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GSi TYMPSTAR PRO User Manual

GSi TYMPSTAR PRO
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RELIABLE
CLINICAL
TYMPANOMETER
TYMPSTAR PRO
USER MANUAL

Table of Contents

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GSi TYMPSTAR PRO Specifications

General IconGeneral
BrandGSi
ModelTYMPSTAR PRO
CategoryMeasuring Instruments
LanguageEnglish

Summary

Preface

Manual Conventions

Explains the meaning of warnings, cautions, and notices used in the manual.

Regulatory and Device Symbols

Lists and describes various symbols used on the device and in the manual.

Safety and Precautions

Important Safety Instructions

Highlights general safety precautions and warnings to prevent equipment damage and injury.

Handling Hazards

Covers fluids, damage, electrical safety, battery, and explosion risks.

Environmental and EMC Considerations

Details operating temperature, humidity, and EMC precautions.

Product Overview

Introduction, Indications, and Use

Introduces the system, its intended use, and contraindications.

Essential Performance

States the instrument does not have defined Essential Performance per IEC 60601-1.

Description and Operating Principles

Instrument Components and Probe Functionality

Describes the main components and the probe's role.

Installation and Setup

Unpacking and System Assembly

Provides instructions for unpacking and assembling the system components.

Component Identification

Lists standard and optional accessories included with the TympStar Pro.

System Connections

Rear and Side Panel Connections

Details connectors on the rear, right, and left side panels of the base unit.

Front Panel and Probe Box

Describes controls on the front panel and connections on the probe box.

Operating the TympStar Pro

Preliminary Checks and Test Preparation

Outlines daily checks and patient preparation before starting tests.

Data Collection Procedures

Guides on instructing patients and probe insertion for data collection.

Front Panel Controls Explained

Power, Patient, Examiner, and Data Erase

Explains core front panel buttons for system control and data management.

Test Type Selection

Describes buttons for selecting different test types (Screen, Tymp, Reflex, ETF, More).

Tympanometry Controls and Settings

Manual Test Management

Details manual, hold, stop, start, and pressure control for tympanometry.

Tympanometry Settings

Lists and explains default tympanometry parameters.

Reflex Stimulus Control and Data Transfer

Reflex Stimulus Controls

Explains controls for stimulus level and presentation during reflex tests.

Printing and Data Transfer

Covers printing test results and transferring data to a computer.

Configuration and Settings Management

Configure Instrument Settings

Details options for updating software, print settings, and exporting logs.

Settings Menu Options

Explains settings for transducer, display pointer, date/time, brightness, and altitude.

Licensing and Print Menus

Covers license management and print settings dialogs.

Test Type Displays

Display Elements and Navigation

Describes the title bar, test information, tabs, and test menu for navigation.

Common Icons and Test Results

Explains common icons and how test results are displayed.

Screener Tests

Screener Screen Overview

Explains the screener screen layout for tympanometry and reflexes.

Screener Test Menu Options

Details menu options for probe, sweep rate, auto start, and marking tests.

Zoom and Settings

Zoom Functionality

Describes how to use the zoom dialog to view tympanogram details.

Settings and Comments

Explains how to adjust tympanogram parameters and add comments.

Tympanometry Procedures

Tympanometry Screen Overview

Explains the diagnostic tympanometry screen and result tabs.

Manual Tympanometry

Details how to perform manual tympanometry using the pressure knob.

Tympanometry Test Menu

Test Menu Options

Explains auto sequence, probe, immittance, baseline, and sweep rate settings.

Age and Zoom Function

Explains age setting impact and the zoom functionality for tympanograms.

Tympanometry Settings Details

Baseline, Normative Data, Peak Indicator

Details baseline, normative data, and peak indicator settings.

Auto Sequence and Comments

Auto Sequence Protocols

Explains how to change auto sequence protocols.

Comments Section

Describes how to enter and review comments.

Reflex Test Overview

Reflex Screen and Data Display

Explains the reflex screen layout and how data is displayed.

Reflex Test Data Handling

Explains storing reflex results and the reflex settings overview.

Threshold Seek Settings

Threshold Seek Parameters

Explains start level, stop level, dB step, and verification for threshold seek.

Non-Threshold Seek Settings

Details parameters for reflex testing without threshold seek.

Reflex Stimulus and Timing Settings

Stimulus and Timing Controls

Details timing, stimulus types, averages, quantity, scaling, and immittance.

Reflex Decay Tests

Reflex Decay Screen and Menu

Explains the reflex decay screen layout and menu options.

Stored Reflex Decay Data

Describes how to view stored reflex decay results.

Reflex Decay Settings and Zoom

Zoom and Store Functions

Explains zoom functionality and how to store reflex decay graphs.

Reflex Decay Settings

Details parameters for collecting reflex decay tests.

Acoustic Reflex Latency Test (ARLT)

ARLT Screen Overview

Explains the ARLT screen and data display for latency tests.

ARLT Data Handling and Settings

Details stored results, test menu, and settings for ARLT.

