GSi 18 User manual

TRAVELING
SCREENING
AUDIOMETER
GSI 18
USER MANUAL

Title: GSI 18 Audiometer User Manual
Manufacturer
Grason-Stadler, Inc.
10395 West 70
th
Street
Eden Prairie, MN 55344
USA
[phone]
[e-mail]
Copyright © 2018 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 0123 mark identifies compliance with the Medical Device Directive 93/42/EEC. Grason-
Stadler is an ISO 13485 certified corporation.
European Authority Representative
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 18™ Audiometer User Manual
D-0004603 Rev G Page 3 of 53
TABLE OF CONTENTS
TABLE OF CONTENTS...............................................................................................................................3
Preface ....................................................................................................................................................6
Safety Summary ..................................................................................................................................6
Warning........................................................................................................................................... 6
Caution............................................................................................................................................6
Safety Notes........................................................................................................................................6
Customer Responsibility .....................................................................................................................9
Regulatory Symbols ..........................................................................................................................11
Device Symbols .................................................................................................................................13
Safety Precautions ................................................................................................................................14
Cautions - General.........................................................................................................................14
Recycling / Disposal ..........................................................................................................................15
Warranty and Repair............................................................................................................................. 16
Electromagnetic Compatibility..............................................................................................................17
Indications for Use ................................................................................................................................18
Introduction ......................................................................................................................................18
Intended Use.....................................................................................................................................18
Unpacking and Inspection.....................................................................................................................19
Supplied Accessories.........................................................................................................................19
Optional Accessories.........................................................................................................................20
GSI 18 Initial Set Up............................................................................................................................... 21
Rear Panel Connectors......................................................................................................................21
Bottom Panel ....................................................................................................................................22
Controls and indicators.....................................................................................................................23
LCD display ........................................................................................................................................25
AC Power...........................................................................................................................................27
Connecting the AC POWER ...........................................................................................................27
Disconnecting the AC Power.........................................................................................................27
Battery Operation .........................................................................................................................27
Sleep Mode ...................................................................................................................................28
Low Battery Indicator ...........................................................................................................28
Replacing the Batteries .................................................................................................................28
ReMoving the Batteries ................................................................................................................28

GSI 18™ Audiometer User Manual
D-0004603 Rev G Page 4 of 53
Placing New Batteries ...................................................................................................................29
Operation.............................................................................................................................................. 30
Preliminary Check .............................................................................................................................30
Pretest Noise Recovery Period .........................................................................................................31
Test Environment.............................................................................................................................. 32
Providing Patient Instructions...........................................................................................................32
Placement of Earphones (applied part) ............................................................................................ 33
Placement of Insert Earphones (applied part).................................................................................. 33
Response Handswitch .......................................................................................................................33
GSI Audiogram Form.........................................................................................................................34
Routine Test Administration .............................................................................................................35
Transducer Selection.....................................................................................................................35
HL Knob .........................................................................................................................................35
Range Extension Push Button .......................................................................................................35
Tone Type Selector........................................................................................................................35
Typical Testing Session......................................................................................................................36
Pretest Review ..............................................................................................................................36
Familiarization...............................................................................................................................36
Determining the Threshold (Pure Tone).......................................................................................36
Testing Procedure .........................................................................................................................37
Routine Maintenance ...........................................................................................................................38
Preventative Maintenance................................................................................................................38
Cleaning the GSI 18 ...........................................................................................................................38
Cleaning and Disinfecting Agents......................................................................................................39
Cleaning Patient Contact Reusable Devices......................................................................................39
Routine Calibration Check................................................................................................................. 40
Earphone Cords.................................................................................................................................40
Hum and Random Noise ................................................................................................................... 41
Distortion and Frequency Shift .........................................................................................................41
Cal .....................................................................................................................................................41
Exx .....................................................................................................................................................42
Appendix A - Technical Data .................................................................................................................43
Standards .......................................................................................................................................... 43
Appendix B: Secifications......................................................................................................................44
Audiometry .......................................................................................................................................44

GSI 18™ Audiometer User Manual
D-0004603 Rev G Page 5 of 53
Transducers...................................................................................................................................44
Intensity Levels .............................................................................................................................44
Tone Format ..................................................................................................................................44
Power ................................................................................................................................................45
Environmental...................................................................................................................................45
Mechanical - Instrument...................................................................................................................45
Reference Threshold Values .............................................................................................................46
Appendix C: Bibliography......................................................................................................................47
Appendix E: Electromagnetic Compatibility (EMC)...............................................................................48
Cautions regarding EMC ...................................................................................................................48
Guidance and manufacturer’s declaration Electromagnetic emissions ...........................................49
Recommended separation distances between portable and mobile RF communications equipment
..........................................................................................................................................................50
Guidance and Manufacturer’s Declaration Electromagnetic Immunity...........................................51

