User GUide
Contents
1. After pressing the On Off button to turn the device on low battery is indicated by the heart shaped indicator blinking three times and then turning off The battery cover is located at the top of the Smartheart housing 1 Remove the battery cover by APA placing your thumb against the submerged groove on the battery cover and pushing the door down and outwards away from the device 2 Remove the old batteries and place the new batteries in the recess according to the and markings engraved in the housing The marking on the housing indicates that the side of the battery should be facing upwards 3 Place the battery cover halfway over the batteries and push and slide the battery cover into the housing until it clicks NOTE Verify that the batteries are operating properly by pressing the On Off button and making sure that the heart shaped indicator lights up If this indicator does not light up remove the batteries and repeat the procedure above For assistance you may contact us at support getsmartheart com Old or used batteries should never be disposed of by burning 24 5 EQUIPMENT CLASSIFICATION 0344 The Smartheart complies with the EU Medical Device Directive MDD 93 42 EEC as assessed by notified body 0344 Type of protection against electrical shock Type BF Internally battery powered and isolated equipment No mains or earth connections provided or required M2. is lying flat against your body and is not twisted 9 Position the retractable waist electrode at the belt line underneath your lower garment and against your bare skin halfway between your navel and left hip Either side of the waist electrode can be placed against the skin 3 2 PERFORMING THE ECG 1 When you are ready to perform the ECG sit down and lean back slightly and place both hands between your thighs Hold your arms down lightly against your sides and make sure that there is contact between the inner arms and the electrodes on the outside of the belt 2 The ECG data recording and transmission is controlled via the Bluetooth enabled communication device O NOTE While performing the ECG you should sit completely still and lean back slightly No vigorous muscle exertion or tension is required During the recording and transmission the heart shaped indicator blinks Transmission is activated from the Bluetooth enabled communication device O NOTE If the housing chest electrodes are not in complete contact during the recording use your left hand to press the housing flat against your skin 20 3 3 SHUTTING DOWN THE SMARTHEART The device will shut itself off automatically after five minutes of inaction or you can turn it off manually by pressing the On Off button continuously until the heart shaped indicator is off approximately 5 seconds 3 4 PACKING THE SMARTHEART A CAUTION Make sure the Smartheart and it
3. Telemedicine smartheart USER GUIDE ABOUT THIS DOCUMENT This document describes how users can use the Smartheart device A wARNING Smartheart ECG results should always be submitted to a medical professional for review The purchase of this device should not be substituted for the care recommended by your family physician or cardiologist NOTE We strongly recommend reading this manual carefully and entirely before using the device A thorough understanding of the operation and use of the Smartheart is required for correct and accurate ECG transmission In case of any doubts or questions regarding the use of this device please contact us at support getsmartheart com ZA WARNING Federal law restricts this device to sale by or on the order of a physician TABLE OF CONTENTS 1 Introducing the Smartheart occicicinininininnnncnnnnnnnninncncnnnn 4 Tintended Usina 1 2 Conditions for Usage 1 3 Device Description ss icicoimitariciniris 1 4 Using the Smartheart Device sser 9 2 Setting up the Smartheart occiciccnicnnninininnnninincnninincnnnos 10 2 1 Putting in the Smartheart Batteries oo ee 10 2 2 Pairing the Smartheart Bluetooth s 11 2 3 Adjusting the Elastic Band oo cesseseeseeeeeeeeeeeeees 13 3 Performing the ECG a ssissssdessiessiscceesed tstebincs guest eandeles 15 3 1 Getting Ready to Perform the ECG cesses 15 3 2 Performing the ECG ceeecceeseeeeeeeeeteteteeeeeeeeeeeeeneees 18 3 3 Shuttin
4. cate with the paired communication device O NOTE In order to use the Smartheart you should have a compatible smartphone or tablet Bluetooth activated and a Smartheart compatible App Information regarding compatible devices and Apps can be found at www getsmartheart com Information regarding downloading the app and the pairing process can be found in the attached application and pairing guide 2 SETTING UP THE SMARTHEART Step 1 Putting in the Smartheart Batteries Step 2 Pairing the Smartheart Bluetooth Step 3 Adjusting the Elastic Band Buckle 2 1 PUTTING IN THE SMARTHEART BATTERIES The Smartheart comes with two AAA lithium 1 5 Volt batteries 1 Remove the battery cover by placing your thumb against the submerged groove on the battery cover and pushing the door down and outwards away from the device Place the two batteries in the device according to the and marking engraved in the housing the marking on the housing indicates that the side of the battery should be cha upwards Place the battery cover halfway above batteries then press and slide it into place until the cover clicks shut A WARNING Press the on off button to make sure that the batteries are working Check that the heart shaped indicator is on If the indicator is off remove the batteries and put them in again For assistance please contact us at support getsmartheart com Old or used batteries should never be disposed of by burni
