Welch Allyn 29350 Instruction Manual

Ear Wash System
29350
Operating
Instruction
Manual

Table of Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Warnings and Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Getting Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Unpacking and Verifying Contents . . . . . . . . . . . . . . 3
Diagram of the Welch Allyn Ear Wash System . . . . 4
Faucet Aerator Installation . . . . . . . . . . . . . . . . . . . . 5
Chamber Aerator Installation . . . . . . . . . . . . . . . . . . 6
Using the Ear Wash System . . . . . . . . . . . . . . . . . . . . . . . 7
Steps for Irrigation . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Attaching the Tubing and Chamber . . . . . . . . . . . . . 8
Attaching an Ear Tip . . . . . . . . . . . . . . . . . . . . . . . . . 8
Irrigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Disassembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Cleaning and Disinfecting the System . . . . . . . . . . 12
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Types of Cerumen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Anatomy And Physiology . . . . . . . . . . . . . . . . . . . . 19
Cerumenolytic Agents . . . . . . . . . . . . . . . . . . . . . . 19
Cross Contamination / Backflow Prevention . . . . . 19
Warranty and Service Information . . . . . . . . . . . . . . . . 20
Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Technical Service Department . . . . . . . . . . . . . . . . 21
Replacement Parts and Accessories . . . . . . . . . . . . . . . 22
Ordering Information . . . . . . . . . . . . . . . . . . . . . . . 22
Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
General Specifications . . . . . . . . . . . . . . . . . . . . . . 23
Patents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Ear Tips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

1
Introduction
Thank you for purchasing the Welch Allyn Ear Wash System.
The Welch Allyn Ear Wash System provides a safe and effective way to
remove cerumen from patients of all ages. 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 fea-
tures:
• 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 pres-
sures 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 7 to minimize patient
discomfort and to avoid the risk of perforating a patient’s tympanic mem-
brane.
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 invali-
dates the manufacturer’s warranty.

2
Warnings and Symbols
This manual uses the icons and symbols described below.
ATTENTION: Refer to the operating instructions. This symbol is
intended to advise the user of the presence of important oper-
ating or maintenance instructions in the documents accompa-
nying the instrument.
Performance specifications verified by ETL Laboratories
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
Authorized European Representative Address:
European Regulatory Manager
Welch Allyn, Ltd.
County Meath, Republic of Ireland
Telephone: [phone]
Fax: [phone]
Only a licensed health care professional or a properly trained per-
son 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 evi-
dent only as an immobile tympanic membrane. Irrigation is not
advised if the patient presents with severe pain, vertigo (espe-
cially with nystagmus), sensorineural hearing loss, active and sig-
nificant 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.
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.

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.
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 war-
ranty 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 han-
dle/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

4
For safe use, verify the plastic flow limiter is in ALL aer-
ators. If your facility has multiple exam rooms with snap
aerators, you MUST inspect each one to verify the plas-
tic flow limiter is inside. Replace all aerators that have
missing components. Call Welch Allyn Technical Sup-
port if assistance is needed.
Use the figure shown to familiarize yourself with the features of the
Welch Allyn Ear Wash System.
Diagram of the Welch Allyn Ear Wash System
1 Snap 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
5 Return 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
Plastic Flow
Limiter
1
2
3
4
5
6
7
8
9
10
11
12
14
13

5
Faucet Aerator Installation
ATTENTION: This system is designed for use on faucets where
line pressure does not exceed 100 PSI or flow rate of 5.7 gal-
lons / 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 diffi-
culty in removing it, soak your current
aerator in distilled vinegar for about
twenty minutes and try again.
NOTE: Failure to remove all parts of the aer-
ator 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 aer-
ator 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.

6
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.
NOTE: 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

7
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 dis-
charge 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 mem-
branes 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. (not required)

8
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 irri-
gation 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 fac-
ing 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.

9
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.
NOTE: 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 sen-
sor to function correctly.
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 longitu-
dal 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.
If the water is too cold, the patient may become experience vertigo
and/or light-headedness. Please verify that the thermal indicator is
white before proceeding with the irrigation

10
5. It is important to aim the stream of water away from the longitu-
dal 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, conversation regarding patient status will pro-
vide confidence to the patient.
7. If the temperature of the irrigating water becomes too hot, the
unit will restrict the flow to the handle, while continuing to dis-
charge 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 sec-
onds to vacuum any residual irrigating water.
NOTE: 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. When the irrigation is complete,
grasp the tab located on the dispos-
able ear tip and pull the ear tip off of
the handle with a downward
motion. Please place in an appropri-
ate receptacle.
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.
Ear tips are intended for single use only. Discard after use.
Pull Tab

11
Disassembly
1. Turn off the faucet and disconnect the
tubing 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.
If the application of non-sterile tap water in a patient’s ear is a con-
cern, administer a few drops of the following solutions as a preven-
tative measure:
• 70% Isopropyl Alcohol
• Hydrogen Peroxide
• Solution of 1 part Vinegar/1 part Isopropyl Alcohol
NOTE: Discoloration or staining of the tubing can occur over time
due to local water conditions and/or introduction of other ear clean-
ing solutions.
(A) (B)

12
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 micro-
organisms 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 open-
ing of the coupler. (Save the remainder of the
solution for later steps in this procedure).
• Replace the chamber on the faucet and sub-
merge 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.
• 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.

