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User Manual

Part No. 7-50-00000

Doc. No. 7-50-0000/U2

Summary of Contents for OTOflex 100

Page 1: ...User Manual Part No 7 50 00000 Doc No 7 50 0000 U2...

Page 2: ...ithout the prior written consent of GN Otometrics A S Copyright 2003 GN Otometrics A S Printed in Denmark by GN Otometrics A S Denmark All information illustrations and specifications in this manual a...

Page 3: ...of the OTOflex 100 12 2 3 1 Front view 12 2 3 2 Top view 12 2 3 3 Bottom view 13 2 3 4 Reverse side view 13 2 3 5 The charger 14 2 4 Probe 15 2 5 Assembly and installation 15 2 5 1 Location 15 2 5 2 P...

Page 4: ...e with eartip in the ear canal 31 4 Tests 4 1 Starting up the test 33 4 2 Tympanometry 34 4 2 1 Tympanometric sweep 34 4 3 Reflex testing 36 4 3 1 Acoustic Reflex Threshold 37 4 3 2 Acoustic Reflex De...

Page 5: ...ing the test cavity 61 8 3 5 Changing the acoustic filter 61 8 3 6 Cleaning the OTOflex 100 62 8 3 7 Eartips 63 8 3 8 Disposal of disposable articles 63 8 3 9 Batteries and charger 63 8 3 10 Safety in...

Page 6: ...4 Data interface 74 11 1 5 Type identification 75 11 1 6 Power supply 75 11 1 7 Dimensions and weight 75 11 2 Charger unit 75 11 2 1 Type identification 75 11 2 2 Power supply 75 11 2 3 Dimensions an...

Page 7: ...designed for use on infants children and adults and is light weight fast reliable and easy to use The OTOflex 100 uses technologies which are highly effective for clinical and screening purposes Tympa...

Page 8: ...with the following issues Installation The sections Section 2 1 Unpacking on page 11 Section 2 3 Views of the OTOflex 100 on page 12 and Section 2 5 Assembly and in stallation on page 15 contain a ful...

Page 9: ...at there is risk of danger to persons and or device Caution A caution indicates that there is risk of damage to the device Note A note indicates that you should take special notice 1 4 2 Navigation Bu...

Page 10: ...10 GN Otometrics A S User Manual OTOflex 100...

Page 11: ...ect the equipment for possible visual damage If damage has occurred do not put the OTOflex 100 into oper ation Contact your supplier for assistance 3 Make sure that you have received all necessary par...

Page 12: ...angles You will find a description of the keypad and how to navigate and enter data in the OTOflex 100 in Section 2 6 Display keypad on page 21 2 3 1 Front view 2 3 2 Top view Ear selector On Off but...

Page 13: ...GN Otometrics A S 13 OTOflex 100 User Manual 2 3 3 Bottom view 2 3 4 Reverse side view Charger cavity Battery casing with cover Probe Label Track for probe cable mounted with short cable Label...

Page 14: ...14 GN Otometrics A S User Manual OTOflex 100 2 3 5 The charger Front view Rear view Charger tab Probe test cavity Charging diode for the device Base Mains socket...

Page 15: ...hnical Specifications on page 73 must be complied with The OTOflex 100 can be used as a handheld device with no specific requirements to location However keep the OTOflex 100 away from all liquids and...

Page 16: ...elivered with batteries Before you can operate the OTOflex 100 you must insert the batteries Use only the batteries listed in Chapter 11 Technical Specifica tions on page 73 1 The first time you inser...

Page 17: ...upwards until it is released and snaps out of place Battery status When the OTOflex 100 is powered on it shows the current status of the battery in the top right corner of the display 2 5 3 The charg...

Page 18: ...charging diode on the charger front When charging the diode indicates the following Green steady The OTOflex 100 is fully charged Yellow steady The OTOflex 100 is charging Green flashing There is a fa...

Page 19: ...do not pull the plug by the cable Grip the sleeve of the plug and free it by pulling it backwards The probe will not be released if you pull anywhere else than on the sleeve of the plug Using the prob...

