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LifeWatch ACT III, Руководство для врачей

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Page 28 

ECG Replacement Template  

There are situations where the ECG signal is replaced by a 
template. There are four cases where a template will be used. 

 

Template Description 

Where 

Impedance 
Measurement 

Inserted when impedance is 
being measured (no 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 
Impedance 

Replaces ECG data between 
two consecutive impedance 
measurements which are 
above the threshold (on all 
three leads in ACT III) 

Full Disclosure 

ECG 

Missing Data  Replaces missing ECG data 

(ex: Event detected at 
beginning of application) 

Events 

 

Содержание ACT III

Страница 1: ...ACT III Physician Manual SUP547 Rev B CR 16 002...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

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