Sparrow ASCENT Manuale utente

Sparrow®Ascent

Instructions for Use

(tAN®: Transcutaneous Auricular Neurostimulation)

Table of Contents

INDICATION FOR USE & Device Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Sparrow Ascent Patient Controller – Model 110 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Menu Options. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6

Stimulation Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7

Therapy Timer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Bluetooth Connectivity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Device Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9

Sparrow Ascent Earpiece—Model 210 / 211 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Sparrow Ascent Cable – Model 810 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Directions for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Step 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Apply the Earpiece. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Step 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Connect the Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Step 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Start Stimulation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Understanding Stimulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

General Warnings and Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

WARNINGS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

CAUTIONS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Patient Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

WARNINGS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

CAUTIONS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Maintenance, Cleaning, and Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Changing the Earpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Changing Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Factory Reset. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22

Product Handling. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Operating Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Storage/Transport Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Service Life . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

SPARROW ASCENT: INSTRUCTIONS FOR USE 2

Technical Details. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Sparrow Patient Controller Device Specications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Sparrow Earpiece Specications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Electrical Specications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Environmental Specications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Stimulation Outputs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Conguration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

BLE Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

EMC Declarations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Electromagnetic Emissions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Electronic Immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Recommended Separation Distances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

System Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Symbols and Nomenclature Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Contact Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Caution: Rx Only. US Federal Law restricts this device to

sale by or on the order of a licensed healthcare provider.

SPARROW ASCENT: INSTRUCTIONS FOR USE 3

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 SparrowRx.com/Resources

SPARROW ASCENT: INSTRUCTIONS FOR USE 4

Indication for Use & Device Description

The Sparrow Ascent is a wearable, battery-operated neurostimulation device intended to

transcutaneously stimulate nerves on and/or around the ear.

The Sparrow Ascent is intended for prescription

use only as an aid to the standard of care. The

patient undergoing therapeutic treatment should

be under the care of a clinical professional trained

in opioid reduction, detoxication, and/or recovery.

Sparrow Ascent is designed to be used up to 24

hours a day or as needed for relief of withdrawal

symptoms. 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

and Cable is recommended as needed.

The Sparrow Ascent is designed to be used only with the accessories described below:

Device Type Model Number

Patient Controller 110

Disposable Left Earpiece 210

Disposable Right Earpiece 211

Cable 810

AAA batteries N/A

Alcohol wipes N/A

Belt Clip 610

Indication for Use

The Sparrow Ascent is a transcutaneous nerve

eld stimulator that is intended to be used

in patients experiencing opioid withdrawal

in conjunction with standard symptomatic

medications and other therapies for opioid

withdrawal symptoms under the supervision of

trained clinical personnel.

SPARROW ASCENT: INSTRUCTIONS FOR USE 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” LCD screen

display. The Patient Controller allows users to:

The Patient Controller also indicates to the user:

• Alerts and notications

• Earpiece errors

• Cable disconnections

View Status Indicator

Insert Cable

Power ON / OFF

View Stimulation Status,

Battery Life, and Optional

Therapy Timer

Navigate the Menu and

Screen Options

Select or Enable/Disable

Settings and Start / Stop

Stimulation

Navigate the Screen Options

and Adjust the Stimulation

Strength

SPARROW ASCENT: INSTRUCTIONS FOR USE 6

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.

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

option by pressing the OK button on the Patient Controller. There are 4

screen options to which the user can navigate:

Stimulation status

Therapy timer

Bluetooth connectivity

Device information

Stimulation Status Therapy Timer Bluetooth Connectivity Device Information

Inner 10

Outer 10

01:15

Clear

01:15

Pause

Turn on

Bluetooth?

CancelOK

SN Xyyww0001

FW v2.0

YYMMDD

Inner 10

Outer 10

Menu Bar

Tip: Select the < or > icons to

view more screen options

SPARROW ASCENT: INSTRUCTIONS FOR USE 7

Stimulation Status

The stimulation status screen allows the user to turn stimulation ON / OFF or adjust stimulation strength.

Inner

ERR

Outer 10

BATTERY LIFE

Change batteries when the battery

icon turns red.

ADJUST STIMULATION

Enable Adjustments – First, use

the directional buttons to highlight

stimulation strength (0-50) for

the Inner or Outer Electrode.

