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GSI Novus™ Newborn Hearing Screening System User Manual

D-0113050 Rev H

Page 73 of 96

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PPENDIX

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ECHNICAL

D

ATA

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.

STANDARDS COMPLIANCE
Safety and Electromagnetic
compatibility (EMC)

IEC 60601-1, Type B and BF applied parts
IEC 60601-1-2
IEC 60601-2-40

Calibration and Test Signal

ISO 389-2
ISO 389-6
IEC 60645-3

OAE

IEC 60645-6: 2009, Type 2

Note

: An alternate stimulus level control procedure and

stimulation intensities beyond the range required by the
standard are used by Novus

ABR

IEC 60645-7: 2009, Type 2

Markings
IP02
IP20

IP marking is an ingress protection marking. The marking
specifies the protection provided against ingress of
particle matter and liquids. This device has different IP
marking with the follow impact:
IP02: To protect the device against rain and water always
use the carrying bag during transport.
IP20: This marking can be found on the device parts
meaning that the parts are not protected against water

NOTE

: The charger, power supply and cradle are not to

be used in home healthcare environments

GENERAL SPECIFICATIONS

ENVIRONMENTAL

Transport and
Handling

Transport package shall be kept away from rain and in
dry conditions

Temperature

Operation: + 15° C to + 35° C ( + 59° F to + 95° F)
Transport:- 20° C to + 50° C (- 4° F to + 122° F)
Storage: 0° C to + 50° C ( +32° F to + 122° F)

Humidity

Operation: Maximum relative humidity 90 %, non-
condensing
Transport and Storage: Maximum relative humidity 93 %,
non-condensing

Ambient air pressure

98 kPa – 104 kPa

Altitude

Maximum altitude: 2000 m (6561 feet) above sea level

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Summary of Contents for GSI NOVUS

Page 1: ...NEWBORN AABR OAE SCREENER NOVUS USER MANUAL...

Page 2: ...veloped 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...

Page 3: ...ity 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...

Page 4: ...mp 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 P...

Page 5: ...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 In...

Page 6: ...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 P...

Page 7: ...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 Cri...

Page 8: ...rranty 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 Rec...

Page 9: ...ent 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...

Page 10: ...g 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...

Page 11: ...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 h...

Page 12: ...idual 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 SAFE...

Page 13: ...rument 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...

Page 14: ...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 con...

Page 15: ...ng 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 me...

Page 16: ...le 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 St...

Page 17: ...ponents 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 ORI...

Page 18: ...it 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 softw...

Page 19: ...ovus 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 Indi...

Page 20: ...mplifier 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 EARPHO...

Page 21: ...roper size for the patient s ear onto the probe tip ELECTRODE LEAD WIRES FOR ABR ONLY Electrode lead wires are provided with the system purchase when ABR is included The color coded plugs connect to t...

Page 22: ...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 Only use the UES12LCP 050160SPA Power Supply tha...

Page 23: ...et at the top of the Novus Insert the plug and push it securely into place CONNECTING THE INSERT EARPHONE CABLE OR OAE PROBE TO THE PREAMP Align the plug at the end of the insert earphone cable or OAE...

Page 24: ...U shaped placement guides Proper placement in the cradle is needed to ensure charging of the battery Magnets in the cradle and the device form a connection to reduce the chance that the Novus will fa...

Page 25: ...of paper by displaying the message Out of paper on the screen and the blue LED ERROR flashes To insert a new label roll into the label printer open the printer by pressing the small latch button Inse...

Page 26: ...dby or Power Off automatically In the power save mode the display will turn off and the LED will blink green Pressing the Home button briefly will awaken the device Upon awakening from standby the scr...

Page 27: ...pending on the options enabled for the configuration of the device The PC Application HearSIM is used to define the configuration of the device The Quick Test is a configurable item which is enabled b...

Page 28: ...me using the on screen keyboard After entering the name of the screener select the Search button again to obtain a list of matching entries Select the screener name from the list to proceed to the pas...

Page 29: ...touchscreen when it is powered on Symbol Charge status Charging Remaining charge is indicated 10 Approx 30 minutes of active test time remaining 5 Testing cannot be performed recharge 3 Automatic shut...