Page 20: ...ture For instance for clinical and diagnostic purposes you can use the probe without the probe fixture 5 If required remove the probe from the probe fixture 6 Remove the probe fixture from the OTOflex...

Page 21: ...than those listed below may appear Left softkey Main functions Cancel Back or up in menu hierarchy Right softkey Main functions Start stop Continue or Next in a sequence Select ear Pressure release T...

Page 22: ...surement settings see Section 5 1 1 Chang ing measurement settings on page 43 2 7 Device setup When you have installed the OTOflex 100 there are a number of de vice settings you can customise to accom...

Page 23: ...l procedures for the setting in which you are working Always use clean eartips Wipe the plastic probe tip with a disinfectant between patients or replace it with a spare one 3 2 Preparing the probe Wh...

Page 24: ...can use the probe with the handgrip fitted on the OTOflex 100 The handgrip provides enhanced maneouverability when you are testing with a screening eartip If you are testing with a short probe cable...

Page 25: ...ited for diagnostic and clini cal test purposes The probe is connected directly to the OTOflex 100 via the cable This allows for placing the OTOflex 100 near the patient or for using it wall mounted i...

Page 26: ...out a probe test to make sure that the probe functions correctly see Section 3 3 1 Probe test on page 26 If not proceed with the section Selecting a patient on page 28 3 3 1 Probe test 1 Press Select...

Page 27: ...1 Probe test on page 26 6 If the probe should be faulty contact your service department for repair and if possible use another probe 3 3 2 Fitting the eartip on the probe WARNING Choking hazard Do not...

Page 28: ...body and not by the cable Note Accurate testing is only guaranteed if you use the eartips designed specifically for the OTOflex 100 by GN Otometrics A S 3 3 3 Selecting a patient On the Main Menu sele...

Page 29: ...you can select the appro priate user for the session Scroll to the User icon on the main screen and press Select A list of users appears Scroll to the appropriate user and press Select With the OtoDi...

Page 30: ...outer ear before you insert the probe If you can see apparent narrowing of the ear canal it may be blocked by vernix or debris or it may not be straight Note Because infants ear canals are very soft t...

Page 31: ...ear tip applied Using a probe with an unsuitably sized eartip or applying excessive force may irritate the ear canal 1 To fit the probe with the eartip in the ear canal of the patient gently pull the...

Page 32: ...32 GN Otometrics A S User Manual OTOflex 100...

Page 33: ...set up the sequence to suit your purposes 4 1 Starting up the test 1 Do as described in Chapter 3 Preparing for testing on page 23 2 Tell the patient that there will be a change of pressure in the ea...

Page 34: ...r discontinuity otosclerosis rigidity in the ossicular chain flaccid hypermobile eardrum due to aging perforated eardrum obstruction of the ear canal middle ear fluid dried ear wax and Eustachian Tube...

Page 35: ...e probe tip or use another probe tip or eartip The test continues when the probe fit is good Note If the patient seems to be troubled by the pressure applied to the ear currently being tested press th...

Page 36: ...test Printing the Tymp Sweep test results 1 Press Select to access the Menu list 2 Select Print report 4 3 Reflex testing In audiology the term Reflex testing refers to the Stapedius Reflex a mechanis...

Page 37: ...t the ear on which you wish to start the test Quick access settings Quick access is provided to a range of settings and functions These settings you can change to suit your purposes They apply only to...

Page 38: ...lected the wrong ear when you make the test you can swap ears so that the test result refers to the correct ear 1 Press Select to access the Menu list 2 Scroll to Swap ear data Saving test results 1 I...

Page 39: ...lect and scroll to the bottom of the Menu list where these settings and functions are listed With this test you can change the pump pressure and volume set tings during the test Deflection curves are...

Page 40: ...t refers to the correct ear 1 Press Select to access the Menu list 2 Scroll to Swap ear data Saving test results 1 If you want to save the test result press Save Viewing Reflex Decay test results 1 Pr...

