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Welch Allyn AM282
Audiometer
+10dB
ACPWR
FM
dB HL
Hz
R
L
R
dB HL
Hz
S3.6/ISO389
Ref.ANSI
Directions for use
Part Number 28204 Rev. D
ii |
Welch Allyn AM282 Audiometer |
©2011 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 this 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.
Software in this product is Copyright 2010 Welch Allyn or its vendors. All rights are reserved. The software is protected by United States of America copyright laws and international treaty provisions applicable worldwide. Under such laws, the licensee is entitled to use the copy of the software incorporated with this instrument as intended in the operation of the product in which it is embedded. The software may not be copied, decompiled, reverse-engineered, disassembled, or otherwise reduced to human-perceivable form. This is not a sale of the software or any copy of the software; all right, title, and ownership of the software remain with Welch Allyn or its vendors.
For information about any Welch Allyn product, call Welch Allyn Technical Support:
Tel.: 1-800-535-6663 (In U.S.A. only)
Tel.:1-800-561-8797 (in Canada only)
REF 28204 (Printed, English only) 28204 Rev. D, 2011-01
Compliance
The CE0344 mark identifies compliance with the Medical Device Directive 93/42/EEC. Grason-Stadler is an ISO 13485-certified corporation.
Manufactured for Welch Allyn by
Grason-Stadler
7625 Golden Triangle Drive Suite F
Eden Prairie, MN 55344 www.grason-stadler.com
Welch Allyn, Inc.
4341 State Street Road
Skaneateles Falls, NY 13153-0220 USA
www.welchallyn.com
Directions for use |
iii |
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Unpacking and inspection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Supplied Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Recycling / disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Safety Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Preliminary check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Pretest noise recovery period. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Test environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Routine Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Preventive maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Cleaning patient contact reusable devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Routine calibration check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Standards, Specifications, and Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Standards and Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 Frequency Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 Intensity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 Tone Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 Head set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 Environmental. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 Mechanical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Appendix A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A
Bibliography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B
iv |
Welch Allyn AM 282 Audiometer |
1
1 Introduction
The AM282 Audiometer is a single-channel, pure tone, air conduction, portable instrument designed to provide basic audiometric screening capability for physicians' offices and industry. The lightweight design allows easy transport to a variety of testing locations. The clearly labeled front panel controls and full frequency range make accurate, reliable testing a simple matter for any user.
The AM282 Audiometer is a precisely designed and calibrated instrument. With proper care it will deliver accurate sound-pressure levels to subjects' ears for hearing screening programs
Note The AM282 Audiometer should be calibrated yearly (or sooner if a problem develops) by a Welch Allyn certified technician. See Chapter 3.
Unpacking and inspection
Although this AM282 Audiometer was carefully tested, inspected and packed for shipping, it is good practice after receiving the instrument to immediately examine the exterior of the container for any signs of damage. Notify the carrier if any damage is noted.
Carefully remove the AM282 Audiometer from its shipping container. If the instrument appears to have suffered mechanical damage, notify the carrier immediately so that a proper claim can be made. Be certain to save all packing materials so that the claim adjuster can inspect it as well. As soon as the carrier has completed the inspection, notify a Welch Allyn representative.
If the instrument must be returned, repack it carefully (in the original AM282 Audiometer container if possible) and return it prepaid to Welch Allyn for necessary adjustments.
Supplied Accessories
Check that all accessories itemized in Accessories supplied below are received in good condition. If any accessories are missing, contact Welch Allyn immediately. See “Accessories” on page 25 for the catalog numbers of accessories and also for a listing of optional accessories.
Welch Allyn Part Number |
Welch Allyn Description |
28203 |
DD45 Audiometry Headset External |
28208 |
AM282 Audiogram Forms (1 pad of 50) |
28204 |
AM282 Directions for Use Manual (printed, English only) |
28205 |
AM282 Directions for Use Manual (printed, French only) |
2 |
Introduction |
Welch Allyn AM282 Audiometer |
|
28202 |
AM282 Carry Case |
|
28207 |
AM282 Power Plug |
|
28201 |
AM282 Power Supply |
|
28206 |
Threshold Audiometry Card |
|
Optional Accessories |
|
|
23220 |
Audiometry Patient Response Switch |
|
23221 |
Audiometry Single Patch Cord, 2-Conductor |
|
23222 |
Audiometry Audiocups |
WARNING To ensure patient safety and optimal product performance, use only Welch Allyn recommended accessories and supplies
Recycling / disposal
Caution Many local laws and regulations require special procedures to recycle or dispose of electric equipment-related waste including batteries, printed circuit boards, electronic components, wiring and other elements of electronic devices. Follow all of your respective local laws and regulations for the proper disposal of batteries and any other parts of your system.
Safety Summary
Before using the AM282 Audiometer, familiarize yourself with the sections of this directions for use that pertain to your use of the AM282 Audiometer.
•Failure to understand and observe any warning statement in this manual could lead to patient injury, illness, or death.
•Failure to understand and observe any caution statement in this manual could lead to damage to the device or other property, or loss of patient data.
