AmpliVox 260 User manual

D-0115700-J
INSTRUCTION FOR USE

ABOUT THIS MANUAL
1 MODEL 260 INSTRUCTION FOR USE
ABOUT THIS MANUAL
READ THIS OPERATING MANUAL BEFORE ATTEMPTING TO USE THE INSTRUMENT.
This manual is valid for the Model 260 (applies from firmware version 2T06 onwards –please refer to section 1.3).
This product is manufactured by:
Amplivox Ltd
3800 Parkside, Solihull Parkway,
Birmingham Business Park, Birmingham,
West Midlands,
B37 7YG
www.amplivox.com
For all enquiries please contact us under:
Amplivox Ltd
10393 West 70th Street
Eden Prairie
MN 55344
United States
Tel: 888 941 4208
Fax: 952 903 4100
Amplivox Ltd
3800 Parkside, Solihull Parkway,
Birmingham Business Park, Birmingham,
West Midlands,
B37 7YG
United Kingdom
Tel: +44 (0)1865 880846

TABLE OF CONTENTS
2 MODEL 260 INSTRUCTION FOR USE
TABLE OF CONTENTS
ABOUT THIS MANUAL 1
TABLE OF CONTENTS 2
1. INTRODUCTION 4
1.1. THANK YOU 4
1.2. INTENDED APPLICATIONS 4
1.3. UNPACKING 4
1.4. FIRMWARE VERSION 4
1.5. STANDARD CONTENTS 4
1.6. OPTIONAL ACCESSORIES 5
2. IMPORTANT SAFETY INSTRUCTIONS 6
2.1. PRECAUTIONS 6
2.2. ELECTROMAGNETIC COMPATIBILITY (EMC) CONSIDERATIONS 6
2.3. MAINS SUPPLY OPERATION 6
2.4. AUDIOMETER CONNECTIONS 7
2.5. DATA TRANSFER TO A PRINTER 8
2.6. DATA TRANSFER TO A COMPUTER 8
2.7. LINE IN/OUT CONNECTION (AUDIO) 8
3. USING THE AUDIOMETER 9
3.1. SWITCHING THE AUDIOMETER ON AND OFF 9
3.2. TESTING THE PATIENT RESPONSE SWITCH 9
3.3. AUDIOMETER DISPLAY 9
3.4. AUDIOMETER CONTROLS 9
3.4.1. Multifunction Keys 9
3.4.2. MENU 10
3.4.3. Description of Function of Other Keys 11
3.4.4. TEST MENU 12
3.5. THRESHOLD RETENTION FUNCTION 12
3.6. SAVING AUDIOGRAMS IN INTERNAL MEMORY 13
3.7. LOADING AUDIOGRAMS FROM INTERNAL MEMORY 13
3.8. PRINTING AUDIOGRAMS 13
3.9. DATA TRANSFER TO NOAH OR AMPLISUITE 14
4. SUGGESTED SEQUENCE OF OPERATION AND TEST PROCEDURE 15
4.1. AUDIOMETRY PREPARATION AND AMBIENT CONDITIONS 15
4.2. TEST SYSTEM ARRANGEMENT 15
4.3. HEADSET 15
4.4. PATIENT INSTRUCTIONS 15
4.5. PRE-TEST 16
4.6. TEST 16
4.7. POST-TEST 16
5. SPECIFICATION 17
5.1. OUTPUT DATA 17
5.2. MAXIMUM HEARING LEVELS PROVIDED AT EACH FREQUENCY 18
5.3. PHYSICAL DATA 18