Page 41: ...or instance if the test result was not satisfactory press New Swapping ear results If you have selected the wrong ear when you make the test you can swap ears so that the test result refers to the cor...

Page 42: ...42 GN Otometrics A S User Manual OTOflex 100...

Page 43: ...ype and press Select again The test screen is displayed 2 Press Select scroll to Meas settings and press Select again The test specific settings menu is shown 3 For a description of the test specific...

Page 44: ...shown only in mmho The value in Y unit below automatically changes to mmho 226 Hz 1000 Hz Recommended for testing on infants younger than 4 6 months Press rng Pressure range Default Norm Norm 200 to...

Page 45: ...t measurement will be assigned no 2 to a maximum of three 3 individual measurements After no 3 no 1 will be overwritten Normal area Default Adult None Adult Based on Modified Jerger norm range Infant...

Page 46: ...Off 5 1 4 Reflex Threshold settings Man ual timing Default Off Probe tone Default 226 Hz If you select 226 Hz you can set admittance to be shown in mmho or in ml in the field Y unit listed below If yo...

Page 47: ...IPSI dB HL or SPL Max activator signal level Default 105 dB HL or SPL Rsm Resume on seal Default Off Start level Default 75 dB HL or SPL Y unit Default mmho The 1000 Hz frequency is as default shown...

Page 48: ...probe tone settings are always shown as posi tive Pos All deflection curves are shown as positive Neg All deflection curves are shown as negative Y scale Default 300 l If you select Auto the most sui...

Page 49: ...purposes combined with a probe tone of 226 Hz Stim ulus 1 kHz Default On For diagnostic purposes combined with a probe tone of 226 Hz Stim ulus 2 kHz Default On Stim ulus 3 kHz Default On Stim ulus 4...

Page 50: ...ain 2 The Device Settings menu is shown Scroll and press Select to access the menu items They are described in the following Set user In this screen you can select the user who is going to do the test...

Page 51: ...can adjust the sequence and define which tests to perform These settings are available in the Measurement Settings dialog box 1 Select Main Menu Tools Measurement Settings or click on the Measurement...

Page 52: ...ault On Auto cl ient id Default On Patient sel ection Default Before Start ear Default Right Default test Default Tymp Auto print D Default Off Auto print E Default OFF Audible seal Default On Audible...

Page 53: ...nce Bob Crawford 2003 09 24 8 14 A Tymp A Tymp A RThreshold A RThreshold Amelia Davis 2003 10 28 13 15 A Tymp A Tymp A RDecay A RDecay 3 Scroll to the result you want to view 4 Press Select to view th...

Page 54: ...54 GN Otometrics A S User Manual OTOflex 100...

Page 55: ...ance Bob Crawford 2003 09 24 8 14 A Tymp A Tymp A RThreshold A RThreshold Amelie Davis 2003 10 28 13 15 A Tymp A Tymp A RDecay A RDecay 3 Scroll to the result you want to print 4 Press Select to print...

Page 56: ...56 GN Otometrics A S User Manual OTOflex 100...

Page 57: ...nnel WARNING Do not disassemble the OTOflex 100 charger as there is a risk of elec tric shock For the sake of safety and in order not to void the warranty service and repair of electromedical equipmen...

Page 58: ...e cases large amounts of cerumen in the ear canal may result in debris being deposited on the probe tip If this is the case clean the probe tip sound channels with the cleaning wire Note Check the cha...

Page 59: ...clean the sound channels Always clean from the rear 3 If you are cleaning the probe tip during a session where you are testing a patient use the cleaning brush to clean the cleaning wire especially w...

Page 60: ...he sound channels in the probe body mechanically or with liquids Doing so may cause damage to the probe 5 Fit the probe tip and screw the threaded ring back onto the probe body Cleaning and disinfecti...

Page 61: ...ecting the test cavity Caution The test cavity is located in the charger which contains electrical components and mains connection Therefore do not use bath or autoclaving If the test cavity has been...

