ICS AirCal User Guide Rev 03 Release March 2015

Copyrightnotice No part of this documentation orprogram may be reproduced, stored in a retrieval system, ortransmitted, in any form orby any means, electronic, mechanical, photocopying, recording,or otherwise,without the prior written consent of GN Otometrics A/S. Copyright© 2015, GN Otometrics A/S Published in Denmark byGN Otometrics A/S, Denmark All information, illustrations, and specifications in this manual are based on the latest productinformation available at the time of publication. GN Otometrics A/Sreserves the right to make changes at any time without notice. Registered trademarks and Trademarks MADSEN Itera II,MADSEN OTOflex 100, OTOsuite,AURICAL FreeFit, AURICAL Visible Speech, MADSEN Astera², MADSEN Xeta, ICS Chartr 200 VNG/ENG, ICS Chartr EP, OTOcam 300, MADSEN AccuScreen, MADSEN AccuLink,ICS AirCal, AURICAL Aud, AURICAL HIT, ICS Impulse, OTObase and MADSEN Capella² are either registered trademarks ortrademarks of GN Otometrics A/S. Versionrelease date 2015-03-02 Technicalsupport Please contact your supplier.

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Table of Contents 1

Device description

4

2

Getting started

5

3

ICS AirCal Front Panel

13

4

ICS AirCal Delivery Head & Foot Switch

16

5

Performing a Caloric Irrigation

18

6

ICS AirCal System Safety

20

7

Service, cleaning, and maintenance

22

8

Other references

23

9

Technical Specifications

23

10 Guidance and manufacturer’s declaration tables

25

11 Troubleshooting

28

12 Firmware procedures

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1 Device description

1

Device description The ICS AirCal irrigator is a convenient and accurate air caloric stimulator to be used for evoking nystagmus during VNG/ENG examinations. The system provides thermal stimulation through the use of a carefully controlled flow of air. The air temperature is adjustable from 12°C to 50°C. The system provides for presetting two temperatures -- one for the warm and one for the cool caloric stimulation. Precise temperature control is maintained through the use of a thermistor located close to the point of airflow delivery. The innovative design of the otoscopic delivery head allows observation of the point of stimulation, assuring valid and repeatable responses.

1.1

Intended Use Users: To be used only by qualified medical personnel with prior knowledge of the medical and scientific facts underlying the procedure. Use: An air caloric stimulator is a device that delivers a stream of air to the ear canal at controlled rates of airflow and temperature and that is intended for vestibular function testing of a patient's body balance system. The vestibular stimulation of the semicircular canals produces involuntary eye movements that are measured and recorded by a nystagmograph.

1.1.1

Typographical conventions The use of Warning, Caution and Note To draw your attention to information regarding safe and appropriate use of the device or software, the manual uses precautionary statements as follows:

Warning • Indicates that there is a risk of death or serious injury to the user or patient.

Caution • Indicates that there is a risk of injury to the user or patient or risk of damage to data or the device.

Note • Indicates that you should take special notice.

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2 Getting started

2

Getting started

2.1

Room Setup

A. B. C. D. E.

Sink VNG/ENG Equipment Counter Cabinets over counter Examiner's stool

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F. G. H. I.

Light bar Footstool Examining table Telephone

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2 Getting started

The ICS AirCal is designed to be used at any convenient level such as on a table, or cart. The ICS AirCal can be stacked with the Chartr 200 VNG/ENG hardware. It is best if the ICS AirCal is on top in order to refill the water as needed. Make sure the delivery head can reach the patient's ear. Make sure the stool can be adjusted to a height that will allow you to view the tympanic membrane (i.e., the eardrum) while performing irrigation.

Note • The ICS AirCal can be ordered in 2 different cable lengths 3 meter/10 feet (standard) and 4 meter/13 feet (extended). The decision on which to order should occur prior to purchase.

