easyTymp Operating Instructions Jan 2012

Operating Manual easyTymp Table of Contents

Page

1 Introduction ... 3 1.1 Description ... 3 1.2 Safety Notes ... 4 2 Impedance measurements ... 6 2.1 Tympanometry ... 6 2.2 Acoustic Reflex ... 6 3 Getting started ... 8 3.1 PC system requirements... 8 3.1.1 Supported Software ... 8 3.2 Unpacking and inspecting... 8 3.2 System installation ... 10 3.2.1 Hardware installation ... 10 3.2.2 Optional Software ... 14 3.3 Preparing the test ... 15 3.3.1 Patient Instruction ... 15 3.3.2 Visual inspection of the ear canal... 15 3.3.3 Handling the eartips ... 15 3.4 Cleaning the probe tip ... 16 4 Operating easyTymp ... 17 4.1 Operating Panel... 17 4.2 Getting started ... 17 4.3 Probe status indication... 18 4.4 Operating easyTymp ... 18 4.4.1 Test ... 19 4.4.2 Select Test Screen ... 21 4.4.3 Done ... 21 Geba_easyTymp_Fe_12a.docx

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Operating Manual easyTymp 4.4.4 Select Patient & Save ... 22 4.4.5 Edit New ... 23 4.4.6 View Patients ... 23 4.4.7 View Details ... 24 4.4.8 Edit Details... 24 4.4.9 View Results ... 25 4.4.10 View Results ... 25 4.5 Setup ... 26 4.5.1 Setup Language ... 26 4.5.2 Setup Date & Time ... 27 4.5.3 Setup easyTymp ... 27 4.5.4 Setup Printer ... 27 4.5.5 Setup Clinic Info ... 28 4.5.6 Setup License ... 28 4.5.7 Setup Patient Management ... 29 4.5.8 About ... 29 5 Warranty, Maintenance and Service ... 30 6 Disinfection ... 30 7 Safety Regulations ... 31 7.1 Electrical safety ... 31 7.2 Measurement Safety ... 31 7.3 Instrument Handling ... 31 7.4 Operation... 31 7.5 Patient Safety ... 31 8 Technical Data ... 33

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Operating Manual easyTymp 1 Introduction Thank you for selecting one of our quality products from the MAICO family range. The easyTymp is designed and manufactured to meet all quality and safety requirements, and has been certified with the CE-symbol according to Medical Directive. Particular attention has been taken during the designing phase of the easyTymp to ensure its user-friendliness, meaning that its operation is simple, easy to learn and to understand. As all the functions are software-controlled, upgrading the software and/or adding additional functions at a later date will be simple and cost-effective. By purchasing the easyTymp, you have made a decision towards long-term investment. This operating manual aims to make learning and understanding the different easyTymp functions as quick and as easy as possible. Should you encounter any problems or have ideas for any further improvements, we are only a phone call away. Please do not hesitate to contact us. Your MAICO-Team Note: Although upmost attention has been given to ensure the accuracy of the operating manual, some minor errors may still exist. We do apologize for any inconvenience this may cause.

1.1 Description The easyTymp is an automatic impedance audiometer, well suited to perform tympanometry and screen acoustic reflexes on people of all ages. The easyTymp is intended to be used by hearing healthcare professionals (i.e. ENT doctors, audiologists), trained technicians as well as neonatal nurses and school nurses in a quiet environment. The handheld unit also enables the transfer of data to a PC via USBconnection. The easyTymp cradle serves as a docking station and recharger. It is available as a version with ear tip box or integrated printer.

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Operating Manual easyTymp 1.2 Safety Notes The easyTymp should always be operated in a quiet room with minimal magnetic influence, to ensure that examinations are not disturbed by external noise. Electro-medical instruments that emit strong electromagnetic fields (e.g. microwaves, radiotherapy devices) can affect the operation of the easyTymp. Therefore, the operation of these instruments in close proximity to the easyTymp should be avoided at all times. The examination room should have a normal temperature between 15˚C/ 59˚F and 35˚C/ 95˚F. If the instrument has cooled down during transportation, please wait for it to warm up to room temperature before operation. MAICO easyTymp is specified according to EN 60 601-1. Protection against electrical hazard is guaranteed only when the instrument is connected to a grounded safety. Please note that during operation, the instrument should always be connected to a battery-operated or mains-operated notebook computer that complies with EN 60 601-1 or EN 60 950-1. In the event that a main cable, connector or wall socket is damaged, please do not use the instrument under any circumstance. Allen key for adjustable feet on the cradle unit: An Allen key is enclosed in the packaging of the ear tip box to enable adjustment of the pair of adjustable feet located on the bottom of the cradle. Please ensure that the Allen key is not permanently stored in the ear tip box, that the Allen key is only used to adjust the setting of the adjustable feet on the cradle and that this tool is not used for any other purpose on the easyTymp unit. Attention PLEASE READ THE ENTIRE MANUAL CAREFULLY BEFORE OPERATING THIS INSTRUMENT. Please only use this instrument as described in the manual. Please familiarize yourself with the instrument and its operation before using. Should defects or damages be suspected, please do not, under any circumstances, use or attempt to fix the instrument yourself.

