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Grason-Stadler GSI NOVUS User Manual

Newborn aabr/oae screener
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NEWBORN
AABR/OAE
SCREENER
NOVUS
USER MANUAL

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  • Page 1 NEWBORN AABR/OAE SCREENER NOVUS USER MANUAL...
  • Page 2 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.

  • Page 3: Table Of Contents

    GSI Novus™ Newborn Hearing Screening System User Manual 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 ........................
  • Page 4 GSI Novus™ Newborn Hearing Screening System User Manual 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) ................
  • Page 5 GSI Novus™ Newborn Hearing Screening System User Manual 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 ..........................
  • Page 6 GSI Novus™ Newborn Hearing Screening System User Manual 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 .........................
  • Page 7 GSI Novus™ Newborn Hearing Screening System User Manual 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 .........................
  • Page 8 GSI Novus™ Newborn Hearing Screening System User Manual 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 ......................

  • Page 9: Preface

    GSI Novus™ Newborn Hearing Screening System User Manual REFACE 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.

  • Page 10: Regulatory Symbols

    GSI Novus™ Newborn Hearing Screening System User Manual EGULATORY YMBOLS 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.

  • Page 11: Device Symbols

    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.

  • Page 12: Warnings And Cautions

    GSI Novus™ Newborn Hearing Screening System User Manual ARNINGS AND AUTIONS MPORTANT AFETY NSTRUCTIONS 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.
  • Page 13 GSI Novus™ Newborn Hearing Screening System User Manual 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.

  • Page 14: Explosion

    GSI Novus™ Newborn Hearing Screening System User Manual XPLOSION 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.

  • Page 15: Introduction

    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.

  • Page 16: Dpoae

    GSI Novus™ Newborn Hearing Screening System User Manual 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.

  • Page 17: Unpacking The System

    GSI Novus™ Newborn Hearing Screening System User Manual NPACKING 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.

  • Page 18: Transducers (Included As Selected At Time Of Purchase)

    GSI Novus™ Newborn Hearing Screening System User Manual RANSDUCERS 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...

  • Page 19: Novus Overview

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

  • Page 20: Components

    GSI Novus™ Newborn Hearing Screening System User Manual OMPONENTS 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.

  • Page 21: Ear Probe (For Oae And Abr)

    GSI Novus™ Newborn Hearing Screening System User Manual EAR PROBE (FOR OAE AND ABR) The OAE ear probe is used for OAE screening. It may also be used as the transducer to deliver the acoustic stimulus for ABR screening as well by connecting to the preamplifier box.

  • Page 22: Cradle

    GSI Novus™ Newborn Hearing Screening System User Manual CRADLE Insertion Guides Insertion Guides LED Power indicator Power supply connector The USB plug is used to safely disconnect the mains from the cradle. Do not position the cradle in a manner that would make it difficult to disconnect it from AC power.

  • Page 23: System Assembly

    GSI Novus™ Newborn Hearing Screening System User Manual YSTEM ASSEMBLY The Novus will require some assembly before use. Depending on the screening test types purchased, the system assembly may include: Connecting the preamp cable (ABR license) • • Connecting the insert earphone cable (ABR license) Connecting the OAE probe (DPOAE or TEOAE or ABR license) •...

  • Page 24: Connecting The Electrode Lead Wires

    GSI Novus™ Newborn Hearing Screening System User Manual CONNECTING THE ELECTRODE LEAD WIRES Connect the three electrode lead wires securely into the electrode jacks on top of the preamplifier, matching the color of the lead wire with the jack. Be sure they are fully inserted into the jack.

  • Page 25: Using The Optional Label Printer

    GSI Novus™ Newborn Hearing Screening System User Manual SING THE OPTIONAL LABEL PRINTER POWERING THE LABEL PRINTER The label printer is powered by a Lithium-ion battery. In order to charge the battery, you must insert the plug of the charger into the DC socket on the printer and plug the power supply into an outlet.

  • Page 26: Getting Started With Novus

    GSI Novus™ Newborn Hearing Screening System User Manual ETTING TARTED WITH OVUS OWER The Novus can be operated in or out of the cradle. Briefly press the Home button on the front of the Novus to turn on the device.

