natus ICS Aircal User manual

ICS Aircal® Air Caloric Irrigator
User Guide
Doc. No. 7-50-1240-EN/07
Part No. 7-50-12400-EN

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ICS Aircal
Copyright notice
© 2012, 2021 Natus Medical Denmark ApS. All rights reserved. ® Natus, the Natus Icon, ICS Aircal, ICS Chartr, and HORTMANN
are r egistered trademarks of Natus Medical Denmark ApS in the U.S.A. and/or other countries.
Version release date
2021-11-11
Technical service and support
Please contactyour supplier.

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Table of Contents
1 Device description...................................................................................................................5
1.1 Intended use ...................................................................................................................5
1.2 Intended users and patient target group .........................................................................5
1.3 Clinical benefits...............................................................................................................5
1.4 Contraindications and side effects...................................................................................5
1.5 Typographical conventions..............................................................................................5
2 Getting started........................................................................................................................6
2.1 Room setup.....................................................................................................................6
2.2 Installation and setup......................................................................................................7
2.2.1 Removing the transportation screws.........................................................................7
2.2.2 Installing the Delivery Head Cradle............................................................................7
2.2.3 Understanding the ICS Aircal Back Panel ...................................................................8
3 ICS Aircal Front Panel............................................................................................................13
3.1 ICS Aircal device on/off .................................................................................................13
3.2 Standby/Operation mode..............................................................................................13
3.3 Temperature.................................................................................................................14
3.3.1 Recommended and default temperature ................................................................14
3.3.2 Setting a new temperature .....................................................................................14
3.3.3 Switching between cool and warm temperature.....................................................14
3.4 Duration Timer..............................................................................................................14
3.4.1 Recommended and default Duration Timer ............................................................14
3.4.2 Setting a new duration time....................................................................................14
3.5 Airflow Rate ..................................................................................................................15
3.5.1 Recommended and default Airflow Rate.................................................................15
3.5.2 Setting a new Airflow Rate......................................................................................15
3.6 Beep volume.................................................................................................................15
3.6.1 Default Beep setting ...............................................................................................15
3.6.2 Setting a new Beep volume.....................................................................................15
3.7 Changing the Stored Default Values ..............................................................................15
3.8 Water level display........................................................................................................15
3.8.1 Refill procedure ......................................................................................................16
4 ICS Aircal Delivery Head and Foot Switch...............................................................................16
4.1 Delivery Head................................................................................................................16

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4.1.1 Speculum................................................................................................................17
4.1.2 Lens........................................................................................................................17
4.1.3 Light on/off button .................................................................................................17
4.1.4 Activation Trigger Operation...................................................................................18
4.2 Foot Switch ...................................................................................................................18
5 Performing a Caloric Irrigation...............................................................................................18
5.1 Preparation for testing ..................................................................................................18
5.2 Testing procedure .........................................................................................................19
6 ICS Aircal system safety.........................................................................................................19
6.1 Glossary of symbol ........................................................................................................20
6.2 General warnings, cautions and notes...........................................................................23
6.2.1 Warnings ................................................................................................................24
6.2.2 Cautions .................................................................................................................25
6.2.3 Notes......................................................................................................................25
6.3 Manufacturer................................................................................................................25
6.3.1 Responsibility of the Manufacturer.........................................................................26
6.3.2 Instructions to access the eIFU................................................................................26
7 Service, cleaning, and maintenance.......................................................................................26
7.1 Service ..........................................................................................................................26
7.2 Cleaning........................................................................................................................26
7.2.1 Lens on the Delivery Head ......................................................................................26
7.2.2 Speculum (outer) ....................................................................................................27
7.2.3 Disposal..................................................................................................................27
7.3 Maintenance.................................................................................................................27
8 Other references...................................................................................................................27
9 Technical specifications.........................................................................................................28
9.1 Accessories ...................................................................................................................30
10 Notes on EMC (Electromagnetic Compatibility)......................................................................31
11 Troubleshooting ...................................................................................................................37
12 Firmware procedures ............................................................................................................37
12.1 Upgrading the firmware................................................................................................38
12.2 Installing the device driver ............................................................................................38

