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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.

FireWire® is a registered trademark of Apple Inc., registered in the United States and other countries.

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other countries.

Содержание Aqua Stim

Страница 1: ...Instructions for Use US Aqua Stim Water Irrigator 8525550 D 0128227 A 2020 12 Science made smarter ...

Страница 2: ...ithout 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 FireWire is a registered trademark of Apple Inc registered in the United States and other countries Windows is a registered trademark of the Microsoft Corporation registered in the United States and other countries ...

Страница 3: ...m the Irrigation 8 3 8 Turn off the irrigator 9 3 9 Draining the internal water 9 3 10 Trouble shooting 10 4 MAINTENANCE 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 vin...

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Страница 5: ... 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 representa...

Страница 6: ...long 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 ...

Страница 7: ...urn 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 expl...

Страница 8: ...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...

Страница 9: ...er 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 i...

Страница 10: ...ct the USB cable to the VNG computer otherwise leave the USB cable disconnected Figure 3 Tubes and Electrical Connection Figure 4 External 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 ir...

Страница 11: ...ts 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 5 Place silicone tip on irrigation handle Figure 6 Pull lightly on silicone tip to verify it is secure 3 4 Maintain water level As a good practice verify the ext...

Страница 12: ...rigation 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 ...

Страница 13: ... 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...

Страница 14: ...d 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 desir...

Страница 15: ...e 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 Howeve...

Страница 16: ...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 ...

Страница 17: ...erification 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 ...

Страница 18: ...e 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 t...

Страница 19: ...rized 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 a...

Страница 20: ...nd 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 pro...

Страница 21: ...6 d x 8 7 h in Water hose detachable 3m 9 8ft length with a rubber protective cover Weight of hose and handle 0 9 kg 2 lbs Weight of cabinet drained 5 4 kg 11 9 lbs Voltage 110 130 VAC or 220 240 VAC Power 600 watts External Fuse size 110 130VAC 2x T8AH 250V Fuses 220 240VAC 2x T4AH 250V Fuses Internal Fuse 220 240VAC T2 5AL 250V The CE mark indicates that Interacoustics A S meets the requirements...

Страница 22: ...netic emissions or decreased electromagnetic immunity of this equipment and result in improper operation The list of accessories and cables can be found in this section Portable RF communications equipment including peripherals such as antenna cables and external antennas should be used no closer than 30 cm 12 inches to any part of this equipment including cables specified by the manufacturer Othe...

Страница 23: ...romagnetic environment in which radiated RF disturbances are controlled The customer or the user of the AquaStim can help prevent electromagnetic interferences by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the AquaStim as recommended below according to the maximum output power of the communications equipment Rated Maximum output power of...

Страница 24: ...environment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or residential environment Voltage dips short interruptions and voltage variations on power supply lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip ...

Страница 25: ...n meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol NOTE1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagati...

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Страница 27: ...rformed local repair Returned according to agreement with Interacoustics 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 1 In order to ensure instant and effective treatment of returned goods it is important that this form is filled in and placed toge...

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