LifeWatch ACT I User Manual
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LifeWatch ACT I User Manual

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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

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  • Page 1 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...
  • Page 2 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.
  • Page 3 Email: users@cardguard.com webmaster@lifewatch.com 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...
  • Page 4 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.

  • Page 5: Table Of Contents

    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 ..............
  • Page 6 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 ........
  • Page 7 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.

  • Page 8: Introduction

    ACT I – CG 6108 Sensor Cell Phone Monitor 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...
  • Page 9 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.
  • Page 10 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: ...
  • Page 11 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.

  • Page 12: Important Symbols

    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.

  • Page 13: Warnings And Cautions

    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.
  • Page 14  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. ...
  • Page 15  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 Warning...
  • Page 16 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. ...
  • Page 17 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...
  • Page 18 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...
  • Page 19  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.
  • Page 20  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. Caution The cell phone monitor manual can be downloaded from the Internet. ...
  • Page 21 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.

  • Page 22: Symbols On Equipment And Labeling

    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. Label Description Warning, consult accompanying text or documents Caution, consult accompanying text or documents Notes, indicates important general information for using the system successfully.
  • Page 23 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 Page 23...

  • Page 24: Glossary

    Glossary Electrocardiogram; a representation of the heart's electrical activity recorded from electrodes on the body. Ambulatory Cardiac Telemetry; Continuous ECG Monitor and Arrhythmia Detector (sensor and monitor) The service of collecting and analyzing recorded ECG data (usually 24 hours) using the ACT Ex ACT device.
  • Page 25 Irregular heartbeat Arrhythmia Event manually recorded by a patient when Manual event he/she feels it is necessary Page 25...

  • Page 26: General Description

    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.
  • Page 27 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.

  • Page 28: System Description

    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.

  • Page 29: The Act Kit

    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 1. ACT sensor with integrated or 5. Carrying pouch detachable lead wires 6.

  • Page 30: Table Of Figures Figure 1. Front View Of Act I Sensor

    Lead wires for connecting the electrodes. 1, 2 - Buttons for manual recording of an event. Figure 1. Front view of ACT I sensor Battery cover closed Battery cover open Figure 2. Rear view of ACT I sensor Page 30...

  • Page 31: The Act Iii 3-Lead Description

    The ACT III 3-lead Description Sliding Battery Cover Lead wires for connecting the electrodes. 1, 2 - Buttons for manual recording of an event. Figure 3. Front view of ACT III sensor (slide open battery cover) Battery cover closed Battery cover open Figure 4.

  • Page 32: The Act Iii 3-Lead Description With Connectable Patient Lead Wires

    The ACT III 3-lead Description with Connectable Patient Lead Wires Flip Open Battery Cover 1, 2 - Buttons for manual recording of an event. Lead wires for connecting the electrodes. Figure 5. Front view of ACT III sensor (flip open battery cover) Battery cover closed Battery cover open Figure 6.

  • Page 33: Cell Phone Monitor Information

    Cell Phone Monitor Information One of the following cell phone monitors will be provided with the kit. Right soft Left soft HTC Ozone mobile phone HTC Ozone monitor keys and buttons Power Navigation Samsung SGH-i617 mobile phone SGH-i617 monitor keys and buttons Page 33...
  • Page 34 Samsung SGH-i637 mobile phone SGH-i637 monitor keys and buttons 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 cellular phone. The cell phone monitor manual can be downloaded from the internet.

  • Page 35: Important Information Before Use

    The sensor and the cell phone monitor should not be in the bathroom while bathing or showering. Please consult your doctor or LifeWatch regarding the end of the service. You must take the fully charged cell phone monitor with you and wear the sensor at all times (except when showering or bathing).

  • Page 36: Starting/Stopping The Act Sensor

    (2 hours for ACT I; 6 hours for ACT III). In case the disconnection period is longer than the maximum recording time, the sensor will store the LAST time period (2 hours for ACT I; 6 hours for ACT III) of the disconnection period.

