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 - EN
Sera™

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Summary of Contents for Interacoustics Sera

  • Page 1 Science made smarter Instructions for Use - EN 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 off line ......................14 The Sera hardware......................15 Connecting the probe cable to the Sera ................
  • Page 4 4.5.2 Common f unction 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 conf lict ...................... 29 4.5.7 Selecting f rom the patient list ..................30 General test inf ormation ......................
  • Page 5 Probe integrity test for TEOAE..................... 61 Probe integrity test for DPOAE .................... 62 Maintenance ..........................63 General maintenanc e procedures ..................63 General maintenanc e 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

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

  • Page 8: Product Description

    3.14 Licenses f or more inf ormation. The Sera operates with dif f erent transducers and cable conf igurations. The table below shows which transducers and cable conf igurations are possible f or use with the Sera TRANSDUCER / CABLE CONFIGURATION DPOAE...

  • Page 9: Clinical Benefit

    Probe tip kit • • Disposables are single use only! Reuse of disposables can impact test results and the patient’s saf ety. Ref er to sections 2.7 Saf ety precautions. All disposable supplies included with Sera are supplied by Sanibel Supply ®...

  • Page 10: Warnings

    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-0112389-I – 2022/04 Page 4 Sera™...

  • Page 11: Safety Precautions

    Interacoustics is aware that saf ety rules within individual organizations vary. If a conf lict 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-0112389-I – 2022/04 Page 6 Sera™ - Instructions for Use - EN...

  • Page 13: Use In Home Healthcare Environment

    Always ensure proper operation of the instrument by f ollowing routine check procedures f or audiometric equipment D-0112389-I – 2022/04 Page 7 Sera™ - Instructions for Use - EN...
  • Page 14 D-0112389-I – 2022/04 Page 8 Sera™ - Instructions for Use - EN...

  • Page 15: Unpacking And Installation

    Keep carton for future shipment Sera comes in its own shipping carton, which is specially designed f or the Sera . Please keep this carton. It will be needed if the instrument must be returned f or 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, Identif ication No.

  • Page 17: Installing The Cradle

    USE ONLY UES12LCP-050160SPA - POWER SUPPLY. Do not attempt to use any other power supply. It can cause risk of f ire or electrical shock to operator or patient. D-0112389-I – 2022/04 Page 11 Sera™ - Instructions for Use - EN...

  • 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 f rom Interacoustics. NOTICE: Only printers purchased through Interacoustics distributors or Sanibel Supply® are compatible with the Sera D-0112389-I – 2022/04 Page 12 Sera™...

  • Page 19: Battery Charging

    Indicator will f lash, 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 bef ore 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 must be powered of f af ter use with one Sera to then connect to the other SeraTM device successf ully.

  • Page 21: The Sera Tm Hardware

    At the base of the device, there is a micro-USB connector (1) and the built-in slot f or attaching a neck lanyard (2) f or transport of the device. D-0112389-I – 2022/04 Page 15 Sera™ - Instructions for Use - EN...

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

    Sera Align the raised dot on the probe plug/preamplif ier cable plug with the one on the f ront of the socket at the top of the Sera . Insert the plug and push it securely into place.

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

    (ear tips or EarCups) it is calibrated f or. Misuse may lead to incorrect results due to dif ferences in the calibration. 3.10 Connecting to the optional pass-checker The ABRIS pass-checker can be used f or assessing the integrity of the hardware, electrode leads and transducer. D-0112389-I – 2022/04 Page 17 Sera™ - Instructions for Use - EN...

  • 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 specif ic Sera device. Sera will automatically detect the transducer type and read the calibration data f rom 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 •...

  • Page 26: Indication Lights On Sera

    USB up to 90% (PC) 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

    USB stick. 6. Enter the new license key provided and press the Set license button 7. The f irmware is now up to date and the new test type should now be available on your Sera device. 3.16 Updating the firmware Interacoustics will periodically release new f irmware f or the Sera device.
  • Page 28 Connect the Sera device to the PC via the supplied USB cable. Run the FirmwareUpgradeSera.exe f ile located in the “Tools” f older on the Sera USB stick. Press Upgrade and f ollow the onscreen instructions. D-0112389-I – 2022/04 Page 22 Sera™...

