AmpliVox 170 User manual

Model 170
Operation Manual

ABOUT THIS MANUAL
READ THIS OPERATING MANUAL BEFORE ATTEMPTING TO USE THE
INSTRUMENT.
This manual is valid for the Model 170 (applies from firmware version
2N22 onwards –please refer to section 1.3).
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]
[e-mail]
Tel: [phone]
Fax: [phone]
[email protected]

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

Contents
1 Introduction 1
1.1 Intended applications 1
1.2 Unpacking 1
1.3 Firmware version 1
1.4 Standard contents 2
1.5 Optional accessories 2
2 Important Safety Instructions 2
2.1 Precautions 2
2.2 Electromagnetic compatibility (EMC) considerations 3
2.3 Mains supply operation 3
2.4 Audiometer connections 4
2.5 Data transfer to a printer 5
2.6 Data transfer to a computer 5
3 Using the Audiometer 6
3.1 Switching the audiometer on and off 6
3.2 Testing the patient response switch 6
3.3 Audiometer display 6
3.4 Audiometer controls 6
3.5 Threshold Retention Function 10
3.6 Saving audiograms in internal memory 11
3.7 Loading audiograms from internal memory 11
3.8 Printing audiograms 11
3.9 Data transfer to Audibase or AudiView 12
4 Suggested Sequence of Operation and Test Procedure 12
4.1 Audiometry preparation and ambient conditions 12
4.2 Test system arrangement 13
4.3 Headset 13
4.4 Manual audiometry 13
4.5 Automatic audiometry 15
5 Specification 19
6 Symbols 20
7 Technical Information 21
8 Routine Maintenance 22
8.1 Audiometer maintenance 22
8.2 Transducer maintenance 22
8.3 Mains adapter maintenance 23
9 Instrument Storage and Transportation 23
10 Calibration and Repair of the Instrument 23
11 Guarantee 24
12 Ordering Consumables and Accessories 25
13 Disposal Information 26
Appendix 1 - EMC Guidance & Manufacturer’s Declaration 27
Appendix 2 - Use with Non-medical Electrical Equipment 34

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D-0115687-C (OM008) –170 Operating Manual
1 Introduction
Thank you for purchasing an Amplivox audiometer. The Amplivox Model
170 is an automatic screening audiometer that will give many years of
reliable service if treated with care.
1.1 Intended applications
The Model 170 screening audiometer is designed for use by general
practitioners, occupational health staff and child health professionals and
is the ideal instrument for primary care groups, schools and industry. The
audiometer may also be used for manual audiometry, but it is not intended
for use to determine the full extent and scope of a patient’s hearing
deficiency.
Test results may be printed using the specified printer option or
transferred to a PC running the Amplivox Audibase or AudiView
applications.
1.2 Unpacking
Open the shipping carton and carefully remove all the equipment. Check
against the delivery note that all the accessories ordered have been
included with your audiometer. If anything is missing, please contact
Amplivox Customer Support ([phone]; [e-mail]). If
you have purchased from a distributor you should contact them directly.
Please retain the shipping carton and packing materials as the audiometer
will need calibrating on an annual basis and should be returned to
Amplivox in its original shipping carton.
1.3 Firmware version
This operating manual is for firmware versions 4v47 onwards. To check
the version of firmware on your audiometer press and hold the MENU
button followed by the TALKOVER button.

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D-0115687-C (OM008) –170 Operating Manual
1.4 Standard contents
Model 170 Audiometer Audiometric headset
Carrying case Patient response switch
Mains adapter Audiogram cards
Operating manual & Audiview Calibration certificate
1.5 Optional accessories
Additional audiogram cards
Audibase software USB Cable
Printer(s) Printer cable(s)
Audiocups (noise reducing earphone enclosures)
2 Important Safety Instructions
The Model 170 instrument must be used only by
practitioners qualified to perform audiometric tests. It
is intended for use as a screening tool.
2.1 Precautions
READ THIS OPERATING MANUAL BEFORE ATTEMPTING TO USE
THE INSTRUMENT
To comply with the standards IEC 60601-1 for safety and IEC 60601-1-2
for EMC the audiometer is designed to be used only with the medically-
approved mains adapter supplied, which is specified as part of the
equipment. Do not use any other type of mains adapter with this
instrument. Refer to Section 12 for the stock number of the adapter.
The audiometer is for indoor use only and should be used only as
described in this manual.
The transducers supplied with the audiometer are specifically calibrated
with it; if these transducers are changed calibration will be required.