  • Page 27: Home Screen

    GSI Novus™ Newborn Hearing Screening System User Manual CREEN After the system completes the boot up process the Home screen is presented. The Home screen displays the buttons controlling entry into the major functions of Novus. Screen Header Battery Status...

  • Page 28: User Login (Optional)

    GSI Novus™ Newborn Hearing Screening System User Manual OGIN OPTIONAL When the user login is enabled, a Select Screener List is presented after the device boots up. The list of screeners is created in the HearSIM PC program and transferred into Novus. If there are more than 8...

  • Page 29: Home Screen Functions

    GSI Novus™ Newborn Hearing Screening System User Manual CREEN UNCTIONS BATTERY STATUS The charge status of the battery is represented graphically in the status bar at the top of the Novus touchscreen when it is powered on. Symbol Charge status...

  • Page 30: New Patient

    GSI Novus™ Newborn Hearing Screening System User Manual NEW PATIENT Select New Patient to enter demographics for a new patient. After entry of the patient’s information you can save the name to the database for screening later or immediately proceed with the screening.

  • Page 31: Entering Or Choosing A Patient For Testing

    GSI Novus™ Newborn Hearing Screening System User Manual NTERING OR CHOOSING A PATIENT FOR TESTING ADDING A NEW PATIENT Select the New Patient button from the Home screen to enter patient information. Add another patient Page down to additional fields...

  • Page 32: Selecting From The Patient List

    GSI Novus™ Newborn Hearing Screening System User Manual SELECTING FROM THE PATIENT LIST Choose the Select Patient button on the Home screen to present the Patient list. Sort Order Patient ID, Last Name, First Name Test Status indicator If there are more than 7 patients in the list, Up and Down arrow controls in the bottom control bar allow you to move through pages of names.
  • Page 33 GSI Novus™ Newborn Hearing Screening System User Manual The Patient Information screen shows the details of the patient that were entered from the Add Patient data entry. If the patient has not yet been tested, you may edit the details. If there is test data from the patient on the device, the data for the patient may not be edited and the fields will appear with a grey background.

  • Page 34: Function Buttons

    GSI Novus™ Newborn Hearing Screening System User Manual UNCTION BUTTONS Go Back Start Test One Screen Save View Test Stop Test Cancel List Add New Pause Test Page Up Patient Search Resume Page Down Test Switch User Print Comment Settings...

  • Page 35: Preparing For Testing

    GSI Novus™ Newborn Hearing Screening System User Manual REPARING FOR TESTING REPARING THE TEST ENVIRONMENT GENERAL The ideal environment for hearing screening is one that is acoustically quiet with minimal potential for electrical interference. This is not easily achieved in a hospital, where most newborns are screened.

  • Page 36: Preparing The Patient

    GSI Novus™ Newborn Hearing Screening System User Manual If the screener notices high levels of electrical artifact during testing or an increase in refer rates, these sources of electrical interference should be considered and eliminated if possible. The screener may need help from the infant’s nurse or physician to troubleshoot electrical interference issues if it involves other types of monitoring equipment attached to the baby that are critical to the child’s care.
  • Page 37 GSI Novus™ Newborn Hearing Screening System User Manual • Right mastoid • Left mastoid Regardless of the electrode placement you choose, the skin at the electrode locations must be cleaned with an electrode skin preparation product. Rub the product gently, but briskly on the skin at each position.

  • Page 38: Fitting The Ear Couplers For Abr

    GSI Novus™ Newborn Hearing Screening System User Manual FITTING THE EAR COUPLERS FOR ABR At the time of purchase, you chose your preferred style of acoustic transducer. If insert earphones were selected you also chose your preferred ear coupling method, the EarCup or the Ear tip.

  • Page 39: Eartips (With Oae Probe)

    GSI Novus™ Newborn Hearing Screening System User Manual canals. Apply the eartips onto the eartip adapters at the end of the insert earphone tubing. Insert the eartip attached to the red tubing into the baby’s right ear. Do this by pulling gently down and out on the baby’s ear lobe to open the ear canal.

  • Page 40: Testing

    GSI Novus™ Newborn Hearing Screening System User Manual ESTING ENERAL NFORMATION A screening may be initiated in several ways: Quick Test (in Home screen) • After entering New Patient information • From the Patient Information screen after you have chosen a patient from the •...

