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Summary of Contents for Sparrow Link 910
- Page 1 Sparrow Link ® Instructions for Use (tAN : Transcutaneous Auricular Neurostimulation) ®...
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Page 2: Table Of Contents
Table of Contents INDICATION FOR USE & Device Description Sparrow Link Pulse Generator – Model 910 Menu Options Stimulation Status Pulse Generator Output Therapy Timer Bluetooth Connectivity Device Information Sparrow Ascent Earpiece—Model 210 / 211 Sparrow Ascent Cable – Model 810... - Page 3 If you have any other questions or concerns, please contact Spark Biomedical, Inc at (844) 654-SPRK (7775). For more detailed instructions, visit Sparrow Link resources at sparkbiomedical.com/research/sparrow-link S P A R R O W L I N K : I N S T R U C T I O N S F O R U S E...
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Page 4: Indication For Use & Device Description
App, Sparrow Link Hub, and Sparrow Link Application Programming Interface (API) Researchers may customize the Sparrow Link Pulse Generator's device settings and stimulation output parameters by using the Sparrow Link Mobile Application or Sparrow Link Hub with the Sparrow Link API developed by Spark Biomedical, Inc... -
Page 5: Sparrow Link Pulse Generator - Model 910
The Sparrow Link Pulse Generator is a hand-held, battery-powered, bi-phasic pulse generator designed to be carried while receiving tAN® therapy The Sparrow Link Pulse Generator is compatible with Sparrow Ascent components and accessories The Pulse Generator delivers adjustable stimulation to the Sparrow Ascent Earpiece via the Sparrow Ascent Cable The Pulse Generator has a physical user interface comprising a 6-button keypad with a 1 5”... -
Page 6: Menu Options
Menu Options The Pulse Generator has a menu bar located at the bottom of the screen Use the menu bar to navigate Pulse Generator features Inner Use the directional buttons to place the cursor over an icon in the menu bar The cursor selection will appear highlighted Select the highlighted screen Outer option by pressing the OK button on the Pulse Generator controls There are... -
Page 7: Stimulation Status
Stimulation Status The stimulation status screen allows the user to turn stimulation ON / OFF or adjust stimulation strength BAT TE RY LIFE NOTIFICATIONS Change batteries when the battery ERR – A minor system error icon turns red is detected Check the Cable connection and press firmly against the Earpiece at the Electrodes to ensure full contact... -
Page 8: Pulse Generator Output
The Pulse Generator has default settings consistent with the therapeutic settings on the FDA-cleared Sparrow Ascent Patient Controller Using the Sparrow Link Mobile App or Sparrow Link Hub with API, you can modify the parameters of the biphasic waveform output by the Pulse Generator for the Inner and Outer channels See Table 1.0 below for the list of default settings and ranges of waveform modifications. - Page 9 Link Mobile App will have the following frequencies available to select and attempts to set the following frequencies using the Sparrow Link Hub and API will return true The Sparrow Link platform will support the combinations with nominal output listed below in Table 1.2 Table 1.2: Sparrow Link Pulse Generator...
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Page 10: Therapy Timer
Therapy Timer The therapy timer is an optional feature that controls the amount of time stimulation is delivered When the timer is used, stimulation will remain ON for the timer duration set by the user OR until the user stops stimulation for both Inner and Outer Electrodes S E T TIM E R DU R ATION Enable Adjustments –... -
Page 11: Bluetooth Connectivity
Sparrow Link Hub via Bluetooth Low Energy (BLE) to receive custom modifications to the default stimulation settings. SN:123456 Complete the following steps to pair the Sparrow Link Pulse Generator to the Cancel Sparrow Link Mobile Application on an android tablet or mobile device Enable Bluetooth, WiFi, and location sharing on your tablet or mobile device... -
Page 12: Sparrow Ascent Earpiece-Model 210 / 211
Pulse Generator The Earpiece is a single-use disposable component of the Sparrow Link and is designed to stay adhered to the skin of the left or right ear for up to 24 hours of electrical connectivity The Inner Electrode interfaces... -
Page 13: Sparrow Ascent Cable - Model 810
Sparrow Ascent Cable – Model 810 The Sparrow Ascent Cable is 37 inches long and connects the Pulse Generator to the Earpiece The Cable length is designed to allow the user to carry the Pulse Generator in a pocket or worn in the Belt Clip (model... -
Page 14: Directions For Use
Directions for Use Get started with Sparrow Link in 3 easy steps: Inner Outer Step 1: Apply the Earpiece Prepare the skin, unpackage the Earpiece Apply the Earpiece in front of a mirror when applying to yourself Application of the Electrodes may be completed in any order It is recommended however that... - Page 15 Place the Earpiece on the ear with the Outer Electrode in front of the ear Next, remove the adhesive liner covering the Inner Electrode NOTE: Try not to touch the hydrogels/adhesive surface during the Earpiece application Insert the Inner Electrode into the hollow area of the ear, just above the ear canal. Press firmly to ensure the entire Inner Electrode is adhered to the skin Next, remove the adhesive liner covering the Outer Electrode. Press firmly to ensure the entire Outer Electrode is adhered to the skin Next, remove the adhesive liner covering the Back Electrode. Press firmly to ensure the entire Back...
