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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.

Declaration of Conformity

Conformance to Standards

– non-clinical testing demonstrated

conformance to voluntary Safety standard IEC 60601-1:1998

(with Amendments 1 & 2)

and to EMC standard IEC 60601-1-2:2001 Class B

Card Guard’s Quality System conforms to ISO-9001:2008,

ISO 13485:2003, and complies with CE MDD requirements

Tested for compliance with FCC 47 CFR Part 15,

subpart B and subpart C

Содержание ACT I

Страница 1: ...SUP362 ACT Patient User Guide Rev C DCR 11 023 ACT I and ACT III Patient User Guide PLEASE CALL 1 800 517 6330 FOR 24 7 CUSTOMER SUPPORT...

Страница 2: ...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 cont...

Страница 3: ...arks 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...

Страница 4: ...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 Illust...

Страница 5: ...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...

Страница 6: ...ectivity 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 Techn...

Страница 7: ...f 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...

Страница 8: ...ts 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 Mo...

Страница 9: ...nterpretation The monitoring system is not intended for use as an emergency response system for patients who may experience life threatening arrhythmias The following list represents patient populatio...

Страница 10: ...et 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 t...

Страница 11: ...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 batte...

Страница 12: ...arning 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 con...

Страница 13: ...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 14: ...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 th...

Страница 15: ...ular 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 betwee...

Страница 16: ...s 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 employ...

Страница 17: ...thin 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 monitor...

Страница 18: ...se 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...

Страница 19: ...ooth 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...

Страница 20: ...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...

Страница 21: ...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 22: ...eling 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 us...

Страница 23: ...t 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...

Страница 24: ...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 Blu...

Страница 25: ...Page 25 Arrhythmia Irregular heartbeat Manual event Event manually recorded by a patient when he she feels it is necessary...

Страница 26: ...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...

Страница 27: ...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 wi...

Страница 28: ...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...

Страница 29: ...and all the accessories needed for use of the system Contents 1 ACT sensor with integrated or detachable lead wires 2 ACT sensor batteries 3 6 V AA lithium thionyl chloride 3 Disposable electrodes 4...

Страница 30: ...lead Description Figure 1 Front view of ACT I sensor Battery cover closed Battery cover open Figure 2 Rear view of ACT I sensor Lead wires for connecting the electrodes 1 2 1 2 Buttons for manual rec...

Страница 31: ...g Battery Cover Figure 3 Front view of ACT III sensor slide open battery cover Battery cover closed Battery cover open Figure 4 Rear view of ACT III sensor Lead wires for connecting the electrodes 1 2...

Страница 32: ...Lead Wires Flip Open Battery Cover Figure 5 Front view of ACT III sensor flip open battery cover Battery cover closed Battery cover open Figure 6 Rear view of ACT III sensor Lead wires for connecting...

Страница 33: ...of the following cell phone monitors will be provided with the kit HTC Ozone mobile phone HTC Ozone monitor keys and buttons Samsung SGH i617 mobile phone SGH i617 monitor keys and buttons Navigation...

Страница 34: ...can be downloaded from the internet CAUTION Do not change the cell phone monitor settings Do not turn the cell phone monitor sound off Do not mute the volume so that it is inaudible Do not use the ce...

Страница 35: ...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...

Страница 36: ...e the ECG data 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...

Страница 37: ...ble application installed Follow instructions for electrode placement For ACT III with flip open battery cover Make sure that the sensor lead wire is well connected to the sensor See Troubleshooting S...

Страница 38: ...ectrodes can be requested by calling LifeWatch Skin Preparation Wash the skin on your chest and abdomen using warm water and gentle soap Remove excess hair by carefully clipping with scissors Avoid sh...

Страница 39: ...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 wir...

Страница 40: ...t 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 Attach the black lead wire with electrode to the low...

Страница 41: ...the imaginary line that extends down from the midpoint of the collarbone as shown in ACT III Electrode Placement figure Place the black lead wire with electrode at the point where a horizontal line fr...

Страница 42: ...continuous motion You may want to remove the electrodes in the shower or by using a wet warm washcloth Do not rapidly remove the electrode to avoid skin damage Remove any excess adhesive or dead skin...

Страница 43: ...ell phone monitor the sensor will not be able to record including manual events until the sensor is within Bluetooth range of the cell phone monitor Once in range the connection will be renewed after...

Страница 44: ...then 1 short beep 2 A Low sensor battery message is displayed on the cell phone screen Note For a visually or hearing impaired patient replace the sensor battery EVERY 48 HOURS 2 Place sensor within...

