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LifeWatch ACT III Physician's Manual

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ACT III
Physician Manual
SUP547 Rev B CR 16-002

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  • Page 1 ACT III Physician Manual SUP547 Rev B CR 16-002...
  • Page 2 Tel: +1.847.720.2100 Fax: +1.847.720.2111 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.
  • Page 3 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.  Page 3...
  • Page 4 Authorized representatives: Europe Israel LifeWatch Services, Inc. LifeWatch O’Hare International Obelis s.a Technologies Ltd. Center II Boulevard Général 2 Pekeris Street 10255 West Higgins Road Wahis 53 Rehovot 7670202 1030 Brussels, Rosemont, IL 60018 Israel BELGIUM Toll Free: Tel: 972 8 9484000 Tel: + (32) 2.

  • Page 5: Table Of Contents

    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............

  • Page 6: About This Manual

    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.

  • Page 7: 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 III device and accessories. Label Description Symbol indicates a potentially hazardous...
  • Page 8 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 Page 8...

  • Page 9: Introduction

    ACT III –CG 6108 Sensor Cellular phone 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...
  • Page 10 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 ...
  • 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: 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. The prescribing physician is responsible for reading and understanding all warnings and cautions prior to prescribing the ACT monitoring system.
  • Page 13 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.
  • Page 14 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.
  • Page 15 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.
  • 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 (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...
  • Page 18 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...
  • Page 19 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. Caution ...
  • 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.

  • Page 21: Glossary

    Glossary Electrocardiogram; a representation of the heart's electrical activity recorded from electrodes on the body. Mobile Cardiac Telemetry; Continuous ECG Monitor and Arrhythmia Detector (sensor and cellular phone) (ACT) The service of collecting and analyzing recorded ECG data (usually 24 hours) using ACT Ex the ACT device (ACX).

  • Page 22: System Description

    System Description ACT Description The ACT continuous ECG cellular phone and arrhythmia detector is designed for self-testing by patients at home and for analysis by medical professionals at a remote monitoring center. The ECG chest-worn sensor is used for the acquisition and transmission of the ECG signal.

  • Page 23: Act Ex (Optional Mode)

    ACT Ex (Optional Mode) The ACT Ex option allows the system to function in full disclosure mode. In addition to monitoring each heart beat and auto transmitting when an arrhythmia is noted, the recorded ECG data is transmitted (once every 10 minutes) until the requested amount of data for the full disclosure period has been collected.

  • Page 24: Theory Of Operation

    Theory of Operation The ACT continuous ECG cellular phone and arrhythmia detector consists of a chest-worn ECG sensor ("sensor") with electrodes and a cellular phone with proprietary ACT cellular phone software. The sensor records the ECG data and transmits the ECG signals via Bluetooth to the cellular phone.

  • Page 25: Act Algorithm

    General The arrhythmia detection algorithm is implemented by a proprietary LifeWatch Technologies Ltd. software application that runs on the cellular phone as part of the ACT system. The algorithm processes the ECG acquired by the sensor in order to detect various ECG arrhythmia related events.
  • Page 26 Bradycardia – Heart rate slower than normal heart rate. The Arrhythmia Detection algorithm detects Bradycardia when the HR is below a programmable value Heart Rate Threshold for a specified interval (Bradycardia Interval Threshold). Bradycardia programmable values: Parameter name Values Default value Heart Rate Threshold 30-65 Bradycardia Interval Threshold...
  • Page 27 Main Processing Modules QRS Detection The QRS detection stage is performed based on the signal slope since the derivative of the complexes is significantly higher. In addition, this decision is also affected by noise detection. Pause Immediate Detection The Pause immediate detection mechanism searches every QRS complex for a continuous-enough flat signal without waiting for a sequential QRS.
  • Page 28 High Replaces ECG data between Full Disclosure Impedance two consecutive impedance measurements which are above the threshold (on all three leads in ACT III) Missing Data Replaces missing ECG data Events (ex: Event detected at beginning of application) Page 28...
  • Page 29 Example: Impedance Measurement Template Impedance is measured every two (2) minutes in order to indicate the connectivity status of the leads. This informs the user if a lead is not connected properly and assists the algorithm in reducing the reporting of false positive events. Events are not sent when the leads are not connected and the data might contain noise.