2.2

Installation and setup

2.2.1

Removing the transportation screws To prevent possible damage during shipping, the air pump housing is secured with transportation screws. These screws must be removed to allow the housing to move and thereby reduce the amount of noise the air pump produces. It is important to keep the transportation screws to secure the housing in the event the device needs to be shipped. 1. Remove transportation screws (A) and (B). 2. Store them with your Syringe Kit, Funnel and Allen Key.

2.2.2

Installing the Delivery Head Cradle Caution • Install the cradle prior to filling the water reservoir. Installation requires that the ICS AirCal is tilted more than 20°. If the water reservoir has water in it, tilting the device could introduce air into the system. There is little chance of damage to the system but, priming of the water reservoir would be required to make the system operate properly and not overheat.

Before installing the cradle for the delivery head determine how it should be mounted:

6

•

The cradle can be mounted on the left or right side of the unit.

•

For units placed away from the edge of the table, it is recommended that the cradle is mounted in the horizontal position (A). For units placed at the edge of the table, it is recommended that the cradle is mounted at an angle (B).

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2 Getting started

1. Locate the bag shipped with the cradle that contains 3 screws and an Allen key. 2. With the side chosen to hold the cradle facing the ceiling and the bottom of the unit facing you, lay the ICS AirCal on its side. 3. Locate the bracket mounting holes.

4. Attach the bracket to the unit using the Allen key to tighten the screws. 5. Hold the cradle with the end that holds the bottom of the delivery head facing the front of the unit. Slide the cradle onto the bracket in the horizontal position.

6. For units placed at the edge of the table, tilt the bracket forward until it stops. 7. Ensure the mounting hole on the bracket aligns with the mounting hole of the cradle. Attach the cradle to the bracket using the Allen key to tighten the screw. 8. Store the Allen key with the syringe kit. You will need it when filling the water reservoir.

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2 Getting started

2.2.3

Understanding the ICS AirCal Back Panel

Note • The USB port

2.2.3.1

allows for firmware upgrades. Refer to Firmware procedures ► 29

Connecting the Foot Switch The foot switch comes standard with the ICS AirCal. Connect the foot switch to the back of the irrigator

. If the

ICS AirCal is connected to an ICS VNG/ENG system and you want to use the foot switch to start tests other than the caloric test, you need to have the irrigator on in order to use the foot switch.

2.2.3.2

Connecting to an ICS VNG/ENG system The ICS AirCal can be connected to an ICS VNG/ENG system. Connect the irrigator cable to the back of the irrigator and to the ICS VNG/ENG system. Connecting the 2 devices together gives additional functionality. See Activation Trigger Operation ► 18 for more information.

2.2.3.3

Connecting the Mains power cable The ICS AirCal should be connected to an electrical wall outlet by attaching the power cable to the ICS AirCal irrigator and plugging the cable into the electrical wall outlet.

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2 Getting started

A. Connector for power cable

2.2.3.4

Filling and priming procedure The ICS AirCal uses water to cool the air. It is required that the water reservoir be filled prior to use of the device.

Warning • To prevent electrical shock, the ICS AirCal irrigator must be turned off and disconnected from the electrical wall outlet when filling or refilling the water reservoir.

Caution • Use this procedure if: 1) the ICS AirCal was just received from shipping dry. It needs to be filled and primed, 2) If the water level in the display has gone to zero because user never refilled it when orange bar was present. 3) If the ICS AirCal was tilted at more than 20° with the water pump running. If none of these criteria were met and the water level display is showing an orange bar and needing refill, please follow the instructions in Refill Procedure: ► 15

Caution • Only use distilled water. Using common water from the tap will result in mineral deposits and will harm the ICS AirCal.

Filling 1. Turn off the ICS AirCal irrigator and unplug from the electrical wall outlet. 2. Wipe off any dust on the top of the case. 3. Facing the front panel, locate the small cover at the back right side. Using the Allen key (supplied with the cradle) unscrew the reservoir cover and remove.

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2 Getting started

A. Reservoir cover

4. Using the Allen key unscrew the internal cover and remove.

A. Internal cover

5. Expand the funnel supplied with the ICS AirCal irrigator and place in the refill hole of the reservoir.

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2 Getting started

A. Funnel

6. Pour water into the funnel to fill the reservoir. 7. Monitor the water level closely. Fill to the bottom of the lip. Do NOT overfill the reservoir. 8. Remove the funnel. 9. Wipe up any excess water that might have spilled into the small indentions where the internal cover is placed. 10. Replace the internal cover.

