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.

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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

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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

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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.

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IMPORTANT SAFETY INSTRUCTIONS
WARNING
The GSI Allegro instrument must be used only by medical professionals including,
but not limited to, Physicians, Physician Assistants, Nurse Practitioners, Nurses,
Audiologists and Medical Technologists knowledgeable in the theory and
application of the screening tests provided by this instrument. It is intended for transient use as
a screening and diagnostic tool; however, no surgical or medical procedure should be undertaken
solely based on results obtained from the instrument.
PRECAUTIONS
READ THIS USER MANUAL BEFORE ATTEMPTING TO USE THE
INSTRUMENT
In case of death or serious incident in relation to the use of the device, the incident must
immediately be reported to Grason-Stadler and the local national competent authority.
Users should use their professional skills when interpreting the results and this should be done
in conjunction with other testing as deemed appropriate given their professional skills. Incorrect
use could lead to wrong results.
To comply with the standards IEC 60601-1 for safety and IEC 60601-1-2 for EMC the
tympanometer is designed to be used only with the medically-approved mains adapter supplied,
which is specified as part of the equipment. Do not use any other type of mains adapter with
this instrument.
The tympanometer is for indoor use only and should be used only as described in this manual.
Before the first use of the instrument each day, or if suspect or inconsistent results are apparent,
the checks specified in the Performing Daily Checks section should be carried out. If the system
is not functioning properly, do not operate it until all necessary repairs are made and the unit is
tested and calibrated for proper functioning in accordance with Grason-Stadler published
specifications.
Never insert the probe into a patient’s ear canal without a suitable ear tip fitted to the probe.
Use only the recommended disposable ear tips. These are for single use only - that is, each ear
tip is intended to be used once only for a single ear for a single patient. Do not reuse ear tips as
this will pose the risk of ear-to-ear or patient-to-patient cross infection.

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Latex is not used anywhere in the manufacturing process. The base material for the ear tips is
made from silicone rubber.
Do not immerse the unit in any fluids. See the Routine Maintenance Section of this manual for
the proper cleaning procedure for the instrument and its accessories and the function of single-
use parts.
Do not use the instrument in an oxygen-rich environment or in the presence of a flammable
anesthetic mixture or other flammable agents.
Thermal paper printouts fade with exposure to light or heat. Photocopying the patient record
test results will ensure a more permanent record is kept.
Do not drop or otherwise impact this instrument. If the instrument is dropped or damaged, return
it to the manufacturer for repair and/or calibration. Do not use the instrument if any damage is
suspected.
The instrument must be stored and used indoors within the specified temperature, pressure and
humidity ranges.
As with all instruments of this nature the measurements taken will be influenced by significant
changes in elevation and pressure. The GSI Allegro tympanometer should be re-calibrated at the
intended operating elevation.
Do not attempt to open, modify or service the instrument. Return the instrument to the
manufacturer or distributor for all repair and servicing requirements. Opening the instrument
will void the warranty.
This instrument contains a rechargeable Nickel-Metal Hydride (NiMH) battery-pack. The battery
is not intended to be changed by the user. Batteries may explode or cause burns, if disassembled,
crushed or exposed to fire or high temperatures. Do not short-circuit.
ELECTROMAGNETIC COMPATIBILITY (EMC) CONSIDERATIONS
Medical electrical equipment needs special precautions regarding EMC and needs to be installed
and put into service according to the EMC information in the Appendix. This provides guidance
on the electromagnetic environment in which to operate the instrument.
Portable and mobile radio-frequency (RF) communications equipment can affect medical
electrical equipment. The instrument should not be used adjacent to or stacked with other
equipment; if this is unavoidable the instrument should be observed to verify normal operation.

