Welch Allyn 35900-NP-TE, Directions For Use Manual

Page 1: ...Welch Allyn OAE Hearing Screener Directions for use ...

Page 2: ...ilure to use this product in accordance with the instructions cautions warnings or statement of intended use published in this manual For patent information please visit www welchallyn com patents For information about any Welch Allyn product contact Welch Allyn Technical Support www welchallyn com about company locations htm GSI is an ISO 13485 certified corporation GSI 8108699 DIR 80022349 Ver A...

Page 3: ...ystem 11 Cradle 12 Charge the battery 12 Install the probe 13 Attach the probe tube 14 Eartips 14 Probe holder 15 Clock settings 16 Device overview 19 Control panel 19 Access menus 19 Device settings 20 Wireless device pairing 20 Clear test results 21 Minimum amplitude 22 Change the language 22 Reset to default 22 Operating instructions 23 Turn on the screener 23 Automatic shutdown interval 23 Mai...

Page 4: ...sults 37 DPOAE printout 37 TEOAE printout 37 Rounding results 38 Maintenance 39 General maintenance 39 Clean and disinfect 39 Calibrate the screener 40 Replace the probe tube 40 Repairs 41 Troubleshooting 43 Status Error messages 46 Standards and compliance 47 General compliance and standards 47 EMC compliance 48 Warranty 53 Appendices 55 Appendix A Specifications 55 Appendix B Flowchart Measureme...

Page 5: ...finition applies to both yellow and black and white symbols Regulatory symbols Symbol Description Symbol Description Serial number Transport and storage temperature range Date of manufacture Keep dry Manufacturer B Patient Applied Part According to IEC60601 1 Return to Authorized Representative special disposal required Consult directions for use DFU A copy of the DFU is available on this website ...

Page 6: ...ion NOISE Amber The indicator labeled NOISE displays an amber light when the noise level measured during the test exceeds a nominal threshold It also is used to indicate some error conditions and when the outcome of test is REFER NOISY or NO SEAL TEST Yellow The indicator labeled TEST displays a yellow light when the selected test is being performed A steady yellow light indicates that a test is i...

Page 7: ...damage to the screener can result when a three prong to two prong adaptor is connected between the screener power supply and a mains outlet WARNING Safety risk Only qualified Welch Allyn service representatives should modify the screener Improper modifications could be hazadous to patients and personnel WARNING Safety risk Any program aimed at obtaining reliable measurements of otoacoustic emissio...

Page 8: ...id installation and use of this screener in proximity to other products or equipment that may emit or be susceptible to electromagnetic interference including cellular phones If the screener is used adjacent to other products or equipment you are instructed to verify that no disturbance is found in the operation of this or other equipment in proximity CAUTION The screener and its components will p...

Page 9: ...ccordance with Welch Allyn published specifications before using CAUTION Do not drop or otherwise cause undue impact to the screener If the screener is dropped or otherwise damaged return it to Welch Allyn for repair and calibration Do not use the screener if any damage is suspected CAUTION Recycle batteries whenever possible In the United States call 1 800 8 BATTERY for information about recyclin...

Page 10: ...6 About warnings and cautions Welch Allyn OAE Hearing Screener ...

Page 11: ...ed by a series of clicks that are directed into the ear canal Otoacoustic emissions are low level audio frequency sounds that are produced by the cochlea as part of the normal hearing process Available evidence suggests that otoacoustic emissions are generated by the cochlea s outer hair cells and that the presence of OAEs is an indication that the outer hair cells are viable Clinical evidence ind...

Page 12: ...ide the signal processing and display the test results The screener also contains a rechargeable lithium ion battery The screener displays the test status using a liquid crystal display LCD and three light emitting diodes LEDs You control testing printing and test protocol resets using four keypad push buttons The probe contains the speaker and microphone which produce test stimuli and measure the...

Page 13: ...ncies Frequency Range tested The frequency range tested is approximately 2 kHz to 5 kHz for DPOAEs The frequency range for TEOAEs is 1 5 kHz to 4 kHz Results storage and reporting When the screener is set in its default settings the instrument stores the results from one patient left and right ears in its non volatile memory for subsequent printing The screener is capable of storing up to 250 test...

Page 14: ...10 Introduction Welch Allyn OAE Hearing Screener ...

