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LifeWatch ECG Mini Скачать руководство пользователя страница 19

Page 19

1.5 Glossary

ECG

Electrocardiogram; a representation of the
heart's electrical activity recorded from
electrodes on the body.

ECG Mini

Continuous ECG Monitor and Arrhythmia
Detector (ECG sensor, Brain and Gateway)

Patch

ECG Mini device attached to patient.

Gateway

Hand held device/cellular phone using ECG
Mini monitoring software.

Heart Rate

Number of heart beats per minute,
measured as bpm (beats per minute).

Nordic RF

Wireless communication protocol.

Monitoring
Center

Monitoring center responsible for reviewing
clinical data transmissions, and providing
them to the physician.

Charger

Power supply for recharging Gateway
cellular device.

Arrhythmia

Irregular heartbeat.

Manual event

Event manually recorded (on Gateway) by
a patient when he/she feels it is necessary.

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Содержание ECG Mini

Страница 1: ...ECG Mini User Guide ECG Mini User Guide PLEASE CALL 1 800 517 6330 FOR 24 7 CUSTOMER SUPPORT...

Страница 2: ...ensed by the law of the State 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 ECG Mini system must have...

Страница 3: ...Street Rehovot 7670202 Israel Tel 972 8 9484000 Fax 972 8 9484044 Email users lifewatch com Copyright Declaration Copyright 2015 LifeWatch Services Inc All rights reserved LifeWatch Watching Life Life...

Страница 4: ...FROM THE FURNISHING PERFORMANCE OR USE OF THIS MATERIAL Illustrations included in this manual are general representations only and are not meant to comply with specific regulatory requirements ATTENTI...

Страница 5: ...23 HOW MUCH CHARGE IS IN THE BATTERY 24 4 Important Information Before Use 26 4 1 GENERAL 26 4 2 NO CONNECTION WITH GATEWAY CELLULAR DEVICE 26 5 Using the ECG Mini 27 5 1 BEFORE STARTING 27 5 2 RECHA...

Страница 6: ...on 42 10 Care 43 10 1 CONDITIONS OF USE 43 10 2 CLEANING 43 10 3 ENVIRONMENTAL CONSIDERATIONS 43 11 Troubleshooting 44 12 Maintenance 45 12 1 CONDITIONS OF USE 45 12 2 CARING FOR YOUR ECG MINI 45 12 3...

Страница 7: ...cription 23 Figure 1 Area to prepare for ECG Mini Patch 30 Figure 2 ECG Mini 1 lead Placement 31 Figure 3 ECG Mini 1 lead Properly Placed 32 Figure 4 Placing ECG Mini Transmitter into Cradle 33 Figure...

Страница 8: ...The ECG Mini must be removed from the patient s skin before he she undergoes MRI procedure The ECG Mini is not to be used with external defibrillator The ECG Mini is not a life saving or therapeutic d...

Страница 9: ...he patch enables easy insertion of the brain to its cradle by the user The brain receives its power from a 1 4V coin non rechargeable battery integrated within the patch The brain transmits ECG raw da...

Страница 10: ...ricular Arrhythmias evaluation of various Brady arrhythmias This includes post operative monitoring for these rhythms Patients recovering from coronary artery bypass graft CABG surgery who require mon...

Страница 11: ...service interruption As with all standard cell phones charge the Gateway cellular device whenever possible and at least every night The performance of the Gateway cellular device including data record...

Страница 12: ...cription Serial Number Date of Manufacture Type BF Applied Part Batch code Do not use if package is damaged Use by Keep dry Store at specified temperatures Electrical and Electronic Equipment The ECG...

Страница 13: ...es that information to the physician for his her final diagnostic interpretation The ECG Mini is not intended for use as an emergency medical response system and should not be used by patients at risk...

Страница 14: ...damage the ECG Mini or the ECG Mini may interfere with the operation of the defibrillator The ECG Mini MUST be removed prior to defibrillation as it contains metals that could cause the defibrillator...

Страница 15: ...d using the Gateway cellular device In general most manufacturers recommend the following Keep a distance of at least six inches 15 cm between the Gateway cellular device and a pacemaker or ICD Carry...

