Interacoustics Sera Instructions For Use Manual
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Interacoustics Sera Instructions For Use Manual

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Science made smarter
Instructions for Use - US
Sera™

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Summary of Contents for Interacoustics Sera

  • Page 1 Science made smarter Instructions for Use - US Sera™...

  • Page 3: Table Of Contents

    Battery charging ........................ 13 3.4.2 Installing label paper in the printer ..................13 3.4.3 Turning the printer on and off .................... 13 3.4.4 Connecting the wireless printer to the Sera ..............13 3.4.5 Printer offline ........................14 The Sera hardware ........................15 Connecting the probe cable to the Sera ..................
  • Page 4 4.5.2 Common function buttons ....................26 4.5.3 Keyboards (special characters) ..................26 4.5.4 Home screen ........................28 4.5.5 Adding a new patient ......................28 4.5.6 Patient ID conflict ......................29 4.5.7 Selecting from the patient list .................... 30 General test information ......................31 4.6.1 Patient preparation –...
  • Page 5 Probe integrity test for TEOAE ....................61 Probe integrity test for DPOAE ....................62 Maintenance ............................63 General maintenance procedures ....................63 General maintenance procedures ....................63 Cleaning the Sera ........................64 6.3.1 Touch screen ........................64 6.3.2 Case, cradle and cables ....................64 6.3.3...

  • Page 7: Introduction

    Intended use The Sera with DPOAE is intended for use in the audiologic evaluation and documentation of ear disorders using Distortion Product Otoacoustic Emissions. The target population for Sera with DPOAE includes all ages. The Sera with TEOAE is intended for use in the audiologic evaluation and documentation of ear disorders using Transient Evoked Otoacoustic Emissions.

  • Page 8: Product Description

    License configurations can be added even after the device has been purchased and taken into use. Refer to section 3.14 Licenses for more information. The Sera operates with different transducers and cable configurations. The table below shows which transducers and cable configurations are possible for use with the Sera TRANSDUCER / CABLE CONFIGURATION DPOAE TEOAE...

  • Page 9: Clinical Benefit

    • • Disposables are single use only! Reuse of disposables can impact test results and the patient’s safety. Refer to sections 2.7 Safety precautions. All disposable supplies included with Sera are supplied by Sanibel Supply . The system has only been tested using disposables manufactured by Sanibel Supply .

  • Page 10: Malfunction

    In case of death or serious incident in relation to the use of the device, the incident must immediately be reported to Interacoustics and the local national competent authority. D-0113323-F – 2020/11 Sera™...

  • Page 11: Safety Precautions

    Interacoustics is aware that safety rules within individual organizations vary. If a conflict exists between the instructions in this manual and the rules of the organization using this instrument, the more stringent rules should take precedence.

  • Page 12: Environmental Factors

    Do NOT use the Sera in a highly oxygen-enriched environment, such as a hyperbaric chamber, oxygen tent, etc. D-0113323-F – 2020/11 Sera™ - Instructions for Use - US Page 6...

  • Page 13: Use In Home Healthcare Environment

    Always ensure proper operation of the instrument by following routine check procedures for audiometric equipment D-0113323-F – 2020/11 Sera™ - Instructions for Use - US Page 7...
  • Page 14 D-0113323-F – 2020/11 Sera™ - Instructions for Use - US Page 8...

  • Page 15: Unpacking And Installation

    Keep carton for future shipment Sera comes in its own shipping carton, which is specially designed for the Sera . Please keep this carton. It will be needed if the instrument has to be returned for service.

  • Page 16: Markings

    Failing to do so may endanger the environment. The CE-mark indicates that Interacoustics A/S meets the requirements of Annex II of the Medical Device Directive 93/42/EEC. TÜV Product Service, Identification No.

  • Page 17: Installing The Cradle

    USE ONLY UE08WCP- 050160SPA- POWER SUPPLY. Do not attempt to use any other power supply. It can cause risk of fire or electrical shock to operator or patient. D-0113323-F – 2020/11 Sera™ - Instructions for Use - US Page 11...

  • Page 18: Installing The Hm-E200 Label Printer (Optional)

    The connection of the Sera and the HM-E200 label printer is made via wireless pairing. Only use the recommended printer from Interacoustics. NOTICE: Only printers purchased through Interacoustics distributors or Sanibel Supply® are compatible with the Sera D-0113323-F – 2020/11 Sera™...

