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D-0112389-I – 2022/04
Sera™ - Instructions for Use - EN

Page

7.3 Calibration reference values for the CE-Chirp® stimulus

Probe and insert stimuli are calibrated in SPL values using an ear simulator coupler made in accordance to

IEC 60318-4.

Transducer

peRETSPL

[dB re. 20 μPa]

RadioEar IP30 with ear tips

31.5 dB SPL

RadioEar IP30 with EarCups

58.5 dB SPL

OWA probe

35 dB SPL

SnapPROBE

34.1 dB SPL

Reference values for the CE-Chirp

stimulus are Interacoustics standard values.

7.4 Calibration reference values for the click stimulus

Probe and insert stimuli are calibrated in SPL values using an ear simulator coupler made in accordance to

IEC 60318-4.

Transducer

peRETSPL [dB re. 20 μPa]

RadioEar IP30 with ear tips

35 dB SPL

RadioEar IP30 with EarCups

61.5 dB SPL

OWA probe

33.5 dB SPL

SnapPROBE

37.4 dB SPL

7.5 Coupler types used for calibration

ABRIS:

Probe and insert stimuli are calibrated in SPL values using an ear simulator coupler made in accordance

with IEC 60318-4.

DPOAE:

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.

Содержание Sera

Страница 1: ...Instructions for Use EN Sera Science made smarter 8501165 D 0112389 I 2022 04...

Страница 2: ......

Страница 3: ...13 3 4 3 Turning the printer on and off 13 3 4 4 Connecting the wireless printer to the SeraTM 13 3 4 5 Printer offline 14 3 5 The SeraTM hardware 15 3 6 Connecting the probe cable to the SeraTM 16 3...

Страница 4: ...3 2 Time bar 39 4 7 3 3 Test done screen 39 4 8 OAE testing 41 4 8 1 OAE initial test screen 41 4 8 2 Probe check screen 42 4 8 3 OAE measurement screen 44 4 8 3 1 Probe stability bar 45 4 8 3 2 Noise...

Страница 5: ...3 3 Disposables 64 6 4 Cleaning the OWA probe tip 65 6 5 Cleaning the SnapPROBETM 67 6 6 Accessories replacement parts 67 6 7 Repair 68 6 8 Warranty 68 7 General technical specification 69 7 1 SeraTM...

Страница 6: ......

Страница 7: ...ns The target population for SeraTM with TEOAE includes all ages The SeraTM with ABRIS is intended for use in the audiologic evaluation and documentation of ear and nerve disorders using auditory evok...

Страница 8: ...different transducers and cable configurations The table below shows which transducers and cable configurations are possible for use with the SeraTM TRANSDUCER CABLE CONFIGURATION DPOAE TEOAE ABRIS S...

Страница 9: ...Optional Snap Electrodes Optional Tab electrodes Optional Optional Gauze swaps Optional Conductivity gel Optional Alcohol pads Optional Printer label paper Optional Optional Probe tip kit Disposables...

Страница 10: ...mportant to protect patients users and other persons against harm Therefore if the product has caused or potentially could cause such harm it must be quarantined immediately Both harmful and harmless...

Страница 11: ...device If the instrument is damaged return it to the manufacturer for repair and or calibration Do not use the instrument if any damage is suspected This product and its components will perform relia...

Страница 12: ...Do not touch the contacts on the bottom of the instrument and the patient at the same time The consequence could be a too high leakage current to the patient Do not open the case of the instrument Re...

Страница 13: ...or damage the parts Within the European Union it is illegal to dispose of electrical and electronic waste as unsorted municipal waste Electrical and electronic waste may contain hazardous substances a...

Страница 14: ...D 0112389 I 2022 04 Sera Instructions for Use EN Page 8...

Страница 15: ...perfections Inspect before connection Prior to connecting the product it should once more be inspected for damage The cabinet and the accessories should be checked visually for scratches and missing p...

Страница 16: ...tion Refer to instructions for use Follow Instructions for Use WEEE EU directive This symbol indicates that when the end user wishes to discard this product it must be sent to separate collection faci...

Страница 17: ...ction provided by the enclosure against ingress of objects Effective against objects greater than 12 5 mm IP02 Degree of protection provided by the enclosure against ingress of liquid Effective agains...

