GSI Tympstar User Manual Ver 1 Rev C

Title:

GSI TympStar Version 1 Middle-Ear Analyzer Reference Instruction Manual

Copyright © 2011 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 0344 mark identifies compliance with the medical Device Directive 93/42/EEC. Grason-Stadler is an ISO 13485 certified corporation. European Authority Representative

Grason-Stadler Kongebakken 9 2765 Smørum Denmark

0344 Electromagnetic Compatibility

Preface This manual contains the information necessary to install and operate the GSI TympStar Version 1 Middle-Ear Analyzer. This information is essential for the efficient use of the middle-ear analyzer, and must be read and understood to avoid test errors.

GSI TympStar Version 1 Reference Instruction Manual

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Preface

Conventions used in this manual Icons

This manual uses the following icon conventions to draw special attention to information: NOTES Note icons indicate important related information, reminders, recommendations, and suggestions. Notes are shown in bold type. CAUTIONS Caution icons indicate information regarding a situation or condition that could result in equipment malfunction or damage, or in lost data. Cautions are shown in bold type. WARNINGS Warning icons indicate information regarding a situation or condition that could result in personal injury or death. Do not proceed until having thoroughly read and understood the warning information. Warnings are shown in bold type.

Operating controls

Equipment Symbols

References to user controls on the instrument’s front panel or LCD panel are shown as UPPER CASE in operating procedures and other instructions.

Attention, consult accompanying documents

Serial Number

Reference Symbol

Manufacturer

Manufacture Date

Warning Dangerous Voltage

B Patient Applied Part according to IEC60601-1

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Equipment Symbols Continued

Fuse

EU Authorized Representative

Return to Authorized Representative

Keep Dry

Fragile

Consult Operating Instructions

This Side Up

Monitor

Disk Drive

Patient Response Switch

Keyboard

Input

Output

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Preface

Safety Considerations General safety precautions must be followed when operating electical equipment. Failure to observe these precautions could result in damage to the equipment and injury to the operator or patient.

Warning! 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 60601-11. 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 IEC 60601-1-1. If in doubt, consult the technical service department or your local representative.

The employer should instruct each employee in the recognition and avoidance of unsafe conditions and the regulations applicable to his or her work environment to control or eliminate any hazards or other exposure to illness or injury. It is understood that safety rules within individual organizations vary. If a conflict exists between the material contained in this manual and the rules of the organization using this instrument, the more stringent rules should take precedence.

WARNING The GSI TympStar Middle-Ear Analyzer is designed to be used with a hospital grade outlet. Injury to personnel or damage to equipment can result when a three-prong or two-prong adapter is connected between the GSI TympStar power plug and an AC outlet or extension cord. WARNING The use of ACCESSORY equipment not complying with the equivalent safety requirements of this equipment may lead to a reduced level of safety of the resulting system. Consideration relating to the choice shall include: • Use of the ACCESSORY in the PATIENT VICINITY • Evidence that the safety certification of the ACCESSORY has been performed in accordance with the appropriate IEC 601-1 and/or IEC 601-1-1 harmonized national standard. ANY EQUIPMENT CONNECTED TO THE GSI TYMPSTAR AND USED IN THE PATIENT VICINITY MUST BE POWERED BYAN ISOLATED POWER SOURCE TO MAINTAIN THE ELECTRICAL SAFETY OF THE OVERALL SYSTEM. The isolated power source can be purchased directly from GSI, or elsewhere when approved for use by GSI.

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Preface

WARNING - ELECTRIC SHOCK HAZARDS Do not open the case of the TympStar. Refer servicing to qualified personnel. Do not remove any TympStar covers. Refer servicing to qualified personnel. WARNINGS - ELECTRICAL GROUNDING This device uses a three wire power cord with a hospital grade plug (for international applications, IEC 601-1 approved plug). The chassis is earth grounded. For grounding reliability, connect the device to a hospital grade or hospital only receptacle (for international applications, IEC 601-1 approved receptacle). Inspect the power cord often for fraying or other damage. Do not operate the apparatus with a damaged power cord or plug. Improper grounding is a safety hazard. Do not use extension cords for the TympStar. Extension cords can cause ground integrity and impedance problems. Periodically check the system ground integrity. WARNING - EXPLOSION This system is not explosion proof. Do not use in the presence of flammable anesthetics or other gasses.