5. e Smartheart components from the back 12 Housing Chest 13 Belt Chest Electrodes Electrodes 15 Waist Electrode aes Storage Compartment 14 Label Smartheart Components Back 12 Housing Chest Electrodes Two electrodes located on the back of the housing 13 Belt Chest Electrodes The five electrodes located on the inner side of the belt 14 Label Specifies the serial number gender Male Female and size of the belt Small Medium Large or Extra Large of the Smartheart device O I SHL smartheart Rev V1 0 Telemedicine J Manufactured by SHL Telemedicine International Ltd 90 Yigal Alon St Tel Aviv 67891 Israel 06 2011 a Nh ee ii ini TT BT MAC 00078044EE62 N NANN i NIN NW NANA NUNN EN 14000001 a Male Size Medium User s Gender Size example only example only PIN Code Serial Number 15 Waist Electrode Storage Compartment Stores the waist electrode 1 4 USING THE SMARTHEART DEVICE The Smartheart acquires ECG data and transmits it to a Bluetooth equipped communication device such as a cellohone personal computer or a dedicated communication device installed with an enabling software that can relay the data to a remote location To accomplish this communication both the Smartheart and the communication device must be linked through an initial Bluetooth pairing process After the pairing process is complete the Smartheart will automatically communi
6. ectrode belt is too loose or too tight take off the device and adjust the elastic band with the assistance of the buckle Repeat this step until it fits firmly around your chest 3 PERFORMING THE ECG Step 1 Getting Ready to Perform the ECG Step 2 Performing the ECG Step 3 Shutting Down the Smartheart 3 1 GETTING READY TO PERFORM THE ECG 1 Take the Smartheart out of its case 2 Unwind the Smartheart electrode belt 3 Pull out the waist electrode stored in the back of the Smartheart 4 Press and hold the On Off button until the heart shaped indicator lights up 5 Verify that the Bluetooth enabled communication device is on and is within range If you are using a smart phone and an application to submit the data make sure that the smart phone is on and the application is working 6 Stand up and remove your shirt and or upper garments The Smartheart requires electrode contact with bare skin 7 Place the back of the Smartheart housing against the center of your chest wrap the electrode belt around your chest and snap the T shaped buckle in to the Smartheart housing 8 Position the belt Male Approximately one centimeter 1 2 under a the nipples y Female Immediately under the breasts as high as possible 77 Make sure that the belt is not bem Ral bunching or twisted O NOTE Make sure that e The electrodes on the back of the housing are positioned firmly against your chest e The electrode belt
7. g Down the Smartheart ssec 20 3 4 Packing the Smartheart ccceseeseteeeeeeeeteteeeeeeeteees 20 4 Maintaining the Smartheart sssr 21 4 1 Cleaning the Device oo cecceeeesetceeeeeteeeeeteeseeeaeees 21 4 2 Replacing the Batteries oo eects 22 5 Equipment Classification eee 24 6 Operating and Storage Conditions 0 0 cee 25 7 Technical Specifications 0 eee eerie 26 7 1 Smartheart SiZ8S ooonoccnnccccoccnoncconncnonn conc cannnonncarnonono 28 8 Troubleshooting vita a 29 9 Warranty seragame se Gouidasseipeeuesenans 31 1 INTRODUCING THE SMARTHEART 1 1 INTENDED USE The Smartheart device is intended to condition an electrocardiographic signal so that it can be transmitted digitally via Bluetooth technology and a cellphone or other communication device to a remote location The Smartheart device is designed to be used by a patient to transmit a 12 lead ECG and rhythm strip in real time to enable review at a physician s office hospital or other medical receiving center NOTE A cell phone device must be a smart phone with an operating system compatible with the Smartheart 1 2 CONDITIONS FOR USAGE Individuals who are unable to perform ALL of the following tasks should refrain from using the Smartheart e Read and understand this user manual e Place the Smartheart against the chest holding it steadily in place for up to 30 seconds e Operate a simple push button device e Operate the device while sit