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ICS Aircal
Device description
1Device description
The ICS Aircal® Air Caloric Irrigator is a convenient and accurate air caloric stimulator to be used for evoking nystagmus
during VNG/ENG examinations. The device 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
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.
1.2 Intended users and patient target group
The ICS Aircal system is to be used only by qualified medical personnel with prior knowledge of the medical and
scientific facts underlying the procedure.
The ICS Aircal system is intended for patients of all ages who can tolerate testing.
1.3 Clinical benefits
The caloric test is a conventional clinical procedure that involves the clinician directing warm and cool air or water
into the patient’s ear canal for a given period of time; the resultant eye movements are measured and analyzed.
Caloric testing is performed initially without fixation, and then fixation is provided at a given period of time following
the end of the stimulus presentation. These tests are designed to be part of a battery of vestibular tests to aid in
differential diagnosis.
1.4 Contraindications and side effects
Do not perform irrigation on patients with tympanic membrane perforations.
1.5 Typographical conventions
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
pre-cautionary statements as follows:
Warning • Indicates that there is a possibility of injury, death, or other serious adverse reactions associated
with the use or misuse of the device.
Caution • Indicates that there is a possibility of a problem with the device associated with its use or
misuse. Such problems include device malfunction, device failure, damage to the device, or damage to
other property.
Note • Indicates that you should take special notice.

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ICS Aircal
Getting started
2Getting started
2.1 Room setup
A. Sink
B. Computer
C. Equipment counter
D. Cabinets over counter
E. Examiner's stool
F. Footstool
G. Examining table
H. Telephone
The ICS Aircal device is designed to be used at any convenient level such as on a table or cart. The ICS Aircal device can
be stacked with the ICS Chartr® 200 VNG/ENG hardware. It is best if the ICS Aircal device is on top so that water can be
refilled 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 (the eardrum) while performing irrigation.
F
A
B
C
D
E
G
H

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Getting started
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 if the device ever needs to be
shipped.
Remove transportation screws (A) and (B).
Store them with your syringe kit, funnel, and Allen key.
2.2.2 Installing the Delivery Head Cradle
Before installing the cradle for the delivery head, determine how it should be mounted:
•The cradle can be mounted on the left or right side of the unit.
•For units that are placed away from the edge of the table, it is recommended that the cradle is mounted in the
horizontal position (A).
For units that are placed at the edge of the table, it is recommended that the cradle is mounted at an angle (B).
Caution • The ICS Aircal system is intended to be used only by qualified medical personnel.
Note • Install the cradle prior to filling the water reservoir. Installation requires that the ICS Aircal device is tilted
more than 20°. If the water reservoir has water in it, tilting the device could introduce air into the system. The risk
of damage to the system is small, but priming of the water reservoir would be required to make the system
operate properly and not overheat.

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Getting started
Locate the bag that shipped with the cradle that contains three screws and an Allen key.
With the side chosen to hold the cradle facing the ceiling and the bottom of the unit facing you, lay the ICS Aircal
device on its side.
Locate the bracket mounting holes.
Attach the bracket to the unit using the Allen key to tighten the screws.
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.
For units placed at the edge of the table, tilt the bracket forward until it stops.
Ensure that 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.
Store the Allen key with the syringe kit. You will need it when filling the water reservoir.
2.2.3 Understanding the ICS Aircal Back Panel
The USB port allows for firmware upgrades. Refer to Firmware procedures ►37.

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ICS Aircal
Getting started
2.2.3.1 Connecting the Foot Switch
The ICS Aircal device includes the foot switch. Connect the foot switch to the back of the irrigator . If the ICS
Aircal device is connected to an ICS VNG/ENG system and you want to use the foot switch to start tests other than the
caloric test, the irrigator must be turned on to use the foot switch.
2.2.3.2 Connecting to an ICS VNG/ENG system
The ICS Aircal device 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 two 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 device should be connected to an electrical wall outlet by attaching the power cable to the ICS Aircal
device and plugging the cable into the electrical wall outlet.
A. Connector for power cable
2.2.3.4 Disconnecting the Mains power cable
The ICS Aircal device and any device to be connected that has its own power supply must be turned off before any
connections are established
2.2.3.5 Filling and priming procedure
The ICS Aircal device uses water to cool the air. The water reservoir must be filled before the device is used.
Warning • To avoid the risk of electric shock, this equipment must only be connected to a mains supply with
protective ground.
Warning • To disconnect the device from the mains supply, pull the mains plug out of the electrical wall
outlet. Do not position the unit so that it is difficult to pull the mains plug out of the electrical wall outlet.