Page 15: ...ns Cable USB A Micro B 1 Communications Cable USB A B 1 Charging Cable PSU 5V Micro B 1 Calibration Certificate 1 OAE Hearing Screen software CD includes Quick Start Guide Data Manager software DFU and Data Manager software If any part is missing contact Welch Allyn Technical Support www welchallyn com about company locations htm We recommend that you save the shipping box and packing materials in...

Page 16: ...in increments corresponding to the discharge of the battery Note Misalignment of the Micro USB plug and socket can cause damage The plug and socket should be visually inspected prior to each installation of the charging cable If you see damage contact Welch Allyn Technical Support www welchallyn com about company locations htm Battery status indicator A blue battery status indicator light located ...

Page 17: ...ates a fully charged battery The battery icon segments turn off as the battery charge decreases 1 Insert the Micro USB plug into the Micro USB port on the bottom of the screener 2 Insert the wall charger into the mains outlet Charge the battery using the cradle Note The Micro USB port on the cradle does not support data transfer 1 Insert the Micro USB plug into the Micro USB port on the back of th...

Page 18: ...e a probe tube applied and an eartip attached before inserting it into an ear canal The eartip must seal the ear canal The best test results are obtained when the eartip is inserted deeply into the ear canal instead of flush with the ear canal opening Caution must be taken however to ensure that the eartip does not extend too deeply into the ear canal Use only the eartips approved for use with the...

Page 19: ... gaps between the eartip and the collar of the probe head 3 To remove the eartip grasp the probe tube gently at the base and slightly twist it while pulling the eartip off of the probe tube Grasping the base of the probe tube will prevent it from being inadvertently pulled out of the probe head along with the eartip Probe holder The probe holder is a receptacle attached to the HDMI cable that secu...

Page 20: ...nal time changes such as Daylight Saving Time also require resetting the clock Note If the screener is being powered on for the first time or if the battery is completely discharged and is not charged within approximately one hour an Error Reference source not found may appear If this message appears reset the date and time Access the clock menu 1 While viewing the MAIN menu press the DOWN control...

Page 21: ...turn to the main menu If either the date or time are not correct go to Step 2 2 If the month is incorrect from the Main menu press the DOWN control panel button three 3 times to advance to the Month menu 3 Press the LEFT or RIGHT control panel button to advance to the correct month 4 Press the DOWN control panel button to advance to the Day menu 5 Press the LEFT or RIGHT control panel button to ad...

Page 22: ...18 Setup Welch Allyn OAE Hearing Screener ...

Page 23: ...ss the print command from the Main menu Access menus 1 While viewing the MAIN menu press the down control panel button on the control panel The PROTOCOL menu appears DPOAE screeners will show DP 4s in the MAIN menu TEOAE screeners will show TE 64s in the MAIN menu 2 While viewing the PROTOCOL menu press the down control panel button on the control panel The Clock menu appears with the current date...

Page 24: ...ly pair one device with the screener at any given time Pair the screener and wireless device Note When pairing to a computer for use with the data manager confirm the computer has wireless availability or a wireless dongle will be required Confirm the wireless settings of the computer by selecting Allow wireless devices to find this PC 1 Turn on the device to be paired with the screener 2 On the s...

Page 25: ...pairing with the message WIRELESS DEVICE PAIRED 4 Press the MainMenu control panel button to exit the wireless pairing menu 5 See Troubleshooting in the Maintenance section if wireless pairing is unsuccessful or if any error messages appear Clear test results The Test Results menu enables you to clear the test results stored in the screener without printing them 1 See Access menus for how to acces...

Page 26: ... used in the screener 1 See Access menus for how to access menus 2 Press the DOWN control panel button to advance to the LANGUAGE menu 3 Press either the LEFT or RIGHT control panel button to scroll to the desired anguage 4 Press the UP control panel button repeatedly to return to the MAIN menu Reset to default The RESET TO DEFAULT menu returns all screener settings to its original factory default...

Page 27: ...o prolong battery life The screener automatically shuts down after one 1 minute of inactivity but the interval can be adjusted The interval choices are 30 seconds 1 minute 2 minutes 4 minutes See Change the automatic shutdown interval for directions on how to select a different interval Note To power on the screener from the MAIN menu press the DOWN control panel button To power off the screener m...

Page 28: ...he day month time and AM PM 3 Battery status Displays the amount of charge remaining or the charging status when plugged into a mains outlet with the Micro USB cable 4 Selected protocol Displays protocol options DP 4s default and DP 2s on DPOAE screeners TE 64s default or TE 32s on TEOAE screeners 5 Start right ear test Press to start a right ear test 6 Change protocol and settings Press to change...