Priming 1. Plug in the irrigator into the electrical wall outlet and turn on. 2. Turn off the airflow. 3. Locate the priming switch on the back panel

.

4. Press the priming switch to turn on and hold 5 seconds. 5. Release the priming switch to turn off and wait 5 seconds. 6. Repeat steps 4 and 5 for a total of 10 times on and 10 times off. 7. Press the cool button

. Decrease the temperature to 12°C.

8. If the temperature reaches the set temperature, then the irrigator is primed. Continue to step 10. 9. If the temperature does not reach 12°C in approximately 3 minutes or, if the over temperature alarm sounds, skip to the procedure Priming with bent tube ► 12. 10. Turn off the irrigator and unplug from the electrical wall outlet. 11. Remove the internal cover. 12. Check if the water reservoir is full. If not, place the funnel in the refill hole of the reservoir and add additional water.

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2 Getting started

13. Remove the funnel and replace the internal cover. Tighten the screws to secure. 14. Replace the external cover and tighten screws to secure. 15. Plug in the irrigator into the electrical wall outlet and turn on.

Note • The default airflow rate for caloric irrigation is 8 liters per minute. Shipping may cause the airflow knob to move. You may have to reset the airflow.

Priming with bent tube 1. Take the syringe with bent tube and remove enough water from the reservoir to fill the syringe. 2. Put the end of the bent tube into the pump inlet hole. The tube will be facing toward the front of the irrigator.

3. While pressing the priming switch

, inject the water into the inlet.

4. Release the priming switch. 5. Press the priming switch to turn on and hold 5 seconds. 6. Release the priming switch to turn off and wait 5 seconds. 7. Repeat steps 5 and 6 for a total of 10 times on and 10 times off. 8. Press the cool button

. Decrease the temperature to 12°C.

9. If the temperature reaches the set temperature, then the irrigator is primed. Continue to step 11. 10. If the temperature does not reach 12°C in approximately 3 minutes or,repeat steps 1 through 9. 11. Turn off the irrigator and unplug from the electrical wall outlet. 12. Check if the water reservoir is full. If not, place the funnel in the refill hole of the reservoir and add additional water. 13. Remove the funnel and replace the internal cover. Tighten the screws to secure. 14. Replace the external cover and tighten screws to secure. 15. Plug in the irrigator into the electrical wall outlet and turn on.

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3 ICS AirCal Front Panel

Caution • Due to the possibility of freezing during shipment, water must be drained from the reservoir before shipping the ICS AirCal. See Troubleshooting ► 28 for draining instructions.

3

ICS AirCal Front Panel This section describes all operational controls located on the front panel of the ICS AirCal.

3.1

ICS AirCal device on/off This is a push on/push off switch located on the bottom left of the front panel that applies power to the ICS AirCal. On is indicated by the illumination of a green LED and the digital display. When the ICS AirCal is first turned on it is in operation mode.

3.2

Standby/Operation Mode When the ICS AirCal is turned on the default is airflow on. Pressing the airflow

button will switch the ICS AirCal

between standby mode and operation mode. In standby mode (airflow off), the irrigator is on but the airflow, water and air pump, fan, warming and cooling mechanisms are off. Standby mode is recommended when the ICS AirCal is connected to an ICS VNG/ENG and the foot switch is used for starting other tests (e.g., Dix Hallpike) in the Chartr software. Turn off the airflow when the device is not in use.

3.3

Temperature

3.3.1

Recommended/Default Temperature The default temperatures are 24°C for cool and 50°C for warm.

