GSI TYMPSTAR PRO User Manual Rev B

Title: GSI TympStar Pro ™ Clinical Middle Ear Analyzer User Manual Manufacturer Grason-Stadler 10395 West 70th Street Eden Prairie, MN 55344 USA Copyright © 2022 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.

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.

GSI TympStar Pro User Manual

TABLE OF CONTENTS Table of Contents ... 1 Preface ... 12 Manual Conventions ... 12 Regulatory and Device Symbols ... 13 Warnings and Cautions ... 16 Important Safety Instructions ... 16 Safety Precautions... 16 Fluids ... 17 Damage ... 17 Electrical Warnings... 17 Line Voltage Brownout and Interruptions ... 18 Connections ... 18 Connecting Additional Equipment ... 18 Battery Safety... 19 Explosion ... 19 ENVIRONMENTAL FACTORS ... 19 ELECTROMAGNETIC COMPATIBILITY (EMC) CONSIDERATIONS ... 19 Introduction ... 20 Indications for Use ... 20 Intended Use ... 20 Contraindications ... 20 Essential Performance ... 20 Description and Operating Principles... 21 Installation... 23 Unpacking the system... 23 Standard Components... 24 Optional Accessories ... 24 System Assembly... 25 Base Unit Rear Panel... 25 D-0129427 Rev. B

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Connections ... 25 Right Side Panel ... 28 USB Ports... 28 USB A/B Cable ... 29 Left Side Panel ... 29 Monitor ... 30 Operating the TympStar Pro... 31 Preliminary Checks... 31 Prepare to Test ... 31 Helpful hints ... 31 Data Collection ... 32 Instructing the Patient ... 32 Positioning the Probe Box ... 33 Probe Insertion ... 33 Front Panel Controls... 34 Power ... 34 Examiner ... 34 Patient ... 34 Data Erase ... 35 Test Type Buttons... 35 Screener ... 35 Tymp... 35 Reflex ... 35 ETF ... 35 More ... 35 Tympanometry Controls ... 36 Manual ... 36 Hold ... 36 Stop ... 36 Start ... 36 Pressure Control ... 36 D-0129427 Rev. B

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Reflex Stimulus Controls... 37 Stimulus ... 37 Level ... 37 Present ... 37 Print ... 37 Instrument Operation While Printing ... 37 Print Messages ... 37 Printout ... 38 Data Transfer ... 38 Configure ... 39 Print Settings Menu ... 40 Test Type Displays ... 41 Title Bar ... 41 Test Type Information... 42 Test Tabs ... 42 Test Menu ... 42 Time and Date ... 42 Common Icons ... 43 Settings Icon ... 43 Comments Icon... 43 Screener Tests ... 44 Probe Status Indicator ... 45 Admittance and Pressure Meters ... 45 Tympanometry Test Results ... 45 Set Type... 46 Reflex Parameter Buttons ... 46 Reflex Result... 47 Screener Test Menu ... 47 Zoom ... 48 Settings... 49 Comments ... 49

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Tympanometry ... 50 Probe Status Indicator ... 51 Admittance and Pressure Meters ... 51 Manual ... 51 Tympanometry Test Results ... 52 Set Type... 52 Tympanometry Test Menu ... 53 Reflex Test... 58 Probe Status Indicator ... 59 Admittance and Pressure Meters ... 59 Reflex Stimulus Information ... 60 Reflex Test Menu ... 60 Auto Zero ... 60 Probe ... 60 Stimulus Ear ... 60 Threshold Seek ... 60 NR Store ... 61 Store ... 61 Zoom ... 61 Settings... 62 Threshold Seek ... 62 Non-Threshold Seek ... 63 Timing... 64 Stimulus... 64 Scaling ... 64 Immittance ... 65 Comments ... 65 Reflex Decay ... 66 Probe Status Indicator ... 67 Admittance and Pressure Meters ... 67 Reflex Stimulus Information ... 67

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Stored Reflex Decay Information ... 68 Reflex Decay Test Menu... 68 Auto Zero ... 68 Probe ... 68 Stimulus Ear ... 68 Zoom ... 69 Store ... 69 Settings... 69 Level ... 70 Timing... 70 Scaling ... 70 Immittance Component ... 70 Comments ... 70 Acoustic Reflex Latency Test (ARLT) [Licensed Option] ... 71 Probe Status Indicator ... 72 Admittance and Pressure Meters ... 72 Reflex Stimulus Information ... 72 Stored Reflex Latency Information ... 73 Reflex Latency Test Menu ... 73 Auto Zero ... 73 Probe ... 73 Stimulus Ear ... 73 Store ... 73 Zoom ... 74 Settings... 75 Level ... 75 Measurement... 75 Timing... 76 Averages... 76 Scaling ... 76 Immittance ... 76 Comments ... 77 D-0129427 Rev. B