3 MODEL 260 INSTRUCTION FOR USE
5.4. EQUIPMENT CLASSIFICATION 18
6. SYMBOLS 20
7. TECHNICAL INFORMATION 21
8. ROUTINE MAINTENANCE 23
8.1. AUDIOMETER MAINTENANCE 23
8.2. TRANSDUCER MAINTENANCE 23
8.3. MAINS ADAPTER MAINTENANCE 24
9. INSTRUMENT STORAGE AND TRANSPORTATION 25
10. CALIBRATION AND REPAIR OF THE INSTRUMENT 25
11. GUARANTEE 25
12. ORDERING CONSUMABLES AND ACCESSORIES 26
13. DISPOSAL INFORMATION 27
APPENDIX 1 - SPEECH AUDIOMETRY 28
A1.1 LIVE VOICE SPEECH AUDIOMETRY TO HEADPHONES 28
A1.2 LIVE VOICE SPEECH AUDIOMETRY WITH CONTRALATERAL MASKING 29
A1.3 RECORDED SPEECH AUDIOMETRY TO HEADPHONES 29
A1.4 RECORDED SPEECH AUDIOMETRY TO HEADPHONES WITH CONTRALATERAL MASKING 30
A1.5 FREE FIELD LIVE VOICE SPEECH AUDIOMETRY 30
A1.6 FREE FIELD RECORDED SPEECH AUDIOMETRY 31
A1.7 FREE FIELD RECORDED SPEECH AUDIOMETRY WITH COMPETING NOISE (AUDIOMETER-GENERATED) 31
A1.8 FREE FIELD RECORDED SPEECH AUDIOMETRY WITH COMPETING NOISE (RECORDED) 31
APPENDIX 2 - FREE FIELD CALIBRATION PROCEDURE 32
A2.1 ASSURANCE OF CALIBRATION 32
A2.2 EXTERNAL AMPLIFIER AND LOUDSPEAKER 32
A2.3 CALIBRATION OVERVIEW 32
A2.4 FREE-FIELD SPEECH CALIBRATION 32
A2.5 FREE-FIELD WARBLE TONES CALIBRATION 34
A2.6 FREE-FIELD LIVE SPEECH CALIBRATION 35
APPENDIX 3 - EMC GUIDANCE & MANUFACTURER’S DECLARATION 36
APPENDIX 4 - USE WITH NON-MEDICAL ELECTRICAL EQUIPMENT 40

INTRODUCTION
4 MODEL 260 INSTRUCTION FOR USE
1.INTRODUCTION
1.1. THANK YOU
Thank you for purchasing an Amplivox audiometer. The Amplivox Model 260 is a diagnostic audiometer that will give
many years of reliable service if treated with care.
1.2. INTENDED APPLICATIONS
The Model 260 diagnostic audiometer is designed for use by audiologists, general practitioners, hearing aid dispensers
and child health professionals. Capable of undertaking both air and bone conduction tests with or without masking, the
audiometer has many additional features such as the facility to support speech audiometry from live or recorded
sources, the option to select free-field equivalent output from the headphones in speech mode and clinical audiometry
tests.
1.3. 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 (+44 1865 880846; supp[email protected]). 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.
1.4. FIRMWARE VERSION
This operating manual is for firmware versions 2T06 onwards. To check the version of firmware on your audiometer
press and hold the MENU button followed by the TALKOVER button.
1.5. STANDARD CONTENTS
Model 260 Audiometer Audiometric headset
Bone vibrator headset Patient response switch
Mains adaptor Audiogram cards
Operating manual & ampliSuite ampliSuite software
Carrying case Calibration certificate

INTRODUCTION
5 MODEL 260 INSTRUCTION FOR USE
1.6. OPTIONAL ACCESSORIES
Masking earpiece Additional audiogram cards
Microphone and monitor headset Insert earphones
Printer(s) Printer cable(s)
USB Cable Audiocups (noise reducing earphone enclosures)

IMPORTANT SAFETY INSTRUCTIONS
6 MODEL 260 INSTRUCTION FOR USE
2.IMPORTANT SAFETY INSTRUCTIONS
The Model 260 instrument must be used only by practitioners qualified to perform audiometric
tests. It is intended for use as a screening and diagnostic 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 and the function of single-use parts.
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 in Appendix 3. 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.

IMPORTANT SAFETY INSTRUCTIONS
7 MODEL 260 INSTRUCTION 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.
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
MIC 1
3.5mm jack
Speech Input Microphone *
MONITOR
3.5mm jack
Monitor Earphone *
BONE
6.3mm jack
Grey
Bone Vibrator Headset *
INSERT
3.5mm jack
Masking Earphone *
RIGHT
LEFT
6.3mm jack
6.3mm jack
Red
Blue
Air conduction headset *
MIC 2
3.5mm jack
Talkback Microphone *
POWER
2.5mm power jack
Mains AC/DC Adapter *
RESPONSE
6.3mm jack
Black
Patient Response Switch *
LINE IN
LINE OUT
3.5mm jack
3.5mm jack
CD/tape player
External amplifier
See 2.7
DATA
6 pin mini DIN
Printer *
See 2.5
USB
USB Connector
Type B
Computer (via USB port)
See 2.6
The relevant part numbers are indicated in Section 12.
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 260
Diagnostic 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 see Appendix 4.