  • Page 19: Battery Charging

    Indicator will flash, while the display turns black. Push the power button shortly to get the printer out of standby mode. 3.4.4 Connecting the wireless printer to the Sera Pairing the printer to the Sera is necessary before wireless printing is possible.

  • Page 20: Printer Offline

    It is possible to share one printer with multiple Sera devices. However, only one device can be paired with the printer at a time. This means that only one Sera can be turned on in range of the printer and the printer...

  • Page 21: The Sera Tm Hardware

    (1) is placed. At the base of the device, there is a micro-USB connector (1) and the built-in slot for attaching a neck lanyard (2) for transport of the device. D-0113323-F – 2020/11 Sera™ - Instructions for Use - US Page 15...

  • Page 22: Connecting The Probe Cable To The Sera Tm

    Sera Align the raised dot on the probe plug/preamplifier cable plug with the one on the front of the socket at the top of the Sera . Insert the plug and push it securely into place. The Sera is designed to guide the probe plug/preamplifier into the correct position.

  • Page 23: Use Of The Ip30 Transducer With Ear Tips Or Earcups (Abris Only)

    IP30 stereo ID EarCups – insert the black EarCup adapters directly into the holes of the pass-checker. (The Pass-Checker is not required for patient testing.) D-0113323-F – 2020/11 Sera™ - Instructions for Use - US Page 17...

  • Page 24: Transducers And Calibration

    (also known as an ID transducer). Transducers (probes, insert phones etc) can be swapped between devices without requiring recalibration to a specific Sera device. Sera will automatically detect the transducer type and read the calibration data from the ID transducer.

  • Page 25: Charging And Powering Sera

    Do not expose the battery to water • Do not short circuit the battery or reverse the polarity • The battery automatically starts charging when the Sera is placed properly into • the AC-powered cradle or when connected via USB to the PC Use only the charger provided with the Sera •...

  • Page 26: Indication Lights On Sera

    90% (PC) up to 90% and cradle up to 90% 3.13.1 Indication lights on Sera The table below summarizes the LED indicator light colors displayed on Sera under varying conditions (see Table 32). Table 2: LED Status on Sera and Cradle.

  • Page 27: Hearsim Tm Software Bundle

    5. Run the ErisLicenseManager.exe file located in the Sera Tools folder on the Sera USB stick. 6. Enter the new license key provided and press the Set license button 7. The firmware is now up to date and the new test type should now be available on your Sera device. Updating the firmware Interacoustics will periodically release new firmware for the Sera device.
  • Page 28 Ensure you have the last released version of the Sera software bundle. Connect the Sera device to the PC via the supplied USB cable. Run the FirmwareUpgradeSera.exe file located in the “Tools” folder on the Sera USB stick. Press Upgrade and follow the onscreen instructions. D-0113323-F – 2020/11 Sera™...

  • Page 29: Operating Instructions

    Do not use the instrument if any damage is suspected. See the Sera Additional Information for symptoms, possible causes and suggested troubleshooting. D-0113323-F – 2020/11 Sera™ - Instructions for Use - US Page 23...

  • Page 30: Switching The Sera Tm On And Off

    When the battery’s power level becomes so low that measurements can no longer be performed, a warning will appear on screen, the measurement will be stopped, and all recorded data will be stored. You will have to place the Sera in the cradle or connect it to a PC via USB cable to be able to continue testing.

  • Page 31: Sera Tm Operation And Button Overview

    4.5.1 The Sera screen format The general Sera screen format includes: Screen title Status/sub-header Main screen Battery indicator Function button Control bar with function buttons D-0113323-F – 2020/11 Sera™ - Instructions for Use - US Page 25...

  • Page 32: Common Function Buttons

    The default keyboard uses the English language character set. To access special characters from other languages, tap and hold down the most similar letter to the special character you are trying to insert. Available alternative characters will be displayed for selection. D-0113323-F – 2020/11 Sera™ - Instructions for Use - US Page 26...
  • Page 33 Special characters are available from the following English alphabet characters: D-0113323-F – 2020/11 Sera™ - Instructions for Use - US Page 27...

  • Page 34: Home Screen

    . Some settings can only be changed using HearSIM 4.5.5 Adding a new patient Patient information can be entered manually into the Sera via the New Patient screen. Select the New Patient button on the Home screen. In the New Patient screen, select a field for data entry by touching the desired field.

