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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ICS Aircal
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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ICS Aircal
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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ICS Aircal
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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ICS Aircal
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.