Interacoustics Aqua Stim User manual

Instructions for Use - US
Aqua Stim
Water Irrigator
8525550 - D-0128227-A – 2020/12
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Interacoustics A/S. The information in this document is subject to change without notice. No part of
this document may be reproduced or transmitted in any form or by any means without a prior written
permission of Interacoustics A/S.
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other countries.

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 .................................................................................................. 2
2UNPACKING AND INSTALLATION............................................................................................ 3
2.1 Unpacking and inspection................................................................................................... 3
2.2 Storage................................................................................................................................ 3
2.3 Marking ............................................................................................................................... 4
2.4 Panel connections............................................................................................................... 5
2.5 Installation ........................................................................................................................... 5
2.6 Irrigator connections ........................................................................................................... 6
2.7 Drawing water from the tank ............................................................................................... 6
3OPERATING INSTRUCTIONS .................................................................................................... 7
3.1 Using the Aqua Stim with VNG/ENG software ................................................................... 7
3.2 Turn on the irrigator ............................................................................................................ 7
3.3 Attach the hose tip .............................................................................................................. 7
3.4 Maintain water level ............................................................................................................ 7
3.5 Select the irrigation temperature......................................................................................... 8
3.6 Set the irrigation time .......................................................................................................... 8
3.7 Perform the Irrigation .......................................................................................................... 8
3.8 Turn off the irrigator ............................................................................................................ 9
3.9 Draining the internal water .................................................................................................. 9
3.10 Trouble shooting ............................................................................................................... 10
4MAINTENANCE ......................................................................................................................... 11
4.1 General cleaning procedure.............................................................................................. 11
4.1.1 General Precautions ............................................................................................... 11
4.1.2 Recommended cleaning agent and frequency....................................................... 11
4.2 After every patient use ...................................................................................................... 12
4.3 Daily ................................................................................................................................ 12
4.4 Weekly .............................................................................................................................. 12
4.5 Quarterly ........................................................................................................................... 13
4.6 Annually ............................................................................................................................ 13
4.7 Annual cleaning procedure ............................................................................................... 13
4.7.1 Tools needed .......................................................................................................... 13
4.7.2 Prepare vinegar & water solution (mineral deposit removal).................................. 13
4.7.3 Prepare irrigator for use.......................................................................................... 14
4.8 Replacing the water filters................................................................................................. 14
4.9 Warranty and service ........................................................................................................ 15
4.9.1 Product warranty..................................................................................................... 15
4.9.2 Concerning product repair / service........................................................................ 15
4.10 Component disposal ......................................................................................................... 16
4.11 Malfunction........................................................................................................................ 16
5GENERAL TECHNICAL SPECIFICATIONS............................................................................. 17
5.1 Device specifications ........................................................................................................ 17
5.2 Electromagnetic compatibility (EMC)................................................................................ 18

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1Introduction
1.1 About this manual
This manual is valid for the Aqua Stim Water Irrigator.
Manufacturer: Interacoustics A/S
Audiometer Allé 1
5500 Middelfart
Denmark
Tel. : [phone]
Fax: [phone]
E-mail: info@interacoustics. com
Web: www. interacoustics. com
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, VisualEyes 515, and
VisualEyes 525 VNG/ENG software and Micromedical Spectrum VNG via USB. When integrated with one of
the aforementioned software programs, use of the Aqua Stim irrigator will start the caloric test with the
correct irrigation temperature.
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.
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.
If service is required, please contact Interacoustics or the local Interacoustics distributor.
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.
Contraindication:
Do not perform irrigation on patients with tympanic membrane perforations.

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1.3 Product description
The Aqua Stim™ caloric irrigator is used for clinical testing of the head-motion sensors in the ear using warm
44°C or cool 30°C water delivered into the external ear canal. The Aqua Stim™ caloric irrigator has a lighted
handle to illuminate the ear. The Aqua Stim™ caloric irrigator uses an external water tank so it may be used
in offices without a sink. The Aqua Stim™ caloric irrigator can be operated as a standalone device or
communicate with a VNG/ENG system directly via USB.
NOTICE: If the irrigator system is used along with VNG/ENG software, refer to the respective software user
manual for computer specification and supported operating system related information.
The systems consist of the following included parts:
Qty
Designation
1
1
1
1
1
1
1
1
1
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 Filter Cone
1.4 Warnings and precautions
Throughout this manual the following meaning of warnings, cautions and notices are used:
The WARNING label identifies conditions or practices that may present danger
to the patient and/or user.
The CAUTION label identifies conditions or practices that could result in
damage to the equipment.
NOTICE NOTICE is used to address practices not related to personal injury.
WARNING
CAUTION

