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natus Madsen AccuScreen User Manual Download Page 15

Madsen AccuScreen OAE & ABR Screener User Manual 

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 ear coupler adapter for right ear 
 

Ear couplers 

 

 
 

 

Summary of Contents for Madsen AccuScreen

Page 1: ...Madsen AccuScreen OAE ABR Screener User Manual Doc No 7 50 0920 GB 14 Part No 7 50 09200 GB...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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