AURICAL Aud - Otometrics

AURICAL Aud - Otometrics
AURICAL Aud
User Guide
Doc. No. 7-50-1270-EN/07
Part No. 7-50-12700-EN
Copyright notice
© 2012, 2017 GN Otometrics A/S. All rights reserved. ® Otometrics, the Otometrics Icon, AURICAL, MADSEN, ICS and HORTMANN
are registered trademarks of GN Otometrics A/S in the U.S.A. and/or other countries.
Version release date
2017-03-12 (153432)
Technical support
Please contact your supplier.
2
Otometrics - AURICAL Aud
Table of Contents
1
Device description
4
2
Intended use
4
3
Unpacking
5
4
Installation
5
5
Connecting accessories to AURICAL Aud
6
6
Powering the device
8
7
Connecting AURICAL Aud to OTOsuite
9
8
On-screen controls
9
9
PC keyboard controls
10
10 Toolbar icons in the Audiometry Module
10
11 Proper transducer placement
12
12 The Masking Assistant
13
13 Performing tone audiometry
16
14 Performing speech audiometry
17
15 Service, cleaning and calibration
19
16 Other references
20
17 Technical specifications
20
18 Definition of symbols
34
19 Warning notes
34
20 Manufacturer
37
Otometrics - AURICAL Aud
3
1 Device description
1
Device description
AURICAL Aud
AURICAL AudHI-PRO 2
AURICAL Aud
with speaker unit
AURICAL AudHI-PRO 2
with speaker unit
AURICAL Aud is a PC-controlled audiometer for testing a person's hearing.The audiometer is operated from the OTOsuite
Audiometry Module PC software.
•
With AURICAL Aud you can perform all standard audiometric tests, tone and speech audiometry and special tests.
•
With AURICAL Aud with HI-PRO 2 you can program hearing instruments.
•
You can connect other devices easily through the built-in USB Hub, and AURICAL Aud provides the necessary connections to carry out probe microphone measurements using the OTOsuite PMM module, and counseling using the
OTOsuite Counseling and Simulations module.
Note • For information about the PMM software, see the manual for AURICAL FreeFit and the PMM module, and for
information about the Counseling and Simulations software, see the manual for AURICAL Visible Speech and the Counseling and Simulations module.
2
Intended use
AURICAL Aud and the Audiometry module
Users: audiologists, ENTs and other health care professionals in testing the hearing of their patients.
Use: diagnostic and clinical audiometric testing.
AURICAL Aud with HI-PRO 2 and the Audiometry module
Users: audiologists, ENTs, hearing instrument dispensers and other health care professionals.
Use: As for AURICAL Aud, and hearing instrument fitting.
Speaker unit
Users: audiologists, hearing instrument dispensers and other health care professionals.
4
Otometrics - AURICAL Aud
3 Unpacking
Use: The AURICAL speaker unit is intended to present audio signals. The AURICAL speaker unit is for use with AURICAL Aud
and the Audiometry module, with AURICAL FreeFit and the OTOsuite PMM module and the OTOsuite Counseling and Simulations module.
2.1
Typographical conventions
The use of Warning, Caution and Note
To draw your attention to information regarding safe and appropriate use of the device or software, the manual uses precautionary statements as follows:
Warning • Indicates that there is a risk of death or serious injury to the user or patient.
Caution • Indicates that there is a risk of injury to the user or patient or risk of damage to data or the device.
Note • Indicates that you should take special notice.
3
Unpacking
1. Unpack the device carefully.
When you unpack the device and accessories, it is a good idea to keep the packing material in which they were
delivered. If you need to send the device in for service, the original packing material will protect against damage during transport, etc.
2. Visually inspect the equipment for possible damage.
If damage has occurred, do not put the device into operation. Contact your local distributor for assistance.
3. Check with the packing list to make sure that you have received all necessary parts and accessories. If your package is
incomplete, contact your local distributor.
4. Check the Test Report (Calibration Certificate), make sure that the transducers (headphones and bone oscillator) are
the correct ones, and that they comply with the ordered calibration standards.
4
Installation
Install OTOsuite on the PC before you connect to AURICAL Aud from the PC.
For instructions on installing OTOsuite, see the OTOsuite Installation Manual, which you can find on the OTOsuite installation medium (disk or memory stick).
To mount AURICAL Aud on the wall or under the desktop, see the AURICAL Aud Reference Manual.
AURICAL Aud is fully assembled on delivery, and you simply have to connect cables.
Otometrics - AURICAL Aud
5
5 Connecting accessories to AURICAL Aud
Caution • To connect AURICAL Aud to the PC, use the supplied USB cable. The cable length must not exceed
3 m (approx. 10 feet).
AURICAL Aud
A. External power supply cable
B. USB cable between AURICAL Aud and the PC
AURICAL speaker unit
A. USB cable between AURICAL Aud and the PC
B. External power supply cable
Connecting to OTOsuite
•
Run the OTOsuite Configuration Wizard to connect to and set up communication with AURICAL Aud: Select Tools >
Configuration Wizard
5
Connecting accessories to AURICAL Aud
The installation must be carried out in accordance with IEC 60601-1-1 plus addendum in the form of Part 1:
General provisions -1 and UL 60601-1, CAN/CSA-C22.2 NO 601.1-90. The supplementary provisions on the reliability of electro-medical systems.
It is a general rule for all electrical equipment used in the proximity of the client that:
•
The connected equipment must comply with IEC 60601-1 and/or IEC 60601-1-1
except for the PC, and equipment connected to the line in and the line out sockets of AURICAL Aud.
6
Otometrics - AURICAL Aud
5 Connecting accessories to AURICAL Aud
See also General warning notes ► 36.
For a detailed description of the connection panel, see the AURICAL Aud Reference Manual.
Connection panel - AURICAL Aud
A. PC/USB connection
I.
Patient Responder
B. Powered USB connections for accessories
J.
Bone oscillator
C. External power supply
K. Speaker, Analog (line output)
D. Sound field speaker output (optical digital line-out)
L.
E. Sound field speaker output (coaxial digital line-out)
M. Operator monitor headset - headphones
F.
N. Operator monitor headset - boom microphone
Sound field speakers (power output)
Line-in
G. Insert earphones
O. Counseling and Simulations headphones
H. Headphones - air conduction
P. Talk-back microphone
Note • Blue corresponds to Left and red corresponds to Right.
Warning • Use only the power supply provided by Otometrics.
Caution • When you connect other electrical equipment to AURICAL Aud, remember that equipment that does not
comply with the same safety standards as AURICAL Aud can lead to a general reduction in the system's safety level.
Connection panel - HI-PRO 2
The HI-PRO 2 connection panel contains the sockets for hearing
instrument connection cables, and light indicators relating to PC
communication and powering.