  • Page 37: Using The Act Monitoring System

    See Troubleshooting, “Sensor lead wire disconnected”, for instructions on reconnecting the lead wire. Note Contact LifeWatch to receive instructions on using the system for the first time as shown in “First Time Activation”, section. Page 37...

  • Page 38: Electrode Information

    ECG electrodes. To ensure maximum safety and performance of the ACT monitoring system, use only the ECG electrodes supplied with the ACT monitoring system kit. If electrodes irritate your skin, please contact LifeWatch for alternative electrodes. Do not apply electrodes to skin that is broken or irritated.

  • Page 39: Electrode Placement

    Electrode Placement 1. Place the electrodes as shown in Figures 7 (ACT I) and 8 (ACT III). 2. The electrodes should be replaced periodically, according to the electrode's manufacturer instructions as described below. Preparing Electrodes (three for ACT 1 and four for ACT III) Snap each lead wire onto an electrode.

  • Page 40: Figure 7. Act I Electrode Placement

    ACT I Electrode Placement Attach the white lead wire with electrode under the second right rib. (3 fingers below the collarbone) towards the breastbone (center). Attach the red lead wire with electrode on the lower right portion of your chest.

  • Page 41: Figure 8. Act Iii Electrode Placement

    ACT III Electrode Placement Attach the white lead wire with electrode under the second right rib. (3 fingers below the collarbone) towards the breastbone (center). Place the red lead wire with electrode in a direct line from the end of the breastbone that intersects with the imaginary line that extends down from the midpoint of the collarbone, as shown in ACT III Electrode Placement figure.

  • Page 42: Changing Electrodes

    Minor skin irritation can occur with electrode use. If skin irritation occurs, do not re-apply electrode to the immediate area. Apply in close proximity to that location on healthy skin.  If irritation worsens or becomes severe, contact LifeWatch. Page 42...

  • Page 43: Sensor Battery Insertion / Replacement

    4) If the sensor battery has been changed while disconnected from the cell phone monitor and within the maximum recording time of the sensor (ACT I up to 2 hours; ACT III up to 6 hours) then upon reconnection to...

  • Page 44: Figure 9. Removing Battery Cover

    6) Place any used and unused batteries in the return envelope provided in the kit and return to LifeWatch at the end of your monitoring period. ACT with Slide-off Cover 1. Change the sensor battery when the following occurs: 1. The sensor beeps two times, 1 long beep then 1 short beep.

  • Page 45: Figure 10. Replacing Battery

    10 seconds of placing a new battery. If no sound is heard after ten seconds, verify that the battery has been placed in the correct position. If the position is correct, try another battery. If the second battery fails, contact LifeWatch. Figure 10. Replacing Battery...

  • Page 46: Figure 11. Replacing Battery Cover

    3. Connect the sensor to the neck strap (if it was not attached). Note  Before changing the sensor battery, make sure the cell phone monitor is within range 20 inches (50 cm).  If you are missing batteries, contact LifeWatch. Page 46...
  • Page 47 ACT III with Flip Open Battery Cover 1. Place sensor within 20 inches (50 cm) from the cell phone monitor, place the battery in the sensor: a. Hold the ACT sensor with the battery compartment facing up. Press the orange button on the upper part of the ACT sensor to release the battery compartment cover.
  • Page 48 10 seconds of inserting a new battery. If no sound is heard after ten seconds, verify that the battery has been place in the correct position. If the position is correct, try another battery. If the second battery fails, contact LifeWatch. Figure 13. Replacing Battery d.
  • Page 49 Cell Phone Monitor Placement For optimal system performance, the recommended distances between the cell phone monitor and sensor should be as follows: Within 20 inches (50 cm) for normal operation Within 10 feet (3 meters) during cell phone monitor charging Within 30 feet (10 meters) maximum distance Page 49...

