Welch Allyn AM282 Audiometer
Contents
1. 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 Range2. 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 co
3. 4 Make whatever notations your procedure requires on the audiogram form Pretest noise recovery period Two prerequisites are of particular importance to the procurement of reliable audiograms Prior to testing allow enough time for the subject to recover from the effects of noise exposure Exposure to high levels of sound unmuffled lawn mowers power tools loud music gunfire etc tends to create a temporary threshold shift TTS which diminishes with time after exposure If a subject is tested too soon after noise exposure a hearing test may indicate a hearing loss that does not reflect the subjects true hearing It is recommended that the testing procedure prescribe some time interval usually at least 16 hours between the last exposure to high level sound and the administration of any hearing test Caution Always handle earphones with care Neither drop them nor permit them to be squeezed together Severe mechanical shock may change their operating characteristics and require their replacement Note Always clean and maintain earphone cushions for hygiene purposes Check periodically for cracking or signs of wear Cleanse cushions daily or after each use depending upon population being tested Use a solution of diluted alcohol or mild soap and water Do not allow any of the cleaning solution to enter into the earphone speaker Use earphones only when completely dry Insert the earphone cords between the earphone cushion
4. Standards and Compliance The AM282 meets Frequency Range Intensity The above intensity ranges apply to the external headset earphones ANSI S3 6 2004 Specification for Audiometers Type 4 IEC 60645 1 2002 Electroacoustics Audiological Equipment Pure Tone Audiometers Type 4 IEC 60601 1 2003 Medical Electrical Equipment Part 1 General Requirements for Safety UL 60601 1 Medical Electrical Equipment Part 1 General Requirements for Safety CAN CSA C22 2 No 601 1 M90 2003 Medical Electrical Equipment Part 1 General Requirements for Safety IEC EN 60601 1 2 2001 Medical Electrical Equipment Part 1 Electromagnetic compatibility requirements Discrete Frequencies 125 250 500 750 1000 1500 2000 3000 4000 6000 8000 Hz Accuracy 2 Total Harmonic Distortion lt 2 5 measured acoustically at the maximum Hz for frequencies below 5000 Hz and measured electrically above 5000 Hz Ranges In increments of 5 dB steps 125 Hz 10 to 50 dB HL 500 to 4000 Hz 10 to 90 dB HL 6000 Hz 10 to 85 dB HL 250 and 8000 Hz 10 to 70 dB HL Note The maximum output values in dB HL are reduced by 10 dB when insert phones are used except for 6 kHz where the maximum dB HL is reduced by 20 dB A 10 dB button extends the maximum at all frequencies by 10 dB 24 Standards Specifications and Accessories Welch Allyn AM282 Audiometer Tone Type Head set Power Environmental Ac
5. 1983 Since individual thresholds can shift up or down as much as 5 dB from one day to the next variation within this range may be considered acceptable Variations that exceed this range however are likely to reveal problems that require attention The routine maintenance checks described in this chapter may suggest the source and solution to the problem If they do not the instrument should receive technical service by a certified technician before further use Earphone cords With extended use earphone cords tend to fray internally at the junctions of both earphone and audiometer connectors This fraying will ultimately decrease the signal level in the associated earphone or cause signals to be intermittent as the cord is flexed To check for either condition 1 Set the Audiometer frequency control to 1000 or 2000 Hz 2 Set the HL knob at a comfortable audible level and use a Steady Tone type 3 Press the Present bar and flex earphone cord next to plug at both ends listening for intermittent signal abrupt changes in signal level or a scratchy sound superimposed over the signal that coincides with the flexing of the cord The presence of any of these three conditions signifies that the cord should be replaced Hum and random noise With the instrument set on 1000 Hz move the HL knob from 0 to 60 dB and listen for low frequency hum and random noise hiss or low rushing sound at all attenuator levels Some audible rando
6. A Welch Allyn AM282 Audiometer Bibliography ANSI S3 6 2004 Specification for Audiometers Type 4 Criteria for Permissible Ambient Noise During Audiometric Testing ANSI S3 1 1977 Methods for Manual Pure Tone Threshold Audiometry ANSI S3 21 1978 Michael P L and Bienvenue G R Noise Attenuation Characteristics of Supra Aural Audiometric Headsets Using the Models MX41 AR and 51 Earphone Cushions J Accoust Soc Am 70 5 Nov 1981 1235 1238 Newby H A Audiology 4th ed New Jersey Prentice Hall Inc 1979 U S Department of Labor Occupational Noise Exposure CFR 1910 95 March 8 1983 American Speech and Hearing Association 1975 Guidelines for identification audiometry Rockville MD IEC 60645 1 2002 Electroacoustics Audiological Equipment Pure Tone Audiometers Type 4