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3 ICS AirCal Front Panel

3.3.2

Setting a new temperature

3.3.2.1

Temporary Adjustment To adjust the temperature for a single patient use, press the

buttons. The - decreases the temperature, the

+ increases the temperature. Press button quickly if small increments are needed or press and hold to change more rapidly. The range for the cool temperature is 12°C to 37°C. The range for the warm temperature is 37°C to 50°C. The temperatures are adjustable in 1/10 of a degree increments. To change the warm or cool temperature stored default value, see Changing the Stored Default Values ► 15.

3.3.3

Switching between cool and warm temperature The warm

or cool

temperature buttons allow the operator to select the stimulus desired. If the ICS AirCal

is connected to an ICS VNG/ENG system, selecting the caloric protocol (e.g., Left Warm) will automatically select the temperature on the irrigator. Therefore, no manual selection is needed. However, the default startup temperature of the ICS AirCal should match the temperature of the first caloric protocol in your list (e.g. if you start with Left Cool - default the ICS AirCal to start with Cool). The startup temperature (cool or warm) can be stored. The default is cool.. See Section Changing the Stored Default Values ► 15. Temperature selection will be indicated on the display panel. If the ICS AirCal is in operation mode only the temperature currently selected will display. The digital display shows the actual and set temperatures. Once a temperature has been selected, the display will flash until it reaches +/- 0.4 degrees from the set or default temperature. Time to reach the temperature is < 60 seconds. If the ICS AirCal is in standby mode both the warm and cool set temperatures will display, the actual temperature will not display.

3.4

Duration Timer

3.4.1

Recommended/Default Duration Timer The default duration for caloric irrigation is 60 seconds.

3.4.2

Setting a new Duration Time To adjust the duration time, press the

buttons. The - decreases the time, the + increases the time. Press

button quickly if small increments are needed or press and hold to change more rapidly. The range for the time is 1 to 99 seconds. To change the duration time stored default value, see Changing the Stored Default Values ► 15. Duration Time selection will be indicated on the display panel. If the ICS AirCal is in operation mode, the digital display shows the set time. Once an irrigation is started by using the foot switch or activation trigger on the delivery head, the actual timer will count down to 0. A beep will sound when the timer reaches 0 to alert the tester to stop irrigation. If the ICS AirCal is in standby mode only the set time will display.

3.5

Airflow Rate

3.5.1

Recommended/Default Airflow Rate The default airflow rate for caloric irrigation is 8 liters per minute.

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3 ICS AirCal Front Panel

3.5.2

Setting a new Airflow Rate Turn the knob to the right of the airflow

button to adjust the flow rate. Turn the knob counterclockwise to

increase the airflow and clockwise to decrease the airflow. The range for the airflow rate is 4 to 10 liters per minute. The airflow rate is set based on the knob position. The flow rate selection (actual only) will be indicated on the display panel. If the ICS AirCal is in operation mode, the digital display shows the actual flow rate. If the ICS AirCal is in standby mode the display will be off.

3.6

Beep Volume A beep will sound when the timer reaches 0 to alert the tester to stop irrigation. A 2000 Hz beep is presented.

3.6.1

Default Beep setting The default Beep is set to level 2.

3.6.2

Setting a new beep volume To adjust the beep volume, press and hold the beep

button until a beep is sounded that you want as the default.

There are 4 levels for the beep volume. To change the beep volume stored default value, see Changing the Stored Default Values ► 15.

3.7

Changing the Stored Default Values Change all settings to the desired setting. Decide what temperature for the ICS AirCal to start up in. Press and hold either the warm

or cool

temperature button for 3 seconds to set all default settings (warm and cool tem-

peratures, startup temperature, duration timer and beep volume). A 1 second beep will be sounded to confirm that the default settings have been stored. Remember, the default startup temperature of the ICS AirCal should match the temperature of the first caloric protocol in your list (e.g. if you start with Left Cool - default the AirCal to start with Cool).

3.8

Water level display The water level of the water in the reservoir is displayed. The blue bar will display. The

symbol indicates that the water reservoir is full and a

symbol indicates that the water reservoir is half full a blue bar will display. Between half full

and empty the bar will change from blue to orange this indicates that the water reservoir needs to be refilled. And symbol indicates that the water reservoir is empty.