Page 29: ...xcessive cerumen vernix debris or foreign bodies in the ear canals should be referred to a physician or other qualified health care professional for removal of the blockage prior to testing 1 Place the patient in a position that will allow easy access to the ear canal 2 Instruct the patient to remain quiet and still during the test Start a test 1 Gently pull up and back on the outer ear during ear...

Page 30: ...he ear canal wall or the probe tube may be completely clogged Gray Ear seal indicator remains gray until a seal is obtained Troubleshoot the AutoStart probe check Appropriate adjustments of the eartip position and size selection should be made until the indicator falls within the green area and remains stable If the test will not progress past the AutoStart probe check stage 1 Change the probe tub...

Page 31: ...for viewing the results The default view is a signal to ratio SNR bar graph It displays the SNR for each DP test frequency or TE frequency band The value graph view displays the absolute emission and noise levels for each DP test frequency or TE frequency band SNR bar graph view The default SNR bar graph view displays the emissions and noise floor NF as they are measured Each column represents one...

Page 32: ...he SNR and value graph views 1 See Access menus for how to access menus 2 Press the DOWN control panel button to access the GRAPH menu 3 Press the LEFT or RIGHT control panel button to change between the SNR and value graph views Normative data display The Norms setting allows the user to display the Expanded Boys Town Norms template on the Value Graph for eligible DPOAE protocols The normative da...

Page 33: ...izer PE tubes 1 Pull gently up and back on the outer ear to straighten the ear canal 2 Insert the probe with the appropriate eartip into the ear canal and obtain a proper seal 3 Press and hold the arrow key that corresponds to the ear being tested until the green READY light turns off 4 Release the arrow key The screener calibrates and tests as before applying the appropriate in the ear stimulus i...

Page 34: ... test The following screens represent the possible test results PASS The ear tested passed screening REFER The ear tested did not pass screening NOISY Excessive noise was present during the test NO SEAL A seal was not maintained throughout the test FIT ERR Inadequate probe placement in the ear canal to produce target stimulus intensities See Manage test results for more information on managing res...

Page 35: ...the screener is not intended for long term storage of test results Note You are strongly encouraged to print or transfer all test results at the completion of testing to avoid potential loss of data The screener has two operating modes for saving and storing test results SAVE L R SAVE 250 SAVE LR is the default operating mode SAVE L R mode When operating in the default SAVE L R mode the screener s...

Page 36: ...her tests can be done Do one of the following Print the results Transfer the results to the PC software Clear the results from memory Change the SAVE mode between SAVE L R and SAVE 250 Before changing the SAVE mode print all tests stored in memory 1 See Access menus for how to access menus 2 Press the DOWN control panel button to advance to the SAVE L R screen 3 Press the LEFT OR RIGHT control pan...

Page 37: ... Names are uploaded from the data manager to the screener A warning is provided that data will be deleted Data can be deleted in the screener from the data manager when the screener is connected to the data manager by the USB cable or by wireless When Names is selected the window allows data to be deleted using the Clear Instrument button To delete data using the TEST RESULTS menu 1 See Access men...

Page 38: ... and ensure that the screener is charged 2 Power on the computer and then launch the data manager The message Waiting On PC appears on the screener 3 If this is the first time the screener is being connected using wireless then on the Transfer section of the Home tab click Detect Com Port 4 Ensure that the screener is paired to your computer Pairing is only required upon initial data transfer 5 On...

Page 39: ... Confirm that the printer is on and ready for printing 2 Confirm that the screener is paired with the printer 3 From the main menu press the UP control panel button The CONNECT TO PRT screen appears 4 Press the LEFT or RIGHT control panel button to connect to the printer The screener searches for the paired printer when the screener pairs with the printer all stored results print All printed test ...

Page 40: ...36 Manage results Welch Allyn OAE Hearing Screener ...

Page 41: ...oor NF in dB SPL The emission level DP in dB SPL The signal to noise ratio SNR DP level minus the NF in dB The Value or SNR graph as selected on the screener MIN if the Minimum Amplitude setting was enabled TEOAE printout The following information is provided for each test The time and date of the test based on the setting of the internal clock if the clock is set correctly this time and date will...

