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