Otometrics - AURICAL Aud
7
6 Powering the device
A. Hearing instrument connection cables
B. PC communication, light indicator
C. Power, light indicator
Connection panel - AURICAL speaker unit
To access the AURICAL speaker unit connection panel, remove the speaker cover.
A.
B.
C.
D.
E.
USB to AURICAL Aud
BT (Bluetooth) for PMM communication
24V DC out power supply to AURICAL Aud
24V DC in for external power supply
Speaker input for connecting to AURICAL Aud
Connecting external speakers
External speakers can be connected to AURICAL Aud via powered output terminals or line-out terminals. In both cases you
should contact your service department for installation and calibration. See also Calibration ► 20.
6
Powering the device
AURICAL Aud is powered through an external power supply connected directly to the mains outlet.
Warning • AURICAL Aud is not provided with a mains switch.
To connect AURICAL Aud to the mains supply, plug the mains plug into the wall mains outlet.
To disconnect AURICAL Aud from the mains supply, pull the mains plug out of the wall mains outlet. Do not position
the unit so that it is difficult to pull the mains plug out of the wall mains.
1. Plug the external power supply into the Power socket in the connection panel.
2. Plug the mains plug of the external power supply into an AC mains outlet with a three-wire protective ground.
8
Otometrics - AURICAL Aud
7 Connecting AURICAL Aud to OTOsuite
Switching on AURICAL Aud
Use only the power supply specified in Technical Specifications.
1. Connect the mains plug of the external power supply directly to an AC mains outlet with a three-wire
protective ground.
2. Switch on the mains supply.
3. The On/Off indicator on AURICAL Aud lights green.
AURICAL Aud
AURICAL Aud with HI-PRO 2
Switching off AURICAL Aud
1. To switch off AURICAL Aud, disconnect the power supply from the mains outlet.
7
Connecting AURICAL Aud to OTOsuite
When you use AURICAL Aud for the first time, run the Configuration Wizard to set up the connection between AURICAL
Aud and OTOsuite. After you have configured OTOsuite for the first time, if AURICAL Aud is turned on when you open the
Control Panel in OTOsuite, then AURICAL Aud will connect to OTOsuite automatically. Otherwise, you can connect
AURICAL Aud as follows:
1. Switch on the device.
2. Launch OTOsuite.
3. In the OTOsuite toolbar, click Control Panel.
4. In the Control Panel, click Connect.
8
On-screen controls
Test controls provide a means of operating the audiometer if you use the mouse and on-screen options to perform tests.
•
To enable test controls, select Tools > Options > Audiometry > General > On-screen controls > Show > On.
Otometrics - AURICAL Aud
9
9 PC keyboard controls
Silence Mode
Silence Mode allows you to control tone levels and presentation by hovering the mouse cursor over the respective onscreen controls. This is particularly useful when the operator of the audiometer and the person being tested are in the
same room.
9
•
To enable silence mode, select Tools > Options > Audiometry > General > On-screen controls > Silence Mode > On.
•
To change the level and frequency by more than one click at a time, use the mouse scroll wheel.
PC keyboard controls
You can open a separate PDF-file to have a proper view of the keyboard shortcuts.
After you install OTOsuite, you can find OTOsuite manuals and related documentation on your PC. In the Start menu, open OTOsuite Manuals, which
contains an overview with links to all manuals.
Note • The actual position of the keys may depend on your keyboard
type.
10
Toolbar icons in the Audiometry Module
The icons available in the toolbar depend on the test function that you have selected.
10
Otometrics - AURICAL Aud
10 Toolbar icons in the Audiometry Module
Audiometry icons
Tone audiometry
Speech audiometry
Menu item
Combined Audiogram
Icon
Description
Click to toggle between viewing both ears in a single audiogram (combined audiogram) or both a left and a right audiogram on your screen.
Combined View
•
Click to view both ears in a single audiogram.
Split View
•
Masking Assistant
Click to view separate audiograms for each ear.
Enable or disable the Masking Assistant.
The Masking Assistant causes an unmasked threshold to flash repeatedly
if masking is recommended.
Standard / All / High
frequencies
The graph shows up to 20,000 Hz. AURICAL Aud presents stimulus up to
12,500 Hz.
•
Click to choose between viewing:
Standard Frequencies
Displays the audiogram from 125 to 8000 Hz.
All Frequencies
Displays the audiogram from 125 to 20,000 Hz.
High Frequencies
Displays the audiogram from 8000 to 20,000 Hz.
New Audiogram
Otometrics - AURICAL Aud
Select new audiogram. You will be prompted to save or cancel current
data.
11
11 Proper transducer placement
Menu item
Frequency Resolution
Icon
Description
The options for frequency resolutions are 1/6, 1/12, 1/24 and 1/48
octave as well as 1 Hz. Select the different tone stimulus resolutions
from the toolbar or from Tools > Options > Audiometry > General.
You can store up to 24 points for each audiometry curve. You will be
prompted if you try to store more than the maximum number of points.
Monitoring
Enables or disables the monitor speaker for monitoring stimuli presented to the patient from the Stimulus or Masking channel.
Talk Forward
Enables communicating with the patient in the sound booth. This will
display the Talk Forward dialog box, where you can control the talk forward microphone sensitivity and the output level (in dB HL) to the
patient.
Select Orientation
Click to select the perspective of the patient's ears as presented on the
screen for graph and table views.
You can also select the location of the stimulus control.
11
Proper transducer placement
Headphones
1. Loosen the headband and place both the left and right side of the headphones simultaneously.
Note • If the headphones are not placed properly, there is risk of causing the ear canal to collapse which will result in
elevated thresholds.
2. Aim the center of the headphones towards the patient's ear canals and gently place them against the ears.
3. Tighten the headband while holding the headphones in place with your thumbs.
4. Examine the placement of the headphones to make sure they are level, and properly positioned.
Insert Earphones
Young children tolerate insert earphones better than headphones.
1. Select the largest foam eartip that will fit into the patient's ear.
If the eartip is too small the sound will leak out and the dB level will not be accurate at the eardrum.
Insert earphones have greater attenuation between ears especially at the low frequencies; this reduces the need for
masking.
2. It is best to clip the insert earphone transducers behind the child or on the back of their clothing and then fit the
foam eartip into the child's ears.
12
Otometrics - AURICAL Aud
12 The Masking Assistant
Bone Oscillator
Note • For unmasked bone thresholds, you can store binaural data:
- Selecting Binaural bone in the routing section of the control panel.
Note • If there is a difference of 10 dB or greater between the bone conduction threshold and the air conduction
threshold of the same ear, masking is needed. The Masking Assistant can assist you in determining which thresholds
need to be masked.
Note • If the SRT of the test ear and the SRT or PTA of the nontest ear differ by 45 dB or more, masking is needed.
If the SRT of the test ear and the bone conduction PTA of the nontest ear differ by 45 dB or more, masking is needed.
