GSI 18 User Guide Rev E

GSI 18

Title:

GSI 18 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-certifed corporation.

European Authority Representative Grason-Stadler Kongebakken 9 2765 Smørum Denmark

0344

1718-0100 Rev. E

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GSI 18

Supplied Accessories Check that all accessories itemized in Accessories supplied below are received in good condition. If any accessories are missing, contact GSI immediately. See the Specifications section for the catalog numbers of accessories and also for a listing of optional accessories.

Part Numbers Test headset (DD45) (with Headband)

8000-0181

Audiogram Forms (1 pad of 50)

1718-9600

Instruction Manual

1718-0100

Bag, Carrying

143-414700

AC Power Module (1718-9700 or 1718-9701 only)

North America/Japan

UK-Ireland

UE100503HKKK3-P

Australia, China

Europe, Italy, India, Israel, S. Africa, Korea, Russia

5 each, AA Alkaline Batteries (1718-9705 or 1718-9706 only) Quick Reference Guide - Threshold Audiometry

1718-0140

Optional Accessories Response Handswitch

7874-0156

Patch Cord, 2 Conductor

4204-0505

Audiocups

8000-0155

Insert Phone Assembly 3A (10 ohm impedance)

1700-9710

Insert Phone Assembly 5A (50 ohm impedance)

1700-0882

!

WARNING Use only Grason-Stadler supplied components and accessories.

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GSI 18

Safety Summary 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 you identify areas of possible confusion and avoid potential problems during system operation.

Safety Notes

! WARNING The GSI 18 is designed for compliance to IEC and UL 60601-1 when used in the patient vicinity. The GSI 18 is equipped with a specific power transformer (pn: UE100503HKKK3-P), 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 anywhere in the manufacturing process. The base material for the earphone cushions is made from natural and synthetic rubber.

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GSI 18

! WARNING This symbol indicates the location of a service adjustment part and is intended for service personnel only. The GSI 18 is a specifically calibrated audiometer 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 18 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. Anyone 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 local GSI representative.

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GSI 18

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 visibly 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 maintain continued compliance to IEC and UL 60601-1.

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GSI 18

Warranty We, Grason-Stadler, 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. Within one year after original shipment, if 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 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 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 in advance 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 OF FITNESS FOR A PARTICULAR PURPOSE.

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GSI 18

Specifications

The GSI 18 meets the following standards:

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ANSI S3.6 (2004)

Specification for Audiometers (Type 4)

IEC 60645-1 (2002)

Electroacoustics - Audiological Equipment Pure Tone Audiometers (Type 4) It is Class 1, internally powered with Type B applied parts.

IEC 60601-1 (2003)

Medical Electrical Equipment Part 1 - General Requirements for Safety

UL 60601

Medical Electrical Equipment, Part 1 -General Requirements for Safety

CAN/CSA-C22.2 No. 601.1-M90 (2003)

Medical Electrical Equipment - Part 1: General Requirements for Safety

IEC/EN 60601-1-2 (2001)

Medical Electrical Equipment Part 1 Electromagnetic compatibility requirements

1718-0100 Rev. E

GSI 18

Frequency Range Discrete Frequencies:

125, 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000, 8000 Hz

Accuracy:

±2%

Total Harmonic Distortion:

<2.5% measured acoustically at the maximum Hz for frequencies below 5000 Hz and measured electrically above 5000 Hz.

Intensity Ranges

In increments of 5 dB steps

125 Hz

-10 to 50 dB HL

500 to 4000 Hz

-10 to 90 dB HL

6000 Hz

-10 to 85 dB HL

250 and 8000 Hz

-10 to 70 dB HL

The above intensity ranges apply to the DD45 earphones. NOTE: The maximum output values in dB HL are reduced by 10 dB when insert phones (EAR 3A/5A) are used, except for 6 kHz where the maximum dB HL is reduced by 20 dB. NOTE: A “+10” dB button extends the maximum at all frequencies by 10 dB. Accuracy:

125 to 4000 Hz, ±3 dB 6000 to 8000 Hz, ±5 dB

Signal to Noise Ratio:

>70 dB

Tone Type Rise/Fall Time:

20-50 msec

Continuous:

Steady when present bar depressed

Pulsed:

2.5 pulse/sec

FM:

±5%, 5 Hz, Triangular modulation

Head set DD45 Earphones with Type 51 Cushions (10 ohm impedance). Headband:

1718-0100 Rev. E

Exerts a force between 4 and 5 N when the earphones are separated by 145mm.

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GSI 18

Power Line Voltage:

The AC-DC adapter is a universal auto-ranging with an input voltage range of 100 - 240VAC at 50 - 60 Hz.