7. alkaline batteries It can also use 5 x 1 2V AA NiMH or NiCad batteries if rechargeable batteries are desired Directions for Use Introduction 11 Inserting new batteries Before inserting new batteries in the battery compartment always inspect batteries for leakage and do not use batteries that show any signs of damage 1 Insert the batteries starting with the battery slot farthest from the slot that is not used Be sure to match the side of the battery with the marked side for each battery slot 2 Place the side of the battery in at an angle and then push down on the side of the battery until the battery fits securely 3 Replace the battery compartment cover by inserting the square pegs into the slots and gently pushing down until the tab snaps into place and the compartment door is flush with the bottom of the AM282 Audiometer 12 Introduction Welch Allyn AM282 Audiometer 2 13 Operation Preliminary check Throughout this chapter are references to front panel F and rear panel R connectors controls and indicators Please refer to Rear panel connectors on page 5 Controls and indicators on page 7 and LCD display on page 8 of this manual for specific descriptions and locations 1 Prior to testing ensure that the power cord or the batteries are in place and earphone cords are plugged in securely 2 Turn the audiometer on 3 Select the desired tone type steady pulsed or FM
8. in order to show continued compliance to IEC and UL 60601 1 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 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 Symbols on the AM282 Audiometer 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 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 CATAL
9. C power 1 Turn the system OFF 2 Disconnect the power supply from the wall outlet 3 Remove the power supply from the rear panel Battery operation The AM282 Audiometer requires 5 x 1 5V AA alkaline batteries It can also use 5 x 1 2V AA NiMH or NiCad batteries if rechargeable batteries are desired The AM282 Audiometer does not have a built in charger rechargeable batteries should be purchased with the recommended charger for those batteries Welch Allyn recommends the purchase of extra rechargeable batteries to ensure a fully charged supple of batteries will be available The system was designed to operate for 10 hours on rechargeable batteries Alkaline batteries may last longer than 10 hours Sleep mode When using battery power the AM282 Audiometer will enter a power saving mode this is called sleep mode and is indicated by dashes on the LCD display if the buttons on the Front Panel have not been pressed for 5 minutes To exit the sleep mode press the Presentation button WARNING Use only the Welch Allyn 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 120VAC Caution Remove the batteries from the AM282 Audiometer if it is not going to be used for an extended time 10 Introduction Welch Allyn AM282 Audiometer Low battery indicator When there is approx
10. OG NUMBER 6 Introduction Welch Allyn AM282 Audiometer Bottom panel 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 Symbol Description B1 Serial number of system B2 Battery compartment See Replacing the batteries on page 10 for detailed instructions B1 B2 Directions for Use Introduction 7 Controls and indicators F1 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 F2 Liquid Crystal Display LCD F3 Selects steady stimulus tone type The symbol is shown in the upper right hand corner of the display when selected F4 Selects pulsed stimulus tone type The symbol is shown in the upper right hand corner of the display when selected F5 Selects frequency modulated stimulus tone type FM is shown in the upper right hand corner of the display when selected F6 Selects the calibration file for external headset transducers When the button is pressed the display will flash Press the button again to engag
11. 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 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 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 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
12. Welch Allyn AM282 Audiometer Directions for use Part Number 28204 Rev D 10dB R L dB HL Ref ANSI S3 6 ISO 389 Hz FM dB HL Hz R AC PWR 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
13. curacy 125 to 4000 Hz 3 dB 6000 to 8000 Hz 5 dB Signal to Noise Ratio gt 70 dB Rise Fall Time 20 50 msec Continuous Steady when present bar depressed Pulsed 2 5 pulse sec FM 5 5 Hz Triangular modulation Capacity Minimum of 10 hours of power for either battery type DD45 External Headset Earphones with Type 51 Cushions 10 ohm impedance Headband Exerts a force between 4 and 5 N when the earphones are separated by 145 mm Line Voltage The AC DC adapter is a universal auto ranging with an input voltage range of 90 264V at 47 63 Hz Consumption 1 5 Watts Battery Types 5 each Alkaline AA 1 5V 5 each Rechargeable Nicad or NIMH AA 1 2V Note The instrument does not provide a recharging circuit for these batteries Capacity Minimum of 10 hours of power for either battery type A Low Battery icon will display when there is approximately 1 hour of power remaining Operating Temperature 59 F to 104 F 15 C to 40 C Note Warm up time is required if storage temperature is different from room temperature Ambient Pressure 98 kPa to 104 kPa Warm up Time 10 minutes for instruments stored at room temperature Storage Shipping 30 F to 149 F 34 C to 65 C Battery Storage 4 F to 105 F 20 C to 40 C Humidity 15 to 95 Directions for Use Standards Specifications and Accessories 25 Mechanical Electromagnetic Compatibility Electromagnet
