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.

Customer Responsibility
Warning! This product and its components will perform reliably only when operated and
maintained in accordance with the instructions contained in this manual,
accompanying labels, and/or inserts. A defective product should not be used.
Make sure all connections to external accessories are snug and secured properly.
Parts which may be broken or missing or are visibly worn, distorted or
contaminated should be replaced immediately with clean, genuine replacement
parts manufactured by or available from GSI.
This product should not be used in the presence of fluid that can come into
contact with any of the electronic components or wiring. Should the user suspect
fluids have contacted the system components or accessories, the unit should not
be used until deemed safe by a GSI certified service technician.
Do NOT use in the presence of flammable gaseous mixtures. Users should
consider the possibility of explosions or fire when using this device in close
proximity to flammable anesthetic gases.
Do NOT use the Pello in a highly oxygen-enriched environment, such as a
hyperbaric chamber, oxygen tent, etc.
Periodically, have a service technician perform electrical safety checks on the
unit in order to maintain continued compliance to IEC and ES 60601-1.
Equipment is not user repairable. Repairs and battery replacement must be
performed by a qualified service representative only. GSI will make available
any instructions and diagrams to repair devices that it deems appropriate to be
repaired in the field.
Elimination of Ambient Noise
The GSI Pello may be installed in a single room environment or as part of a two
room suite.
Excessive noise in the test environment, such as that produced by conversation,
office equipment, or printers, reduces test validity because it tends to mask the
test signals. This is especially true at the lower frequencies where earphone
cushions provide less effective attenuation. A room that attenuates sound may be
required if ambient noise at the patient’s ears reaches levels sufficient to cause
apparent hearing loss at the lower frequencies.
The following table shows the maximum background levels that can be present
inside the room while a valid hearing test is being conducted. These values apply
for hearing threshold measurements to 0 dB HL.

Maximum Ambient Noise
Test Tone Freq. (Hz)
125
250
500
750
1000
1500
2000
3000
4000
6000
8000
Test Room level Max
dB SPL, Ears covered
29.0
17.5
14.5
16.5
21.5
21.5
23.0
28.5
29.5
33.0
38.5
Max dB SPL,
Ears not covered
23.0
13.5
9.5
7.5
9.0
5.5
3.5
3.5
4.0
9.0
5.5
Notes: Maximum permissible 1/3 octave band level. If the Hearing Level to be measured is -10 dB
HL, then 10 dB should be subtracted from the levels listed in this table.
NOTE: A room providing sound isolation from ambient noise is highly
recommended so that hearing threshold values may be obtained. If a separate
examination (sound) room is used, it is considered sufficiently quiet for the
purposes of these tests if a group of otologically “normal” listeners with their
ears occluded is unable to detect any ambient noise during the test period. See
ANSI S3.1 (R2003) Criteria for Permissible Ambient Noise during Audiometric
Testing for maximum allowable outside octave band noise levels with three
prefabricated sound room types.
NOTE: Live voice testing requires a separate sound attenuated room for the
patient in order to avoid feedback and direct transmission of the test stimuli.

Sound Attenuation
Sound Attenuation for Earphones per ISO 4869-1
Frequency
(Hz)
Attenuation
DD45 with
MX41/AR or
PH51 Cushion
(dB)
IP30 inserts
(dB)
DD450
(dB)
HDA 300
(dB)
125
3
33.5
14.5
12.5
160
4
200
5
250
5
34.5
16
12.7
315
5
400
6
500
7
34.5
22.5
9.4
630
9
750
-
800
11
1000
15
35.0
28.5
12.8
1250
18
1500
-
1600
21
2000
26
33.0
32
15.1
2500
28
3000
-
3150
31
4000
32
39.5
45.5
28.8
5000
29
6000
-
6300
26
8000
24
43.5
44
26.2

Safety Precautions
The following safety precautions must be observed at all times. General Safety
precautions must be followed when operating electrical equipment. Failure to
observe these precautions could result in damage to the equipment and injury to
the operator or patient.
The employer should instruct each employee in the recognition and avoidance of
unsafe conditions and the regulations applicable to his or her work environment
to control or eliminate any hazards or other exposure to illness or injury.
It is understood that safety rules within individual organizations vary. If a
conflict exists between the material contained in this manual and the rules of the
organization using this instrument, the more stringent rules should take
precedence.
This device should only be used by hearing health care professional such as an
audiologist, otolaryngologist, researcher or a technician under the direct
supervision by the aforementioned specialist. 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.
The maximum sound levels (over 100 dB HL) that can be generated by the
system can cause serious injury to the ear. Before attaching the earphones to the
patient, ensure that:
a. The system is running.
b. The hearing levels in the test set to be used are appropriate.
c. A biologic check of the stimulus has been performed by the operator.
The customer is responsible for maintaining all system software in a safe, secure
location.
Do not use extension cords with this instrument or for the Isolation Box. If
extension cords are used they can cause ground integrity and impedance
problems.
In addition to electrical safety considerations, poorly earthed mains power outlets
could cause inaccurate test results due to the introduction of electrical
interference from the mains.
ANY EQUIPMENT CONNECTED TO THE GSI INSTRUMENT AND USED
IN THE PATIENT VICINITY MUST BE POWERED BY AN ISOLATED
POWER SOURCE TO MAINTAIN THE ELECTRICAL SAFETY OF THE
OVERALL SYSTEM. The isolated power source can be purchased directly from
GSI, or elsewhere when approved for use by GSI.
The operator should take care to not make contact with the computer or printer
and the patient at the same time.

