VitalSignum Beat2Phone Instruction Manual Download Page 44 | Manualshive

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VitalSignum Beat2Phone Instruction Manual Download Page 44

44

Beat2Phone ECG Instruction Manual

The UDI number has two parts: UDI-DI (device identifier) and UDI-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 soft-
ware related to the device.
UDI-PI is a combination of the sensor’s and the charging connector’s serial num-
ber and batch number. For device accessories, UDI-PI is the date of manufac-
ture.

NOTE!

Standard electrode lead markings do not apply for the Beat2Phone ECG

Electrode Strap as no ECG cables are used and only one bipolar lead is
measured by the sensor.

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Summary of Contents for Beat2Phone

Page 1: ...Beat2Phone ECG Instruction Manual Version 2 7 2022 9 2...

Page 2: ...20 6 4 1 PQRST measurement tool 23 6 4 2 Millimeter paper viewing and sharing 24 6 5 Uploading and viewing sensor recordings Patient user 25 6 6 Identifying problems with recorded ECG waveforms 25 6...

Page 3: ...nector GTIN 6429810109019 Beat2Phone ECG Electrode Strap GTIN 6429810109033 Beat2Phone ECG Application GTIN 6429810109064 The information in this document is subject to change without prior notice 059...

Page 4: ...single lead electrocardiogram accurate enough to de tect arrhythmia It is suitable for monitoring adults of normal weight that require heart condition monitoring The collected data on electric activit...

Page 5: ...t require any medical training from the patient users or per sons assisting them The product allows medical professionals to conduct large scale health surveys and screenings cost efficiently The EDF...

Page 6: ...ation proof The sensor includes a Bluetooth BLE 5 0 radio transmitter Do not use it in environments with special restrictions on electronic device radio emission Avoid proximity with interfering devic...

Page 7: ...The electrical safety of the device is not guaranteed in low air pressure Take precaution when using the device less than 1 5 km from AM FM or TV broadcast antennas Do not disassemble or try to repair...

Page 8: ...8 Beat2Phone ECG Instruction Manual Always make sure the sensor the charging connector and the electrode strap are clean Excessive lint or dust can hinder the performance of the de vice...

Page 9: ...TIN 6429810109064 These products are placed in three slots inside the product kit There packaging has slots for the sensor the charging connector and the electrode strap Labelling information on the p...

Page 10: ...transferred to the mobile device using the mobile application and then stored to the mobile device memory Keep your mobile device charged The sensor has a BLE 5 radio that is used for displaying ECG i...

Page 11: ...is not part of the ME System provided by VitalSignum Oy All provided parts are in the product package Make sure you re in a comfortable clean and private environment before attach ing the device to y...

Page 12: ...paste is needed for skin con tact Moisten the electrode strap contacts with a damp cloth moistened with water before using the strap This improves the electrical contact between the skin and electrode...

Page 13: ...Internet connec tion ECG registration does not require Internet access once the profile is acti vated 6 2 1 Application professional user When the application is opened for the first time in the mobil...

Page 14: ...he organization If the request is approved you will re ceive a join code in your organizational email address after which you can input the code and join the organization by selecting I HAVE A CODE Pa...

Page 15: ...eate delete and modify profiles change their pass words modify all application settings and view the entire patient recording his tory in the mobile device You cannot start ECG recordings from the Pro...

Page 16: ...ng out of the Pa tient profile will end the patient monitoring period Figure 6 7 Change patient logout A Patient profile can be deleted by tapping the Patient profile in the Patient se lection creatio...

Page 17: ...toring screen can be turned off by turning the mobile device screen off Measurement is ongoing and data is stored Recording time is shown at the top right corner of the screen The moni toring view has...

Page 18: ...e application sends a Do you want to stop monitoring mes sage to confirm stopping the recording The user can then discard the message or stop the recording In addition this message reminds the user of...

Page 19: ...er only has to create a profile and connect the sensor after which measurements can be started NOTE A consumer user is required to accept the privacy statement in order to activate the user profile NO...

Page 20: ...tery from discharging during transport The sensor will also go to sleep mode automatically when not in use or when moved and not charging In this case shaking the sensor will turn it on 6 4 Uploading...

Page 21: ...t sensor All patient ECG recordings in the mobile device can be viewed in the Profes sional history view The default view is the List view showing the newest pa tient recording on top To open a record...

Page 22: ...22 Beat2Phone ECG Instruction Manual Figure 6 15 History list view Figure 6 16 File transfer dialogue in the History view Figure 6 17 Opening a file in the History view...

Page 23: ...ECG graphs on a mobile device s touchscreen by dragging and swiping Hori zontal zoom by fingers is also available To restore the default scale touch the Beat2Phone heart icon Figure 6 18 The History...

