Interacoustics Aqua Stim User manual

Instructions for Use - US
Aqua Stim
Water Irrigator
8525550 - D-0128227-A – 2020/12
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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).