GSi PELLO User manual

Setting The Clinical Standard www.grason-stadler.com
Grason-Stadler, 10395 West 70th Street, Eden Prairie, Minnesota 55344
800-700-2282 • 952-278-4402 • fax [phone] • e-mail [email protected]
GSI PELLO™
USER MANUAL
O
Part Number D-0114341 Rev. C

Title: GSI Pello™ Audiometer User Manual
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.
Grason-Stadler
c/o DGS Diagnostics A/S
Audiometer Alle 1,
5500 Middelfart
Denmark
0123
Grason-Stadler
10395 West 70th Street
Eden Prairie MN 55344 USA

Table of Contents
Indication for Use .........................................................................................................................................6
Warranty....................................................................................................................................................6
Audiometric Standards..................................................................................................................................7
Warnings, Cautions, and Errors....................................................................................................................8
Status/Error Messages...............................................................................................................................9
Customer Responsibility .........................................................................................................................10
Elimination of Ambient Noise ................................................................................................................10
Safety Precautions.......................................................................................................................................13
Cautions - General...................................................................................................................................14
Warning - Connecting Additional Equipment.........................................................................................14
Warning - Electric Shock Hazards..........................................................................................................14
Warning - Electric Grounding.................................................................................................................15
Warning - Explosion ...............................................................................................................................15
Warning - Line Voltage Brownout and Interruptions .............................................................................15
Warning - Connections............................................................................................................................15
Warning - Battery Safety.........................................................................................................................15
Warning - General...................................................................................................................................15
Shutdown Procedure................................................................................................................................15
Recycling / Disposal................................................................................................................................15
Regulatory Symbols....................................................................................................................................17
Audiometric Symbols .................................................................................................................................19
Chapter 1: Introduction...............................................................................................................................21
Chapter 2: Installation.................................................................................................................................22
External Inspection..................................................................................................................................22
Unpacking ...............................................................................................................................................22
Accessories..............................................................................................................................................23
Chapter 3: Connectors, Controls and Indicators.........................................................................................25
Rear Panel ...............................................................................................................................................25
Right Side Panel......................................................................................................................................27
Left Side Panel ........................................................................................................................................27
Bottom Panel Label.................................................................................................................................28
Chapter 4: Front Panel Controls..................................................................................................................29
Power.......................................................................................................................................................29
Stimulus Intensity Level(s) .....................................................................................................................29

Talk Forward...........................................................................................................................................30
Interlock ..................................................................................................................................................30
Tracking ..................................................................................................................................................30
Status / Audiogram Button......................................................................................................................30
Data Transfer...........................................................................................................................................30
Printing....................................................................................................................................................31
Stimulus Channel 1 .................................................................................................................................34
Stimulus Channel 2 .................................................................................................................................34
Transducer Output Selector.....................................................................................................................35
Routing Output........................................................................................................................................35
Attenuators (HL Controls).......................................................................................................................36
Channel 1 Present Bar / Interrupt............................................................................................................36
Channel 2 Interrupt Button......................................................................................................................36
Frequency Up / Down .............................................................................................................................36
Data Store................................................................................................................................................36
Navigation Controls ................................................................................................................................37
Scorer / Timer..........................................................................................................................................37
Monitoring...............................................................................................................................................37
Test Type Buttons ...................................................................................................................................37
Function Buttons.....................................................................................................................................38
Chapter 5: Test Type Displays....................................................................................................................39
Monitor....................................................................................................................................................39
Tone Test Type - Audiogram..................................................................................................................41
Tone Test Type - Status...........................................................................................................................45
Speech Test Type - Status.......................................................................................................................46
Speech Test Type - Audiogram...............................................................................................................51
More Test Type.......................................................................................................................................52
Chapter 6: Operation...................................................................................................................................53
Preliminary Checks .................................................................................................................................53
Typical Evaluations.................................................................................................................................54
Test Type Buttons ...................................................................................................................................54
Routine Test Procedures..........................................................................................................................56
Threshold Determination (Pure Tone): Modified Hughson-Westlake....................................................56
Spondaic Speech Testing, Speech Reception Threshold (SRT)..............................................................57
Word Recognition (PB Words)...............................................................................................................57
Stenger test..............................................................................................................................................58