Страница 16: ...nnel may repair the system components To avoid damage to the system the system and accessories should be kept away from extreme heat including placement of the ECG Mini on the dashboard of a car or ne...

Страница 17: ...not turn off the sound of the Gateway cellular device or reduce the volume so that it is inaudible Take the charged Gateway with you and wear the sensor at all times except when bathing during the mo...

Страница 18: ...Mini is activated and is attached certain screens are displayed that are not seen during normal operation These screens are used for calibration Please refer to First Time Activation section of the ma...

Страница 19: ...e cellular phone using ECG Mini monitoring software Heart Rate Number of heart beats per minute measured as bpm beats per minute Nordic RF Wireless communication protocol Monitoring Center Monitoring...

Страница 20: ...ECG Mini with ECG electrodes transmits the ECG signs via a reusable transmitter Brain to a Gateway cellular device The Brain plugs into a cradle which is part of the 1 lead patch and is connected to...

Страница 21: ...igger an event by clicking on an icon on the screen of the Gateway cellular device Note The Gateway automatically transmits the detected ECG events to the monitoring center and the user has the abilit...

Страница 22: ...Page 22 3 THE ECG MINI KIT The ECG Mini Kit provides the ECG Mini with Brain transmitter and one Gateway Gateway including charger 1 Lead ECG Configuration...

Страница 23: ...iption Gateway keys and buttons Menu Home Back Power button Touch screen Notifications area Volume Power USB connector Figure 1 Gateway Physical Description Note to access the USB connector the flap o...

Страница 24: ...verify the Gateway is fully charged Use only the supplied adaptor DSA 5PFK 05 FUS Input is 100 to 240 V 50 to 60 Hz 0 3A Output is 5 V 0 7A 3 5 W maximum How much charge is in the battery If the batte...

Страница 25: ...Gateway cellular device Do not turn the Gateway sound off Do not mute the volume so that it is inaudible Do not use the Gateway for any reason outside of the designated monitoring function The ECG Mi...

Страница 26: ...ake the fully charged Gateway with you and wear the sensor at all times except when showering or bathing Caution Do not use the provided Gateway for any reason other than the designated monitoring fun...

Страница 27: ...nitiate the service ECG Mini patch single use disposable ECG Mini Brain reusable ECG Mini Gateway cellular device with compatible application installed reusable Note Contact LifeWatch to receive instr...

Страница 28: ...evice For optimal system performance the recommended distances between the Gateway and sensor should be as follows Within 40 inches 1 meter for normal operation Within 10 feet 3 meters preferred dista...

Страница 29: ...way charger unit into a standard wall outlet A red or yellow light color depends on Gateway type indicating charging is needed will appear on the Gateway when the charger is properly connected When ch...

Страница 30: ...lular device is turned on 6 3 Placing the Patch Before attaching the Patch prepare the chest skin as set out below 6 3 1 Preparing the Skin 1 Remove excess hair from the areas by carefully clipping wi...

Страница 31: ...on are very dry skin or contact immediately after attaching the electrodes Contact LifeWatch if you have any questions concerning the use of the device or if you experience any irritation problems 6 3...

Страница 32: ...Page 32 Figure 4 ECG Mini Patch Properly Placed...

Страница 33: ...ve signals from the sensor ECG Mini Transmitter in patch ON removal of ECG Mini Transmitter OFF Figure 5 Placing ECG Mini Transmitter into Cradle Note Ensure that the ECG Mini Transmitter is positione...

Страница 34: ...the ECG Mini Transmitter 2 Gently pull up the ECG Mini Transmitter to remove from the cradle 3 Place the transmitter and patch in the envelope to return to LifeWatch If necessary to continue the moni...

Страница 35: ...y to start the application The application is automatically launched and the will display the opening screen before the main application screen Press OK to proceed to the main screen Note The maximum...

Страница 36: ...Page 36 7 2 ECG Mini Screen The ECG Mini main screen comprises the following items Action bar Notification icon area Record manual event button...

Страница 37: ...ly shown if there is an active alert that doesn t appear on the main screen 4 911 emergency call Pressing will open a dialog box Press Yes to automatically dial 911 5 Signal strength Indicates cellula...

Страница 38: ...al event is initiated on the touch screen then a confirmation screen will be displayed Confirm or cancel the event by pressing on the touch screen The questionnaire screens are for adding information...