Cautions - General
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.
Warning - Connecting Additional Equipment
External equipment intended for connection to signal input, signal output or other
connectors shall comply with the relevant product standard e.g. IEC 60950-1 for
IT equipment and the IEC 60601-series for medical electrical equipment. In
addition, all such combinations –Medical Electrical Systems –shall comply with
the safety requirements stated in the collateral standard IEC 60601-1-1 or the
general standard IEC 60601-1, edition 3, clause 16. Any equipment not
complying with the leakage current requirements in IEC 60601-1 shall be kept
outside the patient environment i.e. at least 1.5 m from the patient support or
shall be supplied via a separation transformer to reduce the leakage currents.
Any person who connects external equipment to signal input, signal output or
other connectors has formed a Medical Electrical System and is therefore
responsible for the system to comply with the requirements. If in doubt, contact
qualified medical technician or your local representative.
A Separation Device (isolation device) is needed to isolate the equipment located
outside the patient environment from the equipment located inside the patient
environment. In particular such a Separation Device is required when a network
connection is made. The requirement for the Separation Device is defined in IEC
60601-1-1 and in IEC 60601-1, edition 3, clause 16.
The AC power outlets on the isolated transformer/power box are intended for use
with GSI approved components only. Use of any other equipment may result in
damage to the power unit. Follow all safety standards set by each place of
employment.
NOTE: If the instrument is connected to a PC, power to the monitor and
computer must be controlled by the isolation transformer. Always leave the
monitor and computer power switches in the ON position and control power from
the isolation transformer. Always turn OFF system power before connecting or
disconnecting system components to help guard against personal injury.
Warning - Electric Shock Hazards
Do not open the case of the GSI Instrument. Do not remove any GSI instrument
covers. Refer servicing to qualified personnel.

Warning - Electric Grounding
This device uses a three wire power cord with a hospital grade plug (for
international applications, IEC 60601-1 approved plug). The chassis is earth
grounded. For grounding reliability, connect the device to a hospital grade or
hospital only receptacle (for non US applications, IEC 60601-1 approved
receptacle). Inspect the power cord often for fraying or other damage. Do not
operate the apparatus with a damaged power cord or plug. Improper grounding is
a safety hazard. Periodically check the system ground integrity.
Warning - Explosion
This system is not explosion proof. Do not use in the presence of flammable
anesthetics or other gases.
Warning - Line Voltage Brownout and Interruptions
There are four (4) UV detectors in the digital domain, two (2) over current
detectors in the analog domain, one for USB and four (4) OV/UV detectors on
the main supply lines. If just ONE fails, all output to the transducers will be
muted.
Warning - Connections
Do not switch on any system power until all cables have been properly connected
and verified. See this manual, which accompanies all deliveries of the system, for
setup instructions. Switch off the system power before connecting or
disconnecting any system component(s) or accessories.
Warning - Battery Safety
This instrument contains a coin-type lithium battery for a real time clock. The life
expectancy of the battery is 10 years. 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.
Warning - General
Proper use of this device depends on careful reading of all instructions and labels.
Follow all safety standards set by each place of employment.
Shutdown Procedure
To turn off the GSI Pello, use the power switch on the right side of the device.
Recycling / Disposal
Many local laws and regulations require special procedures to recycle or dispose
of electrical equipment and related waste including batteries, printed circuit

boards, electronic components, wiring and other elements of electronic devices.
Follow all local laws and regulations for the proper disposal of batteries and any
other parts of this system.
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 Diagnostic A/S
Audiometer Alle 1
5500 Middelfart
Denmark
Within the European Union, it is illegal to dispose of electric and electronic items
in unsorted municipal waste. Electric and electronic waste may contain
hazardous substances and therefore has to be collected separately. Such products
will be marked with the crossed-out wheeled bin symbol, shown below. The
cooperation of the user is important in order to ensure a high level of reuse and
recycling of electric and electronic waste. Failing to recycle such waste products
in an appropriate way may endanger the environment and consequently the
health of human beings.

Regulatory Symbols
No.
Symbol
Description
1
Conforms to European Medical Device Directive 93/94/EEC. Classified
under the Medical Device Directive (93/42/EEC) as a Class IIb device.
2
GSI Part number and model
3
Symbol for "SERIAL NUMBER."
4
Return to Authorized Representative, Special disposal required.
5
Medical Equipment Classified by Intertek Testing Services NA Inc.
with respect to electric shock, fire, and mechanical hazards only, in
accordance with UL 60601-1. Classified under the Medical Device
Directive (93/42/EEC) as a Class IIa device.
6
Symbol for “European Representative.”
7
Symbol for “Manufacturer.”
8
Symbol for “Date of Manufacture.”
9
Attention, consult accompanying documents.
10
Type B Patient Applied Part according to IEC 60601-1.
11
Consult Operating Instructions.
12
or
On/Off - Next to power mains.
13
Keep Dry.
14
This side up.

No.
Symbol
Description
15
Patient response switch.
16
Follow Instructions for Use.
17
China RoHS compliance.

Audiometric Symbols
The Pello can support different symbol sets to accommodate the conventions in
different countries. The country symbol sets that are supported include:
•Australia
•China
•Hong Kong
•UK
•USA
The Pello Configuration Application (Config App) allows the selection of the
desired symbol set. The symbol sets are shown in the following table. For
symbols that are not specified in the reference documents for specific countries,
the USA symbols are used.
Abbreviations used in the following symbol set table
AC: Air Conduction
NR: No Response
BC: Bone Conduction
SF: Sound Field
MCL: Most Comfortable Level
UCL: Uncomfortable Level