  • Page 50: Cell Phone Monitor Recharging Procedure

    Cell Phone Monitor Recharging Procedure Charge the cell phone monitor whenever possible during the day. In addition, charge the monitor every night (regardless of battery indicator status), making sure that it is within 10 feet (3 meters) of the sensor. 1.

  • Page 51: Figure 14. Htc Ozone Monitor Power Button And Socket

    HTC Ozone mobile Power button phone Connection for power supply Figure 14. HTC Ozone monitor power button and socket Samsung Power button SGH-i617 mobile phone Connection for power supply Figure 15. SGH-i617 monitor power button and socket Page 51...

  • Page 52: Figure 16. Sgh-I637 Monitor Power Button And Socket

    Power button Samsung SGH-i637 mobile phone Connection for power supply Figure 16. SGH-i637 monitor power button and socket Page 52...

  • Page 53: First Time Activation

    First Time Activation The first time the ACT monitoring system is activated, it performs a baseline capture and calibration procedure. The screens you see during this process will only be seen once when the cell phone monitor is turned on for the first time. 1.
  • Page 54 3. When the welcome screen comes up, press Ok using the right soft key to continue or Exit to close the program.” Note ACT III is used as an example for this section. 4. Place the battery in the sensor. 5.
  • Page 55 6. Step 1 – Data collection and sending baseline recording. Remain relatively still, without moving or exerting yourself until the baseline recording is sent. 7. When Step 1 is finished the monitoring screen will be displayed for a few seconds, then Step 2 will be displayed. Note Step 1 and Step 2 may be performed in parallel by the system and the Step 2 screen may not be...
  • Page 56 Note If you have any questions on the use of the ACT Monitoring System, please contact LifeWatch. CAUTION Take a charged cell phone monitor with you and wear the sensor at all times during the monitoring period (except when showering or bathing).

  • Page 57: Monitoring Period

    Monitoring Period This section describes the steps that you need to know if you exit the ACT application after first time activation and additional information about the monitoring period. The recommended distance between the cell phone monitor and sensor is within 20 inches (50 cm) (see Cell Phone Monitor Placement section).
  • Page 58 After a few seconds the application will start automatically. 4. The following screens will be displayed. ACT III ACT I Page 58...
  • Page 59 5. Please place the battery in the sensor (as shown in Sensor Battery Insertion / Replacement section). After the connection is established between cell phone monitor and sensor (which can take up to five minutes), the heart icon will be pulsing indicating the system is running (does not represent patient’s actual pulse).
  • Page 60 Note ACT Ex icon may be displayed during the service period. REMEMBER: The events that are recorded automatically will also be transmitted automatically while the application is running. Note If there is a problem with the cellular communication or CG-3800BT modem (if in use), the device will continue to function and store the recordings for sending later when the problem is resolved.

  • Page 61: Manual Event Recording

    Manual Event Recording If you experience dizziness, fatigue, chest pain or any other symptom, record a manual event. There are two options for recording a manual event, by pressing the sensor side buttons or by pressing the cell phone monitor manual event button.
  • Page 62 Select and mark the applicable symptom(s) then press the Send button to send the form. If your symptom is not on the list, select and mark “Other” and send the form. If you don’t have any symptom, select and mark “No Symptoms” and send the form. Scroll If “Send”...
  • Page 63 Second Option Recording a Manual Event with the cell phone monitor Press the cell phone monitor right soft key to initiate a Manual Event recording. If you have pressed the cell phone monitor’s Manual Event button the following confirmation screen will be displayed on the cell phone monitor.
  • Page 64 When Yes has been pressed, the manual event form will be displayed. Select and mark the applicable symptom(s) then press the Send button to send the form. If your symptom is not on the list, select and mark “Other” and send the form. If you don’t have any symptom, select and mark “No Symptoms”...
  • Page 65 Note Situations when it is not possible to record a manual event with the cell phone monitor. During the process of collecting manual event data it is not possible to initiate a new manual event. When the sensor and the cell phone monitor are disconnected for any reason, the manual event can be recorded with the sensor.
  • Page 66 During the process of downloading data from the sensor (reconnection after battery replacement), manual event recording is not available. Page 66...

