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OM020-3 Amplivox 270 Operating Manual - com USB
OM020-3 Amplivox 270 Operating Manual - com USB
Diagnostic Audiometer
Operating Manual
(Applies from serial number 5950 onwards)
Amplivox Ltd
29-30 Station Approach
Kidlington
Oxford OX5 1JD
ENGLAND
1 Introduction 3
1.1 Intended applications 3
1.2 Unpacking 3
1.3 Standard contents 3
1.4 Optional accessories 3
2 Important Safety Instructions 4
2.1 Precautions 4
2.3 Mains supply operation 5
2.4 Audiometer connections 5
2.5 Data transfer to a printer 6
2.6 Data transfer to a computer 6
2.7 Line in/out connection (audio) 7
3 Using the Audiometer 7
3.1 Ambient conditions 7
3.2 Switching the audiometer on and off 7
3.3 Testing the patient response switch 8
3.4 Audiometer display 8
3.5 Audiometer controls 8
3.6 Threshold Retention Function 12
3.7 Saving audiograms in internal memory 12
3.8 Loading audiograms from internal memory 13
3.9 Printing audiograms 13
3.10 Data transfer to a NOAH3 database 13
4 Sequence of Operation and Suggested Test Procedure 13
5 Specification 15
5.1 Output data 15
5.2 Maximum hearing levels provided at each frequency 16
5.3 Physical Data 16
5.4 Equipment classification 16
6 Symbols 17
7 Technical Information 18
8 Routine Maintenance 19
8.1 Audiometer maintenance 19
8.2 Transducer maintenance 19
8.3 Power supply maintenance 20
9 Instrument Storage and Transportation 21
10 Calibration and Repair of the Instrument 21
11 Guarantee 21
12 Ordering Consumables and Accessories 22
Appendix 1 - Speech Audiometry 23
Appendix 2 - Free Field Calibration Procedure 28
Appendix 3 - EMC Guidance & Manufacturer’s Declaration 30
Appendix 4 - Use with Non-medical Electrical Equipment 36
Page 2 OM020-3 Amplivox 270 Operating Manual
1 Introduction
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 (+44 1865 842411; sales@amplivox.ltd.uk). 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.
2.1 Precautions
The audiometer is for indoor use only and should be used only as
described in this 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.
The instrument must be stored and used within the specified temperature,
pressure and humidity ranges (see Sections 7 and 9).
Safety Note:
Please refer to Appendix 4 for important information regarding the
connection of non-medical electrical equipment to medical electrical
equipment
Safety Note:
Please refer to Appendix 4 for important information regarding the
connection of non-medical electrical equipment to medical electrical
equipment
Safety Note:
Please refer to Appendix 4 for important information regarding the
connection of non-medical electrical equipment to medical electrical
equipment
The Amplivox 270 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 FREFIELD is selected.
The following connections apply to both LINE IN and LINE OUT.
For more information on live and recorded speech please see Appendix 1.
Press the ON key highlighted centre right of front panel. No warm-up time
is required. The display will briefly show the model and the type of
headphone currently selected for use.
If the TDH39 and E-5A headphones have both been enabled it will then
be necessary to select the required headphone as follows:
• Either - press the key under OK (on the display) to confirm the current
headphone selection
• Or - press the key under CHANGE to toggle to the other option and
then OK to confirm the selection
To switch off, press the ON key again and then the key under YES to
confirm.
Press the patient response switch and the light labeled RESPONSE (to
the right of the display) will illuminate.
This indicates that when the PRESENT key is pressed, the tone
presented will be at 30dBHL at a frequency of 1kHz (1000 Hz) to the
designated ear. On start up, the audiometer defaults to the left ear.
3.5.1 SoftKeys
Four softkeys are provided below the display that refer to an associated
option shown on the display. In this operating manual these are
referenced as Softkey 1 to Softkey 4 from left to right.
