Interacoustics Aqua Stim Instructions For Use Manual Download Page 19

 

 

 

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

 

Page 

15

 

 

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. 

 

 

 

 

 

 

 

Summary of Contents for Aqua Stim

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

Page 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 ...

Page 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...

Page 4: ......

Page 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...

Page 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 ...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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 ...

Page 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...

Page 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...

Page 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...

Page 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 ...

Page 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 ...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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 ...

Page 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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Page 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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