GSI 18™ Audiometer User Manual
D-0004603 Rev G Page 6 of 53
PREFACE
READ THIS ENTIRE MANUAL BEFORE ATTEMPTING TO USE THIS SYSTEM!
Safety Summary
In this manual, two symbols identify potentially dangerous or destructive conditions and procedures.
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.
NOTICE NOTICE is used to address practices not related to personal injury
NOTE: Notes help you identify areas of possible confusion and avoid potential problems during
system operation
Safety Notes
1. 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 must 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 – must comply with the safety requirements stated in the general
standard IEC 60601-1, (edition 3.1), clause 16. Any equipment not complying with the leakage
current requirements in IEC 60601-1 must be kept outside the patient environment i.e. at least
1.5m from the patient support or must be supplied via a separation transformer to reduce the

GSI 18™ Audiometer User Manual
D-0004603 Rev G Page 7 of 53
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 these requirements. If in doubt, contact a qualified medical technician or
your local representative.
2. A Separation Device (isolation device) is needed to isolate the equipment located outside the
patient environment from the equipment located inside the patient environment. Such a
Separation Device is required when a network connection is made. The requirement for the
Separation Device is defined in IEC 60601-1 clause 16.
3. To avoid the risk of electric shock, this equipment must only be connected to supply mains using
the power supply provided with the device (pn: UES24LCP-070300SPA).
4. Do not use any additional multiple socket-outlet or extension cord. For safe setup please refer to
section 1.3 (Installation).
5. No modification of this equipment is allowed without the authorization of Grason-Stadler. Grason-
Stadler will make available on request circuit diagrams, component part lists, descriptions,
calibration instructions, or other information. This will assist service personnel to repair, the parts
of this audiometer that are designated by the Grason-Stadler service personnel as repairable. 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.
6. For maximum electrical safety, turn off the power to a mains-powered instrument when it is left
unused.
7. The instrument is not protected against ingress of water or other liquids. If any spillage occurs,
check the instrument carefully before use or return for service.
8. No part of the equipment can be serviced or maintained while in use with the patient.
9. Do not use the equipment if it is showing visible signs of damage.
CAUTION
1. Never insert, or in any way use, the insert headset without a new clean and non-defective test tip.
Always make sure that the foam or ear-tip is mounted correctly. Ear tips and foam are for single
use only.
2. The instrument is not intended for use in environments exposed to fluid spills.
3. The instrument is not intended for use in oxygen rich environments or for use in conjunction with
flammable agents.
4. Check calibration if any parts of the equipment are exposed to shock or rough handling.
5. Components marked for “single use” are intended for a single patient during a single procedure,
and there is a risk of contamination if the component is re-used.

GSI 18™ Audiometer User Manual
D-0004603 Rev G Page 8 of 53
6. Do not switch the power on/off for the GSI 18 device while a patient is connected.
7. The specifications for the device are valid if the device is operated within the environmental limits.
8. When connecting the device to its accessories, use only the dedicated socket as described in the
section “Rear Panel Connectors”. If the wrong socket is selected for the transducer, the stimulus
sound pressure level (SPL) will not meet the calibrated level as set in the user interface and this
could lead to an incorrect diagnosis.
9. To ensure safe operation and valid measurements, the GSI 18 device and its accessories must be
checked and calibrated at least once a year or more frequently, if required by local regulations or
if there is any doubt about correct GSI 18 device function.
10. Use only sound stimulation intensities that will be acceptable to the patient.
11. It is recommended that parts which are in direct contact with the patient (e.g. the probe) are
subjected to standard infection control procedures between testing patients. Please refer to
cleaning section
12. Ensure that the right/left transducer is connected to the corresponding ear of the patient and that
the correct test ear is selected from within the user interface.
NOTICE
1. Use only transducers calibrated with the actual instrument. To identify a valid calibration, the
serial number for the instrument will be marked on the transducer.
2. Although the instrument fulfils the relevant EMC requirements, precautions should be taken to
avoid unnecessary exposure to electromagnetic fields, e.g. from mobile phones etc. If the device
is used adjacent to other equipment, it must be monitored to ensure that there is no mutual
disturbance. Please also refer to EMC considerations in Appendix E.
3. Use of accessories, transducers, and cables other than specified, except for transducers and cables
sold by GSI or representatives, may result in increased emission or decreased immunity of the
equipment. For a list of accessories, transducers and cables that fulfil the requirements please
refer to Appendix E.
4. Within the European Union, it is illegal to dispose of electric and electronic items in unsorted
municipal waste. Electric and electronic waste may contain hazardous substances and therefore
must be collected separately. Such products will be marked with the crossed-out
wheeled bin symbol. The cooperation of the user is important in order to ensure
a high level of reuse and recycling of electric and electronic waste. Failing to
recycle such waste products in an appropriate way may endanger the environment and
consequently the health of human beings.
5. Outside the European Union, local regulations should be followed when disposing of the product
after end of life.
6. Essential performance for this instrument is defined by the manufacturer as:
This instrument does not have an ESSENTIAL PERFORMANCE Absence or loss of ESSENTIAL
PERFORMANCE cannot lead to any unacceptable immediate risk. Final diagnosis shall always be