Pressing the OPTIONS key and then using the softkeys allows the
operator to step through the options (the NEXT softkey) and modify the
settings as required. Pressing the softkey below QUIT exits the options
menu and saves the settings.
Load audiogram no (1): Use the UP key to identify the required storage
location and press LOAD key
Set freefield levels?: If yes, press YES key followed by QUIT key; enter
the required calibration value at the required test
frequency using the SIGNAL rotary control and
the frequency Hz ÕÖ keys; press STORE key to
accept the values
This key enables the selection of the following. Exit each test by pressing
TEST MENU key.
SPEECH Use with Softkey 1 to select input from MIC 1 (for live
speech) or LINE input (recorded speech)
+20dB Press the +20dB key and use the SIGNAL dBHL control to
access headphone output levels between 100 and 120
dBHL. This function does not operate in REVERSE mode.
TALKOVER Interrupts test and routes operator’s voice from the internal
microphone (or MIC 1 input) to headset. The attenuation
level can be adjusted with the SIGNAL rotary control.
TALKBACK While selected (as indicated by the LED above the key) the
signal from MIC2 is routed continuously to the MONITOR
output. Press the key again to de-select. The talkback level
may be adjusted by the SIGNAL dBHL control while key is
held down.
PRINT Press to print audiogram; see Section 3.9 for further details
This function stores the last presented combination of ear, tone and
frequency for every frequency tested in the audiometer’s memory (air
conduction and bone conduction). Each value is stored by pressing the
STORE key. The operator can then retrieve the results at the end of the
test and record them on an audiogram card, print with the optional printer
and/or transfer results to a NOAH database on a computer.
To clear the Threshold Retention memory, press the OPTIONS key, select
“Clear test? No”. Press YES to clear the memory and QUIT to return to
the test.
Press the OPTIONS key, press NEXT repeatedly until “Load Audiogram
No 1” appears on screen. Select the required audiogram (1-12), using the
UP key then press the LOAD key. Press the QUIT key once confirmation
that the thresholds have been retrieved appears on screen.
• 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) are not compatible.
• Ensure the printer is switched on and ready to print.
• Load the desired audiogram as described in 3.8; to print the current
audiogram ignore this instruction
• Press the PRINT key. On the prompt “Is printer ready?” press the YES
key. The audiogram will then print.
4.2 Test
4.3 Post-test
(16)Use the Threshold Retention Function to review the results (See 3.6)
(17)If required do one or more of the following:
Page 14 OM020-3 Amplivox 270 Operating Manual
Record the results on an audiogram card, or
Save the results to the internal memory (Section 3.7), or
Print the results (Section 3.9), or
Transfer the results to a computer (Section 3.10)
To clear the memory at the end of a test, press and the OPTIONS key and
press NEXT to select “Clear test? No”. Press YES key followed by QUIT
key to clear the memory.
5 Specification
The Model 270 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.
Audiometer
Audiometer type: Type 2 (IEC 60645-1:2001)
Type B-E (IEC 60645-2:1993)
Type 3BE (ANSI S3.6:2004)
Frequency Modulation
Carrier frequencies: 125Hz to 8kHz as per pure tones
Modulation waveform: Sinusoidal
Rising and falling symmetry: Symmetrical on linear frequency scale
Modulating frequency: 15.625Hz
Frequency deviation: +/-10%
Speech Channel
Frequency response: +/- 3dB from 100Hz to 10kHz electrical
Voltage requirement at 0dB
input level setting to zero meter: 1.20Vrms at 1kHz
Output level: 90dBSPL at 1kHz for attenuator setting of
70dBHL with level meter at 0dB
Masking Sounds
Masking sounds available: Narrow bands at test frequencies and
Speech weighted noise
Narrow-band noise bandwidth: Meets IEC 60645-1; ANSI S3.6
Speech noise bandwidth: Meets IEC 60645-2; ANSI S3.6
Reference levels: Refer to ISO 389-4
Transducers
Types and reference levels: TDH-39: ISO 389-1, Table 2
E-5A: ISO 389-2, Table 1
B-71: ISO 389-3, Table 1
Static headband force: Headphones: 4.5N
Bone vibrator: 5.4N
Bone vibrator calibrated: For mastoid placement &
unoccluded test ear
Sound attenuation characteristics: ISO8253-1, Table 3
Airborne sound from bone vibrator: See Br. J. Audiol. 1980, P73-75
Environmental
Operating temperature: +10 degrees to +40 degrees centigrade
Operating humidity: 30% to 90% (non-condensing)
Atmospheric pressure: 700 hPa to 1060 hPa
Input / Output
Power input: 2.5mm barrel-type socket.