  • Page 41: Additional Test Fields

    GSI Novus™ Newborn Hearing Screening System User Manual ADDITIONAL TEST FIELDS Using the Novus PC application HearSIM, your Novus may be configured to require the entry of the Facility Name and Hospital Status information with each test. When this function is enabled, a Test field entry screen will appear, so you can complete these fields for the patient.

  • Page 42: Reason For Incomplete Test

    GSI Novus™ Newborn Hearing Screening System User Manual REASON FOR INCOMPLETE TEST Using the Novus PC application HearSIM, an administrator can configure your Novus to require the entry of the Stop Reason when a test is manually stopped. This stop reason information is saved with the test record.

  • Page 43: Abr Test

    GSI Novus™ Newborn Hearing Screening System User Manual ABR T During the ABR testing process the screens will change to reflect the processes taking place and the options available to the screener. There are 4 screens that are part of the...

  • Page 44: Impedance Check Screen

    GSI Novus™ Newborn Hearing Screening System User Manual IMPEDANCE CHECK SCREEN During the impedance check, the electrode symbols on the graphic of the baby’s head will display in green or orange with the impedance value (kΩ) shown toward the bottom of the screen.

  • Page 45: Abr Testing Screen

    GSI Novus™ Newborn Hearing Screening System User Manual ABR TESTING SCREEN During the ABR measurement, a bar graph shows the progress toward a Pass result. A red bar reflects the test progress for the right ear. A blue bar reflects the test progress for the left ear.

  • Page 46: Test Done Screen

    GSI Novus™ Newborn Hearing Screening System User Manual TEST DONE SCREEN At the end of a screening, the result of the will be displayed. The ear selection control will return so that the user can select the other ear for testing or can repeat a screening measure on the same ear.

  • Page 47: Oae Test Screens

    GSI Novus™ Newborn Hearing Screening System User Manual OAE T CREENS During the OAE process the screens will change to reflect the processes taking place and the options available to the screener. There are 4 screens that are part of the OAE...

  • Page 48: Probe Check Screen

    GSI Novus™ Newborn Hearing Screening System User Manual PROBE CHECK SCREEN During the probe check, information is displayed regarding the quality of the fit of the probe in the ear canal. Once the probe fit is good the probe check terminates and the OAE measurement begins automatically.

  • Page 49: Oae Testing Screen

    GSI Novus™ Newborn Hearing Screening System User Manual OAE TESTING SCREEN During the OAE measurement, a bar graph for each of the frequencies in the test protocol reflects the progress toward a pass. The bar will fill in completely with green color and a checkmark will appear above the bar when the criteria for a pass is achieved at that frequency.

  • Page 50: Test Done Screen

    GSI Novus™ Newborn Hearing Screening System User Manual TEST DONE SCREEN At the end of a screening, the result of the most recently completed screening will continue to be visible. The ear selection control will return so that the user can select the other ear for testing or can repeat a screening measure on the same ear.

  • Page 51: Quick Test

    GSI Novus™ Newborn Hearing Screening System User Manual UICK ENERAL Selection of Quick Test from the Home screen bypasses entry of patient information or selection of a patient from the database. The process of a Quick Test is identical to that of a standard test.

  • Page 52: Printing

    GSI Novus™ Newborn Hearing Screening System User Manual RINTING ABEL PRINTER Use only the recommended label printer from GSI. Pairing of the Bluetooth printer and the Novus is accomplished in the in the Setup/Printer screen. It is possible share one printer with multiple Novus devices.

  • Page 53: Reviewing Patients & Tests

    GSI Novus™ Newborn Hearing Screening System User Manual & T EVIEWING ATIENTS ESTS ELECT ATIENT The Select Patient button on the Home screen presents the list of names of patients contained in the device database. Sort Button Patient ID and...

  • Page 54: Patient Information

    GSI Novus™ Newborn Hearing Screening System User Manual ATIENT NFORMATION When you have selected a patient from the list that patient’s details will display for review. Start Test Back Test List Editing of patient information on the Novus will be possible if the Administrator has enabled editing on the device using the HearSIM PC application.

  • Page 55: Test List

    GSI Novus™ Newborn Hearing Screening System User Manual The test list is sorted chronologically with the most recent test at the top. Each row represents one test. If more than eight (8) tests are saved, the Up and Down arrow buttons will be in the bottom control bar can be used to page through the list.

