AmpliVox 116 User manual

OM006-12 Model 116 Operating Manual Page 1
Model 116
Operation Manual

ABOUT THIS MANUAL
READ THIS OPERATING MANUAL BEFORE ATTEMPTING TO USE THE
INSTRUMENT.
This manual is valid for the Model 116 (applies from firmware version
4v47 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.ltd.us
For all enquiries please contact us under:
Tel: [phone]
Fax: [phone]
[email protected].uk
Tel: [phone]
Fax: [phone]
[email protected].us

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 1
1.5 Optional accessories 2
2 Important Safety Instructions 2
2.1 Precautions 2
2.2 Electromagnetic compatibility (EMC) considerations 3
2.3 Power supply options 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 9
3.6 Printing audiograms 10
3.7 Data transfer to Audibase or AudiView 10
4 Suggested Sequence of Operation and Test Procedure 10
5 Specification 13
5.1 Output data 13
5.2 Maximum hearing levels provided at each frequency 14
5.3 Physical Data 14
5.4 Equipment classification 14
6 Symbols 15
7 Technical Information 15
8 Routine Maintenance 16
8.1 Audiometer maintenance 16
8.2 Transducer maintenance 17
8.3 Mains adapter maintenance 17
8.4 Batteries 17
9 Instrument Storage and Transportation 18
10 Calibration and Repair of the Instrument 18
11 Guarantee 18
12 Ordering Consumables and Accessories 19
13 Disposal Information 20
Appendix 1 - EMC Guidance & Manufacturer’s Declaration 21
Appendix 2 - Use with Non-medical Electrical Equipment 27

OM006-12 Model 116 Operating Manual Page 1
1 Introduction
Thank you for purchasing an Amplivox audiometer. The Amplivox Model
116 is a manual screening audiometer that will give many years of reliable
service if treated with care.
1.1 Intended applications
The Model 116 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 is not intended for use by hearing specialists to determine the
full extent and scope of a patient’s hearing deficiency.
The instrument is completely portable, and if required may be specified to
operate from integral internal batteries (see Section 2.3 below). 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.
1.4 Standard contents
Model 116 Audiometer Audiometric headset
Carrying case Patient response switch
Mains adapter Audiogram cards
Operating manual & AudiView Calibration certificate

Page 2 OM006-12 Model 116 Operating Manual
1.5 Optional accessories
Battery power function Additional audiogram cards
Audibase software USB Cable
Printer(s) Printer cable(s)
Audiocups (noise reducing earphone enclosures)
2 Important Safety Instructions
The Model 116 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.
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.

OM006-12 Model 116 Operating Manual Page 3
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 Power supply options
The audiometer is designed for continuous operation and may be
powered either by a mains adapter (which is supplied, and specified as
part of the equipment) or optional internal batteries.
Battery operation
To fit batteries (if configured for this option), remove the battery
compartment cover on the base of the audiometer, fit the 4 x 1.5V ‘C’
batteries supplied (UK only) according to the indications on the battery
holder and replace the battery cover.
Batteries should only be changed outside the patient
environment. The operator should not touch the
battery connectors and the patient simultaneously.
Note: If using batteries, the instrument will automatically switch off
approximately 90 seconds after the last key was pressed in order to save
battery power. Any test results will be automatically saved.
The display will show “Low Batt” when the battery voltage is low. It is
advisable to change the batteries as soon as this happens. Once the

Page 4 OM006-12 Model 116 Operating Manual
voltage of the batteries is too low to operate the instrument, the message
“Replace Battery” will appear. Note that local regulations are likely to
cover disposal of used batteries.
Mains operation
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.
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.
If a replacement mains adapter is required, please contact Amplivox or
your Amplivox distributor.
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 *

OM006-12 Model 116 Operating Manual Page 5
The relevant part numbers are indicated in Section 12
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 Model 116
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 3.6). 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 3.7). You must use
the designated USB cable which is available from Amplivox (see Section
12).

Page 6 OM006-12 Model 116 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 the switch marked again, or 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 designated
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), LEFT (NO), RIGHT
(YES) and FREQUENCY (MENU SELECT). The use of these keys is
described below.