GSI 18™ Audiometer User Manual
D-0004603 Rev G Page 9 of 53
based on clinical knowledge There are no deviations from the collateral standard and allowances
uses.
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 needs 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 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 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 near flammable anesthetic gases.
Do NOT use the GSI 18 in a highly oxygen-enriched environment, such as a
hyperbaric chamber,
oxygen tent, etc.
Periodically, have a service technician perform electrical safety checks on the unit in order to show
continued compliance to IEC and UL 60601-1.
The GSI 18 is not intended to be used for home healthcare.
To avoid the risk of electric shock, this equipment must only be connected to
supply mains with
protective earth.
This device uses a three-wire power cord with a hospital grade plug (for
international applications,
IEC 60601-1 approved plug). The chassis is earth
grounded. 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

GSI 18™ Audiometer User Manual
D-0004603 Rev G Page 10 of 53
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 with this instrument. If extension cords are used, they 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.
Do not block access to the power switch.

GSI 18™ Audiometer User Manual
D-0004603 Rev G Page 11 of 53
Regulatory Symbols
Symbol
Description
Conforms to European Medical Device Directive 93/42/EEC.
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.
Symbol for “European Representative.”
Symbol for “Manufacturer.”
Symbol for “Date of Manufacture.”
China RoHS symbol for products with a 50 year life cycle.
Patient applied part Type B according to IEC 60601-1
Alkaline (1.5V) or Rechargeable (1.2V), NiCad or NiMH
AUD
The Left respective Right transducer of the headset is connected to this output
for Audiometry measurements.
Consult Operating Instructions.

GSI 18™ Audiometer User Manual
D-0004603 Rev G Page 12 of 53
Symbol
Description
Follow Instructions for Use.
Keep Dry
This side up
Fragile – handle with care

GSI 18™ Audiometer User Manual
D-0004603 Rev G Page 13 of 53
Device Symbols
The following symbols appear on the instrument
Symbol
Description
Patient applied part Type B according to IEC 60601-1
Follow instructions for use
Service Adjustment Part
Stand-By Switch
DC Power
Patient Response Hand switch
Left Ear
Right Ear
Power Supply Part Number

GSI 18™ Audiometer User Manual
D-0004603 Rev G Page 14 of 53
SAFETY PRECAUTIONS
WARNING
The following safety precautions must be always 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 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.
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.

GSI 18™ Audiometer User Manual
D-0004603 Rev G Page 15 of 53
Recycling / Disposal
Many local laws and regulations require special procedures to recycle or dispose of
electrical equipment and related waste including batteries, printed circuit boards,
electronic components, wiring and other elements of electronic devices. Follow all local
laws and regulations for the proper disposal of batteries and any other parts of this
system.
Below is the contact address 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
c/o DGS Diagnostics A/S
Audiometer Alle 1
5500 Middelfart
Denmark