8. his accessory with an iPod iPhone or iPad may affect wireless Pertas 9 WARRANTY As stated in the warranty document Manufacturer SHL Telemedicine International Ltd 90 Yigal Alon Street Tel Aviv 67891 Israel Tel 972 3 5612212 Fax 972 3 6242414 Authorized Representative SHL Telemedicine B V Keizersgracht 616 1017 ER Amsterdam The Netherlands Tel 31 20 7784141 Fax 31 20 3305444 31 SHL mn Telemedicine D 062 0 USA 1 1 0
9. ication device in accordance with the instructions of the Bluetooth enabled communication device 4 When the devices are successfully paired the Smartheart s heart shaped indicator stops blinking and remains on continuously From now on these two devices will automatically recognize and communicate with each other 5 Should there be any questions concerning the pairing process please contact us at support getsmartheart com O NOTE If it is desired to replace the Bluetooth enabled device at a later time with another device restart the pairing procedure for the new device by repeating 1 4 of this section 2 3 ADJUSTING THE ELASTIC BAND Perform the following steps to ensure that the Smartheart belt fits tightly around your chest and is not bunching or twisted 1 This adjustment is best performed while standing 2 Remove your shirt and or upper garments 3 Place the back of the Smartheart housing against the center of your chest wrap the electrode belt around gt your chest and snap the T shaped i Wa a buckle into the Smartheart housing 4 Position the belt sea Male Approximately one centimeter 1 2 E under the nipples bem Rad Female Immediately under the breasts as high as possible NOTE Make sure of the following e The electrodes on the back of the housing are positioned firmly against your chest e The electrode belt is lying flat against your body and is not twisted 5 If the el
10. ng 2 2 PAIRING THE SMARTHEART BLUETOOTH The following describes how to pair the Smartheart with a Bluetooth enabled communication device This step must be performed only once in order to enable the Smartheart to transmit its data via the Bluetooth enabled device Pairing should be performed according to the instructions of the manufacturer of the Bluetooth enabled communication device See examples of the pairing process at our website www getsmartheart com NOTE The distance between the Smartheart and the Bluetooth enabled communication device should be within the range of 10 meters 33 1 Turn on the Bluetooth enabled communication device Place the Bluetooth communication deviceinto its pairing mode and follow the device s pairing instructions 2 Press and hold down the Smartheart On Off button continuously for at least six seconds until the heart shaped indicator starts to blink The Smartheart goes into pairing mode and searches for nearby Bluetooth devices 3 During the pairing our smartheart process the SHL Rev V1 0 communication device ev SHL Telemedicine International Ltd 90 Yigal Alon St Tel Aviv 67891 Israel may require the entry CE AR CTS ser of the Smartheart PIN T U i code This PIN code A IT is the serial number SN 14000001 Gender Male Size Medium PIN Code Serial Number printed on the label of the Smartheart Enter the Smartheart PIN code into the commun
11. ode of operation Intermittent Degree of protection against ingress of liquids Not protected IP30 Degree of protection against flammable gases The equipment is not protected against the presence of a flammable anesthetic mixture of air oxygen or nitrous oxide 6 OPERATING AND STORAGE CONDITIONS 40 C to 60 C Temperature 40 F to 140 F some Romi ening Atmospheric 599 hPa 1060 hPa Temperature Soe a a F Opa Feet Sen Atmospheric 799 hPa 1060 hPa A CAUTION e Always keep the device in the original carrying case when not in use e Do not leave the device in an enclosed warm space where temperature can exceed 140 F 60 C 25 26 7 TECHNICAL SPECIFICATIONS Physical Dimensions hag ht without batteries Housing L x W x H 11x8 5x1 5 cm Electrode Belt 1109 Battery Two AAA lithium iron disulfide 1 5V Battery Life 6 hours of continuous recodin and transmission about 100 ECGs Current Drain Transmission 180 mA max Shutdown mode lt 1pA Idle mode 40mA typical Amplifier CMRR 80cB min Frequency response 0 05 150 Hz System noise lt 15uVRMS r t i 12 seconds of continuous rhythm strip lead II ECG Data Transmission V2 V3 V4 sai eed l II vi Il AVR AVL and AVF are calculated at the receiver Calibration Automatic on power on 2mVp p 2Hz Squa