Mastoid placement
1. Move any hair covering the mastoid out of the way and place the flat round part of the bone oscillator securely on the
boniest portion of the mastoid without any part of the transducer touching the external ear.
2. Make sure the bone oscillator is tight on the mastoid but still comfortable.
3. If you are going to perform masking with earphones, position the other end of the bone oscillator headband over the
patient's temple on the opposite side of the head so that the headband of the earphones and bone oscillator fit on
the patient's head.
Loudspeaker placement
The environment in which sound-field audiometry is performed may affect the sound field near the patient.
The performance of loudspeakers for AURICAL Aud was tested by Otometrics under free-field conditions in a large
anechoic chamber. Sound pressure level, frequency response and distortion were measured by a microphone placed 1 m
from the front of the speaker.
When speakers are installed in other types of environment, the characteristics of the resulting sound field should evaluated by qualified personnel.
12
The Masking Assistant
If the Masking Assistant is enabled, it will at all times check for frequencies that may require testing with
masking. This also applies to old audiograms imported from NOAH or XML as long as a supported transducer
was stored with the data.
The Masking Assistant is a tool provided to help you with an indication that there may be frequencies where testing with
masking1 is recommended.
1(Katz, J., Lezynski, J. (2002). Clinical Masking. In J. Katz, ed., Handbook of Clinical Audiology, Williams and Wilkins, Baltimore.)
Otometrics - AURICAL Aud
13
12 The Masking Assistant
•
The audiogram symbol will flash at the specific frequencies where contralateral masking may be recommended1.
•
The masking criteria are configurable so that you can
set them up to match your local recommendations for
masking. You can for instance choose either frequency
specific criteria, which increases the efficacy of your
work, or the traditional "one-level-fits-all" criteria.
Select the Tools > Configuration Wizard > Audiometry - Configure... > Masking Assistant to set up
the masking criteria.
All masking signals are calibrated in effective masking.
How does the Masking Assistant work?
Terminology
AC
AC test ear
ACc
AC contra
BC
BC
BCc
BC contra
Min IA
Minimum inter-aural attenuation.
When is masking required?
Masking is recommended when the following conditions are met:
AC
AC > ACc + Min IA
or
BC
AC > BCc + Min IA
BC < AC - x* dB
Only stored thresholds measured without masking are checked. Levels which did not evoke a response are excluded from
the check. This means that as soon as a masked threshold has been stored, the flashing stops for that frequency.
* denotes configurable Air/Bone gap criterion (Tools > Configuration Wizard > Audiometry - Configure... > Masking
Assistant).
1Based on criteria described in Clinical Masking, Essentials of Audiology, Stanley A. Gelfand, Thieme 1997, and Meas-
urement of Pure Tone Hearing Thresholds, Audiologists’ Desk Reference - Vol 1, James W. Hall III, H. Gustav Mueller
III, Singular Publishing Group 1997. and Munro K.J., Agnew N. A comparison of inter-aural attenuation with the Etymotic ER-3A insert earphone and the Telephonics TDH-39 supra-aural earphone. Br J Audiol 1999; 33: 259-262.
14
Otometrics - AURICAL Aud
12 The Masking Assistant
Min IA is frequency specific
These are the Min IA tables for TDH-39 and Otometrics Inserts used in the Masking Assistant 1.
Min IA (supraaural phone: TDH-39), frequency specific
Hz
dB
125
35
Katz & Lezynski, (2002)
250
48
Munro & Agnew, BJA (1999)
500
44
Munro & Agnew, BJA (1999)
750
40
N/A - fulfill traditional approach
1000
48
Munro & Agnew, BJA (1999)
1500
40
N/A - fulfill traditional approach
2000
44
Munro & Agnew, BJA (1999)
3000
56
Hall J.W. III & Mueller G.H. III / Munro & Agnew, BJA (1999)
4000
50
Katz J / Munro & Agnew, BJA (1999)
6000
44
Hall J.W. III & Mueller G.H. III / Munro & Agnew, BJA (1999)
8000
42
Katz J / Munro & Agnew, BJA (1999)
Min IA insert phone
Hz
dB
125
60
N/A - traditional value
250
72
Munro & Agnew, BJA (1999)
500
64
Munro & Agnew, BJA (1999)
750
60
N/A - traditional value
1000
58
Munro & Agnew, BJA (1999)
1500
60
N/A - traditional value
2000
56
Munro & Agnew, BJA (1999)
3000
58
Munro & Agnew, BJA (1999)
4000
72
Munro & Agnew, BJA (1999)
6000
54
Munro & Agnew, BJA (1999)
8000
62
Munro & Agnew, BJA (1999)
1Katz, J., Lezynski, J. (2002). Clinical Masking. In J. Katz, ed., Handbook of Clinical Audiology, Williams and Wilkins, Baltimore. Munro, K.J., Agnew, N. A comparison of inter-aural attenuation with the Etymotic ER-3A insert earphone and
the Telephonics TDH-39 supra-aural earphone. Br J Audiol 1999; 33: 259-262. Hall, JW., MUELLER, HG. (1997). The audiologists’ desk reference, Volume I., Singular Publishing Group, San Diego.
Otometrics - AURICAL Aud
15
13 Performing tone audiometry
13
Performing tone audiometry
A. Quick Select panel
B. Test Options panel
C. Monitor/Level panel
Whenever the test buttons and other functions are used, you can use the corresponding keys on the keyboard, or the onscreen controls located at the top of the screen or in the Control Panel to the left.
For detailed examples of audiometric testing, see the AURICAL Aud Reference Manual.
1. Select the Tone screen in the OTOsuite Audiometry module.
2. Prepare the patient. If you wish to instruct the patient after you have placed the transducers on the head of the
patient, you can use the Talk Forward button. You can talk to the patient to adjust the patient communication levels
when Talk Forward is active.
3. In the Control Panel, select test conditions for ear, transducer, unmasked/masked, and test type.
4. Select the test frequency with the Right/Left arrow buttons (or on keypad).
5. Select the stimulus level with the Up/Down arrow buttons (or on keypad).
6. Present the tone stimulus with the Present button or the space bar on the keypad.
7. Use the Store button (the S key on the keypad) to store the data point and proceed to the next frequency.
8. Repeat steps 4 to 7 until all the measurements you need have been completed. If needed, did you test:
–
Both ears
–
Air conduction
–
Bone conduction
–
Masking (Mask button or M on the keypad
–
Audiogram threshold, MCL and UCL
9. Save the audiogram.
16
Otometrics - AURICAL Aud
14 Performing speech audiometry
Note • White noise can be selected for masking of pure tones. The white noise signal is calibrated for pure tone effective masking, i.e. the white noise sound pressure level varies with the pure tone frequency. If you wish to obtain a certain white noise level measured in dB SPL, you should use Conversion Table 2 to determine the appropriate
attenuator setting. See AURICAL Aud ► 20
14
Performing speech audiometry
A. Quick Select panel
B. Test Options panel
C. Monitor/Level panel
Whenever the test buttons and other functions are used, you can use the corresponding keys on the keyboard, or the onscreen controls located at the top of the screen or in the Control Panel to the left.
