Welch Allyn Ear Wash System Manual

Welch Allyn®Ear Wash
System
Directions for use

ii Welch Allyn Ear Wash System
© 2017 Welch Allyn. All rights are reserved. To support the
intended use of the product described in this publication, the
purchaser of the product is permitted to copy this publication, for
internal distribution only, from the media provided by Welch Allyn.
No other use, reproduction, or distribution of the publication, or
any part of it, is permitted without written permission from Welch
Allyn.
Welch Allyn assumes no responsibility for any injury to anyone, or for any
illegal or improper use of the product, that may result from failure to use
this product in accordance with the instructions, cautions, warnings, or
statement of intended use published in this manual.
Welch Allyn®is a registered trademark of Welch Allyn.
For patent information, please visit www.welchallyn.com/patents.
For information about any Welch Allyn product, contact Welch Allyn
Technical Support: www.welchallyn.com/about/company/locations.htm.
726920,
DIR 80022121 Ver. A
Revision date: 2017-05
Welch Allyn, Inc.
4341 State Street Road
Skaneateles Falls, NY 13153 USA
This manual applies to
901001 Accessory, Eye, Ear,
Nose, and Throat
Regulatory Affairs Representative
Welch Allyn Limited
Navan Business Park
Dublin Road
Navan, County Meath,
Republic of Ireland
www.welchallyn.com

Directions for use Contents iii
Contents
Introduction.........................................1
About this Manual .............................1
Warnings and Symbols ................................2
Miscellaneous symbols .........................2
Reimbursement Information .....................3
Getting Started ......................................4
Unpacking and Verifying Contents.................4
Diagram of the Welch Allyn Ear Wash System .......5
Using the Ear Wash System............................8
Steps for Irrigation .............................8
Attaching the Tubing and Chamber ................9
Attaching an Ear Tip............................9
Maintenance .......................................14
Cleaning and Disinfecting the System.............14
Troubleshooting ....................................17
Types of Cerumen ..................................21
Anatomy And Physiology.......................21
Cerumenolytic Agents .........................22
Cross Contamination / Backflow Prevention ........22
Warranty and Service Information ......................23
Warranty ...................................23
Replacement Parts and Accessories ....................24
Ordering Information ..........................24
Specifications ......................................25
General Specifications .........................25
Ear Tips ....................................25

iv Welch Allyn Ear Wash System

Directions for use 1
Introduction
Thank you for purchasing the Welch Allyn Ear Wash System.
The Welch Allyn Ear Wash System provides a safer and more effective
way to remove cerumen. This method of irrigation is much cleaner and
safer than other irrigation methods currently on the market. The Welch
Allyn Ear Wash System provides the following features:
• Patient Comfort - Hydrovac action
• Patient Safety- High temperature water shut-off
• Water pressure regulation inside chamber
• User Friendly - Visual temperature feedback sensor
• Superior Engineering - Fully functional at variable water pressures as
well as different faucets
This manual describes how to operate and maintain the Welch Allyn Ear
Wash System. Please follow these instructions to ensure many years of
accurate and reliable service. Carefully read the instructions regarding the
method on “Using the Ear Wash System” on page 8 to minimize patient
discomfort and to avoid the risk of perforating a patient’s tympanic
membrane. For additional information on cerumen types and the irrigation
process, see the “Types of Cerumen” section.
About this Manual
This manual serves as guide for ear irrigation using the Welch Allyn Ear
Wash System. The Welch Allyn Ear Wash System is intended for use by
Healthcare Professionals. Any use other than the intended use invalidates
the manufacturer’s warranty.

2Welch Allyn Ear Wash System
Warnings and Symbols
This manual uses the icons and symbols described below.
WARNING The warning statements in this manual identify conditions
or practices that could lead to illness, injury, or death. Warning
statements appear with a grey background in a black and white
document.
CAUTION The caution statements in this manual identify conditions or
practices that could result in damage to the equipment or other
property, or loss of data. This definition applies to both yellow and
black and white symbols.
The CE mark on this device indicates that it has been tested and
conforms to the provisions noted within the 93/42/EEC Medical Device
Directive.
Miscellaneous symbols
Reorder Number
Do Not Reuse
Consult Directions for use
Manufacturer