OM006-12 Model 116 Operating Manual Page 7
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 (see also Section 3.5)
Contrast: Adjust contrast using the SIGNAL  keys
Store on 2 of 3?: If activated a hearing threshold will be stored
automatically when the patient makes a
response to 2 out of 3 tone presents (see
Section 3.5.2)
Default level: Adjust the default tone presentation level using
the SIGNAL  keys
Select printer: Use the SIGNAL  keys to select either the
Able AP1300 or the Sanibel MPT-II printer
3.4.3 Description of Function of Other Keys
PRINT Press to print the threshold levels displayed
(see Section 3.6)
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

Page 8 OM006-12 Model 116 Operating Manual
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
PULSE/CONSTANT Press this key once to enable the pulse tone
present function when the PRESENT key is
operated (“Pulse” is displayed); press the key
again to enable constant tone presentation (the
indicator above the key illuminates green) and
use the PRESENT key to interrupt the tone;
press the key once again to return to default
+20dB This enables tone levels to be presented with
up to 20dB higher output; press the key and
then use SIGNAL to access the extra 20dB
in 5dB steps; an indicator above the key
illuminates green to show that the function is
active Note: this function will not operate if
constant tone presentation has been
enabled
WARBLE When selected, the instrument presents a
warble tone a green indicator above the key is
used to show that the function is active; this
feature may be used in conjunction with the
PULSE/CONSTANT key
FREQUENCY Press the key to select a lower frequency
and the key to select a higher frequency
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; when the
key is released the output levels return to their
default values

OM006-12 Model 116 Operating Manual Page 9
PRESENT Press to present the displayed test signal to the
patient. The “PRESENT” indicator above the
display will be illuminated green during tone
presentation.
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 3.6), or transfer the results to a computer (see Section 3.7).
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

Page 10 OM006-12 Model 116 Operating Manual
To clear the Threshold Retention memory, use the Clear Test menu
option described in Section 3.4.2.
3.6 Printing audiograms
Two designated thermal printers (the Able AP1300 or the Sanibel MPT-II)
are available as options for use with the Model 116 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 that the printer is fully charged, switched on, loaded with paper
and ready to print.
Press the PRINT key and on the prompt “Is printer ready?” press the
YES key. The audiogram will then print. To cancel press NO.
3.7 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. 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.

OM006-12 Model 116 Operating Manual Page 11
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.
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 Patient instructions
The patient should be given the following instructions using the
TALKOVER function:
“As soon as you hear the tone, press the response switch. When you
no longer hear the tone release the response switch”
4.5 Pre-test
Operator
Audiometer
Computer (optional)
Patient, wearing headset
Headset lead
Response switch & lead

Page 12 OM006-12 Model 116 Operating Manual
(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 3.5.2) and that a
patient response switch is in use
(5) Prepare the test environment & patient (see Sections 4.1 to 4.4)
(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) Select the better hearing ear (according to the patient) by pressing
either the LEFT or RIGHT key and start the familiarisation session.
4.6 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 4.7 and start measuring the patient’s hearing
thresholds; if not, repeat the familiarisation process
4.7 Test
(1) Present the first test tone at 30dB at 1kHz
(2) 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
(3) If the patient does not respond, increase the signal level in 5dB steps
until there is a response and then continue with step 4.
(4) Repeat the test by reducing the signal level in 10dB steps until the
patient no longer responds. Then increase the signal level in 5dB
steps until they do respond and note this level.
(5) Repeat step 4 until the patient responds three out of a maximum of
five times at the same signal level. This indicates the patient’s hearing

OM006-12 Model 116 Operating Manual Page 13
threshold level for that frequency. Either mark the threshold on an
audiogram card or press the appropriate ear key once to activate the
Threshold Retention Function and save the threshold level on screen.
(6) Proceed to the next test frequency. It is common practice to test the
frequencies in the following order: 1k, 2k, 3k, 4k, 6k, 8k and 500 Hz.
(7) Repeat steps 1 to 6 for the other ear.
4.8 Post-test
(1) Use the Threshold Retention Function to review the results (See 3.5)
(2) If required do one or more of the following:
Record the results on an audiogram card, or
Print the results (Section 3.6), or
Transfer the results to a computer (Section 3.7)
Refer to Section 3.4.2 to clear the thresholds at the end of a test and, if
required, switch off the audiometer.
5 Specification
5.1 Output data
Outputs: Left and Right earphone
Frequency range: 125Hz to 8kHz
Frequency accuracy: <1%
Distortion: <2%
Output level range: -10dBHL min; see Section 5.2 for maximum
Output level accuracy: Within 3dB
Output level step size: 5dB
Output transducer: DD45 earphones (supplied)
Tone present: Single, warble or pulsed
Communication: Integral talk over facility
USB interface: Transfer of test results to a computer