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D-0115687-C (OM008) –170 Operating Manual
Do not immerse the unit in any fluids. See Section 8 of this manual for the
proper cleaning procedure for the instrument and its accessories.
Do not use the instrument in an oxygen-rich environment or in the
presence of a flammable anaesthetic mixture or other flammable agents.
Do not drop or otherwise impact this instrument. If the instrument is
dropped or damaged, return it to the manufacturer for repair and/or
calibration. Do not use the instrument if any damage is suspected.
The instrument must be stored and used within the specified temperature,
pressure and humidity ranges (see Sections 7 and 9).
Do not attempt to open, modify or service the instrument. Return the
instrument to the manufacturer or distributor for all repair and servicing
requirements. Opening the instrument will void the warranty.
2.2 Electromagnetic compatibility (EMC) considerations
Medical electrical equipment needs special precautions regarding EMC
and needs to be installed and put into service according to the EMC
information provided in Appendix 1. This provides guidance on the
electromagnetic environment in which to operate the instrument.
Portable and mobile radio-frequency (RF) communications equipment can
affect medical electrical equipment. The instrument should not be used
adjacent to or stacked with other equipment; if this is necessary the
instrument should be observed to verify normal operation.
2.3 Mains supply operation
The audiometer is designed for continuous operation and is powered by a
mains adapter which is supplied, and specified as part of the equipment. If
a replacement is required, please contact your Amplivox distributor.
All other connections must be made before connecting the output lead
from the adapter into the POWER input socket on the back of the
audiometer. Switch on the mains supply - the indicator on the adapter and
the POWER indicator on the audiometer will both illuminate green,
showing that the instrument is ready for use.

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D-0115687-C (OM008) –170 Operating Manual
The output from mains adapter is fitted with electronic circuit protection. In
case of overload the adapter will shut down and the indicator will be
extinguished. When the fault is cleared the adapter will operate as normal.
The input to the mains adapter is protected with a non-replaceable fuse. If
this fails the adapter will not operate.
The mains adapter is the mains disconnect device and therefore the
audiometer should be positioned such that easy access to the mains
adapter is possible.
2.4 Audiometer connections
All the relevant accessory terminals and connections are labelled to
ensure correct identification and connection as follows:-
Socket Label
Socket Type
Colour
Code
Connected Part
Notes
RIGHT
LEFT
6.3mm jack
6.3mm jack
Red
Blue
Air conduction headset *
PRINTER
RJ12 socket (6-way)
Printer *
See
2.5
USB
USB Connector
Type B
Computer (via USB port)
See
2.6
N/A
6 pin mini DIN
Reserved port; Amplivox
diagnostic use only
See
below
POWER
2.5mm power jack
Mains AC/DC Adapter *
RESPONSE
6.3mm jack
Black
Patient Response Switch *
The relevant part numbers are indicated in Section 12

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D-0115687-C (OM008) –170 Operating Manual
Note regarding the 6-pin mini DIN connector:
This is a restricted socket for Amplivox use only. No user access is
permitted. For connected parts marked * only connect the
accessories supplied with the instrument or supplied
by Amplivox or an Amplivox distributor. These parts
have been tested for use with the Model170 Screening
Audiometer for compliance with the standards IEC
60601-1 and IEC 60601-1-2. The use of accessories
other than those specified may compromise
compliance with these standards. For other sockets
refer to Appendix 2.
2.5 Data transfer to a printer
Please refer to Appendix 2 for important information
regarding the connection of non-medical electrical
equipment to medical electrical equipment
The audiometer can be upgraded with an option to allow connection to
one of three designated portable thermal printers for printing audiometric
test results (see Section 3.8). You must use the designated cable for each
printer, which is supplied with this option.
Upon receipt of the printer it must be initially charged for a minimum of 15
hours prior to use.
2.6 Data transfer to a computer
Please refer to Appendix 2 for important information
regarding the connection of non-medical electrical
equipment to medical electrical equipment
The audiometer is supplied with software to allow connection to a
computer for the transfer of test results (see Section 3.9). You must use
the designated USB cable which is available from Amplivox (see Section
12).

