GSi 61 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 61
™
USER MANUAL
Part Number 1761-0100 Rev B

Title:
GSI 61 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 CE 0344 mark identifies compliance with the Medical Device Directive 93/42/EEC. Grason-
Stadler is an ISO 13485 certified corporation.
European Authority Representative
Grason-Stadler
Kongebakken 9
2765 Smørum
Denmark
0344
1761-0100Rev.B i

The GSI 61 ClinicalAudiometer is designed to be used with a hospital grade outlet. Injury to
personnel or damage to equipment can result when a three-prong or two-prong adaptor is
connected between the GSI 61 power plug and anAC outlet or extension cord.
Audiometers which bear the Underwriters Laboratories, Inc
. label should be interconnected
with accessories that have the proper electrical compatibility and are listed as meeting the
requirements of the UL Medical and Dental Equipment Standard. Connection of accessories
not meeting these requirements may result in electrical leakage currents in excess of those
allowed by the standard and present a potential electrical shock hazard to the person being
tested.
This warning icon found on the back of the LCD panel indicates dangerous voltage within the
panel. Access to the LCD panel is limited to authorized Grason-Stadler
service representatives.
When testing with the High Frequency earphones, do not allow the
presentation of the signal at the maximum dB HL to exceed 10 minutes.
The buildup of increased temperature can cause harm to the earphones.
This caution label refers the user to the accompanying literature and
manuals.
Cautions
This icon indicates that the GSI 61 is in compliance with Class 1,
Type B requirements of IEC 601-1.
The following is the list of status messages which will occur
withoperationoftheGSI 61Audiometer. Thesemessageswill
be displayed in one of the bottom three message areas.
Warnings, Cautions and Errors
Warnin
g
!
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
.
Everyone 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 a local
representative.
Cautions
ii 1761-0100 Rev. B

Grason-Stadler GSI
®
61 CLINICAL AUDIOMETER
Status Messages
UsingDefaultData Indicates that the selected transducer and stimulus are not
calibrated to standard specified (ANSI/ISO) levels.
ErasingData Indicates that the GSI 61 is clearing stored test information.
SavingData Indicates that the test information is being saved into memory.
NoTestDataStored Indicates that there is no test data available to be erased or
printed.
CheckHi-FreqCables Indicates that the High Frequency function is enabled but the
cables plugged into the L&R phone jacks are not the GSI-
specified type.
InvalidSelection Indicates that an incorrect selection, such as incompatible
transducers, has been made.
NotAvailable Indicates an uninstalled option has been selected.
NoTestDataStored Indicates that there is no data available for printing, although
the Print Audiogram button has been pressed.
DataTransfer Indicates that data has been processed either by the printer or
by a remote computer.
CheckPrinter A check is done to see if the printer is connected and ready to
receive data by checking the hardware flow control line. If
printer is not ready this message will be flashed.
Printing This is an informational message which is displayed while
outputting data to the printer. It appears on the lower right
section of the LCD.
NoPrinterResponse Ifcommunicationsproblemsoccur duringthe courseofprinting,
this error message will be flashed.
Communications Error Messages
The following communication errors may occur during data transmission through the RS 232
communications:
Commerror: parity Check GSI61 and PCparitysettings.
Commerror: framing Check GSI 61 and PC selections for number of stop
bits and number of bits per command.
Commerror: overrun See‘framing’.
Commerror: multiple Check parity, baud rate, number of stop bits and
bytesizeonGSI61.
Commerror: spurious Soft error. Should not be repeatable; if so, problem
couldbe anywherein GSI61 digitalcircuitsor PC’s
communicationcircuits.
Commerror: break See ‘spurious’.
Ifthe word “Help” followedbyan errorcodeisdisplayed,notethe Help Codenumber. Seethe
GSI 61 Service Manual (1761-0110) for detailed descriptions of these. Turn off the power to
the GSI61 and wait 30 seconds. Restarttheinstrument. Often theerrorwill becleared bythis
action. If the error persists, contact an authorized Grason-Stadler service representative.
iii
1761-0100 Rev. B

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. 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: Changes in 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.
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.
iv
1761-0100 Rev. B

