Innovia EarCheck User manual

Use & Care
Manual
IMPORTANT: Read this manual
completely before using the
EarCheck®Middle Ear Monitor.
Save these instructions.
For answers to questions about
use or service, call our Customer
Care department toll free at:
1-888-EAR-CHEK
(1-888-327-2435)
or visit www.earcheck.com

EarCheck Use & Care Manual 2
TABLE OF CONTENTS
THANK YOU FOR PURCHASING EARCHECK MIDDLE EAR MONITOR ............ 3
IMPORTANT SAFETY INFORMATION .......................................................... 4
EAR INFECTIONS AND YOUR CHILD .....................................................5 - 6
WHEN TO USE EARCHECK MIDDLE EAR MONITOR .................................... 7
MONITORING YOUR CHILD’S EAR HEALTH ............................................ 7
GETTING TO KNOW YOUR EARCHECK MIDDLE EAR MONITOR ................... 8
USING YOUR EARCHECK MIDDLE EAR MONITOR ................................9 - 12
READING RESULTS ................................................................................. 13
INTERPRETING EARCHECK LEVELS ..................................................13 - 14
REPLACING BATTERIES .......................................................................... 15
CARE, CLEANING AND STORAGE .....................................................16 - 17
HELPFUL HINTS ..................................................................................... 18
TROUBLESHOOTING ........................................................................19 - 20
TECHNICAL SPECIFICATIONS .................................................................. 21
GUARANTEE .......................................................................................... 22
Middle Ear Monitor

3 EarCheck Use & Care Manual
Thank You for Purchasing EarCheck Middle Ear Monitor,
one of the most thoroughly tested and independently evaluated consumer
medical products available. To date, EarCheck has been used by more than
5,000 medical professionals and 70,000 parents.
Though EarCheck Middle Ear Monitor is for home use, it is based on acoustic
reflectometry (sound waves), the same patented and proven technology used
in doctor’s offices since 1997. Acoustic reflectometry technology is included
in the American Academy of Pediatrics’ and American Academy of Family
Physicians’ Clinical Practice Guideline for the Diagnosis and Management of
Acute Otitis Media (middle ear infection).1
1Source: American Academy of Pediatrics Subcommittee on Management of Acute Otitis Media.
Clinical Practice Guideline for Diagnosis and Management of Acute Otitis Media. Pediatrics.
2004;113(5):1451-1465. The EarCheck Pro®model used by physicians. The AAP/AAFP have not
specifically recommended the EarCheck Middle Ear Monitor.
Please read this entire Use & Care Manual prior to using your EarCheck
and keep it in a safe place for future reference.
For more information, please visit our website at www.earcheck.com or
call our Customer Care Team at 1-888-Ear-Chek (327-2435).
Innovia Medical, LLC
Customer Care
1-888-EAR-CHEK • 1-888-327-2435
This manual includes specific information as to your rights and obligations
under the guarantee offered by the Manufacturer.
EarCheck and EarCheck logo are trademarks of Innovia Medical, LLC
© Innovia Medical 1997, 1998, 2008. All rights reserved.
Middle Ear Monitor

EarCheck Use & Care Manual 4
IMPORTANT SAFEGUARDS
When using electrical products, especially when children are present, basic
safety precautions should always be followed, including the following:
READ ALL INSTRUCTIONS BEFORE USE
SAVE THESE INSTRUCTIONS
DANGER – To reduce the risk of electrocution:
➊Do not use while bathing.
➋Do not place or store product where it can fall or be pulled into
a bathtub or sink.
➌Do not place in or drop into water or other liquids.
WARNING – To reduce the risk of burns, electrocution, fire or injury to persons:
➊Close supervision is necessary when this product is used by,
on or near children or invalids.
➋Use this product only for its intended use as described in this
Use & Care Manual. Do not use attachments not recommended by
the manufacturer.
➌Do not use EarCheck Middle Ear Monitor as a substitute for consulting
your doctor if your child needs medical attention or treatment.
➍Batteries can corrode and leak toxic liquid. Do not allow contact with
skin or get into eyes. Discard device appropriately.
➎There are NO User Serviceable Parts. Do not attempt to take device
apart or repair.Contact Customer Care at 1-888-EAR-CHEK (1-888-327-2435).
CAUTION – The EarCheck Middle Ear Monitor should NOT be used
for the following children:
• Children under 6 months of age
• Children with ear tubes (ventilation tubes)
• Children with water in the outer ear, such as those
with swimmer’s ear
• Children with known perforation or rupture of the eardrum
• Children with excessive cerumen (wax) blockage
• Children with facial or ear deformities
• Children with visible drainage of pus or blood in the outer ear canal
IMPORTANT SAFETY INFORMATION

