Please refer to the Electromagnet ic Comp atibilit y Refer ence Guide on C D (part n umber 482 -6387x x)
for EMC information concerning your sy stem.
Compatibilité électromagnétique (CEM)
Veuillez vous reporter au guide de référence de compatibilité électromagnétique sur CD
(numéro de pièce 482-6387xx) pour des informations sur la CEM relatives à votre système.
Elektromagnetische Verträglichkeit (EMV)
Informationen über die EMV des Systems finden Sie im Referenz-Handbuch
Elektromagnetische Verträglichkeit auf der CD (Teilenummer 482-6387xx).
Compatibilità elettromagnetica (EMC)
Vedere la guida alla consultazione per la compatibilità elettromagnetica contenuta sul CD (numero di
parte 482-6387xx) per informazioni sulla compatibilità elettromagnetica relativa al sistema in dotazione.
Compatibilidad electromagnética (CEM)
Consulte la Guía de referencia sobre com patibilidad electro mágnetica in cluida en el CD (n úmero
de pieza 482-6387xx) para obtener la inform ación sobr e la CEM de su sistem a.
Addenda
b
SELECTPRO
4:2OUTO
F
SELEC
Addendum to Chapter 4:
Using the GSI 70 Single-Patient Screener
Two default protocols are available:
OAE 1: GSI Default
OAE 4: 2 OUT OF 3
Selecting a Protocol
1. Turn the GSI 70 Automated OAE Screener on by pressing any button. (The Screener
can be in the Printer/Charger cradle during this procedure.)
.
When the DPGram appears on the display, simultaneously press the LEF T (blue)
2
and RIGHT (pink) buttons to enter the UTILITY MENU.
3
.
Use the down arrow button (blue) to highlight
CHANGE PRO TOCOL. The Select Protocol screen
appears.
.
Use the down arrow button (blue) or up arrow
4
button (pink) to highlight either:
OAE 1: GSI Default or
OAE 4: 2 OUT OF 3
1: GSI DEFAULT
4
CANCEL
TOCOL
3
Once highlighted, press the SELECT button (green)
to choose the desired protocol.
▼
5. The UTILITY MENU is now displayed. Use the down arrow
utton (blue) or up
T
arrow button (pink) to scroll to and highlight the word EXIT. Press RUN to return to
the DPGram screen.
The label to the right of the Pass/Refer line indicates the protocol being used
once the TEST (green) button is pressed.
▲
Addenda
Protocol Scoring Rules
OAE 1: GSI Default
■
Scores the test result as PASS when all three response s are at or above the
Pass/Refer line and each response is individually scored as a Pass.
■
Scores the test result as REFER when at least one re sponse is below the Pass/Refer
line and its response is individually scored as a Refer.
■
Scores the test result as NOISE when at least one response is individually scored as
noise.
OAE 4: 2 OUT OF 3
■
Scores the test result as PASS when at least 2 out of 3 responses are at or above the
Pass/Refer line and these 2 responses are individually scored as Pass.
■
Scores the test result as REFER when at least 2 out of 3 responses are below the
Pass/Refer line and these 2 responses are individually scored as Refer.
■
Scores the test result as NOISE when at least 2 out of 3 responses are individually
scored as Noise.
■
If one response is PASS, one is REFER, and one is NOISE, the test result is scored
as NOISE.
Selection of protocol OAE 1 versus OAE 4 depends upon the program's
performance objective for hearing screening.
It is possible to save and print one ear with OAE 1 and the other ear with
OAE 4.
GSI 70 User Manual
Addendum to Chapter 5:
E
RASES
ELEC
Using the GSI 70 Multi-Patient Screener
Two default protocols are available:
OAE 1: GSI Default
OAE 4: 2 OUT OF 3
Selecting a Protocol
1. Turn the GSI 70 Automated OAE Screener on by pressing any button. (The Screener
can be in the Printer/Charger cradle during this procedure.)
.
Once the DPGram appears on the display, simultaneously press the NAME (blue)
2
and DATA (pink) buttons to enter the UTILITY MENU screen.
3. Use the down arrow button (blue) to select
CHANGE PROTOCOL. The Select Protocol
screen appears.
.
Use the stylus to select either the GSI Default
4
(OAE1) or the 2 OUT OF 3 (OAE4) protocol.
Once highlighted, press SELECT to activate this
protocol and return to the Utility Menu screen.
