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Grason-Stadler gsi 39 - User Manual

Grason-Stadler gsi 39
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GSI 39
USER MANUAL
Part Nu
mber D-0121780
Rev
.
C
Setting The Clinical Standard www.grason-stadler.com
Grason-Stadler, 10395 West 70th Street, Eden Prairie, MN, USA55344
800-700-2282 • 952-278-4402 fax 952-278-4401 • e-mail info@grason-stadler.com

Table of Contents

Question and Answer IconNeed help?

Do you have a question about the Grason-Stadler gsi 39 and is the answer not in the manual?

Summary

Preface and Safety Summary

Safety Summary

Highlights potentially dangerous conditions and procedures in the manual.

Safety Notes

Provides important safety information regarding compliance and material usage.

Service Symbol and Customer Responsibility

Warning: Service Symbol

Indicates service adjustment parts and emphasizes use by authorized personnel.

Customer Responsibility

Outlines user obligations for proper operation, maintenance, and safety.

Regulatory and Device Symbols

Regulatory Symbols

Explains various symbols related to medical device directives and compliance.

Device Symbols

Illustrates and describes symbols found on the GSI 39 instrument itself.

Safety Precautions and Warnings

CAUTIONS - GENERAL

General cautionary advice for operating the GSI 39 instrument correctly.

Specific Hazard Warnings

Details warnings for warm elements, equipment connection, shock, explosion, and general use.

WARNING - VOLTAGE; CURRENT DETECTORS

Information about output muting if voltage or current detectors are tripped.

Recycling; Disposal

Procedures and contact information for recycling or disposing of electronic waste.

Warranty and Repair Information

Indications for Use and Introduction

Indications for Use

Information on when and by whom the GSI 39 instrument should be used.

Introduction

Overview of the GSI 39 Auto Tymp and its capabilities.

Tympanometry and Reflex Testing Principles

Tympanometry and Gradient

Explanation of tympanometry principles and the role of gradient in measurement.

Gradient

Details on gradient measurement and its interpretation in tympanometry.

Screening Acoustic Reflex

Explanation of acoustic reflex testing and its application.

Screening Audiometry

Description of how screening audiometry is performed with the GSI 39.

Instrument Setup and Components

Unpacking and Inspection

Steps for safely unpacking and inspecting the instrument and accessories.

Standard Components - General

List of standard components included with the GSI 39 instrument.

Combo Probe -related Components

List of components specifically related to the combo probe.

Optional Accessories

List of optional accessories available for purchase.

GSI 39 Initial Set Up

Step-by-step guide for setting up the GSI 39 instrument for initial use.

Instrument Components and Operation Basics

Components Overview

Identification of the instrument's main parts including display, printer, and probes.

Loading the Paper

Instructions on how to load thermal printer paper.

Paper Storage

Recommendations for storing spare thermal printer paper rolls.

Operation

General operational procedures and interface indicators.

226 Hz Probe Indicators

Explanation of the indicator lights on the 226 Hz probe.

Combo Probe Indicators

Explanation of the indicator lights on the combo probe.

Preparing the Probe Assembly

Steps for connecting and preparing the probe assembly for testing.

Front Panel Controls and Indicators

Print, Data Transfer, and Memory Operations

Controls for printing, data transfer, and memory management functions.

Mode and Test Type Selection

Buttons for selecting test modes, transducers, frequencies, and reflex types.

Audiometry Tone and Intensity Adjustment

Controls for adjusting intensity, tone type, and presenting signals in audiometry.

Individual Display Formats

226 Hz Tympanometry Screen

Format of the display for 226 Hz tympanometry results.

226 Hz Tympanometry;Reflex Screen

Format of the display for 226 Hz tympanometry and reflex results.

1000 Hz Tympanometry Screen

Format of the display for 1000 Hz tympanometry results.

1000 Hz Tympanometry;Reflex Screen

Format of the display for 1000 Hz tympanometry and reflex results.

Audiometry Screen

Format of the display for audiometry test results.

Tympanometry Testing Procedures

Tympanometry Testing Information

General information and helpful hints for performing tympanometry.

Obtaining a Seal

Procedures for achieving a proper seal with the probe tip in the ear canal.