  • Page 56: Test Details

    GSI Novus™ Newborn Hearing Screening System User Manual ETAILS Select one of the tests in the Test List to view the details of the test. The test details screen will be like the test complete screen and the content depends on the Test Type.

  • Page 57: Setup

    GSI Novus™ Newborn Hearing Screening System User Manual ETUP Select the Setup button on the bottom control bar of the Home screen to access a list of the settings that can be made directly on the Novus. ANGUAGE Select Language to display a list of available languages.

  • Page 58: Device

    GSI Novus™ Newborn Hearing Screening System User Manual EVICE Select Device to set your preference for Power Save, Power Off, set the time and date, and to delete data from the device. Power Save (Standby) can be set to Never, 1-5 •...

  • Page 59: Printer

    GSI Novus™ Newborn Hearing Screening System User Manual RINTER Select Printer to pair to the optional Bluetooth printer. Select the Search button in the bottom control bar to find matching printers. Be sure that the printer is powered on. The name HM-E200 or MLP2 and the serial number will display when the printer is successfully found.

  • Page 60: Cleaning And Maintenance

    GSI Novus™ Newborn Hearing Screening System User Manual LEANING AND AINTENANCE LEANING THE OVUS TOUCH SCREEN Use a lens cleaning or microfiber cloth to clean the Novus touchscreen. CASE, CRADLE AND CABLES Use caution while cleaning. • Before cleaning, remove the Novus from the cradle and unplug the cradle from AC power.

  • Page 61: Use Of The Cleaning Tool

    GSI Novus™ Newborn Hearing Screening System User Manual Remove the tool from the shell dispenser. The tool has two pins, one empty for removal and one with the new wax filter. Empty pin (1): Push this pin in the wax guard and pull the wax guard straight out of the probe body.

  • Page 62: Disposables

    GSI Novus™ Newborn Hearing Screening System User Manual ISPOSABLES Use only the Sanibel Supply disposable supplies that are supplied with your Novus system. Eartips, EarCups and adhesive electrodes are intended for single use only. These should be discarded after use. They cannot be cleaned.

  • Page 63: Troubleshooting

    GSI Novus™ Newborn Hearing Screening System User Manual ROUBLESHOOTING In case of problems, consult the table below for symptoms, possible causes and suggested troubleshooting. Symptom Possible cause Suggested troubleshooting Cannot pass ABR Ineffective skin Remove electrode and use impedance for one or...
  • Page 64 GSI Novus™ Newborn Hearing Screening System User Manual Symptom Possible cause Suggested troubleshooting the outlet to run on battery only. Electromagnetic Shut down all unnecessary interference is present devices near the test area from other electronic including cell phones, tablets, devices in the lights, TVs, etc.
  • Page 65 GSI Novus™ Newborn Hearing Screening System User Manual Symptom Possible cause Suggested troubleshooting remove noisy siblings from the test room. Close the door to reduce noise coming from the hallway or nearby rooms. Move away from noise sources such as air conditioning vents, devices that have motors that turn on and off.
  • Page 66 GSI Novus™ Newborn Hearing Screening System User Manual Symptom Possible cause Suggested troubleshooting Replace the insert earphone cable with a new one (ABR) Check the OAE probe tip to be sure it is clear of any wax or debris in any of the holes.

  • Page 67: Pass-Checker

    GSI Novus™ Newborn Hearing Screening System User Manual HECKER The Pass-Checker accessory may be used to perform a quality check of the Novus that has the ABR option. This can be done on a regular basis or may be performed if you suspect a problem with the Novus hardware.
  • Page 68 GSI Novus™ Newborn Hearing Screening System User Manual Pass checker symptoms, possible causes and suggested troubleshooting. Symptom Possible cause Suggested troubleshooting Cannot pass Electrode lead wire is not Check connections at the impedance for one or fully attached to the preamp cable jack and on the more electrodes.

  • Page 69: Accessories/Replacement Parts

    GSI Novus™ Newborn Hearing Screening System User Manual Low battery on the Pass- Contact an authorized service Checker? Is the LED center regarding change of flickering? battery on the Pass-Checker. We recommend annual battery change at the time of calibration of your Novus device.