5 EarCheck Use & Care Manual
The Ear
A healthy middle ear allows sound waves to easily enter the canal, causing
the eardrum to vibrate and the ear to clearly hear sounds. If the middle ear
becomes filled with fluid (called effusion), the eardrum’s vibrations can
be restricted and may result in temporary hearing loss (called conductive
hearing loss).
Ear Infections
Young children are more likely to have middle ear fluid and develop ear
infections. This is because their Eustachian tubes (the tubes that connect the
ear to the back of the nose and help drain and control fluids in the middle
ear) are shorter, narrower and more horizontal than adults’. As a result,
infected fluids from the nose and throat may reach the middle ear more
easily. When the middle ear becomes inflamed and infected the condition is
called a middle ear infection or acute otitis media.
Common Signs of Ear Infections
The signs of a middle ear infection can range from mild to severe,
but often include:
• Fluid in the middle ear
• Runny/stuffy nose or cough
• Irritability
• Pulling or rubbing the ear (indicating ear pain)
• Decrease in appetite
• Fever
It is important to note that fluid may be present in the middle ear without
an active infection; this is called otitis media with effusion and is often
associated with an oncoming ear infection or recovery from one.
Middle Ear Monitor
Ear Infections and Your Child

EarCheck Use & Care Manual 6
Treatments
Parents of children who have signs of an ear infection should consult their
child’s physician, who may prescribe antibiotics. Additionally, the option of
observation or “watchful waiting” (for 48-72 hours) may be considered for a
child who has mild-to-moderate signs and/or an uncertain diagnosis and is
older than 2 years of age.2
2 Bluestone CD, Klein JO. Otitis Media in Infants and Children, Fourth Edition. 2007:
BC Decker, Inc. Hamilton.
Why Monitor Fluid in the Ear at Home
Home monitoring of middle ear fluid is important because common signs
of an ear infection—like pain, fever or irritability—can also be signs of other
ailments, especially in younger children. Knowing the likelihood of fluid in a
child’s middle ear can help parents and physicians determine whether or not
the child might have an ear infection. Plus, it can be useful after treatment to
help determine if the fluid is going away or gone.
Impact on Hearing
In some children, the fluid in the middle ear may create a sensation of ear
fullness or popping. In addition, the fluid behind the eardrum can block
sound, so temporary hearing loss can happen, but may not be obvious.3
3 Source: Kids Health. Middle Ear Infections. www.kidshealth.org. Accessed August 1, 2007.
Your doctor is the best source of information about your child’s health. At any time if
you have a question or concern about your child’s health, contact your doctor.
Middle Ear Monitor
Ear Infections and Your Child - Continued

7 EarCheck Use & Care Manual
EarCheck is recommended for use on children 6 months to young adult.
Use EarCheck Middle Ear Monitor if your child:
• Shows signs of an ear infection
• Is being treated for an ear infection
• Has a cold
• Suffers from frequent ear infections
NOTE: EarCheck Monitor should NOT be used on children under 6 months of
age, or on those who have ear tubes (ventilation tubes), water in the outer
ear (swimmer’s ear), known perforation or rupture of the eardrum, excessive
cerumen (wax) blockage, facial/ear deformities or visible drainage of pus or
blood in the outer ear canal.
If your child is already being treated for an ear infection, you can continue
to use your EarCheck to monitor your child’s ear health. If middle ear fluid
is still present after a reasonable amount of time or if other signs of illness
get worse, consult your doctor.
Middle ear fluid can fluctuate. A well child may have occasional high Level
readings that do not last which may be due to a temporary blockage of the
Eustachian tube. If a seemingly well child has occasional readings in Levels
3-5, continue to monitor daily to determine if the condition is temporary.
If the child is sick, consult your doctor. If a child with known middle ear fluid
has an occasional low reading, the child may have temporarily cleared the
middle ear fluid by sneezing, blowing the nose, etc. Higher Level readings
may return until the condition clears.
Your doctor is the best source of information about your child’s health. At any time if
you have a question or concern about your child’s health, contact your doctor.
When to Use EarCheck Middle Ear Monitor
Monitoring Your Child’s Ear Health
Middle Ear Monitor

EarCheck Use & Care Manual 8
Your EarCheck package contains the following:
• EarCheck Middle Ear Monitor
• Verification Tube
• 2 AA Alkaline Batteries
• Use & Care Manual
•Quick Reference Guide
Getting to Know Your EarCheck Middle Ear Monitor
SCAN Button
Battery Door
➞
➞
➞
Display Panel:
Level Indicators
Low Battery Indicator
Error Indicator
Retry Indicator
Middle Ear Monitor
Verification Tube

