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SAVING Savvy ECG User Manual

Personal cardiac activity monitoring system pcard
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User's Manual
Savvy
Personal CARDiac activity monitoring system - (PCARD)
Osebni sistem za spremljanje srčne aktivnosti - PCARD
Version: UM 1.19.3 Revision date: 31.05.2017
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All rights reserved! Non authorized copy and/or not agreed usage of document prohibited.

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Summary of Contents for SAVING Savvy ECG

  • Page 1 User’s Manual Savvy Personal CARDiac activity monitoring system - (PCARD) Osebni sistem za spremljanje srčne aktivnosti - PCARD Version: UM 1.19.3 Revision date: 31.05.2017 Page 1 All rights reserved! Non authorized copy and/or not agreed usage of document prohibited.
  • Page 2 Sales and Service Information SAVING d.o.o. sales and service centre network is world-wide. Headquarters Address SAVING d.o.o. Finžgarjeva 4 SI-1000 Ljubljana, Slovenia Phone: +386 (0) 30.707.202 E-mail: info@savvy.si Web: www.savvy.si READ THIS FIRST 1. First read the Section 3.1. about General warnings.

  • Page 3: Table Of Contents

    Contents INTRODUCTION ............................5 TERMS AND CONDITIONS .......................... 5 SAFETY ............................... 7 3.1..........................7 ENERAL WARNINGS 3.2............................8 RECAUTIONS 3.3..........................9 NTENDED OPERATOR PRODUCT DESCRIPTION AND TECHNICAL SPECIFICATIONS ................ 9 4.1........................... 9 ASIC EQUIPMENT 4.1.1. Savvy sensor ..........................9 4.1.2.
  • Page 4 MAINTENANCE ............................27 9.1......................27 HARGING THE AVVY SENSOR BATTERY 9.2..........................28 ISUAL INSPECTION 9.3.........................28 LEANING INSTRUCTIONS 9.4....................28 APPLICATION SER MAINTENANCE 9.5........................29 RODUCT LIFE AND STORAGE 9.6..........................30 INFORMATION TROUBLESHOOTING ..........................32 WARRANTY INFORMATION ........................32 MANUFACTURER DATA ..........................32 Page 4 All rights reserved! Non authorized copy and/or not agreed usage of document prohibited.

  • Page 5: Introduction

    Doctor for further diagnose. 2. Terms and conditions Manufacturer and distributor Saving d.o.o., Finžgarjeva 4, Ljubljana, has, with the participation of the Jozef Stefan Institute in Ljubljana, developed the device with the commercial designation Savvy, in accordance with technical data which is an integral part of the user manual of the device.
  • Page 6 Manufacturer and seller of Saving d.o.o. are in no way obligated to enable access for any system upgrades of said product to customers or users.

  • Page 7: Safety

    3. Safety 3.1. General warnings WARNING! The SAVVY medical device is not intended for individuals with potentially life- threatening arrhythmias or individuals who require inpatient or hospital monitoring. WARNING! The user must carefully read the instructions for use in the user’s manual. The user should be able to operate smart phones or tablets and understand the user’s manual.

  • Page 8: Precautions

    Savvy sensor on another recommended position and/or replace the electrodes. • The Savvy sensor should be removed prior to external defibrillation or an MRI scan. • Make sure that the PDA has enough free storage space (at least 2 GB) for saving the measurements.

  • Page 9: Intended Operator

    3.3. Intended operator The user itself can normally act also as the operator; additionally, a caregiver can act as an operator by assisting the user. In both cases, the operator should fulfil the following issues: a) Education: - Not prescribed, see item b), b) Knowledge: - Literacy, - Understanding of all information in the User’s manual,...

  • Page 10: Charging Dock

    4.1.2. Charging dock The charging dock (see Figure 2) is essentially a cable extension from charger and the Savvy sensor. Output VDC: 6,0 V Max. load: 150 mA Figure 2: Savvy sensor placed in the charging dock. 4.1.3. Charger The charger must have the following characteristics: Model name: VEL05US090-EUJA Input voltage: 90-264 VAC, Input frequency 47-63Hz Output VDC: 9,0 V, Max.

  • Page 11: Accessories Of The Medical Device

    • Visualization of up to 10 seconds of the ongoing measurement. • Storing the measured data on the PDA storage. • Interaction with the user. • Transferring the measurements to a secure storage server or cloud platform. 4.2. Accessories of the medical device Accessories are sold separately and should be provided by user.

  • Page 12: Labels And Graphic Symbols

    1. SKINTACT monitoring ECG electrodes (http://www.skintact.com/48.0.html, see Figure 4 (left)). Type T-60 Aqua-Wet, Silver/Silver Chloride (Ag/Ag Cl) Backing Microporous tape Dimensions 60 mm Suggested Use Long term (> 48 hours) 2. NIKOMED monitoring ECG electrodes (www: http://www.nikomedusa.com/stress_lab.cfm), see Figure 4 (right). Type No.
  • Page 13 Consult the instructions of the device for information on how to properly use it. Type BF medical equipment "Keep dry". Both temperature limits should be noted next to the upper and lower horizontal lines. Both humidity limits should be noted next to the upper and lower horizontal lines.
  • Page 14 Figure 5: Savvy labeling Figure 6: Charging dock labeling Figure 7: Labeling of packaging Page 14 All rights reserved! Non authorized copy and/or not agreed usage of document prohibited.

