Interacoustics Aqua Stim User manual

Item No. 8011853 D-0004883-C–2020/05
Instructions for Use – Part 1
Aqua Stim
Caloric Irrigator
EN Instructions for Use
ES Manual de instrucciones
SV Bruksanvisning
FR Instructions d’utilisation
EL Οδηγίες χρήσης
DE Gebrauchsanweisung
IT Istruzioni per l'uso
PT Instruções de Utilização

Instructions for Use - EN
Aqua Stim Caloric Irrigator

Table of Contents
1INTRODUCTION ............................................................................................... 1
1.1 About this Manual ............................................................................................................... 1
1.2 Intended Use....................................................................................................................... 1
1.3 Product Description............................................................................................................. 2
1.4 Warnings and Precautions.................................................................................................. 3
2UNPACKING AND INSTALLATION................................................................. 5
2.1 Unpacking and Inspection................................................................................................... 5
2.2 Storage................................................................................................................................ 5
2.3 Marking ............................................................................................................................... 6
2.4 Connection Panel Dictionary............................................................................................... 7
2.5 Installation ........................................................................................................................... 8
2.6 Irrigator Connectors ............................................................................................................ 8
2.7 Draining Water from the Tank............................................................................................. 8
3OPERATING INSTRUCTIONS ....................................................................... 11
3.1 Attach the Hose Tip .......................................................................................................... 11
3.2 Maintain Water Level ........................................................................................................ 11
3.3 Select Automatic Control of the Irrigator........................................................................... 12
3.4 Select the Irrigation Temperature ..................................................................................... 13
3.5 Set the IrrigationTime........................................................................................................ 14
3.6 Perform the Irrigation ........................................................................................................ 14
3.7Draining the Internal Water ............................................................................................... 16
3.8 Trouble Shooting............................................................................................................... 17
4MAINTENANCE .............................................................................................. 19
4.1 General Maintenance Procedures .................................................................................... 19
4.2 Preventive Maintenance ................................................................................................... 19
4.3 Cleaning Procedure to Reduce Bio-film Build-up inside the AquaStim™ Caloric Irrigator19
4.4 How to clean Interacoustics Products............................................................................... 20
4.5 Concerning Repair ............................................................................................................ 21
4.6 Warranty............................................................................................................................ 21
4.7 Component Disposal......................................................................................................... 22
5GENERAL TECHNICAL SPECIFICATIONS .................................................. 25
5.1 Device Specifications........................................................................................................ 25
Appendix A ................................................................................................................................ 27

Aqua Stim Water Irrigator Instructions for Use - EN Page 1
1Introduction
1.1 About this Manual
This manual is valid for the Aqua Stim Air Irrigator. The product is manufactured by:
Interacoustics A/S
Audiometer Allé 1
5500 Middelfart
Denmark
Tel.: [phone]
Fax: [phone]
E-mail: [e-mail]
Web: www.interacoustics.com
Copyright © March 2012 by Interacoustics. All rights reserved. Information in this document is subject to
change without notice. Companies, names, and data used in example herein are fictitious unless otherwise
noted. No part of this document may be reproduced or transmitted in any form or by any means, electronic or
mechanical, for any purpose, without express written permission of Interacoustics or its licensees.
Windows®, Windows XP®, and Windows 7® are trademarks of the Microsoft Corporation. Other trademarks
are the property of their respective owners.
1.2 Intended Use
The Aqua Stim caloric irrigator is used for stimulating the motion sensors in the ear using warm or cool water
pumped into the external ear canal. This standard clinical test is used to determine if the motion sensors are
working properly in patients with dizziness or balance problems. Typically four irrigations are performed, a
cool and a warm for each ear. Responses to the irrigation are then compared to determine if one ear motion
sensor is weaker than the other ear sensor.
The Aqua Stim can be used in conjunction with the Interacoustics VN415/VO425 VNG system during caloric
testing. The Aqua Stim will interface with VN415/VO425 when using InteracousticsVNG software version
7.0.6 or later via USB. The Aqua Stim USB driver is available on the Interacoustics Installation CD.
All personnel who operate the Aqua Stim should familiarize themselves with the
contents of this manual prior to using the irrigator with a patient. Additional
training can be requested via Interacoustics or one of its representatives.
If service is required, please contact Interacoustics or your local Interacoustics distributor. Do not attempt to
repair the unit yourself.
Aqua Stim should be used for irrigating the external ear canal only for the
purposes of caloric stimulation as a part of VNG/ENG test protocol. The device
is not intended for clearing ear wax.