Страница 18: ...ement in the cradle is needed to ensure charging of the battery Grasp the upper portion of the SeraTM above the cradle placement guides and lift it out of the cradle 3 4 Installing the HM E200 label p...

Страница 19: ...urn the printer on and press the feed button on the left side so that the printer can properly align the labels with the print head Optionally thermal paper can be used with the HM E200 thermal printe...

Страница 20: ...ect to the other SeraTM device successfully If you want to print measured results on the connected printer it is recommended to switch on the printer before doing the measurements This will allow the...

Страница 21: ...ng icons Viewing your SeraTM from the front side you will see the touch screen display 1 and the On Off Home button 2 and a charging light indicator LED 3 On the top of the device an ABR preamp OAE pr...

Страница 22: ...and push it securely into place The SeraTM is designed to guide the probe plug preamplifier into the correct position 3 7 Connecting transducers to the preamplifier The preamplifier cable is required...

Страница 23: ...daptor The transducer is labeled Calibrated for use with EarCups The IP30 stereo ID EarCups can also be used with EARturtleTM The EARturtleTM Click requires a special adapter see picture while the EAR...

Страница 24: ...ecker The Pass Checker is not required for patient testing 3 11 Transducers and calibration The transducers used with SeraTM use a special omnetics plug that allows the calibration data to be stored w...

Страница 25: ...other connectors has formed a Medical Electrical System and is therefore responsible for the system to comply with the requirements If in doubt contact qualified medical technician or your local repre...

Страница 26: ...switched off during charging Table 1 Estimated time of charging the SeraTM in hours 3 13 1 Indication lights on SeraTM The table below summarizes the LED indicator light colors displayed on SeraTM un...

Страница 27: ...osoft supported operating systems that are kept fully security updated 3 15 Licenses When you receive the SeraTM it already contains the license s for the modules you have purchased If you would like...

Страница 28: ...evice 1 Ensure you have the last released version of the SeraTM software bundle 2 Connect the SeraTM device to the PC via the supplied USB cable 3 Run the FirmwareUpgradeSera exe file located in the T...

Страница 29: ...ach day to ensure that the transducers the probe and or cable is functioning correctly for Automated ABR TEOAE and DPOAE measurements 9 Clean the probe tip regularly to ensure wax or other debris stuc...

Страница 30: ...nterference may introduce noise into the recording prolonging the test time and increasing the chances of a refer result Therefore testing while the device is connected to a PC or to mains power is no...

Страница 31: ...30 minutes of active test time remaining 5 Testing cannot be performed recharge ASAP 3 Automatic shutdown 4 5 SeraTM operation and button overview 4 5 1 The SeraTM screen format The general SeraTM scr...

Страница 32: ...ds Proceed to test start test Pause test Stop test Resume test Quick add of new patient Both ears test Right ear Left ear Sort order alphabetical Sort order chronological Change screener 4 5 3 Keyboar...

Страница 33: ...D 0112389 I 2022 04 Sera Instructions for Use EN Page 27 Special characters are available from the following English alphabet characters A C D E G I L N O R S T U Z...

Страница 34: ...e Patient Information The Change User control will be unavailable for selection if user login is disabled Select Change User to log out of the current user and display the User list for selection of a...

Страница 35: ...ID can be overwritten when entering the patient data Configuring SeraTM to use an automatically entered ID number is accomplished via HearSIMTM When you have completed entry of data you can proceed i...

Страница 36: ...only matching entries Page down or up using the arrow keys to find the desired patient name Select the patient of interest to open the Patient information screen After selecting the patient you can p...

Страница 37: ...in The electrodes used by SeraTM with ABRIS are intended for use on intact external skin around the ears and on the scalp They should not be used if the skin is not intact of the baby has a contagious...

Страница 38: ...t to patient and potentially affect the delivery of the correct stimulus level to the patient s ear Ensure that the EarCup and EARturtleTM Slide is correctly fitted to the EarCup adaptor or in case of...

Страница 39: ...amplifier must be connected with an appropriate transducer to see Automated ABR tests Please refer to the SeraTM Additional Information for further information about the protocols 4 6 7 Test related f...

Страница 40: ...provided in Table 3 Table 3 Screening Result Symbols 4 6 9 Stop reason for incomplete test The administrator can enable a feature in SeraTM via HearSIMTM for automatically displaying a Select Stop Re...