TheGSI®61ClinicalAudiometermeets or exceedsthefollowingstandards:ANSI S3.6-1989;
ANSIS3.43-1992;IEC645-1(1992);IEC645-2(1993);ISO389; UL2601-1MedicalElectrical
Equipment; IEC 601-1 Medical Electrical Equipment and CSA C22.2, No. 601.1-M90
Electromedical Equipment.
TheCEmarkon thisproduct indicatesitconformswith theprovisionsnotedin the93/42/EEC
MedicalDevicesDirective.
CE Mark per Medical Device Directive (93/42/EEC)
Frequency Range
Air Conduction 125Hzto12000Hz
High Frequency (optional) 8kHzto20kHz
Bone Conduction 250Hzto8000Hz
Sound Field (optional) 125Hzto12,000Hz(125Hzto16,000Hz
only withHigh Frequencyoption,1761-9630, enabled)
Paired Insert (optional) 125 Hzto8000Hz
SingleInsert(optional) 250Hzto6000Hz
Accuracy ± 1%
Total HarmonicDistortion £2% (earphones and paired insert phones*)
£5% (bone vibrator)
Intensity Range **
AirConduction: -10dBHLto120dB HL
High Frequency:* -20dBHLto100dB HL(withSennheiserHDA200
Phones)
Bone Conduction:
Mastoid -10 dB HL to 80 dB HL
Forehead -10 dB HL to 70 dB HL
SoundField:* -10dBHLto96dBHL
Paired Inserts:* -10dBHLto110dBHL
SingleInsert:* -10 dBHLto 110dBHL
Masking Intensity Range (Calibrated in effective masking)
NarrowBandNoise: MaximumdBHLis15dBbelowtone
White Noise: MaximumdB HL is30 dBbelow tone
* Optional accessories
** The maximum HL values are applicable to the middle frequencies only.
GSI® 61 is a registered trademark of Grason-Stadler. All rights reserved.
v
Specifications
Standards
Pure Tone - Channel
1 and Channel 2
European Authority Representative
Grason-Stadler A/S
Kongebakken 9
2765 Smørum
Denmark
0344
1761-0100 Rev. B

Microphone: For live voice testing and communications
External A and External B: Accepts recorded speech material from external
stereo tape cassette or CD player
Intensity Range:
AirConduction: -10dBHLto105dBHL
Bone Conduction:
Mastoid -10 dB HLto 65dBHL
Forehead -10 dBHL to55 dBHL
Sound Field:*** -10dBHLto90dBHL
Paired Inserts:*** -10dBHLto95dBHL
Single Insert:*** -10dBHLto95dBHL
Masking Intensity Range
Speech Noise:
Air Conduction (TDH 50P and Insert Phones*) and Bone
Conduction
Maximum dB HL are the same as the speech type signals.
SoundField: -10dBHL to80dBHL
White Noise: Equal to Speech Noise
*** Optional Accessories
Steady: Tone continuously present.
Pulsed: Tonepulsed200mSecON,200msecOFF.
FM: Tone modulated ± 5% of center frequency at a rate of 5 Hz.
ALT: Tone alternating between Channel1 and Channel 2: Channel
1is400mSecON, 400mSecOFF followedbyChannel2,400mSec
ON,400mSecOFF.
SISI: An intensity increment is added to a tone in the selected channel for
200 mSec, every 5 seconds. The HL increments are available in 1, 2
or 5 dB steps.
HighFrequency: Tone testing in the frequency range of 8kHz to 20 kHz
using High Frequency phones or Sound Field.
Thefrequenciesavailablefortesting are:8 kHz, 9kHz,
10kHz,11.2kHz,12.5kHz,14kHz,16kHz,18kHz
and20 kHz(Optional).
TalkForward: Permits the tester to speak through the test microphone into the
selected transducer at the intensity level set by the front panel
controls.
TalkBack: Allows the tester to listen to comments from the subject in the
testing booth.
Monitor: The monitor headset or monitor speaker can be used by the tester
to listen to Channel 1, Channel 2 and/orTalk Back signals.
WxDxH: 20inchesx15inchesx 12.6 inches(LCDraised)
50cmx39cmx32cm
Heightwith LCDlowered-6 inches(15cm)
Weight: 19 pounds 8.7kg
Shipping Weight: 30 pounds 13.6kg
Grason-
S
tadler GSI® 61 CLINICAL
Speech Channel 1 and
Channel 2
Signal Format
Special Test
Capabilities
Communications and
Monitoring
Dimensions and
Weight
vi 1761-0100 Rev. B

