AmpliVox ER75 User manual

ER75 Electro-Acoustic
Ear Simulator
Operating Manual

ABOUT THIS MANUAL
READ THIS OPERATING MANUAL BEFORE ATTEMPTING TO USE THE INSTRUMENT.
This manual is valid for the ER75 Electro-Acoustic Ear Simulator.
This product is manufactured by:
Amplivox Ltd.
6 Oasis Park, Eynsham
Oxfordshire, OX29 4TP
United Kingdom
www.amplivox.ltd.uk
Amplivox Ltd.
10393 West 70th Street
Eden Prairie
MN 55344
www.amplivox.us
For all enquiries please contact us under:
Tel: [phone]
Fax: [phone]
[email protected]k

For supply in US only
Caution: Federal Law restricts this device to sale by or on the order of a licenced medical professional.

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D-0115622-C (OM011) –ER75 Operating Manual
TABLE OF CONTENTS
1. Introduction..........................................................................................................................................................1
1.1. Thank you .....................................................................................................................................................................1
1.1. Intended applications...................................................................................................................................................1
1.2. Unpacking .....................................................................................................................................................................1
1.3. Standard contents and optional accessories................................................................................................................1
1.4. Warranty card (UK Customers only).............................................................................................................................1
1.5. Guarantee.....................................................................................................................................................................1
1.6. Warnings.......................................................................................................................................................................1
2. Important Safety Instructions ...............................................................................................................................2
2.1. Precautions...................................................................................................................................................................2
2.2. Electromagnetic compatibility (EMC) considerations ..................................................................................................2
3. Using the ER75 ......................................................................................................................................................3
3.1. Installing & replacing batteries.....................................................................................................................................3
3.2. Low Battery Indication..................................................................................................................................................3
3.3. Service Indication .........................................................................................................................................................3
3.4. Switching on and Off ....................................................................................................................................................3
3.5. Testing the Response Indicator ....................................................................................................................................4
3.6. Sequence of Operation and Suggested Test Procedure ...............................................................................................4
3.6.1. General .........................................................................................................................................................................4
3.6.2. Pre-Test.........................................................................................................................................................................4
3.6.3. Test procedure for manual audiometers......................................................................................................................4
3.6.4. Test procedure for automatic audiometers .................................................................................................................4
3.6.5. Action following test procedure ...................................................................................................................................4
4. Routine Maintenance ...........................................................................................................................................5
5. Verification and Repair of the Instrument.............................................................................................................5
6. Technical Specification..........................................................................................................................................5
6.1. Performance .................................................................................................................................................................5
7. Ordering Consumables and Accessories ................................................................................................................6
8. Disposal Information.............................................................................................................................................6

INTRODUCTION
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D-0115622-C (OM011) –ER75 Operating Manual
1. INTRODUCTION
1.1. THANK YOU
Thank you for purchasing an Amplivox ER75 Electro-acoustic ear simulator. This product will give many years
of reliable service if treated with care.
1.1.INTENDED APPLICATIONS
The intended application of the ER75 is to perform an objective performance check of the pure tone air
conduction output of an audiometer as part of the routine checking regime specified in Clause 12 of ISO 8253-
1:2010. It is not a calibration unit and does not replace the need for regular factory calibration of an audiometer.
1.2.UNPACKING
Please check the contents of the shipping carton against the contents listed below to make sure that all items
ordered have been included. If anything is missing, please contact the distributor who supplied the product or
Amplivox if purchased directly.
1.3.STANDARD CONTENTS AND OPTIONAL ACCESSORIES
STANDARD COMPONENTS
ER75
2 off 1.5V ‘AA’ batteries
Patient response interconnecting lead
Patient response interconnecting lead
Operating manual
1.4.WARRANTY CARD (UK CUSTOMERS ONLY)
Please complete the enclosed warranty registration card and return it to Amplivox. This will enable us to
register your purchase, help with your enquiries and provide technical support.
1.5.GUARANTEE
All Amplivox instruments are guaranteed against faulty materials and manufacture. The instrument will be
repaired free of charge for a period of two years from the date of despatch if returned, carriage paid, to the
Amplivox service department. Return carriage is free of charge for customers in the UK and chargeable for
overseas customers.
1.6.WARNINGS
Throughout this manual, the following meanings of warnings and cautions apply:
The WARNING label identifies conditions or practices that may present danger
to the patient and/or user.
The CAUTION label identifies conditions or practices that could result in damage
to the equipment.
WARNING
CAUTION