Page 62: ...switch off the OTOflex 100 and disconnect it from any external power source Dismount the probe from the OTOflex 100 Regular cleaning Clean the OTOflex 100 with a damp cloth if required use a surface d...

Page 63: ...le and should not be cleaned or re used Al ways throw away disposable eartips after use on a patient See Section 8 3 8 Disposal of disposable articles on page 63 for instruc tions on disposal 8 3 8 Di...

Page 64: ...throw the batteries into the fire and keep them away from fire as they may explode Incorrect handling applying excessive charging current can overcharge or destroy the batteries The battery terminals...

Page 65: ...s the power button The batteries need charg ing if rechargeable or replacing Charge the batteries if recharge able or fit OTOflex 100 with new batteries The charging indicator does not light up when I...

Page 66: ...66 GN Otometrics A S User Manual OTOflex 100...

Page 67: ...EN 60601 1 See Section 7 16 Standards on page 42 The OTOflex 100 is marked with this symbol when it is important that the user refers to associated informa tion given in this manual The OTOflex 100 i...

Page 68: ...stry Canada tech nical specifications were met Symbols on buttons to operate Otoflex 100 see Sec tion 2 6 Display keypad on page 21 The charger unit is marked with this symbol to indi cate compliance...

Page 69: ...ecommend that the use of such devices in the vicinity of OTOflex 100 is restricted as much as possible Note 5 Changes or modifications not expressly approved by the manufac turer could void the user s...

Page 70: ...interference to the licensed serv ice this device is intended to be operated indoors and away from windows to provide maximum shielding Equipment or its trans mit antenna that is installed outdoors i...

Page 71: ...45 72 111 548 E mail info gnotometrics dk www gnotometrics com 10 3 1 Responsibility of the manufacturer The manufacturer is to be considered responsible for effects on safe ty reliability and perform...

Page 72: ...72 GN Otometrics A S User Manual OTOflex 100...

Page 73: ...acy 0 5 Range 0 1 ml to 8 0 ml 5 or 0 1 ml whichever is greater 11 1 2 Acoustic Reflex 11 1 2 1 Contra lateral Stimulation Pure tones 500Hz 1000Hz 2000Hz 3000Hz 4000Hz Frequency Accuracy 0 5 Noise Whi...

Page 74: ...dB HL 3 dB 4000 Hz 50 to 100 dB HL 3 dB THD 3 in 2 cc 11 1 3 Air pressure system Range Normal 200 to 400 daPa s Extended 400 to 600 daPa s Pump speed 50 100 200 400 daPa s A F A P and manual pressure...

Page 75: ...level The following battery indications apply Charging Fully charged 100 Medium 60 Low 30 Discharged 0 Estimated battery life The device is able to handle a working day 8 hours with normal audiologic...

Page 76: ...Warm up time 2 min 11 4 Operating environment Temperature 10 C to 35 C Air Humidity 30 to 90 non condensing Air Pressure 600 hPa to 1060 hPa Operation at temperatures below 20 C or above 60 C may cau...

Page 77: ...andard 1 OTOflex 100 w built in Bluetooth interface 1 Charger cradle w 2cc cavity and straight power cable 1 Immittance probe w wax filter kit and cleaning kit select probe type in E 1 Eartip start ki...

Page 78: ...78 GN Otometrics A S User Manual OTOflex 100...

Page 79: ...f electronic equip ment called an audiometer This testing is usually administered by a trained technician called an audiologist Bone Conduction BC Sound transmitted through the bone Click Evoked Respo...

Page 80: ...f the period The unit is the cycle per second cps or Hz HL Hearing Level Lowest intensity level that a person can hear a sound of a particular frequency represented as the number of decibels above an...

Page 81: ...be a signal type e g narrow band noise or wide band noise with a specified spectrum Otolaryngologist Physician specializing in the medical and surgical treatment of dis orders in the ear nose and thr...

Page 82: ...d Transducer Electronic component transforming e g an electrical signal into sound sound into an electrical signal or a pressure into a voltage Tone Sinusoid or steady state ongoing sound of a single...

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