Instrument Specifications
90 Watts
Test Headset (Matched set TDH-50P) -------------------------------------------------- 8000-0063
BoneVibrator(B71) ----------------------------------------------------------------------- 8000-0130
Subject Response Handswitch ----------------------------------------------------------- 7874-0156
Test Microphone/Monitor Headset with coiled cord---------------------------------- 1761-9623
Talk Back Microphone -------------------------------------------------------------------- 8000-0039
PatchCords,6 ft.Grey (4/each) ---------------------------------------------------------- 4204-0505
Power Cord --------------------------------------------------------- (Country and voltage specific)
Instruction Manual - English ------------------------------------------------------------- 1761-0100
Instruction Manual - Spanish ------------------------------------------------------------- 1761-0104
GSI Suite Audiometic Data Management Software ----------------------------------- 1010-9600
CD Player ----------------------------------------------------------------------------------- 1761-9621
Stereo Tape Cassette ---------------------------------------------------------------------- 1761-9622
Speakers,Basic(90 dB) with cables(125 -16kHz) ------------------------------------- 1761-9630
Speakers, HighPerformance(96dB)with cables (125 -8kHz) ----------------------- 1761-9635
Booster Amplifier(220-240V)withcables,
for use with the High Performance Speakers only----------------------------------- 1761-9636
Booster Amplifier(100-120V)withcables,
for use with the High Performance Speakers only----------------------------------- 1761-9637
SoundFieldSystem,HighPerformance(102dB, 220-240V, 125 -8 kHz)
includes High Performance Speakers and BoosterAmp---------------------------- 1761-9638
SoundFieldSystem,HighPerformance(102dB, 100-120V, 125 -8 kHz)
includes High Performance Speakers and BoosterAmp---------------------------- 1761-9639
PairedInsert Phones(E•A•RTONETM 3A)----------------------------------------------- 1700-9606
E•A•RTONETM ReplacementFoamEartips,Std----------------------------------------- 1700-9604
E•A•RTONETM ReplacementFoamEartips,Small -------------------------------------- 1700-9605
Single Insert Phone (470) ----------------------------------------------------------------- 1700-9609
High Frequency Headphones w/booth cables ----------------------------------------- 1761-9602
High Frequency Cables (to sound booth) ---------------------------------------------- 1761-9603
(If using High Freq Headphones, these cables are required to connect to the GSI 61)
High Frequency Headphones w/cables to GSI 61 ------------------------------------- 1761-9604
High Frequency Cables (to GSI 61) ------------------------------------------------------ 1761-9605
(If using High Freq Headphones, these cables are required to connect to the GSI 61)
RemoteRS232/PrinterInterface---------------------------------------------------------- 1761-9680
Printer, Color (NorthAmerica only) ------------------------------------------------------ 1761-9610
Service Manual ----------------------------------------------------------------------------- 1761-0110
Audiocups ---------------------------------------------------------------------------------- 8000-0155
OtoAccess (Network Software for GSI Suite)--------------------------------------- 1015-9600
vii
Power Consumption
Accessories Supplied
Optional Accessories
1761-0100 Rev. B

Catalog Listings GSI61 Clinical Audiomete
r
withou
t
Remote
English ---------------------------------------------------------------------------------- 1761-9700-XX
E
French ----------------------------------------------------------------------------------- 1761-9700-XX
F
German ---------------------------------------------------------------------------------- 1761-9700-XX
G
Italian -----------------------------------------------------------------------------------1761-9700-XXI
Spanish --------------------------------------------------------------------------------- 1761-9700-XXS
GSI61 Clinical Audiometer withUSB Remote
English -------------------------------------------------------------------------------- 1761-9780-XXE
French --------------------------------------------------------------------------------- 1761-9780-XXF
German -------------------------------------------------------------------------------- 1761-9780-XXG
Italian -----------------------------------------------------------------------------------1761-9780-XXI
Spanish--------------------------------------------------------------------------------- 1761-9780-XXS
Notes -XX refers to the voltage and plug requirements for the country of operation.
Grason-
S
tadler GSI® 61 CLINICAL
viii 1761-0100 Rev. B

Electromagnetic Compatibility (EMC)
ix
1761-0100 Rev. B