LifeWatch ACT I User manual

SUP362, ACT Patient User Guide, Rev C, DCR 11-023
ACT I and ACT III
Patient User Guide
PLEASE CALL
1.800.517.6330
FOR 24/7 CUSTOMER SUPPORT

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ACT I and ACT III Patient User Guide
This user guide includes information and instructions about the
ACT (Continuous ECG Monitor and Arrhythmia Detector) monitoring
system. Please read it carefully before you begin testing.
If you have any questions regarding the ACT monitoring system
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 ACT 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 ACT monitoring system is activated
and is attached to you, it will display screens that are
not seen in regular use. These screens are calibration
procedures the ACT monitoring system needs to
perform to adjust its operation for first time use. Please
read the “First Time Activation” section, for more details.

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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, 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
Card Guard Scientific
Survival, Ltd.
2 Pekeris St.
Rabin Science Park
Rehovot 76100
Israel
Tel: [phone]
Fax: [phone]
Email:
[email protected]
Copyright Declaration
Copyright ©2011 LifeWatch Services, Inc. All rights reserved.
LifeWatch, Watching Life, and LifeStar ACT are trademarks of
LifeWatch Services, Inc. LifeWatch reserves the right to change
specifications at any time without notice.
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.
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.
Card Guard, Card Guard logo, Instromedix, Instromedix logo,
CG-6108, ACT, ACT-III and PMP4® are trademarks or registered
trademarks of the LifeWatch® Group of Companies.
All other brand names and product names used in this document are
trade names, service marks, trademarks, or registered trademarks of
their respective owners.

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The information and screens provided in this manual are subject to
change without notice.
Card Guard Scientific Survival 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.

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Table of Contents
1. Introduction...............................................................8
Intended Use .................................................................8
Important Symbols.......................................................12
Warnings and Cautions ...............................................13
Symbols on Equipment and Labeling ..........................22
Glossary.......................................................................24
2. General Description ...............................................26
3. System Description................................................28
4. The ACT Kit.............................................................29
Contents ......................................................................29
The ACT III 3-lead Description.....................................31
The ACT III 3-lead Description
with Connectable Patient Lead Wires..........................32
Cell Phone Monitor Information ...................................33
Important Information Before Use................................35
General........................................................................35
Starting/Stopping the ACT Sensor...............................36
No Connection with Cell Phone Monitor ......................36
Sensor Sound Prompts................................................36
5. Using the ACT Monitoring System........................37
Before Starting.............................................................37
Electrode Information...................................................38
Electrode Placement....................................................39
Changing Electrodes ...................................................42
Sensor Battery Insertion / Replacement ......................43

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Cell Phone Monitor Recharging Procedure..................50
First Time Activation ....................................................53
Monitoring Period.........................................................57
Manual Event Recording..............................................61
6. Cell Phone Monitor Messages...............................67
Sensor Battery Low......................................................68
Cell Phone Monitor Battery Low...................................69
Sensor (Bluetooth) Disconnection................................70
Cell Phone Monitor Transmission Problem..................71
Electrode Connectivity.................................................72
Code Messages...........................................................76
7. Maintenance............................................................77
Conditions of Use.........................................................77
Caring for your ACT.....................................................77
Environment.................................................................78
Preventive Maintenance ..............................................78
8. Troubleshooting .....................................................79
9. Technical Specifications........................................85
ACT I Sensor Technical Specifications........................86
ACT III Sensor Technical Specifications......................88
10. Appendix A Monitor (Cellular Phone) Warnings 90
Using Your Phone Near Other Electronic Devices.......90
Implantable Medical Devices .......................................90
Hearing Aid Compatibility with Mobile Phones.............90
Other Medical Devices.................................................92
Children Using Wireless Phones..................................92

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Body-worn Operation...................................................93
11. Appendix B Message Codes................................94
12. Limited Warranty ..................................................96
13. Software End User License Agreement..............98
Table of Figures
Figure 1. Front view of ACT I sensor ........................................... 30
Figure 2. Rear view of ACT I sensor............................................ 30
Figure 3. Front view of ACT III sensor (slide open battery cover). 31
Figure 4. Rear view of ACT III sensor.......................................... 31
Figure 5. Front view of ACT III sensor (flip open battery cover) ... 32
Figure 6. Rear view of ACT III sensor.......................................... 32
Figure 7. ACT I Electrode Placement........................................... 40
Figure 8. ACT III Electrode Placement......................................... 41
Figure 9. Removing Battery Cover............................................... 44
Figure 10. Replacing Battery................................................... 45
Figure 11. Replacing Battery Cover ........................................ 46
Figure 14. HTC Ozone monitor power button and socket........ 51
Figure 15. SGH-i617 monitor power button and socket........... 51
Figure 16. SGH-i637 monitor power button and socket........... 52
Figure 17. Sensor Manual Recording...................................... 61