Страница 41: ...small green checkmark appearing on a printer icon at the right side of the row You can deselect a test by touching the symbol You can select other tests in the list for printing according to your pre...

Страница 42: ...t screen The initial Automated ABR screen displays the following information and instructions Table 4 Table 4 Initial Automated ABR screen Displayed graphic Function name Description Patient informati...

Страница 43: ...r impedance persists it may be necessary to remove the electrode and use the skin preparation product to clean the skin again or use a conductive gel It may be possible to reapply the same electrode b...

Страница 44: ...be accepted and processed by the response detection algorithm If the incoming EEG samples contain high noise due to myogenic or electrical noise the checkmark will disappear and the noise bar will re...

Страница 45: ...esting or can repeat a test measure on the same ear The ear selection control can also be used to toggle between the last Automated ABR test performed on the right and left ear during the session Tabl...

Страница 46: ...he ear test has just passed and asks for confirmation of a desire to retest the same ear again Users can select the checkmark to proceed with a retest or can select the cancel button to cancel the ret...

Страница 47: ...initial test screen The initial OAE screen displays the following information and instructions Table 8 Table 8 OAE initial test screen Displayed graphic Function name Description Patient information D...

Страница 48: ...heck terminates and the OAE measurement phase begins automatically Table 9 DPOAE Probe check screen Displayed graphic Function name Description Probe check status Displays the probe check status in ea...

Страница 49: ...ear canal Ensure the baby is relaxed and quiet or sleeping and or attend to any acoustical noise in the test environment Displayed graphic Function name Description Probe check status Displays the pr...

Страница 50: ...ogress appear When noise and probe stability are acceptable a checkmark appears next to the horizontal bar Table 11 DPOAE measurement screen Screenarea graphic Function name Description Test status in...

Страница 51: ...ugh to be accepted and processed by the response detection algorithm If the incoming data sample contains high noise the checkmark will disappear and the noise bar will reflect noise exceeding the rej...

Страница 52: ...the test will terminate automatically 4 8 4 Test done screen At the conclusion of a screening the result of the most recently completed screening will continue to be visible The ear selection control...

Страница 53: ...the result s of the most recent screening performed in this test session Overall result appears at the top Results for individual frequencies appear above ear bar Probe stability Indicates the quality...

Страница 54: ...e result s of the most recent screening performed in this test session Overall result appears at the top Results for individual frequencies appear above ear bar Stimulus stability Indicates the stabil...

Страница 55: ...ing during testing 4 8 4 2 Stimulus stability TEOAE only When the measurement is finished the Stimulus stability provides an indication of how stable the stimulus level was throughout the measurement...

Страница 56: ...ermanently deleted from SeraTM Please note Quick test functionality can be enabled disabled by an Administrator via HearSIMTM If Quick Test is disabled on your device then the Quick Test button will n...

Страница 57: ...the Test List screen that can be accessed from either the Test Done screen or from the Patient Information screen Print from the Test Done screen Print from the Patient Information Screen 4 10 2 Labe...

Страница 58: ...use the Search button in the control bar to open a keyboard screen Type in all or a portion of the patient s last name or ID number and select Search again to return to a shortened list containing onl...

Страница 59: ...tton only appear on the screen if your SeraTM has the wireless and Printer settings enabled via HearSIMTM and if an HM E200 printer has been paired with the device Otherwise these controls are hidden...

Страница 60: ...d in HearSIMTM and transferred to the SeraTM will display after the device boots up Select your username from the list to proceed to the password entry screen Up and down arrows in the control bar all...

Страница 61: ...t password If an incorrect password is entered a message will appear indicating that the password you entered was incorrect The message will display for several seconds and then it will disappear clea...

Страница 62: ...Spanish French Italian Portuguese Dutch Polish Finnish Russian Chinese Korean Norwegian Turkish and Japanese 4 13 2 Device Set your time preference for Power Save and Power Off features Power Save Sta...

Страница 63: ...eted Warning sound a warning sound is presented when an electrode becomes detached during Automated ABR testing or when the battery charge is low Select the Checkmark button in the control bar to conf...

Страница 64: ...2022 04 Sera Instructions for Use EN Page 58 4 13 5 About Select the About item to view information about the SeraTM including Firmware versions Serial numbers and calibration dates Battery informati...

Страница 65: ...ss checker for automated ABR optional The optional SeraTM ABRIS Pass Checker accessory can be used to perform an integrity check of the electrode cables and transducer used for Automated ABR testing w...