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Getting started
Filling
Turn off the ICS Aircal device and unplug it from the electrical wall outlet.
Wipe off any dust on the top of the case.
Facing the front panel, locate the small cover at the back right side. Using the Allen key (supplied) unscrew the
reservoir cover and remove.
A. Reservoir cover
Using the Allen key (supplied with the cradle), unscrew the internal cover and remove.
Warning • To prevent electrical shock, the ICS Aircal device must be turned off and disconnected from the
electrical wall outlet when filling or refilling the water reservoir.
Note • Use this procedure:
1. If the ICS Aircal device was just received from shipping and is dry. It must be filled and primed.
2. If the water level in the display has gone to zero because the user never refilled it when the orange bar was
present.
3. If the ICS Aircal device 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 needs a refill, follow the
instructions in Refill procedure.
Note • Only use distilled water. Using common water from the tap will result in mineral deposits and will harm
the ICS Aircal device.

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ICS Aircal
Getting started
A. Internal cover
Expand the funnel supplied with the ICS Aircal device and place it in the refill hole of the reservoir.
A. Funnel
Pour water into the funnel to fill the reservoir.
Monitor the water level closely. Fill to the bottom of the lip. Do NOT overfill the reservoir.
Remove the funnel.
Wipe up any excess water that might have spilled into the small indentions where the internal cover is placed.
Replace the internal cover.
Priming
Plug the power cable of the device into the electrical wall outlet and turn it on.
Locate the priming switch on the back panel .
Press the priming switch to turn on and hold 5 seconds.
Release the priming switch to turn off and wait 5 seconds.
Repeat steps 4 and 5 for a total of 10 times on and 10 times off.
If the temperature reaches the set temperature, then the irrigator is primed. Continue to step 10.

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ICS Aircal
Getting started
Turn off the device and unplug from the electrical wall outlet.
Remove the internal cover.
Check if the water reservoir is full. If not, place the funnel in the refill hole of the reservoir and add additional water.
Remove the funnel and replace the internal cover. Tighten the screws to secure.
Replace the external cover and tighten screws to secure.
Plug the power cable of the device into the electrical wall outlet and turn it on.
Priming with Bent Tube
Take the syringe with the bent tube and remove enough water from the reservoir to fill the syringe.
Put the end of the bent tube into the pump inlet hole. The tube will be facing toward the front of the irrigator.
While pressing the priming switch , inject the water into the inlet.
Release the priming switch.
Press the priming switch to turn on and hold 5 seconds.
Release the priming switch to turn off and wait 5 seconds.
Repeat steps 5 and 6 for a total of 10 times on and 10 times off.
Press the cool button . Decrease the temperature to 12°C.
If the temperature reaches the set temperature, then the irrigator is primed. Continue to step 11.
Caution • 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.
Note • The default airflow rate for caloric irrigation is 8 liters per minute. If the device is transported, the airflow
knob setting might be changed. You may have to reset the airflow.

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ICS Aircal Front Panel
If the temperature does not reach 12°C in approximately 3 minutes, repeat steps 1 through 9.
Turn off the device and unplug from the electrical wall outlet.
Check if the water reservoir is full. If not, place the funnel in the refill hole of the reservoir and add additional water.
Remove the funnel and replace the internal cover. Tighten the screws to secure.
Replace the external cover and tighten screws to secure.
Plug the power cable of the device into the electrical wall outlet and turn it on.
2.2.3.6 Water removal procedure
Turn the ICS Aircal device off and unplug it from the electrical wall outlet.
Wipe off any dust on the top of the ICS Aircal device prior to opening the case to refill the reservoir.
Face the front panel. On the back right side is a small cover. Using the Allen key (supplied with the cradle), unscrew
the exterior cover and remove.
Using the Allen key unscrew the internal cover and remove.
Using the syringe kit provided, remove the water from the reservoir. Replace both covers after the water is
removed.
3ICS Aircal Front Panel
This section describes all operational controls located on the front panel of the ICS Aircal device.
3.1 ICS Aircal device on/off
This switch is a push on/push off switch on the bottom left of the front panel that turns the ICS Aircal device on and
off. The device is on when the green LED and the digital display turn on. When the ICS Aircal device is turned on, it is
in operation mode.
3.2 Standby/Operation mode
When the ICS Aircal device is turned on, the default mode is airflow on. Pressing the airflow button switches
the ICS Aircal device between standby mode and operation mode. In standby mode (airflow off), the irrigator is on,
but the airflow, water and air pump, fan, and warming and cooling mechanisms are off. Standby mode is
recommended when the ICS Aircal device is connected to an ICS VNG/ENG and the foot switch is used for starting
other tests (e.g., Dix Hallpike) in the ICS Chartr software. Turn off the airflow when the device is not in use.

