Welch Allyn AM 232 User Manual

AM 232

Manual Audiometer

Operating Instruction Manual

Part Number 1717-0101 - Rev. 05

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Electromagnetic compatibility (EMC)

CE Mark per Medical Device Directive (93/42/EEC)

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Table of contents

Electromagnetic compatibility (EMC) 2 Table of contents 3 Service and repair 5 Recalibration 5 Warranty 5 Rechargeable battery warranty 5 Safety notes 6 Specifications 7

Standards 7

Chapter 1

Introduction 9

Unpacking and inspection 10

Accessories supplied 10

Connectors, Controls, Indicators 11

Front panel controls and indicators (see Figure 1) 11 Rear panel connectors and indicators (see Figure 2) 12

Installation 14 Pretest procedure 15

Pretest noise recovery period 15 Elimination of ambient noise 16 Permissible noise levels 16

Disposal of non-contaminated electrical and electronic equipment directive 2002-96-EC-WEEE 17

Chapter 2

Battery Option 19

NiCad BATTERY OPERATION 2 0 Recharging NiCad batteries 21 Replacing NiCad batteries 22 Alkaline battery installation/operation 23

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Chapter 3

Operation 25

Preliminary check 26 Instructing the subject 27 Placing the earphones 27 Response handswitch 27 Audiogram form 28 Routine calibration check 29 Routine test administration 30

HL control (F3) 30 Range Extension pushbutton (F2) 30 Tone Type Selector (F9) 30

Typical testing session 31

Pretest Review 31 Familiarization 31 Determining the threshold (Pure Tone) 32 Testing procedure 32

Chapter 4

Routine Maintenance 33

Calibration 34 Earphone cords 34 Hum and random noise 35 Distortion and frequency shift 35 Special messages 35

CAL 35 Exx 36

Bibliography 37

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Service and repair

Technical Service Department Technical Service Department Welch Allyn, Inc. Welch Allyn Canada Limited 4341 State Street Road 160 Matheson Boulevard, East Skaneateles Falls, NY 13153-0220 Mississauga, Ontario, Canada L4Z 1V4 Tel.: 1-800-535-663 (in U.S.A. only) Tel.: 1-800-561-8797 (in Canada only)

Recalibration

Welch Allyn recommends that the AM 232 Manual Audiometer be recalibrated annually. Arrangements may be made by returning the instrument registration card or by contacting Welch Allyn’s Technical Service Department (as listed above). A moderate fee is charged for recalibration.

Warranty

Note: Return of the instrument registration card is required for proof of purchase and warranty validation.

Welch Allyn, Inc. warrants the AM 232 Manual Audiometer to be free of original defects in material and workmanship and to perform in accordance with manufacturer’s specifications for a period of one year from the date of purchase. If this instrument or any component thereof is found to be defective or a variance from the manufacturer’s specifications during the warranty period, Welch Allyn will repair, replace or recalibrate the instrument or component(s) at no cost to the purchaser.

This warranty only applies to instruments purchased new from Welch Allyn or its authorized distributors or representatives. The purchaser must return the instrument directly to Welch Allyn or an authorized distributor or representative and bear the costs of shipping.

This warranty does not cover breakage or failure due to tampering, misuse, neglect, accidents, modification or shipping, and is void if the instrument is not used in accordance with manufacturer’s recommendations or if repaired or serviced by other than Welch Allyn or a Welch Allyn authorized representative.

No other express or implied warranty is given.

Rechargeable battery warranty

Welch Allyn nickel-cadmium batteries are guaranteed by Welch Allyn for two years from date of manufacture (when used in Welch Allyn instruments only). Defective batteries will be replaced on a pro rata basis should failure occur prior to expiration data on battery.

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Safety notes

WARNING

with a hospital grade outlet. Injury to personnel or damage to equipment can result when a three-prong or two-prong adapter is connected between the AM 232 Manual Audiometer power plug and an AC outlet or extension cord. Additionally, the AM 232 Manual Audiometer is equipped with a specific power transformer which should not be interchanged with any other transformer or supply.

This symbol indicates the location of a service adjustment part and

is intended for service personnel only. The AM 232 Manual Audiometer 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 Welch Allyn service technician.

CAUTION

with the EMC requirements according to IEC 60601-1-2.

Radio transmitting equipment, cellular phones, etc. shall not be used in the close proximity of the device since this could influence the performance of the device. Particular precaution must be considered during use of strong emission sources such as High Frequency surgical equipment and similar device so that e.g., the HF-cables are not routed on or near the device. If in doubt, contact a qualified technician or your local representative. Refer to the Electromagnetic Compatibility (EMC) Guide on CD 482-638702.

The AM 232 Manual Audiometer is designed to be used

The AM 232 Manual Audiometer is designed to comply

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Specifications

Standards

The AM 232 Manual Audiometer meets ANSI S3.6 and IEC 645 Type 4 Audiometer Standards. UL 60601-1 Medical Electrical Equipment Requirements for Safety IEC/EN 60601-1 General Requirements CSA C22.2 No.601-1-M90

Protective Classification

This system is intended for continuous operation and has a protective classification of Class II, Type B.

Class II Type B

Degree of protection against harmful ingress of water: Ordinary (no protection)

Frequency Range

Discrete Frequencies: 125, 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000, 8000 Hz Accuracy: ±3% Total Harmonic Distortion: <2%

Intensity

Ranges: 125 Hz: -1 0 to 5 0 dB H L

500 to 6000 Hz: -10 to 9 0 dB HL 250 and 8000 Hz: -10 to 70 dB HL (Increments of 5 dB steps)

Note: A “+10” dB switch extends maximum at all frequencies by 10 dB.

