMITTER...........33
6.5 REMOVING THE ECG MINI.................................34
7Using the Gateway Application............................35

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7.1 STARTING THE APPLICATION ..............................35
7.2 ECG MINI SCREEN ...........................................36
7.3 GATEWAY NOTIFICATIONS..................................39
8Heart Rate Calculation Method.............................42
8.1 INTRODUCTION..................................................42
8.2 METHOD OF CALCULATION.................................42
9Pause Calculation...................................................42
10 Care ..........................................................................43
10.1 CONDITIONS OF USE.......................................43
10.2 CLEANING......................................................43
10.3 ENVIRONMENTAL CONSIDERATIONS .................43
11 Troubleshooting .....................................................44
12 Maintenance............................................................45
12.1 CONDITIONS OF USE.......................................45
12.2 CARING FOR YOUR ECG MINI..........................45
12.3 PREVENTIVE MAINTENANCE.............................46
13 Technical Specifications .......................................47
13.1 ECG MINI TECHNICAL SPECIFICATIONS............48
Appendix A Monitor (Cellular Phone) Warnings........51
FCC Radio Frequency Interference Statement..........56

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Table of Figures
Figure 1 –Gateway Physical Description........................23
Figure 1 - Area to prepare for ECG Mini Patch ...............30
Figure 2 –ECG Mini 1-lead Placement...........................31
Figure 3 –ECG Mini 1-lead Properly Placed ..................32
Figure 4 - Placing ECG Mini Transmitter into Cradle ......33
Figure 5 –ECG Mini notification screen with notification 39

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1 INTRODUCTION
1.1 Intended Use
The ECG Mini System is intended for use by patients who experience
transient symptoms that may suggest cardiac arrhythmia. The
device continuously monitors patient ECG and transmits the
recorded data wirelessly to a monitoring center. The monitoring
center provides the ECG data to the medical practitioner for
evaluation.
The device has not been tested for and it is not intended for pediatric
use.
Contraindications for Use:
The ECG Mini is not to be used in a magnetic resonance
imaging (MRI) environment. The ECG Mini must be removed
from the patient’s skin before he/she undergoes MRI
procedure
The ECG Mini is not to be used with external defibrillator.
The ECG Mini is not a “life-saving” or therapeutic device; the
ECG Mini supplies vitalsigns data to a doctor or technician
for the purpose of diagnosis by such (or other qualified)
personnel
The ECG Mini is not intended for use on patients with
unhealed surgical incisions/dressings on the thoracic or
abdominal regions
The ECG Mini is not intended for use on patients with skin or
soft tissue damage in the area where the Patch is placed
(such as burns, irritation, infections, wounds, etc.).
The ECG Mini is not intended for use in the diagnosis of
myocardial infarction or for chest pain monitoring.

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1.2 General Description
The ECG Mini system consists of 3 main components:
Disposable 1-lead patch with ECG electrodes
Reusable processing and transmitter device, also called
“Brain”
Gateway cellular device
The 1-lead ECG patch contains 3 electrodes which are used for
1-lead arrhythmia detection. The 1-lead patch ECG is attached to
the upper chest of the body.
The 1-lead patch contains 3 ECG electrodes, a cradle for the Brain
and one coin battery for powering the Brain.
The 1-lead patch is a disposable part which is mounted on the
patient body throughout the service period. Special slot within the
patch enables easy insertion of the brain to its cradle by the user.
The brain receives its power from a 1.4V coin non-rechargeable
battery integrated within the patch.
The brain transmits ECG raw data to the Gateway cellular device
wirelessly using unique RF protocol. In addition, the Brain contains a
32MB Flash memory chip that can store 6 hours of data in case of
communication failure with the Gateway cellular device.
The Gateway cellular device is located in the patient home and
receives the ECG signs data from the Patch wirelessly over a unique
RF protocol. The Gateway cellular device analyzes the ECG data
and generates events which reflect 4 arrhythmias –Pause, AFIB,
Tachycardia and Bradycardia. These events are transmitted to the
monitoring center backend system of LifeWatch Services over