Page 42: ...oach is used to preserve the full precision of the test results but can result in some apparent errors in the printout due to the effects of rounding Assume that the actual values at a given frequency were DP 5 5 dB and NF 0 4 dB which results in a SNR 5 9 dB The printout values are rounded up to the nearest integer and are shown as DP 6 NF 0 and SNR 6 This can result in what appears to be an erro...

Page 43: ...l safety checks in order to maintain continued compliance with IEC and UL 60601 1 Clean and disinfect WARNING Eartips are for single patient use only Failure to do so may cause infection WARNING Use a new eartip for each patient Failure to do so may cause infection CAUTION Do not insert any object into probe Exposing the device to these conditions may affect the stability of the device CAUTION Do ...

Page 44: ...ed if there is any sign of contamination or if the test will not progress past the AutoStart phase Disinfection of the probe tube between patients is not required External parts of the instrument probe can be cleaned to remove visible particulate contamination Do not attempt to insert any object into probe This instrument is not designated as a sterile device Wiping with a clean cloth or towel pro...

Page 45: ...l or a Welch Allyn Service Center should repair products out of warranty If you are advised to return a product to Welch Allyn for repair or routine maintenance schedule the repair with the service center nearest you Welch Allyn Technical Support If you have a problem with the device that you cannot resolve call the Welch Allyn Technical Support Center nearest you for assistance A representative w...

Page 46: ...42 Maintenance Welch Allyn OAE Hearing Screener ...

Page 47: ... canal Check that the instrument will start in your own ear using the proper eartip for your ear If the test will not start or if the AutoStart tones sound unusual replace the probe tube If the problem persists across several patients contact Welch Allyn Technical Support www welchallyn com about company locations htm The results will not print Check the printer status Turn the printer on or wake ...

Page 48: ...eless Error xxx Check wireless device printer or PC status Attempt to connect to wireless device again If the problem persists contact Welch Allyn Technical Support www welchallyn com about company locations htm Wireless Not Configured Printing has been attempted but no wireless device is paired with the Welch Allyn OAE Screener Establish wireless pairing Device Not Responding The printer is not r...

Page 49: ...ort www welchallyn com about company locations htm Memory almost full Saved tests are within 5 tests of the maximum limit Print or transfer test results to avoid interruption in testing Memory Full The maximum number of saved tests has been reached Clear the memory in order to perform additional tests Power Low The battery charge level is too low for operation Charge the battery in order to perfor...

Page 50: ...h Refit the eartip and probe and retry the test Fit Error Too Low The level of the calibration tone is too low Refit the eartip and probe and retry the test Limit Error Overflow error during the calculation of the DFTs for a DP test Repeat the test Memory Almost Full Saved tests are within 5 tests of the 250 maximum limit Memory Full The maximum saved test limit of 250 is reached Clear the memory ...

Page 51: ... audiometers IEC 60645 3 2007 Electroacoustics Audiometric equipment Part 3 Test signals of short duration IEC 60645 6 2010 Electroacoustics Audiometric Equipment Part 6 Instruments for the measurement of otoacoustic emissions ISO 14971 2012 Application of Risk Management to Medical Devices ISO 10993 2009 Biological Evaluation of Medical Devices EN 60601 1 2 2014 Medical electrical equipment Part ...

Page 52: ...netic compatibility EMC must be taken for all medical electrical equipment This device complies with IEC EN 60601 1 2 2007 All medical electrical equipment must be installed and put into service in accordance with the EMC information provided in this document the Welch Allyn OAE Hearing Screener Directions for use Portable and mobile RF communications equipment can affect the behavior of medical e...

Page 53: ...transient burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines 2 kV for power supply lines 1 kV for input output lines Mains power quality should be that of a typical commercial or hospital environment 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 hospital envi...

Page 54: ...hese guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the ele...

Page 55: ... 0 1 0 37 0 37 0 74 1 1 20 1 20 2 30 10 3 70 3 70 7 40 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note 1 At 80 MHz a...

Page 56: ...52 Standards and compliance Welch Allyn OAE Hearing Screener ...

Page 57: ...n facility If field service is requested there will be no charge for labor or material however there will be a charge for travel expense at the service center s current rate Note Changes in the product not approved in writing by Welch Allyn shall void this warranty Welch Allyn shall not be responsible for any indirect special or consequential damages even if notice has been given in advance of the...

Page 58: ...54 Warranty Welch Allyn OAE Hearing Screener ...