9 EarCheck Use & Care Manual
Step 1 - Install Batteries
Before using the Monitor, install the two
(2) AA Alkaline batteries that are included
in your package. To install the batteries,
use the tip of a ballpoint pen and press the
battery cover lock while pressing the top of
the cover with your thumb and forefinger
(see Figure A).Once the cover releases,slide
it down. Install the batteries making sure that
they are positioned as indicated inside the
battery compartment (see Figure B). Slide
the top lip of the cover into place. Press the
lower edge of the cover down and slide up
until it snaps into place (see Figure C).
Middle Ear Monitor
Using Your EarCheck Middle Ear Monitor
Figure A
Figure C
Figure B

EarCheck Use & Care Manual 10
Step 2 - Test Monitor for Use
To test to make certain the Monitor is
functioning properly, insert the EarCheck
Monitor tip into the Verification Tube then
press the SCAN button. The Monitor will
sound a short series of beeps while each
Level indicator flashes in sequence. When
the Red Level 5 indicator light remains on
the display, the Monitor is ready for use.
If Red Level 5 is not displayed, take a second
reading. If Red Level 5 is still not displayed, or the ERROR symbol appears,
refer to the Troubleshooting section (pg. 19).
CAUTION: EarCheck uses sound waves to detect middle ear fluid and should
be used in a quiet area. Excessive noise may prevent the Monitor from
obtaining a reading and cause the RETRY Symbol to be displayed.
WARNING: To prevent possible choking hazard, keep the Verification Tube away
from young children.
Step 3 - Stabilize the Child
Make sure the child is sitting in an upright position – sitting (on your lap
if necessary) or standing.
NOTE: Do not lay the child down as this may affect accuracy.
Step 4 - Hold the Ear Up and Back
Holding the ear up and back straightens
the natural curve of the ear canal and allows
the Monitor to send sound waves straight
down the ear canal. Continue to hold the
ear in this position while the Monitor scans
the ear for fluid. If the RETRY Symbol
appears, try holding the ear straight back
or straight back and down.
Middle Ear Monitor
Using Your EarCheck Middle Ear Monitor - Continued
Step 2
Step 4

11 EarCheck Use & Care Manual
Step 5 - Insert the EarCheck Tip
Carefully insert the Monitor’s tip into the
child’s ear canal until the canal is fully
covered, making certain the tip points
directly down the canal opening.
NOTE: The EarCheck tip is designed for safety,
preventing it from being inserted too far into
the ear. However, remove the EarCheck tip
from the child’s ear at any indication or sign
of discomfort.
Step 6 - Press the SCAN Button
Continue to hold the ear up and back
with the EarCheck Monitor tip in the ear.
Press the SCAN button once; EarCheck
will make a soft chirping sound as the
Level indicators light up in a sequence.
You will hear a series of short tones
followed by one long tone alerting you
that the SCAN is complete. Level results
will be indicated on the display panel.
NOTE: It may be helpful to slowly move the
EarCheck tip in a small circular motion. If the
child’s ear were a clock, rotate the Monitor from
4 to 8 o’clock.
CAUTION: Excessive noise, such as a crying child or background sounds from a TV or radio,
may affect the performance of EarCheck. If this occurs, move to a quiet area and re-check.
Middle Ear Monitor
Using Your EarCheck Middle Ear Monitor - Continued
Step 6
Step 5

EarCheck Use & Care Manual 12
Step 7 - Read Results of SCAN
Remove EarCheck tip from ear and
read results. Results will display for
approximately 5 seconds after SCAN
is complete.
NOTE: Do NOT remove the EarCheck tip from the
ear without first hearing the long tone or you may
get an incorrect reading.
RETRY Symbol
Due to variances in usage, as you are familiarizing yourself with the EarCheck
Monitor, you may occasionally receive the RETRY Symbol . If this occurs,
repeat Steps 3 to 6 as listed above. If you continue to receive the RETRY
Symbol , refer to the Troubleshooting section (pg. 19).
IMPORTANT: If, after following the above steps, the RETRY Symbol
continues to appear on the display, try taking a reading on both ears. If you
obtain a reading on one ear but the RETRY Symbol appears on the other,
consult your doctor. An ear condition that EarCheck cannot measure may
exist. (See list of conditions that EarCheck should not be used for on pg. 7.)
Using Your EarCheck Middle Ear Monitor - Continued
Step 7
Middle Ear Monitor