Chapter 7: Application Software & Integration..........................................................................................59
Config App..............................................................................................................................................59
Instrument................................................................................................................................................60
Audiometry..............................................................................................................................................60
GSI Instrument Services..........................................................................................................................61
GSI Suite.................................................................................................................................................62
OtoAccess™............................................................................................................................................62
Noah 4 .....................................................................................................................................................62
AudBase..................................................................................................................................................62
Chapter 8: Routine Maintenance.................................................................................................................63
Biological Calibration Check..................................................................................................................63
Periodic Checks.......................................................................................................................................63
Earphone and Bone Vibrator Cords ........................................................................................................63
Hum and Noise........................................................................................................................................63
Distortion and Frequency Shift ...............................................................................................................63
Speech Level Check................................................................................................................................64
Internal Controls Check...........................................................................................................................64
Bone Vibrator Check...............................................................................................................................64
Masking Level Check..............................................................................................................................64
Talk Forward Check................................................................................................................................64
Cleaning the System................................................................................................................................64
Cleaning and Disinfecting Agents...........................................................................................................65
Chapter 9 Optional Features and Functionality..........................................................................................66
High Frequency License..........................................................................................................................66
Special Test License................................................................................................................................68
ABLB ....................................................................................................................................................70
SISI.......................................................................................................................................................72
TEN Test ..............................................................................................................................................74
Tone Decay.......................................................................................................................................... 76
Speech Plus License................................................................................................................................78
More Test Type ................................................................................................................................... 78
BKB-SIN ...............................................................................................................................................79
QuickSIN..............................................................................................................................................83
AZBio and AZBio Pediatric................................................................................................................... 86
Appendix 1: Specifications.........................................................................................................................87

Appendix 2: Calibration Reference & Maximum Levels ...........................................................................90
Earphones - Pure Tone RETSPL.............................................................................................................91
Earphones - ANSI Speech RETSPL .......................................................................................................92
Earphones - IEC Speech RETSPL ..........................................................................................................93
Earphones - Pure Tone max HL..............................................................................................................94
Earphones - NB noise effective masking level........................................................................................95
Earphones - NB noise max HL................................................................................................................96
Earphones - ANSI Speech max HL.........................................................................................................97
Earphones - IEC Speech max HL............................................................................................................97
Insert Earphones - Pure Tone RETSPL...................................................................................................98
Insert Earphones - ANSI Speech RETSPL .............................................................................................99
Insert Earphones - IEC Speech RETSPL ................................................................................................99
Insert Earphones - Pure Tone max HL..................................................................................................100
Insert Earphones - NB noise effective masking level ...........................................................................101
Insert Earphones - NB noise max HL ...................................................................................................102
Insert Earphones - ANSI Speech max HL.............................................................................................103
Insert Earphones - IEC Speech max HL................................................................................................103
Bone Vibrators - Pure Tone RETFL .....................................................................................................104
Bone Vibrators - ANSI Speech RETSPL..............................................................................................105
Bone Vibrators - IEC Speech RETSPL.................................................................................................105
Bone Vibrators - Pure Tone max HL ....................................................................................................106
Bone Vibrators - NB noise effective masking level..............................................................................107
Bone Vibrators - NB noise max HL......................................................................................................108
Bone Vibrators - ANSI Speech max HL...............................................................................................109
Bone Vibrators - IEC Speech max HL..................................................................................................109
Free Field Speakers –ANSI RETSPL and Max HL.............................................................................110
Appendix 4: EMC Compatibility..............................................................................................................112
Electromagnetic Compatibility..............................................................................................................113
Electrical Safety, EMC and Associated Standards................................................................................113
Guidance and Manufacturer’s Declaration - Electromagnetic Emissions.............................................113
Recommended Separation Distances between Portable and Mobile RF Communications Equipment and
the GSI Pello .........................................................................................................................................114
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity .............................................114
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity .............................................115
Appendix 4: Reference Materials .............................................................................................................117

