Beat2Phone ECG
Instruction Manual
B
e
a
t2
P
hone ECG
Powered by VitalSignum
Version: 2.3
2020-
08
-
19
Page 1: ...Beat2Phone ECG Instruction Manual Beat2Phone ECG Powered by VitalSignum Version 2 3 2020 08 19...
Page 2: ...the recordings in the sensor professional user 19 6 5 Uploading and Viewing the recordings in the sensor patient user 23 6 6 Identifying proper ECG waveform 23 6 7 Beat2Phone application messages 27 6...
Page 3: ...ng connector GTIN 6429810109019 Beat2Phone ECG Electrode Strap GTIN 6429810109033 Beat2Phone ECG Application GTIN 6429810109064 The information in this document is subject to change without prior noti...
Page 4: ...ead electrocardiogram accurate enough to detect arrhythmia The people to be monitored are normal weight adults in need for monitoring their heart condition The measured data containing the electric ac...
Page 5: ...equire medical training of the patient users or assisting people The product allows medical professionals to conduct large scale health surveys and screening cost efficiently EDF ECG regis tration dat...
Page 6: ...egrees Celsius Do not place the sensor in or near microwave appliances to avoid damage to the battery Do not use the device with a defibrillator as the high voltage pulse is detrimental to the sensor...
Page 7: ...under water or at higher than 60 or lower than 20 degrees Celsius temperature The battery can be damaged and the sensor ceases to operate Do not use the device in an altitude higher than 2000m The el...
Page 8: ...8 Beat2Phone ECG Instruction Manual Always keep the sensor the charging connector and the electrode strap clean Excessive lint or dust can hinder the performance of the device...
Page 9: ...033 and Beat2Phone ECG Application GTIN 6429810109064 The parts are in three slots inside the box Sensor and charging connector slot and the electrode strap slot The information on the box labelling B...
Page 10: ...cordings can be transferred to the mobile de vice using the mobile application and stored to the mobile device memory Keep the mobile device charged Sensor has a BLEv5 radio that is used for displayin...
Page 11: ...e is not part of the ME System pro vided by VitalSignum Oy You will find the parts in the product package Make sure that the environment is comfortable clean and private before attaching the device to...
Page 12: ...chest with the electrode strap Gently use wet wipe to clean the skin under the electrode strap before placing the electrode strap on the skin No electrode gel or paste is needed for contact with the...
Page 13: ...e Beat2Phone ECG application The application in cludes different views and functions for professional users and patient users A pa tient user can safely use all the functions of the device although th...
Page 14: ...igure 4 The professional start view First join with your professional organization by opening the user profile menu from the top right corner In the profile view you can see all your organizations on...
Page 15: ...gnal disturb ance As a professional user you can create delete modify profiles change your pass word modify all application settings and view all the patient s recording history in the mobile device Y...
Page 16: ...th the heart rate curve in the patient monitoring view The yellow number indicates heart rate in beats per minute and the yellow curve indicates the heart rate curve If the display of heart rate varia...
Page 17: ...annotation to the recording in the patient annotation view which opens when you open the application in the mobile device after the monitoring view has turned off Keep the mobile device close by to e...
Page 18: ...he sensor memory which can be read by the application and stored as an EDF file in the mobile device memory from where it can be retrieved for analysis by a qualified medical professional NOTE When th...
Page 19: ...the application remove the sensor from charger choose SETTINGS SENSOR INFORMATION POWER OFF SEN SOR The sensor can be powered on again by placing it in the charging connector Only the professional us...
Page 20: ...es sional history view List view is the default view showing the latest patient record ing on top The recording is opened for viewing from the list by touching the list item In case the recording is s...
Page 21: ...21 Beat2Phone ECG Instruction Manual Figure 14 The history list view Figure 15 File transfer dialogue in the history view...
Page 22: ...tory view The mobile device touch screen allows the user to move the HR and ECG graphs by dragging and swiping Horizontal zoom by fingers is also availa ble Default scales are returned by touching the...
Page 23: ...ients can upload and view their own ECG recordings in the mobile device in the patient history view Patients cannot delete their recordings but can share the EDF file Time for the measurements is take...
Page 24: ...l Figure 19 The sensor is not attached to the electrodes or the electrodes are not attached to skin Figure 20 The sensor is not attached to the electrodes or the electrodes are not attached to skin Th...
