VivaLNK VV330 Instructions For Use Manual

Medical wearable platform sdk 01

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Medical Wearable Platform

SDK 01

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INSTRUCTIONS FOR USE

LBL 75-06-78 Rev AA

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Page 1 Medical Wearable Platform SDK 01 Lorem ipsum INSTRUCTIONS FOR USE LBL 75-06-78 Rev AA...
Page 3: Table Of Contents
Contents What’s Included Intended Use & Precautions Instructions for Use Charging, Storage & Maintenance Troubleshooting Certification & Disclaimer Electromagnetic Compatibility (EMC) Tables Wireless Technology Technical Specifications Definition of Symbols...
Page 4: What's Included
What’s Included ontinuous ECG Recorder ECG Recorder (the Patch) Charging Case Adhesives USB Charging Cable...
Page 5: Intended Use & Precautions
Intended Use and Precautions Intended Use Medical Wearable Platform SDK-01 is intended to record, store and transfer electrocardiogram (ECG) and accelerometer data. The platform has the capability to provide Heart Rate, Respiratory Rate and R-R Interval using the ECG rhythm. The ECG recorder patch is an ambulatory, continuous recording patch, intended for at-home or hospital, by clinicians or health professionals who intend to monitor their patient's physiological and health conditions for an extended period of time.
Page 6 (MRI), or electro-cautery procedures. The Patch humidity range; c) mechanical shock (for example, being dropped) is MR Unsafe. 14. Please contact customer service at support@vivalnk.com if 8. Exposure of the wireless communications features of the you have any questions.
Page 7 VivaLNK provided SDK package. The bluetooth protocol of follow Troubleshooting steps listed below. the Patch and SDK is proprietary to VivaLNK and cannot be intercepted 27. When the Patch battery is fully discharged,charge the patch by other unknown devices.
Page 8: Instructions For Use
Instructions for Use - Charging the Patch 1. Place the patch in the 2. Fully charge the patch before use 3. Once charged, see charger to recharge instructions for “Applying the Patch” Note: For the charger base, just clean with a dry cloth Indicates Fully Charged Align the two dots on the patch with Indicates Charging...
Page 9 Instructions for Use - Applying the Patch 1. Prepare Skin 2. Peel adhesive starting 3. Place the patch on with tab #1 the adhesive Ideally, clean the left, upper Be sure to press patch firmly middle chest area with an onto the adhesive.
Page 10 Instructions for Use - Applying the Patch 4. Peel adhesive using 5. Place the Recorder around the middle tab #2 of upper left chest area at a roughly inclined angle as shown below Tab #2 is located on the Press the patch firmly on bottom side of the patch.
Page 11 Instructions for Use - Removing and Cleaning the Patch 1. Remove the patch from 2. Remove the adhesive from 3. Clean the patch with chest by pulling from the the patch itself by peeling warm water yellow tab of the from the edge adhesive Start at the yellow tab of the...
Page 12 Instructions for Use - Tips before Showering Note: While the patch is water resistant, avoid excessive exposure 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.
Page 13: Charging, Storage & Maintenance
Charging, Storage & Maintenance Patch Storage & Charging Charger Indicators It is recommended to store the Patch inside the charging case when not in use for better. •When the Patch is placed inside the charger,red light Charging can start when the USB cable is indicates the patch is charging.
Page 14: Troubleshooting
Troubleshooting Solutions Symptom 1. Contact your device provider. 1. This device might be damaged. 2. Recheck device’s location or contact with skin. 2. This device might not be worn correctly. Unusual Data 3. Use this device under instructed operation 3. The operation temperature is too high or too low. temperature.
Page 15: Certification & Disclaimer
Certification & Disclaimer Notes: This device has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in according with the instructions, may cause harmful interference to radio communications.
Page 16 Certification & Disclaimer For private households: Information on Disposal for Users of Alternatively, in some countries, you may be able to return your WEEE products to your local retailer upon purchase of an equivalent new product. Disposing of this product correctly will help save valuable resources and prevent any potential negative effects on human Battery Removal health and the environment, which could otherwise arise from...
Page 17: Electromagnetic Compatibility (Emc) Tables
Electromagnetic Compatibility (EMC) Tables Table 1 Emission Test Levels Professional Healthcare Facility Environment Home Healthcare Environment (E.g. physician offices, dental offices, clinics etc.) (E.g. restaurants, cafes, shops, etc.) Phenomenon IEC 60601 Test Level IEC 60601 Test Level Conducted and a) b) CISPR 11 CISPR 11 radiated RF EMISSION...
Page 18 Electromagnetic Compatibility (EMC) Tables Table 2 Immunity Test Levels Phenomenon and Professional Healthcare Facility Environment Home Healthcare Environment Basic EMC standard (E.g. physician offices, dental offices, clinics etc.) (E.g. restaurants, cafes, shops, etc.) or test method Electrostatic discharge ± 8 kV contact IEC 61000-4-2 ±...
Page 19: Wireless Technology
Wireless Technology VivaLNK Continues ECG Recorder uses Bluetooth Low Energy (LE) wireless technology (IEEE 802.15.1, managed by Bluetooth Special Interest Group now) to transfer data between the ECG Recorder and the SDK, including ECG, RRI, HR, ACC data, and device information, which complies with the BLE 4.0 and above.
Page 20: Technical Specifications
Note: 24 hours of data storage on the patch during no wireless transmission. (After adhesive bag is open, use within one month. Product Shelf Life: 1 Year Charger Power Source: VV330 Charging Base (micro-USB) Charger Power Source: VV330 Charging Base (micro-USB) Otherwise, the water evaporation of the adhesive tape...
Page 21 Technical Specification Specification VV330 ECG Recorder Specification VV330 ECG Recorder Frequency Band 2.4GHz ISM Band (2.402 – 2.480 GHz Utilized) Channel Usage Frequency-Hopping Spread Spectrum (FHSS) Channels 40 channels with 2 MHz spacing (3 advertising Power Consumption ~0.01x to 0.5x of reference (depending on use case)
Page 22: Definition Of Symbols
Definition of Symbols Polyethylene terephthalate FCC icon Manufacturer - window only WEEE icon Date of Manufacture Radio emission Consult Instructions Serial Number Bluetooth For Use Type-BF applied part Lot/batch Number Disposable Catalog Number Non Sterile Temperature Limitation Atmospheric Pressure Humidity Limitation MR Unsafe Limation...
Page 23 Emergo Europe B.V. Prinessegracht 20 2514 AP The Hague, The Netherlands 2797 LBL 75-01-78 Rev AA...
Page 24 THANK YOU Manufactured by VivaLNK, Inc. 51 East Campbell Avenue, Suite #160 Campbell CA, 95008 USA (408) 868-2898...