13 EarCheck Use & Care Manual
Compare the Level indicated on your EarCheck Monitor display panel with the
chart below:
LEVEL COLOR PROBABILITY OF
MIDDLE EAR FLUID
5Red – Consult Doctor High
4Red – Consult Doctor Moderate to high
3Red – Consult Doctor Moderate
2Yellow – Monitor Low to moderate
1Green – Fluid Unlikely Low
LEVEL COLOR COURSE OF ACTION
RED (LEVELS 3-5) THIS RESULT MAY APPEAR WITH:
A sick child (a child with pain,
fever or other signs of illness) with
an untreated ear infection.
OR
CONSULT DOCTOR.
A sick child who has been treated
for an ear infection, but is not
responding to antibiotics within a
reasonable amount of time.
CONSULT DOCTOR.
A sick child who appears to be
getting better.
CONTINUE MONITORING
DAILY. If reading Level
does not continue to
decrease within a
reasonable amount of
time, consult doctor.
Middle Ear Monitor
Reading Results
Interpreting EarCheck Levels

EarCheck Use & Care Manual 14
LEVEL COLOR COURSE OF ACTION
YELLOW (LEVEL 2) THIS RESULT MAY APPEAR WITH:
A sick child whose signs of illness
may warrant medical attention.
MONITOR.
CONSULT DOCTOR if
Level does not decrease
within a reasonable
amount of time.
A sick child who appears to be
getting better.
OR
A well child. (Note: Some well
children will always have Level 2
as a normal reading.)
CONTINUE
MONITORING DAILY.
If reading Level does not
continue to decrease
within a reasonable
amount of time,
consult doctor.
GREEN (LEVEL 1) THIS RESULT MAY APPEAR WITH:
A well child.
A sick child who does not have
middle ear fluid.
NO ACTION REQUIRED.
CONSULT DOCTOR if
signs of illness warrant
a medical opinion.
NOTE: Fluid may remain in the middle ear for several weeks after an ear
infection has cleared. If it does, consult with your doctor.
IMPORTANT: Make sure to inform your doctor of any other signs and/or
symptoms of illness the child may have, such as fever, pain, pulling or
rubbing the ear, etc. Your doctor is the best source of information about
your child’s health. At any time if you have a question or concern about your
child’s health, contact your doctor.
Middle Ear Monitor
Interpreting EarCheck Levels - Continued

15 EarCheck Use & Care Manual
EarCheck Middle Ear Monitor operates
using two (2) AA Alkaline batteries. Replace
batteries when the LOW BATTERY symbol
appears. Low batteries or defective
batteries can result in a false or inaccurate
reading.
To replace batteries, use the tip of a ballpoint
pen and press the battery cover lock while
pressing the top of the cover with your
thumb and forefinger (see Figure A). Once
the cover releases, slide it down and off to
remove batteries. Dispose of used batteries
in the appropriate manner.
Replace with new batteries making sure that
they are positioned as indicated inside the
battery compartment (see Figure B). Slide the
top lip of the cover into place. Press the lower
edge of the cover down and slide up until it
snaps into place (see Figure C).
After replacing batteries, test with
verification tube to make sure EarCheck
is working properly.
Middle Ear Monitor
Replacing Batteries
Figure A
Figure C
Figure B

EarCheck Use & Care Manual 16
Caring for Your EarCheck Middle Ear Monitor
Your EarCheck is simple to use and easy to maintain. However, it must
be handled carefully to remain in good operating condition. Follow these
instructions at all times:
➊Do not drop your EarCheck Monitor. Damage to the Monitor’s
electronics may result.
➋Never let your EarCheck get wet. It could become permanently
damaged if water or other liquids get inside.
➌ Do not use cleaning solvents (with the exception of rubbing alcohol to
sterilize the tip) as they may damage the Monitor. For EarCheck
Monitor cleaning instructions, see pg. 17.
➍Do not introduce foreign objects into your EarCheck tip’s opening.
This can damage sensitive parts.
➎Do not take your EarCheck apart, as this will invalidate the Monitor’s
guarantee. Contact Customer Care at 1-888-EAR-CHEK (1-888-327-2435).
➏Do not expose your EarCheck to direct sunlight, temperature or
humidity extremes, moisture or dust.
➐Always replace batteries when LOW BATTERY symbol appears.
Low batteries or defective batteries can result in a false or
inaccurate reading.
Middle Ear Monitor
Care, Cleaning and Storage