Combo Probe Insertion

Step-by-step guide for inserting the combo probe into the ear canal.

Audiometry Testing Procedures

Audiometry Testing (Version 3 and Version 4)

Procedures for conducting audiometry tests on specific instrument versions.

INSTRUCTING THE PATIENT

Guidance on how to instruct patients before and during audiometry testing.

PLACEMENT OF EARPHONES

Instructions on correctly positioning earphones for audiometry testing.

PLACEMENT OF INSERT PHONES

Instructions for properly inserting insert phones for audiometry.

RESPONSE HANDSWITCH (OPTIONAL ACCESSORY)

Information on using the optional patient response handswitch.

Test Sequences and Programming

Tympanometry;Reflex Test Sequence

Describes various test sequences for tympanometry and reflex testing.

TYMPANOMETRY ONLY MODE

Steps to perform tympanometry tests without reflex measurements.

TYMPANOMETRY AND IPSILATERAL REFLEX

Procedure for performing tympanometry followed by ipsilateral acoustic reflex tests.

TEMPORARY PROGRAMMING OF IPSILATERAL ACOUSTIC REFLEX TEST FREQUENCIES

How to temporarily adjust reflex test frequencies.

TYMPANOMETRY AND CONTRALATERAL REFLEX (VERSION 2 AND VERSION 3)

Procedure for tympanometry with contralateral acoustic reflex tests.

TYMPANOMETRY AND IPSILATERAL;CONTRALATERAL REFLEXES (VERSION 2 AND VERSION 3)

Test sequences combining ipsilateral and contralateral reflexes.

Exit tympanometry;reflex

Instructions on how to exit tympanometry or reflex testing modes.

Audiometry Sequence and Controls

Audiometry Sequence (Version 3 and Version 4)

Steps for performing audiometry tests on specific instrument versions.

TO ENTER THE AUDIOMETRY MODE

How to access and initiate the audiometry testing mode.

TRANSDUCER SELECTION

How to select the appropriate headphones or insert phones for audiometry.

To change the frequency

Instructions for changing the test frequency during audiometry.

To change the intensity level of the test tone

How to adjust the intensity (dB HL) of the test tone during audiometry.

Screening audiometry

Detailed steps for conducting screening audiometry.

AUDIOMETRIC THRESHOLD

Methods for performing audiometric threshold testing.

Manual Threshold Audiometry

Procedure for manual threshold audiometry.

AUTOMATIC HEARING LEVEL

How the Auto HL mode works for automated audiometry.

Theory of Operation

Explanation of the principles behind automated hearing level testing.

Performing the Auto HL Procedure

Step-by-step guide for executing the Auto HL audiometry procedure.

Exit audiometry

Methods to exit the audiometry mode.

Memory Management and Printing

TESTS IN MEMORY

Information about how test results are stored in the instrument's memory.

Page mode

How to navigate and review stored test results.

Memory erase

Procedures for erasing specific or all test results from memory.

Printing test results

How to print single or all stored test results.

Program Mode Settings

PROGRAM MODE

Introduction to the Program Mode for configuring instrument settings.

Basic button functions for moving through the Program menu

Explanation of navigation buttons within the Program Mode.

PROGRAM MODE MENU ITEMS

List of available settings within the Program Mode menu.

Program Menu Page 1 Option Descriptions

Detailed descriptions of options available on Program Menu Page 1.

PROBE HZ

Submenu to determine the probe frequency displayed upon startup.

TYMP OPTIONS

Submenu for tympanogram display and test options.

NEWBORN NRM ON 1 k; NEWBORN NRM OFF 1 k

Option to enable or disable the newborn normal box for 1000 Hz tympanograms.

50 th PERCNT ON 1 k; 5 OthPERCNT OFF 1 k

Option to display or hide the 50th percentile line for infant data.

BASELINE ON 1 k; BASELINE OFF 1 k

Options to control baseline display for compensated or uncompensated tympanograms.

AUTOSTART ON 1 k; AUTOSTART OFF 1 k

Option to enable or disable automatic test start for 1000 Hz.

Reflex Display

Options for how reflex test results are displayed and printed.

REFLEX DB HL PLUS CURVE

Default display format showing dB HL and response curve.

