GSi TYMPSTAR PRO User manual

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]
GSI TYMPSTAR PRO™
USER MANUAL
Part Number D-0105594 Rev G

D-0105594 Rev. G i

GSI TympStar Pro ™ Clinical Middle-Ear Analyzer
ii D-0105594 Rev. G
Title: GSI TympStar Pro ™ Clinical Middle Ear Analyzer User Manual
Manufacturer
Grason-Stadler, Inc.
10395 West 70
th
Street
Eden Prairie, MN 55344
USA
Copyright © 2018 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.
This product incorporates software developed by others and redistributed according to license
agreements. Copyright notices and licenses for these external libraries are provided in a supplementary
document that is included with the other software applications distributed with this product.
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

D-0105594 Rev. G iii
Table of Contents
Preface ..........................................................................................................................................................1
Manual Conventions..................................................................................................................................1
Regulatory Symbols..................................................................................................................................1
Caution......................................................................................................................................................4
Safety Precautions.....................................................................................................................................4
Warnings and Cautions .............................................................................................................................5
Warning - General.....................................................................................................................................6
Warning - Connecting Additional Equipment...........................................................................................6
Warning - Electric Shock Hazards............................................................................................................6
Warning - Electric Grounding...................................................................................................................6
Warning - Explosion .................................................................................................................................7
Warning - Line Voltage Brownout and Interruptions ...............................................................................7
Warning - Connections..............................................................................................................................7
Warning - Battery Safety...........................................................................................................................7
Cautions - General.....................................................................................................................................7
Shutdown Procedure..................................................................................................................................7
Recycling / Disposal..................................................................................................................................8
Customer Responsibility ...........................................................................................................................8
Warranty....................................................................................................................................................9
Chapter 1: Introduction...............................................................................................................................10
Indication for Use....................................................................................................................................10
Intended Use............................................................................................................................................10
Contraindications ....................................................................................................................................10
Description and Operating Principles......................................................................................................10
Chapter 2: Installation.................................................................................................................................13
External Inspection..................................................................................................................................13
Unpacking ...............................................................................................................................................13
Initial Set Up ...........................................................................................................................................14
Chapter 3: Connectors, Controls and Indicators.........................................................................................15
Rear Panel ...............................................................................................................................................15
Right Side Panel......................................................................................................................................17
Left Side Panel ........................................................................................................................................18
Bottom Panel Label.................................................................................................................................19
Probe Box................................................................................................................................................21

GSI TympStar Pro ™ Clinical Middle-Ear Analyzer
iv D-0105594 Rev. G
Chapter 4: Front Panel Controls..................................................................................................................22
Power.......................................................................................................................................................22
Examiner .................................................................................................................................................22
Patient......................................................................................................................................................22
Data Erase ...............................................................................................................................................22
Test Type Buttons ...................................................................................................................................23
Screener...................................................................................................................................................23
Tymp .......................................................................................................................................................23
Reflex......................................................................................................................................................23
ETF..........................................................................................................................................................23
More........................................................................................................................................................23
Tympanometry Controls..........................................................................................................................24
Manual.....................................................................................................................................................24
Hold.........................................................................................................................................................24
Stop..........................................................................................................................................................24
Start .........................................................................................................................................................24
Pressure Control......................................................................................................................................24
Reflex Stimulus Controls........................................................................................................................25
Stimulus...................................................................................................................................................25
Intensity...................................................................................................................................................25
Present.....................................................................................................................................................25
Print.........................................................................................................................................................25
Data Transfer...........................................................................................................................................27
Configure.................................................................................................................................................27
Chapter 5: Test Type Displays....................................................................................................................29
Display Monitor ......................................................................................................................................29
Test Type Screens ...................................................................................................................................29
Screener Tests .........................................................................................................................................32
Tympanometry ........................................................................................................................................38
Reflex Test ..............................................................................................................................................46
Reflex Decay...........................................................................................................................................54
Acoustic Reflex Latency Test (ARLT) ...................................................................................................60
Eustachian Tube Function (ETF) - Intact................................................................................................67
Eustachian Tube Function (ETF) - Perforated........................................................................................74
Patulous Eustachian Tube Test (ETF).....................................................................................................77
Chapter 6: Operation...................................................................................................................................92