Mic input impedance: 2500 Ohms
Mic input connection: Mono 3.5mm Jack socket
Line input impedance: 6800 Ohms
Line in/out connections: Stereo 3.5mm Jack Sockets
Patient response input: 6.3mm Jack socket
Left / Right / Bone outputs: 6.3mm Jack socket
Monitor output: Mono 3.5mm Jack socket
Insert output: Mono 3.5mm Jack socket
USB: Type B socket
Maximum voltage at any output: 12V peak
8 Routine Maintenance
Earphones
Clean the ear cushions (including those on the Audiocups, if used) with a
recognised disinfectant, e.g. a “Mediswab”.
Insert Masker
Never insert or in any way use the insert masker without using a new,
clean and fault-free test tip.
Insert Earphones
♦ Ensure that the black tubing protruding the foam eartip is not applied
to the patient; this must be attached to the sound tube of the insert
transducer
♦ Roll the foam eartip into the smallest possible diameter
♦ Insert the eartip into the ear canal of the patient
♦ Hold the eartip until it has expanded and a seal is achieved
♦ After testing the patient the foam eartip including the black tubing
must be detached from the sound tube
♦ The insert transducer should be examined prior to attaching a new
foam eartip
Periodically check the Mains AC adapter for signs of wear and/or damage.
If you find any, please replace it immediately by contacting Amplivox or
your Amplivox distributor, requesting part number: A091-5. DO NOT USE
ANY OTHER MAINS ADAPTER WITH THIS INSTRUMENT.
Please note that this instrument can be stored or transported with the
following environmental parameters:
When packing the instrument for shipping, please use the shipping carton
and packing materials the instrument was supplied in. Please also ensure
that the headset leads are not wrapped around the headband of the
headset.
11 Guarantee
Important Note:
The following exceptions apply:
Note that the line outputs from the instrument (used for free-field testing)
are only active when FREEFIELD is selected.
• If headphone testing is being performed, it is recommended that any
attached amplifier should be switched off
• If Free Field testing is being performed, this option must always be
selected on the audiometer; this disconnects headphones, bone
vibrator and masking insert outputs, and ensures that the correct
calibrated output levels are achieved
• If free-field equivalent output is required from the headphones in
Speech mode this option should be selected (see Section 3.5.2)
Operator Monitoring
Display Counter
The display counter is active only in Speech mode (once it has been set –
refer to ‘Menu Options’ in Section 3.5). The operator selects ‘Right’ or
‘Wrong’ according to the response made by the patient. The display then
shows the percentage correct alongside the total number of responses.
Pressing Softkey3 clears the counter to zero. While in this mode, pressing
Softkey4 switches to a display that allows the monitor level to be changed
using the +Hz and -Hz keys. To return to the Display Counter screen
press Softkey3.