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standard wide range cellular network. ECG events are displayed at
the monitoring center (LifeWatch Services) by means of cardiac data
software called “Paceart”.
The patient can manually trigger an event by clicking on an icon on
the screen of the Gateway cellular device.
The following list represents patient populations for whom use of the
ECG Mini is most appropriate. This list should be used in conjunction
with Medicare and other payor medical necessity guidelines:
Patients with dizziness or lightheadedness
Patients with palpitations
Patients with syncope of unknown etiology
Patients who require monitoring for non-life-threatening arrhythmias,
such as Atrial Fibrillation, Supra-ventricular Arrhythmias, evaluation of
various Brady arrhythmias.
This includes post-operative monitoring for these rhythms.
Patients recovering from coronary artery bypass graft (CABG) surgery
who require monitoring for arrhythmias
Patients requiring monitoring for arrhythmias-including co-morbid
conditions such as hyperthyroidism or chronic lung disease
Patients with obstructive sleep apnea to evaluate possible nocturnal
arrhythmias
Patients requiring arrhythmia evaluation for etiology of stroke or
transient cerebral ischemia, possibly secondary to Atrial Fibrillation
To use the ECG Mini, the user or primary care provider must be able
to perform all of the following:
Understand the principle of operation and system messages described
in this manual
Place the patch on the chest
Operate a handheld device (Gateway)
The ECG Mini is safe for use by patients wearing an oxygen mask
for breathing.

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The function of the ECG Mini is dependent on cellular phone service
and short range RF technology (Nordic). Limitations in data
transmission may occur if there is limited cellular service in the area.
You may occasionally experience a delay in the ability to send
recorded events due to unexpected cellular limitations. If this occurs,
contact LifeWatch as soon as possible. Any technical difficulties
should be reported as quickly as possible so as to resolve the issue
with minimal service interruption.
As with all standard cell phones, charge the Gateway cellular device
whenever possible, and at least every night. The performance of the
Gateway cellular device, including data recording and transmission,
may be adversely impacted if not adequately charged.
1.3 Symbols on Equipment and Labeling
The following section contains a complete description of all symbols
that may be located on either the equipment or labeling of ECG Mini
and accessories.
Label
Description
Warning, consult accompanying text or
documents
Caution, consult accompanying text or
documents
Notes, indicates important general
information for using the system
successfully.
Consult instructions for use

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Label
Description
Serial Number
Date of Manufacture
Type BF Applied Part
Batch code
Do not use if package is damaged
Use by
Keep dry
Store at specified temperatures
Electrical and Electronic Equipment
The ECG Mini is MR unsafe

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1.4 Warnings and Cautions
The following section contains a complete list of the major warnings
and cautions relevant to the ECG Mini. These warnings and cautions
are also repeated, as appropriate, in sections of this manual. Your
prescribing physician is responsible for reading and understanding
all warnings and cautions prior to prescribing the ECG Mini.
Warning
The ECG Mini is intended to be used in
conjunction with a monitoring service that
reviews the recorded transmissions and
provides that information to the physician for
his/her final diagnostic interpretation.
The ECG Mini is not intended for use as an
emergency medical response system and
should not be used by patients at risk for
serious or life-threatening cardiac
arrhythmias, such as ventricular tachycardia
and ventricular fibrillation. Refer to the
Physician Manual Specification for the types
of arrhythmias detected by the ECG Mini.
The ECG Mini is not intended for use in the
diagnosis of myocardial infarction or for chest
pain monitoring.
Due to the risk of ignition or fire, the ECG Mini
is not intended for use in a hyperbaric
chamber, within an oxygen tent or in the
presence of flammable anesthetics / medical
gases.

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Warning
To prevent fire or shock hazard, do not expose
the ECG Mini to moisture, liquids or
condensation.
To prevent an allergic reaction, do not use the
ECG Mini or accessories if you have a known
allergy to nickel or other metals.
The ECG Mini is not defibrillation-proof.
Exposure to defibrillation may damage the
ECG Mini, or the ECG Mini may interfere with
the operation of the defibrillator. The ECG Mini
MUST be removed prior to defibrillation as it
contains metals that could cause the
defibrillator to arc.
Use of conductive, connected devices and
patient lead wires/electrodes like the ECG Mini
in MRI procedures may result in serious burns.
If you should come into possession of your
ECG recording do not take any actions of a
medical nature based on your understanding
UNLESS you are a medical professional.

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Warning
Use with Implanted Conventional
Pacemakers and ICDs (ICD device max
energy 30 Joules)
If you have an implanted pacemaker or ICD,
the manufacturer may recommend certain
precautions when using a cellular phone.
Since the ECG Mini Gateway is also a cellular
phone, you should take the same precautions
when carrying and using the Gateway cellular
device. In general, most manufacturers
recommend the following:
Keep a distance of at least six inches
(15 cm) between the Gateway cellular
device and a pacemaker or ICD.
Carry the Gateway cellular device on the
opposite side of the body from the
pacemaker or ICD.
Don’t carry a cell phone in a breast pocket
or on a belt if that would place the phone
within six inches (15 cm) of the
pacemaker or ICD.
Refer to the manufacturer's information for
guidance regarding the pacemaker/ICD
and interference issues.