WARNINGS - CONNECTIONS Do not switch on any system power until all cables have been properly connected and verified. See this manual for setup instructions, which accompanies all deliveries of the system. Switch off the system power before connecting or disconnecting any system component(s) or accessories. This may damage the device(s). WARNINGS - GENERAL Proper use of this device depends on careful reading of all instructions and labels. Follow all safety standards set by each place of employment. Prolonged use of auditory stimuli can cause damage to patient hearing.

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CAUTIONS - ELECTRICAL POWER Electrical Shock Hazard. Do not remove covers. Refer servicing to qualified personnel only. Make sure the power cord plug is proper for the power outlet into which it will be plugged. I.e., plug in a 120V rated power cord into a 120V outlet only. TympStar test results data is not stored when the power is turned off. To maintain test results data in the presence of power brown-outs or temporary power interruptions, an Uninterruptable Power Supply (UPS) must be used. CAUTION - CONNECTIONS Please be careful to reconnect cables in their proper locations.

CAUTIONS - PREVENTIVE MAINTENANCE Preventative maintenance does not require access to the interior of the instrument and may be performed by the user. For this device, preventative maintenance consists of periodically cleaning and inspecting the exterior of the instrument. Periodic electrical safety testing is recommended. It is recommended a schedule be established for these purposes, with at least an annual cleaning, calibration and safety testing. Cleaning consists of removing all dust from the exterior surface of the system with a soft brush or cloth. Use a brush to dislodge any dirt on or around the connectors and panel edges. Remove any dirt with a soft cloth. CAUTIONS - GENERAL If the system is not functioning properly, do not operate it until all necessary repairs are made and the unit is tested and calibrated for proper functioning in accordance with Grason-Stadler published specifications. Equipment is not user repairable. Repairs and battery replacement must be performed by a qualified service representative only. Prolonged use of auditory stimuli can cause damage to patient hearing.

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Preface

Product Warranty We, Grason-Stadler, warrant that this product is free from defects in material and workmanship and, when properly used, will perform in accordance with applicable specifications. If within one year after original shipment, it is found not to meet this standard, it will be repaired, or at our option, replaced at no charge except for transportation costs, when returned to an authorized GrasonStadler facility. Changes in the product not approved by Grason-Stadler shall void this warranty. Grason-Stadler shall not be liable for any indirect, special or consequential damages, even if notice has been given of the possibility of such damages. THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.

Recycling / disposal

CAUTION

Many local laws and regulations require special procedures to recycle or dispose of electric equipment-related waste including batteries, printed circuit boards, electronic components, wiring and other elements of electronic devices. Follow all of your respective local laws and regulations for the disposal of batteries and any other parts of this system.

Check the Grason-Stadler website for recommended instructions and addresses for proper return or disposal of electronic wastes relating to Grason-Stadler products in Europe and other localities. The contact information for the WEEE – In Europe Grason-Stadler A/S Kongebakken 9 2765 Smørum Denmark CRV no. 21113379

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Contents Preface

Title………………………………………………………………………..……..i Conventions used in this manual…………………………………………….….ii Icons………………………………………………………………………..…...ii Equipment Symbols………………………………………………………….….ii Safety Considerations…………………………………………………………..iv Product Warranty……………………………………………………….…..…..v Recycling/Product Disposal………………………………………………...vii

Introduction General ... 1-1 Equipment connections and options... 1-2 The probe ... 1-2 Instrument controls ... 1-3 Hardkeys and softkeys ... 1-3 Rotary pressure control ... 1-3 Test modes and menu navigation ... 1-3 Changing parameter settings ... 1-5 Menu diagrams ... 1-5 GSI default parameter settings ... 1-5

Installation Unpacking and inspecting the GSI TympStar Version 1... 2-1 TympStar Accessories Supplied ... 2-2 Equipment connections ... 2-4 Rear panel ... 2-4 Probe ... 2-5 Power ... 2-5 Preparing the probe assembly ... 2-6 Powering the instrument ... 2-7 Prior to applying power ... 2-7 Applying power ... 2-7 Preparing the printer ... 2-8 Paper supply... 2-8 Adjusting the display contrast ... 2-12 Front panel controls ... 2-13 Hardkeys ... 2-13 Softkeys ... 2-15 Menu diagrams ... 2-15 GSI default parameter settings ... 2-15 GSI TympStar Version 1 Reference Instruction Manual