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Page 16: Connect The Cable
Step 2: Connect the Cable Connect the Earpiece to the Cable, then connect the Cable to the Pulse Generator Press down fully on the grey Cable button and insert the end of the Earpiece into the Cable Connector until the wide part of the Earpiece end is flush against the connecter The Earpiece end should easily insert in the connector slot and... -
Page 17: Start Stimulation
Step 3: Start Stimulation Turn the stimulation ON/OFF and adjust the stimulation strength Inner Outer Power ON the Pulse Generator Press and hold the power button until the Spark logo appears on screen Toggle Stimulation ON Once the Stimulation Status screen is displayed, use the directional buttons to highlight the Inner or Outer toggle bars Press OK while the toggle bar is highlighted to turn ON or OFF stimulation output... -
Page 18: General Warnings And Cautions
Do not use Sparrow Link or Sparrow Ascent components in an explosive atmosphere or in the presence of flammable gas mixtures. • Do not apply the Sparrow Ascent Earpiece model 210 / 211 on/near the thorax as it may increase the risk of fibrillation. • Do not apply/use the Sparrow Ascent Earpiece model 210 / 211 in the presence of a wound,... -
Page 19: Cautions
• Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Sparrow Link Pulse Generator model 910, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result Cautions •... -
Page 20: User Safety
• Do not use the device in unintended areas • Do not use other devices in/on the ear at the same time as Sparrow Link Note • Electromagnetic interference—This device conforms to ANSI/AAMI/EN/IEC 60601-1-2:2014 •... -
Page 21: Troubleshooting
Troubleshooting Problem Cause Solution Comments Alert Message The battery life is Power OFF the Pulse See Changing Batteries in insufficient to continue Generator and replace the Maintenance section “Low Battery! Replace to therapy the batteries with 3 new for more information resume therapy ” AAA batteries Power ON the Pulse Generator and resume therapy... - Page 22 Problem Cause Solution Comments I changed the batteries The batteries inserted are Verify that the three AAA and now the Pulse depleted or not inserted batteries are inserted as Generator will not turn ON correctly indicated in the battery or shows low battery level. compartment Be sure to use new AAA batteries Skin irritation around...
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Page 23: Maintenance, Cleaning, And Disposal
Figure 6: Battery Orientation needed and should be sanitized between each user Do not use corrosive substances such as bleach to clean any part of Sparrow Link Do not use the Pulse Generator or Cable if the devices appear damaged... -
Page 24: Factory Reset
Ensure the Cable connector and Cable wire are fully dry before reconnecting components and powering ON the Pulse Generator NOTE: Follow your internal guidelines for sanitizing the Pulse Generator and Cable before each user Sparrow Link is non-sterile Do not attempt to sterilize any portion of Sparrow Link or Sparrow Ascent components Factory Reset... -
Page 25: Product Handling
Do not store the device in places where it could be subjected to vibrations or sudden impacts Service Life The service life of Sparrow Link is 3 years See the Sparrow Ascent Instructions for Use for the service life of Sparrow Ascent components and accessories... -
Page 26: Technical Details
Technical Details Sparrow Link Pulse Generator Specifications Specification Description Dimensions (H X W X D) 111mm x 66mm x 24mm (HxWxD) Weight 111 4g including battery Disposal According to WEEE: Directive 2012/19/EU - Device, accessories, and packaging waste must be... -
Page 27: Stimulation Outputs
Transmitter effective radiated power will not exceed 0 dBm BLE Use The Sparrow Link Pulse Generator offers wireless configuration using Bluetooth Low Energy (BLE). This interface, when used with the Sparrow Link Mobile App or Sparrow Link Hub, can export Sparrow Link Pulse Generator history, erase history, reset to default factory settings and configure custom stimulation parameters and Pulse Generator settings See the Sparrow Link Mobile Applicaiton Instructions for Use... -
Page 28: Emc Declarations
Emission test Compliance Electromagnetic environment - guidance RF emissions CISPR 11 Group 1 The Sparrow Link Pulse Generator is suitable for use in commercial, hospital, and typical home use environments RF emissions CISPR 11 Class B Harmonic emissions IEC Class B... - Page 29 AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which Sparrow Link is used exceeds the applicable RF compliance level above, then Sparrow Link should be observed to verify normal operation If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating Sparrow Link b Over the frequency range 150 k Hz to 80 M Hz, field strengths should be less than 3 V/m.
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Page 30: Recommended Separation Distances
Refer to the following table for recommended separation distances between the Sparrow Link and portable and mobile RF communication equipment Sparrow Link is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The user of Sparrow Link can help prevent electromagnetic interference by maintaining... -
Page 31: System Information
System Information Symbols and Nomenclature Description Device Model Number and Name Disposal Manufacture Date Caution Manufacturer Warning Serial # Applied Part FCC Symbol and ID Note Expiration Date Single-Use Follow Instructions for Use Keep Dry Lot # IP Rating Storage Temperature Contact Information Customer Success: Manufacturer:... - Page 32 Spark Biomedical, Inc., 18208 Preston Road, Ste D9-531, Dallas, TX 75252, USA Version: LBL-072 Rev 0 www.sparkbiomedical.com | (844) 654-SPRK (7775)
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