For detailed examples of audiometric testing, see the AURICAL Aud Reference Manual.
1. Select the Speech screen in the OTOsuite Audiometry module.
2. If needed, click the Scoring and Playing icon to set up word or phoneme scoring.
3. Prepare the patient. If you wish to instruct the patient after you have placed the transducers on the head of the
patient, you can use the Talk Forward button. You can talk to the patient to adjust the patient communication levels
when Talk Forward is active.
4. In the Control Panel, select test conditions for ear, transducer, unmasked/masked, and test type.
5. Select the stimulus level with the Up/Down arrow buttons (or on keypad).
6. Select speech input signals.
You can choose from either microphone input or recorded input source. Combining recorded Source A and Source B
as Input sources in the Test Options section of the Control Panel will replace the audiometer speech masking with a
recorded input.
7. Select your speech input from the right-click menu in the control panel (or for Source A or Source B from the dropdown lists in the Test Options section of the Control Panel).
–
Int.CD (CD material in CD/DVD drive)
Otometrics - AURICAL Aud
17
14 Performing speech audiometry
–
Int.File (integrated OTOsuite Speech Material or regular sound files)
–
Line In (analog input from external sound players, eg. CD, MD, MP3 or cassette recorders connected to the audiometer via the Line In input).
Important • If an external playback device is used to generate speech stimuli via the line input, care must be
taken to ensure that the player has a flat frequency response in the range 125 to 6300 Hz. The maximum allowable deviation from the average response level is +/-1 dB; the average response level should be measured over the
range 250 to 4000 Hz.
Both the headset microphone and the desktop microphone are ready for use and do not require calibration or
equalization procedures. The headset microphone should be turned to a position just below the operator’s
mouth. The desktop microphone should face the operator.
If an external playback device is used to generate speech stimuli via the line input of AURICAL Aud, only a high
quality CD player or similar device should be used; tape recordings may not provide a sufficient signal to noise
ratio. Preferably, the external device should deliver its output via a fixed-level line out connector. The input gain
on AURICAL Aud should be adjusted to obtain a 0 dBVU reading when the calibration signal is played by the
external device.
8. You can find speech material files in the File/track/list selection drop-down list.
Caution • You should only use speech materials with a stated relationship between the level of the speech signal
and the calibration signal.
Speech materials delivered on CD or other media are normally accompanied by a description of this relationship.
You should follow the instructions supplied with the speech materials, using the VU-meter in OTOsuite for adjustment of input gain.
If you are using built-in speech materials supplied with OTOsuite, the speech levels have been adjusted according
to the original speech material instructions.
Note • Speech signals are calibrated in dB HL.
18
Otometrics - AURICAL Aud
15 Service, cleaning and calibration
If you are using an integrated word list, the word list is shown on the screen.
9. Present the word lists with the Play button.
10. Use the Correct (+) and Incorrect (-) buttons or click directly on the key word to score.
11. Store the current data as the result, either by clicking Store in the highlighted field, or
by pressing (S) on the keyboard.
12. Repeat until all the measurements you need have been completed.
15
Service, cleaning and calibration
Warning • Under no circumstances disassemble AURICAL Aud. Contact your supplier. Parts inside AURICAL Aud must
only be checked or serviced by authorized personnel.
15.1
Service
Warning • For the sake of safety and in order not to void the warranty, service and repair of electro-medical equipment should be carried out only by the equipment manufacturer or by service personnel at authorized workshops. In
case of any defects, make a detailed description of the defect(s) and contact your supplier. Do not use a defective
device.
15.2
Cleaning
The device
•
Remove dust using a soft brush.
•
Use a soft, slightly damp cloth with a small amount of mild detergent or approved non-caustic medical grade disinfectant wipes to clean the unit according to local infection control regulations.
Keep the unit away from liquids. Do not allow moisture inside the unit. Moisture inside the unit can damage the instrument and it may result in a risk of electrical shock to the user or patient.
Accessories
These parts are in constant contact with your patients and should therefore be kept clean.
•
Headphones
Use a non-alcohol based wipe (e.g. Audiowipe) to clean the headphones between patients.
•
Eartips for Insert Earphones
Otometrics - AURICAL Aud
19
16 Other references
The eartips are disposable and therefore should not be cleaned or re-used.
•
Bone oscillator
Clean the bone oscillator between patients, e.g. with a non-alcohol based antibacterial wipe, such as Audiowipes.
Disposal
There are no special requirements for the disposal of eartips, i.e. they can be discarded according to local regulations.
15.3
Calibration
Annual calibration
The audiometer, headphones, bone oscillators, and sound field speakers must be calibrated once a year by your authorized
service department.
Caution • Note that calibration has been performed only on the transducers supplied! If you wish to use any other
transducer for testing with the device, please contact your local distributor first.
16
Other references
For more information, see the online Help in OTOsuite, which contains detailed reference information about AURICAL
Aud and the OTOsuite modules.
For instructions on installing OTOsuite, see the OTOsuite Installation Manual, which you can find on the OTOsuite installation medium (disk or memory stick).
17
Technical specifications
17.1
AURICAL Aud
Type identification
AURICAL Aud is type 1081 from GN Otometrics A/S.
Channels
Two separate and identical channels.
Frequency range
Insert earphones:
20
Standard frequencies: 125 - 8000 Hz
Otometrics - AURICAL Aud
17 Technical specifications
TDH39 earphones:
Standard frequencies: 125 - 12500 Hz
HDA 200/HDA 300:
Standard frequencies: 125 - 12500 Hz
ME-70:
Standard frequencies: 125 - 12500 Hz
HOLMCO:
Standard frequencies: 125 - 12500 Hz
BC:
Standard frequencies: 250 - 8000 Hz
SF:
Standard frequencies: 125 - 12500 Hz
Accuracy:
< 0.03%.
FRESH noise stimulus:
Available in entire frequency range within the transducer specified range (for
SF 125 - 12500 Hz). Accuracy 0.3%
Narrow Band Noise masking:
Available for each stimulus frequency.
Frequency resolution:
125 to 12500 Hz at standard frequencies
Stimulus types
•
Tone
•
Warble
•
Pulsed tone
•
Pulsed warble
•
FRESH Noise
Frequency-specific hearing assessment noise.
Consists of noise bands, with frequency-specific filter width.
The FRESH noise is filtered to obtain very steep slopes outside the passband.