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2Unpacking and installation
2.1 Unpacking and inspection
Check for damage
When the instrument is received, ensure that you have received all the components on the shipping
checklist. All the components should be checked visually for scratches and missing parts before use. All the
contents of the shipment have to be checked for their mechanical and electrical functioning. If the equipment
is found faulty, please contact your local distributor immediately. Keep the shipping materials for the carrier’s
inspection and insurance claim.
Keep carton for future shipment
The instrument comes with shipping cartons, which are specifically designed for the components. It is
recommended to keep the cartons for future shipments in case of any need for return or service.
Reporting and returning procedure
Any missing part or malfunction or any damaged components (due to shipment) should be reported
immediately to the supplier/local distributor along with the invoice, serial number and a detailed report of the
issue. For any on-site service-related information, please contact your local distributor. If the system/
components are to be returned for service, please fill all the details related to product issues in the ‘Return
Report’, which is attached to this manual. It is very important that you describe all the known facts about the
issue in the return report, as this will help the engineer to understand and solve the problem to your
satisfaction. Your local distributor holds the responsibility for coordinating any service/return procedure and
related formalities.
2.2 Storage
Environmental conditions
The Aqua Stim is not suitable for use in the presence of flammable
anesthetic mixtures with air or oxygen or nitrous oxide as there may be an
explosion risk.
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, one 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
Transport
Temperature
20°C ~ 30°C
68°F ~ 86°F
1°C ~ 50°C
34°F ~ 122°F
-15°C ~ 50°C
5°F ~ 122°F
Relative Humidity
10% ~ 90%
10% ~ 90%
10% ~ 95%
Non-condensing
Non-condensing
Non-condensing

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The external water tank should be placed at the same level as the irrigator. 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 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:
[Esc] Name in brackets of the keyboard key to press
An applied part that includes a patient connection that is intended to deliver electrical energy
or an electrophysiological signal to or from the patient shall be a Type BF part. An EOG
amplifier is considered a Type BF part.
An applied part that includes a patient connection which can be disconnected from the patient
immediately is a Type B part. The [Subject] is a Type B part.
Refer to the Instructions for Use
Observe precautions for handling electrostatic sensitive devices
It is against the law to dispose of electronic devices in the trash. The crossed-out wheelie bin
symbol shows that the components cannot simply be tossed into the trash but must be
recycled or disposed in accordance to local environmental regulations.
Chinese RoHS compliance standard where the product contains less than the maximum
concentration value of lead, mercury, cadmium, hexavalent chromium, polybrominated
biphenyls, and polybrominated diphenyl ethers.
Electrical ground
ETL 5003648 - This device has met Electronic Testing Laboratories standards
0123
The CE-mark indicates that the manufacturer meets the requirements of Annex II of the
Medical Device Directive 93/42/EEC for the quality system.
Medical Device

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2.4 Panel connections
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 2 Rear Panel Diagram
A Exhaust fan and filter F Power Switch
B Handle electronics connector G Fuse Holder
C USB B connector H AC Power Cord Connector
D Handle Blue tube disconnect I Water Inlet Disconnect
E Handle Red tube disconnect J Water Outlet Disconnect
K Ground lug
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 a local electrician if there are questions about the capabilities of the 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.
A F C
B D E
A
B C
D
E F
G
K H
I J

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2.6 Irrigator connections
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
3½ L 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 they “snap” in.
To remove the tubes, 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 the fingers while gently pressing in on the connector until it seats and makes connection. A ground
lug is provided on the rear panel for electrical testing by BMETs. Plug in the 240 VAC power cable into the
AC power cord connector. If the Aqua Stim is used in conjunction with video nystagmography (VNG)
software then connect the USB cable to the VNG computer, otherwise leave the USB cable disconnected.
Figure 3Tubes and Electrical Connection
Figure 4External tank with pick up filter
2.7 Drawing water from the tank
The external water tank should be placed on the same table as 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. There will be 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
displayed and that the irrigator is heating to the preset 30ºC temperature.
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.
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 about water purity. The user
should follow the appropriate cleaning and disinfectant procedure (Refer section 4for
the detailed procedure for maintenance).