SELECT PROTOCOL
(OAE)
CANCEL
1: GSI DEFAULT
4: 2 OUT OF 3
: EM PTY
: EMPTY
: EMPTY
The first 2 positions on this CHANGE
PROTOCOL screen are now reserved for factory default protocols.
protocol positions cannot be overwritten by a user-defined protocol.
T LOAD
Both
The
three remaining protocol positions may be used to store user-defined
protocols and may be overwritten.
The OAE 4 protocol is loaded into the GSI 70 DMS program when the first
te s t results for OAE 4 are collected from the Screener.
5. Scroll to the word EXIT by using the down arrow button (blue) or up arrow button
(pink) and press RUN (green button) to return to the DPGram display.
The label to the right of the Pass/Refer line indicates the protocol being used
once the TEST (green) button is pressed.
Addenda
Protocol Scoring Rules
OAE 1: GSI Default
■
Scores the test result as PASS when all three responses are at or above the Pass/
Refer line and each response is individually scored as a Pass.
■
Scores the test result as REFER when at least one re sponse is below the Pass/Refer
line and its response is individually scored as a Refer.
■
Scores the test result as NOISE when at least one response is individually scored as
noise.
OAE 4: 2 OUT OF 3
■
Scores the test result as PASS when at least 2 out of 3 responses are at or above the
Pass/Refer line and these 2 responses are individually scored as Pass.
■
Scores the test result as REFER when at least 2 out of 3 responses are below the
Pass/Refer line and these 2 responses are individually scored as Refer.
■
Scores the test result as NOISE when at least 2 out of 3 responses are individually
scored as Noise.
■
If one response is PASS, one is REFER, and one is NOISE, the test result is scored
as NOISE.
Selection of protocol OAE 1 versus OAE 4 depends upon the program's
performance objective for hearing screening.
If the results for the left and right ears are run with both default protocols
(i.e., OAE 1 and OAE 4), the right and left ear results will be paired for printout in
Index ..................................................................
Index-1
Introduction
Thank you for purchasing the Grason-Stadler GSI 70 Automated OAE Screener.
The GSI 70 provides a quick, reliable way to screen for cochlear function, particularly
among patients from birth to age four or five. This promotes earlier diagnostic testing and
earlier intervention for those with cochlear hearing loss. The Screener offers the
following features:
■
Quickly evaluates cochlear function
■
Displays results as they happen
■
Stores data from two ears before printing (Single-Patient Model)
■
Prints out hardcopy on demand
■
Electronically stores test results in database (Multi-Patient Model)
The Printer/Charger Module prints data stored in the GSI 70 and charges the rechargeable
battery in the GSI 70
Module (PCM).
This manual describes how to operate and maintain the GSI 70 and Printer/Charger.
Please follow these instructions to ensure many years of accurate and reliable service.
.
The Printer/Charger is sometimes referred to as the Printer/Charger
1
For additional information on the technology used in the GSI 70, see the Guide to
Otoacoustic Emissions on page 77.
Product Information
For future reference, record the Screener’s serial number here.
The serial number is printed on a label on the back of the instrument, and has the
following format: 1999 0914 where the first four digits are the year of manufacture and
the next digits are a unique product number assigned by the factory.
1
Chapter 1 Introduction
About This Manual
This manual assumes a certain level of medical knowledge, particularly how to perform
.
tests on infants and small children
instrument may be cared for in a Neonatal Intensive Care Unit (NICU) and may have
been born quite premature
.
screening devices and are familiar with a graphical interface and using buttons to select
different options.
Conventions
Throughout this manual, the following typeface: EXAMPLE OF MESSAGE indicates
the following items:
■
Messages that appear on the Screener LCD display
■
Names of buttons and LEDs on the Screener and the Printer/Charger
Some of the newborns that will be tested with this
In addition, we assume that you have used other medical
Messages that appear on the printouts from the Printer/Charger appear in
This manual also uses icons and symbols, described below.
Provides important related information, reminders, recommendations, and
suggestions.
Indicates patient safety alerts. Also indicates that a specific action could cause
harm to your instrument or result in lost data.
.
Indicates an electrical danger to you or a patient
Follow the guidelines in the
manual or on the instrument itself when handling electrical equipment.
Courier
.
2
GSI 70 User Manual
Product Symbols
Product Symbols
The symbols on the GSI 70 Automated OAE Screener and Printer/Charger Module
(PCM) are defined below.