Consumption:

1.5 Watts

Battery Types:

5 each Alkaline AA 1.5V 5 each Rechargeable Nicad or NiMH AA 1.2V NOTE: The instrument does not provide a recharging circuit for these batteries. Capacity:

Minimum of 10 hours of power for either battery type. A Low Battery icon will display when there is approximately 1 hour left of power.

Environmental Temperature Operating: 59° F to 104° F (15° C to 40° C) NOTE: Warm-up time is required if storage temperature is different from room temperature. Ambient Pressure:

98 kPa to 104 kPa

Warm-up Time:

10 minutes for instruments stored at room temperature

Storage/Shipping:

-30° F to 149° F (-34° C to 65° C)

Battery Storage:

-4° F to 105° F (-20° C to 40° C)

Humidity:

15% to 95%

Mechanical Dimensions:

12.59” W x 8.76” D x 3.18” H (32 cm W x 22.3 cm D x 8.1 cm H)

Weight:

2.55 lbs (1.16 Kg) with 5 AA batteries

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1718-0100 Rev. E

Table of Contents Preface

Title…………………………………..………..……..………...…..i Supplied accessories…….…………….……...……...ii Safety summary...iii Safety notes…………….……………..………..……….…...iii Customer responsibility…….…….…...……...v Warranty ...vi Specifications ...vii Electromagnetic compatibility………..……...………...x

Chapter 1

Unpacking and inspection...1-1 Recycling / disposal...1-2 Installation ...1-3 Rear panel connectors...1-3 Bottom panel ...1-3 Bottom panel ...1-5 Controls and indicators...1-6 LCD display...1-8 AC power...1-10 Connecting the AC power………….….………...…..……...1-10 Disconnecting the AC power……….…….……...……...….1-10 Battery operation ...1-11 Sleep mode ...1-11 Low battery indicator ...1-11 Replacing the batteries ...1-12 Removing batteries………………….…….…...……..…...…1-13 Placing new batteries……………….…….…...…………...…..1-14

Introduction

Chapter 2 Operation

1718-0100 Rev. E

Preliminary check...2-1 Pretest noise recovery period...2-2 Test environment ...2-3 Providing patient instructions...2-4 Placing the earphones...2-4 Response handswitch………..….……………...….…………...2-5 GSI Audiogram form………………...…………….….……...…2-5 Routine test administration...2-6 Transducer selection……………….…………...….…...…….2-6 HL knob………..…………………..……………...…...……..2-6 Range Extension pushbutton………..………….…...……...2-7 Tone Type selector…………………..……………...……...2-7 Typical testing session ...2-8 Pretest review………………………..….……...….……...……2-8 Familiarization……………………..………...……..…...……...2-8 Determining the threshold (Pure Tone)….………...….…...…..2-9 Testing procedure……………………….…..…….…….…...…..2-9

GSI 18

Chapter 3 Routine Maintenance

Preventive maintenance...3-1 Cleaning the GSI 18 …………………….….…...….…...…..3-1 Cleaning and disinfecting agents …..….…...…..…..…..…...3-2 Cleaning patient contact reusable devices….…...…...…...3-2 Routine calibration check ... 3-3 Earphone cords ... 3-4 Hum and random noise... 3-4 Distortion and frequency shift ... 3-4 Special messages ... 3-5 Cal... 3-5 Exx... 3-5

Appendix A GSI Country Kit

Appendix B Reference Threshold Values ii

Bibliography

Index

1718-0100 Rev. E

Chapter 1

Introduction The GSI 18 Audiometer is a single-channel, pure tone, air conduction, portable instrument designed to provide basic audiometric screening capability for physicians’ offices, schools and industry. The lightweight design allows easy transport to a variety of testing locations. The clearly labeled front panel controls and full frequency range make accurate, reliable testing a simple matter for any user. The GSI 18 is a precisely designed and calibrated instrument. With proper care, it will deliver accurate sound-pressure levels to subjects’ ears for hearing screening programs.

NOTE: The GSI 18 should be calibrated yearly (or sooner if a problem develops) by a GSI certified technician. See Chapter 3.

Unpacking and inspection Although this GSI 18 was carefully tested, inspected and packed for shipping, it is good practice after receiving the instrument to immediately examine the exterior of the container for any signs of damage. Notify the carrier if any damage is noted. Carefully remove the GSI 18 from its shipping container. If the instrument appears to have suffered mechanical damage, notify the carrier immediately so that a proper claim can be made. Be certain to save all packing materials 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 must be returned to the factory, repack it carefully (in the original container if possible) and return it prepaid to the factory for necessary adjustments.

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GSI 18 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 proper disposal of batteries and any other parts of this system.D-9

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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Introduction

Installation 1.

Plug the power cord into the appropriate jack (R5) on the rear panel.

2.