Masking types
•
•
•
Narrow Band Noise
–
AC and BC
–
SF
Correlated
Correlated
Speech Weighted Noise
–
AC and BC
–
SF
Correlated
Correlated
White Noise (Wide band noise)
–
AC and BC
–
SF
Correlated
Correlated
White noise for Pure Tone masking
Conversion between displayed “effective masking level” and sound pressure level
The level of white noise used for masking of pure tones is indicated in dB of “effective masking level” in OTOsuite. This
means that the sound pressure level of the power contained in a third-octave band around the presented pure tone frequency will equal the attenuator setting, plus the RETSPL at the pure tone frequency, plus the noise correction factor
from ISO 389-4:1994, Table 1.
The following tables can be used to calculate the actual sound pressure level of the white noise signal for a given attenuator setting (Table 1), or to select the attenuator setting required to obtain a specific level in dB SPL (Table 2).
Otometrics - AURICAL Aud
21
17 Technical specifications
Note: As the sound pressure level of the white noise signal will be quite high even for moderate attenuator settings, a
warning sign will be displayed in OTOsuite when appropriate (for levels above 100 dB HL).
Table 1 - Offset from Effective Masking Level to Sound Pressure Level
Frequency (Hz)
Offset (dB)
125
250
500
750
1000
1500
2000
3000
4000
6000
8000
9000
10000
11200
12500
N/A*
53
37
32
31
29
30
29
27
31
27
26
26
25
25
This table indicates the number (“Offset”) to be added to the displayed masking level in order to calculate the sound pressure level in dB SPL.
* White masking noise is not available at 125 Hz
Table 2 - Attenuator settings required to obtain a white noise level of 80 dB SPL
Frequency (Hz)
Attenuator setting to
125
250
500
750
1000
1500
2000
3000
4000
6000
8000
9000
10000
11200
12500
N/A*
27
43
48
49
51
50
51
53
49
53
54
54
55
55
obtain 80 dB SPL
This table indicates the attenuator settings required to obtain a sound pressure level of 80 dB SPL at indicated frequencies.
Stimulus modulation
FM (Warble):
SISI:
Adjustable modulation rate and depth
•
Modulation rate: 1-20 Hz (default: 5 Hz).
•
Modulation depth: 1-25% of center frequency (default: 5%).
5, 2, 1 dB increments
Accuracy of sound level
Entire level range (AC):
125 to 5000 Hz: ±3 dB, 5000 to 12500 Hz: ±5 dB
Entire level range (BC):
250 to 5000 Hz: ±4 dB, 5000 to 8000 Hz: ±5 dB
The reference conditions for the specification of frequency response and sound pressure level depend on the type of audiometer. AURICAL Aud can be calibrated as either a “corrected” (Type AE) or “uncorrected” (Type A) speech audiometer:
Type AE calibration:
22
•
The output sound pressure level and frequency response are specified in terms of free-field equivalent sound pressure
level.
•
The loudspeaker output is specified as measured under free-field conditions, at 1 m distance, and on the axis of the
loudspeaker.
•
Bone vibrator output is not corrected to obtain a free-field equivalent sound force level; uncorrected output is produced (please see below under “Type A”).
•
Calibration of speech signals is performed using either a 1 kHz pure tone (earphones) or 1 kHz warble tone (loudspeakers).
Otometrics - AURICAL Aud
17 Technical specifications
Type A calibration:
•
The output sound pressure level and frequency response are specified in terms of coupler level. See table below for
coupler/ear simulator used.
•
The loudspeaker output is specified as measured under free-field conditions, at 1 m distance, and on the axis of the
loudspeaker.
•
Bone vibrator output is not corrected to obtain a free-field equivalent sound force level; uncorrected output measured by an artificial mastoid (IEC 60318-6) is produced.
•
Calibration of speech signals is performed using either a 1 kHz pure tone (earphones) or 1 kHz warble tone (loudspeakers).
Transducer type
Coupler/ear simulator
Supra-aural earphone
IEC 60318-3
HDA200/HDA300
IEC 60318-1
Insert phone
IEC 60318-5
Attenuator
1 or 5 dB step resolution over the entire range.
HL Range
The maximum output levels from AURICAL Aud depend on the actual sensitivity of the individual transducers, and they
will be slightly different for each unit. However, the minimum requirements from IEC and ANSI standards are fulfilled for
all units.
They are specified in the following.
Frequencies and minimum output levels (dB HL)
Frequency
Supra-aural
Circum-aural
Insert phone
Bone oscillator
125
60
60
60
N/A
250
80
80
80
45
500
110
110
110
60
1000
110
110
110
70
1500
110
110
110
70
2000
110
110
110
70
3000
110
110
110
70
4000
110
110
110
60
6000
100
100
100
N/A
8000
90
90
90
N/A
Otometrics - AURICAL Aud
23
17 Technical specifications
Distortion of signals occurs for higher stimulus levels. AURICAL Aud complies with IEC and ANSI standards with respect to
maximum distortion. The following specification from IEC 60645-1:2001 applies:
Specification of allowable distortion levels for airborne sound (test level and distortion)
Frequency (Hz)
Test level for
Supra-aural earphone
(dBHL)
Test level for Circum-aural
and Insert earphone
(dBHL)
Allowed THD
(%)
125-250
75
65
2.5
315-400
90
80
2.5
500-5000
110
100
2.5
Specification of allowable distortion levels for bone conducted sound (test level and distortion)
Frequency (Hz)
Test level for
bone vibration
(dBHL)
Allowed THD
(%)
250-400
20
5.5
500-800
50
5.5
1000-4000
60
5.5
For higher output levels than those specified in the tables above, transducers will produce higher distortion levels. The distortion is generated almost exclusively by the transducers, as the audiometer itself produces negligible distortion. Based
on the extensive knowledge which exists regarding the standard transducers, audiologists should determine if levels higher
than those specified above can be used for a particular test.
Total harmonic distortion
Air < 2.5%
Bone < 5%
Selectable transducers1
AC:
TDH 392, ME-70, HOLMCO, HDA 200/HDA 300 headphones, and Insert
Earphones
BC:
Bone oscillator (Mastoid)
SF:
•
Passive sound field speaker using the built-in amplifier, or
•
External amplifier using the line output.
Transducer options depend on how AURICAL Aud is ordered and calibrated.
24
Otometrics - AURICAL Aud
17 Technical specifications
1. All headbands supplied with transducers comply with the ISO 389 series for that model of transducer unless otherwise specified.
2. Headphone TDH-39 can be supplied with two different headbands, HB7 and HB8:
- For adult skulls or above normal skull size, HB8 shall be applied (HB8 is in compliance with ISO 389).
- For children and below normal skull size HB7 shall be applied (HB7 provides a greater force required to accommodate
smaller skull size)
For audiometric testing outside of noise attenuating test rooms, Otometrics recommends using earphones which feature
passive noise reduction. For the applicable earphone models, the attenuation is specified in the following table.