Aqua Stim Water Irrigator Instructions for Use - EN Page 2
The intended use of this product is for irrigation of the patient’s external auditory canal with either warm or
cool water for the purpose of assessing the peripheral vestibular system. The product is intended to be used
by a trained professional in a clinic, hospital, or rehab setting The appropriate patient population includes
children and adults with normal external auditory canal and middle ear anatomy.
Do not perform irrigation on patients with tympanic membrane perforations.
1.3 Product Description
The Aqua Stim caloric irrigator is used for stimulating the motion sensors in the ear using warm or cool water
pumped into the external ear canal. .
The systems consist of the following included and optional parts:
Qty
Designation
Included parts:
1
1
1
1
1
1
1
1
1
Accessories:
Aqua Stim Irrigator
External water tank with tubes
Power cord
User’s Manual
Plastic kidney basin
Irrigator handle
Pack of silicone tubes (single-use)
USB Cable
Spare Water Filter

Aqua Stim Water Irrigator Instructions for Use - EN Page 3
1.4 Warnings and Precautions
Throughout this manual the following meaning of warnings, cautions and notices are used:
Interacoustics – Steps marked with the Interacoustics logo are automatically performed by the USB interface
with Interacoustics VNG software.
WARNING indicates a hazardous situation which, if not avoided, could result
in death or serious injury.
CAUTION, used with the safety alert symbol, indicates a hazardous situation
which, if not avoided, could result in minor or moderate injury.
NOTICE is used to address practices not related to personal injury.

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2Unpacking and Installation
2.1 Unpacking and Inspection
Check box and contents for damage
When the instrument is received please check the shipping box for rough handling and damage. If the box is
damaged it should be kept until the contents of the shipment have been checked mechanically and
electrically. If the instrument is faulty please contact your local distributor. Keep the shipping material for the
carrier’s inspection and insurance claim.
Keep carton for future shipment
The Aqua Stim Water Irrigator comes in its own shipping carton, which is specially designed for the Aqua
Stim Water Irrigator. Please keep this carton. It will be needed if the instrument has to be returned for
service. If service is required please contact your local distributor.
Reporting Imperfections
Inspect before connection
Prior to connecting the product it should once more be inspected for damage. All of the cabinet and the
accessories should be checked visually for scratches and missing parts.
Report immediately any faults
Any missing part or malfunction should be reported immediately to the supplier of the instrument together with
the invoice, serial number, and a detailed report of the problem. In the back of this manual you will find a
"Return Report" where you can describe the problem.
2.2 Storage
Environmental Conditions
The Aqua Stim may not be used in rooms where there are explosion risks. The
equipment is not suitable for use in the presence of flammable anesthetic mixtures
with air or oxygen or nitrous oxide.
Standards Compliance
•Class I device for protection against electric shock
•Type B Applied Part for degree of protection against electric shock
•IPX0 rating for degree of protection against the ingress of water
(I.e. the system will be damaged if any water is absorbed by the electronic equipment)
The Aqua Stim was tested according to IEC60601-1-2 regarding EMC. Thus, you can install and use the
Aqua Stim in a clinical exam room where other medical equipment is located.
Medical electrical equipment needs special precautions regarding electromagnetic compatibility (EMC) and
needs to be installed and put into service according to the EMC information provided.
•Portable and mobile radio frequency (RF) communications equipment (e.g. cell phones, personal
data assistants, etc.) can affect medical electrical equipment. This equipment should not be used at
close distances to the equipment.
•Power frequency magnetic fields should be at levels characteristic of a typical location in a typical
commercial or hospital environment.
Performance Conditions
Storage Conditions
Temperature
of Room
20°C ~ 30°C
68°F ~ 86°F
Temperature
of Room
1°C ~ 52°C
33°F ~ 125°F
Relative Humidity
Non-condensing
Relative Humidity
Non-condensing