  • Page 35: Patient Id Conflict

    ID into the database, an ID conflict message will display. After dismissing the message by selecting the Checkmark in the bottom control bar, change the ID to a different unique number. D-0113323-F – 2020/11 Sera™ - Instructions for Use - US Page 29...

  • Page 36: Selecting From The Patient List

    Tests are saved in the device (between 1 and 49 tests). The maximum number of tests are saved (50). No additional tests can be performed for this patient. D-0113323-F – 2020/11 Sera™ - Instructions for Use - US Page 30...

  • Page 37: General Test Information

    Your choice may also depend on personal preference and the way you perform your test. D-0113323-F – 2020/11 Sera™ - Instructions for Use - US Page 31...

  • Page 38: Use Of Earcups

    Sanibel disposables are latex, DEHP and BPA free and comply to current bio-compatibility standards. Refer to the “Selecting the Correct Ear Tip” Quick Guide included in the Sera Additional Information for an overview of ear tip sizes and selection. Risk of choking.

  • Page 39: Select Test Type

    Underneath the test type (e.g., TEOAE), the name of the protocol is listed. Displayed tests are also dependent on the connected transducer. For example, if only the probe is connected to Sera , then Automated ABR tests will not show in the list. The preamplifier must be connected with an appropriate transducer to see Automated ABR tests.

  • Page 40: Stop Reason For Incomplete Test

    Pass Refer Incomplete 4.6.9 Stop reason for incomplete test The administrator can enable a feature in Sera via HearSIM automatically displaying a Select Stop Reason screen when a test is manually stopped. This information is saved with the test record.

  • Page 41: Printing After Testing

    1. If label printing or wireless communication is disabled on the device via HearSIM 2. If a label printer has not been paired to the Sera D-0113323-F – 2020/11 Sera™ - Instructions for Use - US...

  • Page 42: Automated Abr Testing

    (EarCups, inserts or probe). User instruction. Test instruction information is displayed. Start button. Starts the impedance check. Back button. Returns to the previous screen. D-0113323-F – 2020/11 Sera™ - Instructions for Use - US Page 36...

  • Page 43: Impedance Check Screen

    If impedance remains poor, an impedance timeout message will appear after approximately 60 seconds of impedance checking. Upon dismissing the message, the initial test screen will appear again. D-0113323-F – 2020/11 Sera™ - Instructions for Use - US Page 37...

  • Page 44: Automated Abr Measurement Screen

    If this occurs, you should Pause the test and attend to the noise by calming the baby or managing other sources of noise (electrical). D-0113323-F – 2020/11 Sera™ - Instructions for Use - US Page 38...

  • Page 45: Time Bar

    Begins an impedance check for a new test. Show test list button. Opens up list of all tests performed in this session. Printing available if printer is setup. D-0113323-F – 2020/11 Sera™ - Instructions for Use - US Page 39...
  • Page 46 Users can select the checkmark to proceed with a retest or can select the cancel button to cancel the retest and return to the Test Done screen. D-0113323-F – 2020/11 Sera™ - Instructions for Use - US Page 40...

  • Page 47: Oae Testing

    User instruction. Test instruction information is displayed. Start button. Starts the probe check. Back button. Returns to the previous screen. D-0113323-F – 2020/11 Sera™ - Instructions for Use - US Page 41...

  • Page 48: Probe Check Screen

    All criteria must be met before a test will start. Stop button. Stops the probe check. Pause/continue Pause/Continue the button. probe check. D-0113323-F – 2020/11 Sera™ - Instructions for Use - US Page 42...
  • Page 49 Make sure the probe tip is inserted securely into the ear canal. • Ensure the baby is relaxed and quiet or sleeping and/or attend to any acoustical noise in the test environment. D-0113323-F – 2020/11 Sera™ - Instructions for Use - US Page 43...

  • Page 50: Oae Measurement Screen

    Time bar. Elapsed test time. Stop button. Stops the test; assigns an Incomplete result. Pause/continue Pause/Continue the screening button. measurement. D-0113323-F – 2020/11 Sera™ - Instructions for Use - US Page 44...

  • Page 51: Probe Stability Bar

    If this occurs, you should Pause the test and attend to the noise by calming the baby or managing other sources of ambient noise. The fit of the probe should also be checked. D-0113323-F – 2020/11 Sera™ - Instructions for Use - US Page 45...

