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
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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

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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

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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

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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

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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

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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
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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
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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.