OM020-3 Amplivox 270 Operating Manual Page 23
1. Live Voice Speech Audiometry to Headphones
1.2 Procedure:
The operator may now read the required word list to the subject and
record the responses; the patient may respond either by (a) repeating the
spoken material or (b) writing the words. If the response is spoken, the
operator should press the TALKBACK key to hear this response (see
operator monitoring above).
a) Select MASK
b) Broad band masking is now routed to the opposite earphone to that
selected
c) The MASK dBHL control changes the masking level in 5dB steps
d) If required, readjustment of the input signal level can be accessed by
temporarily deselecting the MASK key - then proceed as in 1.1d)
2.2 Procedure:
a) Connect a CD, tape player, or other sound source to the LINE IN jack
socket; refer to Section 2.7 of this operating manual
b) Press SPEECH and use Softkey 1 to ensure that ‘LINE’ is displayed in
capitals (indicating that the line input is selected)
c) The line input is initially routed to the left earphone. To select the right
earphone press RIGHT
d) The input signal is adjusted in 1dB steps by use of the MASK dBHL
control
e) Play the 1kHz calibration tone on the recorded material and adjust the
input signal such that the LEVEL dB bar graph reads 0dB; the
headphone output measured in an IEC 318 ear simulator will now be
89dBSPL for a setting of 70 dBHL
g) The output level is controlled in 5dB steps by the SIGNAL dBHL
control
3.2 Procedure:
As described in 1.2 except that the operator plays the recorded material to
the subject.
a) Select MASK
b) Broad band masking is now routed to the opposite earphone to that
selected
c) Select INT or EXT masking source using Softkey4 (the option
selected is displayed in capitals); internal will be wideband noise and
external will be the competing noise from the signal source
d) The MASK dBHL control changes the masking level in 5dB steps
e) If required, readjustment of the input signal level can be accessed by
temporarily deselecting the MASK key - then proceed as in 3.1d)
4.2 Procedure:
For the following Free Field modes of operation it is essential for the Free
Field calibration procedure described in Appendix 2 of this operating
manual to have been performed. This aspect may also be subject to local
requirements or legislation.
5.2 Procedure:
As described in 1.2.
As described in 3.2
a) Select MASK
b) Select internal masking source using Softkey4 (the INT option is
displayed in capitals); wideband noise is routed to the competing LINE
OUT channel
c) The level of competing noise is adjusted in 5db steps using the MASK
dBHL control
7.2 Procedure:
8.2 Procedure:
Assurance of Calibration
The equipment and procedures outlined below should be used with the
Amplivox 270 audiometer as a means of performing Free Field calibration.
However it must be emphasised that it is the responsibility of the
equipment operator to ensure that correct Free Field calibration has been
achieved according to the audiometric performance standards.
Calibration Procedure
The following calibration should be performed before any free-field tests
are performed, and repeated if any change to equipment positions or
settings are made, or if there are other changes to the room (e.g. furniture
moved). Place the speaker(s) in the desired position(s), at least 1.5
meters from the subject’s listening position. Refer to the specification for
the test to be performed for correct loudspeaker and subject alignment(s).
IEC 61000-3-3
Recommended separation
distance
b Over the frequency range 150 kHz to 80 MHz, field strengths should
be less than 3 V/m.
NOTE 1 At 80MHz and 800MHz, the separation distance for the higher
frequency range applies.
Any person who connects external equipment to signal input, signal output
or other connectors has created a medical electrical system and is
therefore responsible for the system complying with the requirements of
IEC 60601-1-1 (Safety requirements for medical electrical systems).
The following signal inputs and outputs on the Amplivox 270 audiometer
are electrically isolated to the requirements of IEC 60601-1 in order to
reduce any potential hazard associated with the use of mains-powered
equipment connected to these inputs and outputs:
Equipment not complying with IEC 60601 shall be kept outside the patient
environment, as defined in IEC 60601-1-1 (at least 1.5m from the patient).
The operator must not touch the connected equipment and the patient at
the same time as this would result in an unacceptable hazard.
270
Audiometer
270
Audiometer
Mains Outlet
Printer
Printer via DATA socket
Power
Supply
270
Audiometer
Mains Outlet
PC
Power
Supply
PC
via USB
socket
270
Audiometer
Mains Outlet
CD/Tape Player
via Line In Socket
270
Audiometer
Mains Outlet
Amplifier
via Line Out
Socket