14. e cushions with the slightly damp cloth Prevent moisture from entering the speaker portion of the earphones Routine calibration check The length of time that an audiometer should be operated before re calibration varies depending upon the use and treatment of the instrument and its headset It is recommended that the instrument be fully calibrated by a certified Welch Allyn technician annually It is recommended that a biologic calibration check is established as soon as the instrument is received 1 Make several careful tests of the operators hearing and record the results properly on the audiogram cards provided with the instrument WARNING It is recommended that all repairs be performed by a qualified service representative Any malfunctions resulting from improper maintenance or repair by anyone other than an authorized representative will void all warranties 20 Routine Maintenance Welch Allyn AM282 Audiometer 2 Conduct similar tests with several young adults on whom subsequent retests may be made Record the results on the audiogram forms 3 File these audiogram forms where they will be readily available for comparison with future results If the AM282 Audiometer is to be used to monitor employee thresholds as part of an industrial Hearing Conservation Program this biological listening check must be done at the beginning of each day the audiometer is to be used per CFR 1910 95 Occupational Noise Exposure March 8
15. e the external headset transducer The symbol is shown on the right side of the display when selected F7 Selects internal earphone calibration file for transducers When the button is pressed the display will flash Press the button again to engage the internal earphone transducers The symbol is shown on the right side of the display when selected F8 Control for setting the stimulus frequency Frequency is indicated in the bottom center of the display F9 Select to present the stimulus to the Left ear An L will appear in the lower right side of the display to indicate the stimulus is being routed to the left ear F10 Present bar for stimulus presentation The symbol appears on the left side of the display when the stimulus is being presented F11 Select to present the stimulus to the Right ear An R will appear in the lower left side of the display to indicate the stimulus is being routed to the right ear F12 Hearing Level knob for setting the stimulus intensity level Level is indicated on the center top of the display Note The symbol is located on the rear panel of the AM282 Audiometer and denotes a Type B applied part 8 Introduction Welch Allyn AM282 Audiometer LCD display Legend Icons LEDs Description 1 AC PWR Indicates power is on 2 SW VERSION Indicates the current software version 3 When displayed the stimulus is being presented 4 When displayed an additional 10dB is ava
16. est to ensure the subject understands the task If there is a difference of 20 dB or more between two successive octaves test the inter octave responses i e 750 1500 3000 Hz Record this information on the audiogram form 3 Repeat for the other ear Note Down 10 dB Up 5 dB 18 Operation Welch Allyn AM282 Audiometer 3 19 Routine Maintenance Preventive maintenance To maximize the service life of the audiometer and headset the following is recommended 1 Turn the instrument off when not in use 2 Dust the instrument occasionally with a soft dry cloth 3 Wipe the headset cords and ear cushions occasionally with a warm damp cloth 4 Leave the earphones connected to the audiometer permanently to minimize straining the connections Should it be necessary to remove the headset always grasp the barrel of the connecting plugs and pull straight out never pull on the cords 5 Avoid dropping the earphones or snapping them together as this could affect the calibration accuracy Cleaning patient contact reusable devices To help ensure patient safety prevent cross infection and provide effective service Welch Allyn devices must be properly maintained Maintenance should include cleaning before each use The earphone cushions and patient hand switch can be wiped with a slightly damp cloth containing soap and water isopropyl alcohol ammonia based cleaners or bleach based cleaners Gently wipe the earphon