IMPORTANT SAFETY INSTRUCTIONS
8 MODEL 260 INSTRUCTION FOR USE
2.5. DATA TRANSFER TO A PRINTER
Please refer to Appendix 4 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 two designated portable thermal printers
for printing air conduction, bone conduction and ULL 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 4 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).
2.7. LINE IN/OUT CONNECTION (AUDIO)
Please refer to Appendix 4 for important information regarding the connection of non-medical
electrical equipment to medical electrical equipment.
The Model 260 has audio line in/out connections for CD or tape player input (e.g. for recorded speech testing) and
amplifier output.
Important Note:
Line out connections are switched on only when FREEFIELD is selected. The following connections apply to both LINE IN
and LINE OUT.
Main Body Segment
Mid segment
End segment
Ground
Right Channel
Left Channel
For more information on live and recorded speech refer to Appendix 1.

USING THE AUDIOMETER
9 MODEL 260 INSTRUCTION FOR USE
3.USING THE AUDIOMETER
3.1. SWITCHING THE AUDIOMETER ON AND OFF
Press the ON/OFF key located at the left of the front panel. No warm-up time is required. The display will briefly show
the model and the type of headphone currently in use.
If a secondary headphone has been enabled (e.g. E-5A) it will then be necessary to select the required headphone as
follows:
•Either - press YES to confirm the current headphone selection
•Or - press NO to toggle to the other option and then YES to confirm the selection
Note: headphone selection must be confirmed before any other operation can be performed.
The display will then be as shown in Section 3.3.
To switch off, press and hold the ON/OFF key. While holding the key press YES to confirm. To cancel the switch-off
release the ON/OFF key.
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 FREQUENCY Hz MASKING
30dBHL 1kHz OFF
< > < > THL
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 ON/OFF
(MENU), LEFT (NO), RIGHT (YES) and FREQUENCY (MENU SELECT). The use of these keys is described below.

USING THE AUDIOMETER
10 MODEL 260 INSTRUCTION FOR USE
3.4.2. MENU
Pressing and holding MENU accesses 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
Print audiogram?: Press YES and release MENU; then press YES to confirm the print operation or NO to cancel
Clear test?: Press YES and release MENU to clear the displayed test results; stored test results are not
affected
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
Bone masking: Use the SIGNAL keys to select the AC headset or the optional masking earpiece as the
means of masking
Select phones: This option is only available if a secondary headphone is enabled; use the SIGNAL
keys to select the required headphone type
FF equiv. speech?: This option is only available if either DD45 or TDH39 is the selected headphone; if
activated, free-field equivalent levels will output to the headphone in speech mode (see
Appendix 1)
Store on 2 of 3?: Use the NO and YES keys to activate automatic storage of a threshold if the responses
made to two out of three test signals are at the same hearing level
Warble to phones?: Use the NO and YES keys to send frequency-modulated tones to the headphones
Set freefield level?: This option provides access to the freefield calibration function; refer to Appendix 2 for
details
Default level: Adjust the default tone presentation level (between 20dBHL and 40dBHL) using the SIGNAL
keys
2.5dB step size?: Use the NO and YES keys to disable or enable the 2.5dB step size; otherwise step size is
5dB
External talkover?: Select NO to use the internal microphone and YES to use the MIC 1 input
Select printer: Use the SIGNAL keys to select either the Able AP1300, the Martel MCP8830 printer or
the Sanibel MPT-II printer
Please note: In order to use the Sanibel printer, select ABLE printer in the settings. After
confirming the ABLE printer, the 260 will connect to the Sanibel printer, too.

USING THE AUDIOMETER
11 MODEL 260 INSTRUCTION FOR USE
Air Conduction ULL: Use the NO and YES keys to disable or enable the uncomfortable loudness level (ULL)
function; if enabled, the thresholds recorded will be stored, printed & transferred as ULL
results
3.4.3. DESCRIPTION OF FUNCTION OF OTHER KEYS
PULSE This enables the pulse tone present function when the PRESENT key is operated; the indicator above
the key illuminates green
MASK This switches on masking at 30dBHL; narrow band noise for pure tones, and speech-weighted noise
for speech; the indicator above the key illuminates green
CONSTANT This switches tone or speech signal on continuously; the indicator above the key illuminates green; it
may be interrupted by pressing the PRESENT key
+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; an indicator above the key illuminates green to show that the
function is active, and an additional display message indicates levels greater than 100dBHL. Note: this
function will not operate if continuous tone presentation has been enabled.
FREEFIELD This disconnects the headphones and bone vibrator,routes signals to LINE output socket and outputs
warble tones instead of pure tones; note that no masking is available in Free Field with warble tones;
the indicator above the key illuminates green
SPEECH Use this key to cycle through the selection of LINE input (for recorded speech), MIC input (for live
speech from MIC 1), or speech facility off; the indicator above the key illuminates green
BONE Outputs the signal to the bone vibrator; the indicator above the key illuminates green
TALKOVER Hold this key to interrupt the test and route the operator’s voice from the front panel microphone (or
MIC 1 input) to the headset; the level is adjusted with the SIGNAL keys
TALKBACK Press this key to route the signal from MIC 2 to the MONITOR output; the indicator above the key
illuminates green press again to de-activate; hold the button down to adjust the talkback level using
the SIGNAL keys
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 (or a ULL if this has been
selected)
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 (or a ULL if this has been
selected)
SIGNAL Press the keys to decrease or increase the level of the tone presented in 2.5dB or 5dB steps (see
Section 3.4.2); 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
MASKING With the MASK function on, press the MASKING keys to decrease or increase the masking level
in 2.5dB or 5dB steps (see Section 3.4.2); to scroll through the range keep the key pressed
These keys are also used to set the LINE & MIC levels in SPEECH mode