WARNING Only a licensed health care professional or a properly
trained person under the direction of such a professional should
perform the irrigation procedure. Always inspect the ear before
attempting any irrigation. Do not irrigate with this device: a) if a
perforated tympanic membrane is documented in the patient’s
chart or observed on inspection, b) if a perforated tympanic
membrane is suspected, or c) if the tympanic membrane cannot
be visualized on inspection. Note that sometimes small
perforations are evident only as an immobile tympanic
membrane. Irrigation is not advised if the patient presents with
severe pain, vertigo (especially with nystagmus), sensorineural
hearing loss, active and significant bleeding or severe tinnitus.
Irrigation in a patient with a perforated tympanic membrane may
result in contaminating the middle ear with debris from the ear
canal. Use clinical discretion if the patient has acute otitis media,
chronic or complicated otitis media, PE Tubes or is
immunocompromised.
WARNING If the water is too cold, the patient may experience
vertigo or light-headedness. Please verify that the thermal
indicator is white before proceeding with the irrigation.
Directions for use 3
Reimbursement Information
Coverage - Use of the Ear Wash System in the physician office is usually covered by payers
when medically necessary.
Coding - 69210, removal of impacted cerumen (separate procedure), one or both ears.
Payment - payment for use of the Ear Wash System varies by payer, plan, and provider
contract and may be separately payable in the physician’s office setting.

4Welch Allyn Ear Wash System
Getting Started
Unpacking and Verifying Contents
Inspect the packaging for any damage incurred during shipping. If you
find any damage, notify the carrier.
Complete and return the warranty registration card. It validates the
warranty and allows Welch Allyn to send announcements of product
enhancements.
When you unpack your new Welch Allyn Ear Wash System, verify that the
following items are included:
• Water chamber • Handle/Tubing assembly*
• One snap-aerator • Three different faucet adapters
• Chamber Aerator • One box of ear tips (25 ct)
• Storage Tray • Operating Instructional Manual
• Quick Reference Guide • Warranty Card
If any items are missing, please contact your Welch Allyn distributor.
* This water chamber is designed for use with
handle/tubing assemblies dated after March 2002
only. The date code is located on the face of the
handle interface at the bottom of the crescent
pocket.
Date Code
02
03
Plastic Flow
Limiter
For safe use, verify the plastic flow limiter is in ALL
aerators. If your facility has multiple exam rooms with
snap aerators, you MUST inspect each one to verify the
plastic flow limiter is inside. Replace all aerators that
have missing components. Call Welch Allyn Technical
Support if assistance is needed. (Aerator Flow = 4.0
gpm)

Directions for use 5
Use the figure shown to familiarize yourself with the features of the
Welch Allyn Ear Wash System.
1
2
3
4
5
6
7
8
9
10
11
12
14
13
Diagram of the Welch Allyn Ear Wash System
1Snap Aerator 8 Water Flow Actuator
2 Snap Connector with white ring 9 Water Temperature Sensor
3 Handle Rest Grip Ring 10 Cerumen Trapping Screen in ear tip
4 Irrigation Port - Irrigation water to
ear (blue)
11 Water Jet Output
5Return Port - Return water from
ear (black)
12 Water Suction Input
6 Return Water Exit Port 13 Disposable ear tip
7 Chamber Aerator 14 Ear Tip Removal Tab

6Welch Allyn Ear Wash System
Faucet Aerator Installation
Caution This system is designed for use on faucets where line
pressure does not exceed 100 PSI or flow rate of 5.7 gallons /
minute. If you suspect the line pressure or flow rate is greater,
have it tested prior to use of the Ear Wash System or contact
Welch Allyn Technical Service Department.
1. Remove your current aerator from your
faucet, including any original washers.
You may need to use a pair of pliers to
remove your aerator. If you still have
difficulty in removing it, soak your current
aerator in distilled vinegar for about
twenty minutes and try again.
Caution Failure to remove all parts
of the aerator from the faucet will
affect the Ear Wash System
performance.
2. Ensure all snap aerator parts are intact
and attach the assembly to your faucet
by turning it counter-clockwise. If it does
not fit, locate the appropriate adapter
from the kit included with the unit.
Attempt to match the adapter to your
faucet and then attach the snap aerator.
Verify the rubber washer on the snap
aerator and adapter matches to the old
washer on your faucet. If you need to
use the threadless universal adapter
(only available in certain regions), you
may need to remove the inner rubber o-ring if it is too small for your
faucet.
3. Once the snap aerator is attached to the faucet, the ear cleaning
chamber is easily attached or removed. You can still use your sink
normally when the Ear Wash System is not attached.