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3Operating instructions
3.1 Using the Aqua Stim with VNG/ENG software
The Aqua Stim water irrigator can be configured with compatible1VNG/ENG software. The caloric test
settings or system settings must be configured to communicate with the Aqua Stim irrigator. When the
caloric test is prepared, the irrigator will prepare the irrigator for a warm or cool irrigation based on the test
selected. The test will not be able to start until the irrigator has reached the desired temperature. The
VNG/ENG software will reflect the status of the irrigator as the irrigator prepares for the desired irrigation.
3.2 Turn on the irrigator
Turn on the power switch on the back panel. The Aqua Stim will initialize and go into the standby state.
Select Cool / Warm
3.3 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 tip as
shown. Confirm the silicone tube is on straight and that it tightly grips the tip.
Figure 5Place silicone tip on irrigation handle.
Figure 6Pull lightly on silicone tip to verify it is secure.
3.4 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 display “No water in
tank” if there is not enough water in the tank to perform the next irrigation.
For optimal operation, the water in the external tank should be kept up to 10°C (18°F) cooler than the
desired testing temperature. If the tank water is too warm for the 30°C irrigation, 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 the irrigator will not be used for 30 days, drain the irrigator according to section 3. 9 Draining the
internal water, then empty the external tank.
1Compatible VNG/ENG software includes Spectrum, VN415, VO425, VisualEyes 515, and VisualEyes
525.

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3.5 Select the irrigation temperature
If the Aqua Stim is used as a stand-alone device, 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
show when the irrigator is ready for irrigation.
Select Cool / Warm
Cool:
30°C
30s
Temp:
25.
5°
3.6 Set the irrigation time
The Aqua Stim default irrigation time is 30 seconds. Using the Aqua Stim default flow setting (500 ml/min)
the irrigation volume is 250ml. For the current 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.
3.7 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.
The purpose of a caloric irrigation is to cause a temperature imbalance
between the left and right ear. The irrigation of a functional ear will result in the
patient feeling like the patient is spinning for a minute or two after the irrigation
is over. This is normal. However, some motion sensitive patients may
experience nausea. The examiner should be prepared for some patients who
vomit as a result of the irrigation. Do not perform any more irrigations during
this visit if the patient vomits.
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 could adversely affect the irrigation flow rate.
NOTICE
Irrigation using the handle button is done by the “press and hold” method or the
“push and release” method. The irrigation will continue for the predefined
duration even if the button is released from “press and hold”.
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 ear canal, then click the button
on the irrigator handle to begin water flow and the VNG/ENG software will begin recording. 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.
If the irrigation needs to be suddenly aborted, remove the tip from the ear and direct flow into the emesis
basin. Press and hold the button on the irrigator handle for 2 seconds. The irrigator will beep, stop the
water flow, and display the standby idle screen.
Ten seconds after the irrigation is complete, water will be pumped from the external tank to get ready for
the next irrigation. The display will read “Filling…” during this operation.
Once the final irrigations have been completed, remove the silicone tip and clean the handle tip with Sani-
Cloth wipes.

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3.8 Turn off the irrigator
The Aqua Stim caloric irrigator will go into standby mode from the ready state after ten minutes has
elapsed or the irrigation temperature selection button is pressed twice. If the Aqua Stim is used in
conjunction with the VNG software, then the software will send the Aqua Stim into standby mode at the
end of the test. When the Aqua Stim is in the standby mode, it is safe to turn off the power switch on the
back panel.
Select Cool / Warm
3.9 Draining the internal water
The Aqua Stim holds 300 ml of water internally. Some water will remain inside the irrigator and its tubes
after irrigations. This water must be drained prior to shipment of the irrigator.
NOTICE
To remove the tubes, push on the small ring next to the tube using two finger tips and pull
gently on the tube.
1. When the irrigator is in standby mode press the Time Up/Down buttons simultaneously. This will put
the irrigator in Drain mode.
Use Handle Drain
2. Point the handle into an empty bucket (with at least 500ml capacity) and click the handle button to
initiate a flush of the internal tank.
Draining… 40s
3. At the end of the drain cycle, power off the irrigator.
Drain Complete
Turn Off Power
4. Disconnect all the tubes (red, blue, grey and white), the handle electrical connector and the USB
cable. Some water will come out of the handle tubes. Some water will come out of the Red / Grey
outlet connector. Please have a towel handy to clean up drips. Hang the handle assembly up and put
the tubes in a bucket to drain manually.
The Aqua Stim should now be drained of water and ready for shipping. Drain the external tank,
disconnect remaining tubes / cables and pack the irrigator components with proper packing material in
the provided shipping container.

