Grason-Stadler GSI NOVUS User manual

NEWBORN
AABR/OAE
SCREENER
NOVUS
USER MANUAL

Title: GSI Novus™ Newborn Hearing Screening System
User Manual
Manufacturer
Grason-Stadler, Inc.
10395 West 70
th
Street
Eden Prairie, MN 55344
USA
Copyright © 2020 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 may incorporate 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 Directive
93/42/EEC. Grason-Stadler is an ISO 13485 certified corporation.
European Authority 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 Novus™ Newborn Hearing Screening System User Manual
D-0113050 Rev H Page 3 of 96
TABLE OF CONTENTS
TABLE OF CONTENTS ................................................................................................................. 3
Preface......................................................................................................................................... 9
Manual Conventions .............................................................................................................. 9
Regulatory Symbols..............................................................................................................10
Device Symbols .....................................................................................................................11
Warnings and Cautions............................................................................................................ 12
Important Safety Instructions .............................................................................................12
Safety Precautions................................................................................................................12
Explosion ............................................................................................................................... 14
Environmental factors..........................................................................................................14
Electromagnetic compatibility (EMC) considerations ....................................................... 14
Introduction ..............................................................................................................................15
Indications for Use................................................................................................................15
Contraindications ................................................................................................................. 15
Features .................................................................................................................................15
ABR .....................................................................................................................................15
DPOAE ................................................................................................................................16
TEOAE .................................................................................................................................16
Novus cradle.......................................................................................................................... 16
Novus PC software program Option - HearSIM™ ............................................................. 16
Printing options..................................................................................................................... 16
Unpacking the system.............................................................................................................. 17
Standard Components - general.........................................................................................17
ABR-related Components ....................................................................................................17
Transducers (included as selected at time of purchase).................................................. 18
Disposables supplied with Insert earphones with EarCups ............................................ 18
Disposables supplied with Insert earphones with eartips............................................... 18
Disposables supplied with OAE probe ...............................................................................18
Optional Accessories ............................................................................................................18
Applied Parts ......................................................................................................................... 18

GSI Novus™ Newborn Hearing Screening System User Manual
D-0113050 Rev H Page 4 of 96
Storage...................................................................................................................................18
Novus overview ........................................................................................................................19
Components..........................................................................................................................20
Display................................................................................................................................ 20
Preamp cable (for ABR only) ............................................................................................ 20
Insert earphone cable (for ABR only).............................................................................. 20
ear probe (for OAE and ABR) ...........................................................................................21
Electrode lead wires (for ABR ONly)................................................................................ 21
Carry case .......................................................................................................................... 21
Label printer (optional)..................................................................................................... 21
Cradle .................................................................................................................................22
System assembly ..................................................................................................................23
Connecting the preamp cable OR OAE PROBE to the DEVICE ..................................... 23
Connecting the insert earphone cable or OAE probe to the Preamp......................... 23
Connecting the electrode lead wires ..............................................................................24
Charging Novus.................................................................................................................24
Using the optional label printer ..........................................................................................25
Powering the label printer ............................................................................................... 25
Insert label rolls into the label printer............................................................................25
Connecting the label printer to Novus ........................................................................... 25
Getting Started with Novus .....................................................................................................26
Power On ............................................................................................................................... 26
Power-saving mode and power-off ....................................................................................26
Home button.........................................................................................................................26
Home Screen.........................................................................................................................27
User Login (optional) ............................................................................................................ 28
Home Screen Functions .......................................................................................................29
Battery Status ....................................................................................................................29
New Patient .......................................................................................................................30
Select Patient.....................................................................................................................30
Quick test ........................................................................................................................... 30
Change User ......................................................................................................................30
Setup ..................................................................................................................................30

GSI Novus™ Newborn Hearing Screening System User Manual
D-0113050 Rev H Page 5 of 96
Entering or choosing a patient for testing ......................................................................... 31
Adding a new patient........................................................................................................31
Selecting from the Patient list ......................................................................................... 32
Function buttons................................................................................................................... 34
Preparing for testing ................................................................................................................35
Preparing the test environment.......................................................................................... 35
General...............................................................................................................................35
Acoustical noise................................................................................................................. 35
Electrical noise...................................................................................................................35
Preparing the patient ...........................................................................................................36
General...............................................................................................................................36
Placing electrodes for ABR testing .................................................................................. 36
Fitting the ear couplers for ABR ...................................................................................... 38
EarCups (with Insert earphones)..................................................................................... 38
Ear tips (with Insert earphones) ...................................................................................... 38
Eartips (with OAE probe) ..................................................................................................39
Testing .......................................................................................................................................40
General Information.............................................................................................................40
Quick Test button.............................................................................................................. 40
Select the “Start” button................................................................................................... 40
Select Test Type.................................................................................................................40
Additional Test Fields........................................................................................................ 41
Screening result symbols ................................................................................................. 41
Reason for Incomplete Test............................................................................................. 42
Printing after Screening....................................................................................................42
ABR Test .................................................................................................................................43
Prepare Patient screen.....................................................................................................43
Impedance check screen..................................................................................................44
ABR Testing screen ........................................................................................................... 45
Noise bar ........................................................................................................................ 45
Time bar .........................................................................................................................45
Test Done screen .............................................................................................................. 46
OAE Test Screens ..................................................................................................................47

