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: [phone]
Fax: [phone]
[email protected]
Amplivox Ltd
3800 Parkside, Solihull Parkway,
Birmingham Business Park, Birmingham,
West Midlands,
B37 7YG
United Kingdom
Tel: [phone]
[email protected]

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 ([phone]; 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.