Madsen® AccuScreen
OAE & ABR Screener
User Manual
Doc. No. 7-50-0920-GB/14
Part No. 7-50-09200-GB
Страница 1: ...Madsen AccuScreen OAE ABR Screener User Manual Doc No 7 50 0920 GB 14 Part No 7 50 09200 GB...
Страница 2: ...ightnotice 2010 2021 Natus MedicalDenmarkApS Allrights reserved Natus the Natus Icon Aurical Madsen HI PRO2 Otoscan ICS and HORTMANN are registered trademarks of Natus MedicalDenmarkApSin the U S A an...
Страница 3: ...n Overview 11 2 3 Storage 16 2 4 Assembly 16 2 5 Powering 16 3 GETTING STARTED WITH ACCUSCREEN 20 3 1 Switch on AccuScreen 20 3 2 Patienthandling in AccuScreen 23 4 PREPARING FOR TESTING 27 4 1 Prepar...
Страница 4: ...ta 68 10 5 Memory full 68 11 MAINTENANCE AND CLEANING 69 11 1 Probe tip and probe body 69 11 2 Eartips 71 11 3 Ear coupler cable 71 11 4 Cleaning AccuScreen 72 11 5 Battery safety and maintenance 73 A...
Страница 5: ...lt review and configuration capabilities in a single PC application From AccuLink you can create edit view and print data relating to patients and tests users sites and connected locations and facilit...
Страница 6: ...whether the cochlea is functioning correctly or not Children s emissions are typically strong which makes them easy and fast to detect Emission strength usually decreases with age or hearing impairme...
Страница 7: ...n nearby electronic equipment but negative effect or loss of functionality of other local devices may occur if they are placed in close vicinity of AccuScreen Make sure that the PC and the docking sta...
Страница 8: ...ormation on setting up AccuScreen Safety This manual contains information and warnings which must be followed to ensure the safe performance of AccuScreen Note Local government rules and regulations i...
Страница 9: ...he user to consult the instructions for use 2012 19 EU Waste Electrical and Electronic Equipment WEEE Disposal at the end of operating life instructions Indicates that electrical and electronic equipm...
Страница 10: ...lied Humidity limitation Indicates the range of storage humidity to which the medical device can be safely exposed ISO 15223 1 Symbol 5 3 9 Medical devices Symbols to be used with medical device label...
Страница 11: ...he equipment for possible damage If damage has occurred do not put the device into operation Contact your local distributor for assistance 3 Check with the packing list to make sure that you have rece...
Страница 12: ...ocket Bottom C Docking Station connectors 2 2 3 The docking station Front Indicators POWER Lit when power is supplied to the docking station DATA TRANSFER Lit when data is being transferred as follows...
Страница 13: ...ction to the PC socket Printer Modem Printer modem connection socket Power adapter socket 2 2 4 Display The touchscreen display has icons and fields Note Never use any type of sharp instrument on the...
Страница 14: ...Madsen AccuScreen OAE ABR Screener User Manual 14 2 2 5 Ear probe A Probe tip B Probe body C Probe cable Probe cable plug...
Страница 15: ...15 2 2 6 Electrode cable ABR only A Electrode cable plug B Electrode clips C Electrode cable 2 2 7 Ear coupler cable A Cable connector B Ear coupler cable C Blue ear coupler adapter for left ear D Red...
Страница 16: ...tion See Charging the battery from the docking station 19 by the AccuScreen external charger optional accessory See Charging the battery with the external charger 19 2 5 1 The battery The battery used...
Страница 17: ...the button of the battery compartment upwards The battery compartment pops out 2 If needed remove the battery 3 Place a new charged battery in the compartment Hold the battery so that the arrow with t...
Страница 18: ...ge the battery and recharge it as soon as possible When the battery level drops below 10 test results can be viewed however testing is no longer possible Symbol Remaining battery capacity 100 75 The b...
Страница 19: ...supply To disconnect AccuScreen docking station from the mains supply remove the adapter plug from the mains outlet 2 5 5 Charging the battery from the docking station The battery in AccuScreen charg...
Страница 20: ...ress the On Off switch A start up screen is shown while AccuScreen performs a self test A On Off switch The start up screen shows the name of the device The AccuScreen name is configurable see the Acc...
Страница 21: ...ting the screens in AccuScreen The screens in AccuScreen are divided into 3 or 4 main areas A The title bar showing the time the screen title the battery status B The main screen where you will find t...