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Operating Manual easyTymp To guarantee that the tympanometer works properly, the instrument has to be checked and calibrated at least once a year. The service and calibration must be performed by an authorized service centre. In accordance with the regulations of the EU medical directive we will drop our liability if these checks are not done. The use of non-calibrated tympanometers is not allowed. Uncalibrated instruments may lead to faulty measurements and sometimes even damage the hearing of the examinee. Take note to ensure that all the accessories have been properly connected. To avoid person-to-person cross contamination of communicable diseases, parts that come in direct contact with the patient (i.e. eartips) should only be used one time. In accordance with the Electronic Equipment Act for disposal of electronic equipment, the customer is obliged to dispose of the used consumables, according to appropriate regulation at own cost.

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Operating Manual easyTymp 2 Impedance measurements 2.1 Tympanometry Tympanometry is the objective measurement of middle ear mobility (compliance) and pressure within the middle ear system. During the test, a low-pitched probe tone (226 Hz) is presented to the ear canal by means of the hand-held probe. This tone is used to measure the change in compliance in the middle ear system while the air pressure is varied automatically from a positive value (+200 daPa) to a negative value (-400 daPa max.). Maximum compliance of the middle ear system occurs when the pressure in the middle ear cavity is equal to the pressure in the external auditory canal. This is the highest peak of the curve as it is recorded on the chart. The position of the peak on the horizontal axis and on the vertical axis of the chart will provide diagnostic information regarding the function of the middle ear system. Gradient calculations are reported as the Tympanogram width at half of peak compliance expressed in daPa. A ”limits” box is available on both the display and printout to aid in diagnosis. Compliance is measured with respect to an equivalent volume of air, with the scientific quantity milliliter (ml) for 226 Hz and mmho for 1000 Hz. Air is measured in deca-Pascals (daPa). NOTE: 1.02 mmH2O = 1.0 daPa.

2.2 Acoustic Reflex An acoustic reflex, or contraction of the stapedial muscle, occurs under normal conditions when a sufficiently intense sound is presented to the auditory pathway. This contraction of the muscle causes a stiffening of the ossicular chain which changes the compliance of the middle ear system. As in Tympanometry, a probe tone is used to measure this change in compliance. When the stimulus presentation and measurement are made in the same ear by means of the probe, this acoustical reflex is referred to as an ipsilateral acoustic reflex. For best results, this reflex measurement is automatically conducted at the air pressure value where the compliance peak occurred during the tympanometric test. Stimulus tones of varying intensities at 500, 1000, 2000 or 4000 Hz are presented as short bursts. If a change in compliance greater than 0.03 ml is detected, a reflex is considered present. Because this is an

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Operating Manual easyTymp extremely small compliance change, any movement of the probe during the test may produce an artifact (false response).

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Operating Manual easyTymp 3 Getting started 3.1 PC system requirements Processor: Intel Pentium 4 / Celeron 1.4 GHz Memory: 1 GB RAM Graphic display: 1024 x 768 Operating system: Windows XP Professional (SP3), Windows 7, Professional or Ultimate Version for 32 und 64 Bit Computer Connection: USB 1.1 or higher 3.1.1 Supported Software MAICO Impedance Software, BDT/GDT, NOAH3

3.2 Unpacking and inspecting Check the packaging and content for damage Thoroughly inspect the exterior of the shipping for any sign of damage or tempering. Should any damage be noted, please notify the carrier immediately. If the content box has been damaged during transportation, the instrument should be checked for any electrical or mechanical defects. Should any defects be identified, please contact the responsible dealer. Keep all original packaging to facilitate any insurance claims against the damages. Keep the original packaging for future shipment! The easyTymp is packaged in a specially-designed box. Please keep the box as it will be useful for sending the instrument for the annual instrument checkup, as required by law. Please contact your nearest responsible dealer should the annual instrument check-up be needed. Please check that all accessories listed below are received in good condition. If any accessories are missing or damaged, immediately notify your MAICO Special Instrument Distributor

