Grason-Stadler gsi 39 User manual

GSI 39™
USER MANUAL
Part Number D-0121780 Rev .C
Setting The Clinical Standard www.grason-stadler.com
Grason-Stadler, 10395 West 70th Street, Eden Prairie, MN, USA55344
800-700-2282 • 952-278-4402 • fax [phone] • e-mail [email protected]

Title: GSI 39 Auto Tymp User Manual
Manufacturer
Grason-Stadler, Inc.
10395 West 70
th
Street
Eden Prairie, MN 55344
USA
Copyright © 2019 Grason-Stadler
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 . The information in this
publication is proprietary to Grason-Stadler.
Compliance
The CE 0123 mark identifies compliance with the Medical Device Directive 93/42/EEC. Grason-
Stadler is an ISO 13485 certified corporation.
European Authority Representative
Grason-Stadler
c/o DGS Diagnostics A/S
Audiometer Alle 1
5500 Middelfart
Denmark
0123
Caution: US Federal law restricts this device to sale by or on the order of a physician or licensed
hearing care professional.

TABLE OF CONTENTS
TABLE OF CONTENTS...............................................................................................................................3
Preface ....................................................................................................................................................9
Safety Summary..................................................................................................................................9
Warning...........................................................................................................................................9
Caution............................................................................................................................................9
Notes...............................................................................................................................................9
Safety Notes........................................................................................................................................9
Warning: Service Symbol ..................................................................................................................10
Customer Responsibility ...................................................................................................................10
Regulatory Symbols ..........................................................................................................................12
Device Symbols .................................................................................................................................14
Safety Precautions ................................................................................................................................15
Cautions - General.........................................................................................................................15
Cautions –Warm Elements...........................................................................................................16
Warning –Connection Additional Equipment ..............................................................................16
Warning –Electric Shock Hazards.................................................................................................16
Warning –Explosion .....................................................................................................................16
Warning –Connections.................................................................................................................16
Warning –General ........................................................................................................................16
Warning –Voltage / Current Detectors........................................................................................17
Recycling / Disposal ..........................................................................................................................17
Warranty and Repair.............................................................................................................................18
Indications for Use................................................................................................................................19
Introduction ......................................................................................................................................19
Tympanometry and Gradient ..........................................................................................................21
Gradient ............................................................................................................................................22
Screening Acoustic Reflex .................................................................................................................22
Screening Audiometry ......................................................................................................................24
Unpacking and Inspection.....................................................................................................................25
Standard Components - General ......................................................................................................25
Combo Probe -related Components.................................................................................................26
Optional Accessories.........................................................................................................................26
GSI 39 Initial Set Up...............................................................................................................................27

Components......................................................................................................................................28
Display and Printer........................................................................................................................28
Probe (226 Hz)...............................................................................................................................28
Combo Probe (226Hz and 1kHz) ...................................................................................................28
Rear Panel Labels and Connectors................................................................................................29
Bottom Panel ................................................................................................................................29
Loading the Paper .............................................................................................................................30
Paper Storage................................................................................................................................30
Operation..............................................................................................................................................31
226 Hz Probe Indicators....................................................................................................................31
Combo Probe Indicators (226 Hz and 1000 Hz Probe Tone) ............................................................32
Preparing the Probe Assembly......................................................................................................32
Front Panel Controls and Indicators .................................................................................................34
Individual display Formats ............................................................................................................37
226 Hz Tympanometry Screen..................................................................................................37
226 Hz Tympanometry/Reflex Screen ......................................................................................37
1000 Hz Tympanometry Screen................................................................................................38
1000 Hz Tympanometry/Reflex Screen ....................................................................................38
Audiometry Screen ...................................................................................................................39
Tympanometry Testing Information.................................................................................................40
Obtaining a Seal ................................................................................................................................40
Combo Probe Insertion.....................................................................................................................42
Audiometry Testing (Version 3 and Version 4).................................................................................43
Instructing the Patient ..................................................................................................................43
Placement of Earphones...............................................................................................................43
Placement of Insert Phones..........................................................................................................44
Response Handswitch (Optional Accessory).................................................................................44
Tympanometry/Reflex Test Sequence..............................................................................................45
Tympanometry Only Mode...........................................................................................................45
Tympanometry and Ipsilateral Reflex...........................................................................................47
Temporary Programming of Ipsilateral acoustic Reflex Test Frequencies ...................................48
Tympanometry and Contralateral Reflex (Version 2 and Version 3)............................................49
Tympanometry and Ipsilateral/Contralateral Reflexes (Version 2 and Version 3).......................51
Ipsilateral and Contralateral Acoustic Reflex testing ...............................................................51
Exit tympanometry/reflex.........................................................................................................52