  • Page 67: Cell Phone Monitor Messages

    6. Cell Phone Monitor Messages Messages inform you about a problem that might occur during operation of the ACT monitoring system. The message may include steps to resolve the problem (cellular coverage may resolve by itself). A message screen may be closed (by pressing OK), but if the underlying problem has not been resolved it will be indicated on the cell phone monitor screen.

  • Page 68: Sensor Battery Low

    Sensor Battery Low The low battery message appears when the sensor battery needs to be replaced. Please refer to “Sensor Battery Insertion / Replacement”, section, for information on how to replace the battery. Be aware that the sensor alerts its low battery status with 1 long beep then a short beep from the sensor.

  • Page 69: Cell Phone Monitor Battery Low

    Cell Phone Monitor Battery Low The cell phone monitor low battery message appears when the cell phone monitor needs to be charged. Please refer to “Cell Phone Monitor Charging Procedure” section for information on how to charge the cell phone monitor. “Cell phone monitor low battery”...

  • Page 70: Sensor (Bluetooth) Disconnection

    Sensor (Bluetooth) Disconnection The sensor disconnection message appears when there is Bluetooth disconnection from the cell phone monitor. Be aware that a disconnection can be caused by the sensor being in low battery mode (accompanied by 1 long beep then a short beep from the sensor), please refer to “Sensor Battery Low”...

  • Page 71: Cell Phone Monitor Transmission Problem

    Cell Phone Monitor Transmission Problem The cell phone monitor transmission message appears when there are transmission problems that could be caused by poor cellular coverage, cellular network problems or communication problems with the CG-3800BT modem (if modem is in use). Make sure you have good cellular coverage by checking the cellular...

  • Page 72: Electrode Connectivity

    Even though the electrodes seem to be in good contact with the body, the message will continue to appear. Some examples are very dry skin or right after attaching the electrodes. If the condition does not resolve, contact LifeWatch. Page 72...
  • Page 73 Electrode Messages for ACT I Black electrode problem White electrode problem Red (or all) electrode(s) problem Correct the problem and press Page 73...
  • Page 74 Electrode Messages for ACT III White electrode problem Black electrode problem Red electrode problem Page 74...
  • Page 75 Red and black electrodes problem Note When two electrodes (white, red or black) have problems there will be a message indicating which two electrodes need to be checked. Green (or all) electrode(s) disconnected or lead wire is disconnected from sensor (ACT III sensor with flip-open cover) Correct the problem and press Page 75...

  • Page 76: Code Messages

    Code Messages Code messages are displayed on the cell phone monitor screen whenever an unexpected situation occurs. Please follow the instructions displayed in the screen. See Appendix B for a list of the message codes. Code Message example Page 76...

  • Page 77: Maintenance

    7. Maintenance Conditions of Use Your ACT system conforms to international standards as long as it is used under normal conditions and in accordance with the following instructions. Caring for your ACT CAUTION  Do not open or attempt to repair the sensor or cell phone monitor yourself.

  • Page 78: Environment

    Mechanical Inspection Check for splits, cracks or other related flaws in the ACT monitoring system. If you have any questions or doubts, call LifeWatch. Cleaning To clean the outside of the ACT monitoring system use a lint-free cloth lightly moistened with isopropyl alcohol.