  • Page 70: Infant Ear Simulator

    GSI Novus™ Newborn Hearing Screening System User Manual NFANT IMULATOR The Infant Ear-Simulator accessory may be used to perform a quality check of the Novus that has the OAE option. This can be done on a regular basis or may be performed if you suspect a problem with the Novus hardware or OAE probe.

  • Page 71: Novus Pc Application - Hearsim

    GSI Novus™ Newborn Hearing Screening System User Manual PC A – H OVUS PPLICATION The Novus may be connected to a PC using a USB cable. When connected to a PC, it can communicate with the Novus PC application, HearSIM. Minimum computer specifications for compatibility with the Novus PC application are found in the HearSIM User Manual.

  • Page 72: Supplies And Accessories

    GSI Novus™ Newborn Hearing Screening System User Manual UPPLIES AND CCESSORIES 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.

  • Page 73: Appendix A - Technical Data

    GSI Novus™ Newborn Hearing Screening System User Manual A - T PPENDIX ECHNICAL The Novus is an active, diagnostic medical product. The device is classified as a class IIa device according to the EU medical directive 93/42/EEC and a class II device according to the US FDA.
  • Page 74 GSI Novus™ Newborn Hearing Screening System User Manual PHYSICAL Weight Device: 265 grams (with battery) ABR Preamplifier: 85 grams Dimensions Device: 158 mm x 83 mm x19mm ABR Preamplifier: 85 mmx 5 mm x 25 mm Display 95 mm x 56 mm, color, 272 x 480 resolution Li-ion battery 44794;...
  • Page 75 GSI Novus™ Newborn Hearing Screening System User Manual PRINTER Type/Model Thermal printer MLP2, HM-E200 Connection ® Wireless Bluetooth Battery Lithium Ion, DC 7.4V, 1500 mAh Charger 100-250V AC, 50/60 Hz, 1.0 A Weight 360 grams (12.7 oz.) Paper Thermal paper: 57.5 mm ± 0.5 mm (width)r Labels: 57.5 mm ±...
  • Page 76 GSI Novus™ Newborn Hearing Screening System User Manual Stimulus level 83 dB peSPL, peak to peak calibrated, AGC controlled ( ± 2 A/D resolution 24 bit SNR criteria minimum 4 dB (default protocol) Response amplitude -5 dB (default protocol) minimum...

  • Page 77: Appendix B: Pass/Refer Criteria, Sensitivity And Specificity

    GSI Novus™ Newborn Hearing Screening System User Manual B: P PPENDIX EFER RITERIA ENSITIVITY AND PECIFICITY EFAULT ROTOCOLS The criteria used for the Pass/Refer results are contained in the protocols supplied with the Novus. The specifications of these protocols are listed in the Test Specification in Appendix A.

  • Page 78: Results

    GSI Novus™ Newborn Hearing Screening System User Manual For each of the TEOAE, DPOAE and ABR modalities the Novus was controlled from the PC so that many repeat tests could be automatically performed. The PC was used to control the level of noise, from the simulator, injected into the instrument so that it experienced the full range of noise present in a typical clinical environment.

  • Page 79: Appendix C: Abr And Teoae Stimulus

    GSI Novus™ Newborn Hearing Screening System User Manual C: ABR TEOAE S PPENDIX TIMULUS ABR S TIMULUS A stimulus other than that specified in the standard IEC 60645-3 is used. This CE-Chirp stimulus has the same linear magnitude frequency response as the Click stimulus specified in the standard.

  • Page 80: Teoae Stimulus

    In order to permit comparisons of electrical calibration between the GSI Novus and the IEC 60645-3 reference stimulus, this document provides a comparison of the energy contained within the electrical characteristics of both the reference and the optimised stimulus.
  • Page 81 Using a ‘peak to peak’ measurement: I.e. the rectangular pulse has a height equivalent to the full positive to negative excursion of the optimised bipolar pulse, the optimised stimulus used in the GSI Novus delivers -0.84dB energy relative to the reference rectangular pulse.

  • Page 82: Appendix D: Specification Of Input/Output Connections

    GSI Novus™ Newborn Hearing Screening System User Manual D: S PPENDIX PECIFICATION OF INPUT OUTPUT CONNECTIONS ABR/OAE C OVUS ONNECTOR FOR PREAMPLIFIER REAMPLIFIER ROBE RANSDUCER CONNECTOR Description CH1 out CH1 GND DGND GND A / GND Microphone Microphone – input / Analog balanced in...