17. g individuals because they hold the subject s attention better than the steady tone Typical testing session Pretest review 1 Turn the instrument on 2 Check that the earphones are operating properly 3 Seat the subject comfortably in the test area 4 Explain the test procedure 5 Place the earphones on the subject 6 Select the desired tone type Familiarization 1 Select the transducers Directions for Use Operation 17 2 Select the L or R pushbutton to route the test tone to the selected ear 3 Demonstrate the 1000 Hz tone at a 50 dB level The tone duration should be between 1 and 2 seconds 4 Repeat at 40 dB Hz Determining the threshold Pure Tone 1 Present the first tone at 50 dB in the subjects better ear or if no preference the right ear Decrease the intensity in 10dB steps until the subject no longer responds Increase the intensity in 5dB steps until the patient responds 2 The threshold is considered to be the lowest intensity at which a response has occurred two out of three times Record this setting on the audiogram form using the appropriate symbol for L X or R O Testing procedure 1 A suggested order in which to present frequencies is as follows 1000 Hz 500 250 repeat 1000 2000 3000 4000 8000 Hz An alternative order is as follows 250 Hz 500 1000 1000 again 2000 3000 4000 8000 Hz 2 The 1000 Hz retest is to verify the results of the t
18. ic compatibility EMC Please refer to the Electromagnetic Compatibility Reference Guide on CD part number 482 6387xx for EMC information concerning your system Accessories Dimensions 12 59 W x 8 76 D x 3 18 H 32 cm W x 22 3 cm D x 8 1 cm H Weight 2 55 lbs 1 16 Kg with 5 AA batteries Welch Allyn Part Number Welch Allyn Description 28200 AM282 Manual Audiometer with Case 28201 AM282 Power Supply 28202 AM282 Carry Case 28203 DD45 Audiometry Headset External 28204 AM282 Directions for Use Manual printed English only 28205 AM282 Directions for Use Manual printed French only 28206 Threshold Audiometry Card 28207 AM282 Power Plug 28208 AM282 Audiogram Forms 1 pad of 50 28210 Audiometry Y Cord Headset 2 Plug Shielded 23220 Audiometry Patient Response Switch 23221 Audiometry Single Patch Cord 2 Conductor 23222 Audiometry Audiocups 26 Standards Specifications and Accessories Welch Allyn AM282 Audiometer A A Appendix A DD45 External Headset RETSPL Values for NBS 9A Coupler ANSI S3 6 and ISO 389 2 Reference Thresholds for ER3A ER5A Internal Earphones with Rigid Tube Frequency Hz 125 250 500 750 1000 1500 2000 3000 4000 6000 8000 R L dB 47 5 27 0 13 0 6 50 6 0 8 0 8 0 8 0 9 0 20 5 12 0 Frequency Hz 125 250 500 750 1000 1500 2000 3000 4000 6000 8000 R L dB 26 14 0 5 5 2 0 0 2 0 3 0 3 5 5 5 2 0 0 B Appendix
19. ilable at the test frequency 5 When displayed indicates the Patient Response button is being pressed 6 R Stimulus is being presented to the right ear 7 Stimulus frequency indicator 8 L Stimulus is being presented to the left ear 9 Indicates the battery is low 10 The headset calibration file is applied to the stimulus and Headphones should be used Press this button twice to activate the calibration file 11 The insert phone calibration file is applied to the stimulus and Insert phones should be used as the transducer Press this button twice to activate the calibration file 12 FM The stimulus is a Frequency Modulated FM tone 13 The stimulus is a continuous tone 14 The stimulus is a pulsed tone 15 Stimulus presentation level Not enough power from the batteries to operate the system or Directions for Use Introduction 9 AC power An AC power supply can be purchased to use with the AM282 Audiometer Connecting the AC power 1 Ensure the system is turned off while connecting the AC Power 2 Plug the AC power supply into the power supply receptacle located next to the power switch on the rear panel 3 Connect the power cord to the Power Supply brick 4 Plug the Power cord into the wall socket 5 Turn the power ON When the power supply is plugged into the unit the power from the batteries will be switched off automatically to preserve battery life Disconnecting the A
20. imately 1 hour of battery time left the icon will be displayed on the screen When the battery can no longer provide enough power to operate the AM282 Audiometer the word OFF will be displayed on the LCD and the system will no longer function At that point replace the batteries with new or fully charged batteries or use the AC Power Module to continue testing Replacing the batteries Removing the batteries The battery compartment on the AM282 Audiometer is located on the bottom of the base unit To open the battery compartment 1 Gently squeeze the tab toward the door and away from the concave half circle and lift the door upward 2 Reach into the compartment through the empty battery slot and gently force the battery up until it is free from the silver battery contacts 3 Repeat for all 5 batteries Do not simultaneously touch both sides of the battery contacts at any time WARNING Do not touch the patient and the battery terminals at the same time The battery cover is to be closed at all times except when replacing the batteries Batteries are to be replaced only by qualified personnel Always turn off the system before replacing the batteries Always inspect batteries for leakage and do not use if the batteries show any signs of damage The batteries should be the same type When replacing batteries replace all of the batteries at the same time for optimal battery life The AM282 Audiometer requires 5 x 1 5V AA