Page 24: ...limeter paper view opens In this view you can see 30 seconds of ECG in a standard millimeter paper format 15 seconds before and 15 seconds after the selected location in the ECG recording To share the...

Page 25: ...13Figure 6 13 to Figure 6 16Figure 6 16 Patients can upload view and annotate their own ECG recordings in the mobile device in the Patient history view Patients cannot delete their recordings or shar...

Page 26: ...n sensor not attached to the electrodes or electrodes not at tached to skin Figure 6 24 Waveform when sensor not attached to the electrodes or electrodes not at tached to skin The sensor is near elect...

Page 27: ...al Figure 6 26 Electrodes are not placed correctly and the signal is not strong enough Figure 6 27 Electrodes are not placed correctly and the signal is not strong enough Figure 6 28 Skin electrode or...

Page 28: ...e internet Enable mobile data or connect to a wi fi network to continue This message can also appear if the user tries to transfer recordings from the sensor to the mobile device while the sensor is n...

Page 29: ...or a fully exhausted battery is 90 minutes Sensor lifetime is determined by the number of charge cycles until only one half of battery capacity can be at tained The provided charging connector accesso...

Page 30: ...e older Beat2Phone sensor NOTE Do not place the charger in a position where it will be difficult to operate Warning Do not charge the sensor battery in temperatures below 0 Celcius Do not place the se...

Page 31: ...the heart points down when connected to the strap on the chest Figure 6 32 The heart symbol indicates the correct orientation of the sensor 6 12 Sensor connection to the mobile device The Beat2Phone a...

Page 32: ...d which must be at least 6 characters long special char acters are allowed In addition the professional user must join an organization to be able to add patients Patient user has no profile informatio...

Page 33: ...ame s can also be retrieved through the Beat2Phone ECG service GUI login page Username is sent to the profile email address The mobile application will prompt the user when Internet connection needed...

Page 34: ...by a single patient each new patient should receive a new electrode strap Used electrode straps can be disposed of with household waste Occasionally residual oxidation may accumulate on the sensor sn...

Page 35: ...ient profile Figure 7 1 The firmware update prompt 7 2 Testing the sensor The sensor can be tested to see if it is functioning normally To start the test choose SETTINGS SENSOR INFORMATION TEST SENSOR...

Page 36: ...he charging connector contains electronics so these parts must be recycled appropriately as electronic waster at the end of their lifetime The strap can be disposed with household waste 7 4 Beat2Phone...

Page 37: ...ofile requires access to the Beat2Phone cloud service which requires internet connection Each user ID must be unique Mobile application does not find the sensor First wait for the list of detected sen...

Page 38: ...ECG Electrode Strap should never be replaced with any electrodes and associated wir ing leads other than original accessories specified in this manual WARNING Using non original cables and accessorie...

Page 39: ...s Users can contact the manufacturer via email info vitalsignum com for reporting un expected operation or issues when using the device and for assistance and questions about setting up using and main...

Page 40: ...that it is used in an environment of the speci fied type Emissions test Compliance Electromagnetic environment guidance RF emissions below 1 GHz CISPR 11 EN 55011 30 230 MHz at 10 m 30 dBuV m The Bea...

Page 41: ...15 kV Power frequency mag netic fields EN 61000 4 8 Power frequency mag netic field 30 A m Continuous field 50 60 Hz Power supply networks voltage dips and inter ruptions EN 61000 4 11 Voltage reduct...

Page 42: ...d 800 Mhz the separation distance for the higher frequency range applies NOTE 2 The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 5...

Page 43: ...al Unique device identifier UDI number Figure 11 2 The charging connector label Electrode strap markings Product type Beat2Phone ECG Electrode Strap Disposal Unique device identifier UDI number Figure...

Page 44: ...g connector electrode strap and all accessories and soft ware related to the device UDI PI is a combination of the sensor s and the charging connector s serial num ber and batch number For device acce...

Page 45: ...dispose of EEE Electrical and Electronic Equipment EU WEEE Euro pean Union Directive for Waste of Electronic and Elec trical Equipment Identifies a BF type ap plied part compliant with IEC 60601 1 IE...

Page 46: ...46 Beat2Phone ECG Instruction Manual Warning Magnetic field Refer to instruction manual Rechargeable battery Bluetooth Attention Read all warnings and precautions in instruc tions for use...

Page 47: ...permissible to use consumer mobile electronic communication devices All parts of the Beat2Phone ECG device can be used within the patient environ ment of professional healthcare facilities except the...

Page 48: ...o 40 C 0 to 40 C 20 to 60 C Humidity 10 to 90 20 to 80 10 to 90 Pressure 800 to 1060 hPa 800 to 1060 hPa 500 to 1060 hPa NOTE Any serious incidents that occur in relation to this device should be repo...

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