GSI 18™ Audiometer User Manual
D-0004603 Rev G Page 16 of 53
WARRANTY AND REPAIR
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. This
warranty is extended to the original purchaser of the instrument by GSI through the distributor from
whom it was purchased and covers defects in material and workmanship for a period of one year
from date of delivery of the instrument to the original purchaser. 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 Grason-Stadler 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: Opening the instrument case or changes to the product not approved in writing by
Grason-Stadler shall void this warranty. Grason-Stadler shall not be responsible for any indirect,
special or consequential damages, even if notice has been given in advance of the possibility of
such damages. The transducers may go out of calibration due to rough handling or impact
(dropping). The lifetime of probe, probe seals and eartips is dependent upon conditions of use.
These parts are only guaranteed against faulty materials or manufacture.
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.
We advise you against attempting to rectify any faults by yourself or commissioning non-experts to
do so. Equipment is not user repairable. Repairs must be performed by an authorized service
representative only.
WARNING
No modifications of the equipment are allowed by anyone other than a qualified GSI
representative. Modification of the equipment could be hazardous. If this equipment
is modified, appropriate inspection and testing must be conducted to ensure
continued safe use of the equipment.
In order to ensure that your instrument works properly, the GSI 18 should be checked and calibrated
at least once per year. This check must be carried out by your dealer or authorized GSI service
facility.
When returning the instrument for repairs or calibration it is essential to send the acoustic
transducers with the device. Send the device to an authorized service center only. Please include a
detailed description of faults. In order to prevent damage in transit, please use the original packing
if possible when returning the instrument.

GSI 18™ Audiometer User Manual
D-0004603 Rev G Page 17 of 53
ELECTROMAGNETIC COMPATIBILITY
Portable and Mobile RF communications equipment can affect the GSI 18. Install and operate the
GSI 18 according to the EMC information presented on the CD Reference Guide.
The GSI 18 has been tested for EMC emissions and immunity as a standalone instrument. Do not use
the GSI 18 adjacent to or stacked with other electronic equipment. If adjacent or stacked use is
necessary, the user should verify normal operation in the configuration.
The use of accessories, transducers, and cables other than those specified, with the exception of
servicing parts sold by GSI as replacement parts for internal components, may result in increased
EMISSIONS or decreased IMMUNITY of the device. Anyone connecting additional equipment is
responsible for making sure the system complies with the IEC 60601-1-2 standard.
Although the instrument fulfils the relevant EMC requirements precautions should be taken to avoid
unnecessary exposure to electromagnetic fields, e.g. from mobile phones, etc. If the device is used
adjacent to other equipment it must be observed that no mutual disturbance appears.

GSI 18™ Audiometer User Manual
D-0004603 Rev G Page 18 of 53
INDICATIONS FOR USE
GSI 18 is intended to be used for the identification and etiology of hearing loss in patients of any age.
It is intended to be used by an audiologist, ENT, hearing healthcare professional, or trained
technician in a hospital, clinic, healthcare facility or other suitable quiet environment. There are no
contraindications for the GSI 18.
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 problem develops) by a GSI certified
technician.
Intended Use
This clinical audiometer is designed to be a device for diagnosing hearing loss. Output and specificity
of this type of device are based on the test characteristics defined by the operator and may vary
depending on environmental and operating conditions. The diagnosing of hearing loss using this kind
of clinical audiometer depends on the interaction with of the operator and the patient. However, each
patient will respond differently to the tests, thus requiring the operator to evaluative the overall
result. An operator should not ignore contradictory behavior they witness to what otherwise would
be a “normal hearing” test result. A full audiological evaluation should be administered if concerns
about hearing sensitivity persist.

GSI 18™ Audiometer User Manual
D-0004603 Rev G Page 19 of 53
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.
NOTE: Keep the original packing material and shipping container so the instrument can be well
packaged if it needs to be returned to the local service center for repair or calibration.
WARNING
ONLY GSI approved parts and accessories should be used with this Instrument. The use
of parts or materials that are not recognized to be used with this device can degrade
minimum safety.
Supplied Accessories
Check that all accessories itemized in Accessories supplied below are received in good condition. If
any accessories are missing, contact GSI immediately.
Part Numbers
Descriptions
8106352 1
DD45 Headset with RE7 Headband
8511988
Switching Power Adapter (UES24LCP-070300SPA )
8004664
Softside Carrying Case
8012941
Audiogram Forms (1 pad of 50)
8011933
Quick Reference Guide – Threshold Audiometry
8029312
GSI 18 Quick Guide
1Applied part according to IEC 60601-1

GSI 18™ Audiometer User Manual
D-0004603 Rev G Page 20 of 53
Optional Accessories
Part Numbers
Descriptions
80043652
Response Hand switch
8004383
Patch Cord, 2-conductor
8010855
Audiocups
81030013
Insert Phone Assembly 3A (10 Ohm impedance)
80109214
Insert Phone Assembly 5A (50 Ohm impedance)
2Applied part according to IEC 60601-1
3This applied part is not certified according to IEC 60601-1
4This applied part is not certified according to IEC 60601-1