grason stadler inc

Part Number 2205-0100 Rev B
2205-0100 Rev B
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Preface
Title:
GSI AUDIOscreener+ User Manual
Copyright © 2008 Grason-Stadler Inc. All rights reserved. No part of this
publication may be reproduced or transmitted in any form or by any means
without the prior written permission of Grason-Stadler Inc. The information in this
publication is proprietary to Grason-Stadler.
Compliance
The CE0344 mark identifies compliance with the Medical Device Directive
93/42/EEC. Grason-Stadler is an ISO 9001-certifed corporation.
European Authority Representative
Grason-Stadler
Kongebakken 9
2765 Smorum
Denmark
0344
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Warranty
Grason-Stadler (hereinafter referred to as GSI)
warrants that each GSI AUDIOscreener+ will be free from defects in materials and
workmanship under normal use and service for a period of one year from the date of
delivery by GSI to the first purchaser. If any such defect occurs during the warranty
period, the aforesaid purchaser should communicate directly with GSI. If returned to GSI,
GSI will arrange for repairs or replacement within the terms of the warranty. The defective
device should be properly packaged and promptly returned, postage prepaid. Loss or
damage to device in return shipment to GSI shall be at purchaser’s risk.
In no event shall GSI be liable for any incidental, indirect or consequential damages in
connection with the purchase or use of the GSI AUDIOscreener+. This warranty shall not
apply to, and GSI shall not be responsible for, any loss arising in connection the
purchase or use of any such device that has been repaired by anyone other than an
authorized GSI representative or altered in any way so as, in GSI’s judgment, to affect its
stability or reliability or which has been subject to misuse, negligence or accident, or
which has had the serial or lot number altered, defaced or removed, or which has been
used otherwise than in accordance with the instructions furnished by GSI. GSI neither
assumes nor authorizes any representative or other person to assume for it any other
liability in connection with the sale of such devices.
GSI DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY
IMPLIED WARRANTY OF MERCHANTABILITY OR OF FITNESS FOR A PARTICULAR
PURPOSE OR APPLICATION OTHER THAN THOSE EXPRESSLY SET FORTH IN THE
APPROPRIATE PRODUCT LABELING OR USER INFORMATION MANUAL. IN NO EVENT
WILL GRASON-STADLER BE LIABLE FOR ANY INCIDENTAL, INDIRECT OR
CONSEQUENTIAL DAMAGES IN
CONNECTION WITH THE PURCHASE OR USE OF ITS PRODUCTS, NOR FOR LOSS,
DAMAGE OR INJURY TO OTHERS. THIS LIMITED WARRANTY SHALL NOT EXTEND TO
ANYONE OTHER THAN THE ORIGINAL PURCHASER OF THE PRODUCT AND STATES
YOUR EXCLUSIVE REMEDY.
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Specifications
DPOAE Operating Specifications
Frequency Range:
Frequency Resolution:
Frequency Accuracy:
Level Measurement Accuracy:
Dynamic Range:
Transducer THD:
TEOAE Operating Specification
Analysis Frequency Range:
Stimulus Center Frequency:
Frequency Accuracy:
Level Measurement Accuracy:
Dynamic Range:
Transducer THD:
ABR Operating Specifications
Stimulus Types:
Stimulus Polarity:
Level Measurement Accuracy:
Input Frequency Range:
Waveform Latency Accuracy:
Common Mode Rejection:
Gain:
Patient Leakage Current:
Differential Input Impedance:
Long Term Average System Noise:
Transducer THD:
Alarms
Low Battery, Dead Battery
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2000 Hz – 6000 Hz
50 Hz
± 5% of displayed value
± 1 dB SPL
(configurable to wider ranges)
96 dB
3%
500 Hz - 5000 Hz (resolution 50 Hz)
1000 Hz - 6000 Hz (resolution 1000 Hz)
± 5% of displayed value
± 1 dB SPL (configurable to wider range)
96 dB
3%
Click 100 µsec width, Blackman Windowed
tone pips, (500 Hz, 1000 Hz, 2000, Hz, 4000
Hz)
Rarefaction, condensation, alternating
± 1 dB SPL (measured peak-peak equivalent
per IEC 60645-3, configurable to wider
ranges)
30 Hz - 3000 Hz (3rd order low-pass, 2nd
order high-pass analog filter)
±0.2 msec
108 dB
43 dB
< 100 µA AC, <10µA DC Normal
Condition <500 µA AC, <50 µA DC
Single Fault Condition
1 GOhm
<0.05µV P-P
3%
Page 4
Database Error
Internal Circuit Error
Battery
NiMH 2150 mAh
Battery operating life – approximately 24 hours
Recharge time – approximately 2 hours
Device Dimensions
19.7 cm L x 10.2 cm W x 4.5 cm H
Weight
0.57 kg
Case Material
ABS UL94-V0 Fire Retardant
IR Window Lexan UL94-V0 Fire Retardant
AC Adapter Power Requirements
100-240 VAC, 50-60 HZ, 1.25A (GSI PN: 8000-0265)
Operating Conditions
10 degrees - 40 degrees C (50 degrees - 104 degrees F) 95% Relative humidity
non-condensing 500-1060 hPa atmospheric pressure
Storage Conditions
0 degrees - 50 degrees C (32 degrees - 122 degrees F)
95% Relative humidity non-condensing for 72 hours
500-1060 hPa atmospheric pressure
Type of Protection Against Electric Shock
Class II
Mode of Operation
Continuous
Degree of Protection Against Ingress of Fluids
IPX0 – Ordinary Equipment
Degree of Mobility
Portable
Degree of Protection Against Electric Shock
Type BF
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Degree of Protection Against Flammable Anesthetic Mixtures
Equipment not suitable for use in the presence of a flammable anesthetic
mixture with air or with oxygen or nitrous oxide
Degree of Electrical Connection Between Equipment and Patient
Equipment with an applied part not designed for conductive connection to the
patient
Medical and Electrical Safety Compliance
UL60601-1, CAN/CSA C22.2 NO. 601.1
IEC60601-1-2
CISPR 11 (EN55011)
IEC 1000-4-2
IEC 1000-4-3
IEC 1000-4-4
IEC 1000-4-5
EN 61000-4-11
IEC 1000-4-8
ANSI S3.6-1996
IEC 60601-2-26
IEC 60601-2-40
IEC 60645-3
Electrode Wires
Connectors to the GSI AUDIOscreener+ are compliant to “Safety DIN” standard
(DIN 42-802) with snap connectors for electrodes
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Electromagnetic Compatibility
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Table of Contents
Preface .............................................................................................................................................. 2
Title: ............................................................................................................................................ 2
Warranty ..................................................................................................................................... 3
Specifications .............................................................................................................................. 4
Electromagnetic Compatibility...................................................................................................... 7
Chapter 1 Introduction ....................................................................................................................10
Chapter 2 Installation .....................................................................................................................12
Introduction ............................................................................................................................... 12
AC Adapter ............................................................................................................................... 12
Probe Module ............................................................................................................................ 14
External Devices ....................................................................................................................... 14
External Computer .................................................................................................................... 15
Chapter 3 Basic Operation ..............................................................................................................17
Introduction ............................................................................................................................... 17
The Front Panel ........................................................................................................................ 17
The Main Screen ....................................................................................................................... 18
The Patient Database Section ................................................................................................... 19
OAE Section ............................................................................................................................. 23
ABR Section.............................................................................................................................. 23
Prepare to Test ......................................................................................................................... 24
Testing With the Probe .............................................................................................................. 25
The Probe Module ......................................................................................................................25
Select a Disposable Ear Tip .......................................................................................................25
Attach the Disposable Ear Tip ....................................................................................................26
Couple the Probe to the Ear .......................................................................................................27
The Use of Comfort Cups™ .......................................................................................................27
Testing With Electrodes ............................................................................................................. 28
The Electrodes ...........................................................................................................................28
Select Three Disposable Electrodes ...........................................................................................28
Attach Disposable Electrodes to Wires .......................................................................................28
Prepare Skin ..............................................................................................................................29
Attach Electrodes .......................................................................................................................29
Select Patient Record ................................................................................................................ 30
Perform Test ............................................................................................................................. 31
View Overall Results ................................................................................................................. 33
View Detailed Results ............................................................................................................... 34
Overall Operation ...................................................................................................................... 34
Chapter 4 OAE Advanced Operation ..............................................................................................35
Introduction ............................................................................................................................... 35
Advanced DPOAE Operation .................................................................................................... 35
Advanced TEOAE Operation ..................................................................................................... 40
Chapter 5 ABR Advanced Operation ..............................................................................................45
Introduction ............................................................................................................................... 45
View Detailed Results ............................................................................................................... 48
Chapter 6 Configuration..................................................................................................................52
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Introduction ............................................................................................................................... 52
DPOAE Configuration ............................................................................................................... 54
DP Global Parameters................................................................................................................55
DP Test Frequency Parameters .................................................................................................56
TEOAE Configuration ................................................................................................................ 58
TE Global Parameters ................................................................................................................59
TE Data Acquisition Parameters .................................................................................................60
TE Frequency Bands ..................................................................................................................61
ABR Configuration..................................................................................................................... 63
ABR Global Parameters .............................................................................................................64
ABR Filter Parameters................................................................................................................66
ABR Signal Parameters ..............................................................................................................66
Database Configuration ..............................................................................................................67
Time / Date Configuration .......................................................................................................... 68
Printing Configuration ................................................................................................................ 68
Device Configuration ................................................................................................................. 69
Power Down Screen .................................................................................................................. 70
Chapter 7 Maintenance ...................................................................................................................71
Cleaning.................................................................................................................................... 71
General Maintenance ................................................................................................................ 72
Preventive Maintenance ............................................................................................................ 72
Manufacturer ............................................................................................................................. 72
Service ...................................................................................................................................... 72
Chapter 8 Troubleshooting .............................................................................................................73
Alarms ...................................................................................................................................... 73
Troubleshooting ........................................................................................................................ 74
Appendix A Screening Methods and Criteria .................................................................................75
Appendix B Probe Handling Guide.................................................................................................76
Appendix C Probe Cleaning Guide .................................................................................................76
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Chapter 1
Introduction
The GSI AUDIOscreener+ is an advanced, precision, handheld medical instrument
designed for hearing screening. It measures both otoacoustic emissions (OAE) and
auditory brainstem responses (ABR) in either an automated mode or an advanced mode.
It can implement all screening protocols including the multi-stage protocols
recommended by the National Institutes of Health. Though the self-contained device can
be operated and configured with no external equipment, built-in wireless communication
allows patient records to be transferred to and from patient records to be transferred to
and from an external computer. It has the ability to test a patient with only one click –
right out of the box.
The GSI AUDIOscreener+ is designed for patients of all ages, from newborn infants
through adulthood. It screens auditory function in any individual for whom traditional
behavioral audiometric responses are unreliable including newborns, infants, young children,
and uncooperative or cognitively-impaired individuals. The GSI AUDIOscreener+ is
particularly well suited for all Universal Neonatal Hearing Screening programs.
The OAE section evokes and measures either distortion product otoacoustic emissions
(DPOAE) or transient evoked otoacoustic emissions (TEOAE). A distortion product
otoacoustic emission is a tone generated by the normal ear (fdp) in
response to the simultaneous presentation of two external tones (f1 and f2). The GSI
AUDIOscreener+ presents two tones, f1, f2, simultaneously and measures the distortion
product otoacoustic emission, fdp, in the ear canal, all through a single small probe module
coupled to the external ear canal with a disposable probe tip. The measured level of the
distortion product (Ldp) provides information concerning the outer hair cell function of the
cochlea which in turn is correlated to hearing sensitivity. An otoacoustic emission at an
expected level strongly suggests that outer hair cell function in the cochlea is normal and
that hearing sensitivity is normal and leads to a “Pass” test result. Because a measure of
outer hair cell function does not measure the entire auditory system, a “Pass” result
should not override other clinical indications that hearing may not be normal. In contrast,
the absence of an otoacoustic emission, or an emission that is lower than the expected
level, suggests that outer hair cell function may be abnormal and that hearing sensitivity
may not be normal.
A transient evoked otoacoustic emission is a broad band sound generated by the normal ear
in response to transients (also called clicks) presented to the ear. The same probe is used to
present the clicks and measure the sounds. Similar to the DPOAE, the measured
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level and frequency content of the sound emitted by the ear also provides information about
the outer hair cell function of the cochlea which in turn is correlated to hearing sensitivity. A
transient evoked otoacoustic emission at an expected level strongly suggests that outer hair
cell function is normal and that hearing sensitivity is normal and leads to a "Pass" test result.
Because a measure of outer hair cell function does not measure the entire auditory system, a
"Pass" result should not override other clinical indications that hearing may not be normal. In
contrast, the absence of a TEOAE or an emission that is lower than the expected level
suggests that outer hair cell function is abnormal and that hearing sensitivity may not be
normal.
The ABR section evokes and measures auditory brainstem responses. An auditory
brainstem response is a characteristic electrical waveform made in response to an
auditory signal that is measured by electrodes that are placed on the skin. The GSI
AUDIOscreener+ presents acoustic signals (clicks, or very short tones called “pips”)
through the same small probe module used for OAE that is coupled to the external ear
canal or through a Comfort Cup™ that is placed over the ear. The device measures
electrical signals from the brain through disposable electrodes that are placed on the
surface of the skin. The presence of electrical signals provides correlated information
concerning the integrity of the auditory system from the external ear canal up through the
level of the brain stem. The occurrence of these signals strong-ly suggests that hearing
sensitivity is normal. Whether or not the signals are present can be determined
automatically by the device in the automated mode or manually by a trained professional
in the advanced mode. The combination of an OAE device and ABR device in a single,
handheld unit allows easy implementation of the widely-recommended multi-stage
screening procedures, all with a single device.