Table 1 – Product Symbols
Symbol Means
Refer to User Manual.
Disconnect from the Mains.
Disassembly of the Screener, Probe/Pod, or Printer/Cha rger be yond
the extent described in this manual voids the warranty. Refer all
servicing to Grason-Stadler or a Graso n-Stadler Autho rized Service
Representative.
Charge the Screener battery only in the Printer/Charger or with the
specified Charging Transformer. Do not use either the Printer/Charger
or the Charging Transformer with any other in strume nts.
Disassembly of the Printer/Charger presents a possible electrical
shock hazard. Refer all servicing to Grason-Stadler or a GrasonStadler Authorized Service Representative.
3
Chapter 1 Introduction
4
GSI 70 User Manual
Getting Started
Unpacking and Verifying Contents
Inspect the packaging for any damage incurred during shipping. If you find any damage,
.
notify the carrier
warranty and allows Grason-Stadler to send announcements of product enhancements.
When you unpack your new GSI 70 Automated OAE System, verify that the following
items are included:
■
Automated OAE Screener
■
Screener battery
■
User Manual (this document)
■
Quick-Reference Guide
■
Starter Kit, Single-Use Eartips
■
Quick Check Cavity
■
Cleaning Kit
■
Calibration Certificate
■
Videotape and Training Booklet
■
Printer/Charger Module
■
Two rolls of paper (one thermal paper, one adhesive backed)
■
Hospital-grade Power Cord t o connect the P rinter/Charger to Mains outlet
Complete and return the warranty registration card. It validates the
2
In addition, you may have some of the following, depending on the system and optional
components you purchased:
■
Charging Transformer, for systems with no Printer/Charger
■
Footswitch
■
Stand
■
RS232 Cable and 9 to 25 pin adapter
■
Infrared (IrDA) communication adapter
■
GSI 70 DMS software installation disks (or CD ROM) and User’s Guide
If you believe any items are missing, contact your Grason-Stadler representative.
5
Chapter 2 Getting Started
Precautions
If the Automated OAE is not at room temperature, allow 30 minutes for it to return to
operating temperature range before using.
Do not charge the battery (do not place the Screener in the Printer/Charger
Module or attach the Screener to the Charging Transformer) at temperatures
greater than 113°F (50°C).
Do not store the Automated OAE or Printer/Charger Module at temperatures that exceed
158°F (70°C).
The following is a Key to Screener, Pod and Probe Features Shown on the Next Page:
1 Display Screen (Touchscreen in Multi-Patient Models only)
2
LEFT Ear memory Button (Blue)
3 TEST Button (Green)
4 RIGHT Ear Memory Button (Pink)
5 Pod Storage Cavity
6 Pod (contains probe calibration information)
6D Green LED: Test Progress Indicator
7 Probe (shown with probe tip attached)
8 Stylus (in Multi-Patient Models only; for use with Touchscreen)
The stylus has a pointed end
children.
9 Access Door for Battery and Language Selector Switches
10 Connector for Charging Transformer and Footswitch
11 Charging Contacts for Battery
12 Infrared Port Window
6
GSI 70 User Manual
.
Keep stylus out of reach of infants and small
Unpacking and Verifying Contents
Automated OAE Screener Features
Use this figure to familiarize yourself with the features of the Screener, Pod, and Probe.
10
11
12
7
1
2, 3, 4
5
8
9
6
Automated OAE Screener, Pod and Probe Features
6A
6B
6C
6D
7
Chapter 2 Getting Started
Printer/Charger Features
The front and rear illustrations presented below show the features of the Printer/Charger.
5
6
1
2
3
4
Printer/Charger Features (Front)
1 Print button
2 Paper Advance button
3 Power / Status LED
Off — Charger not connected to Mains power
On — Charger is connected to Mains power
Single Flashes — Out of paper
Double Flashes — Printer or Charger malfunction
For more information, see Troubleshooting on page 69. 4 Battery LED
Off — No Screener in Charger
On — Screener seated correctly in Charger, and charging
5 IrDA port for communication with Screener
6 Charging contacts for recharging Screener
8
GSI 70 User Manual
Unpacking and Verifying Contents
1
23
Printer/Charger Features (Rear View)
1 Fuse drawer and Mains power connector
2 Paper cover
Push here and lift up to open.
