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.