Card Guard scientific survival ACT1 Users Manual

ACT I and ACT III
Patient User Guide
PLEASE CALL
1.800.517.6330
FOR 24/7 CUSTOMER SUPPORT
SUP362, ACT Patient User Guide, Rev C, DCR 11-023
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.
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.
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: mail@obelis.net
USA
LifeWatch, Inc. O’Hare International Center 10255 West Higgins Road Suite 120 Rosemont, IL 60018 Tel: 847-720-2295 Fax: 847-720-1995 Toll Free: 800-633-3361 Fax: 800-954-2375 Email: webmaster@lifewatch.com
Israel
Card Guard Scientific Survival, Ltd. 2 Pekeris St. Rabin Science Park Rehovot 76100 Israel Tel: 972 8 9484000 Fax: 972 8 9484044 Email: users@cardguard.com
Authorized representatives:
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.
Illustrations included in this manual are general representations only and are not meant to comply with specific regulatory requirements.
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.
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
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
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
Sensor
Cell Phone Monitor
Sensor
Cell Phone Monitor
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
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 life­threatening 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
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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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.
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:
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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.
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.
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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.
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FCC Note
Important Safeguard in the Medical Environment
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.
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
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Label
Description
Warning, consult accompanying text or documents
Caution, consult accompanying text or documents
Notes, indicates important general information for using the system successfully.
Tips, indicates important tips on using the system.
Consult instructions for use
Serial Number
Date of Manufacture
Type BF Applied Part
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 ACT device and accessories.
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Label
Description
Batch code
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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ECG
Electrocardiogram; a representation of the heart's electrical activity recorded from electrodes on the body.
ACT
Ambulatory Cardiac Telemetry; Continuous
ECG Monitor and Arrhythmia Detector (sensor and monitor)
ACT Ex
The service of collecting and analyzing recorded ECG data (usually 24 hours) using the ACT device.
Sensor
ACT device attached to patient
Monitor
Hand held device/cellular phone using ACT monitoring software
Heart Rate
Number of heart beats per minute, measured as bpm (beats per minute).
Bluetooth (BT)
Wireless communication protocol.
Monitoring Center
Monitoring center responsible for reviewing clinical data transmissions, and providing them to the physician.
Charger
Power supply for recharging cell phone monitor
Disposable electrode (electrode patch)
Adhesive connector that connects the lead wire to the body.
Glossary
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Arrhythmia
Irregular heartbeat
Manual event
Event manually recorded by a patient when he/she feels it is necessary
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2. General Description
The ACT is an automatically activated cardiac monitoring system that requires no patient intervention to capture or transmit an arrhythmia when it occurs. When an arrhythmia is detected, the ACT monitoring system utilizes an integrated cell phone monitor to transmit the data to the Monitoring Center for analysis.
Sensor
The sensor records and transmits the data to the cell phone monitor. It can hold up to 6 hours (ACT III) or 2 hours (ACT I) of data in its memory. This means that if a patient is away from the cell phone monitor and wearing the sensor, the data is still being recorded. Once the patient is in range (within 30 feet /10 meters) of the cell phone monitor, the data will be transmitted.
Cell Phone Monitor
The cell phone monitor receives ECG data from the sensor via Bluetooth and can store up to 30 days of data. The cell phone monitor has a special application that converts the raw ECG data and sends it using a cellular network to the monitoring center for interpretation or, in the case of no cellular coverage, data can be sent using a landline and a modem. The cell phone monitor should be carried in the supplied pouch whenever possible.
Batteries
The sensor batteries are special batteries. DO NOT use over the counter AA batteries. DO NOT dispose of the batteries – they should be returned to LifeWatch when your monitoring session is completed.
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About Bluetooth
Bluetooth is a wireless technology that enables the sensor and cell phone monitor to communicate with each other. The ACT system uses Bluetooth technology to transmit ECG data from the sensor to the cell phone monitor. The cell phone monitor internal Bluetooth component is on and running continuously (24 hours a day) for the entire monitoring period; therefore, the cell phone monitor must be ON at all times. Bluetooth operates like a radio and is susceptible to interference. If the sensor and cell phone monitor are more than 30 feet (10 meter) apart and a Bluetooth connection cannot be made, no data loss will occur as long as the sensor and cell phone monitor are reconnected within 6 hours (ACT III) or 2 hours (ACT I). When the sensor and cell phone monitor are within 30 feet (10 meter) of one another, the Bluetooth will automatically re-connect. Charge the phone every night for the whole night and whenever possible throughout the day.
For optimal system performance, the recommended distances between the cell phone monitor and sensor during the monitoring period should be as follows:
Normal operation - within 20 inches (50 cm). During cell phone monitor charging - within10 feet (3
meter)
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Note
The cell phone monitor automatically transmits the detected ECG events to the monitoring center and the user has the ability to send manually recorded events. The data is saved on the storage card and the event data is deleted after a successful transmission to the monitoring center.
3. System Description
The ACT Continuous ECG Monitor and Arrhythmia Detector is designed for self-testing by patients at home and for analysis by trained technicians at a remote Monitoring Center.
The sensor is used for the acquisition and transmission of the ECG signal. The sensor is equipped with three (ACT I) or four (ACT III) electrodes on a harness and works in conjunction with a cell phone monitor.
The sensor houses a 3.6V AA lithium-thionyl chloride battery, an ECG channel circuit, an impedance measurement circuit, a pacemaker detection circuit, a flash buffer memory, a Bluetooth transceiver and a buzzer. The ECG signals are received, filtered and amplified in the input circuit, stored in the flash memory buffer and transmitted via Bluetooth to a cell phone monitor. The cell phone monitor runs a proprietary application that is configured to process and transmit the ECG recordings via a cellular network while storing them and the detected physiological events on a micro-SD memory card. When a physiological event is detected, the cell phone monitor transmits the recorded ECG automatically via cellular link, to a Monitoring Center for professional analysis. If the patient is out of the cellular network coverage area, the cell phone monitor will send all events that were stored when the cellular link is re-established. The cell phone monitor can also transmit ECG alarms via landline telephone with an additional POTS Bluetooth modem.
The sensor loops up to 2 hours (ACT I) or 6 hours (ACT III) cyclic buffer of ECG data in the internal flash memory in order to preserve the ECG in cases when the Bluetooth connection to the cell phone monitor is down.
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1. ACT sensor with integrated or detachable lead wires
2. ACT sensor batteries (3.6 V AA lithium-thionyl chloride)
3. Disposable electrodes
4. User Guide
5. Carrying pouch
6. ACT monitor (cell phone)
7. Monitor charger
8. PSTN modem (optional)
9. Pre-paid return envelope
4. The ACT Kit
The ACT Kit provided may contain either the ACT 1-lead or ACT 3-lead sensor, one cell phone monitor and all the accessories needed for use of the system.
Contents
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Lead wires for connecting the electrodes.
1
2
1, 2 - Buttons for manual recording of an event.
The ACT I 1-lead Description
Figure 1. Front view of ACT I sensor
Battery cover closed Battery cover open
Figure 2. Rear view of ACT I sensor
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