Page 14 OM006-12 Model 116 Operating Manual
5.2 Maximum hearing levels provided at each frequency
Frequency,
Hz
Air conduction,
dBHL (DD45)
Frequency,
Hz
Air conduction,
dBHL (DD45)
125
70
2000
100
250
80
3000
100
500
90
4000
100
750
100
6000
100
1000
100
8000
80
1500
100
5.3 Physical Data
Display: 2 lines of 24 characters
Battery power (optional): 4x1.5V “C” cells (alkaline recommended)
Mains power: 100-240Vac; 50/60Hz; 0.4A
Dimensions: 270mm long x 175mm deep x 68mm high
Weight (no batteries): 0.75kg (approx)
Safety: IEC 60601-1 (plus UL, CSA & EN deviations)
EMC: IEC 60601-1-2
CE mark: To the EU Medical Device Directive
5.4 Equipment classification
Type of protection against electric shock Powered via SELV
ClassII mains adapter
Degree of protection against electric shock Type B applied part
Degree of protection against ingress of water Not protected
Mode of operation Continuous operation
Equipment mobility Portable
The Model 116 Audiometer is classified as a Class IIa device under Annex
IX of the EU Medical Devices Directive. It is intended for use as a
screening audiometer instrument.

OM006-12 Model 116 Operating Manual Page 15
6 Symbols
The following symbols appear on the audiometer or mains adapter:
Definition: Refer to instruction manual (mandatory).
Definition: Type B applied part –an applied part
providing protection against electric shock, particularly
regarding allowable patient leakage current and patient
auxiliary current.
The applied parts are the left & right earphones, patient
response switch and the associated cables.
Definition: The output from the mains AC adapter is
Direct Current.
Definition: Class II equipment –equipment in which
protection against electric shock does not rely on basic
insulation only, but in which additional safety precautions
such as double insulation or reinforced insulation are
provided, there being no provision for protective earthing
or reliance upon installation conditions.
7 Technical Information
Audiometer
Audiometer type: Type 4 (IEC 60645-1:2001)
Type 4 (ANSI S3.6:2004)
Battery function
Battery voltage range: 4.0 to 6.0V
Low battery warning: Approx 4.4V
Expected battery life: 6 to 8 hours use from alkaline batteries
Frequency Modulation
Carrier frequencies: 125Hz to 8kHz as per pure tones
Modulation waveform: Sinusoidal
Rising and falling symmetry: Symmetrical on linear frequency scale

Page 16 OM006-12 Model 116 Operating Manual
Modulating frequency: 15.625Hz
Frequency deviation: +/-10%
Transducers
Types and reference levels: DD45: ISO 389-1, Table 2
Static headband force: Headphones: 4.5N
Sound attenuation characteristics: ISO8253-1, Table 3
Earphone Sound Attenuation Characteristics
Frequency, Hz
125
250
500
1000
2000
4000
8000
Attenuation, dB
2
5
7
15
25
31
23
Environmental
Operating temperature: +15oC to +35oC
Operating humidity: 30% to 90% (non-condensing)
Atmospheric pressure: 700 hPa to 1060 hPa
Input / Output
Power input: 2.5mm barrel-type socket.
Patient response input: 6.3mm Jack socket
Left & Right outputs: 6.3mm Jack socket
USB: Type B socket
Printer: RJ12 socket (6-way)
Maximum voltage at any output: 12V peak
8 Routine Maintenance
8.1 Audiometer maintenance
The Model 116 audiometer is a precision instrument. Handle it carefully in
order to ensure its continued accuracy and service. When cleaning the
instrument, first disconnect it from the mains supply. Use a soft cloth and
mild detergent to clean the instrument panel when required. Refer to ISO
8253-1 for additional guidance.