Page 30: ...n a screening QUICK TEST Select Quick Test to proceed immediately to perform a test without entry of patient information Quick tests are saved temporarily under the patient name of Quick Test Later if...

Page 31: ...ompleted to save the data or proceed to a screening It is possible to configure the device to input an automatic ID number into this field so that you do not have to enter an ID This ID can be overwri...

Page 32: ...search for matching patients After entering the information select the Search button again to obtain a list of matching entries An icon in the screen header allows you to sort the entries chronologica...

Page 33: ...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 backgrou...

Page 34: ...TION BUTTONS Go Back One Screen Start Test OK Save View Test List Stop Test Cancel Add New Patient Pause Test Page Up Search Resume Test Page Down Switch User Add Comment Print Settings Select Ear Rig...

Page 35: ...e such as an unoccupied patient or procedure room Close the door to the test room to reduce the noise from others walking in the hallway who may be talking or pushing equipment that is noisy Be aware...

Page 36: ...be prolonged and the chance of a refer result will be increased In this case it would be best to terminate the screening attempt and return when the baby is sleeping Screening can be performed when t...

Page 37: ...idue of the skin prep product so that the skin is dry This will help to ensure good adhesion of the disposable electrode to the skin Connect the white red and blue pinch clip electrode lead wires to a...

Page 38: ...up adapter at the end of each of the insert earphone tube into the hole in the foam at the top of the EarCup so that it is fully inserted Peel the EarCup attached to the red tubing from the backing ca...

Page 39: ...ear at a time It is important that you use the transducer with the red tubing on the right ear and the transducer with the blue tubing on the left ear Place the insert earphone transducer boxes above...

Page 40: ...s PC application HearSIM If the Quick Test is disabled on your device then the Quick Test button will not appear on the Home screen SELECT THE START BUTTON Selection of the Start button begins the scr...

Page 41: ...en the same from patient to patient your selection will be recalled so that you only need to confirm the entry by proceeding with selection of the Start button if the current items displayed in the fi...

Page 42: ...m control bar The full list of screening tests performed for this patient will appear in reverse chronological order The most recently performed right and left ear screening in the current session wil...

Page 43: ...eck Testing Test Complete PREPARE PATIENT SCREEN The initial ABR screen displays setup instructions The Ear Selection Button toggles to change the ear being tested The transducer and coupler displayed...

Page 44: ...sed to indicate a good impedance An orange color indicates a poor impedance If any impedance indicator remains orange the impedance must be improved at this electrode position Make sure that the elect...

Page 45: ...quiet enough to be accepted and processed in the response detection algorithm If the incoming EEG samples contain high noise due to myogenic or electrical noise the check will disappear and the noise...

Page 46: ...d left ear during the session The Back button returns to prior screen before initial test screen The Test List button opens a list of all tests performed in this session The Comment button opens a scr...

Page 47: ...change to reflect the processes taking place and the options available to the screener There are 4 screens that are part of the OAE test Patient Preparation Probe Check Testing Test Complete PREPARE P...

Page 48: ...he ear canal and not moving The line on the bar indicates the maximum acceptable level Stimulus The stimulus parameter is a measure of how well the OAE stimulus is being delivered to the ear Noise The...

Page 49: ...tability is adequate If the probe stability drops below an acceptable level suggesting that the probe is falling out of the ear the check will disappear If this happens you should check the fit of the...

Page 50: ...and left ear during the session The Back button returns to prior screen before initial test screen The Test List button opens a list of all tests performed in this session The Comment button opens a s...

Page 51: ...lected on the Home screen When Quick Test is selected the previous Quick Test session is immediately and permanently deleted from Novus SAVING A QUICK TEST If it is your standard practice to save scre...

Page 52: ...ing of screening results on the label printer can be selected from within the Test List screen The Test List screen can be accessed from either the Test Done screen or from the Patient Information scr...

Page 53: ...des the Quick Test patient appears at the top of the list if one is present Use the UP and Down arrow keys in the bottom control bar to page through the list You can use the Search button in the botto...