13
• Allow the chamber to drip dry. Place the unit in its holding con-
tainer.
• 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.
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 solu-
tion 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 effec-
tive 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.
If hard water/ calcium buildup is a concern, a solution of 100% vine-
gar 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.
Do not use solutions that contain chlorohexidene.
Do not sterilize the unit with other methods such as ETO or auto-
clave. These methods may damage the unit.

14
Troubleshooting
If your Welch Allyn Ear Wash System is experiencing problems, consult
the following table to find the symptom and the likely cause and the solu-
tion. If the information in this table does not describe or solve the prob-
lem you are having, contact the Welch Allyn Technical Service
Department at 1-800-535-6663 / 1-315-685-4653 or an authorized Welch
Allyn Distributor to help you. See Service and Warranty Information Card
for more information.
Problem Possible Cause Solution
No water is coming
out of the handle
even though I am
pulling the actuator.
The temperature shut-
off safety feature has
activated due to the
hot water temperature.
Run COLD water through the
system for 10-30 seconds. This
will reset the temperature shut
off safety feature and allow
water to flow again.
There is a kink in the
tubing.
Make sure there are no bends in
the tubing restricting the flow of
water.
The tubing on the
INSIDE of the handle is
restricting water flow.
Remove the ear tip. Turn off the
faucet and disconnect the tubing
from the chamber. with the ends
of the tubing in the sink and the
actuator squeezed, inject air with
a syringe into the water jet port
of the handle.
Squeeze Actuator
Water Jet Port

15
Excessive water leak-
ing from the ear.
The water is not turned
on high enough.
Turn the cold water on full in
order for the suction system to
work properly (but still within the
right temperature range).
Ear tip attachment
problem.
Replace the ear tip with the tab
side pointing upwards.
Tubing connection
problem.
Ensure that both tube fittings are
fit snugly into the chamber.
Incorrect technique. Check the Quick Reference
Guide to verify you are aiming
the water correctly.
Suction not adequate. Check suction by immersing tip
only into a graduated cup. Verify
the suction is at least 180 ml per
20 seconds. **
Difficulty removing
ear wax.
Water too cold Slowly increase water tempera-
ture until desired results occur.
Water flow inadequate With an ear tip attached, spray
water from the handle into a
graduated cylinder or measuring
cup for exactly 20 seconds. If
there was less than 110 mL or
more than 125mL of measured
water, replace the tip and repeat.
If the results are the same, con-
tact your Welch Allyn Technical
Service Department.
Patient has very hard
ear wax.
Apply ear drops for about 5 - 10
minutes then retry. If unsuccess-
ful, have patient apply ear drops
overnight then retry.
Rotate tip within the ear canal (to
direct stream of water to differ-
ent areas rathern than the same
spot).
Lack of a clean water
stream coming from
ear tip.
Installation of ear tip
has caused a problem.
Apply a new ear tip with the tab
side pointing upwards.
Problem Possible Cause Solution

16
* To properly test suction, follow the steps below:
The water splash is
making a mess or
splashing onto adja-
cent electrical units.
Excess water pressure
from the water line.
Ensure that the chamber aerator
is attached to the bottom of the
chamber.
The water pressure
from the ear tip
seems too high or
too low.
Installation of ear tip
has caused a problem.
Apply a new ear tip with the tab
side pointing upwards.
There is leakage from
the chamber aerator
and/or adapter
Tighten the aerator and/or
adapter with a pair of pliers.
The return water exit
port is clogged on the
bottom of the cham-
ber.
Remove the chamber from the
faucet and dislodge any foreign
materials from the exit port. Pro-
ceed with the normal cleaning
procedure.
There is an internal
malfunction. Check
water pressure from
the sink.
With an ear tip attached, spray
water from the handle into a
graduated cylinder or measuring
cup for exactly 20 seconds. If
there was less than 110 mL or
more than 125mL of measured
water, replace the tip and repeat.
If the the flow is still above 125
ml / 20 seconds, either add regu-
lation to the faucet or move to a
faucet with adquate water pres-
sure and flow. Otherwise, con-
tact your Welch Allyn Technical
Service Department.
Sensor not turning
white even though
water feels warm
coming out of the
bottom of the unit.
The sensor is defec-
tive.
Replace handle/hose assembly.
Delay in change of
color
Keep water flowing from handle
so that warm water reaches the
sensor to change its color.
Algae, fungus, or
other growth in hose.
Hose is not being prop-
erly disinfected.
See “Cleaning and Disinfecting
the System” on page 12.
Use a germicidal or anti-bacterial
soap or Cidex.
Problem Possible Cause Solution