3.8.1

Refill Procedure: Caution • Do NOT use this refill procedure if: 1) the ICS AirCal was just received from shipping dry. It needs to be filled and primed, 2) If the water level in the display has gone to zero because user never refilled it when orange bar was

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4 ICS AirCal Delivery Head & Foot Switch

present. 3) If the ICS AirCal was tilted at more than 20° with the water pump running. If one of these criteria were met please refer to Getting started ► 5 and follow the Filling and priming procedure ► 9.

Caution • Only use distilled water. Using common water from the tap will result in mineral deposits and will harm the ICS AirCal.

1. Turn off ICS AirCal and disconnect from the electrical wall outlet. 2. Wipe off any dust on the top of the ICS AirCal prior to opening the case to refill the reservoir. 3. Face the ICS AirCal front panel. On the back right side is a small cover. Using the Allen key (supplied with the irrigator cradle) unscrew the cover and remove. 4. Using the Allen key unscrew the internal cover and remove. 5. Expand the funnel supplied with the ICS AirCal. 6. Place the funnel in the refill hole of the reservoir. 7. Pour water into the funnel to fill the reservoir. 8. Monitor the water level closely. Fill to the bottom of the lip. Do NOT overfill the reservoir. 9. If water was spilled into the small indentions where the internal cover is placed. Wipe up this excess water before replacing the internal cover. 10. Replace the internal cover and tighten the screws. 11. Replace the external cover and tighten the screws. 12. Plug in the ICS AirCal to the electrical wall outlet and turn on ICS AirCal.

Caution • Due to the possibility of freezing during shipment, water must be drained from the reservoir before shipping the ICS AirCal. See Troubleshooting ► 28 for water removal instructions..

4

ICS AirCal Delivery Head & Foot Switch

4.1

Delivery Head The delivery head can be held in any way that is comfortable for the tester. Flow time activation is accomplished by an activation trigger located on the delivery head. The otoscope light can be turned on and off using the button located on the back of the handle below the lens.

Note • Turn light off when not in use.

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4 ICS AirCal Delivery Head & Foot Switch

Note • Caution symbol indicates that the inner speculum should never be placed in the ear without an Outer Disposable Speculum attached to it.

A. Inner Speculum B. Flow Time Activation Trigger

4.1.1

C. Full View Otoscope Lens D. Light On/Off Button

Speculum Warning • Never place the inner speculum directly into the patient's ear.

An outer disposable speculum should always be placed on the delivery head prior to performing an irrigation on a patient. The outer disposable speculum is intended to be single-use only.

4.1.2

Lens The Lens can be cleaned with a cleaning cloth like the Otometrics optical cleaning cloth (part # 7590527). If the lens is mishandled and broken a new lens can be purchased. Slide the broken lens out and slide the new lens into place. See Section 9.1 for an Accessories list.

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5 Performing a Caloric Irrigation

4.1.3

Light on/off button The light should be left on during irrigation in order to view the tympanic membrane (i.e., the eardrum) to ensure that the airflow is being directed properly.The light defaults to on when the ICS AirCal is in operation mode. The light will flash when the caloric test/irrigator is initiated by pressing the foot switch or the activation trigger on the delivery head to confirm initiation of the devices. If the ICS AirCal has not been used for 10 minutes the light will automatically shut off.

4.1.4

Activation Trigger Operation If airflow is on and temperature is +/- 0.4 of the set value, pressing the activation trigger on the handle will start the countdown timer and flash the light in the delivery head (set temperature must be reached in order to start timer and for light to flash). If the ICS AirCal is connected to an ICS VNG/ENG system: In VNG, first depression also starts the tracing and successive depressions start the video recorder or center tracing depending on software configuration. In ENG, first depression also starts the tracing and successive depressions centers the tracing. If the computer is turned on but the Otometrics VNG/ENG software is not running, flow time may be activated by holding down the flow time activation trigger for 5 seconds. The functions of the flow time activation trigger operate in parallel with the foot switch on the delivery head. Pressing the activation trigger on the handle more than once will NOT stop or restart the countdown timer. If airflow is off, pressing the activation trigger on the handle will NOT start the countdown timer.