The GSI AUDIOscreener+ is shipped with default software settings; one for DPOAE
(QuickDPOAE), one for TEOAE (QuickTEOAE), and two for ABR (QuickABRCups,
QuickABRProbe), that are permanently stored in memory so no software setup is
required. However, the device is very advanced and can be controlled well beyond the
default parameters. Custom sets of test parameters can be defined by the operator,
named, saved and recalled for future tests. The Configuration section of this Operating
Manual provides information on how to view or change software settings allowing for a large
amount of operator control.
This Operating Manual describes the features and operations of the GSI
AUDIOscreener+. Please review the Set Up section before proceeding with the Operation
section of this manual.
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Chapter 2
Installation
Introduction
A new GSI AUDIOscreener+ requires only minimal set-up upon delivery. The Set-Up
section provides information for preparing a new device for the first time. It also can be
a reference when setting up the device later.
AC Adapter
The GSI AUDIOscreener+ is powered by a permanent internal nickel metal-hydride
(NiMH) rechargeable battery. A separate AC adapter is provided for charging the battery
and for operating the device during charging. However, for optimal results it is not
recommended to use the GSI AUDIOscreener+ while is it plugged into a wall outlet.
Insert the appropriate AC outlet plug prior to use.
Use only the supplied AC adapter. Another may cause damage to the unit and increase
the risk of electrical shock. Using the device adapter on other devices could cause
damage to those other devices.
AC Adapter
WARNING: AC ADAPTERS ARE NOT
ALWAYS INTERCHANGEABLE!
High voltage is inside the AC adapter.
DO NOT REMOVE THE COVER!
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Your new GSI AUDIOscreener+ is shipped with a discharged battery. To charge the
battery, insert the hospital-grade plug on the AC adapter into an AC wall outlet (either 110
volts or 220 volts, 60 Hz or 50 Hz). Plug the cable on the other end of the adapter into the
receptacle on the bottom of the GSI AUDIOscreener+. The battery charge indicator light
on the front panel blinks while the battery is charging and glows steadily when the battery
is fully charged.
The battery will charge continuously
whenever the device is plugged into
a wall outlet, even when the OFF
button has been pressed. To be
certain that power to all circuits has
been disconnected, the power cord
must be unplugged from the outlet.
Unplugging the AC adapter from the
device or from the AC wall outlet
automatically switches the device to
battery mode. A new, fully charged
battery will operate the instrument for
approximately
24
hours
of
continuous use and for many days
under typical use. Approximately 10
minutes prior to battery discharge,
AC Adapter connects to the bottom of device
the battery alarm will appear on the
display (see Chapter 8). When complete discharge occurs, the device will automatically
turn itself off.
Reconnect the AC adapter each time the battery is discharged. The battery must be
charged for two hours before using the device on battery power. Though the GSI
AUDIOscreener+ can be used to test patients with the AC adapter connected to the wall
outlet, for optimal performance, it is recommended that the device not be operated while
the battery is charging.
The GSI AUDIOscreener+ should be connected to the AC adapter at least once every two
weeks for a minimum of two hours to prevent battery self-discharge and possible
damage. The battery should last over several years under normal usage. The GSI
AUDIOscreener+ will have to be returned for service should the battery need replacement.
The device should never be opened by the user. (See warranty section).
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Probe Module
The GSI AUDIOscreener+
probe module has a circular connector on the
cable designed to be
inserted into the device
only one way. Line up the
indicator mark on the
probe with the indicator
mark on the device and
insert probe into device.
Care should always be
Line up indicator mark on probe and device
taken with the probe
module to ensure that the
delicate internal loudspeakers and microphones are not damaged. Also, always use care
when handling the probe and avoid dropping it or bumping it against hard surfaces. A
probe holder on the side of the case is designed to protect the probe when not in use.
Each probe module has an ID number and unique calibration data. A probe module
cannot be switched with another probe module without also changing the calibration
data. To ensure that the probe module and the internal calibration data match, the ID
number of the probe module and the date the internal calibration data were entered can
be viewed on the display (described in the Basic Operation section).
External Devices
The GSI AUDIOscreener+ is a self-contained, stand-alone unit that can be used without
any other equipment. However, the base of the device contains an infrared port that
allows convenient wireless connection to other devices such as a printer or a personal
computer.
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External Computer
The GSI AUDIOscreener+ ships with a computer application on a CD-ROM called
AUDIOtrac™. AUDIOtrac™ allows communication between GSI AUDIOscreener+ and an
external computer. If the external computer is a laptop computer, there is a good chance
that it already has an infrared port. If the external computer is a desktop model or a
laptop without a built-in infrared port, an external infrared port (supplied) can be attached.
The AUDIOtrac™ application allows the entry of patient records with a full-sized screen
and keyboard. This is convenient for entering large numbers of patient records. It also
can be used to store and print all patient data and results after the records have been
deleted from the GSI AUDIOscreener+.
The AUDIOtrac™ application allows further communication with tracking software from
other manufacturers such as Oz™ and HiTrack™, as well as the generation of files in
other formats that can be sent by e-mail and read by other computer applications
including conventional web browsers or spreadsheet applications. Please refer to the
separate AUDIOtrac™ user manual for details concerning interaction between the GSI
AUDIOscreener+ and an external computer.
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Chapter 3
Basic Operation
Introduction
This section of the Operating Manual describes the basic operation of the GSI
AUDIOscreener+ and provides sufficient information to begin using the device
immediately. The remaining sections are intended for administrators or advanced
operators. The basic operation of the GSI AUDIOscreener+ is easy to understand. No
external computer is needed to operate the device. Further, complete instructions and
detailed help screens are available on the large display.
The GSI AUDIOscreener+ is a battery-operated, handheld device with a single probe
module. For OAE testing, the probe is coupled directly to the ear with a disposable ear
tip. The probe module delivers test sounds and measures the sounds in the ear canal
generated by the ear. For ABR testing, the same probe delivers the test sounds either
directly to the ear or through a Comfort Cup™ that fits over the ear. Three electrode
wires, attached to the skin with disposable electrodes, are used to pick up electrical
signals from the brain during ABR testing. The device operates solely with the buttons on
the front of the device for both OAE and ABR testing.
The Front Panel
The front panel has several sealed membrane buttons, two indicator lights and a large
display. The buttons are used to operate the device. The indicator lights indicate the
patient test results and the battery charging status. The large display shows screens that
change as the device is operated and has a bright backlight that makes it easy to view in
low light environments. The front panel is impervious to moisture and most liquids and
can be kept clean by occasionally wiping it with a soft, damp cloth.
The four blue buttons located directly below the display are COMMAND buttons. The
functions for the COMMAND buttons change depending on the screen being displayed
but are always clearly labeled with text at the bottom of the display just above each button.
If a COMMAND button does not have a function for a particular screen, there will be no
label. The operator operates the GSI AUDIOscreener+ by observing the selected text
on the screen, then pressing a labeled blue COMMAND button to start the
selected operation.
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The UP, DOWN, LEFT and RIGHT arrow buttons surrounding the large HELP button on
the front panel are ARROW buttons. The ARROW buttons move a selection box on the
display. The selection box is a small black box surrounding white text and functions like
a cursor on a conventional computer. The ARROW buttons also activate new screens,
similar to turning pages in a book. The HELP button can be pressed at any time for
further information.
The front panel also has an AC indicator light and a PA SS/REFER indicator light. The
AC indicator light is off if the AC adapter is not plugged in. If the AC adapter is plugged
in, the light blinks green while the battery is charging and glows steady green when the
battery is fully charged. The PA SS/REFER indicator light indicates the status of the test
results being displayed. The PA SS/REFER light is off if no testing has been done and
glows amber if the testing was started but is incomplete. When testing is complete, the
light glows green for a PA SS result and orange for a REFER result.
The ON/OFF button located at the bottom left of the front panel is used to turn on and
turn off the GSI AUDIOscreener+. If the display does not light up when turning on the
device, connect the external AC adapter. After the battery has charged for a few minutes,
the device can then be turned on. You also can turn off the device manually by pressing
the ON/OFF button. When turning off the device, text on the display will ask to confirm
that you wish to turn it off. To conserve the battery charge, an auto-shutoff feature
automatically turns off the device after 10 minutes have passed since the last button
push. The auto-off setting can be configured for both shorter and longer durations.
Turn on the GSI AUDIOscreener+. An Introductory screen briefly appears and after a
few seconds, the Main screen appears.
The Main Screen
The multipurpose Main screen is used for scrolling through patient records in the internal
database, selecting the ear and type of test (OAE or ABR), selecting the operator’s
name, initiating the test, viewing test results. The very bottom of the display is divided
into four sections that label each of the blue COMMAND buttons below the display. To
operate the device, it is only necessary that you understand the information on the Main
screen.
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A selection box initially appears for the
right ear in the OAE section. The DOWN
ARROW button can be used to move this
selection down to the left ear in the OAE
section, down further to the right or left
ear in the ABR section, and down further
to the operator’s name. The up arrow can
be used to move the selection box up to
the otoacoustic emissions header that will
show either DPOAE or TEOAE. Once the
header is selected, the left or right arrows
can be used to change the type of OAE
test. If the header shows TEOAE,
pressing either the left or right arrow will
change it to DPOAE and vice versa. The
UP ARROW button can be used to move
the selection box up to the Patient
Database section. The selection box
wraps around from the bottom of the
display to the top, or vice versa
depending on which arrow key is
pressed.
Main Screen
The Patient Database Section
The Patient Database section at the top of the Main screen always displays a single
patient record from the internal patient database identified with a unique patient ID
number. Each patient record must contain a unique ID number but may also contain the
patient’s first and last name, and other patient data including gender and birth date. This
information is shown below the ID number if present. Each patient record holds all OAE
and ABR test results including all relevant test settings. Up to twelve separate tests can
be saved in each individual patient record, three OAE tests for each ear (up to 5
frequencies per test) and three ABR tests for each ear (up to 8 waveforms per test). The
internal patient database can hold up to 300 patient records that are preserved even if the
battery is entirely discharged.
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Patient Data Entry
The internal patient database contains a
special patient record with a patient ID number
of “0” and a patient name of “Trial Patient”. The
Trial Patient record is a permanent patient
record that cannot be deleted and is always
displayed first after turning on the device. The
Trial Patient record is very convenient because
it can be used to collect test results from
practice tests, from training tests, or from any
other measurement situation including tests
from an actual patient without first having to
create an actual patient record. The Trial
Patient record can contain only one test result
for each ear for each type of test. Any test
result obtained for the Trial Patient will be
deleted if another test is performed or if the
device is turned off. However, once a test
result is obtained, the third COMMAND button
is labeled SAVE which allows you to create a
regular patient record and save the results
from the Trial Patient record.
Actual patient records can be added to the
GSI AUDIOscreener internal patient database in two ways. Patient records can be
added one at a time using only the buttons on the front of the device and without any
other equipment. Patient records also can be entered into AUDIOtrac™ running on a
conventional computer and transferred in large numbers to the device. Patient records
originating in the device can be transferred back to AUDIOtrac™. For computer transfer of
patient records, please see the booklet accompanying the AUDIOtrac™ software
application.
+
To enter an individual patient record from the Main screen, use the UP or DOWN arrow
keys to move the selection box to the patient ID line at the top of the display. The second
COMMAND button will change to a NEW button. Press the NEW COMMAND button to
create a new patient record and display a Patient Data Entry screen called Patient
Information that contains six sections.
ID: A patient ID number can be up to 11 characters long. It can include both letters
and numbers in any combination. If you attempt to create a patient ID number that
is identical to one already in the patient database, you are notified and asked to
change it. This ensures that every ID number in the internal database is unique.
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First: The first name can be up to 14 characters and does not have to be unique.
Last: The last name can be up to 14 characters and does not have to be unique.
Gender: The gender can be MALE or FEMALE.
Gestational Age: The gestational age can be 24 to 44 weeks and has a default
value of 40 weeks. Gestational age is used only for determining normative ABR
Peak V latency values for children under 3 months of age. It can be ignored if
ABR measures do not consider this latency as in the default screening settings, or
if the patient is older than 3 months.
Birth date: The birth date can be from 1/1/1906 through 12/31/2099 and is used to
calculate the age of the patient at the time of the test.
Each section ends with a Data Entry
Area indicated by brackets [ ]. Initially
the selection box is shown on the ID
Data Entry Area. The selection box can
be moved up and down the screen to
other Data Entry Areas using the UP
and DOWN arrows surrounding the Help
button below the display. After a Data
Entry Area has been selected, press the
Enter button to enter data in the Data
Entry Area.
Data are entered in two ways depending
on the type of data.