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3.10 Trouble shooting
LCD Display or Problem
Observed
Cause
Solution
No Water in Tank
External water tank empty
Refill water tank with water at less
than 75°F (24°C). Check hose
connections. Select Cool / Warm to
retry operation
Fill Cool Water
Water in external tank is warmer
than the desired irrigation
temperature
Add cooler water to the external
water tank then select Cool / Warm
to retry operation
Irrig. Timeout
Irrigator left on for 10 minutes
without performing another
irrigation, will return to Standby
screen
Press Cool or Warm to initiate
irrigation procedure, otherwise none
Select Cool / Warm to retry
operation
No water comes out of the
irrigator handle after
irrigator displays “Ready”
and pressing the irrigation
button.
Possible blockage in the irrigator
handle.
Disconnect the handle from the
irrigator. Push air with a syringe into
the blue tube to flush out water and
impurities. Discard water coming out
of the red tube.
Water dribbles out of the
irrigation handle when the
irrigator is running in Cool or
Warm mode. This happens
before “Ready” state is
reached.
Fault in the electronics power
module for the handle.
Check the handle’s electrical
connector on the back panel is
properly connected.
Too Warm
Residual warm water in the
irrigator preventing reaching the
desired temperature
Stop current operation by pressing
Cool / Warm. Then retry desired
temperature Cool / Warm. Aqua Stim
will purge the internal water by filling
from the external water tank.
Handle does not light or
respond to button press.
Electrical connector not making
good contact.
Power-down irrigator then check
connections on back.
Call TechSupport
(note additional error
message)
Internal problem requiring
technical support for assistance
Call Interacoustics Technical
Support with the additional error
message on the display (e. g.
“Level Sense Error” etc).
Prior to calling Interacoustics Technical Support note the firmware version of the Aqua Stim irrigator. This
is shown on the display briefly when the Aqua Stim first starts.
Select Cool / Warm
Aqua Stim v1. 6

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4Maintenance
4.1 General cleaning procedure
4.1.1 General Precautions
•Before cleaning always switch off and disconnect from the power supply
•Do not autoclave, sterilize, or immerse the instrument or accessory in any fluid
•Do not use hard or pointed objects to clean any part of the instrument or accessory
•Do not let parts that have been in contact with fluids dry before cleaning
•Disinfectant. The use of organic solvents and aromatic oils must be avoided.
•Ensure that isopropyl alcohol does not have contact with, any screens on the instruments
•Ensure that isopropyl alcohol does not have contact with, any silicone tubes or rubber parts
•To prevent a degradation of the material by the Isopropanol it is recommended to irrigate the
water system with distilled water after disinfecting with 70-85% v/v Isopropyl alcohol.
•It is recommended that the operator use gloves during the operation of the AquaStim™ Caloric
Irrigator and the accessories. The gloves are to be changed after each patient, to minimize the
contact points and cross contamination.
•Use distilled or demineralised water if the local tap water available is of poor quality. It is also
recommended to use distilled or demineralised water if the system usage frequency is low.
This will prevent bacterial and algae growth and deposit of minerals on critical internal
components. When the Aqua Stim is not in use, the hose should be coiled using the hose
management tape.
•Single use components should be replaced after every patient use to avoid potential cross
contamination from patient to patient.
4.1.2 Recommended cleaning agent and frequency
The AquaStim™ caloric irrigator and the temperature-controlled water is intended for contact with intact
skin only. According to the Spaulding classification used by WHO1, it is therefore regarded a non-critical
low risk product in regard to contamination control. The WHO’s recommended level of decontamination
for non-critical devices is cleaning. Disinfection and sterilization are not recommended. However, in case
of an epidemic outbreak, disinfection of both the surface of the device and the entire water system can be
performed.
1. WHO "Decontamination and Reprocessing of Medical Devices for Health-care Facilities"
Cleaning Agent
The AquaStim™ Caloric Irrigator is recommended to undergo the regular cleaning procedure with
appropriate cleaning agent. The cleaning agent must be able to remove any foreign material (e. g. , soil,
organic, in-organic, and microbial contaminants) from the system. It is recommended to use nonabrasive
cleaning solution like pH neutral detergent as cleaning agent.
Disinfectant
Though the AquaStim™ Caloric Irrigator is categorized as non-critical device, it is also recommended to
disinfect the system on a regular interval with an appropriate disinfectant to reduce biofilm development.
It is recommended to use 70-85% v/v Isopropyl alcohol as disinfectant agent for the AquaStim™ Caloric
Irrigator which is also approved by WHO111as standard disinfectant agent. Isopropyl alcohol 70-85% v/v
will also have a mild effect on the materials. The user can also alternatively use chlorine solution
according to their local standards as disinfectant agent.
Frequency
The minimum requirement for cleaning and disinfection frequencies are discussed below in detail.
However, if the user can decide to improve their cleaning standards with additional cleaning/disinfection
especially during any epidemic outbreaks as per local clinic standards & requirements and WHO
recommendations.

