LifeWatch ACT III User manual

ACT III
Physician Manual
SUP547 Rev B CR 16-002

Page 2
Company Information
Contact information:
Manufacturer:
LifeWatch Technologies Ltd.
2 Pekeris Street
Rehovot, 7670202
Israel
Telephone: [phone]
Fax: [phone]
www.lifewatch.com
Distributor & Service:
USA
LifeWatch Services, Inc.
O’Hare International Center II
10255 West Higgins Road
Rosemont, IL 60018
Toll Free: +1.877.774.9846
Tel: [phone]
Fax: [phone]
www.lifewatch.com
Copyright Declaration
Copyright © 2016 LifeWatch Services, Inc. All rights reserved.
LifeWatch and LifeStar ACT are trademarks of LifeWatch
Services, Inc. LifeWatch reserves the right to change
specifications at any time without notice.
Android is a trademark of Google Inc.
Microsoft, ActiveSync, MSN, Outlook, Windows, Windows Media,
Win CE, Windows NT, and the Windows logo are either registered
trademarks or trademarks of Microsoft Corporation in the United
States and/or other countries.

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Microsoft products are licensed to OEMs by Microsoft Licensing,
Inc., a wholly owned subsidiary of Microsoft Corporation.
The BLUETOOTH trademarks are owned by Bluetooth SIG, Inc.,
U.S.A. and licensed to Taiyo Yuden Co., Ltd. LifeWatch
Technologies Ltd., LifeWatch Technologies Ltd. logo, Instromedix,
Instromedix logo, CG-6108, ACT, ACT III and PMP4are
trademarks or registered trademarks of the LifeWatch AG Group
of Companies.
The design and other features of the ACT device are protected
under one or more US and Foreign Patents.
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. and LifeWatch Services, Inc.. 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
CONTAINED HEREIN.
Ownership and Use of the Device
This device is the sole and exclusive property of LifeWatch.
Disclaimer
Operation of the ACT device may be subject to governmental and
business restrictions, including but not limited to air travel and
hospital visitations.
ATTENTION: ACT III is a diagnostic tool only and is not an
emergency service.

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Authorized representatives:
Europe
Obelis s.a
Boulevard Général
Wahis 53
1030 Brussels,
BELGIUM
Tel: + (32) 2. 732.59.54
Fax: + (32) 2.732.60.03
E-mail: [email protected]
USA
LifeWatch Services, Inc.
O’Hare International
Center II
10255 West Higgins Road
Rosemont, IL 60018
Toll Free:
+1.877.774.9846
Tel: [phone]
Fax: [phone]
Email:
[email protected]
Israel
LifeWatch
Technologies Ltd.
2 Pekeris Street
Rehovot 7670202
Israel
Tel: [phone]
Fax: [phone]
Email:
[email protected]
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.
Illustrations included in this manual are general representations
only and are not meant to comply with specific regulatory
requirements.

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Table of Contents
About this Manual...........................................................6
Symbols on Equipment and Labeling ............................7
Introduction.....................................................................9
Intended Use .................................................................9
Warnings and Cautions ...............................................12
Glossary.........................................................................21
System Description ......................................................22
ACT Description...........................................................22
ACT Ex (Optional Mode)..............................................23
Cardiac Event Monitor (CEM) - Optional Mode ..........23
Theory of Operation.....................................................24
ACT Algorithm .............................................................25
ACT Sensor.................................................................30
Approved Electrodes ...................................................33
Electrode Placement....................................................33
Changing Electrodes ...................................................36
Specifications................................................................37
ACT Sensor Technical Specifications..........................37
Environmental Conditions............................................40
Physician Selectable Detection Parameters................40
Heart Rate Calculation, Statistic File...........................42
Hourly Statistic File......................................................42
HR Histogram..............................................................42
Max HR calculation:.....................................................42
Min HR calculation:......................................................43
Pause Calculation........................................................43
Professional Information and Support ................................44

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About this Manual
This Physician Manual provides a description of the ACT III
monitoring system including the system features, performance,
intended use and important safety information. This manual
provides the information necessary for the physician to prescribe
the ACT monitoring system to the appropriate patient population.
Please read this manual thoroughly before prescribing the system.
A Patient Instruction Manual is included in each ACT monitoring
system kit and should be referred to for information regarding:
Kit Contents
Instructions for Use
Important Things to Remember
Daily Maintenance
Making a Manual Recording
Return Instructions
Frequently Asked Questions
Please refer to the Patient Instruction Manual for full information
on the ACT system operating instructions.