GSI Novus™ Newborn Hearing Screening System User Manual
D-0113050 Rev H Page 6 of 96
Prepare Patient screen.....................................................................................................47
Probe check screen........................................................................................................... 48
Seal.................................................................................................................................. 48
Stimulus.......................................................................................................................... 48
Noise............................................................................................................................... 48
OAE Testing screen ........................................................................................................... 49
Probe stability (TEOAE only)......................................................................................... 49
Noise bar ........................................................................................................................ 49
Time bar .........................................................................................................................49
Test Done screen .............................................................................................................. 50
Quick Test..................................................................................................................................51
General...................................................................................................................................51
Saving a Quick Test...............................................................................................................51
Printing ......................................................................................................................................52
Label printer..........................................................................................................................52
Ways of printing....................................................................................................................52
Label print format.................................................................................................................52
Reviewing Patients & Tests......................................................................................................53
Select Patient.........................................................................................................................53
Patient Information ..............................................................................................................54
Test List ..................................................................................................................................55
Test Details ............................................................................................................................ 56
Setup ..........................................................................................................................................57
Language ............................................................................................................................... 57
Device.....................................................................................................................................58
Sound .....................................................................................................................................58
Printer ....................................................................................................................................59
About......................................................................................................................................59
Cleaning and Maintenance......................................................................................................60
Cleaning the Novus...............................................................................................................60
Touch screen .....................................................................................................................60
Case, cradle and cables .................................................................................................... 60

GSI Novus™ Newborn Hearing Screening System User Manual
D-0113050 Rev H Page 7 of 96
Probe ..................................................................................................................................60
Use of the cleaning tool................................................................................................61
Cleaning & Disinfection........................................................................................................ 61
Disposables ...........................................................................................................................62
Device Control.......................................................................................................................62
Calibration .............................................................................................................................62
Troubleshooting ....................................................................................................................... 63
Pass-Checker.............................................................................................................................67
Accessories/replacement parts........................................................................................... 69
Infant Ear Simulator .................................................................................................................70
Novus PC Application – HearSIM ............................................................................................71
Configure device settings.....................................................................................................71
Customize device lists .......................................................................................................... 71
Transfer data to PC...............................................................................................................71
Transfer patient information to device .............................................................................. 71
Supplies and Accessories ........................................................................................................ 72
Appendix A - Technical Data....................................................................................................73
Appendix B: Pass/Refer Criteria, Sensitivity and Specificity ................................................ 77
Default Protocols .................................................................................................................. 77
ABR Pass Criteria...............................................................................................................77
TEOAE Pass Criteria ..........................................................................................................77
DPOAE Pass Criteria..........................................................................................................77
Sensitivity and Specificity Testing Method......................................................................... 77
Results....................................................................................................................................78
Appendix C: ABR and TEOAE Stimulus...................................................................................79
ABR Stimulus .........................................................................................................................79
Calibration values for CE-Chirp and Click stimulus........................................................... 79
TEOAE Stimulus.....................................................................................................................80
Appendix D: Specification of input/output connections...................................................... 82
Novus ABR/OAE Connector for ABR preamplifier Preamplifier Probe/Transducer
connector............................................................................................................................... 82
Novus Micro USB Connector ............................................................................................... 82
Novus Cradle Connector......................................................................................................82

GSI Novus™ Newborn Hearing Screening System User Manual
D-0113050 Rev H Page 8 of 96
Appendix E: Available Protocols ............................................................................................. 83
IEC 60645-6 Protocols ..........................................................................................................86
Appendix F - Warranty and Repair ......................................................................................... 88
Appendix G - Recycling / Disposal .......................................................................................... 89
Appendix H: Electromagnetic Compatibility (EMC)............................................................... 90
Cautions regarding EMC ......................................................................................................90
Guidance and manufacturer’s declaration Electromagnetic emissions......................... 91
Recommended separation distances between portable and mobile RF
communications equipment ............................................................................................... 92
Guidance and Manufacturer’s Declaration Electromagnetic Immunity ......................... 93