WARNING Warnings indicate conditions or practices that could lead to illness, injury, or death.
Caution Cautions indicate conditions or practices that could damage the equipment or other property.
Note Notes help you identify areas of possible confusion and avoid potential problems during system operation
Directions for Use |
Introduction |
3 |
Safety Notes
WARNING The AM282 is designed for compliance to IEC and UL 60601-1 when used in the patient vicinity. To achieve this compliance, use of hospital grade plug and receptacles are required. For patient and operator safety, the AM282 must be used with properly grounded plug and receptacles at all times. The AM282 is equipped with a specific power transformer (UE100503HKKK3-P, reorder number 28201), which should not be interchanged with any other transformer or supply.
WARNING Any program aimed at obtaining reliable records of hearing thresholds should be staffed and supervised by appropriately-trained individuals.
Latex is not used any where in the manufacturing process.
The base material for the earphone cushions is made from natural and synthetic rubber.
WARNING This symbol 
indicates the location of a service adjustment part and is intended for service personnel only. The AM282 is a specifically calibrated audiometer and the periodic service and adjustments for the instrument that may be required should be done only by an authorized service technician
WARNING Please read the entire manual prior to using the AM282 to become familiar with the test functions and proper accessory connections.
WARNING Accessory equipment connected to the analog and digital interfaces must be certified to the respective IEC standards (IEC950 for data processing or IEC 60601-1 for medical equipment). Furthermore, all configurations shall comply with the system standard IEC 60601-1-1. Everyone who connects additional equipment to the signal input or signal output port configures a medical system, and is therefore responsible that the system complies with the requirements of the system standard IEC60601-1-1. If in doubt, consult the technical service department or a local Welch Allyn representative.
Customer Responsibility
WARNING This product and its components will perform reliably only when operated and maintained in accordance with the instructions contained in this manual, accompanying labels, and/or inserts. A defective product should not be used. Make sure all connections to external accessories are snug and secured properly. Parts which may be broken or missing or are plainly worn, distorted or contaminated should be replaced immediately with clean, genuine replacement parts manufactured by or available from Welch Allyn.
WARNING This product should not be used in the presence of fluid that can come into contact with any of the electronic components or wiring. Should the user suspect fluids have contacted the system components or accessories, the unit should not be used until deemed safe by a Welch Allyn certified service technician.
4 |
Introduction |
Welch Allyn AM282 Audiometer |
WARNING Do NOT use in the presence of flammable gaseous mixtures. Users should consider the possibility of explosions or fire when using this device in close proximity to flammable anesthetic gases.
WARNING Periodically, have a service technician perform electrical safety checks on the unit in order to show continued compliance to IEC and UL 60601-1.
Warranty
We, Welch Allyn, warrant that this product is free from defects in material and workmanship, and when properly installed and used, will perform in accordance with applicable specifications. If within one year after original shipment it is found not to meet this standard, it will be repaired, or at our option, replaced at no charge except for transportation costs, when returned to an authorized product service facility.
Note Changes in the product not approved in writing by Welch Allyn shall void this warranty. Welch Allyn shall not be liable for any indirect, special or consequential damages, even if notice has been given in advance of the possibility of such damages.
THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY OF FITNESS FOR A PARTICULAR PURPOSE.
Directions for Use |
Introduction |
5 |
Installation
1.Plug the power cord into the appropriate jack (R5) on the rear panel.
2.Plug the power cord from the Power Module into a line power (mains) outlet.
3.Plug the earphones into the earphone jacks on the rear panel. R3 is for the right and R4 is for the left earphone/insert phone.
4.Turn the power switch to ON (R6).
Rear panel connectors
R1 |
Covered by a sticker and intended for service personnel only. |
R2 |
Patient Hand Switch input jack (standard phone jack). |
R3 |
Right ear phone output jacks (standard phone plug). Insert either the External Headset |
|
or Internal Earphone jacks. |
R4 |
Left earphone output jacks (standard phone jack). Insert either external headset or |
|
Internal Earphone plugs. |
R5 |
Power Input jack (2.1 mm pin). |
R6 |
Power switch. |
|
|
Symbols on the AM282 Audiometer
Symbol Description
Attention, consult accompanying documents.
Date of manufacture
CE Marked in accordance with the European Council Directive 93/42/EEC concerning medical devices.
Special Recycling Required. Do not dispose in landfill.
Type B equipment.
Symbol for “CATALOG NUMBER.”
6 |
Introduction |
Welch Allyn AM282 Audiometer |
Symbol Description
Stand-by.
Right Ear.
Left Ear.
Patient Response Button.
AC Power
WARNING Do not turn on/off system power while a patient is wearing the headsets or internal earphones.
WARNING Use only the provided power supply. The AM282 Audiometer provided power supply should only be connected to a power source meeting the following range: 90-246VAC, 47-63Hz. In North America, the power source should be a maximum of 120VAC.
Bottom panel
B1 |
B2 |
B1 Serial number of system
B2 Battery compartment
See “Replacing the batteries” on page 10 for detailed instructions.
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