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Symbols on Equipment and Labeling
A number of symbols are used throughout this manual in order to
draw attention to safety items and other important information.
The following section contains a complete description of all
symbols that may be located on either the equipment or labeling
of ACT III device and accessories.
Label Description
Symbol indicates a potentially hazardous
situation, which, if not avoided, could result in
serious adverse reactions and potential safety
hazards.
Symbol indicates a situation that the user must
take into consideration to ensure the safe and
effective operation of the equipment and
associated accessories.
Symbol indicates important general information for
using the system successfully.
The ACT III is MR Unsafe
Consult instructions for use
Serial Number
Date of Manufacture
Batch code

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Label Description
Type BF Applied Part
Do not use if package is damaged
Use by
Keep dry
Store at specified temperatures
Electrical and Electronic Equipment
MDD (Medical Device Directive certification)
Bluetooth trademark indication conformity to
specifications.
Compliant with FCC Part 15

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Introduction
Intended Use
ACT III –CG 6108
The ACT III Continuous ECG Monitor and Arrhythmia Detector is
intended for use by patients who experience transient symptoms
that may suggest cardiac arrhythmia. The device continuously
monitors patient ECG, automatically generates an alarm triggered
by an arrhythmia detection algorithm, or generates an alarm
manually triggered by the patient, and transmits the recorded data
trans-telephonically to a monitoring center. The monitoring center
provides the ECG data to the medical practitioner for evaluation.
The ACT monitoring system is intended to be prescribed for
patients who have demonstrated a need for cardiac monitoring
and are at low risk of developing life-threatening
arrhythmias. Conditions where the system should not be used
include patients likely to experience primary Ventricular Fibrillation
or Ventricular Tachycardia and patients who have other co-morbid
cardiovascular conditions where an arrhythmia could be
potentially life threatening.
The device has not been tested for and it is not intended for
pediatric use.
The ACT monitoring system 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 monitoring system is not intended
for use as an emergency response system for patients who may
experience life-threatening arrhythmias.
Sensor Cellular phone

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The following list represents patient populations for whom use of
the ACT monitoring system 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 ACT monitoring system, 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 sensor and electrodes on the chest
Operate a handheld device (cellular phone)
Keep monitor nearby the user at all times
The ACT monitoring system is safe for use by patients wearing an
oxygen mask for breathing. See Warnings for other uses in
oxygen rich environments.
The ACT monitoring system is not water resistant and must not
get wet. Do not use or store the ACT monitoring system where
liquids of any nature may come into contact with it. Raindrops,

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water spray, juice, coffee, steam, perspiration, perfume,
deodorant, etc. may also affect the performance of the monitoring
system and cause a possible malfunction. While bathing or
showering, the system should be placed in a dry environment,
outside of the bathroom. The electrode patches may be worn in
the shower or bath as long as they are disconnected from the
sensor.
The function of the ACT monitoring system is dependent on
cellular phone service and Bluetooth technology. 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 cellular phone
whenever possible, during the day and at least every night. The
battery in the sensor should be changed as instructed by the low
battery messages. The performance of the cellular phone and
sensor, including data recording and transmission, may be
adversely impacted if not adequately charged.

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Warnings and Cautions
The following section contains a complete list of the major
warnings and cautions relevant to the ACT monitoring system.
These warnings and cautions are also repeated, as appropriate, in
sections of this manual. The prescribing physician is responsible
for reading and understanding all warnings and cautions prior to
prescribing the ACT monitoring system.
Warning
The ACT monitoring system 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 ACT monitoring system 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 ACT monitoring
system.
The ACT monitoring system 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 ACT
monitoring system 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 ACT monitoring system to moisture, liquids
or condensation.
If you have known allergies to metal or nickel,
please contact Lifewatch Services Customer
Support prior to using the ACT Monitoring
System to prevent an allergic reaction.
The ACT monitoring system is not
defibrillation-proof. Exposure to defibrillation
may damage the ACT monitoring system, or
the ACT monitoring system may interfere with
the operation of the defibrillator. The ACT
monitoring systems MUST be removed prior to
defibrillation as it contains metals that could
cause the defibrillator to arc.
The ACT is MR Unsafe.
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.
The ACT device is not intended to be used
near active HF surgical equipment.
Use of accessories, transducers and cables
other than those specified or provided by the
manufacturer of this equipment could result in
increased electromagnetic emissions or
decreased electromagnetic immunity of this
equipment and result in improper operation.