Eustachian Tube Function (ETF) - Intact

ETF Intact Screen and Procedures

Explains the ETF Intact screen, probe status, meters, and results.

ETF Intact Test Menu

Details menu options for test controls and settings.

Eustachian Tube Function (ETF) - Perforated

ETF Perforated Screen and Results

Explains the ETF Perforated screen, probe status, pressure meter, and results.

ETF Perforated Test Menu

Details menu options for max pressure, time, mark test, and comments.

Patulous Eustachian Tube Test (ETF)

Patulous ETF Screen and Menu

Explains the Patulous ETF screen, probe status, meters, and test menu.

Patulous ETF Results and Settings

Details results storage and settings for Patulous ETF tests.

Multiple Frequency Tympanometry (Multi-Hz)

Multi-Hz Screen Overview

Explains the Multi-Hz screen layout for frequency-specific tympanometry.

Multi-Hz Test Menu and Settings

Details menu options and settings for Multi-Hz tests.

Multi-Hz Results Analysis

Zoom-Delta Peak-Start

Explains how to review and override Delta Peak data using the zoom function.

Wideband Tympanometry (WBT)

WBT Screen and Menu

Explains the WBT screen layout and test menu options.

WBT Settings and Data Analysis

Details WBT settings, normative data, and absorbance updates.

WideBand Test Results Interpretation

WBT Results Display

Explains the first tab of WBT data and how results are presented.

WideBand Tympanogram Curves

Details the display of tympanograms for different frequencies and immittance components.

WideBand Tympanometry Data Analysis

WBT Average and Absorbance Display

Explains the average WBT tympanogram and absorbance graph options.

Typical Evaluations

Test Type Buttons and Tympanometry

Explains test type buttons and provides tympanometry procedure.

Acoustic Reflex Testing

Gives step-by-step instructions for performing acoustic reflex tests.

Application Software & Integration

TympStar Pro Config App

Details installation and customization of the configuration software.

Config App Menu Options

Explains options for upload, new settings, revert, load, save, log, configure, and about.

Configuration Settings Details

Diagnostic Protocols

Explains how test settings are saved as protocols.

GSI Instrument Service

Explains electronic data transmission and public interface options.

Data Transfer and Software Solutions

Public Interface and Data Port

Describes direct data transfer to EMR systems and data port compatibility.

GSI Suite and Related Software

Details GSI Suite, OtoAccess, Noah 4, and AudBase for data management.

Routine Maintenance

Pretest Tympanometry Checks

Explains using the test cavity for quick calibration checks.

Biological Calibration Check

Describes performing daily checks on a normal ear for operational verification.

Cleaning and Probe Care

Cleaning Procedures

Details cleaning the system, LCD screen, and patient contact parts.

Probe Care and Use of Cleaning Tool

Explains probe tip maintenance and use of the cleaning tool.

Error Messages

Common Error Types

Explains common error messages like invalid start direction, no data, and calibration errors.

Appendix A: System Defaults

Instrument and Screener Settings Defaults

Lists default settings for instrument and screener parameters.

Protocol Settings Defaults

Lists default parameters for Tympanometry, Reflex, ETF, Multi-Hz, and WideBand.

Appendix A: Auto Sequence Settings

Auto Sequence Protocol Configurations

Details the default factory and pre-programmed auto sequence protocols.

Appendix B: Technical Data

Standards Compliance and Environmental Specs

Lists compliance standards and environmental operating conditions.

Power and Physical Specifications

Lists power consumption and physical dimensions of the instrument and accessories.

Measuring System Specifications

Probe Signals and Measurement Ranges

Details probe signals, levels, ranges, and accuracy specifications.

Temporal Characteristics and Pneumatic System

Details temporal characteristics and pneumatic system specifications.

Acoustic Reflex Stimulus System

Stimulus Signal Specifications

Lists specifications for pure tone, noise, and click stimulus signals.

Appendix C: Input/Output Connections

Connection Pinouts

Details pin configurations for mains, USB, LAN, monitor, patient input, and headphones.

External Input and Probe Box Connections

Describes external input and probe box connector pinouts.

Appendix D: Safety, EMC, and Standards

EMC Cautions and Performance

Provides warnings about EMC and states the instrument has no Essential Performance.

Electromagnetic Compatibility

Details EMC requirements and necessary accessories for compliance.

Guidance and Manufacturer's Declaration

Electromagnetic Emissions Guidance

Provides guidance on electromagnetic environments and emissions compliance.

EMC Immunity Guidance

Details electromagnetic immunity test levels and environmental guidance.

RF Communications Separation Distances

Recommended Separation Distances

Specifies minimum distances for RF equipment to prevent interference.

Appendix E: Warranty and Repair

Product Warranty

Outlines the warranty terms and conditions for the TympStar Pro.

Repair and Servicing

Advises on authorized repair procedures and yearly calibration.

Appendix F: Recycling and Disposal

Recycling and Disposal Information

Provides contact information for proper disposal of electronic waste in Europe.

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