  • Page 29: Operating Instructions

    Do not use the instrument if any damage is suspected. See the Sera Additional Inf ormation f or symptoms, possible causes and suggested troubleshooting. D-0112389-I – 2022/04 Page 23 Sera™ - Instructions for Use - EN...

  • Page 30: Switching The Sera Tm On And Off

    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 f ormat includes: Screen title Status/sub-header Main screen Battery indicator Function button Control bar with f unction buttons D-0112389-I – 2022/04 Page 25 Sera™ - Instructions for Use - EN...

  • Page 32: Common Function Buttons

    The def ault keyboard uses the English language character set. To access special characters f rom 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 f or selection. D-0112389-I – 2022/04 Page 26 Sera™ - Instructions for Use - EN...
  • Page 33 Special characters are available f rom the f ollowing English alphabet characters: D-0112389-I – 2022/04 Page 27 Sera™ - Instructions for Use - EN...

  • Page 34: Home Screen

    . Some settings can only be changed using HearSIM 4.5.5 Adding a new patient Patient inf ormation 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 f ield f or data entry by touching the desired f ield.

  • Page 35: Patient Id Conflict

    ID into the database, an ID conf lict message will display. Af ter dismissing the message by selecting the Checkmark in the bottom control bar, change the ID to a dif f erent unique number. D-0112389-I – 2022/04 Page 29 Sera™ - Instructions for Use - EN...

  • 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 perf ormed f or this patient. D-0112389-I – 2022/04 Page 30 Sera™ - Instructions for Use - EN...

  • Page 37: General Test Information

    Your choice may also depend on personal pref erence and the way you perf orm your test. D-0112389-I – 2022/04 Page 31 Sera™ - Instructions for Use - EN...

  • Page 38: Use Of Earcups

    DEHP and BPA f ree and comply to current bio-compatibility standards. Ref er to the “Selecting the Correct Ear Tip” Quick Guide included in the Sera Additional Inf ormation f or an overview of ear tip sizes and selection.

  • 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 preamplif ier must be connected with an appropriate transducer to see Automated ABR tests.

  • Page 40: Stop Reason For Incomplete Test

    Pass Ref er Incomplete 4.6.9 Stop reason for incomplete test The administrator can enable a f eature in Sera via HearSIM f or automatically displaying a Select Stop Reason screen when a test is manually stopped. This inf ormation is saved with the test record.

  • Page 41: Printing After Testing

    Please note: The print icons will not appear on Sera under the f ollowing conditions. 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-0112389-I – 2022/04 Page 35...

  • 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-0112389-I – 2022/04 Page 36 Sera™ - Instructions for Use - EN...

  • Page 43: Impedance Check Screen

    If impedance remains poor, an impedance timeout message will appear af ter approximately 60 seconds of impedance checking. Upon dismissing the message, the initial test screen will appear again. D-0112389-I – 2022/04 Page 37 Sera™ - Instructions for Use - EN...

  • 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-0112389-I – 2022/04 Page 38 Sera™ - Instructions for Use - EN...

  • Page 45: Time Bar

    Start button. Begins an impedance check for a new test. Show test list button. Opens list of all tests performed in this session. Printing available if printer is setup. D-0112389-I – 2022/04 Page 39 Sera™ - Instructions for Use - EN...
  • 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-0112389-I – 2022/04 Page 40 Sera™ - Instructions for Use - EN...

  • 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-0112389-I – 2022/04 Page 41 Sera™ - Instructions for Use - EN...

  • 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-0112389-I – 2022/04 Page 42 Sera™ - Instructions for Use - EN...
  • 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-0112389-I – 2022/04 Page 43 Sera™ - Instructions for Use - EN...