Contents - 1

Contents

Pre-Operation Cleaning probe tubes ... 3-1 Caring for eartips ... 3-2 Preparing test materials ... 3-3 Calibration checks... 3-3 Test cavity calibration ... 3-3 Altitude/Barometric pressure calibration ... 3-4 Equivalent compliance values ... 3-4 Tracing/Meter Calibration check for Tympanometry ... 3-5 Pressure range check for tympanometry ... 3-9 Manual pressure check for tympanometry ... 3-9 Screening reflex check - tymp screening ... 3-10 Reflex threshold mode check ... 3-11 Intensity limits check for reflex threshold ... 3-14 Instructing the patient... 3-15 General ... 3-15 Positioning the probe box ... 3-15 Suggested probe insertion technique ... 3-15

Operation Overview of functions... 4-1 Test and other functions ... 4-1 Default parameters ... 4-2 Program modes ... 4-3 Probe tone frequencies ... 4-3 LCD graphic traces ... 4-3 Probe lights... 4-3 LCD screen... 4-3 Erasing and clearing test data ... 4-4 Paging test data... 4-5 Printing tests ... 4-5 Error codes and problem reporting ... 4-5 Test procedures ... 4-6 Tympanometry (Tymp Mode)... 4-6 Two component tympanometry ... 4-7 Gradient ... 4-7 Tymp width method ... 4-7 Ratio method ... 4-8 Selecting the gradient method ... 4-8 Tymp diagnostic softkey menu structure ... 4-9 Automatic tympanometry test procedure ... 4-9 Sweep direction... 4-10 Tymp test: Y at 226Hz ... 4-11 Baseline ON ... 4-11 Baseline OFF ... 4-11 Stopping the test ... 4-11

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Contents

Manual tympanometry test procedure ... 4-12 Tympanometry printout samples ... 4-13 Tympanometry normative values Ytm, 226 Hz ... 4-13 Tymp screening with Reflex (Tymp mode) ... 4-14 Tymp screening softkey menu structure ... 4-14 AUTO START ON ... 4-15 AUTO START OFF... 4-15 BASELINE ON ... 4-15 BASELINE OFF ... 4-16 REFLEX OFF ... 4-16 REFLEX ON ... 4-16 Screening reflex test scoring ... 4-16 Tymp screening sample printout... 4-17 Program mode for tympanometry ... 4-18 Program mode softkey menu structure ... 4-18 Screen and diagnostic softkeys ... 4-18 User softkeys ... 4-18 Program Mode ... 4-18 Programming default parameters for SCREEN and DIAGNOSTIC modes …………………………………………………………………... 4-19 Programming default parameters for user tests ... 4-20 Acoustic Reflex testing ... 4-21 Non-acoustic Reflex testing ... 4-22 Reflex Threshold softkey menu structure ... 4-22 Reflex Threshold automatic test procedure ... 4-23 Stimulus Timing ... 4-23 Auto timing of stimuli ... 4-24 Minimum and maximum timing allowable for reflex threshold ... 4-24 Manual timing of stimuli... 4-24 Auto Zero ... 4-26 Mark Threshold ... 4-26 Threshold Seek ... 4-27 Manual threshold testing ... 4-28 Reflex threshold sample printouts ... 4-30 Reflex Threshold MANUAL test procedure... 4-31 Reflex threshold summary ... 4-32 Program mode for Reflex Threshold ... 4-33 Softkey menu structure ... 4-33 Program mode ... 4-33 Reflex Decay testing... 4-35 Softkey menu structure ... 4-35 Minimum and maximum timing levels allowable in Reflex Decay... 4-36 Reflex Decay sample printout... 4-38 Program mode for Reflex Decay ... 4-39 Eustachian Tube Function Testing for Intact Eardrums ... 4-41 Pressure-swallow test ... 4-41 Softkey menu structure ... 4-42 GSI TympStar Version 1 Reference Instruction Manual