Страница 22: ...on or to send or receive data See the AccuLink User Manual for details 3 1 6 Optional screens The following screens are optional and not part of the default AccuScreen configuration The Location list...
Страница 23: ...fields are defined in AccuLink see the AccuLink User Manual Note You must enter a value in the mandatory fields 2 Optional fields 2 Press a field to enter patient data When you have entered data in a...
Страница 24: ...ening and data will be identifiable in the national database Screen only Screening and data will be saved in the national database but will appear as anonymous to all viewers except for the local scre...
Страница 25: ...ch in an extended list of patients press Find Patient in the Find Patient screen 2 The default search criteria is the patient s last name If you wish to change the search criteria press Search Criteri...
Страница 26: ...anual 26 3 2 3 Editing patient data 1 Find a patient as described in Finding a patient 25 2 In the Patient Details screen press the field you wish to edit 3 Edit the field 4 Press OK to save 5 If need...
Страница 27: ...color changes surface changes of the reusable probe parts before every usage If deterioration occurs contact your distributor 4 2 2 Connecting the probe Note The probe socket is intended to connect th...
Страница 28: ...top end of AccuScreen 3 Gently insert the electrode cable plug into the electrode cable socket The plug does not require force to be inserted properly Disconnecting the electrode cable Note Do not pu...
Страница 29: ...Place AccuScreen face down The sleeve on the plug of the ear coupler cable and the coloring around the ear coupler socket are blue 2 Align the ridges on the plug with the notches in the blue bordered...
Страница 30: ...n ABR electrode cable and electrode cable plug before each patient or if surface is visibly contaminated Use a sterile alcohol wipe to clean the surfaces and wait until the probe body probe cable and...
Страница 31: ...s the patient s ear canal You may have to try out a number of sizes in order to select the appropriate size 2 Gently push the eartip onto the probe tip until it rests firmly against the base of the pr...
Страница 32: ...e cable pointing either upwards or down wards depending on which direction fits best Make sure that the probe fits well Any leakage may increase the test durationbecause of sound leakage excessive noi...
Страница 33: ...r part of the forehead 2 Make sure that the electrodes fit tightly on the skin Warning The hydrogel of the electrodes can dry out Make sure that used packages are closed properly Dried out hydrogel ma...
Страница 34: ...the forehead neck and cheekbone of the baby before you connect the ear couplers See Placing the electrodes for ABR testing on page 33 2 Insert an ear coupler adapter into the tube at the top of each...
Страница 35: ...est 40 ABRtest 46 3 Perform the steps in Preparing for testing 27 5 1 Ready to test You can choose between two methods of starting a test Quick testing Regular testing Quick testing 1 Press Quick Test...
Страница 36: ...nds on the device type the configuration of the device and which cables are connected Selecting available tests is configurable see the AccuLink User Manual 3 See the test descriptions in TEOAEtest 36...
Страница 37: ...Shows that the intensity of a peak is valid and counted by the peak counter Peak counter The test must register a total of at least 8 valid peaks in alternating directions counted both above and below...
Страница 38: ...not achieved the test frequency will time out Max time depends on environmental noise conditions If test conditions are optimal but there is no response measured then the frequency will time out befo...
Страница 39: ...lt is obtained Consider for instance the following when you interpret a Refer No Clear Response result Malfunctions in the transmission of sound are by far the most important causes of emissions not b...
Страница 40: ...quencies tested depend on the setup the standard frequencies are 5 kHz 4 kHz 3 kHz 2 kHz The L1 L2 pair is 59 50 dB SPL Only F2 is shown 5 3 2 Starting the test To start the test 1 Determine the Test...
Страница 41: ...ll be saved as an incomplete test Test details Shows ear being tested Bar chart Noise Registered DPOAE response Frequency passed DPOAE frequency being tested skipped or referred The height of the bars...
Страница 42: ...est is completed the test data is saved and the result is shown on the screen See Optionsin thetestresultscreens 49 for a description of the buttons available The following Pass Clear Response and Ref...
Страница 43: ...ir cell function in the corresponding frequency region of the cochlea The common reasons for non detection are noisy test conditions or a poor probe fit In DPOAEs this is especially true for the lowes...
Страница 44: ...test 1 Place the electrodes on the patient to ensure that they have time to connect well to the skin for instance while you explain the test process to relatives See Placing the electrodes for ABR tes...