  • Page 79: Troubleshooting

    8. Troubleshooting Please follow the steps listed below in order to resolve the problem. If this does not solve the problem contact LifeWatch. Problem Possible Cause(s) Solution 1) Check the battery placement and No beep when polarity. Battery not placed...
  • Page 80 Problem Possible Cause(s) Solution Even though the electrodes seem to be in good contact with the body, the message will continue to appear. Some examples are very dry skin or right after attaching the electrodes. 4) Please refer to “Electrode Placement” section for further information.
  • Page 81 Problem Possible Cause(s) Solution information on how to recharge the cell phone monitor. The cell phone monitor The cell phone needs to be recharged, please refer to “Cell Cell phone monitor low battery monitor low message appears Phone Monitor battery when the cell phone Recharging Procedure”...
  • Page 82 Problem Possible Cause(s) Solution seconds; then re- insert battery. Allow up to 5 minutes for sensor and cell phone monitor to reconnect. 2) Make sure that the sensor lead wire is properly connected to the sensor (for attachable leads). Sensor battery needs to be replaced, please refer to “Sensor Battery Sensor beeps...
  • Page 83 Possible Problem Solution Cause(s) Battery cover 1) Place battery cover on device in separates from the proper place (see picture A device and B) Replace 2) Press down firmly on battery Note: Relevant battery cover at point (1) as shown in to ACT III Flip cover picture C until you hear a click.
  • Page 84 Problem Possible Cause(s) Solution Verify the sensor lead Sensor lead wire is connected to the wire ACT sensor socket by disconnected Sensor lead wire first aligning the arrow detached from on the lead wire (1) with NOTE: for ACT sensor the arrow on the ACT III with Flip sensor (2) and then push...

  • Page 85: Technical Specifications

    9. Technical Specifications IMPORTANT This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) This device must accept any interference received, including interference that may cause undesired operation.

  • Page 86: Act I Sensor Technical Specifications

    ACT I Sensor Technical Specifications Parameter Typical Units MΩ Input Impedance 19.5 20.5 +/- 5 Input dynamic range Average current consumption Peak current Consumption CMRR samples/sec ADC sample rate |mV| DC offset correction 61.8 90.45 LPF cutoff frequency HPF cutoff frequency .043...
  • Page 87 Parameter Typical Units Bluetooth transmission meters range - open space SPP profile, Sniff mode, Auto- Bluetooth protocol connection mode 3.6V lithium-thionyl chloride AA Battery type Battery life (dependent upon Bluetooth Days connectivity) 36,305 MTBF (hours) Operating temperature °C (°F) (50) (104) Transport &...

  • Page 88: Act Iii Sensor Technical Specifications

    ACT III Sensor Technical Specifications Parameter Typical Units Input operating DC voltage MΩ 19.5 20.5 Input Impedance +/- 5 Input dynamic range Average current consumption Peak current consumption CMRR samples/sec ADC sample Rate +/-115 DC offset correction 99.6 157.9 115.7 LPF cutoff frequency HPF cutoff frequency .035 .055...
  • Page 89 Parameter Typical Units ECG buffering time 6:13 N/A 6:19 Hours:Minutes Manual ECG event None triggering None PM detection Bluetooth meters Transmission range - open space SPP profile, Sniff mode, None Bluetooth protocol Auto-connection mode lithium-thionyl chloride Battery type / output Battery life (dependent Days upon Bluetooth...

  • Page 90: Appendix A Monitor (Cellular Phone) Warnings

    Appendix A Monitor (Cellular Phone) Warnings Using Your Phone Near Other Electronic Devices Most modern electronic equipment is shielded from radio frequency (RF) signals. However, certain electronic equipment may not be shielded against the RF signals from your wireless phone. Consult the manufacturer to discuss alternatives.
  • Page 91 of wireless phones under the Hearing Aid Compatibility Act of 1988 (HAC Act) to require digital wireless phones be compatible with hearing-aids. The intent of the HAC Act is to ensure reasonable access to telecommunications services for persons with hearing disabilities.

