How to Use the WavelyDx Middle Ear Fluid Scanner

Start with this overview video:

Then install the WavelyDx iPhone App

Some Important Tips:

  • We want you to have confidence that when you get an “Unlikely” it’s because the chirp played properly into your child’s ear and they are highly unlikely to have an ear infection; you’ll get false “Likelies” if you play chirps into open air or into adult ears

  • The ear tip should be placed against the outside of the ear canal, it doesn’t go inside the ear, and you have to follow the instructions in the app to point the tip towards the child’s nose

If you prefer reading instructions:

Part 1: Install the Ear Tip

Remove phone case and disconnect headphones

With Ear Tip flat, fold along crease 1

Remove liner 2

Fold in half along crease 3 and press closed firmly

"Pop" open with logo towards you and tip rounded

Peel liner off tabs

Align with screen graphic and attach tabs tightly to tip back and press firmly

Part 2: Check and Calibrate Phone

To check ear tip position, tap "Run open air check," hold phone in the air, wait for chirps

To calibrate phone, tap "Run finger check," cover Ear Tip end securely with finger, wait for chirps

Part 3: Conduct a Scan

Select ear to scan then press blue button and place tip in ear angled towards front of face

With child upright hold steady and snugly during chirps; repeat on other ear

Throw away used Ear Tip

Intended Use

The WavelyDx App turns your smartphone into an acoustic reflectometer, which uses sound waves to accurately detect the presence of middle ear fluid that may be associated with acute ear infection.
The Wavely app is intended to help parents determine when to seek medical attention and also to help healthcare practitioners detect middle ear fluid as part of an in-person or virtual examination.
It is designed for use by parents, caregivers and clinicians on children older than 6 months.

Warnings

  • Close supervision is necessary when this product is used by, on or near children.

  • Use this product only for its intended use as described in these Instructions for Use.

  • Only use ear tips provided by themanufacturer.

  • Consult a doctor if you are worried about your child’s symptoms.

Cautions

Do not use with:

  • Phones that have a low battery

  • Children under 6 months of age

  • Children with ear tubes (ventilation tubes)

  • Children with water in the outer ear, such as swimmer’s ear

  • Children with known perforation or rupture of the eardrum

  • Children with excessive cerumen (wax) blockage (some earwax will not impact the test)

  • Children with facial or ear deformities

  • Children with visible drainage of pus or blood in the outer ear canal

Symbol Legend

Catalog Number

Lot Number

Model Number

Expiry Date

Consult Instructions for Use

Do not use if package is damaged

Do not reuse

Non-sterile

Keep dry

Manufacturer

Need more help?

Visit http://www.wavelydx.com/help or contact us at support@wavelydx.com.


LBL-1477 Rev.4.0, March 2024

Wavely Diagnostics, Inc.
2319 N 45th Street #107
Seattle, WA 98103