  • Page 15: Environmental And Transport Conditions

    4.4. Environmental and transport conditions Environmental and transport conditions for the BG and the charging dock are given in the table below: TRANSPORTATION AND Environmental conditions NORMAL OPERATION STORAGE Environmental temperature: C to +40 C to +70 10 % to 95 % (limited 10 % to 95 % (limited Relative humidity: condensation)
  • Page 16 Figure 8: Recommended electrode positions on the body. Page 16 All rights reserved! Non authorized copy and/or not agreed usage of document prohibited.

  • Page 17: Device Operation

    6. Device operation 6.1. Initialization In the following, we show a symbolic design of the MobECG application, because the actual implementation is Android OS dependant. 6.1.1. Activating the MobECG service Upon installation, the MobECG service is activated with tap on the application icon. When activated, the MobECG application icon will appear on the top task bar of the PDA.

  • Page 18: Measurement/Acquisition

    6.2. Measurement/Acquisition 6.2.1. Initiation of measurements After the Savvy sensor is selected, go back to the main screen of the application by clicking “Back” on the PDA or selecting “Overview” from the application menu. The Savvy sensor is listed in the Select Savvy section of the main screen, displaying its status, signal strength and battery level (Figure 11a).

  • Page 19: During Measurement

    Saving the event will change the screen back to the “Overview”. ECG REPORT can be generated either from the Mark Event menu or from the “ECG Reports”...

  • Page 20: Ecg Report

    6.2.4. ECG REPORT This option offers a list of “Measurements” (Figure 12a) and a list of “Reports” (Figure 13b), as two tabs of a tabbed interface. The tab “Measurements” comprises a list of past and ongoing measurements, and the stored events within those measurements.

  • Page 21: Ecg Graph

    mV in amplitude and 25 mm per second in time axis (Fill last page of report if timespan ends in the middle of page). 6.2.5. ECG graph The application provides also an option to visualize the current ECG measurement and BPM. By selecting “ECG Graph”...

  • Page 22: Pause Ecg Graph During Measurement

    (a) Example of a quality ECG (b) Example of a quality ECG (c) Example of inverted ECG (d) ECG while walking (e) Noisy ECG (f) Noise Figure 16: Examples of different signals during measurement. 6.2.6. Pause ECG graph during measurement To temporary pause the visualisation of ECG and see a particular segment currently being detected, just tap on the graph.

  • Page 23: Application Settings

    “Select Savvy” from the application menu. Then deselect the yellow highlighted Savvy with one click. The Savvy will be un-highlighted. At the end, click “Back” on your PDA or select “Overview” from the application menu to return to the main screen. 6.3.

  • Page 24: Manual Transfer

    Figure 17: Symbolic design of the FTP Upload screen. 6.4.2. Manual transfer More advance users of PDAs can also manually transfer the measured data on a personal computer by using means of file transfer from a PDA to other device. It is recommended to delete the measurement files from the PDA after transfer in order to insure space availability for further measurements.

  • Page 25: Exiting From The Mobecg Application

    MobEcg will also continue started measurement if the PDA screen is turned off. Turning the screen off as it will decrease the PDA consumption and enable it to work for longer without recharging. 6.7.2. Exiting from the MobECG application To exit from MobECG, select “Exit” from the application menu. NOTE: The application does not turn of the Bluetooth on the PDA on exit.

  • Page 26: Additional Analysis

    also marked on the graphs. The summary is intended to be used by medical doctors for interpreting long-term measurement, which can last from a few days to a month. NOTE: The design of the summary is subject to further changes. Check regularly for VisECG update.

  • Page 27: Indications And Contraindications

    Figure 19: Summary example. 8. Indications and contraindications 8.1. Indications The SAVVY system is intended to be used for the puposes of heart rhythm monitoring with bluetooth devices. It is capable of detection of abnormally rapid and slow heart rate, and display such in a graphical manner.

  • Page 28: Visual Inspection

    NOTE: When the Savvy sensor is not in use, it is necessary to be placed in the charging dock and in charging mode in order to ensure that the battery will not be discharged. Discharged battery void Guarantee. Figure 20: Savvy sensor placed in the charging dock connected to a Charger, while charging. 9.2.

  • Page 29: Product Life And Storage

    • Battery on the PDA should be kept charged enough to support long measurements or the PDA should be placed on a charger. 9.5. Product life and storage Lifetime of the MD is two years. Environmental conditions for storage are given in Section 3.4. Environmental and transport conditions.

  • Page 30: Emc Information

    9.6. EMC information The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such environment. Emissions test Compliance Electromagnetic environment - guidance The device use RF energy only for its internal function. Therefore, their RF RF emissions Group 1 emissions are very low and are not likely to cause any interference in nearby...
  • Page 31 IEC 60601 Compliance Immunity test Electromagnetic environment - guidance test level level Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

  • Page 32: Troubleshooting

    11. Warranty information For warranty information, please refer to the warranty declaration. 12. Manufacturer data Name and address Saving d.o.o. Finžgarjeva ulica 4 Page 32 All rights reserved! Non authorized copy and/or not agreed usage of document prohibited.
  • Page 33 1000 Ljubljana Official Logo Statutory representatives Boris Simončič, PhD, MD Tina Samardžija Quality management system ISO 13485:2003 (QMS) certificate PIN: MAC ADDRESS: Page 33 All rights reserved! Non authorized copy and/or not agreed usage of document prohibited.

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