Open-ended data: If the data are
open ended and from a large
data set (such as a patient’s
name) a Virtual Keyboard is
shown. The Virtual Keyboard is
Virtual Keyboard
an image of a conventional
keyboard with the numbers 0
through 9, the letters of the alphabet, a dash, an apostrophe,
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and a space character indicated b y an underscore located after the last
character. The COMMAND buttons are labeled CANCL (cancel the data entry
screen), TYPE (type the selected character to the top line), DEL (delete the last
character from the top line) and DONE (finished entering all data). When the
Virtual Keyboard is first opened, the
“1” character is selected. The selection
can be moved around the virtual keyboard using the four Arrow keys to select
other characters. Once the desired character is selected, press the TYPE
COMMAND button to place the character on the top line. Move the selection to
the next desired character and TYPE it. A character on the top line can be deleted
by pressing the DELETE COMMAND button. When all of the desired characters
have been placed on the line, press the DONE COMMAND button to save the data
and return to the Data Entry screen.
Restricted data: If the data is a restricted data set (Male, Female, e.g.) a pop-up
menu is shown listing the restricted set of data. The Up or Down arrows can be
used to make a selection from the pop-up list. Long lists on pop-up menus will
scroll. After the selection is made, press the DONE COMMAND button to save the
selection to the data area, close the pop-up screen and return to the Data Entry
screen.
Only the patient ID is required to create a new patient record. Data in all other data areas
are optional. After all data have been entered, press the DONE COMMAND button to
save the patient record into the internal patient database and return to the Main screen.
Test results obtained f or this patient on the Main screen can now be saved to this new
patient record.
Once individual patient records are in the database, they can be accessed by moving the
selection box to the patient database section at the top of the Main screen and pressing
the LEFT or RIGHT arrow keys to scroll through the records. The patient records display
one at a time and scroll continuously if the arrow button is held down. The records wrap
around to the beginning when the end of the list is reached, and vice versa. The
sequential location of the patient record number in the database followed by a slash mark
and the total n umber of patient records in the database are indicated in the patient
database section. For example, “75/84” indicates that the patient record on the display is
the 75th one of a total of 84 patient records. This information is useful when deter mining
the direction to scroll the records. Note that as you scroll through the patient database, the
PASS/REFER light below the display will indicate the status of the patient shown on the
top line of the Main screen.
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OAE Section
DPOAE or TEOAE test selection for testing or results re view may be preformed
by using the up or down arrow keys to
move the cursor to the OAE heading and
using the left or right keys to switch to the
alternate O AE test. The O AE Section
below the patient database section contains a separate area f or each ear
indicated by a large R for the right ear and
a large L for the left ear. To the right of
the R and the L is a Result Box that
displays the test findings. An empty
Result Box indicates that the ear has not
been tested. A √ symbol indicates that the
ear was tested and that a PASS result
was obtained. A ? symbol indicates that
the ear was tested and that a REFER
Main Screen
result was obtained. The text to the right of
the Result Box indicates whether a test was performed and the time and date of the test. A
Configuration that defines the test parameters will be indicated to the right of the Result
Box if the test was performed. The number of the test followed by a slash mark and the total
number of tests for that ear also are indicated. For example, “2/3” indicates that the test result
shown on the display for that ear is the second one of a total of three tests f or that ear. Note
that the tests are always sorted with the best result first, regardless of the order the tests were
obtained. The results for the other tests for the selected ear can be viewed by using the
LEFT or RIGHT arrow keys. A single DPOAE test can contain measures f or up to 5
frequencies. A single TEOAE test can show the spectral content of the result at up to 5
frequency bands.
ABR Section
The ABR section of the Main screen, below the OAE Section, also contains a separate
area for each ear indicated by a large R for the right ear and a large L for the left ear. To
the right of the R and the L is a Result Box used for displaying the test findings. An
empty Result Box indicates that the ear has not been tested. A √ symbol indicates that
the ear was tested and that a PASS result was obtained. A ? symbol indicates that the ear
was tested and that a REFER result was obtained. The text to the right of the Result Box
indicates whether or not a test was performed and if so, a Configuration that defines the
test parameters and the time and date of the test.
The number of the test for that ear followed by a “/” and the total number of tests for that
2205-0100 Rev B
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ear are also indicated. For example, “2/3” indicates that the test result shown on the
display for that ear is the second one of a total of three tests for that ear. Note that the
tests are always sorted with the best result first, regardless of the order the tests were
obtained. The results for the other tests for the selected ear can viewed by using the
LEFT or RIGHT arrow keys. A single test can contain measures for up to 8 signals (e. g.,
waveforms for clicks at 8 different levels).
Text Section
The text section below the ABR section indicates the overall patient result of the test, the
Operator’s name, an indication of the function of the operation of the ARROW buttons,
an infrared transfer graphic and a battery status graphic.
If the selection box is moved to the Tester section, the LEFT or RIGHT ARROW keys can
be used to select an Operator’s name from a prepared list (see the Configuration Section
for information on how to enter and change the names of the Operator). If the Operator’s
name is not necessary, it may be left blank.
The battery status graphic image represents a battery with black indicating the remaining
charge. You may need to disconnect and then reconnect the AC adapter to the GSI
AUDIOscreener+ to initiate battery charging if a low battery condition occurs when the
GSI AUDIOscreener+ is already connected to the AC adapter.
Prepare to Test
The GSI AUDIOscreener+ can be operated effectively in typical environments without the
need for a sound-treated booth because advanced digital signal processing reduces the
effects of ambient noise. However, it is best to keep ambient noise as low as possible.
Measures should be made in the quietest area available and the user and other
individuals nearby should not be talking or otherwise making noise during the test. Any
nearby devices (telephones, air conditioners, ice making machines, etc.) should be turned
off if possible. If such devices cannot be turned off, measures should be made at times
when these devices produce the least noise. Testing should be done away from
electrical/electronic devices that may produce electrical interference.
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Testing With the Probe
The Probe Module
The GSI AUDIOscreener+
probe module is used
separately for both OAE
and ABR testing. The
Probe Module houses two
miniature loudspeakers that
produce the test stimuli and
a
miniature,
low-noise
microphone that measures
sounds in the ear canal.
The miniature loudspeakers
are connected to two small
stainless steel tubes and the miniature microphone is connected to a single, larger
stainless steel tube. The three stainless steel tubes exit the probe module and are
designed to accept a disposable ear tip. The probe module has a one meter cable with a
circular connector that connects to a receptacle at the top of the GSI AUDIOscreener+.
(See Set Up Section for instructions concerning how to plug in the probe module if it is
disconnected). Care always should be taken with the probe module to ensure that the
delicate loudspeakers and microphone are not damaged. Please refer to Appendix E for
maintenance and care of the probe module.
Select a Disposable Ear Tip
The probe module couples to the ear with a disposable ear tip intended for single-patientuse only. Use a new disposable ear tip for each ear and dispose of the used ear tips in a
manner compliant with applicable medical waste disposal procedures.
WARNING: Never insert the probe into
any ear or test cavity at any time without
a disposable ear tip properly attached.
The disposable ear tip serves three functions:
1. To form an acoustic seal to the ear. Disposable ear tips are designed to form a
tight acoustic seal between the probe module and the ear canal to reduce
external noise. Soft disposable ear tips come in several sizes for use with
neonates, children, or adults. Select a size that is just larger than the diameter of
2205-0100 Rev B
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2.
3.
the external ear canal so that when it is placed into the ear a tight seal is formed.
To hold the probe in the ear. The probe should be coupled to the ear without
having to hold it in place with your hand. The fit of the probe tip should be
sufficient to keep the probe in the ear without having to hold it. The probe
module can be held in the ear with your hand during the test, though this will
increase ambient noise due to unavoidable hand movements.
To direct sound to and from the ear. The disposable probe tip directs sound from
the two small stainless steel tubes into the external ear and from the external
ear back to the larger stainless steel tube that connects to the microphones. The
disposable probe tip allows a firm connection to the Comfort Cup™ for ABR
testing.
Attach the Disposable Ear Tip
The probe tip should be placed on the probe module and sealed all the way.
Attaching ear tip & inserting probe
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Couple the Probe to the Ear
First make sure that the probe module cable is straight. Then insert the probe tip into the
ear canal while pulling the ear slightly upward and backward to insure that the ear canal
is not collapsed. Finally, relieve any pressure on the probe cable. The GSI
AUDIOscreener+ will perform checks prior the testing process to ensure that the probe
has been coupled properly. With practice, the operator (without holding the probe in
place) should be able to couple the probe module to the ear with the sound tubes open,
thus ensuring proper communication with
the ear canal.
Care should be taken to ensure that the
sound opening in the disposable tip is
directed into the ear canal and not against
the canal wall. To become familiar with
probe placement, practice using your own
ear or the ear of a volunteer. Once the
probe is coupled to the patient, OAE
testing can begin.
The Use of Comfort Cups™
Comfort Cups™ are also available for
neonate ABR testing. These ear cups are
a soft foam with an opening that covers
the ear. The probe module is coupled to
the ear cup with a disposable ear tip
(Green 6 mm). The ear cup is held in
place with an adhesive. Couple the probe
to the ear cup, ensuring that the flange is
visible on the inside rim of the cup.
Remove the backing from the ear cup and
position it over the ear to be tested.
If ABR testing is to be performed,
electrodes must be attached. The location
of the electrodes may differ depending on
whether a Comfort Cup™ is being used
Attaching Comfort cups
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Testing With Electrodes
The Electrodes
The GSI AUDIOscreener+ picks up electrical
signals from the brain with disposable
electrodes on the surface of the skin and
delivers them over wires that connect to
receptacles at the top of the GSI
AUDIOscreener+ with Touch-Proof connectors.
Match the color of the electrode wire with the
color of the receptacle and insert the connector
for each electrode wire until it is firmly seated.
Care always should be taken with the
electrodes and wires to ensure that they are not
damaged.
Select Three Disposable Electrodes
The disposable electrodes are intended for
single-patient-use only. Each is mounted on a
small protective sheet of plastic. Use new
disposable electrodes for each patient and
dispose of the used electrodes and backing in a
manner compliant with applicable medical
waste disposal procedures.
The electrodes themselves are small metallic
circular disks. One side of the electrode has a
flat, smooth surface coated with an electricallyconductive gel and is designed to be applied to
the surface of the skin using an integral piece of
adhesive gauze surrounding the electrode to
hold it in place. The other side of the electrode
has a small protuberance that accepts a snap
connector on the electrode wire.
Attach Disposable Electrodes to Wires
Snap an individual electrode onto the snap
connector on each electrode wire prior to
placing on head. Make sure that the electrodes
remain attached to the plastic protective sheet.
2205-0100 Rev B
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Prepare Skin
Preparation of the skin surface is recommended prior to attaching electrodes. Adequate
electrical conductivity is assured if skin oils, lotions, etc. are removed by gently rubbing
the surface of the skin with the abrasive skin prepping gel (NuPrep) or skin prep tape
provided. Apply a small amount of the gel to a cotton swab or gauze and lightly rub the
electrode site. To ensure good adhesion, dry the site with a dry portion of the swab or
gauze before attaching the electrode. Or, alternatively, tear off approximately 1" of prep
tape and using a brushing action, lightly abrade the skin at the electrode site, before
attaching the electrode. Preparation time is minimal, but the low, balanced impedance
values obtained will reduce noise in the ABR acquisition, which in turn will lead to shorter
test times.
NOTE: Prepping with Isopropyl Alcohol (alcohol wipes) alone is not recommended.
The GSI AUDIOscreener+ performs electrical impedance tests to determine the
adequacy of the electrical connection.
Attach Electrodes
The electrodes are attached at different locations depending on whether you use a
Comfort Cup™. Small graphics on the back of the device near the electrode wire
connectors indicate these locations. The test results will be similar regardless of which
method is used.
Midline Electrode Configuration (Must be used with Comfort Cups™)
1)The midline of the forehead just below the hair line (Black wire)
2)The nape of the neck (Blue wire)
3)The shoulder (Red wire)
The midline electrode configuration prevents interference between the ear cup
and the electrodes but uses locations that may not be convenient due to clothing
or blankets.
Mastoid Electrode Configuration
1)The midline of the forehead just below the hair line( Black wire)
2)The right mastoid process, the bone behind the right ear (Red wire)
3)The left mastoid process, the bone behind the left ear (Blue wire)
In neonates, the mastoid electrode configuration is convenient because clothing
or blankets do not have to be loosened.
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Main Screen
DPOAE Test Progress
Select Patient Record
All test results are stored in a single patient record. When first turning on the device, the
Trial Patient record, ID 0, is automatically displayed. The Trial Patient record allows
testing to proceed without having to select a particular patient record. A particular
patient record can be selected if patient records have been entered into the internal
patient database (see page 16).If no test has been performed for the selected patient
record, “No Test Data” is shown to the right of the Result box. The second blue
COMMAND button is labeled TEST, which initiates the selected test on the selected ear.
At this point the test can either be initiated or the test and ear selection can be changed.
2205-0100 Rev B
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Main Screen
TEOAE Test Progress
Perform Test
Press the TEST button to initiate the test. During the O AE test, a Test Progress screen
appears that shows the ID number, patient name, type of test and ear being tested.
Graphic bars move to indicate the percentage of the test completed. The test progress
screen will be either the DPO AE test progress screen or the TEOAE test progress screen
2205-0100 Rev B
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During both the DPOAE and the TEOAE tests, a brief calibration sequence determines
whether the probe is adequately coupled to the ear. If the probe is not adequately coupled to
the ear, the device will instruct you to readjust the probe before proceeding. Next, test signals
are presented and measured in the ear canal. If the levels of the test signals are not the
values specified in the Configuration, a compensation procedure automatically adjusts
them. The test will not proceed if the levels of the stimuli cannot be achieved due to blocked
sound tubes, excess ear wax (cerumen) or amniotic fluid, or from placement of the sound
opening against the canal wall. After the automatic level adjustments have been made, the
test automatically starts with the test frequencies specified in the Configuration.