  • Page 52: Time Bar

    The ear selection control can also be used to toggle between the last OAE test performed on the right and left ears during the session. D-0113323-F – 2020/11 Sera™ - Instructions for Use - US Page 46...
  • Page 53 Back button. Returns to prior screen (before initial test screen). Comment. Select to open up a screen for inserting a comment about the test just performed D-0113323-F – 2020/11 Sera™ - Instructions for Use - US Page 47...
  • Page 54 Back button. Returns to prior screen (before initial test screen). Comment. Select to open up a screen for inserting a comment about the test just performed D-0113323-F – 2020/11 Sera™ - Instructions for Use - US Page 48...

  • Page 55: Probe Stability % (Dpoae Only)

    When the measurement is finished, the total amount of artifact measured during the test will be shown. Time When the measurement is finished, the total test time will be presented here. D-0113323-F – 2020/11 Sera™ - Instructions for Use - US Page 49...

  • Page 56: Quick Test

    Quick tests can be printed immediately after the test is completed, but no identifying information will appear on the print-out. Only the last Quick Test session is saved temporarily in the Sera until the next time that the Quick Test button is selected on the Home screen.

  • Page 57: Printing

    The label printout displays the following information: First Name • Last Name • • Gender • Birthdate • Result of left ear, date and time • Result of right ear, date and time • D-0113323-F – 2020/11 Sera™ - Instructions for Use - US Page 51...

  • Page 58: Reviewing Patients And Saved Sessions

    Each row represents one test. If more than 8 tests are saved, use the Up and Down arrow buttons in the bottom control bar to scroll through the list. D-0113323-F – 2020/11 Sera™ - Instructions for Use - US Page 52...

  • Page 59: Printing A Saved Test

    Test-related Field information. This screen will only be available if the Test Fields option is enabled on the device via HearSIM The Test-related fields cannot be edited on the Sera . If edits are needed, the test data must be first transferred to the HearSIM and edited from there.

  • Page 60: User Management On Device

    Enter your password in the password entry screen using the on-screen keyboard and select the Checkmark button in the control bar. If the password is correct, the Home screen will display. D-0113323-F – 2020/11 Sera™ - Instructions for Use - US Page 54...

  • Page 61: Incorrect Password

    The message will display for several seconds and then it will disappear, clearing the entry field so that you can try to re-enter the password again. D-0113323-F – 2020/11 Sera™ - Instructions for Use - US Page 55...

  • Page 62: Setup

    Setup Select the Setup button in the control bar of the Home screen to access a list of the settings that can be made directly on the Sera 4.13.1 Language screen Use the Up and Down arrows to scroll through the list of languages.

  • Page 63: Sound

    “HM-E200” will display when the printer is successfully paired to the Sera Select the Checkmark button in the control bar to confirm the settings and close the Printer Setup screen. D-0113323-F – 2020/11 Sera™ - Instructions for Use - US Page 57...

  • Page 64: About

    4.13.5 About Select the About item to view information about the Sera including: • Firmware versions Serial numbers and calibration dates • Battery information • • Licenses D-0113323-F – 2020/11 Sera™ - Instructions for Use - US Page 58...

  • Page 65: Equipment (Integrity) Checks

    Automated ABR testing with Sera . An integrity check can be done on a regular basis or can be performed if you suspect a problem with the Sera hardware, electrode cables or transducer. The Pass-Checker can be purchased from your Interacoustics representative.
  • Page 66 Additional Information for symptoms, possible causes and suggested troubleshooting. Please note: The Pass-Checker battery should only be replaced by an authorized Interacoustics 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 product warranty.

  • Page 67: Probe Integrity Test For Teoae

    Probe integrity test for TEOAE A test cavity called the Infant Ear Simulator is provided with Sera for conducting a probe integrity test for the OAE modules. The probe integrity test ensures that system distortions are not being generated by the probe or hardware.

  • Page 68: Probe Integrity Test For Dpoae

    Probe integrity test for DPOAE A test cavity called the Infant Ear Simulator is provided with Sera for conducting a probe integrity test for the OAE modules. The probe integrity test ensures that system distortions are not being generated by the probe or hardware.

  • Page 69: Maintenance

    Recommended cleaning and disinfection solutions: Warm water with mild, non-abrasive cleaning solution (soap) • If disinfection is necessary, 70% isopropyl alcohol may be used on hard cover surfaces only • D-0113323-F – 2020/11 Sera™ - Instructions for Use - US Page 63...