  • 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-0112389-I – 2022/04 Page 44 Sera™ - Instructions for Use - EN...

  • 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 f it of the probe should also be checked. D-0112389-I – 2022/04 Page 45 Sera™ - Instructions for Use - EN...

  • Page 52: Time Bar

    The ear selection control can also be used to toggle between the last OAE test perf ormed on the right and lef t ears during the session. D-0112389-I – 2022/04 Page 46 Sera™ - Instructions for Use - EN...
  • Page 53 Back button. Returns to prior screen (before initial test screen). Comment. Select to open a screen for inserting a comment about the test just performed D-0112389-I – 2022/04 Page 47 Sera™ - Instructions for Use - EN...
  • Page 54 Back button. Returns to prior screen (before initial test screen). Comment. Select to open a screen for inserting a comment about the test just performed D-0112389-I – 2022/04 Page 48 Sera™ - Instructions for Use - EN...

  • Page 55: Probe Stability % (Dpoae Only)

    When the measurement is f inished, the total amount of artif act measured during the test will be shown. 4.8.4.4 Time When the measurement is f inished, the total test time will be presented here. D-0112389-I – 2022/04 Page 49 Sera™ - Instructions for Use - EN...

  • Page 56: Quick Test

    Quick tests can be printed immediately af ter the test is completed, but no identif ying inf ormation 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

    First Name • • Last Name • Gender • Birthdate • Result of lef t ear, date, and time • Result of right ear, date, and time • D-0112389-I – 2022/04 Page 51 Sera™ - Instructions for Use - EN...

  • 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-0112389-I – 2022/04 Page 52 Sera™ - Instructions for Use - EN...

  • Page 59: Printing A Saved Test

    Test-related Field inf ormation. This screen will only be available if the Test Fields option is enabled on the device via HearSIM The Test-related f ields cannot be edited on the Sera . If edits are needed, the test data must be f irst transf erred to the HearSIM and edited f rom 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-0112389-I – 2022/04 Page 54 Sera™ - Instructions for Use - EN...

  • Page 61: Incorrect Password

    The message will display f or several seconds and then it will disappear, clearing the entry f ield so that you can try to re-enter the password again. D-0112389-I – 2022/04 Page 55 Sera™ - Instructions for Use - EN...

  • Page 62: Setup

    4.13 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 successf ully paired to the Sera Select the Checkmark button in the control bar to conf irm the settings and close the Printer Setup screen. D-0112389-I – 2022/04 Page 57 Sera™ - Instructions for Use - EN...

  • Page 64: About

    4.13.5 About Select the About item to view inf ormation about the Sera including: Firmware versions • Serial numbers and calibration dates • • Battery inf ormation Licenses • D-0112389-I – 2022/04 Page 58 Sera™ - Instructions for Use - EN...

  • Page 65: Equipment (Integrity) Checks

    Automated ABR testing with Sera . An integrity check can be done on a regular basis or can be perf ormed if you suspect a problem with the Sera hardware, electrode cables or transducer. The Pass-Checker can be purchased f rom your Interacoustics representative.
  • Page 66 Additional Inf ormation f or 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 f rom an attempt to change the battery by someone other than an authorized representative will not qualif y f or repair under the product warranty.

  • Page 67: Probe Integrity Test For Teoae

    5.3 Probe integrity test for TEOAE A test cavity called the Inf ant Ear Simulator is provided with Sera f or conducting a probe integrity test f or 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

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

  • Page 69: Maintenance

    Do not let parts that have been in contact with f luids dry bef ore cleaning • • Rubber ear-tips or f oam ear-tips are single use components Recommended cleaning and disinfection solutions: • Warm water with mild, non-abrasive cleaning solution (soap) D-0112389-I – 2022/04 Page 63 Sera™ - Instructions for Use - EN...