Страница 45: ...ty marks inside the battery compartment plus sign on the neck strap side minus sign on the sensor lead wire side The sensor should beep once within 10 seconds of placing a new battery If no sound is h...

Страница 46: ...ing the battery cover is now in place see Figure 11 Figure 11 Replacing Battery Cover f It may take up to 5 minutes for the cell phone monitor to display the default recording screen after inserting a...

Страница 47: ...f the ACT sensor to release the battery compartment cover Figure 12 Opening Battery Cover NOTE Do not attempt to remove the battery cover If the battery cover becomes separated from the device please...

Страница 48: ...tery 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 Gently push the battery cover dow...

Страница 49: ...stem 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...

Страница 50: ...supplied cell phone monitor charger unit into a standard wall outlet A red or yellow light color depends on cell phone monitor type indicating charging is needed will appear on the cell phone monitor...

Страница 51: ...e phone Connection for power supply Power button Figure 14 HTC Ozone monitor power button and socket Samsung SGH i617 mobile phone Connection for power supply Power button Figure 15 SGH i617 monitor p...

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

Страница 53: ...e when the cell phone monitor is turned on for the first time 1 Connect the sensor electrodes as shown in Figures 7 and 8 2 Turn on the cell phone monitor by pressing the POWER button of the cell phon...

Страница 54: ...e for this section 4 Place the battery in the sensor 5 The cell phone monitor will display the following screen after the first connection is established which can take up to five minutes A picture of...

Страница 55: ...out 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 S...

Страница 56: ...inutes 9 At the end of Step 2 the success message will be displayed and the service will begin automatically Note If you have any questions on the use of the ACT Monitoring System please contact LifeW...

Страница 57: ...ion NOTE verify the sensor lead wire is connected to the sensor as described in the Troubleshooting section for ACT III with Flip Open Battery Cover 1 Connect the sensor electrodes as shown in Figures...

Страница 58: ...Page 58 After a few seconds the application will start automatically 4 The following screens will be displayed ACT III ACT I...

Страница 59: ...sor 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 Caution The ACT application should not be closed during...

Страница 60: ...re 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 wil...

Страница 61: ...e manual event recording is not available during the baseline process even though pressing the manual event buttons will initiate the manual event recording beep After sensor battery insertion and bef...

Страница 62: ...t and mark No Symptoms and send the form Scroll If Send is not pressed the manual event will be automatically sent at the end of the countdown without the form The cell phone monitor screen will retur...

Страница 63: ...ing If you have pressed the cell phone monitor s Manual Event button the following confirmation screen will be displayed on the cell phone monitor To send the manual event press Yes or press No to can...

Страница 64: ...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 is not pressed th...

Страница 65: ...t When the sensor and the cell phone monitor are disconnected for any reason the manual event can be recorded with the sensor It will be transmitted when the connection to the cell phone monitor is re...

Страница 66: ...Page 66 During the process of downloading data from the sensor reconnection after battery replacement manual event recording is not available...

Страница 67: ...e cell phone monitor screen The message will be accompanied by a sound prompt and cell phone monitor vibration optional It might take a few minutes to remove a message after a correction has been reso...

Страница 68: ...he battery Be aware that the sensor alerts its low battery status with 1 long beep then a short beep from the sensor Sensor battery needs to be replaced screen replace battery and press OK to continue...

Страница 69: ...section for information on how to charge the cell phone monitor Cell phone monitor low battery message press OK and charge the cell phone monitor Screen displayed until cell phone monitor is connected...

Страница 70: ...n 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 section Connection lost between the sensor and the c...

Страница 71: ...d 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...

Страница 72: ...after problem is solved Please follow these instructions to ensure proper contact of the electrodes 1 Make sure that the sensor lead wires are properly connected to the electrodes 2 Make sure the ele...

Страница 73: ...Page 73 Electrode Messages for ACT I Black electrode problem White electrode problem Red or all electrode s problem Correct the problem and press OK...

Страница 74: ...Page 74 Electrode Messages for ACT III White electrode problem Black electrode problem Red electrode problem...

Страница 75: ...odes 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...

Страница 76: ...ode 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 code...

Страница 77: ...re Do not use extreme force when pressing the sensor buttons Do not use solvents to clean your ACT sensor or cell phone monitor Do not spray perfume or other substances on the sensor The ACT sensor is...