Audiometry Sequence (Version 3 and Version 4).............................................................................53
To enter the Audiometry mode....................................................................................................53
Transducer Selection.....................................................................................................................53
To change the frequency ..........................................................................................................53
To change the intensity level of the test tone ..........................................................................54
Screening audiometry...............................................................................................................55
Audiometric Threshold .................................................................................................................55
Manual Threshold Audiometry.................................................................................................55
Automatic Hearing Level...............................................................................................................56
Theory of Operation..................................................................................................................56
Performing the Auto HL Procedure ..........................................................................................57
Exit audiometry.........................................................................................................................57
Tests in memory............................................................................................................................57
Page mode ................................................................................................................................58
Memory erase...........................................................................................................................58
Printing test results...................................................................................................................58
Program Mode......................................................................................................................................59
Program Mode .................................................................................................................................59
Program Mode Menu Items .........................................................................................................59
Program Menu Page 1 Option Descriptions .....................................................................................60
PROBE HZ . . . ................................................................................................................................60
TYMP OPTIONS . . .........................................................................................................................60
NORMAL BOX ASHA/NORMAL BOX OFF...................................................................................60
NEWBORN NRM ON 1k / NEWBORN NRM OFF 1k...................................................................61
50th PERCNT ON 1k / 5OthPERCNT OFF 1k ..............................................................................61
BASELINE ON 1k / BASELINE OFF 1k .........................................................................................61
AUTOSTART ON 1k / AUTOSTART OFF 1k.................................................................................61
Reflex Display....................................................................................................................................62
Reflex dB HL plus curve.................................................................................................................62
Reflex dB HL only ..........................................................................................................................62
Reflex yes/no.................................................................................................................................63
226 Hz Reflex.................................................................................................................................63
1000 Hz Reflex...............................................................................................................................63
Auto HL Setup ..............................................................................................................................64

Programming the Auto HL Procedure ......................................................................................64
Test Frequencies (Hz)................................................................................................................64
Intensity Range (dB Hz).............................................................................................................64
Start Test Ear.............................................................................................................................65
Scoring Rule...............................................................................................................................65
Tone Format..............................................................................................................................65
Language .......................................................................................................................................66
Aud Range Normal/Aud Range Narrow........................................................................................66
Print - Audiogram/Print –Aud Table ................................................................................................67
DEF XDUCER DD45 / DEF XDUCER INSERT ....................................................................................67
Program Menu Page 2 option descriptions ......................................................................................68
Data Xfer Config ............................................................................................................................68
Power Up Settings.........................................................................................................................68
PRN Header GSI/PRN Header Off/PRN Header Custom ...................................................................69
Internal Printer / External Printer.................................................................................................69
RESET TO DEFAULTS .........................................................................................................................70
Exiting the program mode........................................................................................................70
Routine Maintenance ...........................................................................................................................71
Pretest Tymp Checks.........................................................................................................................71
Calibration Quick Check for 226 Hz...............................................................................................72
Calibration Quick Check for Combo Probe ...................................................................................73
Altitude Adjustment..........................................................................................................................74
Pre-Test Audiometric Checks (Version 3 and 4 only)........................................................................76
Noise recovery period...................................................................................................................76
Elimination of ambient noise ......................................................................................................76
Biological Check ................................................................................................................................77
Preventive Maintenance...................................................................................................................78
Cleaning the system......................................................................................................................78
Cleaning and Disinfecting Agents..............................................................................................78
Cleaning patient contact reusable devices...................................................................................79
Probe Care –226 Hz Probe ...............................................................................................................80
Probe nose cone cleaning.............................................................................................................80
The O-Ring.................................................................................................................................81
The probe wire..........................................................................................................................81
Probe reassembly......................................................................................................................82

Probe Care - Combo Probe Tip ........................................................................................................83
Earphone Care (Versions 3 and 4 only) ...........................................................................................85
Paper supply .....................................................................................................................................86
Test Results ...........................................................................................................................................87
Ear canal Volume –226 Hz Probe Tone............................................................................................87
Normal ..........................................................................................................................................87
Abnormal ......................................................................................................................................87
Compliance Peak...............................................................................................................................88
Normal ..........................................................................................................................................88
Abnormal ......................................................................................................................................88
Pressure Peak....................................................................................................................................89
Normal ..........................................................................................................................................89
Abnormal ......................................................................................................................................89
Gradient ............................................................................................................................................89
Normal ..........................................................................................................................................89
Abnormal ......................................................................................................................................89
Acoustic reflex...................................................................................................................................90
Normal ..........................................................................................................................................90
Abnormal ......................................................................................................................................90
Audiometry .......................................................................................................................................90
Normal ..........................................................................................................................................90
Abnormal ......................................................................................................................................90
Special Messages and Error Codes ...................................................................................................91
Sample Test Results ..........................................................................................................................92
Computer Interface...............................................................................................................................95
Introduction ......................................................................................................................................95
Operation..........................................................................................................................................95
Transferring during normal operation..........................................................................................95
Transferring from memory pages .................................................................................................95
Other LCD screen messages..........................................................................................................95
INVALID SELECTION...................................................................................................................95
NO DATA AVAILABLE.................................................................................................................96
NOT AVAILABLE.........................................................................................................................96
Data Transfer Program Mode ...........................................................................................................96
Computer Interface...........................................................................................................................97