USING THE AUDIOMETER
12 MODEL 260 INSTRUCTION FOR USE
PRESENT Press to present the displayed test signal to the patient. The “PRESENT” indicator above the display
will illuminate green during presentation
3.4.4. TEST MENU
Pressing TEST MENU selects the following test options in order. For Stenger and ABLB the indicator above the key
illuminates green.
Test Description
STENGER: Routes tone or speech to both earphones simultaneously. Use the SIGNAL keys to
adjust the left channel level and the MASKING keys to adjust the right Refer to
Appendix 1 for details of the Stenger test in speech mode.
ABLB: Alternate Binaural Loudness Balance: Routes tone to each earphone alternately. Use the
SIGNAL keys to adjust the left channel level and the MASKING keys to adjust the
right. Pressing the PRESENT key interrupts the signal presented.
THL/ULL: Manual audiometry
To exit from the Stenger or ABLB test modes press TEST MENU until THL is displayed (or ULL if this has been selected)
and the green indicator above the key goes out.
3.5. THRESHOLD RETENTION FUNCTION
This function records the thresholds for both ears at each frequency tested (air conduction, bone conduction and ULL).
Once a threshold has been determined press the “selected ear” key once again. Alternatively use the “Store on 2 of 3”
function (see Section 3.5.2). The threshold will be recorded and displayed as shown below.
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) and/or transfer the results to
a computer (see Section 3.9).
To review the retained thresholds, select the required frequency using the FREQUENCYkeys. The recorded values
for the left and right ears are shown on the lower line of the display, designated L and R respectively.
SIGNAL FREQUENCY Hz MASKING
30dBHL 4kHz OFF
[ 20L] [ 10R] THL
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.

USING THE AUDIOMETER
13 MODEL 260 INSTRUCTION FOR USE
Bone Conduction and Uncomfortable Loudness Levels (ULL)
To record and review bone conduction thresholds use the BONE key.
To record uncomfortable loudness levels (ULL) switch to this mode (see Section 3.4.2). The display will be similar to that
shown below, and ULL thresholds are recorded and reviewed as described above.
SIGNAL FREQUENCY Hz MASKING
40dBHL 1kHz OFF
[ 45L] [ 40R] ULL
3.6. SAVING AUDIOGRAMS IN INTERNAL MEMORY
The user may store up to 12 audiograms, referenced by number, in the internal memory of the audiometer. To save the
current set of audiogram thresholds (the “retained” values described in Section 3.5) press and hold the MENU key, press
FREQUENCY 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, press FREQUENCY 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
Three designated thermal printers (the Able AP1300, the Martel MCP8830 or Sanibel MPT-II) are available as options
for use with the Model 260 audiometer. The correct printer must be selected (use the MENU options described in
Section 3.4.2 to make this selection).
•Connect the audiometer to the printer with supplied printer cable (refer to Section 2.5 of this operating
manual for printer set-up). Insert the 6-pin mini DIN into the DATA socket on the back of the audiometer.
Insert the terminal plug into the socket at the back of the printer. Note that the printer cables for the Able
printer (stock number A105) and Martel printer (stock number A104) and the Sanibel MPT-II (A101) 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 and hold the MENU key and press the FREQUENCY key to display “Print Audiogram”. Continue to
hold the MENU key, press the YES key and release the MENU key. On the prompt “Is printer ready?” press
the YES key again. The audiogram will then print. To cancel the print operation press NO.
•Hearing levels will be printed if available for both ears at every frequency for air conduction (ACT),
uncomfortable loudness (AUL), bone conduction unmasked (BC) or bone conduction masked (BM)

USING THE AUDIOMETER
14 MODEL 260 INSTRUCTION FOR USE
3.9. DATA TRANSFER TO NOAH OR AMPLISUITE
To transfer test results stored within the audiometer to a NOAH database the Amplivox ampliSuite NOAH software must be
installed on to a computer. Alternatively, Amplivox ampliSuite 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 ampliSuite for further details.