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1. Introduction
Intended Use
ACT I –CG 6108
The ACT I 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 a
one lead 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.
ACT III –CG 6108-3L
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
Sensor
Cell Phone Monitor
Sensor
Cell Phone Monitor

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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 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.
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 Bradyarrhythmias. 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

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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 (cell phone monitor)
Operate simple push-buttons
The ACT monitoring system is safe for use by patients wearing an
oxygen mask for breathing.
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, 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.
A landline modem can be provided for locations with limited cellular
service coverage and/or if interference with the wireless Bluetooth
connection is experienced.

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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 cell phone monitor
whenever possible, and at least every night. The battery in the sensor
should be changed as instructed by the low battery messages. The
performance of the Cell Phone Monitor and Sensor, including data
recording and transmission, may be adversely impacted if not
adequately charged.

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Important Symbols
A number of symbols are used throughout this manual in order to
draw attention to safety items and other important information.
The following symbols are used:
Warning
Symbol indicates a potentially hazardous situation,
which, if not avoided, could result in death or serious
injury to the user.
Caution
Symbol indicates a situation that the user must take
into consideration to ensure the safe and effective
operation of the equipment and associated
accessories.
Notes
Symbol indicates important general information for
using the system successfully.

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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. Your 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.
To prevent an allergic reaction, do not use the
ACT monitoring system or accessories if you have
a known allergy to nickel or other metals.
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.
Use of conductive, connected devices and patient
lead wires/electrodes like the ACT monitoring
system 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
The ACT monitoring system is not intended
for use on persons with an Implantable
Cardioverter Defibrillator (ICD).
Use with Implanted Conventional Pacemakers -
(not including ICDs)
If you have an implanted pacemaker, the
manufacturer may recommend certain precautions
when using a cellular phone. Since the ACT cell
phone monitor is also a cellular phone, you should
take the same precautions when carrying and
using the cell phone monitor. In general, most
manufacturers recommend the following:
Keep a distance of at least six inches (15 cm)
between the cell phone monitor and a
pacemaker.
Carry the cell phone monitor on the opposite
side of the body from the pacemaker.
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.
Refer to the manufacturer's information for
guidance regarding the pacemaker and
interference issues.

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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.
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 cell phone monitor every night
(irrespective of indicator status), making
sure that it is within 10 feet (3 meter) of
the sensor. In addition, charge the cell
phone monitor whenever possible during
the day.
The cell phone monitor energy
consumption may be high during the first
few days of monitoring (up to 72 hours).
Keep the cell phone monitor 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
cell phone monitor, the sensor will not be
able to connect with the cell phone
monitor and will not be able to record until
it reconnects with the cell phone monitor.

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Caution
If the sensor (ACT I firmware version 0.1g
and ACT III firmware version 1.0.4) is not
connected to the cell phone monitor (via
Bluetooth) for more than 2 hours (ACT I) or 6
hours (ACT III) and the sensor's battery is
replaced, the sensor (on reconnection) will
start with new data and not download the
data stored, thus overriding the data stored
when it was not connected.
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 1 second (ACT I) or
0.5 second (ACT III) of recording every two
minutes.
Do not turn the cell phone monitor sound off
or reduce the volume so that it is inaudible.
After exiting the ACT (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 (monitor) application
again.
Take the charged cell phone monitor 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 cell
phone monitor and the sensor might occur due
to electromagnetic interference. In this case
the sensor will search for the cell phone
monitor device every 3 minutes.
If the cell phone monitor Bluetooth
communication is not active for 60 minutes, the
ACT (monitor) application will automatically
restart the Bluetooth communication.
Always change the sensor battery when
connected (Bluetooth) to the cell phone
monitor, a low sensor battery message
indicates there are up to three 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.

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Caution
Please refer to the user manual of the
manufacturer of the cell phone monitor for
Health and Safety Information pertaining to the
use and operation of the cell phone monitor.
The cell phone monitor manual can be
downloaded from the Internet.
Do not use the cell phone monitor for any
reason outside of the designated monitoring
function.
Keep kit contents away from children.