21. m noise at levels above 60 dB is permissible Below 60 dB however only the signal should be audible Any of these noises can be confused with the signal by naive subjects and affect the accuracy of the audiogram Schedule the audiometer for immediate service if any audible hum or noise is detected for clarity Distortion and frequency shift This check can be best made by listening to the output of the AM282 Audiometer through the earphones while presenting all 11 frequencies at a loud but not uncomfortable level 70 to 80 dB HL for normal ears Listen for rattling rasping or distortion in the tones presented Listen also to verify that signal frequencies change appropriately when the frequency selector is moved to a new position If distortion is heard in one earphone but not in the other the chances are high that the earphones are at fault and should be replaced In any case the audiometer should be scheduled for immediate maintenance Directions for Use Routine Maintenance 21 Special messages The AM282 Audiometer performs a self check each time the instrument is turned on the self check does not occur when instrument operation resumes from the sleep mode Certain messages will be displayed on the front panel LCD if any error in the instrument operation is detected These messages are described below Cal When a transducer or frequency is selected that has a calibration error e g right ear selected at 2000 Hz the wo
22. minate all obstruction between earphone and subject hair eyeglasses earrings hearing aids etc b Adjust the headband so the earphone cushions are centered over the ears and head The earphone cushions will put firm pressure on both ears Response handswitch If the optional response handswitch is used ensure that the plugs and jacks are properly connected Welch Allyn Audiogram Form The Welch Allyn Audiogram Form consists of three distinct parts Space for entering personal information about the subject to be tested A convenient chart for manually plotting test data Space for entering comments about the subject or the test Routine test administration Transducer selection The AM282 Audiometer provides options for either headset or insert transducers Selecting the will apply the calibration values for the headset Selecting the will apply the calibration values for the insert earphones To make the selection for the headset press the button and the headset icon will flash on the LCD 10 0 10 20 30 40 50 60 70 80 90 100 110 120 16 Operation Welch Allyn AM282 Audiometer To confirm the selection push the button again To make the selection for insert earphones press the button and the insert earphone icon will flash on the LCD To confirm the selection push the button again See Appendix A on page A for applied refere
23. nce threshold values RETSPL for both the external headset and the internal earphones HL knob The HL knob increases or decreases the signal intensity in 5 dB increments Rotating the Control knob clockwise increases the intensity counterclockwise decreases intensity When the maximum or minimum available intensity is reached for any frequency the display will flash Range Extension pushbutton This control allows the operator to present tones of up to 10 dB above the standard maximum HL at any frequency It will only function when the intensity is set within 10 dB below the maximum standard intensity at any frequency This feature requires an extra step to access the highest available intensities It prevents accidental presentation of the highest intensities to normal subjects To enable the range extension feature press the button labeled 10 dB while the intensity is at the maximum for that frequency Note that a sign appears on the LCD To disable the feature either press the button a second time reduce the intensity with the HL control knob to 20 dB below the standard maximum HL or change any other parameter Frequency or Routing Tone Type selector This control allows you to choose the type of tone presented to the test subject It can be set on steady pulsed 2 5 pulses per second or FM warble tone Pulsed tones and warble tones are often used with difficult to test subjects such as children and hard of hearin
24. nduction 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 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 go
25. ning reliable records of hearing thresholds should be staffed and supervised by appropriately trained individuals 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 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
26. nly Welch Allyn recommended accessories and supplies 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 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 Latex is not used any where in the manufacturing process The base material for the earphone cushions is made from natural and synthetic rubber Customer Responsibility 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 obtai