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Operating Manual easyTymp Standard Accessories easyTymp handheld unit Probe Probe Tip (replacement) 1 Rechargeable battery Power supply unit for easyTymp handheld unit (only when operating without cradle) Eartip box (configuration see below) Calibration cavity Carrying case Operating manual Short user guide Standard probe configuration in Ear tip box: Eartip flanged 3-5 mm / 10 pieces (red) Eartip mushroom 7 mm / 10 pieces (blue) Eartip mushroom 9 mm / 10 pieces (green) Eartip mushroom 11 mm / 10 pieces (blue) Eartip mushroom 13 mm / 10 pieces (green) Eartip mushroom 15 mm / 5 pieces (blue) Eartip mushroom 19 mm / 5 pieces (yellow) Eartip umbrella 15 mm / 5 pieces (red) Eartip umbrella 19 mm / 5 pieces (blue) MAICO cleaning tool for probe Additional accessories for easyTymp: External probe (35cm) Wall Mount Kit for cradle License for high frequency probe tone of 1 kHz Cradle with integrated ear tip box, power supply unit and additional rechargeable battery Cradle with integrated printer, power supply unit and additional rechargeable battery Software Kit MAICO Impedance Software Consumption material Printer paper

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Operating Manual easyTymp 3.2 System installation 3.2.1 Hardware installation 3.2.1.1 Installing the cradle

Figure 1 Connectors at the rear bottom of the cradle

1 = USB in; 2 = USB out; 3 USB out; 4 USB out 5 Power; 6 = Follow the instructions for use Put the enclosed mains cable into the power connection socket � 5 and its mains plug into a power socket. 3.2.1.2 Cradle indication lights Depending on the version (with or without printer) the cradle has up to three indication lights. easyTymp LED shows solid blue when the easyTymp is placed inside the cradle and the battery is fully charged. The LED will flash as long as the battery is charging. Battery LED shows solid blue when the spare battery in the cradle is fully charged. The LED will flash as long as the battery is charging. Printer LED is red when a printer problem occurs.

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Operating Manual easyTymp 3.2.1.3 Installing paper in the thermal printer Step 1 - Push button to open the printer cover

Step 2 – Pull blue lever upwards

Insert paper roll in the compartment with its loose end to the front of the printer. Position the loose end into the printer roll and hoist it by rotating the printer roll with your finger

Push blue lever down

Close printer cover

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Operating Manual easyTymp 3.2.1.4 Mounting the cradle on the wall To mount the cradle on the wall is an optional wall mount kit available.

3.2.1.5 Installing the easyTymp NOTE: Please note that the battery needs to be charged for a minimum period of approximately 6 hours prior to first use of the easyTymp hand-held tympanometer. The battery compartment is opened by gently pressing the indentation and pulling the cover downwards.

Place the battery inside the compartment. Make sure the battery contacts are correctly placed.

Replace the lid on the easyTymp and push it upwards to close the battery compartment. If not in operation for longer periods it is recommended to remove the battery from the instrument.

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Operating Manual easyTymp 3.2.1.6 Charging the battery The spare battery is stored in the charger in the back of the cradle. Battery LED shows solid blue when the spare battery in the cradle is fully charged. The LED will flash as long as the battery is charging Please observe the following precautions Keep the battery fully charged. Do not place the battery in fire or apply heat to the battery. Do not damage the battery or use a damaged battery. Do not expose the battery to water. Do not short circuit the battery or reverse the polarity. Use only the charger provided with the easyTymp Please see the following section for estimated charging times. 3.2.1.7 Battery lifetime The following table gives an estimate of the charging time (ct) in hours of the battery. Be aware that negative numbers mean that the battery is discharging. Charge times for the spare battery in the cradle and the battery in the easyTymp while in the cradle are the same.

3.2.1.8 Changing probes To release the probe press the button at the back and pull the probe out. Do not pull the cord of the extension cord as this can damage the tubing connections!

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Operating Manual easyTymp Place the probe to the easyTymp by lining up the red triangles and pushing the probe into the unit.

The probe can be attached to the extension cord by lining it up correctly and clicking the probe into the end of the extension cord.

3.2.1.9 Calibration cavities The easyTymp comes with a separate cavity which can be used for a quick check of the validity of the probe calibration. You can use 0.2 ml, 0.5 ml, 2.0 ml and 5.0 ml cylinders for more extended checks. To perform this check, select a protocol which measures a tympanogram. Do not use an ear tip! Place the probe tip completely into the cavity. Perform the measurement. Check the volume which was measured. The allowed tolerance in the volume measurement is ± 0.1 ml for cavities up to 2 ml and ± 5% for bigger cavities. These tolerances count for all probe tone frequencies. We strongly recommended calibrating each probe at least once a year. If a probe is handled roughly (e.g. fallen onto a hard surface) it might need to be calibrated again. Calibration values of the probe are stored in the probe itself. Therefore probes can be exchanged at all times. 3.2.2 Optional Software You can view and store all your measurements also with the MAICO Impedance Software Module. For installation and functions see the software manual.