Страница 45: ...he test Depending on how your device is configured the test may start automatically if the indicators are green or yellow Red nape The Red reading indicates the sum of the Red and the Black common or...
Страница 46: ...e is configured the test may start automatically if the indicators are green or yellow 5 4 3 ABR test The test as it progresses is shown on the display Pausing a test If required press Pause to suspen...
Страница 47: ...e for the current frequency is not achieved the test frequency will time out Max time depends on environmental noise conditions If test conditions are optimal but there is no response measured then th...
Страница 48: ...display is close to the Pass Clear Response criterion but does not result in a Pass Clear Response If this is the case try to improve test conditions and repeat the test Before you refer the patient f...
Страница 49: ...ults See Printing 54 Test Other Ear Starts test in the other ear Start If you wish to repeat the test press the Start button OK Press to return to the Test Menu so that you can test the other ear or c...
Страница 50: ...screen appears If comments have already been addedto a test they are marked here 2 In the Comments screen you can select a predefined comment that may apply to this patient or the test conditions Com...
Страница 51: ...screened by AccuScreen is either given a Pass Clear Response or a Refer No Clear Response If the result is a Pass Clear Response no further action is required If the result is a Refer No Clear Respon...
Страница 52: ...t The Test View screen shows The type of tests that were made On which ear the test was made The date and time on which the test was made The test results Pass Clear Response Refer No Clear Response I...
Страница 53: ...ailable in the Test View and Print screens 6 1 Performing a Quick Test 1 Perform the steps in Preparing for testing 27 However do not add a new patient or assign the test to a specific patient 2 Press...
Страница 54: ...tion or connected to the printer Note Do not switch off AccuScreen while printing is in progress Doing so may result in distorted test data Note If the label printer is not connected or if it is switc...
Страница 55: ...ccuScreen OAE ABR Screener User Manual 55 Selecting the patient 1 Switch on AccuScreen and press Print The Print list appears 2 Select a patient The Test View screen appears If needed see Finding a pa...
Страница 56: ...1 To print the entire list from the Test View screen press Print Patient comments are printed 2 To access a test result press the Result button next to the test you wish to print 3 Press Print in the...
Страница 57: ...nt printout bottom All results The most recent and best results of all tests on this patient are combined in one printout TEOAE DPOAE ABR results If there are no results for a specific test the test t...
Страница 58: ...le in AccuScreen Probe Probetest 58 Electrode cable Electrode cable test 60 Ear coupler cable Ear coupler cabletest 61 Combined Electrode cable Ear coupler cable Combined Electrode Cable Ear Coupler C...
Страница 59: ...ity The test starts automatically Note The probe test does not start automatically e g when a patient is being created If the probe functions correctly Probe OK appears If the probe does not function...
Страница 60: ...robe test 59 8 3 Electrode cable test Before you start testing patients you should test the electrode cable to ensure that it functions correctly 1 Clip the electrode clips on to the ABR Tester metal...
Страница 61: ...s a cable breakage 2 A manual listening test to make sure the ear coupler adapters are not clogged Automatic test 1 Insert the ear coupler adapters into the sockets at each end of the ABR Tester 2 Pre...
Страница 62: ...tion Do not insert the ear coupler adapter into the ear canal Note Your AccuScreen may indicate that the test has failed This is normal since the test is performed in free air and not in the ABR Teste...
Страница 63: ...cable or the electrode cable 2 A manual listening test to make sure the ear coupler adapters are not clogged Automatic test 1 Clip the electrode clips onto the metal bars of the ABR Tester 2 Insert th...
Страница 64: ...not in the ABR Tester 4 Press OK to confirm 5 While listening to the left blue ear coupler adapter press Ear coupler cable on the Quality Tests screen 6 Make sure you can hear the ABR stimulus 7 Press...
Страница 65: ...figured from AccuLink see the AccuLink User Manual 9 1 Date Time Date Go to Settings Time and Date There are multiple date formats Note If you leave the Time and Date screen by pressing OK the seconds...
Страница 66: ...ess dark or bright Note A bright display influences power consumption Note Press Default to use the default display setting 9 4 System Info Go to Settings System info You can view the following system...
Страница 67: ...enter numbers Press to move the cursor Press OK to confirm This action will take you to the next mandatory field 10 2 Function buttons Use the function buttons to find patients sort scroll and view pa...
Страница 68: ...ate All Patients You can delete patients with no activity 14 days 1 2 3 6 months 1 year All test results relating to the selected group of patients will be deleted Note You can searchfor a patient as...