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Caution
The ECG Mini generates, uses, and can
radiate radio frequency energy and, if not
installed and used in accordance with the
instruction manual, may cause harmful
interference to radio communications.
The ECG Mini employs Nordic and cellular
technology. The location of the ECG Mini
and the associated environment, including
cellular phone coverage in the particular
area, may cause transmission interruption
or delay.
Do not open or attempt to repair the sensor.
Only authorized service personnel may
repair the system components.
To avoid damage to the system, the system
and accessories should be kept away from
extreme heat including placement of the
ECG Mini on the dashboard of a car or near
a heater.
The system should not be subjected to
severe impact or bending force. Exposure
to these types of stresses can damage the
system components.
Charge the Gateway cellular device every
night (irrespective of indicator status),
making sure that it is within 10 feet (3
meter) of the sensor. In addition, charge the
Gateway whenever possible during the day.
The energy consumption of the Gateway
may be high during the first few days of
monitoring (up to 72 hours). Keep the
Gateway charged at all times.

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Caution
Electrode disconnection might cause a faulty
ECG analysis and/or false events due to
noise created by the electrode
disconnection.
Impedance test, which may be requested by
the algorithm in rare cases, will override the
ECG recording; this means that the ECG will
lack ~1.5 seconds of recording in those
cases.
Do not turn off the sound of the Gateway
cellular device or reduce the volume so that
it is inaudible.
Take the charged Gateway with you and
wear the sensor at all times (except when
bathing) during the monitoring period.
Keep the Gateway away from extreme heat.
Do not leave it on the dashboard of a car or
near a heater. Do not leave it in any place
that is extremely damp or dusty.
Do not store the ECG Mini in a place where it
will be continuously exposed to moisture or
steam. Extended exposure to moisture may
cause malfunction.

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Caution
A disconnection between the Gateway cellular
device and the sensor might occur due to
electromagnetic interference. In this case the
sensor will search for the Gateway cellular
device every 3 minutes.
First time use –The patient must call
LifeWatch to receive instructions on how to
proceed for the first time use. The first time the
ECG Mini is activated and is attached, certain
screens are displayed that are not seen during
normal operation. These screens are used for
calibration. Please refer to “First Time
Activation” section of the manual for more
details.
Caution
Please refer to the user manual of the
manufacturer of the Gateway cellular device for
Health and Safety Information pertaining to the
use and operation of the Gateway cellular
device.
Do not use the Gateway cellular device for any
reason outside of the designated monitoring
function.
Keep kit contents away from children.

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1.5 Glossary
ECG
Electrocardiogram; a representation of the
heart's electrical activity recorded from
electrodes on the body.
ECG Mini
Continuous ECG Monitor and Arrhythmia
Detector (ECG sensor, Brain and Gateway)
Patch
ECG Mini device attached to patient.
Gateway
Hand held device/cellular phone using ECG
Mini monitoring software.
Heart Rate
Number of heart beats per minute,
measured as bpm (beats per minute).
Nordic RF
Wireless communication protocol.
Monitoring
Center
Monitoring center responsible for reviewing
clinical data transmissions, and providing
them to the physician.
Charger
Power supply for recharging Gateway
cellular device.
Arrhythmia
Irregular heartbeat.
Manual event
Event manually recorded (on Gateway) by
a patient when he/she feels it is necessary.

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2 GENERAL DESCRIPTION
The ECG Mini patch system comprises a disposable 1-lead ECG
Patch with two active electrodes and additional one electrode as
reference, a transmitter (Brain) and proprietary SW running on a
standard cellular device (called the Gateway) with an Android based
operating system. The SW installed in the Gateway is also called the
Gateway application. The Gateway cellular device is equipped with
short range 2.4 GHz ISM RF (“Nordic”) communication capabilities.
The ECG Mini system consists of 3 main components:
ECG Mini with ECG sensor
Transmitter, also called “Brain”
Gateway cellular device (with silicon cover)
The ECG Mini with its 3 ECG electrodes is a disposable part which
is mounted on the patient body throughout the service period. The
ECG Mini with ECG electrodes transmits the ECG signs via a
reusable transmitter (Brain) to a Gateway cellular device.
The Brain plugs into a cradle, which is part of the 1-lead patch, and
is connected to the cradle with a 7 pin connector. The brain receives
the power from the patch from two 1.4V non rechargeable batteries.
The Brain transmits data to the Gateway cellular device using the RF
component. In addition, the Brain contains a 32MB Flash memory
chip that can store 6 hours of data in case of communication failure
with the Gateway cellular device.
The Gateway cellular device located in the patient home receives
the ECG signs data from the sensors patch over a unique RF
protocol. The Gateway cellular device analyzes the ECG data and
generates events which reflect 4 arrhythmias –Pause, AFIB,
Tachycardia and Bradycardia. These events are transmitted to the
monitoring center backend system of LifeWatch Services over
standard wide range cellular network.