17 EarCheck Use & Care Manual
Cleaning Your EarCheck Middle Ear Monitor
To operate properly and to help prevent cross-contamination, it is important
that you keep the EarCheck tip clean. After each use, gently wipe the surface
of the tip with a cotton swab or lint-free, soft cloth moistened with
rubbing alcohol. Allow the alcohol to completely dry prior to using your
EarCheck Monitor. Do not allow alcohol or any objects to get inside the tip
as they may damage the sensitive electronics inside your EarCheck Monitor.
Storing Your EarCheck Middle Ear Monitor
Store your EarCheck Monitor in a dry place away from dust, contamination
and liquids. Store it at room temperature (50ºF - 95ºF). Do not expose your
EarCheck Monitor to extreme temperatures or humidity. For example, do
not store in a car. If your EarCheck Monitor has not been stored at room
temperature, keep it at room temperature at least 60 minutes before using it.
Care, Cleaning and Storage - Continued
Middle Ear Monitor

EarCheck Use & Care Manual 18
While monitoring with EarCheck Middle Ear Monitor, you may occasionally
receive an ERROR symbol . If an ERROR symbol persists, refer to the
Troubleshooting section (pg. 19) of the Use & Care Manual. If you continue
to experience difficulty with EarCheck, please call 1-888-EAR-CHEK
(1-888-327-2435) for product usage assistance and support.
• To familiarize yourself with proper technique, practice using EarCheck on
a well and cooperative child. Refer to the Using Your EarCheck Middle Ear
Monitor section (pg. 9) of this Manual for further information.
• Be sure to hold the child’s ear straight up and back. If you still do not
receive a reading, hold the ear straight back or straight back and down.
• Use EarCheck in a quiet area, eliminating all background noise, such
as TVs and radios. If the child is crying, try to calm him or her down before
taking a reading.
• It is not unusual for EarCheck to display different results for the left and
right ears. This may be an indication that one ear has more fluid present
than the other.
• Middle ear fluid may develop or disappear rapidly or the child may have
a borderline condition; therefore, it is not uncommon to get different Level
readings from the same ear on the same day.
• EarCheck is designed to work properly if some earwax is present in the
canal. However, if the ear canal is blocked by wax, consult your doctor to
remove excess earwax.
For product assistance or more information, call 1-888-EAR-CHEK
(1-888-327-2435) or visit www.earcheck.com.
Middle Ear Monitor
Helpful Hints

19 EarCheck Use & Care Manual
Your EarCheck Middle Ear Monitor is designed for trouble-free use. Should
you encounter difficulty, consult the information below or call our Customer
Care department at 1-888-EAR-CHEK (1-888-327-2435).
PROBLEM POSSIBLE CAUSE ACTION
RETRY Symbol Ear position/hold is incorrect
or not held throughout the
entire testing process.
Try a variety of positions/
holds, holding the ear straight
up and back, down and
back or straight back.
EarCheck tip is not
properly placed over
ear canal (not completely
covering the outer ear
canal).
Make sure EarCheck
tip is over the ear
canal and aimed
straight down the
canal. Continue ear
hold while scanning
(see pg. 9-12).
EarCheck tip is not
aimed straight down
the canal.
Slowly re-aim device
down ear canal, while
continuing ear hold.
EarCheck tip is dirty. Clean EarCheck tip using
proper technique (see pg. 17).
Background noise is
too loud.
Find a quiet area and retry.
Child is crying. Calm child before using.
Ear canal is blocked
with earwax.
Do NOT attempt to remove
earwax. Consult your doctor.
Tip is removed from ear
prior to completing scan.
Take another reading.
Middle Ear Monitor
Troubleshooting

EarCheck Use & Care Manual 20
Your EarCheck Middle Ear Monitor is designed for trouble-free use. Should
you encounter difficulty, consult the information below or call our Customer
Care department at 1-888-EAR-CHEK (1-888-327-2435).
PROBLEM POSSIBLE CAUSE ACTION
Fails Verification Test Verification tube is
blocked.
Remove blockage.
The EarCheck tip is not
properly inserted in
Verification tube.
Insert your EarCheck
tip straight into the
Verification tube as
far as possible
(see pg. 10).
The EarCheck Monitor is
not at room temperature.
Bring EarCheck
Monitor to room
temperature. Wait 60
minutes before using.
ERROR Symbol*
Device malfunction. Test with Verification
tube. If test is successful,
retry. If unsuccessful, call
Customer Care
(1-888-327-2435).
LOW BATTERY Symbol Weak batteries. Replace batteries
(see pg. 15).
*IMPORTANT: If ERROR is still displayed after taking all of the above steps,
SCAN both ears. If the ERROR Symbol appears for one ear, but a Level
reading appears for the other, a condition that the EarCheck Monitor cannot
measure may exist.
Middle Ear Monitor
Troubleshooting - Continued