3 RS-232 connector for attaching the Printer/Charger to a computer (for use with
the GSI 70DMS Software only)
9
Chapter 2 Getting Started
Setting Up the Automated OAE Screener
This section covers setting up the Screener for your working environment. Depending on
the accessories you purchased and the setting in which you intend to use the Screener,
you will need to do one or more of the following:
■
Install the battery
■
Set the Screener date and time (Multi-Patient model)
■
Attach the footswitch to the Screener (Optional)
■
Mount the Printer/Charger on the rolling stand (Optional)
■
Check the battery
■
Adjust the Screener LCD contrast (Optional)
■
Install the GSI 70DMS software into your computer (Multi-Patient model)
■
Connect the infrared (IrDA) communications adapter to your computer (Optional for
the Multi-Patient version of the Screener)
Installing the battery
To install the battery, follow the instructions shown in Removing or Replacing the Battery
on page 58.
Setting the Screener date and time
The date and time are stored in the Multi-Patient version of the Screener and will be
associated with test results. The date and time must be set after the Screener battery is
installed. To set the date and time, follow the instructions shown in Setting the Date and Time on page 53.
Attaching the Footswitch to the Screener
You can use the footswitch (if purchased) to start and stop tests, enabling you to use both
hands to handle an infant or hold the probe tip steady in a premature baby’s ear canal.
To attach the footswitch to the Screener:
1
. Connect the footswitch to DIN connector on the top of the screener unit.
See Automated OAE Screener Features page 7, (#10).
Mounting the Screener or Printer Charger to the optional Rolling S tand
The rolling stand lets you move the Screener, Printer/Charger , a box of eartips, and spare
rolls of printer paper easily from patient to patient in a large nursery, or onto an elevator
for use in multiple departments.
10 GSI 70 User Manual
Setting up the Automated OAE Screener
To mount the Screener to the rolling stand:
1
. Slide the screener into the upper bracket.
2
. Adjust upper bracket for optimal LCD position by rotating control knob.
To mount the Printer/Charger to the rolling stand:
1
. Pull downward on the plate locking mechanism, slide the Printer/Charger mounting
plate within the grooves on stand shelf.
2
. Release the locking mechanism once the Printer/Charger is fully in place.
Checking the Battery
To check the battery, turn on the GSI 70 Automated OAE by pressing any button.
■
If you see a low-battery icon ( ) in the upper-right area of the display, you need to
recharge the Screener battery. This icon means you have up to eight minutes in which
you can conduct and store about six more tests. The Screener will not allow a test to
.
begin unless there is sufficient battery charge to complete the test
See Recharging the
Battery on page 59.
■
If you do not see the low-battery icon, the Screener battery has sufficient charge.
Adjusting the LCD Contrast
You can adjust the contrast of the LCD to improve the readability of the display or better
match the lighting conditions in your work environment.
To adjust the LCD contrast:
1
. Press the left (blue) and right (pink) buttons simultaneously.
The Utilities Menu appears.
Single-Patient Model
Multi-Patient Model
11
Chapter 2 Getting Started
2
. Press the down arrow button to move the pointer to the SET LCD CONTRAST
OPTION, then press RUN.
.
The LCD CONTRAST screen appears
The stars are
there to help you see the contrast better.
3
. Use the up or down arrow buttons to adjust the contrast
to your preference, then press EXIT.
The blank DPGram screen appears, and the Single-
Patient Screener is ready for testing
.
For Multi-Patient
models, see Using the GSI 70 Multi-Patient Screener
on page 29.
Installing the GSI 70DMS Software into your Computer
Multi-Patient Screeners require the GSI 70DMS software to communicate with your
computer. To install the GSI 70DMS software, follow the instructions provided in the
GSI 70DMS User’
s Guide that was shipped with the software installation disk set (or CD
ROM).
Connecting the Optional Infrared (IrDA) Adapter to a Computer
For Multi-Patient Systems that will use a wireless infrared connection as the interface
between the Screener and the computer, connect the optional infrared (IrDA) adapter to
one of the computer’s COM ports following the instructions that were shipped with the
infrared adapter.
Once the GSI 70DMS software is installed on the computer and the infrared
(IrDA) adapter is connected, the GSI 70DMS software must be used to
configure the COM port to communicate with the Screener. Follow the COM Port Configuration instructions provided in the GSI 70DMS User’s Guide.