27. od 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 Note The AM282 Audiometer should be calibrated yearly or sooner if a problem develops by a Welch Allyn certified technician See Chapter 3 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 Optional Accessories Recycling disposal 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 28202 AM282 Carry Case 28207 AM282 Power Plug 28201 AM282 Power Supply 28206 Threshold Audiometry Card 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 o
28. rd CAL will be displayed The audiometer will not function at this frequency with this ear selected to prevent invalid results The word CAL will be displayed as long as the erroneous ear and frequency settings are selected If the calibration error is an isolated situation changing either the frequency or the ear will restore normal instrument function As in the case with any instrument malfunction a certified service technician should be contacted immediately Remember to make note of the combination of selected ear and frequency that cause the CAL message Exx When an error code consisting of an E and a two digit number xx number appears on the audiometer s display a system error has been detected The AM282 Audiometer will enter a lockout mode which will not permit the instrument to operate The specific error code will remain on the display for several seconds then the instrument will shut itself down completely Should an Exx appear on the LCD take the following steps 1 Power down power up again This could be only a temporary failure and may never appear again However should the Exx message appear again proceed to the following a Write down the numbers displayed on the display b Contact a certified Welch Allyn service representative and give them the numbers you recorded 22 Routine Maintenance Welch Allyn AM282 Audiometer 4 23 Standards Specifications and Accessories
29. s during storage to prevent damage from mechanical shock Note The generic term subject used in this manual is used to identify the person whose hearing is being evaluated 14 Operation Welch Allyn AM282 Audiometer Tests should be performed in a quiet area Test environment Excessive noise in the test environment can reduce test validity by masking test tones The test site should be away from conversation printers hallway traffic outside auto traffic and other noise producing environments An acoustically tested room may be required if room noise at the subject s ears reaches objectionable levels Audiocups are available from Welch Allyn as an optional accessory for use with the external headset headphones Insert earphones are another option in noisy test environments They provide greater than 30 dB reduction of external noises If the test subject is in the same room as the audiometer it is recommended that the subject be seated about 1 meter approximately 3 feet away from the instrument Maximum permissible test environment sound pressure levels are specified by American National Standard Criteria for Permissible Background Noise during Audiometric Testing S3 1 1977 revised The table below shows the maximum background levels that can be present inside the room while a valid hearing test is being conducted For more comprehensive information about hearing testing and hearing conservation refer to the Bibliograph
30. 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
31. y Ears covered with earphone mounted in MX 41 AR cushion Providing patient instructions Put the subject as much at ease as possible before the test begins In addition help the subject understand how the test is to be conducted and what the subject will hear Uniform and unvarying instructions should be given to each subject in order to achieve consistent and reliable test results The following is an example of standard instructions I am going to place these earphones over your ears You will hear tones or beeping sounds which may be loud or soft Whenever you hear or think you hear one of these tones raise your hand Lower your hand when you no longer hear the sound Remember raise your hand when you hear the tone and lower your hand when you do not Modify the instructions accordingly if the optional response handswitch is to be used Placing the earphones Proper placement of the earphones on the ears is essential to achieve reliable test results WARNING Any program aimed at obtaining reliable records of hearing thresholds should be staffed and supervised by appropriately trained individuals Training courses leading to certification are available for audiometric technicians in most urban areas Test Tone Frequency Hz 125 250 500 750 1000 1500 2000 3000 4000 6000 8000 Test Room Maximum dB SPL 34 5 23 0 21 5 22 5 29 5 29 0 34 5 39 0 42 0 41 0 45 0 Directions for Use Operation 15 a Eli
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