D-0105594 Rev. G v
Preliminary Checks .................................................................................................................................92
Typical Evaluations.................................................................................................................................94
Test Type Buttons ...................................................................................................................................94
Tympanometry ........................................................................................................................................94
Acoustic Reflex.......................................................................................................................................95
Chapter 7: Application Software & Integration..........................................................................................97
TympStar Pro Config App ......................................................................................................................97
GSI Instrument Services........................................................................................................................101
GSI Suite ...............................................................................................................................................101
OtoAccess™..........................................................................................................................................102
Noah 4 ...................................................................................................................................................102
AudBase................................................................................................................................................102
Chapter 8: Routine Maintenance...............................................................................................................103
Pretest Tympanometry Checks..............................................................................................................103
Calibration Quick Check for Probe.......................................................................................................103
Biological Calibration Check................................................................................................................105
Preventive Maintenance........................................................................................................................105
Cleaning the System..............................................................................................................................105
Cleaning and Disinfecting Agents.........................................................................................................106
Cleaning patient contact devices...........................................................................................................107
Probe care..............................................................................................................................................107
Appendix 1: System Defaults ...................................................................................................................112
Instrument Settings................................................................................................................................112
Screener Settings...................................................................................................................................112
Tympanometry Settings ........................................................................................................................113
Reflex Settings ......................................................................................................................................113
ETF Settings..........................................................................................................................................114
Auto Sequence Settings.........................................................................................................................114
Appendix 2: Specifications.......................................................................................................................116
Appendix 3: Error Messages.....................................................................................................................121
Appendix 4: Safety, EMC and Associated Standards...............................................................................122
Appendix 5: Audiometric Standards.........................................................................................................127

Preface This user manual provides information about the GSI TympStar Pro ™middle
ear analyzer. This manual is intended for technically qualified personnel.
Manual Conventions
In this manual the following two labels identify potentially dangerous or
destructive conditions and procedures.
WARNING
The WARNING label identifies conditions or practices that may present danger
to the patient and/or user.
CAUTION
The CAUTION label identifies conditions or practices that could result in
damage to the equipment.
NOTE: Notes help identify areas of possible confusion and avoid potential
problems during system operation.
Regulatory Symbols
Symbol
Description
Conforms to European Medical Device Directive 93/42/EEC.
Symbol for "SERIAL NUMBER."
GSI Part Number.
Return to Authorized Representative, Special disposal required.

Symbol
Description
Medical Equipment Classified by Intertek Testing Services NA Inc. with
respect to electric shock, fire, and mechanical hazards only, in accordance
with UL 60601-1. Classified under the Medical Device Directive
(93/42/EEC) as a Class IIb device.
Symbol for “European Representative.”
Symbol for “Manufacturer.”
Symbol for “Date of Manufacture.”
Attention, consult accompanying documents.
China RoHS symbol for products with a 50 year life cycle.
B Patient Applied Part according to IEC 60601-1.
On/Off - Next to power mains.
Keep Dry.
This side up.
Monitor.
Patient response switch.
Consult the operating instructions/directions for use.
A copy of the operating manual is available on this website:
www.grason-stadler.com
A printed copy of the operating instructions can be ordered from Grason-
Stadler for shipment within 7 days; or you can contact your local
representative.

Symbol
Description
Consult the operating instructions/directions for use.
A copy of the operating manual is available on this website:
www.grason-stadler.com
A printed copy of the operating instructions can be ordered from Grason-
Stadler for shipment within 7 days; or you can contact your local
representative.