Setting Up the Printer/Charger
For both Single-Patient and Multi-Patient systems, you need to connect the Printer/
Charger to Mains power.
If you purchased the Multi-Patient Screener and intend to use the Printer/Charger as the
interface between the Screener and a personal computer, you also need to co nnect the
12 GSI 70 User Manual
Setting up the Automated OAE Screener
serial cable from the Printer/Charger to the computer. However, if you plan to use a
wireless infrared communication connection between the Screener and computer instead
of the Printer/Charger and serial cable, you will need to connect the optional infrared
(IrDA) adapter to the computer.
Connecting the Printer/Charger to Mains Power
To set up the Printer/Charger and connect it to Mains power:
1
. Place the Printer/Charger on a sturdy, level surface near an electrical outlet. Make sure
the Printer/Charger is not near a source of moisture or direct heat.
2
. Attach the supplied power cord to the back of the Printer/Charger.
See
Printer/Charger Features (Rear View), on page 9.
3
. Plug the other end of the cord into the electrical outlet for Mains power.
The power/status LED on the Printer/Charger turns on.
If you have a Single-Patient Screener, or a Multi-Patient Screener that will communicate
with the computer over an infrared communication connection, the GSI 70 OAE Screener
is ready to use.
Connecting the Printer/Charger to a Computer
For Multi-Patient Systems that will use the Printer/Charger as the interface between the
Screener and the computer, connect the Printer/Charger to the computer you will use to
exchange patient data with the Screener. To connect the Printer/Charger to a computer:
1
. Attach the male end of the supplied DB9-pin serial cable to the back of the Printer/
.
Charger
See Printer/Charger Features (Rear View), on page 9. Tighten the
thumbscrews on the connector.
2
. Locate an available serial port on the back of the computer.
If you are unsure where to connect the cable, consult the documentation that came with
your computer.
3
. Attach the female end of the cable to the serial port and tighten the thumbscrews.
4
. To make sure the computer establishes communications with the Printer/Charger, start
the GSI 70 Data Management Software (DMS) and configure the port
.
See the GSI 70
DMS manual for more information.
The Printer/Charger Module (PCM) is ready to use.
13
T
Chapter 2 Getting Started
N
Preparing for a Test
The Screener must be removed from the Printer/Charger cradle before tests
can be performed.
Selecting an Eartip
Examine the patient’s ear canal then
select an eartip that will fit snugly
.
inside the ear canal
Refer to Table 2.
able 2–Guide to Eartip Selection
Fits These Patients
Eartip Size
3 – 5 mm
5 – 6 mm
6 – 9 mm
9 – 14 mm
(Approximations only)
ewborns
Infants
Young Children
Adults (Age 10 and up)
14 GSI 70 User Manual
Preparing for a Test
Attaching an Eartip to the Probe Tip
To attach an eartip to the probe tip:
1
. Slide and twist the eartip clockwise onto the probe tip until the eartip is seated snugly
against the junction where the probe tip widens (see below).
2
. Inspect the end of the probe tip to ensure you can see the ends of all three metal tubes
clearly (verify the eartip is not blocking any tubes).
No Gap
Attaching an Eartip to the Probe Tip
When removing an eartip, twist the eartip clockwise and pull gently. Discard used eartips.
Always attach and remove eartips using a clockwise twisting motion. A
counter-clockwise twist may remove the probe tip from the Probe.
KEEP EARTIPS OUT OF REACH OF INFANTS AND YOUNG
CHILDREN
.
EARTIPS MAY BE A CHOKING HAZARD.
15
Chapter 2 Getting Started
Securing the Pod and Probe to the Screener
To make it easy to carry the Screener from patient to patient, you can attach the Pod to the
Screener body, and the Probe (without an eartip attached) to the Pod. You can leave the
Pod attached to the Screener while running tests.
Remove the eartip before attaching the Probe to the Pod.
To attach the Pod to the Screener, align the “button” on the under surface of the Pod with
the circular opening in the Screener
into the keyed opening on the Screener. To remove the Pod, slide it forward and pull it out
of the circular opening
snugly. It is not necessary to force the Probe into a secure position.
16 GSI 70 User Manual
Attaching Probe to Pod, and Pod to Screener
.
Press down on the Pod case while sliding the Pod
.
Gently insert the Probe into the opening on the Pod until it fits
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