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Eustachian Tube Function (ETF) - Intact ... 78 Probe Status Indicator ... 78 Admittance and Pressure Meters ... 79 Instructions box ... 79 ETF Intact Test Results ... 79 ETF Intact Test Menu ... 80 Continue ... 80 Probe ... 80 Immittance ... 80 Baseline ... 80 Sweep Rate ... 80 Mark Test ... 80 Zoom ... 81 Settings... 81 Test Options ... 82 Display Options ... 83 Comments ... 83 Eustachian Tube Function (ETF) - Perforated ... 84 Probe Status Indicator ... 85 Pressure Meter ... 85 Notifications box ... 85 ETF Perforated Test Results ... 86 Max Pressure... 86 Time ... 86 Mark Test ... 86 Comments ... 86 Patulous Eustachian Tube Test (ETF) ... 87 Probe Status Indicator ... 88 Admittance and Pressure Meters ... 88 Test Condition ... 88 Patulous ETF Test Results... 88

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Patulous ETF Test Menu... 89 Auto Zero ... 89 Probe ... 89 Store ... 89 Zoom ... 89 Settings... 90 Scaling ... 91 Immittance ... 91 Comments ... 91 Multiple Frequency Tympanometry Test (Multi Hz) [Licensed Option] ... 92 Probe Status Indicator ... 93 Admittance and Pressure Meters ... 93 Multi-Hz Test Results ... 94 Multi-Hz Test Menu ... 96 Auto Start ... 96 Immittance ... 97 Baseline ... 97 Sweep Rate ... 97 Age ... 97 Zoom - Tymp ... 97 Zoom-Delta Peak-Start ... 98 Settings... 99 Test Options ... 100 Display Options ... 100 Comments ... 101 Wideband Tympanometry Test (WBT) [Licensed Option] ... 102 WideBand Tympanometry Test Menu ... 103 Probe Status Indicator ... 107 Admittance and Pressure Meters ... 107 WideBand Test Results ... 107 Typical Evaluations ... 115

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Test Type Buttons... 115 Tympanometry ... 115 Acoustic Reflex... 116 Application Software & Integration ... 118 TympStar Pro Config App ... 118 Installing the Configuration Software ... 118 Customizing the Configuration ... 118 Menu ... 118 Instrument ... 119 Diagnostic Protocols ... 120 Screener Protocols ... 121 Auto Sequence Protocols ... 121 GSI Instrument Service ... 121 Description ... 121 Operation ... 121 Public Interface (Direct) ... 121 Data Port (Direct) ... 122 GSI Suite ... 122 OtoAccess™... 122 Noah 4 ... 122 AudBase ... 122 Routine Maintenance ... 123 Pretest Tympanometry Checks ... 123 Test Cavity ... 123 Calibration Quick Check for Probe... 123 226 Hz ... 123 678 Hz and 1000 Hz... 124 Biological Calibration Check ... 125 Preventive Maintenance ... 125 Cleaning the System... 125 LCD Touch Screen... 125 D-0129427 Rev. B

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Cleaning and Disinfecting Agents ... 126 LCD Touch Screen... 127 Cleaning patient contact devices ... 127 Probe care ... 127 Use of the cleaning tool ... 129 Error Messages ... 131 Error - Invalid Start Direction ... 131 Error – No Data to Print ... 131 XXX is not available... 131 Printer communication error ... 131 Calibration Error ... 131 WideBand Calibration Error ... 131 Altitude Change Error ... 131 Error ... 132 Appendix A: System Defaults... 133 Instrument Settings... 133 Screener Settings ... 134 Tympanometry Settings... 135 Reflex Settings ... 136 ETF Settings ... 137 Multi-Hz Settings ... 138 WideBand Settings ... 139 Auto Sequence Settings ... 140 Factory [System] ... 140 Auto Sequence 1: T+RT-I/C+RD-C [I/C+RD] ... 140 Appendix B – Technical Data ... 141 Measuring System ... 143 Probe Signals ... 143 Probe Signal Level ... 143 Measurement Range... 144 Accuracy of Measurement ... 144 D-0129427 Rev. B

