Welch Allyn Ear Wash System 29350 User Manual

Ear Wash System

29350
Operating Instruction Manual
Table of Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Warnings and Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Getting Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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

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 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.
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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 oper­ating or maintenance instructions in the documents accompa­nying 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
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.
Welch Allyn, Ltd. Navan Business Park Dublin Road County Meath, Republic of Ireland Telephone: 353-46-67700 Fax: 353-46-27128
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.
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Reimbursement Information
Coverage - Use of the Ear Wash System in the physician office is usually
covered by payers when medically necessary.
Coding
Payment
- 69210, removal of impacted cerumen (separate procedure), one or both ears.
- 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 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-
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.
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Date
Code
02 03
For safe use, verify the plastic flow limiter is in ALL aer­ators. If your facility has multiple exam rooms with snap
Plastic Flow Limiter
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)
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

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2
11
3
5
12
13
10
14
9
8
6
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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)
5 Return Port - Return water from
ear (black) 6 Return Water Exit Port 13 Disposable ear tip 7 Chamber Aerator 14 Ear Tip Removal Tab
11 Water Jet Output
12 Water Suction Input
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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 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 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 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.
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