Aqua Stim Water Irrigator Instructions for Use - EN Page 6
The external water tank should be placed at the same level or up to 24 inches (60 cm) below the irrigator
and water can still be drawn into the irrigator using the internal pump. Do not place the external water tank
higher than the irrigator.
Do not place the water tank at a position above the irrigator as this may affect
water fill and overflow functions.
Water is drawn from the external water tank into the irrigator for heating to 30°C or 44°C prior to each
irrigation. Water will remain in the irrigator until it has been emptied by you following the draining
instructions.
Prior to transport, follow the water draining instructions in this manual. Do not
ship the irrigator without draining it as the internal water may damage
components due to freezing and this will void the warranty.
2.3 Marking
The following marking can be found on the instrument:
Symbol
Explanation
Type B applied parts.
Patient applied parts that are not conductive and can be immediately
released from the patient.
or
Refer to instruction manual
WEEE (EU-directive)
This symbol indicates that when the end-user wishes to discard this product,
it must be sent to separate collection facilities for recovery and recycling.
Failing to do so may endanger the environment.
Year of manufacture

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2.4 Connection Panel Dictionary
Figure 1Front Panel Diagram
A Selects Warm Irrigation (2nd press to cancel)
B Selects Cool Irrigation (2nd press to cancel)
C Increase irrigation time by 1 sec per press (30 seconds max.)
D Decrease irrigation time by 1 sec per press (15 seconds min.)
E Handle Rest
F Irrigator status display
Figure 2Rear Panel Diagram
A Exhaust fan and filter F Power Switch
B Handle electrical connector G Fuse Holder
C USB (B-size) connector H AC Power Cord Connector
D Handle Blue tube disconnect I Water Tank Inlet Disconnect
E Handle Red tube disconnect J Water Tank Outlet Disconnect
K Ground lug
E
D
C
F
B
A
J
K
I
H
G
F
E
D
B
C
A

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2.5 Installation
The Aqua Stim consumes 600 watts from a standard AC wall outlet. Do not connect other high current
devices into the same outlet as it may exceed the current limits of the AC outlet and trip a mains circuit
breaker. Contact your local electrician if you have questions about the capabilities of your building circuits.
The Aqua Stim is ventilated by a fan at the back of the device. Do not place the Aqua Stim near a radiator or
other heating source. Provide at least 10 cm (4 in) of free space behind the unit to provide adequate
circulation.
2.6 Irrigator Connectors
Do not plug in the handle electrical connector when the irrigator is powered on. If
the handle does not operate, power down the irrigator and check the handle
electrical cable is plugged in securely into the back of the irrigator.
The Aqua Stim is shipped from Interacoustics without any water in the tank. Please fill the external tank with
a gallon of good quality water (preferably distilled or demineralized) that is not considered “hard water” due
to high mineral content. Do not fill above the 3½ L mark. Connect the color coded Inlet (white) / Outlet
(grey) tubes between irrigator and the external water tank. Push the tubes into the connectors until you feel
them “snap” in. To remove the tubes you will need to push on the small ring next to the tube using two finger
tips while pulling gently on the tube. Connect the red and blue tubes from the handle to the back of the
irrigator. Verify that the arrow [→] on the red tube’s water filter is pointing away from the irrigator. The
electrical connector from the handle plugs into the back of the irrigator. Note that the electrical connector is
keyed for orientation. Rotate the connector between your fingers while gently pressing in on the connector
until it seats and makes connection. A ground lug is provided on the rear panel for hospital grade wiring.
Lastly, plug in the appropriate 120 VAC or 240 VAC power cable into the AC power cord connector.
Figure 3Tubes and Electrical Connection
Figure 4
External tank with pick up filter
2.7 Draining Water from the Tank
The external water tank should be placed on the same table as the irrigator or up to 24 inches (60 cm) below
the irrigator. For the first operation, turn on the irrigator using the power switch on the back of the irrigator at
the power entry. Once the irrigator has power and the front panel display shows Select Cool/Warm, press
the “Cool” button on the front panel. The irrigator will draw water from the external water tank and fill the
internal heater tank. You will hear a change in pitch of the irrigation pump as it self-primes. Some water will
flow from the irrigator back into the external tank from the overflow tube. Read the front panel display to
confirm the current water temperature is being displayed and that the irrigator is heating to a preset 30ºC
temperature. If you do not plan to perform irrigations right away you can return the irrigator to standby mode
(Select Cool/Warm) by pressing the “Cool” button again.
The Aqua Stim uses two filters to catch any contaminants in the water. A pickup filter is attached to the end
of the inlet tube in the external tank. An inline filter is placed within the handle’s red tube. Inspect these
filters periodically to make sure they are not blocked. If you have any questions, contact our service
department.