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Temporal Characteristics ... 144 Pneumatic System ... 144 Acoustic Reflex Activating Stimulus System ... 145 Pure Tone Stimulus Signals ... 145 Pure Tone Harmonic Distortion ... 146 Broad Band Noise Stimulus Signals ... 146 Noise Bandwidths ... 146 Click Stimulus Signals ... 147 Stimulus Interval and Minimum Range... 147 Stimulus Level Control Accuracy ... 147 Multi-Frequency, WideBand Tympanometry WideBand Click Signal ... 147 Stimulus Presentation Control On-Off and Signal-to-Noise Ratios ... 147 Pulsed Stimulus Signal... 147 External Stimulus Signals ... 148 External Stimulus Signals Calibration ... 148 Appendix C – Specification of Input/output Connections ... 149 Mains Cable ... 149 USB Computer Connection ... 149 LAN Connection ... 149 USB Connectors... 150 Patient Response Input... 150 Headphones (2 connectors, R, L) ... 150 DC output (only for use with the 4” Sanibel printer) ... 150 External Monitor Output ... 151 External Input ... 152 Probe box... 152 Appendix D - Safety, EMC, and Associated Standards... 153 Cautions regarding EMC ... 153 Electromagnetic Compatibility ... 154 Guidance and Manufacturer’s Declaration Electromagnetic Emissions ... 155

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Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the TympStar Pro ... 156 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity ... 157 Appendix E - Warranty and Repair ... 160 Warranty ... 160 Repair ... 161 Appendix F – Recycling and Disposal ... 162

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GSI TympStar Pro User Manual

PREFACE This user manual provides information about the GSI TympStar Pro. This manual is intended for technically qualified personnel. This manual contains information pertinent to the use of the TympStar Pro system including safety information as well as maintenance and cleaning recommendations. Proper use of this device depends on careful reading of all instructions and labeling. Also be sure to follow all safety standards set by your facility. Please note: This Instructions for Use is not intended as a training manual. The reader should consult standard audiology texts for the theory and application of the tests provided by this instrument.

READ THIS ENTIRE MANUAL BEFORE ATTEMPTING TO USE THIS SYSTEM!

MANUAL CONVENTIONS Throughout this manual, the following meaning of warnings, cautions and notices are used.

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

NOTE: Notes help you identify areas of possible confusion and avoid potential problems during system operation.

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GSI TympStar Pro User Manual

REGULATORY AND DEVICE SYMBOLS

Symbol

Description Conforms to European Medical Device Directive 93/42/EEC. Indicates that the device is a Medical Device

Symbol for "SERIAL NUMBER."

GSI Part Number. Return to Authorized Representative, Special disposal required. 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 IIa device.

China RoHS symbol for product compliance

Symbol for “European Representative.”

Symbol for “Manufacturer.”

Symbol for “Date of Manufacture.”

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Symbol

Description On/Off

Keep Dry

This side up.

Class II medical equipment

Consult the operating instructions/directions for use. A copy of the operating manual is available on this website: www.grasonstadler.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.

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Symbol

Description WARNING: To avoid the risk of electric shock, this equipment must only be connected to supply mains with protective earth

USB

Connection for USB Cable – used for both type A and type B cable connections

LAN Connection – not used or supported Monitor

Patient response switch

DC connection 2.1 mm – only for use with the 4” Sanibel printer MPT-III, 12 VDC, 0.5A Connection for headphones. The red marking around the connector indicates the right and is used for the optional Contra headset. The blue marking indicates the left connector and not supported. On/Off - Next to power switch.

The following symbol appears on the instrument. Definition: Type B applied part – IEC 60601-1 uses the term applied part to refer to the part of the medical device which comes into physical contact with the patient for the device to carry out its intended function. This icon indicates that the GSI TympStar Pro is Type B, Class 1 according to the international standard IEC 60601-1. The applied parts are the probe assembly, probe clip, wrist strap, shoulder strap, contralateral insert earphone or headphone, and the ear tips.

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WARNINGS AND CAUTIONS IMPORTANT SAFETY INSTRUCTIONS The following safety precautions must always be observed. General safety precautions must be followed when operating electrical equipment. Failure to observe these precautions could result in damage to the equipment and injury to the operator or patient. The instrument must only be used by hearing health care professionals qualified to perform tympanometry and auditory tests such as an audiologist, otolaryngologist, researcher, or a technician under direct supervision by the specialist. Users should use their professional skills when interpreting the results and this should be done in conjunction with other testing as deemed appropriate given their professional skills. Incorrect use could lead to wrong results. 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.