Page 59: ...lent 3 dB Microphone system noise 20 dB SPL 2 kHz 1 Hz bandwidth 13 dB SPL 1 kHz 1 Hz bandwidth Dimensions and weight Length 40 in 1 0 meter Weight 1 00 oz 28 gm Connector HDMI Instrument specifications Item Specification Power supply Lithium Ion rechargeable battery Battery life 15 hours on time Dimensions and weight Instrument Weight 6 4 oz 180 gm Instrument Dimensions 7 in x 2 75 in x 1 25 in 1...

Page 60: ...power supply may affect the stability of the device Item Specification Model No UE08WCP 050160SPA Output 5 0V DC 1 6A Input 100 240V AC 50 60Hz 400 mA Environmental requirements Item Specification Operating temperature 59 F to 95 F 15 C to 35 C Operating relative humidity 30 to 90 non condensing Maximum operating altitude 6000 feet 2000 meters Transport and storage temperature 41 F to 104 F 5 C to...

Page 61: ...der to obtain authorization to use the device for setting up outdoor radio links and or for supplying public access to telecommunications and or network services This device may not be used for setting up outdoor radio links in France and in some areas the RF output power may be limited to 10 mW EIRP in the frequency range of 2454 2483 5 MHz For detailed information the end user should contact the...

Page 62: ...Appendix B Flowchart Measurement 58 Appendices Welch Allyn OAE Hearing Screener ...

Page 63: ...mum voltage A successful calibration leads to the actual test phase TEOAE screener The calibration phase automatically measures the peak pressure obtained from a sequence of clicks and calculates the voltage required to obtain the target peak pressure If the desired peak pressure cannot be obtained the unit will use the maximum voltage A successful calibration leads to the actual test phase Test p...

Page 64: ...or above this threshold are rejected which tends to lower the noise floor of the test In order to reduce the possibility of obtaining an artificially low noise floor the minimum threshold level is limited Variations in the SNR Estimate Be aware that the SNR estimate has an inherent statistical variation due to the effects of random noise especially when no emission is actually present If you perfo...

Page 65: ... DPOAE equipment they have used for months other testers take longer Occasional claims of extraordinarily low probabilities of not detecting an ear with hearing loss appear to be based on poor statistics As discussed by Gorga Mayo Clinic Teleconference 1998 since the incidence of significant hearing loss is roughly 2 per 1 000 verifying 99 7 accuracy would require testing hundreds of thousands of ...

Page 66: ...ties was conducted and it was verified that no increase in false negatives false passes was introduced Under no test conditions was any such degradation uncovered The artifact rejection can only reject the noisiest samples in a measurement period If the ambient noise level rises too high and or the eartip seal is poor then all samples will be noisy and accurate measurements will be impossible in w...

Page 67: ...l uses 4 seconds averaging time per frequency and results in slower test time at a minimum of 16 seconds per tes However it may reduce the false referral rate TEOAE screener Note The protocols included are TE 64s default and TE 32s Protocol Name of Frequency Bands Frequency Center Bands Averaging Time max Pass SNR Passing Frequency for Test Pass DP 4s 6 1 5 2 0 2 5 3 0 3 5 4 0 kHz 32 seconds 4 dB ...

Page 68: ...with the product This device complies with Part 15 of the FCC rules and with the rules of the Canadian ICES 003 as described below Federal Communications Commission FCC This device complies with part 15 of the FCC Rules Operation is subject to the following two conditions This device may not cause harmful interference This device must accept any interference received including interference that ma...

Page 69: ...er IC ID 5123A BGTWT12A has been approved by Industry Canada to operate with the antenna listed in the specification table This Class B digital apparatus complies with Canadian ICES 003 Cet appareil numérique de la classe B est conform à la norme NMB 003 du Canada European Union Czech Grason Stadler tímto prohlašuje že tento vysílač s nízkým výkonem je v souladu se základními požadavky a dalšími p...

Page 70: ...oħra tad Direttiva 2014 53 KE Polish Niniejszym Grason Stadler oświadcza że ten nadajnik o małej mocy jest zgodny z zasadniczymi wymaganiami i innymi istotnymi przepisami dyrektywy 2014 53 WE Portuguese Por este motivo a Grason Stadler declara que este transmissor de baixa potência está em conformidade com os requisitos essenciais e outras disposições relevantes da Diretiva 2014 53 CE Slovak Graso...

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