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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.The
pressure pump and transducers may go out of calibration due to rough handling or impact
(dropping). The lifetime of probe, probe seals and eartips is dependent upon conditions of
use. These parts are only guaranteed against faulty materials or manufacture.
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.
RECYCLING /DISPOSAL
Directive 2002/96/EC-WEEE:
Disposal of noncontaminated electrical and electronic equipment
Many local laws and regulations require special procedures to recycle or dispose of
electrical equipment-related waste including batteries, printed circuit boards,
electronic components, wiring and other elements of electronic devices. Follow all your
respective local laws and regulations for the proper disposal of batteries and any other parts of
this system. Do not dispose of this product as unsorted municipal waste. Prepare this product
for reuse or separate collection as specified by Directive 2002/96/ EC of the European Parliament
and the Council of the European Union on Waste Electronic and Electrical Equipment (WEEE). If
this product is contaminated, this directive does not apply. Below is the contact address 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:
Grason-Stadler
c/o DGS Diagnostics A/S
Audiometer Alle 1
5500 Middelfart
Denmark

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INTRODUCTION
Thank you for purchasing a GSI Allegro, a hand-held, portable tympanometer that will give many
years of reliable service if treated with care. The instrument performs two types of
measurement:
Tympanometry is used to measure the admittance of the tympanic membrane and middle ear
at a fixed frequency over a range of pressures.
Acoustic Reflex tests are used to measure stapedial reflexes. The Allegro measures ipsilateral
reflexes and, when selected, reflex measurement is automatically carried out after a
tympanogram is taken.
Features
•Automatic measurement of ear canal volume, tympanic admittance peak, placement of
the peak and the gradient
•Automatic detection of stapedial reflexes
•Up to 32, dual-ear patient tests can be stored in non-volatile memory
•Configurable settings for user preferences, held in non-volatile memory
•Printout of data to a printer
•English, German, French, Spanish, Portuguese or Italian operating language (selectable by
the user)
INDICATION FOR USE
The GSI Allegro is intended to be used for the measurement of acoustic impedance/admittance
within the human external ear canal. These measures are useful in the evaluation, identification,
documentation and diagnosis of ear disorders. The device is intended to be used on patients of
any age.
INTENDED USE
The GSI Allegro is intended to be used by an audiologist, ear nose and throat physician (ENT),
hearing healthcare professional, or trained technician. The GSI Allegro is intended to be used in
a hospital, clinic, or other healthcare facility with a suitable quiet testing environment such as a
private exam room.

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CONTRAINDICATIONS
Ear canal examination with an illuminated otoscope is an essential prerequisite to successful
middle-ear testing. Make sure that the canal is free of any obstruction. If the canal is completely
plugged at the entrance or if fluid is running from the ear canal, tympanometry should not be
attempted until the condition is cleared. Testing should not be performed on patients with
conditions listed below without a medical doctor’s approval.
•Recent stapedectomy or another middle ear surgery
•Discharging ear
•Acute external auditory canal trauma
•Discomfort (e.g. severe otitis externa)
•Presence of tinnitus, hyperacusis or other sensitivity to loud sounds may contraindicate
testing when high intensity stimuli are used
DESCRIPTION AND OPERATING PRINCIPLES
The GSI Allegro is clinical aural acoustic impedance/admittance instrument (Type 2). The main
components of the instrument consist of a handheld unit with an LCD and a probe assembly and
a cradle. A printer, eartips and test cavity are included with the system.
The probe contains one microphone, two receivers and an air channel. One of the receivers is
used for probe tone signal. The second receiver is used for the acoustic reflex stimulus signal.
The microphone measures the response. The air channel is connected to the pump system which
makes it possible to supply the eardrum with air pressure
ADMITTANCE MEASUREMENT
The Allegro measures the admittance of the tympanic membrane and middle ear by playing a
continuous 226Hz tone into the ear canal at a level calibrated to give 85dB SPL into a 2ml cavity.
The sound level this produces in the ear canal is measured using a microphone and the
admittance calculated from the result. In line with normal audiometric practice admittance is
displayed as an equivalent volume of air in ml.
TYMPANOGRAM
To record the tympanogram the admittance is measured while the air pressure in the ear canal
is varied from +200daPa to -400daPa by means of a small pump. The admittance peaks when the
air pressure is the same on both sides of the tympanic membrane. The changing admittance with
pressure is displayed as a graph.
ACOUSTIC REFLEX MEASUREMENT
Using the same principle, it is also possible to establish whether an acoustic reflex is present. In
this case, the 226Hz tone is used to measure the admittance of the ear, while a short tone at a

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different frequency is presented (the reflex stimulus). The sound pressure level (SPL) of this
stimulus is increased in steps until the middle ear muscles respond causing the tympanic
membrane to become stiffer, or a preset maximum SPL is reached. When the change in
admittance exceeds a predetermined threshold, this constitutes a reflex and the change in
admittance at that level when the stimulus is applied is displayed as a plot against time.
The acoustic reflex is measured at the static ear canal pressure that produces the maximum
membrane admittance, so reflex measurements are taken after the tympanogram is measured
when the peak admittance pressure has been established.
The Allegro can measure an acoustic reflex at any combination of 500Hz, 1000Hz, 2000Hz and
4000Hz. The maximum level for the reflex stimulus may be preset, along with the step size in dB
between the three preceding lower levels of stimulus.