GSI Novus™ Newborn Hearing Screening System User Manual
D-0113050 Rev H Page 9 of 96
PREFACE
This user manual provides information about the GSI Novus Newborn Hearing
Screening System. This manual is intended for technically qualified personnel.
Please note: This operating manual is not intended as a training manual for newborn
hearing screening. The reader should consult standard audiology texts for the theory
and application of the screening tests provided by this instrument.
This operating manual contains information pertinent to the use of the Novus system
including safety information as well as maintenance and cleaning recommendations.
It is highly recommended that users read the manual in its entirety prior to use of the
Novus device on a patient.
READ THIS ENTIRE MANUAL BEFORE ATTEMPTING TO USE THIS SYSTEM!
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.

GSI Novus™ Newborn Hearing Screening System User Manual
D-0113050 Rev H Page 10 of 96
REGULATORY SYMBOLS
Symbol
Description
Conforms to European Medical Device
Directive 93/42/EEC.
Symbol for "SERIAL NUMBER."
GSI Part Number.
Indicates that the device is a Medical Device
Return to Authorized Representative, Special
disposal required.
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.
Symbol for “European Representative.”
Symbol for “Manufacturer.”
Symbol for “Date of Manufacture.”
On/Off
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 Novus™ Newborn Hearing Screening System User Manual
D-0113050 Rev H Page 11 of 96
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.
DEVICE SYMBOLS
The following symbols appear on the instrument, the instrument cradle or the mains
adapter:
Definition: Refer to instruction manual (mandatory).
Definition: Type BF applied part – IEC 60601-1 uses the term applied part
to refer to the part of the medical device which come into physical contact
with the patient for the device to carry out its intended function. Type BF is
used for devices that have conductive contact with the patient or having
medium or long-term contact with the patient. The GSI Novus is Type BF according to
the international standard IEC60601-1. The applied parts are the ear tips, ear cups and
the electrodes.
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 earthing or reliance upon
installation conditions.
Definition: Industry-standard Type-B USB connection to a computer.

GSI Novus™ Newborn Hearing Screening System User Manual
D-0113050 Rev H Page 12 of 96
WARNINGS AND CAUTIONS
IMPORTANT SAFETY INSTRUCTIONS
The following safety precautions must be observed always. 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 instrument must only be used by hearing health care professional qualified to
perform newborn hearing screening tests such as an audiologist, otolaryngologist,
researcher or a technician under the direct supervision by the 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. It is intended for transient use as a screening
tool; however, no surgical or medical procedure should be undertaken solely based on
results obtained from the instrument.
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.
SAFETY PRECAUTIONS
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.
To comply with the standards IEC 60601-1 for safety and IEC 60601-1-2 for EMC the
instrument 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.
In case of emergency, disconnect the instrument from the supply mains by pulling the
plug out of the power USB socket.
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.

GSI Novus™ Newborn Hearing Screening System User Manual
D-0113050 Rev H Page 13 of 96
No parts of the equipment can be serviced or maintained while in use with the patient.
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/cups. 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/cups as this will pose the risk of ear-to-ear or patient-to-patient cross
infection.
Latex is not used anywhere in the manufacturing process. The base material for the ear
tips is made from silicone rubber.
The device is not intended to be used in environments exposed to fluid spills. No
means is specified for fluid protection (not IP classed). Do not use the device in the
presence of fluid that can contact 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 an authorized service technician. 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 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.
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 equipment is intended to be connected to other equipment thus forming a Medical
Electrical System. 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 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. If the instrument is connected to a PC (IT equipment forming a
system) ensure not to touch the patient while operating the PC. If the instrument is
connected to a PC (IT equipment forming a system) assembly and modifications shall be
evaluated by qualified medical technician according to safety regulations in IEC 60601.
The USB connection has a built-in galvanic insulation.