  • Page 70: Cleaning The Sera Tm

    If disinfection is required, use a disinfectant wipe rather than a spray product. Make sure that excess liquid from the wipe does not seep into any sensitive areas such as connectors and seams where plastic pieces connect such as under the rubber rim around the Sera Follow the instructions on the disinfection product.

  • Page 71: Cleaning The Owa Probe Tip

    Thread the cleaning floss into one of the channels from the base of the probe tip. Pull the cleaning floss completely through the probe tip channel. Repeat for each channel if required. D-0113323-F – 2020/11 Sera™ - Instructions for Use - US Page 65...
  • Page 72 Never use tools to affix the probe cap! Please refer to the Sera Additional Information for further information about Cleaning of the probe. D-0113323-F – 2020/11 Sera™ - Instructions for Use - US Page 66...

  • Page 73: Cleaning The Snapprobe

    Accessories/replacement parts Some reusable components are subject to wear with use over time. We recommend that you keep these replacement parts available (as appropriate for your Sera device configuration). D-0113323-F – 2020/11 Sera™...

  • Page 74: Repair

    This warranty is in lieu of all other warranties, express or implied, and of all other obligations or liabilities of Interacoustics. Interacoustics does not give or grant, directly or indirectly, the authority to any representative or other person to assume on behalf of Interacoustics any other liability in connection with the sale of Interacoustics products.

  • Page 75: General Technical Specification

    7 General technical specification Sera instrument – technical specifications Medical CE- The CE-mark indicates that Interacoustics A/S meets the requirements of Annex II mark of the Medical Device Directive 93/42/EEC. Approval of the quality system is made by TÜV – identification no0123...
  • Page 76 0.5 kΩ – 50 kΩ ± 10 % Stimulus Stimuli: CE-Chirp® (200 Hz – 11 kHz), Click (200 Hz – 11 kHz) Stimulus rate: 90 Hz Transducers: IP30 insert phone D-0113323-F – 2020/11 Sera™ - Instructions for Use - US Page 70...
  • Page 77 DPOAEs that is outside the scope of IEC 60645-6 for some protocols. All protocols that include IEC in the name use the specified IEC calibration method. D-0113323-F – 2020/11 Sera™ - Instructions for Use - US Page 71...
  • Page 78 Additional Information for further information about available test protocols, test protocol settings and sensitivity and specificity. Display Transducer, test result bars, result symbols (pass/refer/incomplete), stimulus stability, test time, artifact. D-0113323-F – 2020/11 Sera™ - Instructions for Use - US Page 72...

  • Page 79: Specification Of Input/Output Connections

    Calibration properties Accuracy ABRIS ±2 dB for all stimulus types DPOAE ±1.5 dB for 1000 to 4000Hz and ±3 dB outside range TEOAE ±2 dB for click stimulus D-0113323-F – 2020/11 Sera™ - Instructions for Use - US Page 73...

  • Page 80: Calibration Reference Values For The Ce-Chirp® Stimulus

    Probe stimuli L1 and L2 are calibrated individually in SPL values using the IEC 711 ear simulator coupler made in accordance to IEC 60318-4. TEOAE: Probe stimuli are calibrated in peSPL values using the IEC 711 ear simulator coupler made in accordance to IEC 60318-4. D-0113323-F – 2020/11 Sera™ - Instructions for Use - US Page 74...

  • Page 81: General Information About Specifications

    The performance and specifications of the instrument can only be guaranteed if it is subject to technical maintenance at least once per year. This should be carried out by a workshop authorized by Interacoustics. Interacoustics puts diagrams and service manuals at the disposal of authorized service companies.

  • Page 82: Appendix B: Electromagnetic Compatibility (Emc)

    0,51 The use of the accessories, transducers and cables with medical equipment/system other than this equipment may result in increased emissions or decreased immunity of the medical equipment/system. D-0113323-F – 2020/11 Sera™ - Instructions for Use - US Page 76...
  • Page 83 The Sera is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Sera can help prevent electromagnetic interferences by maintaining a minimum distance between portable and mobile RF communications equipment...
  • Page 84 IEC 61000-4-8 location in a typical commercial or residential environment. Note: UT is the A.C. mains voltage prior to application of the test level. D-0113323-F – 2020/11 Sera™ - Instructions for Use - US Page 78...
  • Page 85 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Sera is used exceeds the applicable RF compliance level above, the Sera should be observed to verify normal operation, If abnormal performance is observed, additional measures may be necessary, such as re- orienting or relocating the Sera Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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