Directions for use 7
Chamber Aerator Installation
The chamber aerator is an optional attachment that is necessary if you are
experiencing a significant amount of water splash around your sink.
1. Find the notch located on the top of the chamber aerator and line it
up with the blue irrigation port on the chamber.
2. Gently press the chamber aerator against the chamber until it is
snug.
The chamber aerator is only capable of attaching to the chamber
if it is aligned correctly. It should go on relatively smoothly and
there is no need to force it onto the chamber.
Notch
Note

8Welch Allyn Ear Wash System
Using the Ear Wash System
Steps for Irrigation
It is essential to follow the technique described in this section for using
the Ear Wash System to minimize patient discomfort and avoid the risk of
perforating the tympanic membrane.
The factors determining the risk of perforating the tympanic membrane
while irrigating the ear canal are the water pressure at the point of
discharge and whether the discharged flow of water directly impinges on
the tympanic membrane.
The typical range of water pressure at the point of discharge in the ear tip
of the Ear Wash System is 10 - 13 PSI. There is great variability among
patients regarding susceptibility to perforation of healthy tympanic
membranes by pressure. Present evidence suggests that a water
pressure of 13 PSI may be capable of perforating healthy tympanic
membranes in a very small percentage of patients, estimated to be less
than.05%, if the water flow directly impacts the tympanic membrane.
This small risk is avoidable if the water flow is directed to impact the wall
of the ear canal, so that only indirect turbulent flow reaches the tympanic
membrane. This technique will also minimize patient discomfort.
Pre-Treatment Procedure
Carefully grasp the pinna and administer the ear
wax softener, which will enhance performance.

Directions for use 9
Attaching the Tubing and Chamber
1. Connect the tubing to the chamber.
Match the black connector to the black
return port on the side of the chamber.
Match the blue connector to the blue
irrigation port on the lower side of the
chamber.
2. To attach the chamber to the faucet, pull
down the white plastic ring on the top of the
chamber, and then insert the chamber over
the snap aerator on the faucet. When the
chamber is positioned, release the white
plastic ring. The chamber is now secure.
Attaching an Ear Tip
1. Line up the grooves on the side of the ear
tip with the corresponding indentations
on the handle interface. Verify that you
are attaching the ear tip with the tab
facing upwards.
2. Press firmly on the ear tip until it is flush
against the handle interface. You will feel
a slight snap when the ear tip is in place.

10 Welch Allyn Ear Wash System
Irrigation
1. Initially, you may cover the patient with a cloth drape to eliminate
splashing onto his or her clothes. Once the technique of sealing the
ear canal is mastered, this is not necessary.
2. Begin to run water through the unit by turning the hot and cold water
on full power. Adjust the water exiting the bottom of the chamber
until it feels close to body temperature.
Reducing the hot or cold water will impact the pressure.
3. Check the temperature of the irrigating
water by looking at the thermal sensor
while depressing the water flow actuator.
If the thermal sensor is blue, the irrigating
water is not warm enough. If the thermal
sensor white, the water temperature is at
least 90°F and the procedure may begin.
You must depress the actuator on the
handle for the temperature sensor to
function correctly.
WARNING If the water is too cold, the patient may experience
vertigo and/or light-headedness. Please verify that the thermal
indicator is white before proceeding with the irrigation.
4. To irrigate the ear, grasp the patient’s
pinna. Pull gently back to straighten a
child’s ear canal or up and back for an
adult. While maintaining tension on the
pinna, insert the tip of the handle into the
ear to create a seal. Tilt the handle so the
ear tip is directed away from the
longitudal axis of the ear canal and toward
any point on the wall of the ear canal.
Squeeze the actuator on the handle and
slowly rotate the tip. By adjusting how
much force you push on the actuator,
some control over the flow rate is
attained.
Note

Directions for use 11
5. It is important to aim the stream of water away from the longitudal
axis of the ear canal and toward the ear canal walls by tilting and
rotating the handle during the irrigation. Flood the ear with water. The
suction return system will return the discharge away from the ear.
6. During the irrigation, provide inquiries about patient comfort to
provide confidence. Periodically stop irrigation. View the ear canal
(using an otoscope) to check on progress. (Wax evacuation is not
always evident watching the ear tip/suction tubing.)
7. If the temperature of the irrigating water becomes too hot, the unit
will restrict the flow to the handle, while continuing to discharge out
the bottom of the unit. For the unit to reset, bring the water
temperature down to a safe level by adjusting the knobs on the
faucet until the water cools sufficiently.
8. Release the actuator and keep the ear tip in the canal for 5 to 10
seconds to vacuum any residual irrigating water.
The procedure typically takes 30 seconds to 5 minutes
depending on the type of cerumen and whether or not a wax
softening agent is used. In severe cases, the process could take
longer.
9.
Pull Tab
When the irrigation is complete,
grasp the tab located on the
disposable ear tip and pull the ear
tip off of the handle with a
downward motion. Please place in
an appropriate receptacle.
WARNING If there is no water flow out of the ear tip and the
actuator is depressed, check to see if the hot water shut-off has
tripped by running cold water through the unit. This should restore
water flow to the handle.
Note