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Contents

ETF-Intact automatic test procedure ... 4-43 ETF-Intact sample printout ... 4-45 ETF-Intact normative data ... 4-45 Eustachian Tube function testing for perforated eardrums ... 4-46 Softkey menu structure ... 4-46 ETF-Perforated TM automatic test procedure ... 4-47 Minimum and maximum levels allowable ... 4-48 ETF-Perforated TM sample printout ... 4-49 ETF-Perforated TM manual test procedure ... 4-50 ETF-Perforated TM normative data ... 4-50 Program mode for ETF... 4-51 Softkey menu structure ... 4-51 Program mode ... 4-51 Altitude Calibration Mode ... 4-53 Calibration procedure ... 4-53 Auto Sequence testing ... 4-55 Auto Sequence test procedure ... 4-55 Auto Sequence program mode... 4-57 Instrument options ... 4-58 Softkey menu structure... 4-58 Print format ... 4-58 Data Transfer Settings ... 4-61 Language... 4-61 Test Sequence... 4-61 Remote Settings ... 4-62 GSI Suite …... 4-62 Date and Time ... 4-62 Facility Name ... 4-63

Index Appendix A Specifications………………………………………………………………………….A-1

Appendix B Bibliography…………………………………….……………………………………..B-1

Appendix C Basic Problem Solving………………………………………………………………...C-1

Appendix D Remote Specifications…………………………………………………………………D-1

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Introduction General

1

The GSI TympStar Version 1 Middle-Ear Analyzer is a technically advanced, computer-based admittance instrument designed to be used in a clinical or research setting. The TympStar builds on the sophistication, functionality and flexibility of the GSI 33, offering unparalleled testing capabilities. It contains total capabilities for complete, manual or automatic diagnostic testing for analysis of middle ear function. Admittance (Y) may be measured with a probe tone frequency of 226 Hz. The extensive battery of test mode choices include: • Diagnostic Tympanometry • Acoustic Reflex Threshold and Decay Measurements • Eustachian-Tube Function Testing (Both intact and perforated eardrums) • Screening Tympanometry/Reflex (Automatic Only) Operators have a choice of using GSI preprogrammed test parameters, or programming their own test criteria. Alarge liquid crystal display (LCD) clearly displays test parameter choices and the possible alternatives. Admittance and pressure indications are shown on the LCD along with a continuous digital readout. Test status and invalid choices are also shown on the LCD. The tympanometric measurement results are automatically scaled and presented in equivalent ml of compliance at “Y,” 226 Hz. Sensitivity scales for the display of reflex measurement results can be selected manually. A cursor is available in all test modes for calling out numeric positions on the X and Y axes.

Test results are displayed in real-time. The user can view the results as they are being measured and then has the choice of printing the display or retesting the patient. The high-speed printer generates reports in concise graphic formats that are easy to read.

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Chapter 1

Equipment connections and options

TympStar Version 1 options that can be connected to the rear panel include RS232 serial communication, a keyboard for entering patient information, an HP DeskJet® or LaserJet® printer and a VGA monitor for displaying test results. Other options offered for the TympStar Version 1 for managing and archiving data, include: • Internal memory for storing up to 26 test results • Data export to an external PC via RS232 serial interface • Remote control of the TympStar via RS232 commands from an external PC.

Functional in TympStar Version 2 only

The probe

The innovative lightweight probe is designed for patient comfort, ease-of-seal, and accurate test results. A wide variety of both standard and special sized eartips are supplied with the GSI TympStar to hermetically seal the ear canal. In addition, a set of screening eartips is provided for screening tymp and reflex tests. The operator has a choice of three mountings to support the probe box; the standard lightweight shoulder mounting, standard clothes clip, or an optional operator wrist attachment. The probe box has 2 LED’s to indicate test status. Within the probe box there are two small loudspeakers, a microphone and a pressure transducer. One loudspeaker delivers the probe tone to the ear canal, while the microphone monitors the intensity of the probe tone within the ear canal. The second loudspeaker delivers the ipsilateral (ipsi) stimuli to the ear canal. The contralateral (contra) insert phone contains its own loudspeaker. The pressure within the ear canal can be varied up to a range of +400 daPa to -600 daPa. At no time is it possible to exceed specified maximum limits. Pressure can be varied automatically or manually and from negative to positive or from positive to negative values. Pressure within the ear canal is monitored continuously in order to maintain pressure accuracy throughout each test sequence.

