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Summary of Contents for Sparrow ASCENT
- Page 1 Sparrow Ascent ® 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 Ascent Patient Controller – Model 110 Menu Options Stimulation Status Therapy Timer Bluetooth Connectivity Device Information Sparrow Ascent Earpiece—Model 210 / 211 Sparrow Ascent Cable – Model 810 Directions for Use... - Page 3 Biomedical, Inc at (844) 654-SPRK (7775). For more detailed instructions, see Sparrow Ascent training videos at SparrowRx com/Resources S P A R R O W A S C E N T : 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
The disposable Earpiece should be changed daily and the AAA batteries powering the device should be replaced as needed, based on power consumption The Sparrow Ascent is provided non-sterile and should not be sterilized before use, however routine sanitation of the Patient Controller... -
Page 5: Sparrow Ascent Patient Controller - Model 110
The Sparrow Ascent Patient Controller is a hand-held, battery-powered device designed to be carried with the patient during therapy Patients can safely use the Sparrow Ascent in the comfort of their own home and during most daily activities The Patient Controller delivers stimulation to the Sparrow Ascent Earpiece via a removable Cable The Patient Controller is powered by three standard Alkaline AAA batteries The Patient Controller has a physical user interface comprised of a 6-button keypad with a 1 5”... -
Page 6: Menu Options
Menu Options The Patient Controller has a menu bar located at the bottom of the screen Use the menu bar to navigate Patient Controller 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 Patient Controller There are 4... -
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: 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 9: Bluetooth Connectivity
Bluetooth Connectivity Bluetooth capability is currently intended to support system diagnostics performed by the Clinician or manufacturer Turn on Bluetooth? Cancel Select ‘Cancel’ to exit back to the stimulation screen Device Information The Device Information screen displays Patient Controller specifications. Use this screen to view Patient Controller serial number, manufacturing date, and firmware version. -
Page 10: Sparrow Ascent Earpiece-Model 210 / 211
Patient Controller The Earpiece is a disposable component of the Sparrow Ascent 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 with... -
Page 11: Sparrow Ascent Cable - Model 810
Sparrow Ascent Cable – Model 810 The Sparrow Ascent Cable is 37 inches long and connects the Patient Controller to the Earpiece The Cable length is designed to allow the user to carry the Patient Controller in a pocket or worn in the Belt Clip... -
Page 12: Directions For Use
Directions for Use Get started with Sparrow Ascent 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 13 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.
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Page 14: Connect The Cable
Step 2: Connect the Cable Connect the Earpiece to the Cable, then connect the Cable to the Patient Controller 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 15: Start Stimulation
Step 3: Start Stimulation Turn the stimulation ON/OFF and adjust the stimulation strength Inner Outer Power ON the Patient Controller 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 16: General Warnings And Cautions
Do not use the Sparrow Ascent in an explosive atmosphere or in the presence of flammable gas mixtures • Do not apply the Sparrow Earpiece model 210 / 211 on/near the thorax as it may increase the risk of fibrillation. •... -
Page 17: Cautions
Do not use other transcutaneous (e g , TENS) or implanted neurostimulators while using the Sparrow Ascent • Do not use the Sparrow Ascent if any of the components are cracked, dented, or appear to be damaged • Do not use the Sparrow Ascent Earpiece model 210 / 211 if it has passed its expiration date indicated on the Earpiece Pouch •... -
Page 18: Patient Safety
• Do not use the device in unintended areas • Do not use other devices in/on the ear at the same time as Sparrow Ascent Note • Electromagnetic interference—This device conforms to ANSI/AAMI/EN/IEC 60601-1-2:2014 •... -
Page 19: Troubleshooting
Troubleshooting Problem Cause Solution Comments Alert Message The battery life is Power OFF the Patient See Changing Batteries in insufficient to continue Controller and replace the Maintenance section “Low Battery! Replace to therapy the batteries with 3 new for more information resume therapy ”... - Page 20 If you have any other questions or concerns, please contact Spark Biomedical, Inc at (844) 654-SPRK (7775) For more detailed instructions, see Sparrow Ascent training videos at www.SparrowRX.com/Resources S P A R R O W A S C E N T : I N S T R U C T I O N S F O R U S E...
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Page 21: Maintenance, Cleaning, And Disposal
Figure 5: Battery Orientation needed and should be sanitized by the Clinician between each user Do not use corrosive substances such as bleach to clean any part of Sparrow Ascent Do not use the Patient Controller or Cable if the devices appear damaged... -
Page 22: Factory Reset
ON the Patient Controller NOTE: Follow your internal guidelines for sanitizing the Patient Controller and Cable before each user The Sparrow Ascent is non-sterile Do not attempt to sterilize any portion of the Sparrow Ascent Factory Reset A factory reset should be performed on the Patient Controller only at the recommendation of the... -
Page 23: Product Handling
100 µs between phases The waveform of the system pulse is biphasic Storage/Transport Conditions • Make sure the device is turned OFF before storing Remove the 3 AAA batteries from the Sparrow Ascent Patient Controller for long term storage •... -
Page 24: Technical Details
Technical Details Sparrow Patient Controller Device 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 25: Stimulation Outputs
Transmitter effective radiated power will not exceed 0 dBm BLE Use The Sparrow Ascent Patient Controller Device offers wireless diagnostic using Bluetooth Low Energy (BLE) from a mobile device This interface, when used with an internal diagnostic tool, can export... -
Page 26: Electronic Immunity
3 Vrmsc3 V/mc Portable and mobile RF communications equipment Radiated RF IEC 6100-4-3 80M Hz3 V/m80 should be used no closer to any part of the Sparrow M Hz Patient Controller Device, including cables, than 2 7 G Hz the recommended separation distance calculated... -
Page 27: Recommended Separation Distances
RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Sparrow Ascent is used exceeds the applicable RF compliance level above, then the Sparrow Ascent should be observed to verify normal operation If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Sparrow Ascent b Over the frequency range 150 k Hz to 80 M Hz, field strengths should be less than 3 V/m. -
Page 28: System Information
System Information Symbols and Nomenclature Description Device Model Number and Name Storage Temperature Manufacture Date Disposal Manufacturer Caution Serial # Warning FCC Symbol and ID Applied Part Prescription Only Note Expiration Date Single-Use Follow Instructions for Use Keep Dry Lot # IP Rating Contact Information Customer Success:... - Page 29 Spark Biomedical, Inc., 18208 Preston Road, Ste D9-531, Dallas, TX 75252, USA Version: LBL-048 Rev 5 www.sparkbiomedical.com | (844) 654-SPRK (7775)
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