GSI 39 User Manual Rev E

Preface

Title:

GSI 39 AUTO TYMP User Manual

Copyright © 2011 Grason-Stadler Inc. 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 Inc. The information in this publication is proprietary to Grason-Stadler. Compliance The CE0344 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

1739-0100 Rev. E

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GSI 39

Supplied Accessories 1739-9710 GSI 39 Probe (226 Hz version)

1739-3200

Contralateral Insert Phone (Versions 2 and 3 only)

8000-0079

DD45 Headset (Versions 3 and 4 only)

8000-0181

Test Cavity (226 Hz)

1700-1030

Power Supply

113-405800

Eartips, (Probe) 6 sizes, 2 each (all versions)

1700-9622

Eartips, (Contra Insert Phone) color coded, 8 sizes, 4 each (Versions 2 & 3 only)

1700-9660

Paper 3 rolls, thermal 4" wide (all versions). Shipped with system. 1738-9601

Note: To reorder a single roll of paper, use the following part number: Instruction Manual (all versions)

1739-0100

GSI 39 Quick Reference Guide

1739-0160

1739-9711 GSI 39 Combo Probe (226 Hz / 1 KHz version)

1739-3250

Contralateral Insert Phone (Versions 2 and 3 only)

8000-0079

DD45 Headset (Versions 3 and 4 only)

8000-0181

Test Cavity (226 Hz)

1700-1030

Power Supply

113-405800

Eartips, (Probe) 6 sizes, 2 each (all versions)

1700-9622

Eartips, (Contra Insert Phone) color coded, 8 sizes, 4 each (Versions 2 & 3 only)

1700-9660

Paper 3 rolls, thermal 4" (10.16 cm) wide (all versions). Shipped with system. Note: To reorder a single roll of paper, use the following part number:

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1738-9601

Instruction Manual (all versions)

1739-0100

GSI 39 Quick Reference Guide

1739-0160

Probe Cleaning Kit

2000-9610

Probe Mount - Shoulder

1700-9646

Probe Mount - Wrist

1700-9642

Probe Mount - Clothes

1700-9608

1739-0100 Rev. E

Preface

Safety Summary In this manual, 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.

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CAUTION

The CAUTION label 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

1739-0100 Rev. E

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GSI 39

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, use of hospital grade plug and receptacles are required. For patient and operator safety, the GSI 39 must be used with properly grounded plug and receptacles at all times. The GSI 39 is equipped with a specific power transformer (ref: 113-405800), 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 any where 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.

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1739-0100 Rev. E

Preface

!

WARNING

This symbol 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.

1739-0100 Rev. E

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GSI 39

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. Periodically, have a service technician perform electrical safety checks on the unit in order to show continued compliance to IEC and UL 60601-1.

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1739-0100 Rev. E

Preface

Safety Precautions The following safety precautions must be observed at all times. 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 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. This device should only be used by hearing health care professionals such as an audiologist, otolaryngologist, researcher or a technician under the direct supervision by the fore mentioned specialist. User 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. The maximum sound levels that can be generated by the system can cause serious injury to the ear. Before attaching the earphones to the patient, ensure that: a. The system is running. b. The hearing levels in the test set to be used are appropriate. c. A biologic check of the stimulus has been performed by the operator. The customer is responsible for maintaining all system software in a safe, secure location. Do not use extension cords with this instrument or for the Isolation Box. 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 to the introduction of electrical interference from the mains. ANY EQUIPMENT CONNECTED TO THE GSI INSTRUMENT AND USED IN THE PATIENT VICINITY MUST BE POWERED BY AN 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.

Cautions - General

If the system is not functioning properly, do not operate it until all necessary repairs are made and the unit is test 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.

1739-0100 Rev. E

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GSI 39

Warning - Connecting Additional Equipment Accessory equipment connected to the analog and digital interfaces must be certified to the respective IEC standards (IEC 950 f or data processing or IEC 60601-1 for medical equipment and/or appropriate European Directives). 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 for the system compliance with the requirements of the system standard IEC 60601-1-1. If in doubt, consult the technical service department or your local representative. Connect all nonmedical equipment to the GSI Isolated Power Supply. The AC power outlets on the isolation transformer/power box a re intended for use with GSI approved components only. Use of any other equipment may result in damage to the power unit. Follow all safety standards set by each place of employment. NOTE: If the instrument is connect to a PC, power to the monitor and computer must be controlled by the isolation transformer. Always leave the monitor and computer power switches in the ON position and control power from the isolation transformer. Always turn OFF system power before connecting or disconnecting system components to help guard against personal injury.

Warning - Electric Shock Hazards

Do not open the case of the GSI instrument. Do not remove any GSI instrument covers. Refer servicing to qualified personnel.

Warning - Electric 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. 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 gases.

Warning - 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).

Warning - 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.