REFLEX DB HL ONLY

Display format showing only dB HL for reflex results.

REFLEX YES;NO

Display format for reflex results showing 'yes' or 'no' instead of dB HL.

226 HZ REFLEX

Settings for default stimuli and routing for 226 Hz acoustic reflexes.

1000 HZ REFLEX

Settings for default stimuli and routing for 1000 Hz acoustic reflexes.

AUTO HL SETUP

Section for programming the automated hearing level procedure.

Programming the Auto HL Procedure

Steps to configure Auto HL settings like frequencies and intensity.

Test Frequencies (Hz)

Submenu to select test frequencies for the Auto HL procedure.

Intensity Range (dB HL)

Submenu to define the minimum and maximum intensity levels for Auto HL.

Start Test Ear

Option to select the starting ear for the Auto HL procedure.

Scoring Rule

Defines the number of valid responses needed to determine threshold.

Tone Format

Selects the stimulus type (Steady, Pulsed, FM) for audiometry.

LANGUAGE

Options for selecting the instrument's display language.

AUD RANGE NORMAL;AUD RANGE NARROW

Settings for selecting the frequency range for audiometry.

Print - Audiogram;Print - Aud Table

Options for selecting the print format for audiometric test results.

DEF XDUCER DD45; DEF XDUCER INSERT

Setting the default transducer for audiometry.

Program Menu Page 2 option descriptions

Descriptions of options available on Program Menu Page 2.

DATA XFER CONFIG

Settings for configuring data transfer parameters to a computer.

POWER UP SETTINGS

Determines the default mode displayed upon instrument startup.

PRN Header GSI;PRN Header Off;PRN Header Custom

Options for setting the print header on test reports.

INTERNAL PRINTER; EXTERNAL PRINTER

Setting to choose between internal or external printer output.

RESET TO DEFAULTS

Resets all programmable settings to factory default values.

Routine Maintenance and Calibration Checks

ROUTINE MAINTENANCE

General information on maintaining the instrument.

Pretest Tymp Checks

Performing quick checks on the tympanometry function before testing.

CALIBRATION QUICK CHECK FOR 226 HZ

Procedure for performing a quick calibration check using the 226 Hz probe.

CALIBRATION QUICK CHECK FOR COMBO PROBE

Procedure for performing a quick calibration check using the combo probe.

Altitude Adjustment

Adjusting ECV measurements for variations due to altitude.

Audiometry Pre-Test Considerations

Pre-Test Audiometric Checks (Version 3 and 4 only)

Pre-test checks for audiometry, including noise considerations.

NOISE RECOVERY PERIOD

Importance of time intervals after noise exposure for accurate testing.

ELIMINATION OF AMBIENT NOISE

Strategies for minimizing ambient noise for valid audiometric tests.

Instrument Checks and Preventive Maintenance

Biological Check

Performing daily checks to ensure instrument and test accuracy.

Preventive Maintenance

General guidance on cleaning and maintaining the instrument.

CLEANING THE SYSTEM

Procedures for cleaning the exterior surfaces of the GSI 39.

Cleaning and Disinfecting Agents

Recommended agents and methods for cleaning and disinfecting the instrument.

CLEANING PATIENT CONTACT REUSABLE DEVICES

Procedures for cleaning parts that contact the patient to prevent cross-infection.

Probe Care and Maintenance

Probe Care - 226 Hz Probe

Maintenance and cleaning instructions for the 226 Hz probe.

PROBE NOSE CONE CLEANING

Steps to remove and clean the probe nose cone for the 226 Hz probe.

The O-Ring

Maintenance of the O-Ring on the probe for smooth operation.

The probe wire

Cleaning and maintenance of the probe wire.

Probe reassembly

Instructions for reassembling the probe nose cone after cleaning.

Probe Care - Combo Probe Tip

Cleaning instructions for the metal tubes on the combo probe tip.

Earphone and Paper Supply

Earphone Care (Versions 3 and 4 only)

Instructions for maintaining earphones to ensure longevity and performance.

Paper supply

Advice on checking and maintaining printer paper supply.

Test Result Interpretation

TEST RESULTS

General section for interpreting test results.