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You should always use fresh water in the external tank. Tap water may be used in
the Aqua Stim provided that the water is not “hard water” due to excess mineral
content. Build up and / or damage from mineral deposits is not covered under
warranty. Demineralized or distilled water is always recommended and should be
used if the tap water is “hard” due to mineral content or if there is any question in your
mind about water purity. Unclip and remove the top of the external water tank. Wash
the container weekly using mild dish soap. Rinse the tank after washing to remove
soap residue. Replace cover and check hose connections. Fill with fresh, clean water.

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3Operating instructions
3.1 Attach the Hose Tip
Use Interacoustics provided soft silicone hose tips placed on the end of the delivery handle. The silicone
Tips are single-use-only to prevent transmission of disease between patients. Only use silicone tips from
Interacoustics.
To assemble the silicone tip on the delivery handle, slide the tube over the short stainless steel nipple as
shown in Figures 4 and 5. Confirm the silicone tube is on straight and that it tightly grips the nipple.
Figure 5Place silicone tip on irrigation handle
nipple. Use silicone Tips provided by
Interacoustics that are calibrated for flow rate
and heat transfer.
Figure 6Pull lightly on silicone tip to verify it is secure.
3.2 Maintain Water Level
As a good practice, verify the external water tank is filled completely with water at the start of the day. A full
water tank holds enough water for approximately 14 irrigations. The irrigator will alert you if there is not
enough water in the tank to perform the next irrigation by displaying “No water in tank”.
For optimal operation, the water in the external tank should be kept between 68°F (20°C) and 75°F (24°C).
Warm water in the tank above 27°C will prevent 30°C irrigations. If the tank water is too warm for the 30°C
irrigation, you may add cool water or a few ice cubes to the external tank. Power down, power up and press
the “Cool” button to flush the internal tank with cooled water.
If you have not used or do not plan to use the irrigator for a couple of weeks, drain the irrigator using the
drain procedure in the Error! Reference source not found. to remove any water. Then empty the external
tank.
You should always use fresh water in the external tank. Tap water may be used
in the Aqua Stim provided that the water is not “hard water” due to excess
mineral content. Build up and / or damage from mineral deposits is not covered
under warranty. Demineralized or distilled water is always recommended and
should be used if the tap water is “hard” due to mineral content or if there is any
question in your mind about water purity. Unclip and remove the top from the
external water tank. Wash the container weekly using mild dish soap. Rinse the
tank after washing to remove soap residue. Replace cover and check tube
connections. Fill with fresh, clean water.

