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INSTRUCTIONS FOR USE

SDK 01

Medical Wearable Platform

LBL 75-06-78 Rev AA

Содержание VV330

Страница 1: ...Lorem ipsum INSTRUCTIONS FOR USE SDK 01 Medical Wearable Platform LBL 75 06 78 Rev AA ...

Страница 2: ......

Страница 3: ...utions 2 Instructions for Use 5 Charging Storage Maintenance 10 Troubleshooting 11 Certification Disclaimer 12 Electromagnetic Compatibility EMC Tables 14 Technical Specifications 17 Definition of Symbols 19 Contents Wireless Technology 16 ...

Страница 4: ...i What s Included 1 ECG Recorder the Patch ontinuous ECG Recorder x1 Charging Case x1 Adhesives x8 USB Charging Cable x1 ...

Страница 5: ...tients under 18 years old and it is meant for a single patient use This Instructions for Use is only limited to the use of the hardware and the Software Development Kit SDK It does not include any information about the mobile application or user interfacing device as that is outside the scope of the system 5 6 Do not use the patch with a cardiac pacemaker defibrillators or other implanted electron...

Страница 6: ... Hydrogel that are primary materials of the patch and adhesive 21 The device should be used only with the components recommended for use by the manufacturer 7 Do not wear or use the patch during a magnetic resonance imaging MRI or electro cautery procedures The Patch is MR Unsafe 8 Exposure of the wireless communications features of the device or its accessories may be interfered with by other dev...

Страница 7: ... LOT SN returned to the SDK from the Patch matches with the LOT SN printed on back of the patch Do not connect the SDK to any unknow devices 2 All the Patch data is encrypted for security purposes The SDK needs a decryption key to encrypt the patch data 3 The Patch will not connect or transfer data to any devices that does not use VivaLNK provided SDK package The bluetooth protocol of the Patch an...

Страница 8: ...ructions for Applying the Patch charger to recharge Align the two dots on the patch with the two pins on the charger to properly charge the patch i Instructions for Use Charging the Patch 5 Indicates Fully Charged Indicates Charging Note For the charger base just clean with a dry cloth ...

Страница 9: ...6 1 Prepare Skin Ideally clean the left upper middle chest area with an alcohol swab Shave area if needed Let dry completely 2 Peel adhesive starting with tab 1 3 Place the patch on the adhesive Be sure to press patch firmly onto the adhesive 1 ...

Страница 10: ...ab 2 is located on the bottom side of the patch 5 Place the Recorder around the middle of upper left chest area at a roughly inclined angle as shown below Press the patch firmly on chest and around outer layer of the adhesive Make sure the heart symbol on the patch is upright ...

Страница 11: ...Start at the yellow tab of the transparent film to peel off the patch Use the red tab to peel the adhesive from the patch Do not reuse this adhesive 2 Remove the adhesive from the patch itself by peeling from the edge 3 Clean the patch with warm water Rub off any residue with your fingers wait for patch to dry completely Do not submerge ...

Страница 12: ...ure to water as it can affect the adhesive and sensors 1 Avoid prolonged or hot showers 2 Avoid soap or rubbing around the patch 3 Dry patch by dabbing with towel 4 If the patch dislodges after a shower or you notice a problem with the sensor signals see instructions for Removing and Cleaning the Patch 9 ...

Страница 13: ...de the charger red light indicates the patch is charging The light should stay on when charging It is recommended to store the Patch inside the charging case when not in use for better Charging can start when the USB cable is connected to a USB power source Each Patch comes with 8 medical grade disposable adhesives Adhesives can be used up to 72 hours but some users may want to change adhesives mo...

Страница 14: ...ata or intermittent data received by SDK 1 Enable Bluetooth 2 Move the Patch close to the SDK installed device o 3 Move far away from any electronic equipment or change rooms or move to an open space 4 Check if the Patch is activated 5 Restart the SDK installed device 6 The Patch battery is low and charge it Possible Causes Symptom Solutions 1 Contact your device provider 2 Recheck device s locati...

Страница 15: ...ence to radio or television reception the user is encouraged to try to correct the interference by one or more of the following measures 1 Increase the separation between the Patch and the device r r 2 Connect the equipment into an outlet on a circuit different from that to which the receiver is connected 3 Consult an experienced radio TV technician for help 4 Reorient or relocate the receiving an...

Страница 16: ...be mixed with general household waste For proper treatment recovery and recycling please take this product s to designated collection points where it will be accepted free of charge Alternatively in some countries you may be able to return your products to your local retailer upon purchase of an equivalent new product Battery Removal 2 All batteries accumulators should be disposed separately from ...

Страница 17: ...CAE ED 14G 2011 Therefore use of Section 21 and category M of a more recent edition e g 39 or 40 should be considered In other intended modes or in EM ENVIRONMENTS of transportation applicable standards shall apply Examples of standards that might be applicable include CISPR 25 and ISO 7637 2 Conducted and radiated RF EMISSION Phenomenon Emission Test Levels IEC 60601 Test Level Professional Healt...

Страница 18: ...e adjusted as appropriate for the minimum expected distance Immunity Test Levels Phenomenon and Basic EMC standard or test method Electrostatic discharge IEC 61000 4 2 8 kV contact 2 kV 4 kV 8 kV 15 kV air 30 A m 50Hz or 60Hz Radiated RF EM fields IEC 61000 4 3 Rated power frequency magnetic fields IEC 61000 4 8 3 V m 80 MHz 2 7 GHz 8 AM at 1kHz 10 V m 80 MHz 2 7 GHz 8 AM at 1kHz Professional Heal...

Страница 19: ...reless communication between patch firmware and SDK in line with Bluetooth 4 0 low power Bluetooth protocol works in the 2 4GHZ ISM radio frequency band and belongs to general information technology equipment Through security mechanism in wireless Bluetooth communication protocol stack ensured by Bluetooth Special Interest Group both patch firmware and SDK in APP are required to execute these secu...

Страница 20: ...Note 24 hours of data storage on the patch during no wireless transmission 17 Technical Specifications Product Name Catalog Model VV330 VV 330 Patch Size 90mm x 28mm Patch Thickness 7 9 mm Patch Weight 7 5 g Patch Battery 95 mAh rechargeable Duration of continuous patch use 3 Days Heart Rate Detection Range 40 BPM 300 BPM Operating Conditions Temperature Range 50 F 113 F 10 C 45 C Humidity Range 1...

Страница 21: ... Class 2 2 5 mW 4 dBm Network Topologies Point to Point including piconet Broadcast Power Consumption 0 01x to 0 5x of reference depending on use case Channel Usage Frequency Hopping Spread Spectrum FHSS Application throughput 0 27 1 37 Mbit s Latency from a non connected state 6 ms Robustness Adaptive frequency hopping Lazy Acknowledgement 24 bit CRC 32 bit Message Integrity Check Minimum total t...

Страница 22: ...e window only Date of Manufacture Radio emission Serial Number Disposable Lot batch Number Catalog Number WEEE icon Type BF applied part Temperature Limitation Consult Instructions For Use Bluetooth Non Sterile Humidity Limitation Atmospheric Pressure Limation MR Unsafe 19 ...

Страница 23: ...Emergo Europe B V Prinessegracht 20 2514 AP The Hague The Netherlands 2797 10 50 50 122 LBL 75 01 78 Rev AA ...

Страница 24: ...Manufactured by VivaLNK Inc 51 East Campbell Avenue Suite 160 Campbell CA 95008 USA 408 868 2898 THANK YOU ...

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