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ICS Aircal Front Panel
3.3 Temperature
3.3.1 Recommended and default temperature
The default temperatures are 24°C for cool and 50°C for warm which are the default temperatures.
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 the button quickly if small increments are needed, or press and hold to
change more rapidly. The temperatures are adjustable in 1/10 of a degree increments. The range for the cool
temperature is 12°C to 37°C. The range for the warm temperature is 37°C to 50°C. To change the default value of
warm or cool temperature, see Changing the Stored Default Values.
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 device 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 device should match the temperature of the first caloric protocol in your list (e.g.
if you start with Left Cool, default theICS Aircal device to start with Cool). The startup temperature (cool or warm) can
be stored. The default is cool. See Changing the Stored Default Values.
Temperature selection will be indicated on the display panel. If the ICS Aircal device is in operation mode, only the
temperature currently selected will display. The digital display shows the actual and set temperatures. After a
temperature has been selected,the display will flash until it reaches +/- 0.4 degrees from the set or default
temperature. The time to reach the temperature is < 60 seconds. If the ICS Aircal device is in standby mode, the
warm and cool set temperatures will display, and the actual temperature will not display.
3.4 Duration Timer
3.4.1 Recommended and 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 default value of duration time, see Changing the Stored Default Values.
Duration Time selection will be indicated on the display panel. If the ICS Aircal device is in operation mode, the digital
display shows the set time. After 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 device is in standby mode, only the set time will display.

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ICS Aircal Front Panel
3.5 Airflow Rate
3.5.1 Recommended and default Airflow Rate
The default airflow rate for caloric irrigation is 8 liters per minute.
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 counter clockwise to
increase the airflow and clockwise to decrease the airflow. The range for the airflow rate is 4.0 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 device is in operation mode,
the digital display shows the actual flow rate. If the ICS Aircal device 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 you hear a beep that you want as the
default. There are four levels for the beep volume. To change the default value of the beep volume, see Changing the
Stored Default Values.
3.7 Changing the Stored Default Values
Change all settings to the desired setting. Decide the start temperature for the ICS Aircal. Press and hold either the
warm or cool temperature button for 3 seconds to set all default settings (warm and cool
temperatures, startup temperature, duration timer, and beep volume). A 1-second beep will sound to confirm that
the default settings have been stored. Remember, the default startup temperature of the ICS Aircal device should
match the temperature of the first caloric protocol in your list (e.g. if you start with Left Cool, default the ICS Aircal
device to start with Cool).
3.8 Water level display
The water level in the water reservoir is displayed. The symbol indicates that the water reservoir is full and a blue
bar will display. The symbol indicates that the water reservoir is half full and a blue bar will display. Between half
full and empty the bar will change from blue to orange, which indicates that the water reservoir needs to be refilled.
The symbol indicates that the water reservoir is empty.

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ICS Aircal Delivery Head and Foot Switch
3.8.1 Refill procedure
Turn off the ICS Aircal device and disconnect it from the electrical wall outlet.
Wipe off any dust on the top of the ICS Aircal device prior to opening the case to refill the reservoir.
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 external cover and remove.
Using the Allen key, unscrew the internal cover and remove.
Expand the funnel supplied with the ICS Aircal device and place the funnel in the refill hole of the reservoir.
Pour water into the funnel to fill the reservoir.
Monitor the water level closely. Fill to the bottom of the lip.
Replace the internal cover and tighten the screws.
Replace the external cover and tighten the screws.
Plug the power cable of the ICS Aircal device into the electrical wall outlet and turn it on.
4ICS Aircal Delivery Head and 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 • Do NOT use this refill procedure if:
1. If the ICS Aircal device was just received from shipping and is dry. It must be filled and primed.
2. If the water level in the display has gone to zero because the user never refilled it when the orange bar was
present.
3. If the ICS Aircal device was tilted at more than 20° with the water pump running.
If one of these criteria were met, refer to Getting started and follow the Filling and priming procedure.
Note • Only use distilled water. Using common water from the tap will result in mineral deposits and will harm
the ICS Aircal device.
Warning • Do NOT overfill the reservoir. If water was spilled into the small indentions where the internal
cover is placed, wipe up this excess water before replacing the internal cover.
Note • Due to the possibility of freezing during shipment, water must be drained from the reservoir before shipping
the ICS Aircal. See Water removal procedure.