Page 54: ...diting on the device using the HearSIM PC application Patient information transferred from the HearSIM PC database to the device cannot be edited on the device Editing of this patient information must...

Page 55: ...nter icon to the right of the test summary is a button to select the test for printing When selected the Printer icon in the test row will contain a green checkmark Select as many tests as you want to...

Page 56: ...est Type The Additional Test Fields button in bottom of the Test Details screen to view the Test related Fields This screen will be available only if the Test Fields option is enabled on the device vi...

Page 57: ...ttings that can be made directly on the Novus LANGUAGE Select Language to display a list of available languages Use the Up and Down arrow controls in the bottom bar to page through the list Select the...

Page 58: ...to return to the Device Setup Delete all patients and test data erases all the patient and test information from the device A confirmation is required before the data is deleted To confirm the selecti...

Page 59: ...The name HM E200 or MLP2 and the serial number will display when the printer is successfully found Then select the printer to pair to the Novus To confirm the selection and exit the Sound screen selec...

Page 60: ...rubber rim around the Novus Follow the instructions on the disinfection product PROBE Patient contact parts should be cleaned prior to each use The probe and insert earphones may be wiped with a sligh...

Page 61: ...ol based products contain the active ingredient referred to as quaternary ammonia compound or a hydrogen peroxide based cleaner may be used The quaternary ammonia compound and hydrogen peroxide are sp...

Page 62: ...the acoustic stimulus at least once per week The GSI Pass Checker device may be purchased to perform a more objective test of system integrity CALIBRATION To guarantee that the Novus works properly th...

Page 63: ...replace more than one of the electrode wires Connection of preamplifier cable to the Novus ABR OAE connector is not secure Check the connection of the preamp cable to the Novus remove it and re insert...

Page 64: ...troubleshooting RFID devices used for security that are attached to or near the baby may cause interference Ask the nurse or doctor if they can be temporarily removed Try testing in a different locat...

Page 65: ...ips make sure that the ear tip is securely inserted into the baby s ear canal Stimulus is not coming through the insert earphones ABR or OAE probe Check the connection of the insert earphone cable or...

Page 66: ...test Quiet baby or environment Out of ear message during OAE test OAE probe is coming out of the ear or has fallen out completely Recommend to stop the screening and start again since reinsertion of p...

Page 67: ...osts 3 Insert the insert earphone adapters securely into the holes on either side of the Pass Checker a If the black EarCup adapters are used with your system these will fit into the hole directly b I...

Page 68: ...he wire which may lead to intermittent contact Replace the electrode lead wire with a new one may need to replace more than one of the electrodes Test does not pass in one or both ears Connection of i...

Page 69: ...zed GSI representative Damage to the Pass Checker electronics resulting from an attempt to change the battery by someone other than an authorized representative will not qualify for repair under the p...

Page 70: ...mance use a hard walled cavity It is well known that a hard walled cavity does not reflect the properties of an infant ear Testing this way can produce false responses due to the resonance characteris...

Page 71: ...ner and Comment are displayed for information entry when a test is performed Stop Reason requires the user to enter the reason a test was stopped Could not test Invalid Auto ID automatically assigns a...

Page 72: ...l Labels for HM E200 printer 1 roll 100 labels 8049700 EarCups with snap electrodes 1 box 20 sets 8109096 Disposable snap electrodes 60 pcs 20 screens 8500390 Pinch clip cables for snap electrodes 810...

Page 73: ...protection marking The marking specifies the protection provided against ingress of particle matter and liquids This device has different IP marking with the follow impact IP02 To protect the device a...

Page 74: ...ected lifetime Depending on use typically more than 3 years FUNCTIONAL User Interface Resistive Touch screen User Feedback Integrated speaker Language Settings English default select from 15 options M...

Page 75: ...72 dB Input impedance 10 M 170 pF Noise 25 nV Hz CMR Ratio 100 dB at 100 Hz Sample rate 22 05 kHz A D resolution 24 bit Electrical impedance measurement Before and during testing 40 k required for te...

Page 76: ...76 of 96 Stimulus level 83 dB peSPL peak to peak calibrated AGC controlled 2 dB A D resolution 24 bit SNR criteria minimum 4 dB default protocol Response amplitude minimum 5 dB default protocol Bands...

