SAVING Savvy ECG User Manual Download Page 13 | Manualshive

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SAVING Savvy ECG User Manual Download Page 13

All rights reserved! Non authorized copy and/or not agreed usage of document prohibited.

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.

Symbol accompanied by the name and address of the manufacturer.

Waste separation for batteries.

Waste separation for electronics.

Medical equipment with intended radiation (communication purposes)

CE marking with number of Notified body; SIQ, number 1304

Device labelling

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Summary of Contents for Savvy ECG

Page 1: ...rized copy and or not agreed usage of document prohibited Page 1 User s Manual Savvy Personal CARDiac activity monitoring system PCARD Osebni sistem za spremljanje sr ne aktivnosti PCARD Version UM 1...

Page 2: ...ings 2 Put the Savvy sensor into charging dock 3 Connect charging dock to recommended charger and to the power supply 220V 110V 4 The charging process takes approximately 2 hours 5 Read Section 5 abou...

Page 3: ...OPERATION 17 6 1 INITIALIZATION 17 6 1 1 Activating the MobECG service 17 6 1 2 Selection of Savvy sensor 17 6 2 MEASUREMENT ACQUISITION 18 6 2 1 Initiation of measurements 18 6 2 2 During measuremen...

Page 4: ...bited 9 MAINTENANCE 27 9 1 CHARGING THE SAVVY SENSOR BATTERY 27 9 2 VISUAL INSPECTION 28 9 3 CLEANING INSTRUCTIONS 28 9 4 MOBECG APPLICATION USER MAINTENANCE 28 9 5 PRODUCT LIFE AND STORAGE 29 9 6 EMC...

Page 5: ...nal characteristics A Patient can generate ECG REPORT on mobile device in PDF format which can be printed out or sent by e mail to the patient Doctor for further diagnose 2 Terms and conditions 1 Manu...

Page 6: ...e warranty statement 8 When you first launch mobile application it is required to confirm the statement that the respective buyer is aware of the general terms and conditions of use otherwise the app...

Page 7: ...ensor See troubleshooting section for further instructions WARNING Individuals with known allergies or hypersensitivities to adhesives or hydrogel electrode material should not use the SAVVY medical d...

Page 8: ...rom other devices WARNING Only prescribed charger can be used Using other chargers can cause unacceptable risks related to electrical safety and electromagnetic compatibility WARNING Mains plug of bat...

Page 9: ...ing Slovenian or English At least language used in the User s manual e Experience Recognition of usual graphical shapes of recorded ECG signal is advisable No other special experience is required 4 Pr...

Page 10: ...tion 5 Switch type power supply Operating Temperature range 0 C 60 C Storage Temperature 40 C 85 C Efficiency 78 Insulation class II Electrical safety standard EN 60950 1 2006 A11 2009 A1 2010 A12 201...

Page 11: ...nd a PC A means of point and click user input such as touchscreen or computer mouse A means of ASCII symbol set input such as touchscreen or keyboard Note that the MobECG application is supported only...

Page 12: ...lid gel Silver Silver Chloride Ag Ag Cl Backing Clear Tape Solid Gel Dimensions 50 mm Suggested Use Long term 48 hours Figure 4 Two examples of recommended self adhesive electrodes SAE Equivalent or b...

Page 13: ...rature 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 Symbol accompanied by the name and address...

Page 14: ...Page 14 All rights reserved Non authorized copy and or not agreed usage of document prohibited Figure 5 Savvy labeling Figure 6 Charging dock labeling Figure 7 Labeling of packaging...

Page 15: ...ntact supplier or producer 5 2 Positioning of the electrodes Before initiating the measurements fix the Savvy sensor to the skin using standard self adhesive electrodes First while the electrodes stil...

Page 16: ...Page 16 All rights reserved Non authorized copy and or not agreed usage of document prohibited 1 2 3 4 5 6 7 Figure 8 Recommended electrode positions on the body...

Page 17: ...tions of the application are available by clicking on the menu at the top left corner Figure 9b will appear NOTE The main application screen is the only one that cannot be rotated a b Figure 9 MobECG...

Page 18: ...tatus of the Savvy sensor is disconnected To start the measurement click on the Start button After a short time the sensor connects to the PDA The status of the Savvy sensor changes to Connected When...

Page 19: ...tom event For predefined events click on one of the displayed icons and then on the save button Figure 11c For a custom event either enter the text into the text field or leave it empty and then click...

Page 20: ...round that time Sliding the tab Measurements Figure 12a to the left brigs the tab Reports Figure 12b into the view This tab comprises a list of reports generated so far Selecting a given report will o...

Page 21: ...measurements are shown and described in Figure 13 All forms except the last one Figure 16f are considered as ECG Two examples of quality ECG signal are shown in Figure 16a and Figure 16b An inverted E...

Page 22: ...ment there is an option to lock the screen of the application When the application screen is locked users cannot perform any actions like start stop measurement or preform setup However the user can s...

Page 23: ...out asking for permission The application will only reset the Bluetooth adaptor if it becomes unresponsive Security settings o Lock the selection of Bluetooth SAVVY Checking this option will lock curr...

Page 24: ...rly for updates on Google Play Store The application will guide you through the update process 6 6 Application info Information about the application like version and brief description are available b...

Page 25: ...poses 7 1 Summary of measured data To generate the summary of measured data the measurements need to be first transferred on a local PC see Section 6 4 File transfer Then after starting up the program...

Page 26: ...Additional analysis A medical expert can further analyse the recorded ECG in more details by selecting any recorded interval The selected interval is then displayed for further processing and assessm...

Page 27: ...d by healthcare professionals 8 2 Contraindications The SAVVY system is not intended for use by individuals with potentially life threatening arrhythmias or by individuals who require inpatient or hos...

Page 28: ...k Charger can be cleaned and disinfected only when they are disconnected from power supply and only when fully dry they can be reconnected to power supply The Savvy sensor can be cleaned and disinfect...

Page 29: ...age 29 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...

Page 30: ...ction without intervention reconnection is successful within 60s On charging dock LED could blink during ESD After discharge small peaks could appear on graph In case of malfunction due to electrostat...

Page 31: ...the transmitter Recommended separation distance d d 80 MHz to 800 MHz d 800 MHz to 2 5 GHz where P is maximum output power rating of the transmitter in watts W according to the transmitter manufacture...

Page 32: ...kin very good The gel of the electrodes has degraded or the skin is not clean Clean the skin and or change the electrodes The ECG graph has disappeared The sensor is not in the PDA Bluetooth range Wir...

Page 33: ...ized copy and or not agreed usage of document prohibited Page 33 1000 Ljubljana Official Logo Statutory representatives Boris Simon i PhD MD Tina Samard ija Quality management system QMS certificate I...

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