  • Page 92: Other Medical Devices

    wireless phone. “Normal usage” in this context is defined as a signal quality that is acceptable for normal operation. The M mark is intended to be synonymous with the U mark. The T mark is intended to be synonymous with the UT mark. The M and T marks are recommended by the Alliance for Telecommunications Industries Solutions (ATIS).

  • Page 93: Body-Worn Operation

    that no evidence exists that using a wireless phone causes brain tumors or other ill effects. Their recommendation to limit wireless phone use by children was strictly precautionary; it was not based on scientific evidence that any health hazard exists. Body-worn Operation To comply with RF exposure requirements, a minimum separation distance of 0.50 inch (1.5 cm) must be maintained between the user’s...

  • Page 94: Appendix B Message Codes

    To resolve: Turn phone OFF and then ON If not resolved call LifeWatch at 1-800-517-6330 CODE 212 Monitoring has not started Please call LifeWatch at 1-800-517-6330 to begin monitoring CODE 213 To resolve: Turn phone OFF and then ON If not resolved call LifeWatch at 1-800-517-6330...
  • Page 95 CODE 290 Please call LifeWatch at 1-800-517-6330 CODE 401 ACT Monitor will restart If this re-occurs please call LifeWatch at 1-800-517-6330 CODE 403 Please remove and then re-insert battery into sensor If not resolved call LifeWatch at 1-800-517-6330 CODE 700...

  • Page 96: Limited Warranty

    Limited Warranty This Card Guard® Device ("CG Device") is warranted against defective material and workmanship for a warranty term of 1 year following shipment from Card Guard facility of this product to the customer ("Warranty Term"). If this product or any part thereof, in the judgment of Card Guard, is proven to be defective in material or workmanship within the warranty term, Card Guard will at its sole discretion either repair the item or replace it with a similar one (refurbished...
  • Page 97 which they are installed or to which they are connected; this Section 4 pertains to the importance of liability for Card Guard Products; CARD GUARD SHALL NOT BE LIABLE TO ANY PERSON FOR ANY SPECIAL, CONSEQUENTIAL OR INDIRECT DAMAGES, INCLUDING, BUT NOT LIMITED TO, DAMAGES TO OR LOSS OF PROPERTY OR EQUIPMENT, LOSS OF PROFIT, LOSS OF USE OF DATA, LOSS OF REVENUES OR DAMAGES TO BUSINESS OR REPUTATION ARISING...

  • Page 98: Software End User License Agreement

    Software End User License Agreement Using any part of the enclosed Card Guard Scientific Survival Ltd software (the “Software”) indicates that you agree to the terms and conditions set forth below. If you do not agree to the terms of this Software License Agreement (the “License”), you are not allowed to use the Software.
  • Page 99 CUSTOMER REMEDIES: Card Guard Scientific Survival Ltd's entire liability and your sole remedy shall be repair or replacement of the Software. Replacement Software will be warranted for the remainder of the original warranty period or thirty (30) days, whichever is longer. NO LIABILITY FOR CONSEQUENTIAL DAMAGES: IN NO EVENT SHALL Card Guard Scientific Survival Ltd OR ITS SUPPLIERS BE LIABLE FOR ANY CONSEQUENTIAL (including but not limited for any lost revenue, profit, or data, or punitive damages), SPECIAL,...
  • Page 100 2 Pekeris St., P.O. Box 527 Rehovot, 76100 Israel Telephone: 972-8-948-4000 Fax: 972-8-948-4044 www.cardguard.com Distributor & Service: LifeWatch Corp. O’Hare International Center II 10255 W. Higgins Road ,Suite 100 Rosemont, IL , 60018 Telephone: 1-877-774-9846 Fax: 847-720-2013 www.lifewatch.com Page 100...
  • Page 101 THIS PAGE LEFT INTENTIONALLY BLANK Page 101...
  • Page 102 PLEASE CALL 1.800.517.6330 FOR 24/7 CUSTOMER SUPPORT SUP362, ACT Patient User Guide, Rev C, CR 11-023...

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