Страница 69: ...s or be deposited on the probe tip Caution If needed replace the probe tip with a spare one Note Probe tips and the AccuScreen OAE ABR Screener should be disposed of according to local regulations 11...
Страница 70: ...ents Never clean the sound apertures in the probe body mechanically or with liquids Doing so may cause damage to the probe Warning Even the slightest amount of moisture may dissolve any residual cerum...
Страница 71: ...11 2 Eartips Eartips are disposable and should not be cleaned Note Eartips and the AccuScreen OAE ABR Screener should be disposed of according to local regulations 11 3 Ear coupler cable 11 3 1 Clean...
Страница 72: ...using lifetime avoid the following chemicals Isopropyl 70 Ethanol 40 concentration Formaldehyde Dichloro meta xylenol 5 10 If disinfecting AccuScreen is considered necessary some suitable alternatives...
Страница 73: ...o no disassemble heat above 60 C 140 F or incinerate Incorrect handling applying excessive charging current or reversing the poles can overcharge or destroy the battery Do not open alter or dismantle...
Страница 74: ...batteries can be recycled Note Dispose of used battery promptly Note Keep away from children Environmental protection When the Li Ion rechargeable battery loses its capacity to be charged make sure t...
Страница 75: ...reliability and performance of equipment serviced or repaired by other parties Following repair a qualified electronics engineer should verify the safety of all equipment Calibration should be perform...
Страница 76: ...Management tool in the AccuLink software The real time clock data is invalid Please set time and date The real time clock power backup has been completely drained Set the time and date Select Settings...
Страница 77: ...d that the channels are not blocked Make sure that the test cavity is not blocked by e g dust lint or such Replace the probe with a spare one and carry out the probe test to establish if the probe is...
Страница 78: ...inches ABR ear coupler cable Approx length 145 cm 57 inches External battery charger EarHugs Ear coupler cable for EarHugs Approx length 145 cm 57 inches Expected product lifetime for the cables mark...
Страница 79: ...cepted for test 12 k Impedance control Before test periodically during test stimulus continues during impedance con trol Test display Statistical graph impedances ABR detection probability EEG level a...
Страница 80: ...tion to PC Label printer IR data transmission to docking station RS232 interface from docking station to label printer Modem IR data transmission to docking station RS232 interface from docking statio...
Страница 81: ...t not discard WEEE together with other wastes Users must use the municipal collection schemes or the producer importers take back obligation or licensed waste carriers to reduce adverse environmental...
Страница 82: ...on 80 charged 4 hours Battery Warning Use only the rechargeable battery supplied by Natus Medical Denmark ApS Part no 8 73 02400 Use of any other battery may present a risk of fire or explosion Batter...
Страница 83: ...Approx length 150 cm 59 inches Dimensions Probe body 20 mm x 23 x 11 mm 0 8 inch x 0 9 inch x 0 43 inch Probe tip 3 3 mm x 10 mm 0 13 inch x 0 4 inch Weight Probe incl probe tip Approx 4 5 g Eartips S...
Страница 84: ...onment IEC 60601 1 2 2014 and EN 60601 1 2 2015 Guidanceand manufacturer sdeclaration electromagnetic emissionsfor all equipment and systems MADSEN AccuScreen is intended for use in the electromagneti...
Страница 85: ...s 2kV I O line s to earth 1kV line s to line s Not applicable Not applicable 1kV DC input line s to line s Not applicable Mainspower quality should be that of a typical com mercial or hospital environ...
Страница 86: ...ands Radiated RF IEC 61000 4 3 10V m 80MHzto 2 7GHz 10V m 80MHzto 2 7GHz Proximity fields from RF wire lesscommunications IEC 61000 4 3 27V m 385MHz 28V m 450MHz 27V m 385MHz 28V m 450MHz Separation d...
Страница 87: ...c discharge ESD IEC 61000 4 2 6kV contact 8kV air 6kV contact 8kV air Floorsshould be wood concrete or ceramic tile If floors are covered with synthetic material the relative humid ity should beat lea...
Страница 88: ...ned by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with thissymbol Radiated RF IEC 61...
Страница 89: ...maximum output power of transmitter W Separation distance according to frequency of transmitter m 150kHzto 80MHz d 1 2 80MHzto 800MHz d 1 2 800MHzto 2 5GHz d 2 3 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73...
