GSi 18 User Manual

™

GSI 18

USER MANUAL

Setting The Clinical Standard www.grason-stadler.com

Grason-Stadler, 7625 Golden Triangle Drive, Suite F, Eden Prairie MN 55344

800-700-2282 • 952-278-4402 • fax [phone] • e-mail [e-mail]

Part Number 1718-0100 Rev E

GSI 18

Title:

GSI 18 User Manual

.

Copyright © 2 011 Grason-Stadler Inc

may be reproduced or transmitted in any form or by any means without the prior written
permission of Grason-Stadler Inc
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 Repr esentative

Grason-Stadler
Kongebakken 9
2765 Smørum
Denmark

.

All rights reserved. No part of this publication

The information in this publication is proprietary to

0344

1718-0100 Rev. E i

Supplied Accessories

WARNING

GSI 18

!

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) UE100503HKKK3-P

Europe, Italy, India,

North America/Japan UK-Ireland Australia, China Israel, S. Africa, Korea,

5 each, AA Alkaline Batteries (1718-9705 or 1718-9706 only)

Quick Reference Guide - Threshold Audiometry 1718-0140

Russia

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 Assem

Use only Grason-Stadler su pplied compo nen ts and acc essories.

bly 5A (50 ohm impedance) 1700-0882

ii 1718-0100 Rev. E

Safety Summary

WARNING

the patient and/or user.

!

Safety Notes

WARNING

!

!

iii

GSI 18

In this manual the following two labels identify potentially dangero us or
destructive conditions and procedures:

The

label identifies conditions or practices that may present danger to

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.

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.

1718-0100 Rev. E

WARNING

!

GSI 18

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 fa miliar 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 i n put or si gnal 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.

iv 1718-0100 Rev. E

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 u nit
in order to maintain continued compliance to IEC and UL 60601-1.

v 1718-0100 Rev. E

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.

1718-0100 Rev. E vi

GSI 18

Specifications

The GSI 18 meets the following standards:

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

vii

1718-0100 Rev. E

Frequency Range

GSI 18

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

FM: ±5%, 5 Hz, Triangular modulation

pulse/sec

Head set

DD45 Earphones with Type 51 Cushions (10 ohm impedance).

Headband: Exerts a force between 4 and 5 N when the

earphones are separated by 145mm.

1718-0100 Rev. E

viii

Power

GSI 18

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

Weight: 2.55 lbs (1.16 Kg) with 5 AA batteries

x 8.1 cm H)

ix

1718-0100 Rev. E

1718-0100 Rev. E

x

Electromagnetic Compatibility

GSI 18

Preface

Table of Contents

Chapter 1

Introduction

Chapter 2

Operation

Title…………………………………..………..……..………....…..i

Supplied accessories…….…………….……...……........................ii

Safety summary...............................................................................iii

Safety notes…………….……………..………..……….…............iii

Customer responsibility…….…….…....……...................................v

Warranty ..........................................................................................vi

Specifications .................................................................................vii

Electromagnetic compatibility………..…….....………...................x

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 ..........................................................

Sleep mode ..................................................................................1-11

Low battery indicator ..................................................................1-11

Replacing the batteries ................................................................1-12

Removing batteries………………….…….…...……..….......…1-13

Placing new batteries……………….…….…...…………....…..1-14

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

...............1-11

1718-0100 Rev. E

Chapter 3

GSI 18

Routine

Maintenance

Appendix A

GSI Country Kit

Appendix B

Reference
Threshold Values

Bibliography

Index

ii

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

l...........

Ca

Exx............................................................................................. 3-5

................................................................................... 3-5

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
contai

ner if possible) and return it prepaid to the factory for necessary adjustments.

1718-0100 Rev. E

1-1

GSI 18

Recycling / disposal

CAUTION

Grason-Stadler A/S

!

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:

Kongebakken 9
2765 Smørum
Denmark
CRV no. 21113379

1-2 1718-0100 Rev. E