4.2

Foot Switch

4.2.1

Operation A foot switch is used to activate the flow timer. If an ICS VNG/ENG system is connected and a caloric test has been selected in the software, the first depression of the foot switch will initiate the duration timer and the recording of the trace in the software; subsequent depressions will center the tracing (ENG/VNG) or start the video recording (VNG only). If the computer is turned on but the Otometrics VNG/ENG software is not running, flow time may be activated by holding down the foot switch for 5 seconds. The functions of the foot switch operate in parallel with the flow time activation trigger on the delivery head. Pressing the foot switch more than once will NOT stop or restart the countdown timer. If the ICS AirCal is in standby mode, pressing the foot switch will NOT start the countdown timer. In standby mode the foot switch can start any test in the ICS VNG/ENG software.

5

Performing a Caloric Irrigation

5.1

Preparation for testing Turn the unit on by pressing the power switch at the bottom left of the front panel. The default temperature (cool is

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5 Performing a Caloric Irrigation

manufacturer default) will automatically be selected as indicated by the illumination of the green LED and the digital display. The actual temperature will flash until the set temperature is reached. It takes approximately 60 seconds for set temperature to be reached when the unit is first turned on. When the set temperature is reached (±0.4°C), the actual temperature display will stop flashing. Using a regular otoscope or the delivery head with airflow turned off, examine the ear canal for the presence of cerumen and also to determine how best to direct the airstream. The ear canal should be essentially free of cerumen. If it is not, this must be removed prior to stimulating. Do not use water to remove cerumen as this will cause the temperatures in the ear canal to be cooler than desired due to left over water in the ear canal. Verify that the patient is positioned properly, in the supine position with head flexed 30º.

5.2

Testing Procedure Perform each of the four irrigations as follows: 1. Verify that a new speculum has been placed on the delivery head. 2. Instruct the patient to keep eyes open (VNG) or closed (ENG). 3. Close goggles for VNG. Have patient close their eyes for ENG. 4. Start collecting response and start irrigation. 5. Start tasking patient 20-30 seconds into irrigation. 6. When duration time is reached the ICS AirCal will present a beep, remove the delivery head from the patient's ear and continue tasking. 7. Right after the peak of the response, allow patient to fixate. 8. Collect eye movements until response subsides. 9. Dispose of the speculum and carefully place the delivery head in its cradle. If the ICS AirCal is connected to an ICS VNG/ENG system, subsequent depressions of the flow time activation switch will center the tracing for VNG/ENG or start the video recording for VNG. (If installed, the foot switch will also serve to start and center tracings or start the video recording.)

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6 ICS AirCal System Safety

6

ICS AirCal System Safety This guide contains information, cautions, and warnings which must be followed to ensure the safe performance of the ICS AirCal system. Local government rules and regulations, if applicable, should be followed at all times. When the ICS AirCal device is used in conjunction with a test device, make sure that all information, cautions, and warnings in the User Manual for the test device are followed. For safety specifics concerning test modules and test devices, see the specific manuals.

6.1

Symbols used ICS Impulse System Caution symbol: Refer to ICS AirCal Delivery Head & Foot Switch ► 16.

Consult instructions for use.

Follow instructions for use.

Complies with Type BF requirements of EN60601-1.

MEDICAL - General Medical Equipment as to electrical shock, fire and mechanical hazards only in accordance with UL 60601-1, first edition, 2003 CAN/CSA-22.2 No. 601.1-M90. Electronic equipment covered by the Directive 2002/96/EC on waste electrical and electronic equipment (WEEE). All electrical and electronic products, batteries, and accumulators must be taken to separate collection at the end of their working life. This requirement applies in the European Union. Do not dispose of these products as unsorted municipal waste. You can return your device and accessories to Otometrics, or to any Otometrics supplier. You can also contact your local authorities for advice on disposal. Complies with Medical Devices Directive 93/42/EEC and RoHS Directive (2011/65/EC).

Located on Front Panel. Power on/off switch

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