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Introduction

Instrument controls

A combination of hardkeys and softkeys are used to select the test modes and parameters and to conduct tests.

Hardkeys and softkeys

Hardkeys are located on the front panel and the sides of the LCD panel and provide fixed functions that do not change. Softkeys are located directly under the LCD and change to support the requirements of a test session.

LCD panel

Softkey

Hardkeys

Front panel

Pressure control

Rotary pressure control

A rotary pressure control is also provided to change or fine-tune pressure within the ear canal.

Test modes and menu navigation

Selecting a test mode by pressing a hardkey causes the required test screen to be displayed on the LCD with the appropriate menu of test parameters shown across the bottom. The softkeys are then used in conjunction with a few hardkeys to navigate through the menus and set parameter values for the selected tests. For example, pressing the TYMP hardkey causes the Tymp Diagnostic screen to be displayed.

Tymp hardkey

Tymp Diagnostic screen

Tymp parameter menu

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Chapter 1

Pressing the softkeys displayed across the bottom of the LCD allows the user to navigate through the Tymp Diagnostic parameter menus diagrammed below. GSI default softkey selections are circled on menu diagrams. The first level of parameter menu selections includes AUTO SEQUENCE, P-RANGE, START, GRADIENT, EAR and MORE.

First level

AUTO SEQUENCE

START daPa

P-RANGE daPa

NORMAL

WIDE

-600 -400 -200 +200 +400 MORE

-500

-300

0

EAR

GRADIENT

TYMP WIDTH daPa

RATIO ml

OFF

RIGHT

MORE

LEFT

+300 MORE

Second level

P-RATE daPa/s

12.5

50

200

BASELINE

600/200

MORE

ON OFF

Default selection

First level

A second level of menus can be displayed by pressing the MORE softkey and includes P-RATE, BASELINE and MORE.

Second level

The MORE softkey is used to toggle between the top and lower levels of menus while the test screen portion above the softkeys remains unchanged.

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Introduction

Pressing a parameter menu softkey causes a sub-menu of parameter settings to be displayed. Often submenus will contain MORE softkey selections that provide access to additional setting alternatives.

START daPa

Sub-menu of START daPa

-600 -400 -200 +200 +400 MORE

-500

-300

0

+300 MORE

Sub-menu of START daPa

Changing parameter settings

Settings can be changed for a selected parameter by pressing the desired softkey as shown in this example of changing the Probe Hz from 226 to 1000.

Making the new selection returns the display to the previous menu level with the new setting shown above the selected parameter. If no change is desired, the display can be returned to the previous level by pressing the RETURN hardkey. In the manner described above, menus can be navigated and settings can be changed for any of the test modes. Menu diagrams

Menu structure diagrams like the diagrams shown on these pages will be used throughout the remainder of this manual as a convenience to the user.

GSI default parameter settings

GSI default parameters are circled on menu structure diagrams shown throughout the remainder of this manual.

START daPa

-600 -400 -200 +200 +400 MORE

GSI default value

GSI TympStar Version 1 Reference Instruction Manual

-500

-300

0

+300 MORE

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Chapter 1

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Installation This chapter contains the following information: • Unpacking and inspecting the GSI TympStar and accessories • Equipment connections • Preparing the probe assembly • Powering the instrument • Preparing the internal printer • Preparing an external printer • Adjusting display contrast • Front panel controls

2 page 2-1 page 2-4 page 2-6 page 2-7 page 2-8 page 2-9 page 2-12 page 2-13

Unpacking and inspecting the GSI TympStar This GSI TympStar was carefully tested, inspected, and packed for shipping. It is a good practice after receiving the instrument to examine the outside of the container for any signs of damage. Notify the carrier if any damage is noted. Carefully remove the GSI TympStar and TympStar accessories from the shipping container. If the instrument or accessories appears to have suffered damage, notify the carrier immediately so that a proper claim can be made. Be certain to save all packing material so that the claim adjuster can inspect it as well. As soon as the carrier has completed the inspection, notify a GSI Representative. If the instrument or an accessory must be returned to the factory, repack it carefully (in the original container if possible) and return it prepaid to the factory for the necessary adjustments.

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