Page 25: ...25 Beat2Phone ECG Instruction Manual Figure 21 The skin electrode contact is not good Figure 22 The electrodes are not placed correctly and the signal is not strong enough...
Page 26: ...26 Beat2Phone ECG Instruction Manual Figure 23 The electrodes are not placed correctly and the signal is not strong enough Figure 24 The skin electrode or the electrode sensor contact is loose...
Page 27: ...the user tries to transfer recordings from the sensor to the mobile de vice while the sensor is not powered on Shake the sensor or put it to the charging station to continue 6 8 Mode of operation ON O...
Page 28: ...determined by the num ber of charging cycles until only half battery capacity is attained The provided charging connector accessory must be used for charging the sensor battery in temperature between...
Page 29: ...tors The sensor has four LEDs Green White Orange and Blue They are used to indi cate the sensor state Any other LED behaviour indicates that the device is dam aged and shall not be used When no LED is...
Page 30: ...ion runs on a mobile device and needs a connection to the sensor to start monitoring and recording the live ECG signal to stop the recording and to retrieve the recording from the sensor memory The ap...
Page 31: ...enti fied by a unique profile ID and is given the right connected sensor to use during the monitoring period A patient user cannot disconnect from the assigned sensor The mobile device and the applica...
Page 32: ...ashed in 30 degrees Celsius and only with mild detergents A single electrode strap is intended to be used by a single patient a new patient shall receive a new electrode strap The used electrode strap...
Page 33: ...esting the sensor The sensor can be tested to see if it is functioning normally To start the test choose SETTINGS SENSOR INFORMATION TEST SENSOR In the test the sensor sends a test signal to the mobil...
Page 34: ...attery the charging connector con tains electronics so they shall be left to electronics recycling at the end of their life The strap can be disposed as part of household waste 7 4 Beat2Phone ECG appl...
Page 35: ...ch requires internet connection Each user ID must be unique Mobile application does not find the sensor First wait for the list of detected sensors to update If the sensor is still not found try a dif...
Page 36: ...de strap shall never be replaced with any electrodes and associated wiring leads other than original accessories specified in this manual WARNING Other cables and accessories may negatively affect EMC...
Page 37: ...ls Users can contact the manufacturer via email info vitalsignum com for reporting unexpected operation or events when using the device and for assistance and questions about setting up using and main...
Page 38: ...he Beat2Phone ECG is intended for use in the electromagnetic environment specified below The customer or the user of The Beat2Phone ECG should assure that it is used in such an environment Emissions t...
Page 39: ...61000 4 3 Proximity fields ISM bands according to Table 9 Table 9 of 60601 1 2 2015 ESD EN 61000 4 2 Contact discharge di rect indirect 8 kV Air discharge direct 2 4 8 15 kV Power frequency mag netic...
Page 40: ...ccording to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 The ISM industrial scientific and medical bands between 150...
Page 41: ...r Manufacturer www beat2phone com supply markings 6V DC 6W IP Classification IP21 Orientation heart symbol Disposal Unique device identifier UDI number Figure 32 The charging connector label Electrode...
Page 42: ...PI production identifier DI is a combination of company prefix and the specific GTIN code for the sensor charging connector electrode strap and all accessories and software related to the device UDI P...
Page 43: ...of EEE Elec trical and Electronic Equip ment EU WEEE European Union Directive for Waste of Electronic and Electrical Equip ment To identify a type BF ap plied part complying with IEC 60601 1 IEC TR 60...
Page 44: ...44 Beat2Phone ECG Instruction Manual Warning Magnetic field Refer to instruction man ual Rechargeable battery Bluetooth Attention Read all warnings and precautions in instructions for use...
Page 45: ...where it is permissible to use consumer mo bile electronic communication devices All parts of the Beat2Phone ECG device can be used within the patient environment in a professional healthcare facilit...
Page 46: ...o 40 C from 20 to 60 C Humidity from 10 to 90 from 20 to 80 from 10 to 90 Pressure from 800 to 1060 hPa from 800 to 1060 hPa from 500 to 1060 hPa NOTE Any serious incident that has occurred in relatio...
Page 47: ...s for feedback 6 2 3 added for consumer user 6 6 added pacemaker impact 6 11 added other LED behaviour remark 6 12 added on mobile de vice connection 7 modified cleaning agents added mobile device cha...