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1739-0100 Rev. E

Preface

Warranty We, GSI, warrant that this product is free from defects in material and workmanship, and when properly installed and 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 a t our op tion, replaced at no c harge except for transportation costs, when returned to an authorized GSI product service facility. If field service is requested, there will be no charge for labor or material; however, there will be a charge for travel expense at the service center’s current rate. NOTE: Changes in the product not approved in writing by GSI shall void this warranty. GSI shall not be liable for any indirect, special or consequential damages, even if notice has been given in advance of the possibility of such damages. THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY OF FITNESS FOR A PARTICULAR PURPOSE.

1739-0100 Rev. E

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GSI 39

Specifications Standards:

UL 60601-1 Medical Electrical Equipment Requirements for Safety IEC/EN 60601-1 General Requirements CSA C22.2 No.601-1-M90 ANSI S3.39-1987 Aural Acoustic Impedance Admittance (Type 3) IEC 60645-5 Aural Acoustic Impedance/ Admittance (Type 3) ANSI S3.6-2004 Audiometers (Type 4) IEC 60645-1 Pure Tone Audiometers (Type 4) 2004 Specifications for Audiometers (Type 4) PTB Certificate No. 15.11-94/53 Pure Tone Audiometers (Type 4) GL2005-00014 (ASHA 2005) Guidelines for Manual Pure-Tone Threshold Audiometry

Protective Classification: This system is intended for continuous operation and has a protective classification of Class 1.

Class 1 Type B

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1739-0100 Rev. E

Preface Tympanometry modes Probe Tone: Sound Pressure Level:

Harmonic Distortion: Admittance (Compliance) Range:

1739-0100 Rev. E

226 Hz, ±2% 1000 Hz ±2% 226 Hz: 85.5 dB SPL, ±2.0 dB, measured in a 2.0 cm3 coupler 1000 Hz: 75 dB SPL, ±2.0 dB, measured in a 2.0 cm3 coupler <3% 226 Hz: 0.0 to 1.5 cm3 or 0.0 to 3.0 cm3 1000 Hz: 0.0 to 5.0 mmho and 0.0 to 10 mmho NOTES: 1. The range is automatically selected based upon the amplitude of the compensated tympanogram. 2. The maximum uncompensated (ECV + tympanogram peak) admittance (compliance) range is 0 to 5.0 cm3. 3. ECV/cavity limits for initiating pressurization is 0.2 to 5.0 cm3. Compliance Accuracy: ±0.1 cm3 or ±5%, whichever is greater.

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GSI 39 Pneumatic System Pressure Range:

Pressure Accuracy: Rate of Sweep:

Direction of Sweep: Tympanogram Test Time:

Gradient:

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+200 to -400 daPa NOTES: 1. daPa = 1.02 mmH20 2. For 226 Hz probe tone, pressure sweeps to at least -100 daPa. To save test time, pressure sweep stops when tympanogram returns to baseline after -100 daPa. 3. For 1000 Hz probe tone, pressure sweep does not stop until -400daPa. 4. Full pressure sweep for 5 cm3 from sea level to 7000 ft. altitude with no leak. ±10 daPa or ±15%, whichever is greater 226 Hz: 600 daPa/sec except near tympanogram peak where sweep rate slows to 200 dapa/sec to provide better definition of peak compliance. 1000 Hz: 200 daPa/sec ±10 daPa/sec Positive to negative 226 Hz: Approximately 1 second 1000 Hz: Approximately 3 seconds NOTE: High compliance tympanograms will take somewhat longer. 226 Hz only: Measurement of the tympanogram width taken at 50% of peak compliance.

1739-0100 Rev. E

Preface Acoustic Reflex Stimuli Frequencies:

Accuracy: Total Harmonic Distortion: Rise/Fall Time: Transducers IPSILATERAL: CONTRALATERAL:

1739-0100 Rev. E

226 Hz Probe Tone: 500, 1000, 2000, and 4000 Hz for both ipsilateral and contralateral stimulation 1000 Hz Probe Tone: 500, 2000 and 4000 Hz for both ipsilateral and contralateral stimulation ±3% <5% for outputs less than 110 dBHL and <10% at 110 dBHL 5 to 10 msec GSI design Single Audiovox Model SM-N insert phone (Version 2 and 3 only)

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GSI 39 Output Levels: IPSILATERAL:

CONTRALATERAL:

For 226 Hz Probe Tone: 500 and 4000 Hz: 80, 90,100 db HL (Combo Probe design @ 4000 Hz has 80 and 90 db HL only) 1000 and 2000 Hz: 85, 95, 105 dB HL For 1000 Hz Probe Tone: 500 and 4000 Hz: 80 and 90 dBHL 2000 Hz: 85 and 95 dBHL For 226 Hz Probe Tone: 500, 1000, 2000, 4000 Hz: 90, 100, 110 dB HL For 1000 Hz Probe Tone: 500, 2000 and 4000 Hz: 90 and 100 dB HL NOTES: 1. 226 Hz Probe Tone: Ipsilateral stimuli are time multiplexed with probe tone (93 ms ON, 66 ms OFF). 1000 Hz Probe Tone: Ipsilateral stimuli are time multiplexed with probe tone (62 ms ON, 62 ms OFF). 2. Contralateral stimuli are steady tones. 3. Stimuli are presented at lowest level first. If there is no response, the intensity is increased by 10 dB until a response is detected or the maximum dB HL is reached. 4. Contralateral is available with Versions 2 and 3 only.