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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 ACT monitor is also a cellular phone, you
should take the same precautions when
carrying and using a cellular phone. In general,
most manufacturers recommend the following:
Keep a distance of at least six inches
(15 cm) between the cellular phone and a
pacemaker or ICD.
Carry the cellular phone 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.
Portable RF communications 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 ACT system, including
cables specified by the manufacturer.
Otherwise, degradation of the performance
of this equipment could result.

Page 15
Caution
ELECTROMAGNETIC (EM) DISTURBANCE
produced from other electrical devices in the
vicinity of the patient may result in the following
loss or degradation of performance:
Disrupt communication between the
sensor and smartphone that could prevent
data from being sent to smartphone.
However, the patient data will still be saved
in the internal flash memory of the sensor
for transfer to smartphone at a later time.
Disrupt communication that may delay the
transfer of data from smartphone to server.
However, data will still be saved on
smartphone flash memory for transfer to
the server at a later time.
Produce a noisy ECG signal that in most
cases will be rejected by the device’s
algorithm as non-biological data. The noisy
ECG data may also result in false event
data to be transferred to server. However,
this false event data or signal would be
rejected by ECG technician upon their
review due to the noisy ECG signal
resulting from EM disturbance not being
similar to an actual known ECG signal.

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Caution
The ACT monitoring system is intended to
be worn during normal daily activities. If
vigorous physical activity or exercise is part
of your normal daily activity, the associated
perspiration and lead wire movement can
loosen the electrodes. Contact LifeWatch to
obtain special electrodes for these
situations.
Disposable electrodes must be changed
according to instructions provided in this
manual to assure optimal recording quality
and limited skin irritation.
The ACT monitoring system 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 ACT monitoring system employs
Bluetooth and cellular technology. The
location of the ACT monitoring system 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.
Do not make any changes to monitor
settings.
Over-the-counter batteries should never be
used as they can seriously damage the
sensor. Only use the specialized batteries
included in the kit. If more batteries are
needed, contact LifeWatch.

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Caution
To avoid damage to the system, the
system and accessories should be kept
away from extreme heat including
placement of the ACT monitoring system
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 cellular phone every night
(irrespective of indicator status), making
sure that it is within 10 feet (3 meter) of
the sensor. In addition, charge the
cellular phone whenever possible during
the day.
The cellular phone energy consumption
may be high during the first few days of
monitoring (up to 72 hours). Keep the
cellular phone charged at all times.
Return the used and unused sensor
batteries to LifeWatch for proper
disposal. Do not discard the batteries in
or near a fire.
If the sensor battery is replaced when the
sensor is out of Bluetooth range from the
cellular phone, the sensor will not be able
to connect with the cellular phone and
will not be able to record until it
reconnects with the cellular phone.

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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.
The impedance test (occurring every two
minutes) overrides ECG recording, which
means the ECG will lack 0.5 second (ACT
III) of recording every two minutes.
Do not turn the cellular phone sound off or
reduce the volume so that it is inaudible.
After exiting the ACT III (monitor)
application, it will take up to 3 minutes for all
the processes to end. This means you must
wait 3 minutes before starting the ACT III
(monitor) application again.
Take the charged cellular phone with you
and wear the sensor at all times (except
when showering or bathing) during the
monitoring period.

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Caution
A Bluetooth disconnection between the
cellular phone and the sensor might occur
due to electromagnetic interference. In this
case the sensor will search for the cellular
phone device every 3 minutes.
If the cellular phone Bluetooth communication
is not active for 60 minutes, the ACT III
(monitor) application will automatically restart
the Bluetooth communication.
Always change the sensor battery when
connected (Bluetooth) to the cellular phone.
A low sensor battery message indicates there
are at least six hours before the battery fails.
First time use– The patient must call
LifeWatch to receive instructions on how to
proceed for the first time use. The first time
the ACT monitoring system 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 cellular phone for Health
and Safety Information pertaining to the use
and operation of the cellular phone. The
cellular phone manual can be downloaded
from the Internet.
Do not use the cellular phone for any reason
outside of the designated monitoring function.
Keep the ACT III kit contents away from
children.

Page 20
FCC Note
Important Safeguard in the Medical Environment
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
Note
Modifications not expressly approved by the
manufacturer could void the user authority to operate
the equipment under FCC Rules
.
THE MANUFACTURER IS NOT RESPONSIBLE
FOR ANY RADIO OR TV INTERFERENCE
CAUSED BY UNAUTHORIZED MODIFICATIONS
TO THIS EQUIPMENT. SUCH MODIFICATIONS
COULD VOID THE USER'S AUTHORITY TO
OPERATE THE EQUIPMENT.