Sound attenuation values for earphones
Frequency
(Hz)
Attenuation
TDH39 with
MX41/AR cushion
(dB)
EAR 3A
HDA200
HDA300
(dB)
(dB)
(dB)
63
12.5
125
3
33
14.3
160
4
34
15
200
5
35
16
250
5
36
16
315
5
37
18
400
6
37
20
500
7
38
23
630
9
37
25
750
-
800
11
37
27
1000
15
37
29
1250
18
35
30
1500
-
1600
21
34
31
2000
26
33
32
2500
28
35
37
3000
-
3150
31
37
41
4000
32
40
46
Otometrics - AURICAL Aud
12.5
12.7
9.4
12.8
15.1
28.8
25
17 Technical specifications
Sound attenuation values for earphones
5000
29
41
45
6000
-
6300
26
42
45
8000
24
43
44
26.2
ISO 4869-1:1994
Data obtained from manufacturer’s data sheet.
Outputs
AC:
2 x 2 mono jacks, 6.3 mm (1/4 inch)
BC:
1 x mono jack, 6.3 mm (1/4 inch)
SF power output:
3 x terminals,
3 x 40 W peak, 8 Ω load
SF line output:
2 x 1.6 Vrms,
External inputs
CD/Analog line in:
0.2 to 2.0 Vrms, 10 kΩ, 1 stereo 3.5 mm (1/8 inch) jack
Talk Back microphone:
•
Electret microphone
•
Input voltage: 0.002 to 0.02 Vrms
•
Input resistance: 2.21 kΩ.
•
3.5 mm (1/8 inch) jack
USB 2.0 hub:
•
with 3 powered USB ports
24V DC power supply:
•
DC power, 2.5 mm
Stimulus presentation
Normal:
The signal is presented when the Stimulus Presentation button is activated.
Continuous ON:
The signal is interrupted when the Stimulus Presentation button is activated.
Pulse:
The signal is pulsed.
Pulse duration:
200 ms on and 200 ms off configurable
Bone oscillator
Bone oscillator output
The maximum speech output level from the bone oscillator depends on the actual sensitivity of the vibrator. The actual
maximum output is therefore determined at the time of calibration. The actual maximum output level may be determined by the operator by simply increasing the output level until the attenuator setting no longer increases.
26
Otometrics - AURICAL Aud
17 Technical specifications
Additionally, AURICAL Aud includes a feature which allows the operator to select the maximum output level from a bone
oscillator . Using this feature, the maximum output may be set lower than the physically available output level (installation
option).
As the maximum available output level will result in significant distortion from the bone oscillator , the specification below
limits the speech output level to 60 dBHL. Typical distortion levels (median values of a sample of bone oscillator ) are indicated in the following table.
Total harmonic distortion (THD), %
Speech hearing level (dBHL) ->
60
50
40
30
250
34,7
13,7
4,4
2,2
500
3,7
1
0,3
0,2
1000
2,6
0,9
0,3
0,3
Frequency below (Hz)
Frequency response
Frequency
(Hz)
Nominal response level
(dB re. 1kHz level)
Tolerance
(dB)
250
-1.5
±4
500
6.5
±4
750
1.0
±4
1000
0.0
01
1500
1.5
±4
2000
-6.5
±4
3000
-15.5
±4
4000
-11.0
±6
Operator accessories
Operator monitor headset - headphones: •
•
Operator microphone (desktop or boom): •
Otometrics - AURICAL Aud
40 mW 16 Ω
3.5 mm (1/8 inch) stereo jack
Electret microphone
•
Input voltage: 0.002 to 0.02 Vrms,
•
Input resistance: 2.21 kΩ.
•
3.5 mm (1/8 inch) jack
27
17 Technical specifications
USB port connector
Type:
USB device port
Compliant:
USB 2.0
Speed:
High speed
Transport and storage
Temperature:
-30°C to +60°C (-22°F to 140°F)
Air humidity:
10% to 90%, non-condensing
Air pressure:
500 hPa to 1060 hPa
Operating environment
Mode of operation:
Continuous
Temperature:
+15°C to +35°C (59°F to 95°F)
Air humidity:
30% to 90%, non-condensing
Air pressure:
700 hPa to 1060 hPa.
(Operation in temperatures exceeding -20°C (-4°F) or +60°C (140°F) may cause permanent damage.)
Warm-up time
< 5 min.
Note • Should be extended if AURICAL Aud has been stored in a cold environment.
Disposal
AURICAL Aud can be disposed of as normal electronic waste, according to WEEE and local regulations.
Dimensions
AURICAL Aud:
Approx. 275 x 205 x 60 mm, (10.8 x 8.0 x 2.4 inches)
Weight
AURICAL Aud with HI-PRO 2:
Approx. 0.85 kg, (1.875 lb)
AURICAL Aud without HI-PRO 2:
Approx. 0.65 kg, (1.433 lb)
Power supply
External power supply, type:
28
MeanWell MES50A-6P1J, 50W
Output: 24 V, 2.08 A; Input: 100-240 V AC, 50/60 Hz, 1.5 - 0.8 A
Power consumption
< 60 VA
Otometrics - AURICAL Aud
17 Technical specifications
Mains cables
8-71-240
POWER CABLE, W/ SCHUKO PLUG
8-71-290
MAINS CORD, H05VV, DK PLUG
8-71-80200
MAINS CORD, H05VV, UK PLUG
8-71-82700
POWER CABLE AUSTRALIA
8-71-86400
POWER CABLE CHINA
7-08-027
MAINS CORD, H05VV, CH PLUG
7-08-017
POWER CABLE, SJ, US HOSP. PLUG
8-71-93600
1081 YC12 POWER CABLE JAPAN
Standards
17.2
Audiometer:
IEC 60645-1, Type 2, 2010; IEC 60645-2, Type A, 1993;ANSI S3.6
Patient Safety:
Complies with IEC 60601-1, Class 1, Type B; UL 60601-1; CAN/CSA-C22.2 NO
601.1-90.
EMC:
IEC 60601-1-2
HI-PRO 2 (built-in)
Ports for hearing instruments
2 x 6-pin mini-DIN sockets:
For connecting programmable hearing instruments
Safety:
EN 60601-1, Class 1, Type BF and UL 544.
EMC:
EN 60601-1-2; EN 300 328-2; EN 301 489-17
Accessories
•
17.3
Test software. See the AURICAL Aud Service Manual.