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1739-0100 Rev. E

Preface Pressure:

Reflex Determination: Reflex Test Time:

Probe LED Indicators

226 Hz Probe Tone: Reflex measures are set automatically to pressure at peak compliance with an offset of -20 daPa if peak pressure is negative and +20 daPa if peak pressure is positive. 1000 Hz Probe Tone: Reflex measures are taken at 0 daPa regardless of peak pressure. 226 Hz: Compliance change of 0.05 cm3 or greater. 1000 Hz: Compliance change of 0.1 mmho. 1 to 12 seconds depending upon the number of ipsilateral and/or contralateral test frequencies selected (4 maximum) and intensity required.

226 Hz Probe: Steady yellow: Blinking green: Steady green: Steady orange: No Light:

Occlusion Ready to start Test in progress Leak in pressure Test is finished

Combo Probe: Blinking green: Steady green: Steady orange: Blinking orange: No light:

Ready to start Test in progress Occlusion Leak in pressure Test is finished

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GSI 39 Audiometry mode (Versions 3 and 4 only) Frequencies: Accuracy: Total Harmonic Distortion:

Transducers Audiometric Headset:

Insert Earphones:

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125, 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000, 8000 Hz ±2% < 2.5% (125 to 3000 Hz measured acoustically at maximum dB HL; 4000 and 6000 Hz measured electrically) Pair DD45 earphones with Type 51 cushions (10 ohms impedance) Headband force per ANSI S3.6 and IEC 645 (4.5 ±0.5) ER-3A (10 ohm impedance)

1739-0100 Rev. E

Preface Intensity Levels DD45 Headphones Insert Phones 125 Hz -10 to 50 dB HL 125 Hz -10 to 40 dB HL 500 to 4000 Hz -10 to 90 dB HL 500 to 4000 Hz -10 to 80 dB HL 6000 Hz -10 to 85 dB HL 6000 Hz -10 to 70 dB HL 250 and 8000 Hz -10 to 70 dB HL 250 and 8000 Hz -10 to 60 dB HL NOTE: An additional +10 dB is available per frequency via the +10 dB button. Accuracy: 125 to 4000 Hz ±3 dB 6000 and 8000 Hz ±5 dB Step Size: 5 dB Signal-to-Noise Ratio: > 70 dB in 1/3 octave; less than -10 dB HL for levels less than 60 dB HL Rise/Fall Time: 20 to 50 msec

Tone Format

Continuous Pulsed FM (frequency modulated)

1739-0100 Rev. E

Tone is normally off until the Present bar is depressed. Tone is steady when present bar is depressed Tone is pulsed at 2.5/sec (i.e., 200 msec ON, 200 msec OFF) Tone is frequency modulated at a rate of 5 Hz, ±5%

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GSI 39 Printer Paper Roll Length: Tests/Roll: Versions 1 and 2: Versions 3 and 4: Assumption: Speed:

External Printer:

Approximately 80 feet (960") Approximately 420 Tympanograms/Reflex or 210 people Approximately 230 tests or 115 people 2 Tympanograms/Reflex + 1 Audiogram per person Approximately 1 minute to print three screens: Tympanogram Tympanogram + reflex (4) Audiogram Optional Deskjet color printer recognizing PCL3 or PCL3 GUI; 8-1/2” x 11” or A4 format

Power Line Voltage: Frequency Range: Power Consumption: Display:

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100 - 240 VAC (±10%) NOTE: Desktop power supply. 47 - 63 Hz (±5%) 16 watts maximum while printing. Low voltage input for desktop power supplies 7 VDC, 5.0 A. 240 x 64 graphical, monochrome LCD

1739-0100 Rev. E

Preface Environmental Temperature Operating: Warm-up time: Storage/Shipping: Ambient Pressure: Humidity:

59O to 104O F (15O to 40O C) 10 minutes for instruments stored at room temperature. -93O to 149O F (-69O to 65O C) 98 kPa to 104 kPa 15% to 95%

Mechanical - Instrument Instrument Dimensions: Weight: Shipping Carton Dimensions: Weight:

1739-0100 Rev. E

12.5" W x 14.5" D x 4.7" H 31.8 cm W x 36.8 cm D x 11.9 cm H 5 lbs (2.3 kg) - unit and probe

19.5" W x 22.5" D x 8.25" H 49.5 cm W x 57.2 cm D x 20.9 cm H 13.1 lbs (6 kg)

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