GSI Novus™ Newborn Hearing Screening System User Manual
D-0113050 Rev H Page 14 of 96
EXPLOSION
This system is not explosion proof.
Do NOT use in the presence of flammable gaseous mixtures. Users should
consider the possibility of explosions or fire when using this device near
flammable anesthetic gases.
Do NOT use the Novus in a highly oxygen-enriched environment, such as a hyperbaric
chamber, oxygen tent, etc.
NOTE: This instrument contains a rechargeable Lithium ion (Li-ion) battery-pack. The
battery is not intended to be replaced by the user. The battery should only be
replaced by an authorized service representative. Damage to the electronics
resulting from an attempt to change the battery by someone other than an
authorized representative will not qualify for repair under the product warranty.
Batteries may explode or cause burns, if disassembled, crushed or exposed to fire or
high temperatures. Do not short-circuit.
ENVIRONMENTAL FACTORS
Use and store the instrument indoors only. It is recommended that the
instrument be operated within an ambient temperature range of 15 °C /
59 °F to 35 °C / 95 °F and in relative humidity between 30 % and 90 % (non-
condensing).
Transport the instrument in temperature between 20 °C / -4 °F to +50 °C / +122 °F and
store the instrument in temperature between 0 °C / 32 °F to 50 °C / 122 °F.
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.
Although the instrument fulfills the relevant EMC requirements, precautions should be
taken to avoid unnecessary exposure to electromagnetic fields, e.g. from mobile phones
etc. This appendix provides guidance on the electromagnetic environment in which to
operate the instrument.
Portable and mobile radiofrequency (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 and that no mutual disturbance appears.

GSI Novus™ Newborn Hearing Screening System User Manual
D-0113050 Rev H Page 15 of 96
INTRODUCTION
Thank you for purchasing the GSI Novus automated hearing screening system.
INDICATIONS FOR USE
The GSI Novus is intended to be used for the measurement and automated analysis of
auditory evoked responses (auditory brainstem responses, ABR) and/or otoacoustic
emissions (distortion product, DPOAE and transient evoked, TEOAE). These measures
are useful in the screening evaluation, identification, documentation and diagnosis of
auditory and hearing related disorders.
The auditory evoked response (ABR) measurement is intended for newborns and
infants up to 6 months of age. The otoacoustic emissions (DPOAE and/or TEOAE)
measurement is intended for use in patients of all ages.
The GSI Novus is intended to be used by a healthcare professional such as an ENT
doctor, nurse or audiologist or by a trained technician under the supervision of a
professional. The device is intended to be used in a hospital, clinic, or other facility with
a suitable quiet testing environment.
CONTRAINDICATIONS
Contraindications to testing with GSI Novus include a discharging ear, acute external
auditory canal trauma, or occlusion of the external auditory canal. Testing should not be
performed on patients with such symptoms without a medical doctor’s approval.
FEATURES
The GSI Novus features a touchscreen display and user-friendly software in a compact
hardware design. Novus may be purchased with various licenses allowing you to
perform different hearing screening tests.
ABR
Novus uses fast rate auditory brainstem response (ABR) technology to screen patients
for hearing loss. A modified click stimulus, the CE-Chirp®of 35 dB nHL is delivered into
the patient’s ear while electrodes placed on the patient’s head measure EEG activity.
The EEG is processed and analyzed automatically using the Novus’s powerful, response
detection algorithm. When a response is detected, the screening is stopped
automatically, and a Pass result is assigned to the test ear. When no response is
detected after 3 minutes of EEG activity has been processed, a Refer result is assigned.
NOTE: More information about the ABR screening and response detection method may be
found in the following publication:
Sturzebecher E, Cebulla M, Werneke, KD. Objective response detection in the frequency
domain: comparison of several q-sample tests. Audiol Neurootol. 1999;4(1):2-11

GSI Novus™ Newborn Hearing Screening System User Manual
D-0113050 Rev H Page 16 of 96
DPOAE
Distortion product otoacoustic emissions (DPOAE) technology uses pairs of pure tones
presented in sequence to screen patients for cochlear hearing loss. Responses to the
stimulus are predictable and therefore can be measured via a microphone placed in the
patient’s ear canal.
TEOAE
Transient otoacoustic emissions (TEOAE) technology uses a click stimulus to screen
patients for cochlear hearing loss. Responses to the stimulus are predictable and
therefore can be measured via a microphone placed in the patient’s ear canal. The
response is divided into frequency bands for assessment.
NOVUS CRADLE
The Novus cradle allows you to:
•Charge the Novus battery
•Perform screenings when the Novus battery charge is too low to support
testing
NOVUS PC SOFTWARE PROGRAM OPTION -HEARSIM™
The Novus PC software allows you to:
•Store, view and manage patient information
•Store, view and manage test data transferred from the Novus
•Transfer names of patients requiring testing to the Novus
•Print test results on a standard PC-compatible printer
•Export patient and test data (HiTrack, OZ and ASCII formats)
•Configure various Novus device settings
•Manage Novus users
•Manage Novus custom lists (e.g. Screening facility names)
PRINTING OPTIONS
Printing test results from the Novus is accomplished in a variety of ways:
•Print directly from Novus using the optional wireless label printer that is
available from GSI.
•Transfer Novus test data into a PC using the HearSIM software and print
results using your standard printer attached to the PC.