Page 77: ...iteria 3 of the 4 bands 1400 2000 2800 4000 Hz must meet the criteria for an overall pass DPOAE PASS CRITERIA Signal to noise ration minimum 6 dB Minimum response amplitude 5 dB Pass criteria 3 of the...

Page 78: ...hat it experienced the full range of noise present in a typical clinical environment RESULTS ABR mode 525 tests were performed no false ABR results occurred the resulting sensitivity has been assessed...

Page 79: ...for E A RTONE 3A with eartips according to PTB report from 2008 05 19 in compliance to the calibration procedure defined in standard DIN EN 60645 3 Correction values for EarCup and OAE probe calibrat...

Page 80: ...frequency components of the TEOAE which originate at the basal end of the cochlea will then be considerably diminished and the test will take longer and be less effective Furthermore the optimised st...

Page 81: ...e 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 rectan...

Page 82: ...GND 3 DGND 4 GND A GND Microphone 5 Microphone input Analog balanced in 6 Microphone input Analog balanced in 7 Power supply 3 5V 8 CH2 out 9 CH2 GND 10 I2C CLK 11 I2C DATA 12 I2C Interrupt NOVUS MIC...

Page 83: ...CE Chirp 30 dB nHL CE Chirp stimulus of 30 dB nHL 99 6 A02 CE Chirp 40 dB nHL CE Chirp stimulus of 40 dB nHL 99 6 A03 CE Chirp 45 dB nHL CE Chirp stimulus of 45 dB nHL 99 6 A04 Click 35 dB nHL Click...

Page 84: ...ch frequency Min OAE level 5 dB SPL Min SNR 7 dB Artifact rejection level 30 dB SPL 99 6 TEOAE Parameters Sensitivity T00 1 5 4 kHz 3_4 SNR 4 dB Center Frequencies 1 4k 2k 2 8k 4k Hz default Stimulus...

Page 85: ...born Hearing Screening System User Manual D 0113050 Rev H Page 85 of 96 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...

Page 86: ...POAE D03 2 5 kHz 65_55 dB SPL IEC F2 Frequencies 5k 4k 3k 2kHz Level L1 L2 65 55 dB SPL F2 F1 ratio 1 22 Max test time 60 s Number Freq for pass 3 4 Mic correction disabled to comply with standard Pas...

Page 87: ...60 dB peSPL 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 NA T04 1 5 4 kHz 70 dB SPL IEC Center Frequenc...

Page 88: ...of such damages The transducers may go out of calibration due to rough handling or impact dropping The lifetime of probe probe seals and eartips is dependent upon conditions of use These parts are onl...

Page 89: ...rcuit boards electronic components wiring and other elements of electronic devices Follow all local laws and regulations for the proper disposal of batteries and any other parts of this system Below i...

Page 90: ...r active HF surgical equipment and RF shielded rooms of systems for magnetic resonance imaging where the intensity of electromagnetic disturbance is high Essential performance for this instrument is d...

Page 91: ...ons CISPR 11 Group 1 The Novus uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emis...

Page 92: ...ance according to frequency of transmitter m 150 kHz to 80 MHz Outside ISM bands d 3 5 V1 150 kHz to 80 MHz ISM bands d 12 V2 80 MHz to 800 MHz d 12 E1 800 MHz to 2 7 GHz d 23 E1 0 01 0 12 0 20 0 12 0...

Page 93: ...5 1 kV differential mode 2 kV common mode Not applicable Mains power quality should be that of a typical commercial or residential environment Voltage dips short interruptions and voltage variations o...

Page 94: ...ter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site su...

Page 95: ...nt could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation To ensure compliance with the EMC requirements as specif...

Page 96: ...990 GSM 1800 CDMA 1900 GSM 1900 DECT LTE Band 1 3 4 25 Pulse modulation b 217 Hz 2 0 3 28 1 845 1 970 2 450 2400 2570 Bluetooth WLAN 802 11 b g n RFID 2450 LTE Band 7 Pulse modulation b 217 Hz 2 0 3 2...

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