Страница 66: ...leshooting make sure that the Pass Checker is still switched on during your tests 5 Perform a standard binaural or monaural for probe Automated ABR test 6 The test should proceed quickly through the i...

Страница 67: ...a standard TEOAE test Let the test run until it stops automatically Do not stop the test manually 3 If the probe is functioning correctly no TE bands get a checkmark it is possible to continue with da...

Страница 68: ...TEOAE test Let the test run until it stops automatically Do not stop the test manually 3 If the probe is functioning correctly no DP frequency points get a checkmark it is possible to continue with da...

Страница 69: ...olution of water and detergent or similar Always disconnect the mains power adaptor during the cleaning process and be careful that no fluid enters the inside of the instrument or accessories 5 After...

Страница 70: ...o clean the plastic parts of the SeraTM and cradle 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 sen...

Страница 71: ...channels of probe tip Use the Thornton Bridge Implant Floss or the Thornton 3 in 1 Floss for cleaning Discard used floss after use Never clean the probe tip while the tip is still attached to the prob...

Страница 72: ...asket back into place after cleaning Reattach the probe tip to the probe and screw the gasket into place DO NOT try to clean the probe tip while it is mounted on the probe Only insert the cleaning flo...

Страница 73: ...inspection of the probe and its filters should therefore be made prior to every measurement If any traces of ear wax debris or the like are present the filters of the probe need to be replaced Remove...

Страница 74: ...e carried out at Interacoustics expense subject to the terms of this warranty The product requiring service should be returned promptly properly packed and postage prepaid Loss or damage in return shi...

Страница 75: ...z 400 mA 5 0V DC 1 6A MAX Operation environment Temperature Relative Humidity Ambient Pressure Boot up time Warm up Time 5 40 C 41 F 104 F 15 93 non condensing 98 kPa 104 kPa 5 sec Nil Transport Stora...

Страница 76: ...eight 85 g 0 19 lbs Preamplifier dimensions 8 5 x 0 5 x 2 5 cm 3 4 x 0 2 x 0 9 inches Printer Thermal printer Optional Type HM E200 Connection Wireless Battery Rechargeable Li polymer DC 7 4 V 1300 mA...

Страница 77: ...Artifact noise rejection system 30 dB SPL Residual noise An RMS average measurement in the DP bin frequency area 26 bins at frequencies 2500 Hz 60 bins 2500 Hz Test Pressure Ambient Display Transducer...

Страница 78: ...sis time 60 seconds Recording window 2 5 14 1 ms A D Resolution 24 bit Artifact noise rejection system 55 dB SPL Test pressure Ambient Residual noise A RMS value for each octave band based on the Baye...

Страница 79: ...nalog balanced in 6 Microphone input Analog balanced in Microphone input Analog balanced in 7 Power supply 3 5V Power supply 3 5V 8 CH2 out CH2 out 9 CH2 GND CH2 GND 10 I2C CLK I2C CLK 11 I2C DATA I2C...

Страница 80: ...ulus Probe and insert stimuli are calibrated in SPL values using an ear simulator coupler made in accordance to IEC 60318 4 Transducer peRETSPL dB re 20 Pa RadioEar IP30 with ear tips 35 dB SPL RadioE...

Страница 81: ...ometer All 1 5500 Middelfart Denmark Tel 45 6371 3555 Fax 45 6371 3522 E mail info interacoustics com Web www interacoustics com 7 7 Appendix A Stimulus Another stimulus than specified in the standard...

Страница 82: ...er than 30 cm 12 inches to any part of this equipment including cables specified by the manufacturer Otherwise degradation of the performance of this equipment could result in improper operation This...

Страница 83: ...ironment in which radiated RF disturbances are controlled The customer or the user of the SeraTM can help prevent electromagnetic interferences by maintaining a minimum distance between portable and m...

Страница 84: ...nment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or residential environment Voltage...

Страница 85: ...RF communications equipment should be used no closer to any parts of the SeraTM including cables than the recommended separation distance calculated from the equation applicable to the frequency of t...

Страница 86: ...eur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site surv...

Страница 87: ...Returned according to agreement with Interacoustics Other Date Person Please provide e mail address or fax No to whom Interacoustics may confirm reception of the returned goods The above mentioned ite...

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