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4.2 After every patient use
Maintain the water level in the Aqua Stim external water tank. After each examination of a patient, it
should be ensured that there is no contamination on the parts in connection with the patient.
4.3 Daily
External surface of the device which is generally used by the healthcare professional is to be cleaned
daily with recommended cleaning solution (refer section 4. 1. 2).
Cleaning procedure: Wipe off the external surface with a disposable, clean, non-linting cloth which is
damped in the cleaning solution until all visible soil is removed. Ensure that moisture doen’t enter the
critical areas of device. Cleaning solution should be changed at each cleaning session and when visibly
soiled.
4.4 Weekly
Internal & external water tube system, external water tank, pickup filter in the external water tank and in-
line filter shall be disinfected every week.
The user shall choose Isopropyl alcohol (70-80% v/v) or chlorine solution to disinfect the system. The
instructions for disinfection procedure are discussed below.
Disinfection with Isopropyl alcohol (70-80% v/v):
Before starting the disinfection procedure, the user should drain the irrigator by pressing the two buttons
on the right side of the irrigator display. Clean the external water tank with dish soap and warm water
before you start the disinfection procedure. Then fill the external water tank with 600 ml of Isopropyl
alcohol (70-80% v/v). Run one complete cycle of cool irrigation. Then drain the irrigator appropriately.
Discard the excess solution carefully in the sink from the external water tank.
Clean the external water tank again with dish soap and warm water. Also, rinse external water tank with
distilled water to remove alcohol residues. Refill the external water tank with 600 ml of distilled water and
run couple of cool irrigation cycles to rinse off the alcohol residues from the system.
As a final step, check both the external pickup and in-line filters for any visual debris, if no debris seen
you can continue using the filters for the normal use. If you see any debris, the filter to be replaced
appropriately. Refer section 4. 8 for filter replacement procedure.
Disinfection with Chlorine solution:
Interacoustics recommends using appropriate safety precautions such as
protective goggles, apron, and gloves when working with chlorine. Leaving the
chlorine solution in the irrigator for longer than 4 hours could cause permanent
damage to irrigator components.
Clean the external water tank with dish soap and warm water before you start the disinfection procedure.
Then fill the external water tank with 60 ml of chlorine solution make up the volume with water to 2 L. Run
three consecutive cool irrigation cycles. Drain the irrigator appropriately. Discard the excess solution
carefully in the sink from the external water tank.
Clean the external water tank again with dish soap and warm water. Also, rinse external water tank with
distilled water to remove disinfectant residues. Refill the external water tank with 900 ml of distilled water
and document the water pH in the external tank. Run three cool irrigation cycles to rinse off the chlorine
residues from the system. At the end of 3rd irrigation cycle, check the pH level of irrigated water. If the pH
level of irrigated water doesn’t match with the water pH in the external tank, repeat the cool irrigation
cycle until the target water pH is achieved.