ABR Impedence Check
ABR Test Progress
During the ABR test, the Test Progress Screen first provides information on the electrical
impedance of the electrodes. If the electrodes are not adequately coupled to the skin, the
device will inform you to readjust them before proceeding. A brief sequence then determines
whether the probe is adequately coupled to the ear and calibrates the level of the stimulus.
The probe fit and calibration sequence will be skipped if using the
2205-0100 Rev B
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Comfort Cups and the default ABR configuration. When this sequence is complete, a second
ABR Test Progress screen appears showing the progress of the ABR test.
Under most conditions, the OAE test will take only a few seconds and the ABR test will
take only a few minutes. Use the UP arrow or DOWN arrow to move the selection box in
preparation for the next test. Note that it is just as easy to select the next type of test as it
is to select the opposite ear so any order of the tests and ears can be performed at
anytime. If the ear is different from the last test, couple the probe to the opposite ear. For
ABR testing, there is no need to switch the electrodes. When any test is complete, the
device will return to the Main screen and show the results.
View Overall Results
The overall status of testing for a particular patient is never ambiguous. First, all test
results on the Main screen are accessible f or the patient listed in the Database Section
at the top of the display.
Second, the best individual test results, both OAE and ABR for each ear, are displayed on
the Main screen. An empty Result Box for an ear indicates that the ear has not yet been
tested. If the test Result Box for an ear contains a PASS or REFER symbol, the ear has
been tested at least once. If multiple tests for that ear have been performed, the best test
results are shown.
Third, the OAE and ABR results are integrated into an overall result for the patient. The
PASS/REFER light below the display and text on the Main screen indicate the overall
result f or the patient based on the combination of all of the test results f or both ears. If
multiple tests are made on an ear, the device will sort and display the best result first. The
best results for each ear are then combined based on the criteria specified in the
Configuration. The PASS/REFER light is off if no tests have been performed and glows
amber if testing has started but is yet incomplete, green for a patient PASS, or orange
for a patient REFER.
When either ear is selected on the Main screen, the second COMMAND button will be
labeled TEST. If at least one test has been performed on the selected ear, the first
COMMAND button will be labeled VIEW. After a test has been performed, the results can
be viewed on the display or printed for the patient’s permanent file.
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View Detailed Results
The first COMMAND button on the Main screen is labeled VIEW if at least one test has
been performed. This button activates the view mode where details of the selected test
results can be viewed on the display. The detailed view functions differ for OAE and ABR
tests and are discussed in their respective sections of the advanced operation portions of
the Operating Manual.
Actual patients can be screened using the Trial Patient record. Simply conduct the tests
while using the Trial Patient record, view the overall result on the PASS/REFER light and
manually record the overall result in the patient’s hospital chart or on the supplied blank
labels. The Trial Patient record can contain only one test result for each ear. Any test
result for the Trial Patient will be deleted if another test is performed or if the device is
turned off.
Overall Operation
The GSI AUDIOscreener+ is easy to understand and use. Because no external
equipment ever is required to operate the device and because the device has a large
display with complete instructions and detailed help screens, a trained operator can learn
quickly how to use it, and remember how to use it even if he or she does not use the
device frequently.
The GSI AUDIOscreener+ has much more capability than these basic screening
operations. The remainder of this manual has complete information concerning the
advanced capabilities of the GSI AUDIOscreener+.
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Chapter 4
OAE Advanced Operation
Introduction
This section of the operating manual describes the advanced OAE operations of the GSI
AUDIOscreener+ and is intended for administrators, supervisors or advanced operators.
Generally, an administrator or supervisor need only use the Basic Operation section of
the operating manual to train a new operator regarding aspects of the device common to
both OAE and ABR screening including issues concerning the probe, electrodes and the
patient database. This section of the operating manual will cover in detail what happens
when an OAE test is initiated as well as advanced OAE testing capability. Refer to the
Configuration section for information on how to set the test parameters.
The up arrow can be used to move the selection box up to the otoacoustic emissions
header that will show either DPOAE or TEOAE. Once the header is selected, the left or
right arrows can be used to change the type of OAE test. If the header shows TEOAE,
pressing either the left or right arrow will change it to DPOAE and vice versa. The advanced
operations of DPOAE and the TEOAE will be explained separately.
Advanced DPOAE Operation
With the selection box set to the DPOAE selection set, the TEST button displays a
DPOAE Test Progress screen and initiates a sequence of events based on a selectable
Configuration that determines all test parameters and other test requirements. The
DPOAE sequence begins with a short, low frequency test signal that determines if the
probe is adequately coupled to the ear. If the probe is not adequately coupled to the ear,
a message instructs you to readjust the probe before proceeding. Next, the two test tones
are presented and measured in the ear canal. If the levels of the tones (L1 and L2) are not
the values specified in the DPOAE Configuration, a compensation procedure
automatically adjusts them. The test will not proceed if the levels of the tones cannot be
achieved due to blocked sound tubes, excess ear wax (cerumen) or amniotic fluid in the
canal, or from placing the sound opening against the canal wall. After the automatic tone
level adjustment is made, the OAE test sequence automatically presents the test signals
sequentially. When all testing in the sequence is complete, the device returns to the Main
screen.
A choice of two test progress screens is available, the default Simple DPOAE Test
Progress screen or a Graph DPOAE Test Progress screen. The Simple DPOAE Test
Progress screen is the default test progress screen and is described in the Test Patient
2205-0100 Rev B
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section of the Operation chapter of this
operating manual. The Simple DPOAE Test
Progress screen is the default test progress
screen and is described in the Test Patient
section of the Operation chapter of this
operating manual. The Simple DPOAE Test
Progress screen displays progress bars during
the test, one for each test frequency. A progress
bar is an empty horizontal bar that fills as the
test progresses. The approximate percentage of
the maxim um test time for that frequency is
displayed in the bar. After each test frequency is
completed, the result for that frequency, either a
PASS or REFER, is displayed and the test
proceeds automatically to the next test
frequency. The sequence of test frequencies
progresses from the first to last frequency (Up)
or from the last to first frequency (Down)
according to the direction parameter set in the
DPO AE configuration section. At any time
Simple DPOAE Test Progress
during the test, the fourth COMMAND button,
labeled STOP, can be used to stop the testing and return to the Main screen. Note that
the Stop button must be held down for a few seconds until the test stops. This Simple
Test Progress screen is best used f or operators who have minimal training. Operators
with more advanced training may wish to use the Graph DPOAE Test Progress screen
that displays the measurements during the test as a graph.
The Graph DPOAE Test Progress screen displays the patient ID, name, ear, and the
test frequency number at the top of the display along with the time and date. As the test
progresses, results are shown in a graph of dB SPL as a function of frequency in Hz. Two
vertical lines indicate the test frequencies in Hz, f1 and f2. The heights of these lines
indicate the respective levels of the test frequencies in dB SPL in the ear canal, L1 and
L2. Because the two test frequencies are displayed continuously, their levels can be
monitored to make sure that the tones remain at the proper levels during the test. Also during
the test, the n umbers of frames accepted and tested (96/128, e.g.) are shown as well as
the current signal to noise ratio (S/N) in dB.
2205-0100 Rev B
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The DPOAE frequency, fdp, is indicated to
the left of f1 and if present, is shown as a
thin vertical line. The height of this line
indicates the level of the distortion product, Ldp in dB SPL. Surrounding the thin
Ldp line is a wide bar that indicates the
level of the noise (Ndp) at fdp. The effect
of noise reduction digital signal processing can be observed during the test. As
the test progresses, the level of the noise
decreases. If a distortion product is present, the level of the noise bar will
decrease sufficiently to reveal the level of
the distortion product. When the test f or
that frequency is complete, the f1 and f2
bars are eliminated leaving only the fdp
bar and the Ndp bar. The difference in
level between Ldp and Ndp is the signal to
noise ratio, S/N, in dB.
Graph DPOAE Test Progress
During the test, one of two letters may
flash in the upper right portion of the display. The letter "C" (Clipping) indicates that the
level of sound exceeds the limits of the microphone system and the measure is discarded.
The letter "N" (Noisy) indicates that the level of noise for a frame exceeded the Frame Reject
setting in the DPO AE Configuration and the measure is discarded. The test proceeds until
a reliable result is obtained or until a maxim um test time occurs.
In noisy environments, the test may stop at a particular frequency and indicate that too
much noise is present. If this occurs, the testing is stopped and a choice is given to start
testing again or stop all testing. While the testing is stopped, the operator should attempt
to reduce the amount of noise (turn off other devices, ask people to stop talking, etc.) or
wait until the noise subsides (a phone stops ringing, the baby stops crying, etc.) and then
start testing again by pressing the TEST button. The current results for the previous test
frequencies will be saved and the test will continue with the test frequency at the point
you were informed of the noisy condition. The STOP button will stop the entire test,
discard the results for the previous frequencies and return to the Main screen.
2205-0100 Rev B
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The program administrator has a choice of
sophisticated noise processing methods that
are described in detail in the Device
configuration section of this manual. In
general, the processing methods differ in
speed of testing. More test time is needed in
noisy environments to maintain reliable
results. If the letters "C" or "N" never appear,
a f aster processing method ma y be used.
If these letters appear often, a slower, but
more reliable processing method can be
selected.
After testing at all frequencies is finished, the
device automatically returns to the Main
screen to show the overall result for the ear.
Because up to three tests can be saved for
each ear, the result for the best of the tests
for that ear will be displayed. In other words,
even if the third test (3/3) was just preformed,
the device may return to the second test (2/3)
if the second test is the best of the three. Only
Simple DPOAE Test Result
the last three tests for that ear are saved. If
more than three tests have been performed for that ear, all earlier results are discarded.
When testing for the first ear is complete, remove the probe from the ear and couple it to the
opposite ear using a new tip. Use the UP arrow or DOWN arrow to move the selection box
from first ear to the opposite ear (or to the ABR section). Press the TEST button to obtain
results for the ear that has not been tested. When the test for the opposite ear is complete,
the device returns to the Main screen and shows the results for both ears.
View Detailed DPOAE Results
To view the DPOAE test results in detail, first use the UP or DOWN arrow keys to select the
desired ear in the DPOAE section. If more than one DPOAE test was obtained for this ear, use
the left or right arrow keys to select the desired test, (1/2 or 2/3, e.g.) and press the VIEW
COMMAND button. A Simple DPOAE Test Result screen similar to the Simple DPOAE
Test Progress screen displays the results in text form with a PASS or a REFER for each
frequency tested and the overall result for the ear.
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From the Simple DPOAE Test Result
screen the results can be viewed as a
graph. Press the UP arrow as indicated
on the screen to activate the Graph
DPOAE Test Result screen. The complete test results f or each test frequency
for the selected ear are shown in the form
of a graph similar to the Graph DPOAE
Test Progress screen.
From the Graph DPOAE Test Result
screen the complete test results at each
frequency can be viewed in numeric form.
Press the UP arrow to display the complete data including all of the test signal
parameters and the test result values for
the first nominal test frequency. Each value is
clearly labeled. The complete results for the
other test frequencies can be accessed b y
pressing the RIGHT or LEFT arrow keys as
indicated on the screen. When finished
viewing the detailed test results, press the
DONE COMMAND button to return to the
Main screen.
Numeric DPOAE Test Result
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Advanced TEOAE Operation
With the selection box set to the TEOAE
selection set, the TEST button displays a
TEOAE Test Progress screen and initiates a
sequence of events based on a selectable
Configuration that determines all test
parameters and other test requirements. The
TEOAE sequence begins with a short, low
frequency test signal that determines if the
probe is adequately coupled to the ear. If the
probe is not adequately coupled to the ear, a
message instructs you to readjust the probe
before proceeding. Next, the test clicks are
presented and measured in the ear canal. If
the level of the test clicks (Lt) is not the value
specified in the TEOAE Configuration, a
compensation
procedure
automatically
adjusts it. The test will not proceed if the level
of the clicks cannot be achieved due to
blocked sound tubes, excess ear wax
(cerumen) or amniotic fluid in the canal, or
from placing the sound opening against the
Simple TEOAE Test Progress
canal wall. After the automatic level
adjustment is made, the TEOAE test sequence automatically presents the test signals.
When testing is complete, the device returns to the Main screen.
A choice of two test progress screens is available, the default Simple TEOAE Test
Progress screen or a Graph TEOAE Test Progress screen. The Simple TEOAE Test
Progress screen is the default test progress screen and is described in the Test Patient
section of the Operation chapter of this operating manual. The Simple TEOAE Test
Progress screen displays a progress bar during the test. A progress bar is an empty
horizontal bar that fills as the test progresses. The approximate percentage of the maximum
test time is displayed in the bar. At any time during the test, the fourth COMMAND button,
labeled STOP, can be used to stop the testing and return to the Main screen. Note that the
Stop button must be held down for a few seconds until the test stops. After the test is
completed, the device returns to the main screen. The Simple TEOAE Test Progress
screen is best used f or operators who have minimal training. Operators with more advanced
training may wish to use the Graph TEOAE Test Progress screen that displays the
measurements during the test as graphs.