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Operating Manual easyTymp 3.3 Preparing the test 3.3.1 Patient Instruction Make sure that the patient is comfortable on a chair or on an examination table if necessary. Small children may feel more comfortable sitting on a parent's lap. Show the probe to the patient and then explain the following: The aim of the test is to test the mobility of the eardrum. The tip of the probe will be inserted into the ear canal, and that it has to make a perfect seal. A small amount of air will flow through the probe to move the eardrum; it produces a sensation equal to pressing a finger slightly into the ear canal. One or more tones will be heard during the test. No participation is expected from the patient. Coughing, talking and swallowing will disturb test results. 3.3.2 Visual inspection of the ear canal Check the external ear canal for wax with an otoscope and remove excessive wax to prevent the probe opening from clogging which will inhibit testing. Excessive hairs may have to be cut. 3.3.3 Handling the eartips Choose an ear tip of the appropriate size from the ear tip set, depending on the size and shape of the ear canal and ear. Put the ear tip tightly on the probe tip. Always use eartips from MAICO or Sanibel. Each eartip should only be used one time.

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Operating Manual easyTymp 3.4 Cleaning the probe tip In order to secure correct impedance measurements it is important to make sure that the probe system is kept clean at all times. Therefore please follow the below illustrated instructions on how to remove e.g. cerumen from the small acoustic and air pressure channels of probe tip. Never clean the probe tip while the tip is still fitted on the probe. Unscrew the probe cap of the probe by turning counter clock direction. Take the probe tip out of the probe.

Take the cleaning tool apart to find the thin brush and thin rigid plastic cord. Use the plastic cord or brush to push contamination out of the probe tip. Always enter the probe tip from the rear to avoid accumulation of contamination inside the vents. Place the probe tip back onto the probe. Make sure that the different holes fit in the corresponding cavities. Screw the probe cap back on the probe. Finger force will tighten the screw sufficiently. Never use tools to fix the probe cap! If any blockage or damage occurs to the sealing gasket, the probe system can only be serviced by MAICO.

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Operating Manual easyTymp 4 Operating easyTymp 4.1 Operating Panel Function Keys: - Top buttons: Function of the keys is related to the functions indicated in the display above the individual function key. (e.g. Select Test, Patient, Stop …) Arrow Keys: Turn on easyTymp by pressing the right or left arrow key. Turn off easyTymp by pressing both keys at the same time. Up and Down buttons: Scroll through the different easyTymp settings menu, test protocols or up and down the display.

4.2 Getting started To get started, take the easyTymp out of the cradle. In default setting it will turn on automatically. If you don’t store the easyTymp in the cradle, press either red or blue arrow key to switch the device on. To switch easyTymp off, press both, red and blue, arrow keys together and hold for one second. easyTymp will always start within the test screen, ready to start a measurement. It will use the same protocol as previously used.

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Operating Manual easyTymp 4.3 Probe status indication If you use the optional external probe the indication the light at the back of the probe indicates the probe status with following colors:

Red – Right ear is selected. Probe is out of ear. Blue – Left ear is selected. Probe is out of ear. Green – Probe is in the ear and is sealing, test is running. Yellow – Probe is in the ear and blocked or leaking. White – The probe has just been attached. Probe status is unknown. The probe status stays white in hand held use if the easyTymp is not monitoring the probe status. If the probe light stays white in any other situation easyTymp might need to be switched off and on again to regain proper probe status. Flashing color to off – easyTymp is pausing during a protocol and waits for you to press continue. The color in which the probe light is flashing indicates the probe status like above. Flashing green to red/blue – easyTymp just finished the protocol.

4.4 Operating easyTymp Operating the easyTymp is very intuitive. After switching on the instrument, it will usually start in the Test screen and is ready to test the same protocol as was used last. After disconnecting easyTymp from a PC it will start in the Select Protocol screen and you have to select which protocol should be used. The battery status bar will show, if the battery power runs down. If the battery is empty, you will be warned and the measurement will be stopped and all recorded data will be stored. You will have to shut down and change the battery. The measurement data will be recovered after you start up again. In that way you can continue measurement without retesting. The following paragraphs describe the precise operation of the different screens you will observe during the use of easyTymp.

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Operating Manual easyTymp 4.4.1 Test Usually the easyTymp starts with the Test Screen. When deleting or saving data after a measurement, you will also return to this screen. The following information can be viewed in the screen

The header shows the status of the probe, showing Ready, in ear, leaking or blocked. In the top at the right you find status of the battery . When the easyTymp is placed in the cradle, it will charge the battery and it will show a moving, charging battery icon. In the upper right corner an icon shows if the easyTymp is testing either left ear or right ear . When entering the Test screen, the second line shows the name of the protocol which is used. As soon as easyTymp detects that the probe is in the ear, the second line will show which test of the protocol is running. Here you find the graphics of the ongoing test. The box indicates the normative area where the peak of the tympanogram is expected under normal conditions.

Display of the determined measurements:

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