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ICS Aircal Delivery Head and Foot Switch
A. Inner Speculum
B. Flow Time Activation Trigger
C. Full View Otoscope Lens
D. Light On/Off Button
4.1.1 Speculum
An outer disposable speculum should alwaysbe placed on the delivery head prior to performing an irrigation on a patient.
The outer disposable speculum is intended to be single-use.
4.1.2 Lens
The lens should be cleaned with optical cleaning cloth. 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 Accessories ►30 for an Accessories list.
4.1.3 Light on/off button
The light should be turned on during irrigation to view the tympanic membrane (the eardrum) to ensure that the air
flow is being directed properly. By default, the light is turned on when the ICS Aircal device 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 device has not been used for 10 minutes, the light
will automatically turn off.
Caution • Never place the inner speculum directly into the patient's ear.

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Performing a Caloric Irrigation
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. (The set temperature must be reached to start the timer and
for the light to flash.)
If the ICS Aircal device 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 Natus 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
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 Natus 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 device is in standby mode, pressing the foot switch will NOT start the countdown timer.In standby
mode, the footswitch can start any test in the ICS VNG/ENG software.
5Performing a Caloric Irrigation
5.1 Preparation for testing
Turn on the unit by pressing the power switch at the bottom left of the front panel. The default temperature (cool is
the 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 turned on, initially. 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 to determine how best to direct the airstream. The ear canal should be essentially free of cerumen. If it is
not, cerumen 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.

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ICS Aircal system safety
Verify that the patient is positioned properly, in the supine position with head flexed 30°.
5.2 Testing procedure
Perform each of the four irrigations as follows:
Verify that a new speculum has been placed on the delivery head.
Instruct the patient to keep eyes open (VNG) or closed (ENG).
Close goggles for VNG. Have patient close their eyes for ENG.
Start collecting response and start irrigation.
Start tasking patient 20-30 seconds into irrigation.
When duration time is reached and the ICS Aircal device beeps, remove the delivery head from the patient's ear and
continue tasking.
Right after the peak of the response, allow the patient to fixate.
Collect eye movements until the response subsides.
Dispose of the speculum and carefully place the delivery head in its cradle.
If the ICS Aircal device 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.)
6ICS Aircal system safety
This guide contains information, cautions,and warnings that must be followed to ensure the safe performance of the
ICS Aircal system.
When the ICS Aircal device is used in conjunction with a VNG/ENG Systems, make sure that all information, cautions,
and warnings in the User Manual for the test device are followed. For safety specifics concerning VNG/ENG Systems,
see the specific manuals.
Any serious incident that has occurred in relation to the device should be reported to Natus Manufacturing Limited
and the competent authority of the Member State in which the user and/or patient is established.
Note • Local government rules and regulations, if applicable, should be followed at all times.

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ICS Aircal system safety
6.1 Glossary of symbol
Symbol Standard
Reference Standard Title of Symbol
Symbol Title
as per
Referenced
Standard
Explanation
N/A N/A An indication of
Medical Device
This product is a medical
device.
XXXX
Directive
93/42/EEC
MDR
2017/745
Medical Device Directive
EU Medical Device
Regulation
CE marking Signifies European technical
conformity.
(Notified body number
appears under symbol.)
21 CFR
801.109(b)(1)
Labeling-Prescription
devices
Prescription
only
Indicates that the product is
authorized for sale by or on
the order of a licensed
healthcare practitioner.
N/A N/A Quantity Number of parts in a
package.
Directive
2012/19/EU
Waste Electrical and
Electronic Equipment (WEEE)
Disposal at end
of operating life
instructions
Indicates that electrical and
electronic equipment waste
should not be discarded
together with unseparated
waste but must be
collected separately.
ISO 15223-
1:2016
Reference no.
5.1.1 (ISO
7000-3082)
Medical devices — Symbols
to be used with medical
device labels, labeling and
information to be supplied
Manufacturer Indicates the medical
device manufacturer.
ISO 15223-
1:2016
Reference no.
5.1.3. (ISO
7000-2497)
Medical devices — Symbols
to be used with medical
device labels, labeling and
information to be supplied –
Part 1: General
requirements.
Date of
manufacture
Indicates the date when the
medical device was
manufactured.
ISO 15223-1
Reference no.
5.1.5
Medical devices — Symbols
to be used with medical
device labels, labeling and
information to be supplied.
Batch code or
Lot code
Indicates the
manufacturer's batch code
so that the batch or lot can
be identified.
ISO 15223-1
Reference no.
5.1.6
Medical devices — Symbols
to be used with medical
device labels, labeling and
information to be supplied.
Catalogue
number
Indicates the
manufacturer’s catalogue
number so that the medical
device can be identified.