WARNING Patient injury risk. To avoid cross contamination, use
ear tips for a single patient. Discard after use.
WARNING If the application of non-sterile tap water in a
patient’s ear is a concern, administer a few drops of the following
solutions to the ear canal after the procedure is completed as a
preventative measure:
• 70% Isopropyl Alcohol
• Hydrogen Peroxide
• Solution of 1 part Vinegar/1 part Isopropyl Alcohol
Discoloration or staining of the tubing can occur over time due to
local water conditions and/or introduction of other ear cleaning
solutions.
12 Welch Allyn Ear Wash System
Note

Directions for use 13
Disassembly
1. Turn off the faucet and disconnect the tubing from
the chamber. (Twist the fitting when removing the
hose from the chamber.)
2. Detach the chamber from the faucet. Press down
the white ring on top of the chamber and then pull
the chamber from the snap aerator. The chamber
will drain through the open hose ports at the front
and bottom.
3. To remove any stagnant water from the tubing,
place the open end of the tubing over the sink. Hold the handle
higher than the tubing and squeeze the actuator (A). Roll the tubing
up into a coil, holding the handle higher than the tubing (B). The water
should run out of the open end into the sink basin.
(A) (B)

14 Welch Allyn Ear Wash System
Maintenance
Cleaning and Disinfecting the System
Clean or Disinfect Ear Wash System daily. High Level Disinfect each
time the unit is used on a patient with compromised skin.
Cleaning the unit eliminates any debris and reduces the number of
microorganisms in the tubing. Disinfecting the unit eliminates most
bacteria and fungi growth.
To Prepare the Unit
• Remove the ear tip and discard.
• Clean the outside of the chamber, handle and hose with a soft
cloth saturated with a mild solution of soap and water
• Detach the chamber from the faucet. Leave the hoses attached
to the unit.
To Clean the Unit
• Prepare a 4 cup solution of soapy water.
• Pour 1/2 cup of the solution into the top
opening of the coupler. (Save the remainder of
the solution for later steps in this procedure.)
• Replace the chamber on the faucet and
submerge the handle interface surface (where the
tip attaches) into the solution. Turn on the water.
Squeeze the actuator to allow the solution to flow
from the handle into the container.
• The suction line will remove the solution. Continue
this process for 5 minutes. Remember to keep the
exposed tip of the handle submerged in the solution.
• Remove both tubes from the chamber and allow the chamber to
drain.
• Remove the chamber from the faucet.

Directions for use 15
• To remove any stagnant solution in the tubing, place the open
end in the sink. Squeeze the actuator and the solution will run out
into the sink basin.
• Allow the chamber to drip dry. Place the unit in its holding
container.
• To facilitate a recommended thorough flush and faster drying
time, pour isopropyl rubbing alcohol inside the chamber and
hoses.
To Disinfect the Unit
Follow Cleaning instructions, except replace the soapy water with a 2 cup
solution of isopropyl rubbing alcohol or a 10% bleach/90% water solution.
Rinse handle thoroughly with water after cleaning solution is used.
To High Level Disinfect the Unit
• Prepare at least 2 cups of .55% Ortho-Phthalaldehyde solution
(Welch Allyn recommends the use of Cidex OPA).
• Pour at least 2 cups of the solution into the top opening of the
coupler.
• Replace the chamber on the faucet and submerge the handle
interface surface (where the tip attaches) into the solution. Turn on
the water. Do not squeeze the actuator. After half of the solution is
removed, turn the water off.
• Remove handle from solution and rest it in the handle rest/grip ring.
This will trap the solution in the return line and allow effective
disinfection. Follow the manufacturers recommendations on soak
times for maximum benefit.
• Remove the chamber from the faucet.
• To remove any residual disinfecting solution in the tubing, place the
open end in the sink, squeeze the actuator and the solution will run
out into the sink basin.

Caution If hard water/ calcium buildup is a concern, a solution
of 100% vinegar can be substituted. Allow the vinegar to soak in
the chamber for no more than 2-3 minutes. A final flush of
isopropyl alcohol is required.
Caution Do not use solutions that contain chlorohexidene.
Caution Do not sterilize the unit with other methods such as
ETO or autoclave. These methods may damage the unit.
16 Welch Allyn Ear Wash System