GSI Novus™ Newborn Hearing Screening System User Manual
D-0113050 Rev H Page 17 of 96
UNPACKING THE SYSTEM
It is recommended that you unpack your Novus carefully making sure that all
components are removed from the packing materials.
Verify that all components are included as shown on the packing slip included
with your shipment.
If any component is missing, contact your distributor immediately to report the
shortage.
If any component appears to be damaged in shipment, contact your distributor
immediately to report it. Do not attempt to use any component or device that
appears to be damaged.
Please check that all accessories listed below have been received in good
condition.
All standard components are part of the medical device (incl. power supply) and
suitable for operation in a patient environment.
If any of your purchased parts are missing, contact your distributor or GSI.
SAVE ALL THE ORIGINAL PACKING MATERIAL AND THE SHIPPING CONTAINER SO THE
INSTRUMENT CAN BE PROPERLY PACKED IF IT NEEDS TO BE RETURNED FOR SERVICE OR
CALIBRATION.
Notify the carrier immediately if any mechanical damage is noted. This will ensure that
a proper claim is made. Save all packing material so the claim adjuster can inspect it as
well. Notify your dealer or GSI when the adjuster has completed the inspection.
STANDARD COMPONENTS -GENERAL
•Novus device
•Novus cradle
•Cradle power supply
•USB cable
•Carrying bag
•Operating Instructions (on USB drive)
•Cleaning cloth for touchscreen
•Stylus Pen
•Neck strap
ABR-RELATED COMPONENTS
•Preamplifier
•Electrode lead wires
•NuPrep™ skin preparation gel
•Hardware Pass-Checker

GSI Novus™ Newborn Hearing Screening System User Manual
D-0113050 Rev H Page 18 of 96
TRANSDUCERS (INCLUDED AS SELECTED AT TIME OF PURCHASE)
•IP 30 (50 Ω) insert earphone with Eartip adapters Kit
•IP 30 (50 Ω) insert earphone with EarCup adapters Kit
•OAE probe
DISPOSABLES SUPPLIED WITH INSERT EARPHONES WITH EARCUPS
•Sanibel Infant EarCup kit with snap electrodes (1 box; 20 screenings)
•ABR EarCup Accessory Kit
DISPOSABLES SUPPLIED WITH INSERT EARPHONES WITH EARTIPS
•Disposable snap electrodes (60 pcs; 20 screenings)
•Novus Eartip Starter Kit
DISPOSABLES SUPPLIED WITH OAE PROBE
•Eartip Starter Kit
OPTIONAL ACCESSORIES
•Label Printer HM-E200 Kit (includes printer, power supply and 1 roll of thermal
label paper)
•Novus PC software HearSIM (software on USB drive)
APPLIED PARTS
The following items are considered applied parts according to IEC60601-1.
•Preamplifier cable
•Insert earphones
•OAE ear probe
•Electrode lead wires
•Disposable snap electrodes
•Probe ear tips
•EarCups
STORAGE
When the Novus is not in use, store it in the carry case or in a location where it will be
safe from damage to the touchscreen or other sensitive components such as the
acoustic transducers and cables. Store according to the recommended temperature
conditions described in the specifications.

GSI Novus™ Newborn Hearing Screening System User Manual
D-0113050 Rev H Page 19 of 96
NOVUS OVERVIEW
LCD Touch
Screen
On/Off/Home
Button
Pre-Amp or
Probe
Connector
Micro USB and
lanyard slot
LED Charge
Indicator

GSI Novus™ Newborn Hearing Screening System User Manual
D-0113050 Rev H Page 20 of 96
COMPONENTS
DISPLAY
The display on the Novus is a resistive touch screen. It
responds to the pressure of touching the icons. This can
be accomplished with a finger or a stylus. Care should be
taken not to scratch the surface of the touch screen.
PREAMP CABLE (FOR ABR ONLY)
The preamplifier cable connects to the top of the Novus.
The electrode lead wires, and the acoustic transducer
connect to the jacks at the top of the preamplifier box for
performing ABR screenings.
INSERT EARPHONE CABLE (FOR ABR ONLY)
The insert earphone cable connects to the jack on the
top edge of the preamplifier box. For testing using
EarCups, the insert earphone EarCup adapters at the
end of the red and blue tubes are inserted into the foam
edge of the EarCups. If Eartips are used, disposable
eartips are attached to the clear eartip adapters at the
end of the tubes.