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The Graph TEOAE Test Progress screen
displays the patient ID, name and ear at
the top of the display along with the time
and date. As the test progresses, results
are shown in a graph form. At the top of
the screen is a graph of the averaged
waveform of the response in dB SPL as a
function of time. The lower part of the
screen shows the spectral content of the
waveform in dB SPL as a function of frequency in Hz. The frequency range is
divided into a number of frequency bands
depending on the setting in the
configuration (See configuration section).
Each frequency band is shown by vertical
bars. The height of the thin bar indicates
the level of the transient evoked emission,
Lte in dB SPL in that band. Surrounding
each thin Lte bar is a wider bar that
indicates the level of the noise in the
Graph TEOAE Test Progress
band, Nte. The effect of noise reduction
digital signal processing can be observed
during the test. As the test progresses, the level of the noise decreases. If a TEOAE is
present, the level of the noise bar will decrease sufficiently to reveal the level of the TEOAE.
The difference in level between Lte and Nte is the signal to noise ratio, S/N, in dB. Above
each bar will be a letter "P" or a letter "R" to indicate if the response exceeded the pass
criterion.
During the test, one of two letters may flash in the upper right portion of the display. The
letter "C" (Clipping) indicates that the level of sound exceeds the limits of the microphone
system and the measure is discarded. The letter "N" (Noisy) indicates that the level of
noise for a frame exceeded the Frame Reject setting in the TEOAE Configuration and the
measure is discarded. The test proceeds until a reliable result is obtained or until a
maximum test time occurs. Also during the test, the numbers of frames accepted and
tested (96/128, e.g.) are shown as well as the current signal to noise ratio (S/N) in dB for
each frequency band.
2205-0100 Rev B
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In noisy environments, the test may stop at a particular point and indicate that too much
noise is present. If this occurs, the testing is stopped and a choice is given to start testing
again or stop all testing. While the testing is stopped the operator should attempt to
reduce the amount of noise (turn off other devices, ask people to stop talking, etc.) or wait
until the noise subsides (a phone stops ringing, the baby stops crying, etc.) and then start
testing again b y pressing the TEST button. The current results for the previous test
frequencies will be saved and the test will continue at the point you were informed of the
noisy condition. The STOP button will stop the entire test, discard the results for the
previous frequencies and return to the Main screen.
The program administrator has a choice of sophisticated noise processing methods that
are described in detail in the Device configuration section of this manual. In general, the
processing methods differ in speed of testing. More test time is needed in noisy
environments to maintain reliable results. If the letters "C" or "N" never appear, a faster
processing method may be used. If these letters appear often, a slower, but more reliable
processing method can be selected.
After testing is finished, the device automatically returns to the Main screen to show the
overall result for the ear. Because up to three tests can be saved for each ear, the result
for the best of the tests for that ear will be displayed. In other words, even if the third test
(3/3) w as just preformed, the de vice may return to the second test (2/3) if the second
test is the best of the three. Only the last three tests for that ear are saved. If more than
three tests have been performed for that ear, all earlier results are discarded.
When testing for the first ear is complete, remove the probe from the ear and couple it to
the opposite ear using a new tip. Use the UP arrow or DOWN arrow to move the selection
box from first ear to the opposite ear (or to the ABR section). Press the TEST button to
obtain results for the ear that has not been tested. When the test for the opposite ear is
complete, the device returns to the Main screen and shows the results for both ears.
2205-0100 Rev B
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View Detailed TEOAE Results
To view the TEOAE test results in detail, first use the UP or DO WN arrow keys to select
the desired ear in the TEOAE section. If more than one TEOAE test was obtained for this
ear, use the left or right arrow keys to select the desired test (1/2 or 2/3, e .g.) and press
the VIEW COMMAND button. A Simple TEOAE Test Result screen similar to the Simple
TEOAE Test Progress screen displays the results in text form with a PASS or a REFER
for each frequency band and the overall result for the ear.
From the Simple TEOAE Test Result (see page 42) screen the results can be viewed as a
graph. Press the UP arrow as indicated on the screen to activate the Graph TEOAE Test
Result screen. The complete test results for each test frequency band for the selected ear
are shown in the form of a graph similar to the Graph TEOAE Test Progress screen.
From the Graph TEOAE Test Result (see
page 42) screen the complete test results
at each frequency band can be viewed in
numeric form. Press the UP arrow to
display the complete data including all of
the test signal parameters and the test
result values for the first nominal test
frequency band. Each value is clearly
labeled. The complete results for the other
test frequency bands can be accessed by
pressing the RIGHT or LEFT arrow keys
as indicated on the screen. When finished
viewing the detailed test results, press the
DONE COMMAND button to return to the
Main screen.
Simple TEOAE Test Result
2205-0100 Rev B
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Numeric TEOAE Test Result
Graph TEOAE Test Result
2205-0100 Rev B
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Chapter 5
ABR Advanced Operation
Introduction
This section of the operating manual describes the advanced ABR operations of the GSI
AUDIOscreener+ and is intended for administrators, supervisors or advanced operators.
Generally, an administrator or supervisor need only use the Basic Operation section of
the operating manual to train a new user regarding aspects of the device common to both
OAE and ABR screening including issues concerning the probe, electrodes and the patient
database. This section of the operating manual will cover in detail what happens when an
ABR test is initiated as well as advanced ABR testing capability. Refer to the
Configuration section for information on how to set the test parameters.
With the selection box in the ABR section, the TEST button initiates a selectable
Configuration that defines all test parameters and other test requirements. The device
measures the electrode impedances individually between two electrodes and displays the
values in kOhms. If these impedance values are less than values specified by the
configuration including the maximum allowed, 12 kOhms (default), or the maximum
impedance difference allowed between two
electrodes, < 5 kOhms (default), the test
sequence proceeds automatically. If the
electrode impedance criteria are not met, the
sequence pauses to give the opportunity to
reapply the electrodes and continue with the
RETRY button or alternatively to continue with
the present impedance values with the TEST
button. The measured impedance values are
saved as part of the patient test record. The
ABR test sequence begins with a check of
electrode impedances. The default ABR
configuration uses Comfort Cups and is set to
skip probe fit and calibration sequences.
However, these sequences can be enabled
(see configuration section) and are useful
when using only the probe.
2205-0100 Rev B
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ABR Impedance Check
Simple ABR Test Progress
If enabled, a short, low frequency test
signal determines if the probe is
adequately coupled to the ear. If the
probe is not adequately coupled to the
ear, a message suggests an adjustment
of the probe before proceeding. Next, a
1000 Hz sinusoid test tone at 65 dB SPL
is presented and measured in the ear
canal using the microphone in the probe
module. If the measured level of this tone
is incorrect (dB peps or dB nil), a
compensation procedure automatically
adjusts it. The test will not proceed if the
level of the test tone cannot be achieved
due to blocked sound tubes, excess ear
wax (cerumen) or amniotic fluid in the
canal, or from placing the sound opening
against the canal wall. After the automatic
tone level adjustment is made, the ABR
test sequence automatically presents the
test signals sequentially and displays an
ABR Test Progress screen. When all
testing in the sequence is complete, the
device returns to the Main screen.
A choice of two test progress screens is available, the default Simple ABR Test
Progress screen or the Graph ABR Test Progress screen
The Simple ABR Test Progress screen displays progress bars during the test, one for
each test signal. A progress bar is an empty horizontal bar that fills as the test progresses.
The approximate percentage of the maximum test time for that test signal is displayed in
the bar. After each test signal is completed, the result f or that waveform, either a PASS or
REFER, is displayed and the test proceeds to the next test signal. During the test, the first
COMMAND button is labeled PAUSE to allow the user (tester) to pause testing and hold
the results collected so far. The PAUSE changes to CONT to allow the testing to
continue. The fourth COMMAND button labeled STOP, can be used to stop the testing
and return to the Main screen.
2205-0100 Rev B
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Note that you have to continuously hold
the PAUSE or the STOP button down for
a few seconds until the command is
initiated.
The Graph ABR Test Progress screen
displays the ongoing averaged waveform,
that is, the voltage coming from the electrodes as a function of time over a 15
msec period. The test parameters
determined by the Configuration are listed
at the top of the screen including the date of
the test, the number of the test in the
sequence (1 to 8), the level of the stimulus,
the number of frames collected and the
number of frames measured (512/1000,
e.g.).
During the test with the Graph ABR Test
Progress screen the first COMMAND button
is labeled P AUSE to allow the operator to
Simple ABR Test Progress
pause testing and hold the results collected
so far. The PAUSE changes to CONT to allow the testing to continue. If enabled, the second
COMMAND button is labeled DONE which stops the entire test sequence, discards the test
measurements and returns to the Main screen. The fourth COMMAND button is labeled
STOP which stops data collection for the displayed stimulus, saves the result and
proceeds to the next test stimulus if more than one stimulus is configured. Note that you
have to continuously hold these buttons down for a few seconds until the command is
initiated.
After testing at all levels is complete, the device automatically returns to the Main screen.
Up to three ABR tests can be saved for each ear with the best result for the tests for that
ear displayed first. In other words, even if the third test (3/3) for this ear was just
performed, the device may return to the second test (2/3) if the second test is the best of
the three. Only the last three tests for that ear are saved. If more than three tests have
been performed for that ear, the earlier results are discarded.
2205-0100 Rev B
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When testing for the first ear is complete, remove the probe from the ear and couple it to
the opposite ear using a new tip. Use the UP arrow or DOWN arrow to move the
selection box from the first ear to the opposite ear. Press the TEST button to obtain
results for the ear that has not been tested. The test sequence automatically selects the
correct electrode pair for the ear being tested. When the test for the opposite ear is
complete, the device returns to the Main screen.
Because the ABR measures are collected automatically under the Configuration,
personnel with minimal training easily can collect reliable ABR data. In the automated
mode, the interpretation of the ABR test results are made based on criteria in the
Configuration. The GSI AUDIOscreener also allows manual analysis of the waveforms
after they have been collected. In the manual mode, the ABR test results are stored
automatically and the Test Result box contains a “U” for “Unevaluated”. The test results
may then be analyzed manually directly on the device in a manner similar to that of
desktop diagnostic ABR devices (cursor control, order of waveforms, determination of the
latency of Wave V, etc.) or transferred to an
external
computer
application
called
AUDIOtrac™ for evaluation later. If the test has
been evaluated directly on the device, the Test
Result box will contain either a symbol for a
PASS or a ? symbol for a REFER.
View Detailed Results
The ABR waveforms and test results are
automatically saved in internal memory and
can be viewed in detail. Use the UP or DOWN
arrow keys to select the desired ear in the
ABR section. If more than one ABR test was
obtained for this ear, use the LEFT or RIGHT
arrow keys to select the desired test, (1/2 or
2/3, e.g.) and press the VIEW COMMAND
button to display an ABR Multiple Waveform
screen with up to 4 individual waveforms. Each
waveform is numbered on the left with the
stimulus level indicated on the right.
Multiple ABR Waveform
2205-0100 Rev B
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Additional waveforms for the test
sequence, if collected, can be viewed by
scrolling the window using the first or second COMMAND keys (not the UP or
DOWN ARROW keys).
From the Multiple ABR Waveform
screen, individual waveforms can be
viewed in more detail by pressing the
RIGHT arrow key sequentially to display
a Single Waveform screen, one for each
stimulus in the sequence. Each Single
ABR Waveform screen is similar to the
Multiple ABR Waveform screen but with
additional information. The top of the
Single ABR Waveform screen displays
the date of the test, the number of the
test stimulus in the sequence, and the
level of the test stimulus using a
reference
stipulated
by
the
Single ABR Waveform
Configuration. A thin vertical bar is
placed on the graph that functions as a cursor set at the latency indicated in msec at the
top of the display. The vertical cursor, which can be turned off and on with the third
COMMAND button, can be moved to the left with the first COMMAND button or to the
right with the second COMMAND button. The latency value is updated numerically at the
top of the display as the cursor is moved.
The GSI AUDIOscreener+ can be used to identify and measure the latency of a peak in
an averaged waveform. If the identified peak is Wave V, GSI AUDIOscreener+ also can
determine if the measured latency is in the normal range. The normative latency value of
Wave V is indicated by a small black horizontal bar at the top of the graph. The center of
the bar represents the normative mean latency and takes into account both the level of
the stimulus and the age of the patient. The width of the bar along the time axis
represents the normative range of latency values. The latency of the identified peak falls
within the normative latency range if the vertical line falls on the normative latency bar.
2205-0100 Rev B
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The mean latency values of Wave V
systematically decrease with increasing
signal level and increasing subject age.
Published mean values (Gorga et al 1987)
are
incorporated
into
GSI
AUDIOscreener+ and set the location of
the normative latency indicator bar. The
default normative latency values can be
changed easily.
The mean normative latency values can
be offset in 0.1 msec steps (Normative
Latency Offset value) which increases the
normative mean values and moves the
normative range latency bar to the right
on the graph. The normative of latencies
(Latency Peak V Range value)
Single ABR Waveform
can be increased in ±0.25 msec steps which
widens the normative latency bar.
From the Multiple ABR Waveform screen or
Single ABR Waveform screen, relevant data
can be viewed numerically by pressing the UP
NAVIGATION button. The Multiple ABR
Numeric screen lists the latency values taken
from the cursor positions on the Single ABR
Waveform screens so they can be assessed
systematically and easily in numeric form. The
Single ABR Numeric screen includes other
numeric data for each waveform. From each
numeric screen, the corresponding waveform
screen can be recalled by pressing the DOWN
NAVIGATION button.