  • Page 70: Cleaning The Sera

    6.3.1 Touch screen Clean the instrument by wiping the outer case with a lint f ree cloth lightly dampened with cleaning solution. Use a lens cleaning or microf iber cloth to clean the Sera touch screen. 6.3.2 Case, cradle and cables Use caution while cleaning.

  • Page 71: Cleaning The Owa Probe Tip

    Thread the cleaning f loss into one of the channels f rom the base of the probe tip. Pull the cleaning f loss completely through the probe tip channel. Repeat f or each channel if required. D-0112389-I – 2022/04 Page 65 Sera™ - Instructions for Use - EN...
  • Page 72 Never use tools to af fix the probe cap! Please ref er to the Sera Additional Inf ormation f or f urther inf ormation about Cleaning of the probe. D-0112389-I – 2022/04 Page 66 Sera™ - Instructions for Use - EN...

  • Page 73: Cleaning The Snapprobe

    6.6 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 f or your Sera device conf iguration). D-0112389-I – 2022/04 Page 67 Sera™...

  • Page 74: Repair

    6.7 Repair Interacoustics is only considered to be responsible f or the validity of the CE marking, ef f ects on saf ety, reliability, and perf ormance of the equipment if : 1. Assembly operations, extensions, readjustments, modif ications, or repairs are carried out by authorized persons 2.

  • Page 75: General Technical Specification

    7.1 Sera instrument – technical specifications Medical CE- The CE-mark in combination with MD symbol indicates that Interacoustics A/S mark meets the requirements of the Medical Device Regulation (EU) 2017/745. Approval of the quality system is made by TÜV no. 0123.
  • 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-0112389-I – 2022/04 Page 70 Sera™ - Instructions for Use - EN...
  • Page 77 DPOAEs that is outside the scope of IEC 60645-6 f or some protocols. All protocols that include IEC in the name use the specif ied IEC calibration method. D-0112389-I – 2022/04 Page 71 Sera™ - Instructions for Use - EN...
  • Page 78 Display Transducer, test result bars, result symbols (pass/ref er/incomplete), stimulus stability, test time, artif act. D-0112389-I – 2022/04 Page 72 Sera™ - Instructions for Use - EN...

  • Page 79: Specification Of Input/Output Connections

    ABRIS ±2 dB f or all stimulus types DPOAE ±1.5 dB f or 1000 to 4000Hz and ±3 dB outside range TEOAE ±2 dB f or click stimulus D-0112389-I – 2022/04 Page 73 Sera™ - Instructions for Use - EN...

  • 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 with IEC 60318-4. TEOAE: Probe stimuli are calibrated in peSPL values using the IEC 711 ear simulator coupler made in accordance with IEC 60318-4. D-0112389-I – 2022/04 Page 74 Sera™ - Instructions for Use - EN...

  • Page 81: General Information About Specifications

    The perf ormance and specif ications 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-0112389-I – 2022/04 Page 76 Sera™ - Instructions for Use - EN...
  • Page 83 The Sera is intended f or use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Sera can help prevent electromagnetic interf erences 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-0112389-I – 2022/04 Page 78 Sera™ - Instructions for Use - EN...
  • Page 85 (a) should be less than the compliance level in each f requency range (b) Interf erence may occur in the vicinity of equipment marked with the f ollowing symbol: D-0112389-I – 2022/04 Page 79 Sera™ - Instructions for Use - EN...
  • Page 86 If the measured f ield strength in the location in which the Sera is used exceeds the applicable RF compliance level above, the Sera should be observed to verif y normal operation, If abnormal perf ormance is observed, additional measures may be necessary, such as reorienting or relocating the Sera Over the f requency range 150 kHz to 80 MHz, f ield strengths should be less than 3 V/m.
  • Page 87 Other : Date : Person : Please provide e-mail address or fax No. to whom Interacoustics may confirm reception of the returned goods: The above mentioned item is reported to be dangerous to patient or user In order to ensure instant and effective treatment of returned goods, it is important that this form is filled in and placed together with the item.

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