SAFETY PRECAUTIONS 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. Make sure all connections to external accessories are snug and secured properly. Parts which may be broken or missing or are visibly worn, distorted, or contaminated should be replaced immediately with clean, genuine replacement parts manufactured by or available from GSI. This instrument is suitable in hospital environments except for near active high frequency (HF) surgical equipment and radio frequency (RF) shielded rooms of systems for magnetic resonance imaging, where the intensity of electromagnetic disturbance is high. In case of emergency, disconnect the instrument from the supply mains by pulling the plug out of the power socket. Before the first use of the instrument each day, or if suspect or inconsistent results are apparent, the checks specified in the Routine Maintenance section should be carried out. If the system is not functioning properly, do not operate it until all necessary repairs are D-0129427 Rev. B

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made and the unit is tested and calibrated for proper functioning in accordance with Grason-Stadler published specifications. No parts of the equipment can be serviced or maintained while in use with the patient. Latex is not used anywhere in the manufacturing process. The base material for the earphone cushions is made from natural and synthetic rubber.

Fluids The device is not intended to be used in environments exposed to fluid spills. No means is specified for fluid protection (not IP classed). Do not use the device in the presence of fluid that can contact 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 an authorized service technician. Do not immerse the unit in any fluids. See the Routine Maintenance Section of this manual for the proper cleaning procedure for the instrument and its accessories and the function of single-use parts.

Damage Do not drop or otherwise impact this instrument. If the instrument is dropped or damaged, return it to the manufacturer for repair and/or calibration. Do not use the instrument if any damage is suspected. Do not attempt to open, modify, or service the instrument. Return the instrument to the manufacturer or distributor for all repair and servicing requirements. Opening the instrument will void the warranty. See Warranty and Repair in the Appendix.

Electrical Warnings The TympStar Pro is designed to be used with a hospital grade outlet. To avoid the risk of electric shock, this equipment must only be connected to supply mains with protective earth. Ensure that the earth connection at the mains electrical power outlet is properly grounded. This device uses a three-wire power cord with a hospital grade plug (for international applications, IEC 60601-1 approved plug). Injury to personnel or damage to equipment can result when a three-prong to two-prong adaptor is connected between the TympStar Pro power plug and an AC outlet or extension cord. For grounding reliability, connect the device to a hospital grade or hospital only receptacle (for non-US applications, IEC 60601-1 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. Periodically check the system ground integrity. Do not use extension cords for the instrument or isolation transformer. Extension cords can cause ground integrity and impedance problems. In addition to electrical safety considerations, poorly earthed mains power outlets could cause inaccurate test results due D-0129427 Rev. B

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to the introduction of electrical interference from the mains. Only use power cords with insulation rated for the voltages and currents being carried and provided/approved by GSI. The third conductor in the power supply cord is only a functional earth. The power supply in the device provides protection against short-circuit, overload and over voltage. The device will not operate outside the specified voltage rating.

Line Voltage Brownout and Interruptions There are four (4) UV detectors in the digital domain, two (2) over current detectors in the analog domain, one for USB and four (4) OV/UV detectors on the main supply lines. If just ONE fails, all output to the transducers will be muted.

Connections Make sure all connections to external accessories are snug and secured properly. Parts which may be broken or missing or are visibly worn, distorted, or contaminated should be replaced immediately with clean, genuine replacement parts manufactured by or available from GSI. Do not switch on any system power until all cables have been properly connected and verified. See this manual, which accompanies all deliveries of the system, for setup instructions. Switch off the system power before connecting or disconnecting any system component(s) or accessories.

Connecting Additional Equipment This equipment is intended to be connected to other equipment thus forming a Medical Electrical System. External equipment intended for connection to signal input, signal output or other connectors shall comply with the relevant product standard e.g., IEC 60950-1 for IT equipment and the IEC 60601-series for medical electrical equipment. In addition, all such combinations – Medical Electrical Systems – shall comply with the safety requirements stated in the general standard IEC 60601-1, edition 3, clause 16. Any equipment not complying with the leakage current requirements in IEC 60601-1 shall be kept outside the patient environment i.e., at least 1.5 m from the patient support or shall be supplied via a separation transformer to reduce the leakage currents. Any person who connects external equipment to signal input, signal output or other connectors has formed a Medical Electrical System and is therefore responsible for the system to comply with the requirements. If in doubt, contact a qualified medical technician or your local representative. If the instrument is connected to a PC (IT equipment forming a system) ensure not to touch the patient while operating the PC. If the instrument is connected to a PC (IT equipment forming a system) assembly and modifications shall be evaluated by qualified medical technician according to safety regulations in IEC 60601.

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