Multiple ABR Numeric
2205-0100 Rev B
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After the latencies of Wave V for each waveform have been determined, the trained
professional can view the results of the test sequence as a whole and determine if the
test sequence should be marked as a PASS or a REFER. This assessment can be based
on conventional diagnostic principles that usually involve a determination if the latency of
Wave V is within the normal range for each test stimulus level and if this latency lengthens
systematically as the level of the stimulus is reduced. The latencies of Wave V across
stimulus levels can be viewed graphically from the Multiple Waveform screen or
numerically from the Multiple Tabular Data screen. If desired, the trained professional
also can estimate the average hearing level in dB HL, though this level cannot be
entered into the database from the GSI AUDIOscreener.
In the manual mode only, the test sequence can be marked as a PASS or a REFER from
the Multiple Waveform screen. Pressing the third blue COMMAND button labeled
“EVAL” displays a pull down menu with UNEVALUATED, PASS, or REFER as options.
Select an option and press the DONE button to mark the test and return to the Main
screen. Note that an evaluation decision can be changed at anytime, including changing
it back to an UNEVALUATED result.
Gorga, M. P., Reiland, J. K., Beauchaine, K. A., Worthington, D. W, & Jesteadt, W. (1987).
Auditory brainstem responses from graduates of an intensive care nursery: normal patterns
of response. J Speech Hear Res, 30(3), 311-8
2205-0100 Rev B
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Chapter 6
Configuration
Introduction
The Configuration option for the GSI
AUDIOscreener+ gives the operator great
flexibility and ease of use and allows
complete control of the device. Many
functions can be configured, adjusted, and
manipulated using only the buttons on the
front panel. Test signals can be selected and
adjusted, digital signal processing methods
can be altered, and PASS/REFER methods
and criteria can be changed. Patient records
in the internal patient database can be deleted
or printed as a group. The time and the date
can be set and the name of your hospital or
institution and the names of the testers can
be entered into permanent memory. The
Configuration option also allows you to
view important device settings. This section
describes how to use the Configuration
options.
Configuration Selection
The Configuration option is accessed from the Main screen by pressing the fourth
unlabeled COMMAND button and holding it down for several seconds. This access is
intentionally obscure to limit the ability of the daily operator to change test parameters or
accidentally delete patient records. Only authorized administrators should be taught how
to access the Configuration option.
From the Main screen, press and hold the fourth unlabeled COMMAND button for at least
4 seconds. The Configuration selection screen appears with the following Configuration
options
DPOAE configuration
TEOAE configuration
ABR configuration
Database configuration
Time/Date configuration
2205-0100 Rev B
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Printing configuration
Device configuration
Tester IDs configuration
Performance configuration
Battery configuration
Use the UP and DOWN arrows to select a
configuration option and press the Enter
COMMAND button.
Data are entered in Data Entry screens that
contain one or more lines that end with a
colon. Following the colon is a Data Entry
Area that is indicated with brackets [ ], if the
data can be changed, or without brackets, if
the data cannot be changed. New data are
entered, or existing data are edited, by either
typing characters or by selecting from a list of
options. The selection box, shown on the first
Data Entry Area, is moved up and down the
screen to other Data Entry Areas using the
UP and DOWN buttons. After a Data Entry
Area has been selected, press the ENTER
On Edit Button.
Example Data Entry
Data are entered into the Data Entry Area in
two ways depending on the type of data. Open-ended data: If the data are from a large
data set and open ended (such as a Configuration name) a Virtual Keyboard appears
(see Basic Operation chapter). The Virtual Keyboard is an image of a conventional
keyboard with keys for the numbers 0 through 9, the letters of the alphabet and additional
characters located after the M letter. The COMMAND buttons are labeled CANCL
(cancel the virtual keyboard), TYPE (type the selected character to the top line), DEL
(delete the last character from the top line) and DONE (finished entering all data). When
the Virtual Keyboard is first opened, the “1” character is selected. The selection is
moved around the virtual keyboard using the four arrow keys to select other characters.
Once the desired character is selected, press the TYPE COMMAND button to type the
character on the top line. Move the selection to the next desired character and TYPE it.
2205-0100 Rev B
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The last character on the top line can be deleted by pressing the DELete COMMAND
button. When all of the desired characters have been placed on the line, press the DONE
COMMAND button.
Restricted data: If the data are from a
small restricted data set (a list of test
frequencies, e. g.) a pop-up menu is
shown listing the restricted set of data.
The Up or DOWN arrows are used to
make a selection from the pop-up list.
After the selection is made, press the
DONE COMMAND button to save the
selection to the data area, close the
popup screen and return to the Data
Entry screen.
DPOAE Configuration
The methods and criteria for determining
whether a patient receives a PASS or
REFER when using DPOAE measures
are listed in Appendix D. Each individual
DPOAE measure has a very large
number of independent test parameters
that can be varied, each of which can
DPOAE Configurations
affect the PASS/REFER decision. To
obtain repeatable PASS/REFER decisions, each of these many test parameters must be
specified and recorded in the Configuration and the same Configuration must be used
for each screening measure.
To facilitate the setting and recording of these test parameters, the DPOAE
Configuration option stores a complete set of DPOAE test settings under a single
Configuration. Up to 10 Configurations can be stored, each with different test
parameters and criteria. The Configuration for each test always is shown with the test
results on the Main screen and on all printed reports. With this arrangement, the simple act
of selecting a Configuration automatically sets all of the test parameters at once and
records the settings as well.
The GSI AUDIOscreener has a default DPOAE Configuration named QuickDPOAE.
QuickDPOAE is not modifiable but its settings can be viewed. This arrangement ensures
that all test parameters are set to known values for every test performed with
QuickDPOAE.
2205-0100 Rev B
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New Configurations can be added to the Configuration list. Press the NEW
COMMAND button to open the Virtual Keyboard and enter a new Configuration
name. The new Configuration name can be
up to 19 characters long but cannot be the
name of an existing Configuration. The new
Configuration initially contains the test
parameters in the last selected Configuration.
Each of the individual test parameters in the
new Configuration can then be adjusted. The
process of creating a new Configuration by
duplicating an existing Configuration and
editing its values, is much faster than entering
a new value for every test parameter. Press
DONE to see the new name in the list of
Configurations. A Configuration also can be
deleted by selecting it and pressing the DEL
COMMAND button.
Global Parameters
The DPOAE Configuration screen also is
used to select a Configuration for testing.
After a Configuration is selected, press
DONE to return to the Main screen. The
device then uses the test settings of the
selected Configuration.
The DPOAE Configuration screen also is used to view or adjust the test parameters of a
Configuration. After a Configuration is selected, press the ENTER COMMAND button
to open the Configure DPOAE screen for the selected Configuration. The Configure
DPOAE screen allows adjustment of all of the individual test parameters. The test
parameters and ranges of settings are listed below.
DP Global Parameters
The DP Global Parameters section is used for setting test parameters that apply to all
DPOAE test operations. The following numbered sections are used for setting test
parameters for each test frequency individually.
Number TF: 1, 2, 3, 4, 5 (number of test frequencies for each ear)
Number T Pass: 1, 2, 3, 4, 5 (number of test frequencies that "Pass" for the ear
to receive a "Pass")
Direction: Up, Down (proceed from high to low or low to high)
Min S/N: 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, (minimum signal to noise ratio in
2205-0100 Rev B
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Note: The QuickScan default values are shown in bold.
dB for a valid Ldp)
Calib tol:
Environment:
Time/freq:
Time/ear:
Max time/ft:
Display mode:
1, 2, 3, 4, 5 (calibration tolerance level of L1 and L2 in dB)
Quiet, Normal, Noisy (Advanced signal processing based on
an estimate of the acoustic noise level in the environment
including noise made by the patient. The Quiet setting is
very fast and intended for use in quiet environments. The
Normal setting is average and intended for use in
environments with average noise levels. The Noisy setting is
the slowest and intended for the noisiest environments. The
maximum time at each test frequency should be extended
for the Noisy condition).
Estimated test time at each frequency computed by the GSI
AUDIOscreener+ OAE+ABR. Cannot be changed.
Estimated test time for each ear computed by the GSI
AUDIOscreener+ OAE+ABR. Cannot be changed.
10, 20, 30, 40, 50, 60 (Desired maximum test time at each
test frequency,
in
seconds)
Simple,
Graph
DP Test Frequency Parameters
A list of DP Test Frequency Parameters,
for each test frequency, is displayed
below Global Parameters. The total
number of DP Test Frequencies in the
is set in the Global Parameters
configuration. The name of each DP Test
Frequency in the list contains the test
number, test frequency, level of L1, in dB
SPL, and level of L2 in dB SPL. The DP
Test Frequency configuration on the right
contains three test frequencies 2000 Hz,
3000 Hz and 4000 Hz each with L1 equal
65 dB SPL and L2 equal to 55 dB SPL.
one
list
to
DP Test frequencies
2205-0100 Rev B
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Each DP Test Frequency configuration can be
selected individually. Pressing ENTER will then
open the DP FT Parameters configuration
screen.
Centering: On F2 (the nominal test frequency is
centered on F2)
TF: Nominal
test
frequency (2000,
3000, 4000, 5000, 6000 Hz)
F2/F1: 1.2 (ratio of F2/F1)
F1: Frequency of F1 in Hz (based on
TF)
F2: Frequency of F2 in Hz (based on
TF)
L1: 55, 56, 57, 58, 59, 60, 61, 62, 63,
64, 65, 66, 67, 68, 69, 70 (level of F1 in dB SPL)
L2: 55, 56, 57, 58, 59, 60, 61, 62, 63,
64, 65, 66, 67, 68, 69, 70 (level of F2 in dB SPL)
Test Parameters
Test Pass Criterion
Min Ldp: -10, -9, -8, -7, -6, -5, -4, -3, -2, -1, 0, 1, 2, 3, 4, 5, (minimum level of Ldp in dB
SPL to be considered a PASS. The default criterion levels are -7, -8, -5, -7 and -7 dB
SPL for 2000, 3000, 4000, 5000 and 6000 Hz, respectively. See Appendix C)
Max Ndp: -2, 0, 2, 4, 6, 8, 10 (maximum allowable noise level) Default level is 4 for
2000Hz, 0 for all others.
Frame Reject
if Ndp>28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48, 50 (level of Ndp in dB SPL for frame
rejection. The default Ndp levels are 42, 34, 32, 30 and 30 dB SPL for 2000, 3000, 4000,
5000 and 6000 Hz, respectively)
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TEOAE Configuration
The methods and criteria for determining
whether a patient receives a PASS or REFER
when using TEOAE measures are listed in
Appendix D. Each individual TEOAE measure
has a very large number of independent test
parameters that can be varied, each of which
can affect the PASS/REFER decision. To obtain
repeat-able PASS/REFER decisions, each of
these many test parameters must be specified
and recorded in the Configuration and the
same Configuration must be used for each
screening measure.
To facilitate the setting and recording of these
test parameters, the TEOAE Configuration
option stores a complete set of TEOAE test
settings under a single Configuration. Up to 10
Configurations can be stored, each with
different test parameters and criteria. The
Configuration for each test always is shown with
TEOAE Configurations
the test results on the Main screen and on all
printed reports. With this arrangement, the simple act of selecting a Configuration
automatically sets all of the test parameters at once and records the settings as well.
The GSI AUDIOscreener+ has a default TEOAE Configuration named QuickTEOAE.
QuickTEOAE is not modifiable but its settings can be viewed. This arrangement ensures
that all test parameters are set to known values for every test performed with
QuickTEOAE.
New Configurations can be added to the Configuration list. Press the NEW COMMAND
button to open the Virtual Keyboard and enter a new Configuration name. The new
Configuration name can be up to 19 characters long but cannot be the name of an
existing Configuration. The new Configuration initially contains the test parameters in the
last selected Configuration. Each of the individual test parameters
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in the new Configuration can then be
adjusted. The process of creating a new
Configuration by duplicating an existing
Configuration and editing its values, is much
faster than entering a new value for every test
parameter. Press DONE to see the new name
in the list of Configurations. A Configuration
also can be deleted by selecting it and
pressing the DEL COMMAND button.
The TEOAE Configuration screen also is used
to select a Configuration for testing. After a
Configuration is selected, press DONE to
return to the Main screen. The device then
uses the test settings of the selected
Configuration.
The TEOAE Configuration screen also is used
to view or adjust the test parameters
of a
Configuration. After a Configuration is
selected, press the ENTER COMMAND
TEOAE Global Parameters
button to open the Configure TEOAE screen
for the selected Configuration. The Configure TEOAE screen allows adjustment of all of
the individual test parameters. The test parameters and ranges of settings are listed
below.
TE Global Parameters
The TE Global Parameters section is used for setting test parameters that apply to all
DPOAE test operations. The following numbered sections are used for setting test
parameters for each test frequency individually.
Number bands:
1, 2, 3, 4, 5 (number of test frequency bands for each ear)
Number bands Pass: 1, 2, 3, 4, 5 (number of test frequency bands that "Pass" for the
ear to receive a "Pass")
Calib tol:
1, 2, 3, 4, 5 (Calibration tolerance level of transients in dB)
Environment:
Normal,
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Display Mode:
Max time:
Repro Type:
Rate:
Level:
Simple, Graph
10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 120, 140, 160, 180, 200,
220, 240, 260, 280, 300 (Desired maximum test time in seconds)
Band, Global
Calculated — read only.
70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87,
88, 89, 90
TE Data Acquisition Parameters
The TE Data Acquisition Parameters section is used for setting data acquisition
parameters that apply to all TEOAE test operations.