AURICAL speaker unit
Interfaces
USB port output, type A
Primarily for USB Bluetooth dongle
USB port input, type B
USB connection from PC
24V DC in
DC power, 2.5 mm
24V DC throughput
DC power, 2.5 mm
Speaker input
RCA phone optimized for 8 Ω. speaker
Dimensions
Speaker:
Otometrics - AURICAL Aud
Approx. 375 x 285 x 145 mm (14.8 x 11.2 x 5.7 inches)
29
17 Technical specifications
Weight
Speaker:
Approx. 1.5 kg (3.3 lb)
Transport and storage
Temperature:
-30°C to +60°C (-22°F to 140°F)
Air humidity:
10% to 90%, non-condensing
Air pressure:
500 hPa to 1060 hPa
Operating environment
Mode of operation:
Continuous
Temperature:
+15°C to +35°C (59°F to 95°F)
Air humidity:
30% to 90%, non-condensing
Air pressure:
980 hPa to 1040 hPa.
(Operation in temperatures exceeding -20°C (-4°F) or +60°C (140°F) may cause permanent damage.)
17.4
Accessories
Standard accessories and optional accessories may vary from country to country - please consult your local distributor.
30
•
TDH 39 headphones (Headband: HB-7, HB-8)
•
ME-70 headphones
•
HOLMCO headphones
•
HDA 300 headphones
•
Bone oscillators: BC-1, B-71
•
Otometrics insert phones
•
AURICAL speaker unit for integration with AURICAL FreeFit
•
Sound field loudspeakers
•
Monitor headphones with boom microphone
•
Desktop microphone
•
Talkback microphone
•
Patient Responder
•
Power supply and mains cable
•
Wall mounting plate
•
Connection cables
•
AURICAL FreeFit
•
AURICAL Aud Reference Manual
•
AURICAL Aud User Guide
Otometrics - AURICAL Aud
17 Technical specifications
17.5
Notes on EMC (Electromagnetic Compatibility)
•
AURICAL Aud is part of a medical electrical system and is thus subject to special safety precautions. For this reason, the
installation and operating instructions provided in this document should be followed closely.
•
Portable and mobile high-frequency communication devices, such as mobile phones, may interfere with the functioning of AURICAL Aud.
Guidance and manufacturer's declaration - electromagnetic emissions for all equipment and systems
AURICAL Aud is intended for use in the electromagnetic environment specified below. The user of AURICAL Aud should ensure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment - guidance
RF emissions
Group 1
AURICAL Aud uses RF energy only for its internal function. Therefore, its RF emissions are very low and are
CISPR 11
RF emissions
not likely to cause any interference in nearby electronic equipment.
Class B
AURICAL Aud is suitable for use in all environments, including domestic environments and those directly
CISPR 11
connected to the public low-voltage power supply network that supplies buildings used for domestic
purposes.
Guidance and manufacturer's declaration - electromagnetic immunity for all equipment and systems
AURICAL Aud is intended for use in the electromagnetic environment specified below. The user of AURICAL Aud should ensure that it is used in such an environment.
Immunity test
IEC 60601
Compliance
test level
level
Electrostatic discharge (ESD)
+/- 6 kV con-
+/- 6 kV con-
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material,
IEC 61000-4-2
tact
tact
the relative humidity should be at least 30 %.
+/- 8 kV air
+/- 8 kV air
Electrical fast transient/burst IEC +/- 2 kV for
+/- 2 kV for
61000-4-4
Electromagnetic environment - guidance
Mains power quality should be that of a typical commercial or hospital environment.
power supply power supply
lines
lines
+/- 1 kV for
+/- 1 kV for
input/output input/output
Surge IEC 61000-4-5
Otometrics - AURICAL Aud
lines
lines
+/- 1 kV line
+/- 1 kV line
(s) to line(s)
(s) to line(s)
+/- 2 kV line
+/- 2 kV line
(s) to earth
(s) to earth
Mains power quality should be that of a typical commercial or hospital environment.
31
17 Technical specifications
Voltage dips, short inter-
<5 % U T (>95
<5 % U T (>95
Mains power quality should be that of a typical commercial or hospital environment. If the
ruptions and voltage variations
% dip in U T)
% dip in U T)
user of the AURICAL Aud requires continued operation during power mains interruptions, it is
on power supply input lines IEC for 0.5 cycle
for 0.5 cycle
recommended that the AURICAL Aud be powered from an uninterruptible power supply or a
61000-4-11
40 % UT (60 % 40 % UT (60 % battery.
dip in U T) for dip in U T) for
5 cycles
5 cycles
70 % U T (30 % 70 % U T (30 %
dip in U T) for dip in U T) for
Power frequency
25 cycles
25 cycles
<5 % U T (>95
<5 % U T (>95
% dip in U T)
% dip in U T)
for 5 s
for 5 s
3 A/m
3 A/m
(50/60 Hz) magnetic field
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
IEC 61000-4-8
U T is the AC mains voltage prior to application of the test level.
Guidance and manufacturer's declaration - electromagnetic immunity - for equipment and systems that are NOT life-supporting
AURICAL Aud is intended for use in the electromagnetic environment specified below. The user of AURICAL Aud should ensure that it is used in such an environment.
Immunity test
IEC 60601
Compliance level
Electromagnetic environment - guidance
3 V/m
Portable and mobile RF communications equip-
test level
Radiated RF
3 V/m
IEC 61000-4-3
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
ment should be used no closer to any part of
AURICAL Aud, including cables, than the recommended separation distance calculated from the
equation applicable to the frequency of the transmitter.
Recommended separation distance:
d = 1.2
d = 1.2
for 80 MHz to 800 MHz
d = 2.3
for 80 MHz to 2.5 GHz,
where P is the maximum output power rating of
the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended
separation distance in metres (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey, a
should be less than the compliance level in each
frequency range. b
Interference may occur in the vicinity of equipment marked with this symbol:
32
Otometrics - AURICAL Aud
17 Technical specifications
Note 1: At 80 MHz and 800 MHz the separation distance for the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and
people.
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio
broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which AURICAL Aud is used exceeds the applicable RF
compliance level above, the AURICAL Aud should be observed to verify normal operation. If abnormal performance is observed, additional measures might
be necessary, such as reorienting or relocating AURICAL Aud.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Recommended separation distances between portable and mobile RF communications equipment and AURICAL Aud
The AURICAL Aud is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the
AURICAL Aud can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the AURICAL Audas recommended below, according to the maximum output power of the communications equipment.
Rated maximum output
power of transmitter
W
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz
d = 1.2
d = 1.2
d = 2.3
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter
manufacturer.
Note 1: At 80 MHz and 800 MHz the separation distance for the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and
people.
Otometrics - AURICAL Aud
33
18 Definition of symbols
18
Definition of symbols
Electronic equipment covered by the Directive 2002/96/EC on waste electrical and electronic equipment
(WEEE).
All electrical and electronic products, batteries, and accumulators must be taken to separate collection at
the end of their working life. This requirement applies in the European Union. Do not dispose of these
products as unsorted municipal waste.
You can return your device and accessories to Otometrics, or to any Otometrics supplier. You can also contact your local authorities for advice on disposal.
Consult user manual for warnings and cautions.
Consult instructions for use.