Accuracy: 125 to 4000 Hz: ±3 dB

6000 to 8000 Hz: ±5 dB

Signal to Noise Ratio: >70 dB

Tone Type

Rise/Fall Time: 20-50 msec Continuous: Steady when present bar depressed Pulsed: 2.5 pulse/sec FM: 5 Hz, ±5%

equipment symbols

Head set

Telephones TDH39 Earphones with MX41AR Cushions (60 ohm impedance).

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Power

Line Voltage: 100-240 V (±10%) Note: Desktop power supply Range: 50-60 Hz (± 5%) Consumption: 9 Watts

Battery

Types: Rechargeable (NiCad) or Non-Rechargeable (Alkaline) Range: 7.0 V - 9.0 V Capacity: NiCad - 22 hours continuous operations

Alkaline - 45 hours continuous operations

Environmental Temperature:

Operating: 60° F to 105° F (15° C to 40° C) Powerline Storage: -40° F to 140 ° F (-40° C to 60° C) Battery Storage: -40° F to 105° F (-40° C to 40° C) Humidity: 5% to 90% Warm-up Time: 10 minutes for instruments stored at room temperature

Mechanical

Dimensions: 13.25" W x 14" D x 3.75" H

(33.66 cm x 35.56 cm x 9.53 cm)

Weight 5.6 lb (2.53 kg) net

8 lb (3.64 kg) shipping 10 lb (4.55 kg) shipping with battery included

Supplied Accessories Catalog Numbers

Test headset (TDH39) 23223 Audiogram Forms (1 pad of 50) 52300 Instruction Manual 232001 AC Power Module 8000-0246

Optional Accessories

Response Handswitch 23220 Patch Cord, 2 Conductor 23221 Audiocups 23222 Replacement NiCad Battery Only 72320 Battery Pack Assembly 72329

Battery Pack includes Welch Allyn supplied NiCad battery. May also be used with six (6), Size C, Alkaline batteries (not included) Replacement NiCad

Catalog Listings

AM 232 Manual Audiometer, AC Power (USA) 23200 AM 232 Manual Audiometer, AC Power and Battery (USA) 23210 AM 232 Manual Audiometer , AC Power (Export) 23205 AM 232 Manual Audiometer, AC Power and Battery (Export) 23215

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Chapter 1

Introduction

The AM 232 Manual Audiometer is a single-channel, pure tone, air conduction, portable instrument designed to provide basic audiometric screening capability for physicians’ offices, schools and industry. The lightweight design allows easy transport to a variety of testing locations, and the built-in storage cavity and case provide enough room to contain all instrument accessories. The clearly labeled front panel controls and full frequency range make accurate, reliable testing a simple matter for any user.

The AM 232 Manual Audiometer is a precisely designed and calibrated instrument. With proper care it will deliver accurate sound-pressure levels to subject ears for your hearing screening program.

Note: The AM 232 Manual Audiometer should be recalibrated yearly (or sooner if a problem develops). See Chapter 4.

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Unpacking and inspection

Although your AM 232 Manual 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 your carrier if any damage is noted.

Carefully remove your AM 232 Manual 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 your Welch Allyn representative.

If the instrument must be returned to the factory, repack it carefully (in the original container if possible) and return it prepaid to the factory for necessary adjustments. Check that all accessories itemized in Accessories supplied below are received in good condition. If any accessories are missing, contact Welch Allyn immediately. See the Specifications section for the catalog numbers of accessories and also for a listing of optional accessories.

Accessories supplied

Test Headset Assembly (TDH39) Audiogram Pad (1 pad of 50) Battery Pack Assembly (used with #23210 and #23215 models only) AC power cord

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Connectors, Controls, Indicators

Figure 1: Front panel.

Front panel controls and indicators (see Figure 1)

F1 - Power switch and indicator for ON and OFF .

F2 - Range extension pushbutton allows you to increase the stimulus intensity 10 dB

above the standard maximum HL at any frequency. When in use, a “+” appears on the LCD.

F3 - HL control for setting stimulus intensity level. Level is indicated on LCD.

F4 - Present bar for stimulus presentation.

F5 - Stimulus being presented via an earphone. Presentation indicated by illuminated

green LED.

F6 - Subject response indicator shows you when the test subject has pressed the

handswitch button by an illuminated green LED (with optional handswitch only).

F7 - Control for setting stimulus frequency. Frequency is indicated in the window

adjacent to the control.

F8 - Routing switch for stimulus presentation to the earphone. Left or right indicated

by illustration of subject.

F9 - Switch for setting the stimulus tone type.

FM = warble tone __ = steady tone

- - - = pulsed tone

F10 - Low battery indicator to alert you of a limited operating time. Recharge or

replace batteries (dependent on whether NiCad or Alkaline batteries are used).

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Rear panel connectors and indicators (see Figure 2)

Figure 2: Rear panel.

R1 - Power input jack (5-pin DIN Connector) with front panel illustration showing its

location and a rear panel label giving the input power specifications.

R2 -

R3 - Earphone output jacks (standard phone jacks). Front panel illustration shows

R4 - Response handswitch input jack (standard phone jack) with front panel illustra-

R5 - Entry by qualified service personnel only.

Note: The above symbol is located inside the storage compartment. It denotes a

Type B, Class II product per IEC 878 as referenced in IEC 60601-1.

Attention, consult accompanying document for instructions or warnings

pertaining to these parts.

left and right phone.

tion showing location.

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