Post Stim Delay:
Sample Time:
Min Frames:
Max Frames:
Max Noisy Frames:
Max Quiet Frames:
Repro Pass:
3.5 (Delay after stimulus that data acquisition begins, in msec).
10.0 (Duration of sample
time, in msec)
64, 128, 256, 512
(Minimum number of
good frames)
128, 256, 512, 1024,
2048, 4096, 8192,
16,384, 32,768
(Maximum total number
of frames, including
rejected frames)
128, 256, 512, 1024,
2048, 3072, 4096
1, 2, 3, 4, 5, 6, 7, 8, 9, 10
0, 60, 70, 80 (percent)
TEOAE Test Parameters
2205-0100 Rev B
Page 60
Max Rejection Level:
Max Noise Rejection:
Max Signal Rejection:
60, 62, 64, 66, 68, 70, 72, 74, 76, 78, 80, (Level of signal
above which frame will be rejected, in dB pSPL)
50, 52, 54, 56, 58, 60, 62, 64, 66, 68, 70, 72, 74, 76, 78, 80,
82, 84, 86, 88, 90
60, 62, 64, 66, 68, 70, 72, 74, 76, 78, 80, 82, 84, 86, 88, 90
TE Frequency Bands
A list of TE analysis frequency bands, one for each frequency band, is displayed below
TE Data Acquisition Parameters. The total number of frequency bands in the list is set in
the Global Parameters configuration. The name of each TE Analysis Frequency Band in
the list contains the band number and the center frequency of the band. The example
TEOAE configuration screen contains five frequency bands. Each TE Analysis
Frequency Band configuration can be selected individually. Pressing ENTER will then
open the TE Analysis Frequency Band configuration screen.
TEOAE Test Frequencies
2205-0100 Rev B
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Low Cutoff
Defaults are:
3500, 2500, 1500
High Cutoff
Defaults are:
4500, 3500, 2500
Decision Cnt:
Defaults are:
Min SNR:
Defaults are:
Defaults are:
3
3, 3, 3, 3, 3, for 4000, 3000, 2000, 1500, and 1000 Hz bands
2, 3, 4, 5, 6, 7, 8, 9, 10 (Minimum signal to noise ratio for the band
response to be considered a "PASS", in dB)
10, 10, 8, 6, 6 for 4000, 3000, 2000, 1500, and 1000 Hz bands
Repro Pass:
0, 60, 70, 80 (Reproducibility value required for the
band response to be considered PASS, in percent)
70, 70, 70, 70 and 70 for 4000, 3000, 2000, 1500, and 1,000 Hz
bands
CAUTION: Setting the reproducibility
value to 0 (per band or global) may result
in an increase in false negative tests
unless the Min SNR for each band is set
higher than 6 dB. This is especially true
for frequency bands that have centers
less than 2000 Hz or Low Cutoff
frequencies less than 1500 Hz. Clinical
evaluation of the GSI AUDIOscreener
TEOAE operation indicates that the
default TEOAE configuration may be
copied and the 3 default bands’
reproducibility set to 0 in environments
with considerable acoustic noise.
ABR Configuration
2205-0100 Rev B
Page 62
ABR Configuration
The methods and criteria for determining
whether a patient receives a PASS or a
REFER when using ABR measures are listed
in Appendix D. Each individual ABR measure
has a very large number of independent test
parameters that can be varied, each of which
can affect the PASS/REFER decision. To
obtain repeat-able PASS/REFER decisions,
each of these many test parameters must be
specified and recorded in the Configuration
and the same Configuration must be used
for each screening measure.
To facilitate setting and recording these test
parameters, the ABR configuration option
stores a complete set of ABR test settings
under a single Configuration. Up to 10
Configurations can be stored, each with
different test parameters and criteria. The
Configuration for each test always is shown
ABR Global Parameters
with the test results on the Main screen and
on all printed reports. With this arrangement, the simple act of selecting a Configuration
automatically sets all of the test parameters at once and records the settings as well.
The GSI AUDIOscreener+ has two default ABR Configurations named QuickABRCups
and QuickABRProbe. These two configurations are not modifiable but their settings can
be viewed. This arrangement ensures that all test parameters are set to known values
for every test performed with QuickABRCups or QuickABRProbe.
New Configurations can be added to the Configuration list. Press the NEW
COMMAND button to open the Virtual Keyboard (see Basic operation) and enter a new
Configuration name. The new Configuration name can be up to 19 characters long but
cannot be the same name as an existing ABR Configuration. The new Configuration
name initially contains the test parameters in the last selected
Note: default values are shown in bold.
2205-0100 Rev B
Page 63
Configuration. Each of the individual test parameters in the new Configuration can then
be adjusted. The process of creating a new Configuration by duplicating an existing
Configuration and editing its values is much faster than entering new values for all test
parameters. Press DONE to see the new name in the list of Configurations. A
Configuration also can be deleted by selecting it and pressing the DEL button.
The ABR configuration screen also is used to select a Configuration for testing. After a
Configuration is selected, press DONE to return to the Main screen. The device will
then use the test settings of the selected Configuration.
The ABR configuration screen also is used to view or adjust the test parameters of an
existing Configuration. After a Configuration is selected, press the ENTER COMMAND
button to open the Configure ABR screen for the selected Configuration. The
Configure ABR screen allows the operator to adjust all of the individual test parameters.
The test parameters and ranges of settings are listed below for QuickABRCups.
ABR Global Parameters
The ABR Global Parameters section and the ABR Filter Configuration section are
used for setting test parameters that apply to all ABR test operations. The following
numbered sections are used for setting test parameters for individual test waveforms. The
number of test waveforms is set in the ABR Global Parameters section.
Transducer:
Cups, Probe (allows indication on reports which transducer was
used) (Probe for QuickABRProbe)
Fit Test: Mandatory, Report, Ignore (Mandatory requires that a tight fit be established
between transducer and ear, Report allows proceeding with the test
if transducer fit test fails but reports the result, and Ignore skips
transducer fit testing.) (Report for QuickABRProbe)
Num stimulus:
1, 2, 3, 4, 5, 6, 7, 8 (number of test waveforms)
Num stim for Pass: 1, 2, 3, 4, 5, 6, 7, 8 (number of test waveforms that receive a PASS
for the ear to receive a PASS)
Stim. Cal:
Mandatory, Report, Ignore (Mandatory requires that real ear
calibration be established, Report allows proceeding with the test if
real ear calibration fails but reports the result, and Ignore skips real
ear calibration.) (Report for QuickABRProbe)
Lev Tol:
3, 4, 5 (stimulus level tolerance in dB)
Lev Ref:
dB nHL, dB peSPL (stimulus level reference)
2205-0100 Rev B
Page 64
Electrodes:
Max Imp:
Max Imp DIF:
Allow Override:
Environment:
Midline or Mastoid (Midline uses black for forehead, blue for nape
of neck, and red for shoulder, and maintains these settings when
testing either ear. Mastoid uses black for forehead, red for right
mastoid process, and blue for left mastoid process, and switches
electrodes for each ear setting. For right ear testing the active
electrodes are black and red and the reference electrode is blue. For
left ear testing the active electrodes are black and blue and the
reference electrode is red.) (Mastoid for QuickABRProbe)
1000, 1500, 2000, 3000, 4000, 5000, 6000, 7000, 8000, 9000,
10000, 11000, 12000, 15000, 20000 (Maximum allowable electrode
impedance in Ohms per channel)
1000, 2000, 5000, 10000 (Maximum allowance difference in
electrode impedance in Ohms between channels)
yes, no (allows test to continue if the electrode impedance criteria
are not met)
Quiet, Normal, Noisy (Advanced signal processing based on an
estimate of the electrical noise level in the environment including
myogenic noise made by the patient. The Quiet setting is very fast
and intended for use in environments with little
electrical interference. The Normal setting is slower
and intended for use in environments with average
electrical interference. The Noisy setting is the
slowest and intended for use in environments with
more than normal electrical interference.)
Display Mode:
Progress display)
Simple, Graph (Type of Test
Allow Done:
averaging process)
yes, no (Allows user to stop
Scoring Mode:
Manual,
waveform analysis)
Auto
(Type
of
ABR Filter Configuration
2205-0100 Rev B
Page 65
ABR Filter Parameters
Low Cutoff:
30, 100, 300 (Low frequency cut off in Hz)
Hi Cutoff:
1000, 1500, 3000 (High
frequency cut off in Hz)
Artifact Reject Lev: 10,20, 30, 40, 50, 60,
70, 80, 90, 100, 110,
120, 130, 140, 150
(Maximum
allowable
input level in µV)
Max % Reject:
10, 20, 30, 40, 50,
Frame Processing: Method: Linear, Scaled
Low Cutoff:
30,100,300
High Cutoff:
1000, 1500, 3000
CAUTION: The default Artifact Reject Level
and Maximum % Reject settings are set for
optimal noise rejection. Changing these
values may result in an increase in false
negative or false positive responses,
depending upon your electrical noise
environment
ABR Signal Configuration
ABR Signal Parameters
Signal:
Click, 2000 HZ Pip, 4000 Hz Pip (type of signal)
Polarity:
Rate:
Number:
Condens., Rarefact., Alternat. (polarity of signal)
32, 37, 42, 47, 52, 57, 62 (rate of stimuli per second)
1000, 2000, 3000, 4000, 6000, 8000,12000, 1600, (maximum
number of frames per test waveform)
0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85,
90, 95, 100 (level of stimulus in dB re level reference)
0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20,
21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38,
39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50 (difference in dB
between SPL and nHL)
NONE, 0.25, 0.50, 0.75, 1.0 (± normative range in msec.
Level:
dB nHL:
Lat Pk V Range:
2205-0100 Rev B
Page 66
Fsp Threshold:
3.0, 3.2, 3.4, 3.6, 3.8, 4.0,
(minimum value of Fsp for ABR waveform to
be considered valid)
Database Configuration
The Database configuration option is used for
managing the internal database. The initial
Database configuration screen has four
options. Select an option and press the
ENTER COMMAND button to initiate the
selected Configuration.
The option Print Record
Summary
prints a report of all patient records in the
database with one patient record per line and
approximately 50 lines per page. Each line
contains the patient ID, patient name, test
Configuration, result for the right ear,
Database Configuration
result for the left ear and overall result for
the patient. Make sure that the printer (if
equipped) has been set up and that it has at
least 7 sheets of paper. The option Print All
Records prints a report (Simple or Detailed,
depending on the setting in Printing
configuration option described below) for
each patient record in the database. Be sure
to have sufficient paper available and to add
paper to the printer as necessary. This option
can produce a maximum of 300 printed
reports depending on how many patient
records are in the internal database.
Time/Date Configuration
2205-0100 Rev B
Page 67
The option Delete One Record opens the Select Patient screen that displays a list of the
patient ID numbers in the patient database. The first patient record is selected. Other
individual patient records can be selected by using the UP or DOWN arrow keys. The
RIGHT or LEFT arrow buttons scroll through the patient records one full screen at a time.
Continuously holding down an arrow key scrolls through the database continuously. Press
the DEL COMMAND button to delete the selected patient record including all test results
associated with it. Press the CANCL COMMAND button cancel the screen and return to
the Database screen.
The option Delete All Records deletes all patient records in the internal patient database.
You will be asked to confirm your decision to delete all records before the records are
actually deleted.
Time / Date Configuration
The Time/Date configuration option is used for setting the date format, the time format,
the time and date. Use the UP or DOWN arrow keys to move the small arrow on the left
of the display to the desired section. Use the LEFT or RIGHT arrow keys to select the
items on the selected line. For the date
and time sections, a + COMMAND key or
— COMMAND key is used to change
values. Press the DONE key to save the
settings.
Printing Configuration
This section does not apply to
AUDIOscreener+. Printing to be done using
AUDIOtrac software.
Device Configuration
2205-0100 Rev B
Page 68
Device Configuration
The Device configuration option is used for setting parameters that apply to the overall
operation of the device. The Device configuration option also is used for viewing internal
information unique to the device.
Institution:
(name of your institution, 19 characters maximum)
Patient Pass:
1, 2 (number of ears tested for the patient to be labeled a PASS)
AutoOff:
0, 1, 2, 5, 10, 15, 30, 45, 60 (number of minutes of key pad inactivity
before device turns off automatically, a value of 0 disables the auto
shutoff feature)
Power Freq:
50, 60 (local power line frequency)
Firmware:
(version number of firmware, read only) (date firmware built, read
only) (time firmware built, read only)
Probe:
(serial number of probe, read only)
S/N:
(serial number of device, read only)
Lang:
Eng X.Y-ZZZZZZ (identifies language module, revision and check
sum, read only)
Operator IDs
The Operator ID configuration creates a list for
20 Operator IDs. The ID is usually the
operator’s name but can also be a number (17
characters for each ID). This list of Operator
IDs can be scrolled on the Main screen under
Operator: to allow a tester to bring up his or
her ID. It may be useful to create a blank
Operator ID using the last character on the
virtual keyboard (underscore) to indicate that
no tester was named. The Operator ID
selected on the main screen is stored with
each test.
Performance
For use only by GSI.
Battery
For use only by GSI.
Operator ID
2205-0100 Rev B
Page 69
Power Down Screen
When shutting down the device, it will prompt
the tester to a power down screen. This
screen will ask if the tester wants to shut down
and will display the number of tests completed
for the last session and the total number of
test in the device lifetime.