SUGGESTED SEQUENCE OF OPERATION AND TEST PROCEDURE
15 MODEL 260 INSTRUCTION FOR USE
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 various 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 audiometry 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 or appropriate
transducer (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 or appropriate transducer 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”
Operator
Audiomete
r
Computer (optional)
Patient, wearing
headset
Headset lead
Response switch & lead

SUGGESTED SEQUENCE OF OPERATION AND TEST PROCEDURE
16 MODEL 260 INSTRUCTION FOR USE
4.5. PRE-TEST
(1) Switch the audiometer on
(2) Perform a listening check
(3) Decide whether to use the Threshold Retention Function (see Section 3.5) or an audiogram card to record the
thresholds
(4) Prepare the test environment & patient (see Sections 4.1 to 4.4)
(5) Select the better hearing ear (according to the patient) by pressing either the LEFT or RIGHT key
4.6. TEST
(6) Present the first test tone at 30dB at 1kHz
(7) If the patient responds, reduce the signal level in 10dB steps until they no longer respond; then increase the signal
level in 5dB steps until the patient responds
(8) If the patient fails to hear the first tone, increase the signal level in 5dB steps until they do respond and then
continue with step 10
(9) 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
(10) If Store on 2 of 3 is selected, go to step 13
(11) Repeat step 10 until the patient responds three out of a maximum of five times at the same signal level, indicating
the patient’s hearing threshold level for that frequency; mark the threshold on an audiogram card or press the
“selected” ear key once to activate the Threshold Retention Function which then displays the threshold on screen
(12) If Store on 2 of 3 is selected, repeat step 10 until the patient has responded 2 out of a maximum of 3 times at the
same signal level; this will automatically display the threshold on the screen
(13) Proceed to the next test frequency and repeat steps
(14) Repeat steps 6 to 13 for the other ear
4.7. POST-TEST
(15) Use the Threshold Retention Function to review the results (See 3.5)
(16) If required do one or more of the following:
•Record the results on an audiogram card, or
•Save the results to the internal memory (Section 3.6), or
•Print the results (Section 3.8), or
•Transfer the results to a computer (Section 3.9)
To clear the Threshold Retention memory, use the Clear test menu option described in Section 3.4.2.

SPECIFICATION
17 MODEL 260 INSTRUCTION FOR USE
5.SPECIFICATION
5.1. OUTPUT DATA
Outputs: Left earphone, Right earphone, Bone (L&R) Insert masking and Freefield
Frequency range (Hz): Air: 125-8KHz
Bone: 250Hz-8KHz
Frequency accuracy: <1%
Distortion: <2%
Output level range (AC): -10dBHL to 120dBHL maximum
Output level range (BC): -10dBHL to 70dBHL maximum
Output level range (FF): Up to 90dB
Insert masking output: 90dBHL max (250-4KHz)
Output level accuracy: Within 3dB
Output level step size: 2.5 or 5dB
Output transducer (AC): DD45 earphones (supplied)
E-5A insert earphones (option)
Output transducer (BC): B-71 bone vibrator (supplied)
Tone present: Single, pulsed, warble or continuous
Masking: Narrowband (tone) or speech-weighted
Clinical tests: Stenger & ABLB (Fowler)
Communication: Integral talk over and talk back facility
Recorded speech: Tape or CD input
Live speech: 1 x microphone input
Monitoring indicator: VU - (to IEC 60268-17; ANSI S3.6:2004)
USB interface: Transfer of test results to a computer

SPECIFICATION
18 MODEL 260 INSTRUCTION FOR USE
5.2. MAXIMUM HEARING LEVELS PROVIDED AT EACH FREQUENCY
Frequency, Hz
Air conduction, dBHL
Bone conduction, dBHL
125
80
-
250
100
45
500
115
60
750
120
65
1000
120
70
1500
120
70
2000
120
70
3000
120
70
4000
115
70
6000
110
50
8000
100
40
5.3. PHYSICAL DATA
Display: 2 lines of 24 characters
Mains Power: 100-240Vac; 50-60Hz; 0.5A
Input Rating: 5Vdc; 0.9 A
Dimensions: 270mm wide x 165mm deep x 60mm high
Weight: 830g
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

SPECIFICATION
19 MODEL 260 INSTRUCTION FOR USE
The Model 260 Audiometer is classified as a Class IIa device under Annex IX of the EU Medical Devices Directive. It is
intended for use as a diagnostic audiometer instrument.
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