  • Page 30: Act Sensor

    The batteries sent with the sensor are specially selected batteries. Patients should not use over the counter batteries and are instructed to return all used and unused batteries to LifeWatch in the return mailer with the ACT monitoring system when the monitoring session is completed.
  • Page 31 CEM mode). The cellular phone has a special application to convert the raw ECG data into usable information that is sent to the LifeWatch monitoring center using a cellular network. ACT and Bluetooth Bluetooth is a wireless technology that enables the sensor and cellular phone to communicate with each other.
  • Page 32 When the sensor and cellular phone are within Bluetooth range, the Bluetooth on the sensor and the cellular phone will automatically re-connect. In order to minimize interference and maximize battery operation time for both the sensor and cellular phone, the patient should keep the sensor and cellular phone as close as possible (recommended within 10 feet).

  • Page 33: Approved Electrodes

    ACT monitoring system kit. Alternative electrodes are available for patients with a history of sensitivity and/allergy to adhesives. Alternative electrodes can be requested by calling LifeWatch customer service at 1-800-517-6330. Skin Preparation 1. Using only scissors, remove any excess hair in the areas where the diagram (page 35) indicated the electrodes are to be placed.
  • Page 34 Preparing Electrodes  Tear open the electrode pouch and remove four electrodes. Fold over the open end of the pouch to protect the unused electrodes from drying out. Electrodes should be stored at room temperature. Snap an electrode onto each ...
  • Page 35 ACT III Electrode Placement Attach the white lead wire with electrode 3 fingers width below the midpoint of the collarbone on your right side. Place the red lead wire above your last rib on your left side aligned with the midpoint of the collarbone.

  • Page 36: Changing Electrodes

     If irritation worsens or becomes severe, contact LifeWatch to obtain an alternative type of electrode. If there are questions regarding treating irritated skin, please contact your prescribing physician or health or care professional.

  • Page 37: Specifications

    Specifications ACT Sensor Technical Specifications Parameter Typica Units Input operating DC voltage Input impedance 19.5 20.5 MΩ Input dynamic range +/-4.5 +/-5.5 +/- 5 Average current consumption Peak current consumption CMRR samples/ ADC sample rate DC offset correction +/-150 +/-115 LPF cutoff frequency 99.6 157.9...
  • Page 38 Parameter Typica Units Manual ECG event None triggering PM detection None Bluetooth transmission range - Meters open space SPP profile, Sniff mode, Bluetooth protocol None Auto-connection mode lithium-thionyl chloride Battery type / output Days (dependent upon the Battery life depend Bluetooth connectivity MTBF (hours)
  • Page 39 Standards Testing and Reporting Performance Results of: Cardiac ANSI/AAMI EC57:2012 Rhythm and ST Segment Measurement Algorithms Medical electrical equipment - Part IEC 60601-1:2005 3rd 2: Particular requirements for the edition / Cor. 1:2006, safety of electrocardiographic Cor. 2:2007 monitoring equipment Medical electrical equipment, Part IEC 60601-1-2, 1-2;...

  • Page 40: Environmental Conditions

    Environmental Conditions The system is designed for operation in: +10 to + 40 C (50 to 104 Operating temperature Transport & storage -20 to +65 C (-4 to 149 temperature 30 to 85%, non-condensing Relative humidity Physician Selectable Detection Parameters Arrhythmia Type: Minimu Maximum...
  • Page 41 ACT monitoring system cannot detect the specified arrhythmias under all conditions. Additional information on the sensitivity and specificity of the ACT monitoring system for particular arrhythmias is available from LifeWatch upon request. Page 41...

  • Page 42: Heart Rate Calculation, Statistic File

    Heart Rate Calculation, Statistic File Hourly Statistic File The ACT device generates an hourly statistic file (not applicable to CEM mode) which contains the following information: 1. For every minute of operation, a HR histogram is attached (the Min HR, Average HR and Max HR). 2.

  • Page 43: Min Hr Calculation

    Min HR calculation: Due to the fact that Min HR is sensitive to extreme values (that are also caused by noise, disconnections and other artifacts), for every minute, the Min HR is calculated as follows: MinHR  LowerX . 1 ( avgHR RawMinHR Where:...

  • Page 44: Professional Information And Support

    10255 W. Higgins Road Suit 100 Rosemont, IL 60018 Telephone: 1-877-774-9846 Fax: 847-720-2013 ©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. UG-00067A-04...
  • Page 45 PLEASE CALL 1.800.517.6330 FOR TECHNICAL SUPPORT...

This manual is also suitable for:

Cg 6108

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