IMPORTANT SAFETY INSTRUCTIONS
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D-0115622-C (OM011) –ER75 Operating Manual
2. IMPORTANT SAFETY INSTRUCTIONS
The Amplivox ER75 is not intended for, or capable of, the calibration of an audiometer.
Such a calibration must always be performed using the appropriate specialist equipment
and qualified personnel.
2.1. PRECAUTIONS
READ THIS OPERATING MANUAL BEFORE ATTEMPTING TO USE THE INSTRUMENT
The ER75 is for indoor use only and should be used only as described in this manual.
The ER75 should be used in similar conditions to those used for audiometry (e.g. a quiet room or an acoustic
booth). Ambient noise and/or vibrations through the test bench/table can affect the results.
2.2. ELECTROMAGNETIC COMPATIBILITY (EMC) CONSIDERATIONS
The ER75 meets the appropriate standards for EMC. However portable and mobile radio-frequency (RF)
communications equipment can affect medical electrical equipment and the ER75 should not be used adjacent to
or stacked with other electronic equipment.
WARNING

USING THE ER75
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D-0115622-C (OM011) –ER75 Operating Manual
3. USING THE ER75
3.1. INSTALLING & REPLACING BATTERIES
The ER75 is designed for continuous operation and is powered by batteries.
To fit the batteries, remove the 2 screws in the base of the ER75 and remove the base & back-panel cover by
carefully sliding it down. Fit 2 x 1.5V ‘AA’ alkaline batteries according to the indications on the battery holder.
Replace the cover and refit the screws.
If the instrument is not likely to be used for three months or longer, please remove the batteries from the
instrument.
Batteries should only be changed outside the patient environment. The operator
should not touch the battery connectors and the patient simultaneously.
Note that local regulations are likely to cover disposal of used batteries.
3.2. LOW BATTERY INDICATION
If the power indicator flashes (approximately 3 times per second) when the “on” button is held the batteries
need to be changed.
Place the audiometric headset earphones over the earphone couplers located on the sides of the ER75 such
that there is a secure and consistent fit. Connect the supplied interconnecting lead between the socket on the
ER75 marked “output” and the socket marked “RESPONSE” or “RESP” which is normally located on the back
panel of an audiometer.
If using the ER75 within an acoustic booth, the interconnecting lead should be inserted into the patient response
socket inside the booth in place of the patient response switch.
3.3. SERVICE INDICATION
If the power indicator flashes slowly (approximately once every two seconds) when the “on” button is held the
unit needs to be serviced and the performance verified.
3.4. SWITCHING ON AND OFF
To switch the ER75 on, Press and hold the “on” button until the power indicator illuminates green. The
instrument will automatically power down approximately 2 minutes after last response was made.
WARNING
Earphone couplers
On button
Power indicator
Response indicator
Output socket

USING THE ER75
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D-0115622-C (OM011) –ER75 Operating Manual
3.5. TESTING THE RESPONSE INDICATOR
Present an audiometer tone (1kHz, 80dBHL) and check that the indicators on the ER75 and the audiometer
labelled “response” illuminate green.
3.6. SEQUENCE OF OPERATION AND SUGGESTED TEST PROCEDURE
3.6.1. GENERAL
In use the ER75 simulates the actions of a patient responding to an audible stimulus. If a tone level greater than
approximately 75dBHL is provided via the audiometric headset a response signal is output to the audiometer.
The ER75 can detect tones at a range of audiometric frequencies and may be used with Amplivox audiometers
operating in both manual and automatic modes.
3.6.2. PRE-TEST
(1) Set the audiometer up as normal with the exception of the patient response switch which should remain
unconnected
(2) Place the earphones over the earphone couplers on the ER75
(3) Connect the patient response interconnecting lead, supplied with the ER75, between the audiometer and
the ER75
(4) Switch the ER75 and the audiometer on.
3.6.3. TEST PROCEDURE FOR MANUAL AUDIOMETERS
(1) Set the audiometer step size to 2.5dB if this facility is available
(2) Present the first test tone at 65dBHL at 1kHz to the left headphone
(3) If the ER75 responds by illuminating the response indicator on the audiometer return the ER75 for
service & verification; if there is no response, move to step 4
(4) Increase the signal level in steps until the ER75 responds - this should occur at approximately 75dBHL;
record this signal level on an audiogram form
(5) Select the next test frequency
(6) Repeat steps 2 to 5, testing the frequencies in the following order: 1kHz, 1.5kHz, 2kHz, 3kHz, 4kHz, 6kHz,
8kHz, 250Hz and 500Hz.
(7) Repeat steps 2 to 6 for the right headphone
3.6.4. TEST PROCEDURE FOR AUTOMATIC AUDIOMETERS
(1) Run the automatic test sequence (using the ‘Bekesy’ test mode if this is available)
(2) Print a copy of the results
(3) If responses are made at any frequency at levels of 65dBHL or less return the ER75 for service &
verification
3.6.5. ACTION FOLLOWING TEST PROCEDURE
Compare the results with the response levels supplied originally with the ER75, or with the most recent
response levels if the ER75 has been re-calibrated. The audiometer should be returned for service &
verification either to Amplivox or to the designated distributor if the two sets of results differ by more than that
specified in the routine checking regime that has been established by the user organization (see ISO 8253-
1:2010).