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D-0115687-C (OM008) –170 Operating Manual
3 Using the Audiometer
3.1 Switching the audiometer on and off
Press and briefly hold the switch marked (located on the back panel).
No warm-up time is required. The display will briefly show the model and
the type of headphone currently in use.
The display will then be similar to that shown in Section 3.3.
To switch off, press and hold the MENU key followed by the YES (RIGHT)
key and then release both.
3.2 Testing the patient response switch
Press the patient response switch and the light labelled RESPONSE
(above and to the right of the display) will illuminate green.
3.3 Audiometer display
On start-up the display will show the following default setting:-
SIGNAL dBHL FREQUENCY Hz
30dB 1kHz
< > < >
This indicates that when the PRESENT key is pressed, a tone will be
presented at 30dBHL at a frequency of 1kHz (1000Hz) to the indicated
ear. On start up the audiometer defaults to the left ear.
3.4 Audiometer controls
3.4.1 Multifunction Keys
Several keys on the audiometer have different functions depending on the
actual mode of operation. These are MENU (OFF), PRINT (RESET),
LEFT (NO), RIGHT (YES), AUTO (RESULTS) and FREQUENCY 
(MENU SELECT). The use of these keys is described below.

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D-0115687-C (OM008) –170 Operating Manual
3.4.2 MENU
Press and hold MENU to access the following options. Use the MENU
SELECT keys to step through the available options and then the NO, YES
or SIGNAL  keys to select an action or modify a setting. Release of the
MENU key then initiates the action or saves the modified setting and
returns to the default display.
Menu Option Description
Switch off?: As described in Section 3.1
Clear test?: Press YES and release MENU to clear the
Threshold Retention Function results from the
previous test
Save audiogram to (1): Use the SIGNAL  keys to select the
required storage location and press the YES
key to save the audiogram; then release MENU
Load audiogram no (1): Use the SIGNAL  keys to select the
required storage location and press the YES
key to load the audiogram; then release MENU
Contrast: Adjust contrast using the SIGNAL  keys;
then release MENU
Print audiogram?: Press YES and release MENU; then press YES
to confirm the print operation or NO to cancel
Use 250Hz in auto?: Press YES to include 250Hz in an automatic
test or NO to exclude from the test
Use 1K5Hz in auto?: Press YES to include 1.5kHz in an automatic
test or NO to exclude from the test
Use 8KHz in auto?: Press YES to include 8kHz in an automatic test
or NO to exclude from the test

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Use familiarization?: Press YES to employ a familiarisation routine at
the start of an automatic test sequence on
either ear (see Section 4.5.2)
Store on 2 of 3?: Press YES to activate automatic storage of the
threshold level at which the patient makes 2 out
of 3 responses in a manual test
Pulse in Manual?: Press the YES key to output a pulse tone in
manual mode
2 of 3 in auto?: Press YES to activate automatic storage of the
threshold level at which the patient makes 2 out
of 3 responses in an automatic test (rather than
the default 3 out of 5)
Default level: Use the SIGNAL  keys to adjust the default
tone presentation level in manual mode
Select printer: Use the MENU SELECT to select either the
Able AP1300 or the Sanibel MPT-II printer
3.4.3 Description of Function of Other Keys
PRINT Press this key to print the current threshold
levels; then press YES to confirm the print
operation or NO to cancel
RESET Press this key during an automatic test to
cancel the test and return to the default display;
any thresholds already found will be retained
+20dB This enables tone levels to be presented with
up to 20dB higher output in manual test mode;
press the key and then use SIGNAL to
access the extra 20dB in 5dB steps; an
indicator above the key is used to show that the
function is active