  • Page 83: Appendix E: Available Protocols

    GSI Novus™ Newborn Hearing Screening System User Manual E: A PPENDIX VAILABLE ROTOCOLS If your NHS program requires different screening parameters than those supplied as the default protocols in Novus, additional protocols are available through the HearSIM™ application. You may choose the protocols in HearSIM and transfer them to your Novus.
  • Page 84 GSI Novus™ Newborn Hearing Screening System User Manual Min OAE level: -5 dB SPL Min SNR: 6 dB Artifact rejection level: 30 dB SPL F2 Frequencies: 6k, 4k, 3k, 2k, 1.5k Hz Level (L1/L2): 65/55 dB SPL F2/F1 Ratio: 1.22 Max.
  • Page 85 GSI Novus™ Newborn Hearing Screening System User Manual Max. test time: 60 s Number Freq. for pass: 3 / 4 Min OAE level: -5 dB SPL Pass criteria for each frequency: Min SNR: 4 dB Band mandatory for Pass: None...

  • Page 86: Iec 60645-6 Protocols

    GSI Novus™ Newborn Hearing Screening System User Manual IEC 60645-6 P ROTOCOLS The following table lists the IEC 60645-6 compliant OAE protocols that are available. These OAE protocol are compliant with the IEC standard. Refer to the detailed explanation provided on PDF file contained in the “IEC protocols” folder on the HearSIM software USB.
  • Page 87 GSI Novus™ Newborn Hearing Screening System User Manual TEOAE Parameters Sensitivity T03 1.5-4 kHz, 60 dB SPL, IEC Center Frequencies: 1.4k, 2k, 2.8k, 4k Hz Stimulus type: Click (non-linear) Level: 60 dB peSPL Max. test time: 60 s Number Freq. for pass: 3 / 4...

  • Page 88: Appendixf - Warranty And Repair

    To ensure that your instrument works properly, the GSI Novus should be checked and calibrated at least once per year. This check must be carried out by your dealer or authorized GSI service facility.

  • Page 89: Appendixg - Recycling / Disposal

    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...

  • Page 90: Appendix H: Electromagnetic Compatibility (Emc)

    Otherwise, degradation of the performance of this equipment could result. The GSI Novus is intended for use in the electromagnetic environment specified below. The customer or the user of the Instrument should assure that it is used in such an environment.

  • Page 91: Guidance And Manufacturer's Declaration Electromagnetic Emissions

    GSI Novus™ Newborn Hearing Screening System User Manual ’ UIDANCE AND MANUFACTURER S DECLARATION LECTROMAGNETIC EMISSIONS Emissions Test Compliance Electromagnetic environment - guidance RF emissions Group 1 The Novus uses RF energy only for its CISPR 11 internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

  • Page 92: Recommended Separation Distances Between Portable And Mobile Rf

    GSI Novus™ Newborn Hearing Screening System User Manual ECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE COMMUNICATIONS EQUIPMENT The Novus is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Novus can help prevent...

  • Page 93: Guidance And Manufacturer's Declaration Electromagnetic Immunity

    GSI Novus™ Newborn Hearing Screening System User Manual ’ UIDANCE AND ANUFACTURER ECLARATION LECTROMAGNETIC MMUNITY Immunity Test IEC 60601 Test Compliance Electromagnetic level Environment- Guidance Electrostatic ±8 kV contact ±8 kV contact Floors should be wood, Discharge (ESD) ±15 kV air ±15 kV air...
  • Page 94 GSI Novus™ Newborn Hearing Screening System User Manual Immunity test IEC / EN 60601 Compliance Electromagnetic test level level environment – guidance Portable and mobile RF communications equipment should be used no closer to any parts of the Novus, including cables, than the...
  • Page 95 GSI Novus™ Newborn Hearing Screening System User Manual field strength in the location in which the Novus is used exceeds the applicable RF compliance level above, the Novus should be observed to verify normal operation, If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Novus.
  • Page 96 GSI Novus™ Newborn Hearing Screening System User Manual Test Specifications for Enclosure Port Immunity to RF wireless communications equipment Immunity Test Maximum Band a Distance Test frequency Service a Modulation b power (MHz) Level (MHz) (V/m) Pulse 380 –390 TETRA 400...

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