Interface configuration ................................................................................................................97
Cable connections ........................................................................................................................97
GSI Suite ............................................................................................................................................97
GSI Suite Interface configuration ................................................................................................97
Uploading data from the GSI 39 to GSI Suite................................................................................98
Appendix A - Technical Data .................................................................................................................99
Standards ..........................................................................................................................................99
Protective Classification....................................................................................................................99
Appendix B: Secifications....................................................................................................................100
Tympanometry Modes....................................................................................................................100
Pneumatic System ..........................................................................................................................100
Acoustic Reflex Stimuli....................................................................................................................101
Probe LED Indicators.......................................................................................................................102
Audiometry mode (Versions 3 and 4 only) .....................................................................................102
Transducers.................................................................................................................................102
Intensity Levels ...........................................................................................................................103
Tone Format................................................................................................................................103
Printer .............................................................................................................................................103
Power..............................................................................................................................................104
Environmental.................................................................................................................................104
Mechanical - Instrument.................................................................................................................104
Appendix C: Glossary of Terms ...........................................................................................................105
Appendix D: Bibliography....................................................................................................................106
Appendix E: Electromagnetic Compatibility (EMC).............................................................................107
Cautions regarding EMC .................................................................................................................107
Guidance and manufacturer’s declaration Electromagnetic emissions .........................................108
Recommended separation distances between portable and mobile RF communications equipment
........................................................................................................................................................109
Guidance and Manufacturer’s Declaration Electromagnetic Immunity.........................................110

Page 9 of 112
PREFACE
READ THIS ENTIRE MANUAL BEFORE ATTEMPTING TO USE THIS SYSTEM!
Safety Summary
In this manual, two symbols identify potentially dangerous or destructive conditions and procedures.
WARNING
The WARNING symbol identifies conditions or practices that may present danger to
the patient and/or user
CAUTION
The CAUTION symbol identifies conditions or practices that could result in damage to
the equipment.
NOTES
NOTE: Notes help you identify areas of possible confusion and avoid potential problems during
system operation
Safety Notes
WARNING The GSI 39 is designed for compliance to IEC and UL 60601-1 when
used in the patient vicinity. To achieve this compliance, the GSI 39 is equipped with a specific power
transformer (ref: 8511988), which should not be interchanged with any other transformer or supply.
Any program aimed at obtaining reliable records of hearing thresholds should be staffed and
supervised by appropriately-trained individuals.
Latex is not used anywhere in the manufacturing process.
The base material for the earphone cushions is made from natural and synthetic rubber.
The material used to manufacture GSI’s eartips is Krayton Thermoplastic Rubber.

Page 10 of 112
Warning: Service Symbol
WARNING
The indicates the location of a service adjustment part and is intended for service
personnel only. The GSI 39 is a specifically calibrated audiometer and Tympanometer,
and the periodic service and adjustments for the instrument that may be required should be done
only by an authorized GSI service technician.
Please read the entire manual prior to using the GSI 39 to become familiar with the test functions and
proper accessory connections.
Accessory equipment connected to the analog and digital interfaces must be certified to the
respective IEC standards (IEC950 for data processing or IEC 60601-1 for medical equipment).
Furthermore, all configurations shall comply with the system standard IEC 60601-1-1. Everyone who
connects additional equipment to the signal input or signal output port configures a medical system
and is therefore responsible that the system complies with the requirements of the system standard
IEC60601-1-1. If in doubt, consult the technical service department or a local GSI representative.
Customer Responsibility
WARNING
This product and its components will perform reliably only when operated and
maintained in accordance with the instructions contained in this manual,
accompanying labels, and/or inserts. A defective product should not be used. Parts
which may be broken or missing or are plainly worn, distorted or contaminated should be replaced
immediately with clean, genuine replacement parts manufactured by or available from GSI.
The responsibility of GSI for a malfunction product is limited by the warranty set forth in this manual.
Should repair or replacement of this product become necessary after the warranty period, the
customer should seek advice from GSI Technical Support prior to such repair or replacement. If this
product is in need of repair, it should not be used until all repairs have been made and the unit is
functioning properly and ready for use. The owner of this product has sole responsibility for any
malfunction resulting from improper use or maintenance, or repair by anyone other than GSI, and
from any malfunction caused by parts that are damaged or modified by anyone other than GSI.
This product should not be used in the presence of fluid that can come into contact with any of the
electronic components or wiring. Should the user suspect fluids have contacted the system
components or accessories, the unit should not be used until deemed safe by a GSI certified service
technician.
Do NOT use in the presence of flammable gaseous mixtures. Users should consider the possibility of
explosions or fire when using this device in close proximity to flammable anesthetic gases.