ROUTINE MAINTENANCE
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D-0115622-C (OM011) –ER75 Operating Manual
4. ROUTINE MAINTENANCE
The ER75 is a precision instrument. Handle it carefully in order to ensure its continued accuracy and service.
When cleaning the instrument use a soft cloth and mild detergent to clean the instrument surfaces and the
earphone couplers. Do not allow any moisture to enter the microphones in the centre of the circular earphone
couplers.
5. VERIFICATION AND REPAIR OF THE INSTRUMENT
Amplivox recommend that the performance of this instrument should be verified on an annual basis. Please
contact Amplivox or the designated distributor for details of verification & calibration services.
The instrument should be returned to the manufacturer for service & repair. There are no user-serviceable
parts within it.
When packing the instrument for shipping, please use the original shipping carton and packing materials.
6. TECHNICAL SPECIFICATION
6.1. PERFORMANCE
Audiometry
Audiometric frequencies
250Hz, 500Hz, 750Hz, 1kHz, 1.5kHz
detected: 2kHz, 3kHz, 4kHz, 6kHz & 8kHz
Frequency detection range
±5% of nominal value
Level to trigger a response
75 dBHL
Response signal duration
1 second (minimum)
Physical
Power (battery)
2 x 1.5V AA cell batteries
Power consumption
120mW operating, 40μW standby
Construction
Plastic
Dimensions
150mm (w) x 110mm (d) x 95mm (h)
Weight (without batteries)
360g
Environmental
Operating temperature range
+15oC to +35oC
Storage & Transportation temperature range
-20oC to +70oC
Storage & Transportation humidity range
10% to 90% (non-condensing)
Storage & Transportation atmospheric pressure
range
500 hPa to 1060 hPa
Standards conformance
Degree of protection against ingress of water
Not protected
Mode of operation
Continuous operation
Equipment mobility
Portable
The ER75 is CE marked to EMC directive and
meets the requirements of the following
standards
EN 61000-6-1:2007
EN 61000-6-3:2007

ORDERING CONSUMABLES AND ACCESSORIES
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D-0115622-C (OM011) –ER75 Operating Manual
7. ORDERING CONSUMABLES AND ACCESSORIES
To order parts, please contact Amplivox Ltd for current prices and delivery charges. The items available are
listed below:
STOCK NO.
DESCRIPTION
A074
Patient response interconnection lead
MANER75
ER75 Operating Manual
8. DISPOSAL INFORMATION
Amplivox Limited is fully compliant with the WEEE (Waste Electrical and Electronic
Equipment) Regulations. Our PRN (Producer Registration Number) is WEE/GA0116XU and
we are registered with the approved WEEE Compliance Scheme, B2B Compliance, approval
number WEE/MP3338PT/SCH.
The main purpose of the WEEE Regulations is to encourage the segregation of waste
electrical items from the general waste stream and into reuse, recovery and recycling routes.
Therefore for any waste electrical units purchased from Amplivox that either:
bear the crossed out wheeled bin symbol with black bar underneath, or
have been replaced with new Amplivox products on a like-for-like basis
please contact our WEEE Compliance Scheme, B2B Compliance, using the details below. B2B Compliance
will be able to provide further information on how to recycle your waste electrical units and answer any queries
you may have.
B2B Compliance
Tel: [phone] (Option 2)
Email: [e-mail]