Interacoustics Aqua Stim Instructions For Use Manual
Water irrigator
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Summary of Contents for Interacoustics Aqua Stim
- Page 1 Science made smarter Instructions for Use - US Aqua Stim Water Irrigator...
- Page 2 Copyright © Interacoustics A/S All rights reserved. Information in this document is proprietary to 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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Page 3: Table Of Contents
Irrigator connections ......................6 Drawing water from the tank ....................6 OPERATING INSTRUCTIONS ....................7 Using the Aqua Stim with VNG/ENG software ..............7 Turn on the irrigator ......................7 Attach the hose tip ......................7 Maintain water level ......................7 Select the irrigation temperature .................. -
Page 5: Introduction
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. -
Page 6: Product Description
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. -
Page 7: Unpacking And Installation
(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. -
Page 8: Marking
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. 0123 Medical Device D-0128227-A – 2020/12 Aqua Stim Water Irrigator – Instructions for Use - US Page 4... -
Page 9: Panel Connections
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. -
Page 10: Irrigator Connections
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. -
Page 11: Operating Instructions
VNG/ENG software will reflect the status of the irrigator as the irrigator prepares for the desired irrigation. 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 Attach the hose tip Use Interacoustics provided soft silicone hose tips placed on the end of the delivery handle. -
Page 12: Select The Irrigation Temperature
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. -
Page 13: Turn Off The Irrigator
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. -
Page 14: Trouble Shooting
(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. -
Page 15: Maintenance
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. -
Page 16: After Every Patient Use
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. -
Page 17: 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. -
Page 18: Prepare Irrigator For Use
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. D-0128227-A – 2020/12 Aqua Stim Water Irrigator – Instructions for Use - US Page 14... -
Page 19: Warranty And Service
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... -
Page 20: Component Disposal
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. D-0128227-A – 2020/12 Aqua Stim Water Irrigator – Instructions for Use - US Page 16... -
Page 21: General Technical Specifications
220 - 240VAC: 2x T4AH 250V Fuses Internal Fuse: 220 – 240VAC: T2. 5AL 250V The CE-mark indicates that Interacoustics A/S meets the requirements of Annex II of the Medical Device Directive 93/42/EEC. Approval of the quality system is made by TÜV – identification no0123 The DEVICE is an active, diagnostic medical product according to the class IIa of the EU medical directive 93/42/EEC. -
Page 22: Electromagnetic Compatibility (Emc)
Conformance to the EMC requirements as specified in IEC 60601-1-2 is ensured if the cable types and cable lengths are as specified below: Description Length (meters) Screened (Yes/No) Power leads <3 <3 D-0128227-A – 2020/12 Aqua Stim Water Irrigator – Instructions for Use - US Page 18... - Page 23 Note 1 At 80 MHz and 800 MHZ, the higher frequency range applies. Note 2 These guidelines may not apply to all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. D-0128227-A – 2020/12 Aqua Stim Water Irrigator – Instructions for Use - US Page 19...
- Page 24 IEC 61000-4-8 environment. Note: UT is the A. C. mains voltage prior to application of the test level. D-0128227-A – 2020/12 Aqua Stim Water Irrigator – Instructions for Use - US Page 20...
- Page 25 AquaStim. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. D-0128227-A – 2020/12 Aqua Stim Water Irrigator – Instructions for Use - US Page 21...
- Page 27 Other : Date : Person : Please provide e-mail address or fax No. to whom Interacoustics may confirm reception of the returned goods: The above mentioned item is reported to be dangerous to patient or user In order to ensure instant and effective treatment of returned goods, it is important that this form is filled in and placed together with the item.