Ear canal Volume - 226 Hz Probe Tone

Normal and abnormal values for ear canal volume measurement.

Compliance Peak

Interpretation of compliance peak values in tympanograms.

Pressure Peak

Interpretation of pressure peak values in tympanograms.

Gradient

Interpretation of gradient values in tympanograms.

Acoustic reflex

Interpretation of normal and abnormal acoustic reflex results.

Audiometry

Interpretation of normal and abnormal audiometry responses.

Instrument Messages and Sample Results

Special Messages and Error Codes

Explains instrument error codes and special messages displayed.

Sample Test Results

Examples of tympanogram printouts and their interpretations.

Computer Interface and Data Transfer

COMPUTER INTERFACE

Information on connecting the GSI 39 to a computer.

Operation

How to transfer test results to a computer.

TRANSFERRING DURING NORMAL OPERATION

Transferring test results during normal testing operation.

TRANSFERRING FROM MEMORY PAGES

Transferring results when reviewing stored pages.

OTHER LCD SCREEN MESSAGES

Explanations of messages like 'INVALID SELECTION'.

NO DATA AVAILABLE

Message displayed when no results are stored for transfer.

NOT AVAILABLE

Message displayed if the computer is not properly connected.

Data Transfer Program Mode

How to configure data transfer settings.

Computer Interface

Details on interface configuration and cable connections.

GSI SUITE INTERFACE CONFIGURATION

Steps to configure GSI Suite software for connection with the GSI 39.

UPLOADING DATA FROM THE GSI 39 TO GSI SUITE

Step-by-step instructions for transferring data from GSI 39 to GSI Suite.

Technical Data and Specifications

APPENDIX A - TECHNICAL DATA

Technical specifications and standards compliance information.

Standards

List of standards to which the GSI 39 conforms.

Protective Classification

Information on the instrument's protective classification.

APPENDIX B: SECIFICATIONS

Detailed technical specifications of the GSI 39 instrument.

Tympanometry Modes

Specifications for tympanometry including probe tone and admittance ranges.

Pneumatic System

Specifications related to the instrument's pneumatic system and pressure.

Acoustic Reflex Stimuli

Details on frequencies, output levels, and transducers for acoustic reflex tests.

Probe LED Indicators

Explains the meaning of the LED indicators on the probes.

Audiometry mode (Versions 3 and 4 only)

Specifications for audiometry mode, including frequencies and accuracy.

INTENSITY LEVELS

Specifies intensity levels for DD45 Headphones and Insert Phones.

TONE FORMAT

Describes the different tone formats available (Continuous, Pulsed, FM).

Printer

Specifications related to the instrument's printer, including paper length and speed.

Power

Technical specifications regarding power input and consumption.

Environmental

Environmental operating and storage conditions for the instrument.

Mechanical - Instrument

Physical dimensions and weight of the instrument and shipping carton.

Appendices and Compatibility

APPENDIX C: GLOSSARY OF TERMS

Definitions of key terms used in the manual.

APPENDIX D: BIBLIOGRAPHY

List of references and sources cited in the manual.

APPENDIX E: ELECTROMAGNETIC COMPATIBILITY (EMC)

Information regarding the instrument's electromagnetic compatibility.

Cautions regarding EMC

Safety warnings and precautions related to electromagnetic interference.

Guidance and manufacturer’s declaration

Manufacturer's declarations regarding electromagnetic emissions.

Electromagnetic emissions

Compliance information and guidance for electromagnetic emissions.

Recommended separation distances between portable and mobile RF communications equipment

Guidelines for maintaining safe distances from RF equipment to prevent interference.

Guidance and Manufacturer’s Declaration

Manufacturer's declarations regarding electromagnetic immunity.

Electromagnetic Immunity

Compliance levels and guidance for electromagnetic immunity.

Grason-Stadler gsi 39 Specifications

General IconGeneral
TypeAudiometer
Frequency Range125 Hz to 8000 Hz
Test TypesAir conduction, Bone conduction, Speech testing
Channels2
Attenuation Steps5 dB
DisplayLCD
Intensity Range-10 dB to 110 dB HL
MaskingNarrow band noise, Speech noise, White noise

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