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D-0115687-C (OM008) –170 Operating Manual
AUTO This initiates an automatic test on the indicated
ear (see Section 4.5)
RESULTS Use this key at the conclusion of an automatic
test to view the results (see Section 4.5.4)
TALK OVER Hold this key to interrupt the test and route the
operator’s voice from the front panel
microphone to the headset; the level is
adjusted with the SIGNAL  keys; if an
automatic test is in progress the current test
frequency will be retested from the default level
when the TALKOVER key is released
LEFT Press once to select the left ear (the indicator
above the key illuminates green); if the left ear
is already selected press again to store the
displayed signal value as a threshold (see
Section 3.5.1)
RIGHT Press once to select the right ear (the indicator
above the key illuminates green); if the right ear
is already selected press again to store the
displayed signal value as a threshold (see
Section 3.5.1)
SIGNAL Press the  keys to decrease or increase
the level of the tone presented in 5dB steps; to
scroll through the range keep the key pressed
FREQUENCY Press the key to select a lower frequency
and the key to select a higher frequency
PRESENT Press to present the displayed test signal to the
patient. The “PRESENT” indicator above the
display will be illuminated green during tone
presentation.

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3.5 Threshold Retention Function
This function records the thresholds for both ears at each frequency
tested. Thresholds may be recorded manually or automatically.
The operator can then review the results at the end of the test and record
them on an audiogram card, print them with the optional printer (see
Section 3.8), save them to the internal memory (see Section 3.6) or
transfer the results to a computer (see Section 3.9).
3.5.1 Recording thresholds manually
Once a threshold has been determined press the “selected” ear key once
again. The threshold will be recorded and displayed as shown in the
illustration in Section 3.5.3. Note: this function will not operate if the
“Store on 2 of 3” option has been enabled (see Section 3.5.2).
3.5.2 Recording thresholds automatically
If the “Store on 2 of 3” option has been enabled (see Section 3.4.2) then a
threshold will be recorded automatically by the audiometer if the patient
makes a response to two out of three manual tone presentations at the
same level and frequency. Thresholds determined using the “Store on 2 of
3” option are displayed within square brackets.
3.5.3 Reviewing retained thresholds
To review the retained thresholds, select the required frequency using the
FREQUENCYkeys. The recorded values for the left and right ears
are shown on the lower line of the display as illustrated below.
SIGNAL dBHL FREQUENCY Hz
30dB 4kHz
20 10
This display shows
thresholds at 4kHz
THRESHOLDS
Left ear 20dBHL
Right ear 10dBHL
To clear the Threshold Retention memory, use the Clear Test menu
option described in Section 3.4.2.

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3.6 Saving audiograms in internal memory
The user may save up to 12 audiograms, referenced by number, in the
internal memory of the audiometer. To save the current set of audiogram
thresholds (these are the “retained” values described in Section 3.5) press
and hold the MENU key, and then press MENU SELECT repeatedly until
“Save Audiogram to 1” appears on screen. Use the SIGNAL  keys to
select a location numbered 1-12, and then press the YES key. Release
the MENU key once confirmation appears on the display.
Note that the Save process will overwrite any records that exist in the
selected memory location.
3.7 Loading audiograms from internal memory
Press and hold the MENU key, and then press MENU SELECT repeatedly
until “Load Audiogram No 1” appears on screen. Use the SIGNAL 
keys to select a location numbered 1-12, and then press the YES key.
Release the MENU key once confirmation appears on the display.
3.8 Printing audiograms
Two designated thermal printers (the Able AP1300 or the Sanibel MPT-II)
are available as options for use with the Model 170 audiometer. The
correct printer must be selected (use the MENU options described in
Section 3.4.2 to make this selection).
Connect the PRINTER socket on the audiometer (6-way RJ12) to the
printer with the supplied cable (refer to Section 2.5 of this operating
manual for printer set-up). Note that the printer cables for the Able
printer (A108) and Sanibel (A102) are not compatible.
Ensure the printer is fully charged, switched on, loaded with paper and
ready to print.
Load the desired audiogram as described in Section 3.7; to print the
current audiogram ignore this instruction.
Press the PRINT key and on the prompt “Is printer ready?” press the
YES key. The audiogram will then print. To cancel the print operation
press NO.