12. re wave Bluetooth Class 2 A CAUTION e The Smartheart should not be used in the presence of electromagnetic interference or an electrostatic discharge or power overload caused by electrosurgical diathermy instruments e The Smartheart should not be used in conjunction with an external defibrillator e The Smartheart should not be used in the presence of flammable anesthetics e The Smartheart is not designed against the ingress of liquids Do not submerse during cleaning 27 7 1 SMARTHEART SIZES The Smartheart belt comes in various sizes according to chest size and gender The label indicates the gender and size SHL smartheart Manufactured by SHL Telemedicine International Ltd 90 Yigal Alon St Tel Aviv 67891 Israel Ci EN aan PIN Code Serial Number AA AA LN SN 14000001 Gender Male Size Medium Gender example only Size example only Additional information on Smartheart sizing can be found at www getsmartheart com 28 8 TROUBLESHOOTING Symptom When pressing on the On Off button the heart shaped indicator blinks and then turns off Solution Change the batteries as described in the Replacing the Batteries section Symptom When pressing on the On Off button the Smartheart does not power on at all Solution Change the batteries as described in the Replacing the Batteries section Symptom The quality of the ECG tran
13. s components are dry and free of any moisture or perspiration Return the waist electrode to its storage compartment in the back of the housing Wind the electrode belt around the device housing and return the Smartheart to its case A CAUTION e Always keep the device in the original case when not in use e Do not leave the device in an enclosed warm space where temperature can exceed 140 F 60 C 4 MAINTAINING THE SMARTHEART 4 1 CLEANING THE DEVICE A CAUTION The Smartheart is not waterproof and should not be immersed in water under any circumstances e The Smartheart generally does not require cleaning e Do not scratch it with abrasive cleaners Abrasive cleaning pads may damage the electrodes and plastic parts e If the housing belt or electrodes become soiled clean them with a soft cloth soaked in rubbing alcohol Available in any pharmacy o f the smartheart is transferred from one user to another clean the device using a soft cloth soaked in rubbing alcohol In case of any questions please contact us at support getsmartheart com 21 22 4 2 REPLACING THE BATTERIES The Smartheart comes with two AAA lithium 1 5V batteries O NOTE Only lithium batteries should be used In case of an emergency alkaline batteries can be used but only if they are fully charged After a few transmissions alkaline batteries can no longer be used in the Smartheart The Smartheart will indicate a low battery
14. smission is poor Solution Be sure that you do the steps as described in the Performing the ECG section but this time you may dampen your body where the electrodes come in contact with the skin using a cotton gauze dampened with water Symptom The Bluetooth transmission device does not recognize the Smartheart Solution Make sure that the Smartheart is on by looking to see if the heart shaped indicator is on If the problem persists refer to the Bluetooth enabled communication device s instruction manual 29 30 Symptom Pairing is not successful Solution Make sure that the heart shaped indicator is blinking and that the PIN code was entered properly on the Bluetooth enabled communication device see section 2 2 Pairing the Smartheart Bluetooth Symptom The T shaped buckle does not snap properly into the housing Solution Make sure that the belt is not twisted The T shaped buckle only snaps properly when it is not twisted If the problem still persists contact us at support getsmartheart com LEGAL NOTICE The terms Made for iPod Made for iPhone and Made for iPad mean that an electronic accessory has been designed to connect specifically to iPod iPhone iPad or iPadmini respectively and has been certified by the developer to meet Apple performance standards Apple is not responsible for the operation of this device or its compliance with safety and regulatory standards Please note that the use of t
15. ting 1 3 DEVICE DESCRIPTION The Smartheart is a personal handheld ECG device that acquires ECG data via the permanently attached electrodes on its belt The Smartheart uses Bluetooth technology to transmit the ECG data The following diagram shows the Smartheart components from the front 9 Elastic Band e paste Band 1 Housing Buckle 7 Battery Cover 4 Electrode Belt 2 Heart shaped La 5 Right Arm Electrodes 11 T shaped Buckle Electrode Smartheart Components Front 1 Housing Contains the electronics and batteries 2 Heart shaped Indicator Located on the front of the housing is continuously illuminated when the device is on 3 On Off Button Activates and deactivates the Smartheart device 4 Electrode Belt Contains electrodes and is attached to the housing 5 Right Arm Electrodes Located on the right outer side of the electrode belt 6 Left Arm Electrodes Located on the left outer side of the electrode belt 7 Battery Cover Holds two lithium AAA batteries and is located on the top of the housing 8 Elastic Band The elastic part of the electrode belt connects the right and left sides of the electrode belt 9 Elastic Band Buckle Enables the adjustment of the length of the elastic band 10 Waist Electrode An oval electrode that is attached to the bottom of the housing by a wire 11 T shaped Buckle Used to close the belt and connect it to the housing The following diagram shows th
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