DPOAE Tests:
TEOAE Tests:
ABR Tests:
Patients:
Number of DPOAE tests,
read only (Number of
DPOAE tests in device
lifetime, read only)
Number of TEOAE tests,
read only (Number of
TEOAE tests in device
lifetime, read only)
Number of ABR tests, read
only (Number of ABR tests
in device lifetime, read only)
Number of patients tested,
read only. (Number of
patients tested in device
lifetime, read only).
2205-0100 Rev B
Power Down
Page 70
Chapter 7
Maintenance
Cleaning
CAUTION: Disconnect device from AC
power source before cleaning.
Upon completion of cleaning,
do not connect to AC power source
until the device is thoroughly dry.
Cleaning of the GSI AUDIOscreener+ must be
performed as follows:
A mild detergent may be used for general cleaning. If necessary, the GSI
AUDIOscreener+ may be cleaned with a 10:1 water/hypochlorite solution; however,
repeated cleaning with this solution can damage the plastic case. Isopropyl alcohol
applied with a damp (not wet) cotton swab may be used for cleaning difficult to reach areas
such as the DPOAE probe connector; however, it should be used sparingly because
repeat cleaning may damage the case.
See Appendix B: Probe Handling Guide.
See Appendix C: Cleaning the Probe.
DO NOT USE strong cleaners such as Spray-Nine, Phisohex, Hibiclens, or
Vesta-Syde because damage to the case can result.
Clean the outside surface with a damp (not wet) cloth or sponge. Avoid excess moisture.
When cleaning around connector receptacles, do not let cleaning solution get inside.
Unless soiling is observed, the charger should not be cleaned. If cleaning the charger is
necessary, wipe the exterior surfaces with a cloth dampened
with isopropyl alcohol.
2205-0100 Rev B
Page 71
CAUTION: Avoid exposing charger to
excess moisture, as this can lead to
an electric shock or fire hazard
General Maintenance
There are no user-serviceable parts contained within the GSI
AUDIOscreener+, probe module, or the AC Adapter. Do not attempt to open
or service these units. Return the device and accessories to the
manufacturer for all service. Opening the instrument, probe module, or AC
adapter case will void the warranty.
Do not drop or otherwise cause undue impact to the probe module. Return
the GSI AUDIOscreener+ and the probe to the manufacturer if the probe or
the device is dropped or otherwise damaged.
Preventive Maintenance
This device must be periodically recertified to assure proper functioning.
The recommended service interval is 12 months, but in no case less than
once each 24 months.
Manufacturer
Grason-Stadler
Service
To arrange for service, contact:
Grason-Stadler
7625 Golden Triangle Drive Suite F
Eden Prairie, MN 55433 USA
Tel: +1-800-700-2282
e-mail: [email protected]
2205-0100 Rev B
Page 72
Chapter 8
Troubleshooting
Alarms
+
The GSI AUDIOscreener provides visible alarms on the display. Alarms are of five types:
1. Confirmation of Certain User Commands (Perform the requested command)
Are you sure you want to shutdown?
Are you sure you want to delete all of the records in the database?
Are you sure you want to delete this record?
Are you sure you want to delete this configuration?
2. Notification of Internal Processing (Wait until processing is completed)
Deleting record...
3. Conditions That Require Intervention (Perform the requested intervention)
The probe is not completely sealed. Please adjust probe. TEST again or STOP?
The test environment is too noisy. TEST again or STOP?
One or both of the test frequencies cannot be calibrated. Please check probe tip, probe module, probe
placement, or ear canal. TEST again or STOP?
The battery is too low to begin testing. Please charge the battery before continuing.
+
The GSI AUDIOscreener battery is critically low. Please discontinue operation and apply the battery charger
immediately.
+
The GSI AUDIOscreener battery is too low to continue operation. Shutting Down...
Conditions That Do Not Require Intervention (Explanation of an invalid user request) No patient records in
database.
4. There are no records in the database.
The test was stopped by the operator.
You may not delete the default configuration.
The data cannot be saved because the storage capacity for this device has been exceeded.
Configuration name is invalid. Please choose a unique name for the new configuration.
You have reached the maximum number of configurations.
Blank Patient IDs are not allowed.
The specified ID is already in use.
Internal Error Conditions (Call technical support)
A startup error has occurred. There is not enough memory to initialize this device.
5. A startup error has occurred. The patient database has been corrupted. It will be cleared.
A startup error has occurred. The configuration has been corrupted. All settings will be reset to factory defaults.
Unrecoverable Error. Cannot initialize the configuration. The device will now power off.
Unrecoverable Error. Cannot initialize the database. The device will now power off.
A database error has occurred.
WARNING: This device has not been calibrated for use with a probe.
There is not enough free memory to perform the operation.
+
WARNING: The GSI AUDIOscreener was not previously shut down properly. Patient data may have been lost
or corrupt. Please examine all records.
IrDA Communications Failure.
Clock Battery is Low. Please contact factory for replacement.
2205-0100 Rev B
Page 73
Troubleshooting
Condition
Probable Cause
Corrections
Device does not turn on
Dead battery
Connect charger for
at least 2 hours
Battery will not charge
- No AC indicator operation
Defective charger
Return charger for
service
- AC indicator never blinks to
show charge cycle in progress
Defective battery
Return GSI
AUDIOscreener+
for service
- L1 or L2 tones are too weak
Inadequate coupling
between probe & ear
Refit ear tip or select
different size ear tip
Bad probe
Return GSI
AUDIOscreener+ and
probe for service
Cannot download patient data
to PC
Bad infrared link
Verify that the GSI
AUDIOscreener+
IRDA port is pointed
directly at IRDA port of
PC
Database Error
Memory full
Delete patient files that
are no longer needed
Probe fit error
Probe not completely
sealed
Readjust probe to
obtain seal
Too noisy error
The noise level is
too high
Reduce source of
noise or set configurations in Global
parameters to “Noisy”
Exceed maximum
configurations
Attempt to create
more than 10
Delete existing
configurations
- L1 or L2 tones not present
2205-0100 Rev B
Page 74
Appendix A
Screening Methods and Criteria
DP Otoacoustic Emission Screening Methods
Presence/Absence Method
A “Pass” or a “Refer” result for each test frequency is based on the presence or absence
of a distortion product otoacoustic emission defined by the signal to noise ratio. The signal
to noise ratio is the level of the emission minus the level of noise in dB. In ears with normal
hearing, signal to noise ratios are zero with no averaging and increase with the amount
of averaging. (Gorga et al., 2000)
Level Method
A “Pass” or a “Refer” result for each test frequency is based first on the presence or
absence of a distortion product otoacoustic emission and second, on the absolute level of
the distortion product otoacoustic emission in dB SPL. In ears with normal hearing,
average emissions levels vary with test frequency parameters but do not change with the
amount of averaging. (Gorga et al., 2000)
TEOAE Screening Methods Presence/Absence Method
The TEOAE test does not use a presence/absence method.
Level Method
A "Pass" or "Refer" result for each frequency band is based first on the presence or
absence of a transient evoked response and second on the absolute level of the transient
evoked emission in dB SPL. In ears with normal hearing, average emissions levels vary with
frequency band but do not change with the amount of averaging.
Auditory Brainstem Response Screening Methods Presence/Absence Method
A “Pass” or a “Refer” result for each test signal is based on the presence or absence of an
auditory brainstem response. The presence of a response is determined in some devices by
matching the response to a template. More commonly, the determination of the presence of
a response is made from an estimate of the signal to noise ratio. The most common
estimate of the signal to noise a value called Fsp. The Fsp value is the ratio obtained by the
variance of a portion of the values in the averaged ABR waveform divided by the variance of
either a single point (original definition) or the average of two points to cancel line frequency
effects (current definition), in each frame for the number of frames that made up the
averaged result. In ears that are unable to hear
2205-0100 Rev B
Page 75
the clicks because of hearing loss, the Fsp values are ~1.0. In ears that are able to hear the
clicks, the Fsp values increase with the amount of averaging. (Sininger et al., 2000)
Latency Method
A “Pass” or a “Refer” result is based first on the presence or absence of an auditory brain-stem
response and second, on the latency of a peak in the auditory brainstem response in msec.
In ears with normal hearing, the average latencies of Peak V vary with test parameters
and patient age but do not change with the amount of averaging. Identification of the
location of a peak, either manually or with an automated procedure, is compromised if the
responses are noisy or atypical. (Hall, 1992)
Analysis of Methods
Screening methods and criteria are not well standardized. Additional screening criteria
include consideration of the number of tests that receive a Pass for the individual ear to
receive a Pass, and the number of ears that receive Pass for the patient to receive a
Pass overall. The most comprehensive and scientific data concerning screening methods
and criteria were provided by a large multicenter study of 7179 neonates sponsored by
the National Institutes of Health (NIH) (Norton et al., 2000). This study reported that an
OAE screen (Presence/Absence Method with 3 dB criterion) followed by an ABR screen
(Presence/Absence Method with a 3.1 Fsp criterion) will result in a refer rate of only 2%
in well baby nurseries and only 2.7% in neonatal intensive care units.
GSI AUDIOscreener+ Default Methods and Criteria
The GSI AUDIOscreener+ can implement all methods with a large range of selectable
criteria for each method. To ensure optimal performance and minimal errors, permanent
default configurations are provided based on the NIH multi-center study - one for
DPOAE, one for TEOAE and one for ABR. A pass result in at least one of these three
types of tests is necessary for the ear to receive a "Pass". For example, if one ear was
tested with DPOAE, TEOAE and ABR and received a "Refer" for DPOAE and ABR but a
"Pass" for TEOAE, the ear would receive a "Pass". Patient Criteria
A Pass result must be obtained in both ears for the
patient to receive a Pass overall.
GSI AUDIOscreener+ DPOAE Default Configuration
The default DPOAE screening configuration is called QuickDPOAE. It is based on the
Level Method with the following criteria:
2205-0100 Rev B
Page 76
Individual Frequency Test Criteria
DPOAE Presence: Signal to Noise ratio 6 dB
DPOAE Level at 2000 Hz: -7 dB SPL (L1=65 dB SPL, L2=55 dB SPL)
DPOAE Level at 3000 Hz: -8 dB SPL (L1=65 dB SPL, L2=55 dB SPL)
DPOAE Level at 4000 Hz: -5 dB SPL (L1=65 dB SPL, L2=55 dB SPL)
Individual Ear Criteria
A Pass result must be obtained at any two of the three test frequencies for the ear
to receive a Pass.
GSI AUDIOscreener+ TEOAE Default Configuration
The default TEOAE screening configuration is called QuickTEOAE. It is based on the
level method with the following criteria:
Individual Frequency Test Criteria
TEOAE Presence: Signal to Noise ratio
TEOAE Reproducibility: 70%
Consecutive Decision Count: 3
6 dB
GSI AUDIOscreener+ ABR Default Configuration
The two default ABR screening configurations are called QuickABRCups and
QuickABRProbe. They are based on the Presence/Absence method with the following
criteria:
Individual Test Criteria
ABR Presence: Fsp 3.2 (rarefaction clicks, 35 dB nHL, one test)
Summary
The two stage NIH recommendation can be implemented with the default configurations.
The NIH recommendation also can be improved with the addition of a single retest.
Alternative methods and criteria can be easily implemented if and when new research
produces different recommendations. Other configurations that are patterned after
diagnostic functions such as systematic changes to stimulus levels or other stimulus
parameters can easily be programmed into the GSI AUDIOscreener+.
Hall, J. Handbook of Auditory Evoked Responses. Boston, Allyn and Bacon, 1992
Don, M, Elberling, C, and Waring M. Objective Detection of Averaged Auditory Brainstem Responses.
Scandinavian Audiology, 13, pp 219-228, 1984
Norton, SJ, Gorga M P, Widen, JE, Folsom, RC, Sininger, YS, Cone-Wesson, B, Vohr, BR and
Fletcher, KA. Identification of Neonatal Hearing Impairment: Summary and
Recommendations, Ear & Hearing, 21:5, pp 529-535, 2000
Sininger, YS, Cone-Wesson, B, Folsom, RC, Gorga M P, Vohr, Widen, JE, Ekelid, M and Norton,
SJ. Identification of Neonatal Hearing Impairment: Auditory Brainstem Responses in the
Perinatal Period, Ear & Hearing, 21:5, pp 383-399, 2000
2205-0100 Rev B
Page 77
Appendix B
Probe Handling Guide
Failure to follow these instructions will void your warranty.
STOP: Please read ALL instructions before handling the GSI Probe.
1
2
3
4
5
The probe is ONLY to be used for
hearing screening purposes.
Store probe in its proper packaging
when not in use.
Handle the probe wire with care. Do
not excessively twist, bend or stretch
the probe wire.
DO NOT insert ANY object(s) into the
probe head. This can cause permanent
damage to the probe. Only use the
cleaning floss to clean the probe tip.
Do not clean the probe tip when it is
attached to the probe wire.
6
7
8
9
10
Do not use water or any kind of liquid
to clean the probe.
For instructions on cleaning the probe,
please refer to "Cleaning the GSI
Probe" on the reverse of this card.
NEVER use the probe without an ear
tip in place.
Do not drop or cause undue impact to
the probe.
DO NOT attempt to service the probe.
Return the probe to the manufacturer
for all service.
Phone:
2205-0100 Rev B
800-700-2282
Page 78
Appendix C
Probe Cleaning Guide
2205-0100 Rev B
Page 79