29350
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
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 features:
•Patient Comfort - Hydrovac action
•Patient SafetyHigh 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 7 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.
1
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 operating 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: 353-46-67700
Fax: 353-46-27128
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.
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.
2
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.
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 han- |
Date |
|
dle/tubing assemblies dated after March 2002 |
Code |
|
only. The date code is located on the face of the |
02 |
|
handle interface at the bottom of the crescent |
|
|
03 |
|
|
pocket. |
|
|
3
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.
Plastic Flow
Limiter
Use the figure shown to familiarize yourself with the features of the Welch Allyn Ear Wash System.
1
13 14 9
2
|
11 |
|
12 |
3 |
10 |
8 |
5
4
6
7
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 |
11 |
Water Jet Output |
|
ear (blue) |
|
|
|
|
|
|
5 |
Return Port - Return water from |
12 |
Water Suction Input |
|
ear (black) |
|
|
|
|
|
|
6 |
Return Water Exit Port |
13 |
Disposable ear tip |
|
|
|
|
7 |
Chamber Aerator |
14 |
Ear Tip Removal Tab |
|
|
|
|
4
ATTENTION: 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.
NOTE: 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.
5