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INSTALLATION
EXTERNAL INSPECTION
Although this GSI Allegro was carefully tested, inspected, and packed for shipping, it is good
practice after receiving the instrument to immediately examine the outside of the container for
any signs of damage. Notify the carrier if any damage is observed.
UNPACKING
Please retain the carton and packaging as the tympanometer will need calibrating on an annual
basis and should be returned to the distributor or GSI in its original shipping carton.
Please check the contents of the shipping carton against the delivery note to make sure that all
items ordered have been included. If anything is missing, please contact the distributor who
supplied the tympanometer or GSI.
STANDARD CONTENTS
•GSI Allegro handset
•Instrument cradle
•Mains power adapter
•4 in 1 calibration test cavity
•Sample kit of disposable ear-tips
•Floss Cleaning Kit
•Carrying case
•User Manual (on USB Drive)
•USB cable (A/B 2 meters)
•Calibration certificate
•Portable printer, cables and additional printer paper

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INITIAL SET UP
Place the cradle on a stable counter or table where it will be used. The location should be near a
properly grounded wall outlet. When placing the handset in the cradle make sure that the
connectors on the handset and cradle align.
POWER SUPPLY
The GSI Allegro tympanometer is designed for continuous operation and is powered by a
rechargeable Nickel-Metal Hydride (NiMH) battery-pack which is fitted in the instrument. If the
instrument is placed onto its cradle the battery within it will be charged.
The mains adapter is supplied and specified as part of the equipment. Connect the output lead
from the adapter into the power socket on the rear of the instrument cradle. Switch on the mains
supply - the indicator on the adapter will illuminate green. The mains adapter is the mains
disconnect device and therefore the tympanometer should be positioned such that easy access
to the mains adapter is possible.
The output from the mains adapter is fitted with electronic circuit protection. In case of overload
the adapter will shut down and the indicator will be off. When the fault is cleared the adapter
will operate as normal.
The input to the mains adapter is protected with a non-replaceable fuse. If this fails, the adapter
will not operate and will need to be replaced.If a replacement mains adapter is required, please
contact your Grason-Stadler distributor.
CRADLE CONNECTIONS
The cradle connections are labeled to ensure correct identification and connection as follows:

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Socket Label
Socket Type
Connected Part
RJ12 socket
Supplied printer *
5V 0.2A
2.5mm power jack
Mains AC/DC Adapter *
USB
USB connector
Type B
Computer (via USB port)
WARNING
For connected parts marked * only connect the parts or accessories supplied with
the instrument or supplied by Grason-Stadler or a Grason-Stadler distributor. These
parts have been tested for use with the GSI Allegro tympanometer for compliance
with the standards IEC 60601-1 and IEC 60601-1-2. The use of accessories other than those
specified may compromise compliance with these standards.
CRADLE LED INDICATORS
The LED indicators on the instrument cradle show the status of the mains connection and the
battery charging.
LED displays green when power is applied to the cradle;
otherwise it will be off.
LED shows green when the handset is in the cradle and its
internal battery pack is charging; it will be off when the
handset is removed.

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HANDSET
Press the On/Off key momentarily to turn the GSI Allegro on (refer to the diagram above). No
warm-up time is required, although a short diagnostic routine will run for a few seconds. During
this time the internal pump will operate. To switch off, again press and hold the On/Off key for a
few seconds.
Press the up ▲and down ▼navigation keys to scroll through the menus or set values
Press the right navigation key ►to accept a menu choice or go to the next step.
Press the left navigation key ◄to cancel an operation or go back to the previous step.
The function of the left and right keys is usually shown on the bottom line of the display.
When not located in the cradle and not performing a test the GSI Allegro will switch off
automatically if no key is pressed for 90 seconds. This time may be extended to 180 seconds in
the CONFIGURATION menu.
Probe
LED
Indicators
LCD
Display
Navigation
Keys
On/Off
Key