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
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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