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.