GSi ALLEGRO User manual

HANDHELD
SCREENING
TYMPANOMETER
ALLEGRO
USER MANUAL

Title: GSI Allegro Tympanometer User Manual
Manufacturer
Grason-Stadler
10395 West 70
th
Street
Eden Prairie, MN 55344
USA
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.
This product incorporates software developed by others and redistributed according to license
agreements. Copyright notices and licenses for these external libraries are provided in a supplementary
document that is included with the other software applications distributed with this product.
Compliance
The CE 0123 mark identifies compliance with the Medical Device Regulation (EU) 2017/745 .
Grason-Stadler is an ISO 13485 certified corporation.
European Authorized 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 Allegro Tympanometer User Manual
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TABLE OF CONTENTS
TABLE OF CONTENTS .......................................................................................................................................................i
Preface ...........................................................................................................................................................................v
Manual Conventions............................................................................................................................................................v
Regulatory Symbols ............................................................................................................................................................vi
Device Symbols .................................................................................................................................................................viii
Important Safety Instructions.............................................................................................................................................ix
Precautions.........................................................................................................................................................................ix
Electromagnetic compatibility (EMC) considerations..........................................................................................................x
Warranty.............................................................................................................................................................................xi
Recycling / Disposal ............................................................................................................................................................xi
Introduction ...................................................................................................................................................................1
Indication for Use ............................................................................................................................................................... 1
Intended Use ...................................................................................................................................................................... 1
Contraindications................................................................................................................................................................ 2
Description and Operating Principles ................................................................................................................................. 2
Admittance measurement .............................................................................................................................................. 2
Tympanogram ................................................................................................................................................................. 2
Acoustic reflex measurement ......................................................................................................................................... 2
Installation .....................................................................................................................................................................4
External Inspection ............................................................................................................................................................. 4
Unpacking ........................................................................................................................................................................... 4
Standard contents .............................................................................................................................................................. 4
Initial Set Up ....................................................................................................................................................................... 5
Power supply ...................................................................................................................................................................... 5
Cradle Connections............................................................................................................................................................. 5
Cradle LED Indicators.......................................................................................................................................................... 6

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Handset ............................................................................................................................................................................. 7
Handset LED Indicators....................................................................................................................................................... 8
Handset probe .................................................................................................................................................................... 8
Printer ............................................................................................................................................................................. 8
Operation and Configuration ........................................................................................................................................10
Start-up and menu displays.............................................................................................................................................. 10
Main Menu Options ..................................................................................................................................................... 10
Configuration.................................................................................................................................................................... 11
Test sequence ............................................................................................................................................................... 13
Ear seal check................................................................................................................................................................ 13
Reflex levels .................................................................................................................................................................. 13
Reflex frequencies ........................................................................................................................................................ 13
Reflex selection ............................................................................................................................................................ 13
Reflex threshold ........................................................................................................................................................... 13
Reflex auto-stop ........................................................................................................................................................... 13
Reflex polarity .............................................................................................................................................................. 14
Reflex filter ................................................................................................................................................................... 14
Set Time/Date............................................................................................................................................................... 14
Power Off Delay............................................................................................................................................................ 14
LCD Contrast ................................................................................................................................................................. 14
Report Cal Date............................................................................................................................................................. 14
Set Date Format............................................................................................................................................................ 14
Hospital Name .............................................................................................................................................................. 14
Department .................................................................................................................................................................. 15
Reload Defaults ............................................................................................................................................................ 15
Language....................................................................................................................................................................... 15
Data Collection .............................................................................................................................................................16
Prior to testing and Ambient conditions........................................................................................................................... 16

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Ear tips ........................................................................................................................................................................... 16
Performing a test .............................................................................................................................................................. 17
Ear seal check ................................................................................................................................................................... 19
Error messages ................................................................................................................................................................. 23
Saving Results in the Database .....................................................................................................................................24
Data entry......................................................................................................................................................................... 24
Database full..................................................................................................................................................................... 25
Sending the Results to a Printer....................................................................................................................................26
Printing results.................................................................................................................................................................. 26
Data Management........................................................................................................................................................27
List records........................................................................................................................................................................ 27
Delete records .................................................................................................................................................................. 28
Print records ..................................................................................................................................................................... 28
Performing Daily Checks ...............................................................................................................................................29
Routine Maintenance ...................................................................................................................................................30
Cleaning the Allegro.......................................................................................................................................................... 30
Eartip and Probe ............................................................................................................................................................... 30
Calibration and Repair of the Instrument......................................................................................................................... 31
Elevation Adjustment.................................................................................................................................................... 31
Error Messages & Fault Conditions ...............................................................................................................................33
Ordering Consumables and Accessories........................................................................................................................35
Ear Tips – Single Use – Sanibel ADI Silicone...................................................................................................................... 35
Appendix - Menu Summary ..........................................................................................................................................36
Main menu........................................................................................................................................................................ 36
Sub-Menu selections ........................................................................................................................................................ 36
Appendix - Technical Specification................................................................................................................................40
Equipment classification ................................................................................................................................................... 44
Audiometric Standards ..................................................................................................................................................... 44

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Appendix - EMC Guidance & Manufacturer’s Declaration .............................................................................................45
Electromagnetic Compatibility ......................................................................................................................................... 45
Electrical Safety, EMC and Associated Standards............................................................................................................. 45
Appendix - Use with Non-medical Electrical Equipment................................................................................................51

GSI Allegro Tympanometer User Manual
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PREFACE
This user manual provides information about the GSI Allegro tympanometer. This manual is
intended for technically qualified personnel. Please note: This User Manual is not intended as a
training manual for tympanometry. The reader should consult standard audiology texts for the
theory and application of the screening tests provided by this instrument.
MANUAL CONVENTIONS
Throughout this manual, the following meaning of warnings, cautions and notices are used.
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
NOTE: Notes help you identify areas of possible confusion and avoid potential problems
during system operation

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REGULATORY SYMBOLS
Symbol Description
Conforms to the Medical Device Regulation (EU) 2017/745 .
Symbol for "SERIAL NUMBER."
GSI Part Number.
Return to Authorized Representative, Special disposal
required.
Symbol for “European Authorized Representative.”
Symbol for “Manufacturer.”
Symbol for “Date of Manufacture.”
Symbol for “Caution”
Type B Applied Part according to IEC 60601-1.
Consult Operating Instructions.
On/Off - Next to power mains.
Keep Dry.
This side up.

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Symbol Description
Consult the operating instructions/directions for use.
A copy of the operating manual is available on this website:
www.grason-stadler.com
A printed copy of the operating instructions can be ordered
from Grason-Stadler for shipment within 7 days; or you can
contact your local representative.
Consult the operating instructions/directions for use.
A copy of the operating manual is available on this website:
www.grason-stadler.com
A printed copy of the operating instructions can be ordered
from Grason-Stadler for shipment within 7 days; or you can
contact your local representative

GSI Allegro Tympanometer User Manual
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DEVICE SYMBOLS
The following symbols appear on the tympanometer, the instrument cradle or the mains adapter:
Definition: Consult operating instructions.
Definition: Type B applied part – an applied part providing protection against
electric shock, particularly regarding allowable patient leakage current and patient
auxiliary current.
The applied part is the ear tip.
Definition: The output from the mains AC adapter is Direct Current.
Definition: Class II equipment – equipment in which protection against electric
shock does not rely on basic insulation only, but in which additional safety
precautions such as double insulation or reinforced insulation are provided,
there being no provision for protective earth connection or reliance upon
installation conditions.
USB Definition: Industry-standard Type-B USB connection to a computer.
Definition: printer connection.