Indication for Use
The GSI Pello 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 as defined in ANSI S3.1 or
equivalent.
Intended Use
The GSI Pello is intended to be used for the purposes of determining patient
hearing sensitivity. It is intended to quantify the patient's level of hearing by
presenting pure tone stimuli through specific transducers at different frequencies
and at different sound pressure levels.
Caution US Federal law restricts this device to sale by or on the order of a physician or
licensed hearing care professional.
Description This instrument is a 1.5 channel audiometer. This instrument has functionality
that makes it ideal for testing in Ear, Nose and Throat (ENT) physicians’ offices,
hospitals, clinics and audiology private practices. The tests are administered via
headphones –supra-aural, circum-aural, or insert phones –or through a bone
vibrator or sound field speakers. User defined test protocols allow for basic
audiometric testing as well as detailed evaluations to assist in diagnosis of
audiologic pathologies. Careful handling of instrument transducers and testing
performed by a properly trained instrument operator should be of high priority.
The patient is to remain relaxed and still while testing is being performed for
optimal accuracy.
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.

Audiometric Standards
The Pello is designed to meet or exceed the following standards:
Audiometer Standard Requirements - Type 2
1. ANSI S3.6 (2010) Specification for Audiometers (Type 2)
2. IEC 60645-1 (2012) Electroacoustics - Audiological Equipment - Pure-
Tone Audiometers Type 2
3. IEC 60645-2 (1993) Electroacoustics - Audiological Equipment -
Equipment for Speech Audiometry Type B
4. ISO 389-1 Reference Equivalent Threshold SPLS for Pure Tones and
Supra-Aural Earphones
5. ISO 389-2 Reference Equivalent Threshold SPLS for Pure Tones and
Insert Earphones
6. ISO 389-3 Reference Equivalent Threshold Force Levels for Pure Tones
and Bone Vibrator
7. ISO 389-4 Reference Levels for Narrow-Band Masking Noise
8. ISO 389-5 Reference Equivalent Threshold SPLS for Pure Tones in the
Frequency Range 8 kHz to 16 kHz
9. ISO 389-7 Reference zero for the calibration of audiometric equipment
10. ISO 389-8 Reference zero for the calibration of audiometric equipment

Warnings, Cautions, and Errors
The GSI Pello Audiometer is designed to be used with a hospital grade outlet.
Injury to personnel or damage to equipment can result when a three-prong to
two-prong adaptor is connected between the GSI Pello power plug and an AC
outlet or extension cord.
Warning! To avoid the risk of electric shock, this equipment must only be connected to
supply mains with protective earth.
Do not block access to the power switch. Do not position the GSI Pello ME
EQUIPMENT so that it is difficult to operate the disconnection device.
Audiometers should be interconnected with accessories that have the proper
electrical compatibility Connection of accessories not meeting these electrical
compatibility 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.
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.
This icon indicates that the GSI Pello is in compliance with applied part Type B
requirements ofIEC60601-1.
The GSI Pello is designed for compliance to IEC and ES 60601-1 when used in
the patient vicinity.
In the presence of high intensities, a yellow light will appear per channel as a
warning indictor (IEC 60645-1 and ANSI S3.6).
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.
Warning! No modifications of the equipment are allowed by anyone other than a qualified
GSI representative.
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.

The CAUTION label identifies conditions or practices that could result in
damage to the equipment.
NOTE: Notes help identify areas of possible confusion and avoid potential
problems during system operation.
Status/Error Messages
Please try another selection: Indicates an incorrect selection. This could include
actions such as incompatible transducers, incompatible routing, or no calibration
data stored for the selected transducers.
No test data stored: Indicates that there is no test data available to be erased,
printed or transferred.
Printer communication error: If communication problems occur during the
course of printing, this error message will be displayed.
Error: If there are general system errors, a dialog box with “Error” in the title
will be shown with the given error.
Record test result in comments: Test results of the ABLB and Tone Decay are
not recorded directly on the report. This message indicates that the results should
be documented in the comments.
The startup configuration for this test type is not fully calibrated; a search
for a different configuration that is calibrated has found the currently
displayed configuration: This message indicates that the selected transducers
have not been calibrated.
The session comments have been updated with the results of the SDT test:
This message indicates that the stored speech detection threshold results will
appear in the comments section and will be printed directly or transferred
electronically.
Not supported in speech: The selected action is not supported in the speech test
type.
Speech data limit exceeded, speech tables limited to 6 test results per ear.
Latest test result will not be saved: Up to six speech tests may be stored in each
ear. This message indicates that the maximum number of tests has been stored
and the latest test has not been added.