Aqua Stim Water Irrigator Instructions for Use - EN Page 12
3.3 Select Automatic Control of the Irrigator
If you have an Interacoustics VN415/VO425 video recording system, then you can set up the Interacoustics
software to automatically control the Aqua Stim irrigator. In the “Configure Caloric Test” menu for caloric
testing, select the stimulus tab and then select the test time in seconds.
The flow standard defines the water flow during test. The Aqua Stim follows the BSA (British Society of
Audiology) standard, which is 500ml/min (recommended time = 30 sec.). The water temperature is fixed to
30°C for cold irrigation and 44°C for warm irrigation. The irrigation time can be set between 15 and 40 seconds.

Aqua Stim Water Irrigator Instructions for Use - EN Page 13
3.4 Select the Irrigation Temperature
Select the irrigation you wish to perform from the Interacoustics software by first clicking on the caloric test
icon and then selecting the green arrow to start/stop a caloric test. From the pop-up menu
click the button for the test you would like to start and then press OK to begin the test process.
The Irrigator will be automatically initiated to the correct temperature setting (cool or warm default
temperature). A popup menu will show you the status of the irrigator preparation of the temperature.
When the irrigator reaches the correct temperature, you will hear a beep and a popup menu will appear
letting you know you can now begin testing.
You may now lift the irrigator handle and position the irrigator tip in the ear canal. Once the tip is properly
positioned and the patient has been instructed, press the start button on the irrigator handle and water will
begin to flow, and the test recording time will start. After the designated time is reached, the water flow will
stop and the recording will continue until the test completion time is reached.
Note: if you manually change the temperature on the Aqua Stim itself by depressing one of the
temperature buttons, it will not change the temperature in the Interacoustics software. If you cancel
the test at anytime the irrigator will go into rest mode until you click on the green arrow button to
start another test.
If you attempt to manually change the temperature once you have collected data you will receive an error
message warning you that the temperature change is not allowed.

Aqua Stim Water Irrigator Instructions for Use - EN Page 14
If you attempt to manually change the temperature while it is trying to reach a selected temperature, you will
get a message telling you the irrigator is idle and the irrigator will go into rest mode. The irrigator will also
show an idle state if you attempt to manually change the temperature while the software is waiting for you to
begin a current test.
If the Aqua Stim is used as a stand-alone device without Interacoustics software, press the front panel “Cool”
button to select the Cool Irrigation or press the front panel “Warm” button to select the Warm Irrigation. The
irrigator display will tell you when the irrigator is ready for you to irrigate.
Select Cool / Warm
Cool:
30°C
30s
Temp:
25.5°
250ml
3.5 Set the IrrigationTime
The Aqua Stim default irrigation time is 30 seconds. Using the Aqua Stim default flow setting (500 ml/min)
the irrigation volume is 250ml. This is indicated on the display while the temperature set point is being
reached. For the next irrigation, the duration can be reduced from 30 seconds to a minimum of 15 seconds
using the front panel up & down “TIME” push buttons. Changing the irrigation duration will also change the
irrigation volume. If you wish to change the default irrigation time please refer to the Error! Reference
source not found..
3.6 Perform the Irrigation
An audiologist or physician should inspect the patient’s ear with an otoscope
prior to testing, looking for infection, open wounds, wax impaction, or a
perforated eardrum. If any of these are observed, DO NOT use the Aqua Stim.
Prior to irrigation, the patient should be supine with their head elevated 30 degrees. The patient’s head
should be at an elevation within 12 inches / 30 cm (higher or lower) relative to the irrigator height. Irrigating
with the patient elevation too high or too low will adversely affect the irrigation flow rate.
Once the selected irrigation temperature has been reached, the Irrigator will beep and say “Ready”. The
LEDs in the handle will also light up. Place the irrigator tip gently into the external ear canal, then click the
button on the irrigator handle to begin water flow. Direct the water at the ear drum. Catch the water in an
emesis basin placed below the ear as it drains from the ear canal. After each irrigation, properly dispose of
this contaminated water.