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As a final step, check the both external pickup and in-line filters for any visual debris, if no debris seen
you can continue using the filters for the normal use. If you see any debris, the filter to be replaced
appropriately. Refer section 4. 8 for filter replacement procedure.
4.5 Quarterly
Verification of the irrigation flow rate can be performed by the clinician with the use of a graduated
cylinder of 500ml capacity with 5ml marks. The clinician should perform a cool irrigation and measure the
output water amount. If the volume of water is in excess of 265ml, then contact Interacoustics for irrigator
calibration.
If the volume is less than 235ml, then disconnect the water filter assembly from the handle and connect
the handle’s red tube directly to the irrigator bypassing the water filter assembly entirely. Perform a cool
irrigation and measure the output water amount. If the volume is 250ml, then follow the instructions in 4.
9 Replacing the water filters section. If the volume is still low, then contact Interacoustics for further
troubleshooting.
4.6 Annually
Replace the cone filter /in-line filter in the internal water tube system every year as a part of maintenance.
And, clean out or replace the pick-up filter in the external water tank. The irrigator system is to be cleaned
with acetic acid every year as a part of demineralization procedure (mineral deposit removal).
Laboratory verification of the irrigation temperatures and flow rates should be performed annually by a
trained service technician. If the irrigator fails temperature or flow rate verification, contact Interacoustics
to send back the irrigator for factory calibration. Note: the irrigator must be drained of water prior to
shipment.
4.7 Annual cleaning procedure
Leaving acetic acid & water solution in the irrigator for longer than 4 hours
could cause permanent damage to irrigator components.
4.7.1 Tools needed
Measuring container, pH strips, 5% acetic acid, graduated cylinder and two in-line filter cones, protective
goggles, rubber gloves, and protective apron.
4.7.2 Prepare vinegar & water solution (mineral deposit removal)
Clean the external water tank with dish soap and warm water before you start the demineralization
procedure.
Fill the external water tank with 2 liters of water and add 8tsp (40ml) 5% acetic acid. Stir the solution
gently. The acetic acid solution is used to remove mineral deposits which is detected by looking at the
blue tube and seeing the blue tube opaque or filled with small particulate. Start cool irrigation cycle and
this will draw and circulate the solution into the internal tank. Wait until the cycle is completed which will
take approximately 10 minutes. After 10 minutes of holding the solution inside the system, drain the
irrigator appropriately. Discard the excess solution carefully in the sink from the external water tank.
Clean the external water tank again with dish soap and warm water. Also, rinse external water tank with
distilled water to remove vinegar residues. Refill the external water tank with 600 mL of distilled water and
document the water pH in the external tank. Run three cool irrigation cycles to rinse off the chlorine
residues from the system. At the end of 3rd irrigation cycle, check the pH level of irrigated water. If the pH
level of irrigated water doesn’t match with the water pH in the external tank, repeat the cool irrigation
cycle until the target water pH is achieved.

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4.7.3 Prepare irrigator for use
1. Drain the irrigator by pushing the Time Up/Down arrows and following instructions on the irrigator.
2. Remove handle and drain water from the handle.
3. Inspect filter on the red tube of the handle assembly. Replace the cone insert if dirty.
4. Fill the external water tank with fresh water.
4.8 Replacing the water filters
This pick-up filter can be rinsed off if it gets clogged. However, if the filter needs replaced, it
can be pulled off the end of the clear intake tube inside the external tank.
If the water filter assembly is not damaged, then the water filter assembly can be
disconnected from the red tube and the filter cone replaced. To remove the tubes, push on the small ring
next to the tube using two finger tips and pull gently on the tube. The caps can be removed with a 9/16”
socket wrench or crescent wrench. The water filter assembly should have an arrow sticker that shows the
direction of the water flow – the water will flow from the tapered end of the filter to the larger end for
maximum filtration. Use the wrench to open the side where the arrow points. The filter can be removed
with a tap of the filter assembly against the table.
After replacing the filter, close the water filter
assembly and tighten just past finger tight using
the socket wrench or crescent wrench. Check
direction of the filter cone in the water filter
assembly. The tapered end should point towards
the irrigator as water is pushed into this tube from
the irrigator. Add the new water filter assembly to
the Red line. Trim the red tube on filter assembly
to the same length as the blue tube before
connecting to the irrigator.

