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Summary of Contents for Interacoustics Air Fx
- Page 1 Science made smarter Instructions for Use - US Air Fx Caloric 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
Preparing the irrigator for first use..................7 OPERATING INSTRUCTIONS ....................8 Maintain distilled water level ....................8 Using the Air Fx with VNG/ENG software ................8 Turn on the irrigator ......................8 Attaching the speculum ....................... 8 Select the irrigation temperature ..................9 Perform the irrigation ...................... -
Page 4: Introduction
1.2 Intended use The Air Fx air irrigator dispenses cool or warm air to perform caloric tests for vestibular diagnosis. The Air Fx requires the operator to aim the air stream at the tympanic membrane through the patient’s ear canal, creating a differential in ear temperatures and resulting in the patient’s eyes displaying nystagmus. -
Page 5: Product Description
1.3 Product description The Air Fx air irrigator dispenses cool or warm air to perform caloric tests for vestibular diagnosis. The systems consist of the following included and optional parts: Designation Included parts: Air Fx Power cord IEC 10 Amperes 1 pack Speculum Ø... -
Page 6: Unpacking And Installation
IPX0 rating for degree of protection against the ingress of water (i. e. the system can be damaged if any water is spilled on the electronic equipment) To avoid the risk of electrical shock, the Air Fx must only be connected to a supply main with protective earth. - Page 7 Non-condensing Non-condensing Non-condensing If the Air Fx is stored in near freezing conditions, allow time to thaw the unit prior to using with patients. To prevent condensation in the device, operate at temperature and humidity below the graphed line. %RH vs. Temp °F...
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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-0128226-A – 2020/12 Air Fx Caloric Irrigator – Instructions for Use - US Page 5... -
Page 9: Panel Connections
Exhaust fan Serial Number Air Inlet Filter Fuses USB B Connector Ground Screw Power Switch AC Input Fill / Drain Valve Fill / Drain Water Outlet D-0128226-A – 2020/12 Air Fx Caloric Irrigator – Instructions for Use - US Page 6... -
Page 10: Preparing The Irrigator For First Use
2.5 Preparing the irrigator for first use The Air Fx is ventilated by a fan at the back of the device. Do not place the Air Fx near a radiator or other heating source. Provide at least 10 cm (4 in) of free space behind the unit to provide adequate circulation. -
Page 11: Operating Instructions
3.3 Turn on the irrigator Turn on the power switch on the back panel. The Air Fx will initialize, show the firmware version, and then go into the standby state. -
Page 12: Select The Irrigation Temperature
3.5 Select the irrigation temperature If the Air Fx is used as a standalone device, press the Cool or Warm button on the front panel to select the irrigation temperature. If the Air Fx is connected to a VNG/ENG system with compatible software, then the software will select the irrigation temperature based on the test or system settings. -
Page 13: Safety
Set the Air Fx irrigator near the edge of the table or cart in order for the hose to hang down, allowing the handle to rest properly in its cradle. When the irrigator is not in use, coil the Air Fx handle tubing using the hose management tape while still allowing the handle to be secured in the cradle. - Page 14 7. Disconnect the syringe and tubing. The tubing can be removed by pushing in the gray gasket around the tubing with one’s finger nails while pulling on the tubing to remove. 8. Replace the cap back on the water reservoir. D-0128226-A – 2020/12 Air Fx Caloric Irrigator – Instructions for Use - US Page 11...
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Page 15: Maintenance
70-85% v/v Isopropyl alcohol. • It is recommended that the operator use gloves during the operation of the Air Fx Caloric Irrigator and the accessories. The gloves are to be changed after each patient, to minimize the contact points and cross contamination. -
Page 16: Daily
Water filter cleaning The Air Fx caloric irrigator uses an inline water filter to collect debris. The water filter cone should be replaced once a year by a qualified service technician. Refer to the section 4. 6 Replacing the Water Filter. -
Page 17: Warranty And Service
4.7.1 Product warranty Interacoustics warrants that: • The Air Fx 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 •... -
Page 18: 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-0128226-A – 2020/12 Air Fx Caloric Irrigator – Instructions for Use - US Page 15... - Page 19 D-0128226-A – 2020/12 Air Fx Caloric Irrigator – Instructions for Use - US Page 16...
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Page 20: General Technical Specifications
220VAC units: T1AL 250V Power consumed: 105VA 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 21: Emc Compliance
5.2 EMC compliance This section is valid for the Air Fx system including all variants. This equipment is suitable in hospital and clinical environments except for near-active HF surgical equipment and RF-shielded rooms of systems for magnetic resonance imaging, where the intensity of electromagnetic disturbance is high. - Page 22 Guidance and manufacturer’s declaration - electromagnetic emissions The Air Fx is intended for use in the electromagnetic environment specified below. The customer or the user of the Air Fx should assure that it is used in such an environment. Emissions Test...
- Page 23 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The Air Fx is intended for use in the electromagnetic environment specified below. The customer or the user of the Air Fx should assure that it is used in such an environment. Immunity Test...
- Page 24 If the measured field strength in the location in which the Air Fx is used exceeds the applicable RF compliance level above, the Air Fx should be observed to verify normal operation, If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Air Fx.
- Page 25 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.
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