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D-0115687-C (OM008) –170 Operating Manual
3.9 Data transfer to Audibase or AudiView
Test results stored within the audiometer may be transferred to the Amplivox
Audibase database which is available as an option and must be installed on to a
computer (see Section 12 for the part number). Alternatively, Amplivox
AudiView allows data to be transferred to a computer and subsequently viewed,
annotated & printed. This software is supplied on a CD which includes this
operating manual.
Refer to the installation & operating instructions provided with Audibase or
AudiView for further details.
4 Suggested Sequence of Operation and Test Procedure
The following applies to air conduction measurements. For illustrative
purposes 5dB steps are used. Refer also to ISO 8253 for guidance.
4.1 Audiometry preparation and ambient conditions
Refer to the appropriate audiometric standards and other relevant
publications for guidance on audiometric testing.
Audiometric testing should always be performed in quiet conditions (e.g. a
quiet room or an acoustic booth). The optional Audiocups can provide an
additional level of isolation from ambient noise. For further explanation on
permissible ambient noise levels, please refer to the standard ISO6189.

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4.2 Test system arrangement
The schematic diagram below shows a typical example of the use of
audiometric test equipment. The audiometer is located on the desk of a
seated operator as shown.
The patient is seated in front of the desk facing away from the operator.
The patient wears a headset (see Section 4.3) and responds to test stimuli
by use of a hand-held switch which is also connected to the instrument.
4.3 Headset
The headset must be fitted by a qualified person to ensure a proper seal
and a comfortable fit. The leads from the headset are connected to the
instrument and the headset is then fitted to the patient.
4.4 Manual audiometry
4.4.1 Pre-test
(1) Switch the audiometer on
(2) Perform a listening check
(3) Decide whether to use the manual or automatic Threshold Retention
Function and/or an audiogram card to record the thresholds
(4) If the automatic Threshold Retention Function is required ensure that
the Store on 2 of 3 option is enabled (see Section 3.4.2) and that a
patient response switch is in use
(5) Prepare the test environment & patient (see Sections 4.1 to 4.3)
Operator
Audiometer
Computer (optional)
Patient, wearing headset
Headset lead
Response switch & lead

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D-0115687-C (OM008) –170 Operating Manual
(6) If the patient response switch is not being used give instructions to the
patient to acknowledge any tone presented by raising or lowering the
finger
(7) If the patient response switch is in use give instructions to the patient
to acknowledge any tone presented as follows:
“As soon as you hear the tone, press the switch. When you no longer
hear the tone, release the switch”.
(8) Fit the headset to the patient. Select the better hearing ear (according
to the patient) by pressing either the LEFT or RIGHT key and start the
familiarisation session.
4.4.2 Familiarisation
(1) Present the tone 30dB at 1kHz for between 1 and 2 seconds. If there
is no response at 30dB, increase the attenuation level in 10dB steps
until the patient responds
(2) When the patient responds, wait for 1 to 2 seconds and present the
tone again at the same level; however, if the patient does respond at
30dB, reduce the signal level in 10dB steps, repeating the
presentation until there is no response, then increase the signal level
in 5dB steps until the patient responds; wait 1 to 2 seconds and
present the tone again at the same level
(3) If the responses are consistent with the pattern of tone presentation
proceed to Section 4.4.3 and start measuring the patient’s hearing
thresholds; if not, repeat the familiarisation process
4.4.3 Test
(1) Use the Clear test option (see Section 3.4.2) to clear any thresholds
(2) Present the first test tone at 30dB at 1kHz
(3) If the patient responds, reduce the signal level in 10dB steps
repeating the presentation until there is no response; then increase
the signal level in 5dB steps until the patient responds
(4) If the patient does not respond, increase the signal level in 5dB steps
until there is a response and then continue with step 4.