Страница 78: ...thly to ensure continued performance of the device at maximum capacity and to reduce the possibility of a failure Mechanical Inspection Check for splits cracks or other related flaws in the ACT monito...

Страница 79: ...ensor battery needs to be changed refer to Sensor Battery Insertion Replacement section for information on how to replace the battery Displays an electrode problem message Electrode connection does no...

Страница 80: ...ge Lack of communication between sensor and cell phone monitor Sensor low battery can cause disconnection accompanied sound prompt of 1 long beep then a short beep from the sensor 1 Make sure the sens...

Страница 81: ...Cell phone monitor communication message The cell phone monitor transmission message appears when there are transmission problems that could be caused by poor cellular coverage cellular network proble...

Страница 82: ...or to reconnect 2 Make sure that the sensor lead wire is properly connected to the sensor for attachable leads Sensor beeps 1 long beep then short beep Sensor battery low or critical Sensor battery ne...

Страница 83: ...e battery cover 1 Place battery cover on device in the proper place see picture A and B 2 Press down firmly on battery cover at point 1 as shown in picture C until you hear a click 4 Press down firmly...

Страница 84: ...T III with Flip Open Battery Cover Sensor lead wire detached from sensor Verify the sensor lead wire is connected to the ACT sensor socket by first aligning the arrow on the lead wire 1 with the arrow...

Страница 85: ...ived including interference that may cause undesired operation Declaration of Conformity Conformance to Standards non clinical testing demonstrated conformance to voluntary Safety standard IEC 60601 1...

Страница 86: ...mple rate 250 250 250 samples sec DC offset correction 150 mV LPF cutoff frequency 61 8 90 45 76 Hz HPF cutoff frequency 043 065 005 Hz Impedance measurement range 0 793 K Arrhythmia algorithm detecti...

Страница 87: ...e Auto connection mode Battery type 3 6V lithium thionyl chloride AA Battery life dependent upon Bluetooth connectivity 2 4 Days MTBF hours 36 305 Hrs Operating temperature 10 50 40 104 C F Transport...

Страница 88: ...ption N A 80 75 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 me...

Страница 89: ...h protocol SPP profile Sniff mode Auto connection mode None Battery type output lithium thionyl chloride AA N A Battery life dependent upon Bluetooth connectivity 2 3 Use dependent Days MTBF hours N A...

Страница 90: ...keep the phone more than six 6 inches 15 cm from their implantable medical device when the phone is turned ON Should not carry the phone in a breast pocket Should use the ear opposite the implantable...

Страница 91: ...nerable to interference you may not be able to use a rated phone successfully Trying out the phone with your hearing device is the best way to evaluate it for your personal needs M Ratings Phones rate...

Страница 92: ...it is adequately shielded from external RF energy Your physician may be able to assist you in obtaining this information Switch your phone off in health care facilities when any regulations posted in...

Страница 93: ...et including the antenna Third party belt clips holsters and similar accessories used by this device should not contain any metallic components Body worn accessories that do not meet these requirement...

Страница 94: ...n phone OFF and then ON If not resolved call LifeWatch at 1 800 517 6330 CODE 220 Please call LifeWatch at 1 800 517 6330 CODE 221 Please call LifeWatch at 1 800 517 6330 CODE 222 Please call LifeWatc...

Страница 95: ...Watch 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 L...

Страница 96: ...nts or any other devices which are not compatible with the CG Device or with the system in which they are installed and do not meet Card Guard s specifications or standards iv Services required as a r...

Страница 97: ...N CONNECTION WITH THIS WARRANTY SHALL IN THE AGGREGATE BE LIMITED TO THE TOTAL PRICE PAID FOR THIS PRODUCT IF SUCH LIABILITY DOES NOT ARISE FROM THE GROSS NEGLIGENCE OR FAULT OF CARD GUARD 6 This warr...

Страница 98: ...e party any copy of the Software and documentation You may not modify reverse engineer reverse compile disassemble or otherwise reduce the Software to a human perceivable form TERM This License is eff...

Страница 99: ...he United States Government s rights with respect to the use duplication or disclosure of the Software by the United States Government are limited by the terms of this License pursuant and otherwise s...

Страница 100: ...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...

Страница 101: ...Page 101 THIS PAGE LEFT INTENTIONALLY BLANK...

Страница 102: ...SUP362 ACT Patient User Guide Rev C CR 11 023 PLEASE CALL 1 800 517 6330 FOR 24 7 CUSTOMER SUPPORT...

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