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 [email protected]
GSI 18™
Part Number 1718-0100 Rev E
USER MANUAL

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 i
GSI 18

ii 1718-0100 Rev. E
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,
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
Supplied Accessories
WARNING
Use only Grason-Stadler supplied components and accessories.
GSI 18
!

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
Safety Summary
In this manual the following two labels identify potentially dangerous or
destructive conditions and procedures:
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
!
WARNING
!
iii
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 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.
iv 1718-0100 Rev. E
WARNING
!
GSI 18

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.
v 1718-0100 Rev. E
GSI 18
Customer Responsibility
WARNING
!

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
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: Exerts a force between 4 and 5 N when the
earphones are separated by 145mm.
1718-0100 Rev. E
viii
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
ix 1718-0100 Rev. E
GSI 18

1718-0100 Rev. E
x
Electromagnetic Compatibility
GSI 18

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 .........................................................................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
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
Preface
Chapter 1
Introduction
Chapter 2
Operation
1718-0100 Rev. E
Table of Contents

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
ii
1718-0100 Rev. E
Chapter 3
Routine
Maintenance
Appendix A
GSI Country Kit
Appendix B
Reference
Threshold Values
Bibliography
Index
GSI 18

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.
1718-0100 Rev. E 1-1
Chapter 1
Introduction

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:
1-2 1718-0100 Rev. E
!
GSI 18
Recycling / disposal
CAUTION
Grason-Stadler A/S
Kongebakken 9
2765 Smørum
Denmark
CRV no. 21113379

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
1-3 1718-0100 Rev. E
No.
Symbol
Description
1 Attention, consult accompanying documents.
2 Date of manufacture.
3
0344
CE Marked in accordance with the European
Council Directive 93/42/EEC concerning medical
devices.
4
3145885
Medical device listing mark for U.S. and Canada
by Intertek Testing Service.
5
Special Recycling Required. Do not dispose in
landfill.
Introduction

1718-0100 Rev. E
No. 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.
GSI 18
1-4

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: 100-
240VAC, 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.
1718-0100 Rev. E 1-5
Introduction
WARNING
!

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 is shown in the upper right hand
corner of the display when selected.
F4 -Selects pulsed stimulus tone type . The symbol is shown in the upper right hand
corner of the display when selected.
F5 -Selects frequency modulated stimulus tone type . FM is shown in the upper right
hand corner of the display when selected.
1-6 1718-0100 Rev. E

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
. P ress 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 appears on the left side of
the display when the stimulus is being presented.
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.
1718-0100 Rev. E 1-7