LifeWatch ACT III Physician'S Manual Download

Page: 1 / 45

ACT III

Physician Manual

SUP547 Rev B CR 16-002

Summary of Contents for ACT III

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...

Page 3: ...ent are trade names service marks trademarks or registered trademarks of their respective owners The information and screens provided in this manual are subject to change without notice LifeWatch Tech...

Page 4: ...0 Fax 1 847 720 2111 Email webmaster lifewatch com Israel LifeWatch Technologies Ltd 2 Pekeris Street Rehovot 7670202 Israel Tel 972 8 9484000 Fax 972 8 9484044 Email users lifewatch com Federal Law U...

Page 5: ...Mode 23 Theory of Operation 24 ACT Algorithm 25 ACT Sensor 30 Approved Electrodes 33 Electrode Placement 33 Changing Electrodes 36 Specifications 37 ACT Sensor Technical Specifications 37 Environmenta...

Page 6: ...to the appropriate patient population Please read this manual thoroughly before prescribing the system A Patient Instruction Manual is included in each ACT monitoring system kit and should be referre...

Page 7: ...d accessories Label Description Symbol indicates a potentially hazardous situation which if not avoided could result in serious adverse reactions and potential safety hazards Symbol indicates a situat...

Page 8: ...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 conformit...

Page 9: ...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 V...

Page 10: ...onditions such as hyperthyroidism or chronic lung disease Patients with obstructive sleep apnea to evaluate possible nocturnal arrhythmias Patients requiring arrhythmia evaluation for etiology of stro...

Page 11: ...may occur if there is limited cellular service in the area You may occasionally experience a delay in the ability to send recorded events due to unexpected cellular limitations If this occurs contact...

Page 12: ...nformation 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...

Page 13: ...of the defibrillator The ACT monitoring systems MUST be removed prior to defibrillation as it contains metals that could cause the defibrillator to arc The ACT is MR Unsafe If you should come into pos...

Page 14: ...llular phone and a pacemaker or ICD Carry the cellular phone on the opposite side of the body from the pacemaker or ICD Don t carry a cell phone in a breast pocket or on a belt if that would place the...

Page 15: ...one at a later time Disrupt communication that may delay the transfer of data from smartphone to server However data will still be saved on smartphone flash memory for transfer to the server at a late...

Page 16: ...o 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 cellul...

Page 17: ...t it is within 10 feet 3 meter of the sensor In addition charge the cellular phone whenever possible during the day The cellular phone energy consumption may be high during the first few days of monit...

Page 18: ...d ACT III of recording every two minutes Do not turn the cellular phone sound off or reduce the volume so that it is inaudible After exiting the ACT III monitor application it will take up to 3 minute...

Page 19: ...s 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...

Page 20: ...use 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 fo...

Page 21: ...software Heart Rate Number of beats per minute measured as bpm beats per minute Bluetooth BT Wireless communication protocol BT Address Network address used for identifying the device PC Personal com...

Page 22: ...in the flash memory buffer and transmitted via Bluetooth to a cellular phone cellular phone The cellular phone runs a proprietary application that is configured to process and transmit the ECG record...

Page 23: ...nsor is not affected Cardiac Event Monitor CEM Optional Mode CEM mode is one of the service modes in which the application can be active besides the regular ACT and ACT Ex mode The mode can be enabled...

Page 24: ...ormed once every two minutes Notes A short Pause episode which takes place during immediately before or right after an impedance check might not trigger a physiological alarm The cellular phone monito...

Page 25: ...ters that can be modified by the monitoring center based on a physician s order Tachycardia A rapid heart rate that exceeds the normal range for a resting heart rate HR The arrhythmia detection algori...

Page 26: ...Pause programmable values Parameter name Values Default value Pause Interval Threshold 3 10 3 Atrial Fibrillation AFIB Irregular heart rhythms in which the atria is out of sync with the ventricles AF...

Page 27: ...s detected a pause event is reported immediately Note Straight line segment is considered as electrode disconnection and will not be reported as Pause Arc Length Transforms The Arc Length transform of...

Page 28: ...ECG signal is recorded at this time Events Full Disclosure ECG Low Voltage Replaces ECG data when a low voltage or non bio signal is detected can be configured in registry Full Disclosure ECG High Im...

Page 29: ...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 t...

Page 30: ...tteries 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 Notes The impedance test oc...

Page 31: ...on and running continuously 24 hours a day for the entire monitoring period therefore the cellular phone must be ON at all times Bluetooth operates like a radio and is susceptible to interference Blu...

Page 32: ...ar phone the patient should keep the sensor and cellular phone as close as possible recommended within 10 feet Charge the cellular phone every night and throughout the day whenever possible using the...

Page 33: ...rs remove any excess hair in the areas where the diagram page 35 indicated the electrodes are to be placed 2 Wash the skin of the electrode sites on your chest and abdomen with warm water and mild soa...

Page 34: ...t are attached to the sensor Using the peel tab peel each electrode from the backing and discard the backing Place each color coded electrode on healthy non irritated skin according to the diagram on...

Page 35: ...your left side aligned with the midpoint of the collarbone Place the black lead wire with electrode 4 5 inches horizontally to the left of the red electrode on your left side in line with the center...

Page 36: ...showering Gently clean away excess adhesive or dead skin between electrode changes using a wet warm washcloth Allow skin to thoroughly dry before applying the new electrodes to skin near the location...

Page 37: ...mA CMRR 60 N A 75 dB ADC sample rate 246 254 250 samples sec DC offset correction 0 150 115 mV LPF cutoff frequency 99 6 157 9 115 7 Hz HPF cutoff frequency 035 055 041 Hz Impedance measurement range...

Page 38: ...e Sniff mode Auto connection mode None Battery type output lithium thionyl chloride AA N A Battery life 2 3 Use depend ent Days dependent upon the Bluetooth connectivity MTBF hours N A N A 26 058 Hour...

Page 39: ...electrical equipment Part 2 Particular requirements for the safety of electrocardiographic monitoring equipment IEC 60601 1 2 Edition 4 0 2014 Medical electrical equipment Part 1 2 Electromagnetic com...

Page 40: ...ature 20 to 65o C 4 to 149o F Relative humidity 30 to 85 non condensing Physician Selectable Detection Parameters Arrhythmia Type Minimu m Maximum Default Atrial Fibrillation N A N A On Bradycardia He...

Page 41: ...ed in a commercial environment The ACT monitoring system is designed to detect the arrhythmias listed in the specification section above Due to the potential variability in ECG signals due to device p...

Page 42: ...n each lead separately as the average between 16 consecutive RR intervals Heart statistics are calculated for every minute The computation of the average HR over one minute is done by calculating the...

Page 43: ...s for min HR i e the raw min HR is being used Note The Max and Min HR calculation may be affected by nearby electromagnetic radiation a sudden movement of the patient disconnection of the electrodes f...

Page 44: ...ncerns regarding the ACT monitoring system or any of its accessories please contact the corporate office LifeWatch Services Inc O Hare International Center II 10255 W Higgins Road Suit 100 Rosemont IL...

Page 45: ...PLEASE CALL 1 800 517 6330 FOR TECHNICAL SUPPORT...

Search results

Summary of Contents for ACT III

Reviews:

Related manuals for ACT III

Brands by name

Popular brands

LifeWatch ACT III, Physician'S Manual

Search results

Summary of Contents for ACT III

Reviews:

Related manuals for ACT III

Brands by name

Popular brands