Страница 39: ...e patch turning red and or the appropriate icon appearing Figure 6 ECG Mini notification screen with notifications An error initiates one of two types of alerts one for the ECG Mini Patch Transmitter...

Страница 40: ...Page 40 7 3 1 1 Patch Error Alerts When the icon of a patch is red this indicates either Icon Message Brain Battery Depleted Press Brain disconnected Press Electrodes Disconnected Press...

Страница 41: ...ss Cellular Connectivity Press NOTE If the Gateway is not charged after the first message of low battery or the Gateway was not charged properly reaching the depletion limit will end monitoring and re...

Страница 42: ...averaged to generate the displayed HR Therefore the reported HR is the mean of the last momentary HR values WHICH CORRESPOND TO THE DETECTED R COMPLEXES FOR THE LAST 8 SECONDS OCCASIONS IN WHICH THE...

Страница 43: ...rts by rubbing with a lint free cloth 10 3Environmental Considerations The battery and electronics of the ECG Mini are covered by the European Directive 2012 19 EC WEEE or by other local national envi...

Страница 44: ...start gateway 4 Remove and replace Transmitter No display when Gateway is activated The battery is very low or depleted Connect the Gateway to charger to charge the battery When charged press power ON...

Страница 45: ...ON Do not open or attempt to repair the patch or Gateway yourself Only authorized service personnel may repair the product Do not drop your patch or Gateway or subject them to severe impact Do not use...

Страница 46: ...ximum capacity and to reduce the possibility of a failure 12 3 1 Mechanical Inspection Check for splits cracks or other related flaws in the ECG Mini components If you have any questions or doubts cal...

Страница 47: ...demonstrated conformance to voluntary Safety standard IEC 60601 1 ed 3 1 and to EMC standard IEC 60601 1 2 2014 Class B LifeWatch Technologies s Quality System conforms to ISO 9001 2008 ISO 13485 2003...

Страница 48: ...rain Dimensions Dimensions max N A N A 38 x 20 x 4 1 6 x 0 8 x 0 2 mm inch Net Weight 5 0 17 gr oz ECG Mini Specifications Parameter Min Max Typical Units Dimensions max 1L Patch N A N A 167 x 69 x 5...

Страница 49: ...0 30 V Operating temperature 10 50 45 113 N A C F Environmental Operation humidity 10 95 Environmental atmospheric pressure 70 106 kPA Transport storage temperature 10 50 32 89 6 N A C F Transport st...

Страница 50: ...frequency 16 MHz Frequency deviation 250kbps 160 kHz Frequency deviation 1Mbps 160 kHz Frequency deviation 2Mbps 320 kHz Non overlapping channel spacing 250kbps 1Mbps 1 MHz Non overlapping channel spa...

Страница 51: ...to avoid potential interference with the device Persons who have such devices Should ALWAYS keep the phone more than six 6 inches 15 cm from their implantable medical device when the phone is turned...

Страница 52: ...ompatible with their hearing devices Not all phones have been rated Phones that are rated have the rating on their box or a label located on the box The ratings are not guarantees Results will vary de...

Страница 53: ...ned 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 r...

Страница 54: ...agers If you want to take steps to lower exposure to radio frequency energy RF the measures described above would apply to children and teenagers using wireless phones Reducing the time of wireless ph...

Страница 55: ...etallic components Body worn accessories that do not meet these requirements may not comply with RF exposure requirements and should be avoided Use only the supplied or an approved antenna Unauthorize...

Страница 56: ...he interference by one or more of the following measures Reorient or relocate the receiving antenna Increase the separation between the equipment and receiver Connect the equipment into an outlet on a...

Страница 57: ...et Rehovot 7670202 Israel Telephone 972 8 948 4000 Fax 972 8 948 4044 www lifewatch com Distributor Service LifeWatch Corp O Hare International Center II 10255 W Higgins Road Suite 100 Rosemont IL 600...

Страница 58: ...Page 58 THIS PAGE IS INTENTIONALLY BLANK...

Страница 59: ...ECG Mini Patient User Guide PLEASE CALL 1 800 517 6330 FOR 24 7 CUSTOMER SUPPORT...

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