Plug the power cord from the Power Module into a line power (mains) outlet.

3.

Plug the earphones into the earphone jacks on the rear panel. R3 is for the right and R4 is for the left earphone/insert phone.

4.

Turn the power switch to ON (R6).

Rear panel connectors R1

R2

R3

R4

R5

R6

Figure 1: Rear panel connectors. R1 -Covered by a sticker and intended for service personnel only. R2 -Patient Hand Switch input jack (standard phone jack). R3 -Right ear phone output jacks (standard phone plug). Insert either DD45 Headphone or Insert Earphone jacks. R4 -Left earphone output jacks (standard phone jack). Insert either DD45 Headphones or Insert Earphone plugs. R5 -Power Input jack (2.1 mm pin). R6 - Power switch.

Table of symbols on the GSI 18 No.

Symbol

Description

1

Attention, consult accompanying documents.

2

Date of manufacture.

3

CE Marked in accordance with the European Council Directive 93/42/EEC concerning medical devices.

0344

Medical device listing mark for U.S. and Canada by Intertek Testing Service.

4 3145885

5

1-3

Special Recycling Required. Do not dispose in landfill.

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GSI 18

No.

1-4

Symbol

Description

6

Type B equipment.

7

Reference Symbol.

8

Stand-by.

9

Right Ear

10

Left Ear

11

Patient Response Button.

12

AC Power

13

Manufacturer.

14

European Representative.

15

Keep Dry.

16

Lot Number.

17

Serial Number.

18

Transport and storage temperature range.

19

This Side Up.

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Introduction

! WARNING Do not turn on/off system power while a patient is wearing the headsets or insert earphones. Use only the GSI provided power supply. The GSI 18 provided power supply should only be connected to a power source meeting the following range: 100240VAC, 50-60Hz. In North America, the power source should be a maximum of 120VAC.

Bottom panel

B1

B2 Figure 2

B1 - Label location includes serial number of system. B2 -Battery compartment See Replacing the Batteries for detailed instructions.

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GSI 18 Controls and indicators F1

F2

F3

F4

F5

FM +10dB

R

L

dB HL

Hz Ref / ANSI S3.6 / ISO 389

F12

F11

F10

F9

F8

F7

F6

Figure 3: Front panel controls and indicators. F1 -Range extension pushbutton allows you to increase the stimulus intensity 10 dB above the standard maximum HL at any frequency. When in use, a “+” appears on the LCD. F2 -Liquid Crystal Display (LCD). F3 -Selects steady stimulus tone type. The symbol corner of the display when selected.

is shown in the upper right hand

F4 -Selects pulsed stimulus tone type. The symbol corner of the display when selected.

is shown in the upper right hand

F5 -Selects frequency modulated stimulus tone type. FM is shown in the upper right hand corner of the display when selected.

1-6

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Introduction

F6 – Selects the DD45 calibration file for transducers. When the button is pressed, the display will flash. Press the button again to engage the TDH 39 Transducer. The symbol

is shown on the right side of the display when selected.

F7 - Selects insert earphone calibration file for transducers. When the button is pressed, the display will flash. Press the button again to engage the insert transducers. The symbol

is shown on the right side of the display when selected.

F8 - Control for setting the stimulus frequency. Frequency is indicated in the bottom center of the display. F9 - Select to present the stimulus to the Left ear. An “L” will appear in the lower right side of the display to indicate the stimulus is being routed to the left ear. F10 -Present bar for stimulus presentation. The symbol the display when the stimulus is being presented.

appears on the left side of

F11 -Select to present the stimulus to the Right ear. An “R” will appear in the lower left side of the display to indicate the stimulus is being routed to the right ear. F12 -Hearing Level knob for setting the stimulus intensity level. Level is indicated on the center top of the display.

NOTE: The above symbol is located on the rear panel of the GSI 18 and denotes a Type B applied part.

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GSI 18 LCD display

1

15

14

13 12

2 11 3

10

4

9 5

6

7

8

Figure 4 - LCD Display Legend

Icons/LEDs

Description

1

Indicates power is on.

2

Indicates the current software version.

3

When displayed, the stimulus is being presented.

4

When displayed, an additional 10dB is available at the test frequency.

5

When displayed, indicates the Patient Response button is being pressed.

6

Stimulus is being presented to the right ear.

7

Stimulus frequency indicator.

8

Stimulus is being presented to the left ear.

9

Indicates the battery is low.

10

The headphone calibration file is applied to the stimulus and Headphones should be used. Press this button twice to activate the calibration file.

11

The insert phone calibration file is applied to the stimulus and Insert phones should be used as the transducer. Press this button twice to activate the calibration file.

12

The stimulus is a Frequency Modulated (FM) tone.

13

The stimulus is a continuous tone.

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