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4.9 Warranty and service
4.9.1 Product warranty
Interacoustics warrants that:
•The AquaStim™ system is free from defects in material and workmanship under normal use and
service for a period of 12 months from the date of delivery by Interacoustics to the first
purchaser
•Accessories are free from defects in material and workmanship under normal use and service for
a period of ninety (90) days from the date of delivery by Interacoustics to the first purchaser
If any component requires service during the applicable warranty period, the purchaser should
communicate directly to the local distributor to determine the appropriate repair facility. Repair or
replacement will be carried out at Interacoustics’ expense, subject to the terms of this warranty. The
product requiring service should be returned promptly with proper packing, and postage prepaid. Loss or
damage in return shipment to Interacoustics shall be at purchaser's risk. In no event shall Interacoustics
be liable for any incidental, indirect or consequential damages in connection with the purchase or use of
any Interacoustics product. This shall apply solely to the original purchaser.
This warranty shall not apply to any subsequent owner or holder of the product. Furthermore, this
warranty shall not apply to, and Interacoustics shall not be responsible for, any loss arising in connection
with the purchase or use of any Interacoustics product that has been:
•repaired by anyone other than an authorized Interacoustics service representative;
•altered in any way so as, in Interacoustics judgement, to affect its stability or reliability;
•subject to misuse or negligence or accident, or which has had the serial or lot number altered,
effaced or removed; or
•improperly maintained or used in any manner other than in accordance with the instructions
furnished by Interacoustics.
This warranty is in lieu of all other warranties, express or implied, and of all other obligations or liabilities
of Interacoustics. Directly or indirectly, Interacoustics does not give/grant the authority to any
representative or other person to assume on behalf of Interacoustics for any other liability in connection
with the sale of Interacoustics products.
INTERACOUSTICS DISCLAIMS ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING
ANY WARRANTY OF MERCHANTABILITY OR FOR FUNCTION OF FITNESS FOR A PARTICULAR
PURPOSE OR APPLICATION.
4.9.2 Concerning product repair / service
Interacoustics is responsible for the validity of the CE marking, effects on safety, reliability and
performance of the equipment if:
• Assembly operations, extensions, readjustments, modifications or repairs are carried out by
authorized persons
• A 1-year service interval is maintained
• The electrical installation of the relevant room complies with the appropriate requirements, and
• The equipment is used by authorized personnel in accordance with the documentation supplied
by Interacoustics
The customer shall reach out to the local distributor to determine the service/repair possibilities including
onsite service/repair. It is important that the customer (through local distributor) fills out the RETURN
REPORT every time when the component/product is sent for service/repair to Interacoustics.

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4.10 Component disposal
NOTICE
In case of a conflict, all information contained herein is superseded by
National, State or Local regulations. If there is any question, contact the local
area authorities for compliance.
Hazardous material
There are no hazardous materials in the system.
Packing material
If storage space allows, packing material for the irrigator should be retained. This original packing
material affords the maximum protection in case any of these items must be returned for service. All
cardboard or paper should be recycled with a local disposal company if possible. If storage space for the
foam packaging material is not available, visit the Alliance of Foam Packaging Recyclers website,
http://www. epspackaging. org/, for suggestions and locations for recycling.
Electronic parts
Some electronic parts can be recycled. The following web site lists the states within the USA and
identifies their programs: http://www. nrc-recycle. org/resources/electronics/policy. htm.
Disposal of product
4.11 Malfunction
In the event of a product malfunction, it is important to protect patients, users, and other persons against
harm. Therefore, if the product has caused, or potentially could cause such harm, it must be quarantined
immediately.
Both harmful and harmless malfunctions, related to the product itself or to its use, must immediately be
reported to the distributor where the product was acquired. Please remember to include as many details
as possible e. g. the type of harm, serial number of the product, software version, connected accessories
and any other relevant information.
In case of death or serious incident in relation to the use of the device, the incident must immediately be
reported to Interacoustics and the local national competent authority.
It is against the law to dispose of electronic devices in the trash. The crossed-out wheelie
bin symbol appears on the irrigator showing that the components cannot simply be tossed
into the trash. Those electronic devices must be recycled or disposed in accordance to
local environmental regulations.