Press OK to enable adjustments.

The strength will ash when

adjustments are enabled.

Increase / Decrease Stimulation

– Next, press the + and - buttons

to adjust the strength from 0-50.

Press OK to save your settings and

disable adjustments.

Stimulation Icon – Turns green

when stimulation is ON.

POWER BUTTON

Turn ON – Press and hold the

power button until the Spark Logo

appears on screen.

Turn OFF – Press and hold the

power button. When prompted,

select OK to turn the device OFF.

Wake / Unlock – Click the power

button to wake the Patient

Controller. Then press OK to

unlock.

Return to Sleep Mode – Click the

power button.

NOTIFICATIONS

ERR – A minor system error

is detected. Check the Cable

connection and press rmly

against the Earpiece at the

Electrodes to ensure full contact

with the ear. See Troubleshooting

section to resolve.

Top Light – The top LED will

periodically ash to indicate

stimulation status.

• Green: Stimulation is ON.

• Red: System error. Unlock

Patient Controller to view alert.

See Troubleshooting section to

resolve.

TURN ON / OFF

STIMULATION

Toggle Stim ON / OFF – Use the

directional buttons to highlight

a toggle bar. Press OK to ip the

toggle switch. Green toggle bar(s)

indicate stimulation is ON for

that Electrode. Grey toggle bar(s)

indicate stimulation is OFF for that

Electrode.

Ramping Stimulation – When

stimulation is toggled ON,

stimulation will slowly ramp

to the pre-set strength (0-50).

When stimulation is toggled OFF,

stimulation will ramp down in 3

seconds.

SPARROW ASCENT: INSTRUCTIONS FOR USE 8

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.

01:30

Clear

Start

HH:MM

SET TIMER DURATION

Enable Adjustments – Use the

directional buttons to highlight

the hours (HH) or minutes (MM).

Press OK to enable adjustments.

The selection will ash when

adjustments are enabled.

Increase / Decrease Duration –

Enable Adjustments then press the

+ and - buttons to adjust the hours

(0-24 Hrs.) or minutes (0, 5, 10, 15,

30, or 45 Min). Press OK to save

each setting.

Clear Timer Duration – To clear the

timer duration, navigate to the timer

screen and highlight the ‘Clear’

option and press OK.

TURN TIMER ON / OFF

Start Timer – Set a timer duration

from 5 minutes up to 24 hours.

Highlight the ‘Start’ option and

press OK to begin the timer. The

timer icon will turn orange while

a timer is activated and the time

remaining will appear in the upper

left corner.

Pause / Resume Timer – To

pause or resume the timer,

navigate to the timer screen and

highlight the ‘Pause’ or ‘Resume’

option and press OK. The timer

will automatically pause when

stimulation is turned OFF and

resume when stimulation is turned

ON up to 24 hours.

Timer Icon – Turns orange when

the timer is active.

!Time remaining displays in the

upper left corner when enabled.

!A pop up message will appear

on screen when your timer is

nished.

Timer

00:00

Ended

SPARROW ASCENT: INSTRUCTIONS FOR USE 9

Select ‘Cancel’ to exit back to the

stimulation screen.

Bluetooth Connectivity

Bluetooth capability is currently intended to support system diagnostics performed by the Clinician or

manufacturer.

Device Information

The Device Information screen displays Patient Controller specications. Use this screen to view Patient

Controller serial number, manufacturing date, and rmware version.

Turn on

Bluetooth?

CancelOK

SN Xyyww0001

FW v2.0

YYMMDD

Serial Number

Manufacturing Date

Firmware Version

SPARROW ASCENT: INSTRUCTIONS FOR USE 10

Sparrow Ascent Earpiece — Model 210 / 211

The Sparrow Ascent offers both Left and Right Earpieces. Most kits include Left Earpieces only. Right

Earpieces may be ordered separately. The Earpiece connects to the Cable to receive electrical inputs from

the 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

the cymba concha and the Outer Electrode interfaces with the trigeminal nerve. The Back Electrode is the

return Electrode for both the Inner and Outer Electrodes.

Inner Electrode

Earpiece End

Back Electrode

Outer Electrode

The Earpiece End can be

inserted into the Cable in

any direction.

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