Without HI-PRO 2
Complies with Type B requirements of IEC60601-1.
With HI-PRO 2
Complies with Type B requirements of IEC60601-1.
Complies with Type BF requirements of IEC60601-1.
Complies with Medical Devices Directive 93/42/EEC and RoHS Directive (2011/65/EC).
MEDICAL - General Medical Equipment as to electrical shock, fire and mechanical hazards only in accordance with UL 60601-1, first edition, 2003 CAN/CSA-22.2 No. 601.1-M90.
Suitable for direct current only.
Used in error message dialogs if software program fails. See the detailed information in the dialog box.
19
Warning notes
This manual contains information and warnings, which must be followed to ensure the safe performance of the devices and
software covered by this manual. Local government rules and regulations, if applicable, should also be followed at all times.
34
Otometrics - AURICAL Aud
19 Warning notes
Standards and safety-related issues relating to HI-PRO 2 are comprised by the AURICAL Aud symbols, standards and warning
notes.
See Definition of symbols ► 34, Connector warning notes ► 35 and General warning notes ► 36.
19.1
Connector warning notes
Warning • Never mix connections between the two types of connectors shown below:
Direct connectors
•
All connectors within the red frame are connected directly to patient transducers.
Fig. 1
Sockets with direct connections to patient transducers - AURICAL Aud connection panel
Isolated connectors
•
All connectors within the red frame are isolated from patient transducers.
Note • The safety standards listed in Technical specifications ► 20 do not apply to the isolated connectors used in
the AURICAL Aud audiometer.
Fig. 2
Connectors isolated from patient transducers - AURICAL Aud connection panel
Otometrics - AURICAL Aud
35
19 Warning notes
19.2
General warning notes
Warning • For warning notes applying to the AURICAL speaker unit charger when in use with AURICAL FreeFit, see the
warning notes in the AURICAL FreeFit Safety section in the AURICAL FreeFit documentation.
1. This class of equipment is allowed in domestic establishments when used under the jurisdiction of a health care professional.
2. AURICAL Aud is intended for diagnostic and clinical use by audiologists and other trained health care professionals in
testing the hearing of their patients.
3. To prevent cross-infection, use new eartips when you test the next client.
4. Accidental damage and incorrect handling can have a negative effect on the functionality of the device. Contact your
supplier for advice.
5. For the sake of safety and in order not to void the warranty, service and repair of electro-medical equipment should
be carried out only by the equipment manufacturer or by service personnel at authorized workshops. In case of any
defects, make a detailed description of the defect(s) and contact your supplier. Do not use a defective device.
6. It is recommended to install the unit in an environment that minimizes the amount of static electricity. For example,
anti-static carpeting is recommended.
7. Do not store or operate the device at temperatures and humidity exceeding those stated in the Technical Specifications, Transport and storage.
8. Keep the unit away from liquids. Do not allow moisture inside the unit. Moisture inside the unit can damage the
instrument and it may result in a risk of electrical shock to the user or patient.
9. Do not use the instrument in the presence of flammable agents (gases) or in an oxygen-rich environment.
10. No parts may be eaten, burnt, or in any way used for purposes other than the applications defined in the Intended Use
section of this manual.
11. To avoid the risk of electric shock, this equipment must only be connected to a mains supply with protective ground.
12. The device and any device to be connected which has its own power supply should be turned off before any connections are established. To disconnect the device from the mains supply, pull the mains plug out of the wall mains
outlet. Do not position the unit so that it is difficult to pull the mains plug out of the wall mains.
13. For safety reasons and due to effects on EMC, accessories connected to the equipment's outlet fittings must be
identical to the type supplied with the system.
14. It is recommended that an annual calibration be performed on accessories containing transducers. Furthermore, it is
recommended that calibration be performed if the equipment has suffered any potential damage (e.g. headphones
dropped on the floor).
Note that calibration has been performed only on the transducers supplied! If you wish to use any other transducer for
testing with the device, please contact your local distributor first.
15. Disposable accessories, such as eartips, should not be reused and must be replaced between patients to prevent crossinfection.
16. We recommend that the device should not be stacked with other equipment or placed in a poorly ventilated space as
this may affect the performance of the device. If it is stacked or placed adjacent to other equipment, make sure that
the operation of the device is not affected.
36
Otometrics - AURICAL Aud
20 Manufacturer
17. Unwanted noise may occur if the device is exposed to a strong radio field. Such noise may interfere with the performance of the device. Many types of electrical devices, e.g. mobile telephones, may generate radio fields. We
recommend that the use of such devices in the vicinity of AURICAL Aud be restricted.
Likewise, we recommend that the instrument is not used in the vicinity of devices sensitive to electromagnetic fields.
18. Changes or modifications not expressly approved by the manufacturer could void the user's authority to operate the
equipment.
19. The device can be disposed of as normal electronic waste, according to local regulations.
20. Use only the specified power supply.
See the Technical Specifications, Power Supply.
When assembling an electro-medical system, the person carrying out the assembly must take into account
that other connected equipment which does not comply with the same safety and EMC requirements as this
product (e.g., cables, PC and/or printer) may lead to a reduction in the overall safety level or EMC compliance
level of the system. The equipment must comply with IEC 60950.
When selecting accessories connected to the device, the following points must be considered:
•
Use of connected equipment in a patient environment
•
Proof that connected equipment has been tested in accordance with IEC60601-1 and/or IEC60601-1-1
and UL60601-1 and CAN/CSA-C22.2 NO 601.1-90.
21. To comply with EN 60601-1-1 computer and printer must be placed out of reach of the client, i.e. not closer than
approx. 1.5 meters/5 ft.
22. The charger unit should be kept away from the client area.
23. There are no user-serviceable parts inside the charger unit cabinet. For the sake of safety, and in order not to void the
warranty, the cabinet should only be opened and serviced by authorized service personnel. In case of defects, please
make a detailed description of the defect(s) and contact your supplier. Do not use a defective instrument.
24. The charger unit can be disposed of as normal electronic waste, according to local regulations.
20
Manufacturer
GN Otometrics A/S
Hoerskaetten 9, 2630 Taastrup
Denmark
( +45 45 75 55 55
7 +45 45 75 55 59
www.otometrics.com
20.1
Responsibility of the manufacturer
The manufacturer is to be considered responsible for effects on safety, reliability, and performance of the equipment only
if:
Otometrics - AURICAL Aud
37
20 Manufacturer
•
All assembly operations, extensions, re-adjustments, modifications or repairs are carried out by the equipment manufacturer or personnel authorized by the manufacturer.
•
The electrical installation to which the equipment is connected complies with EN/IEC requirements.
•
The equipment is used in accordance with the instructions for use.
The manufacturer reserves the right to disclaim all responsibility for the operating safety, reliability and performance of
equipment serviced or repaired by other parties.
38
Otometrics - AURICAL Aud
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