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D-0128226-A – 2020/12 
Air Fx Caloric Irrigator – Instructions for Use - US 

 

Page 

21

 

 

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 

IEC / EN 60601 test 

level 

Compliance level  Electromagnetic environment – 

guidance 

 

 

 

 

Portable and mobile RF 

communications equipment 

should be used no closer to any 

parts of the 

Air Fx,

 including 

cables, than the recommended 

separation distance calculated 

from the equation applicable to 

the frequency of the transmitter.  

 

Recommended separation 

distance: 

 

Conducted RF 

3 Vrms 

3 Vrms 

P

d

2

,1

=

 

IEC / EN 61000-4-6 

 

150kHz to 80 MHz 

 

 

 

Radiated RF 

3 V/m 

3 V/m 

P

d

2

,1

=

    80 MHz to 800 MHz 

IEC / EN 61000-4-3 

80 MHz to 2,7 GHz 

 

P

d

3

,

2

=

   800 MHz to 2,7 

GHz 

 

 

 

Where 

P

 is the maximum output 

power rating of the transmitter in 

watts (W) according to the 

transmitter manufacturer and 

d

 is 

the recommended separation 

distance in 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 propagation is affected by 

absorption and reflection from structures, objects and people.  

a)

 

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and 

land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted 

theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an 

electromagnetic site survey should be considered. 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. 

 

b)

 

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.  

 

Содержание Air Fx

Страница 1: ...Instructions for Use US Air Fx Caloric Irrigator Science made smarter 8525533 D 0128226 A 2020 12...

Страница 2: ...thout 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...

Страница 3: ...re 9 3 6 Perform the irrigation 9 3 7 Safety 10 3 8 Turn off the irrigator 10 3 9 Draining the water reservoir 10 4 MAINTENANCE 12 4 1 General cleaning procedure 12 4 1 1 General Precautions 12 4 1 2...

Страница 4: ...the caloric test with the correct irrigation temperature All personnel who operate the Air Fx should familiarize themselves with the contents of this manual prior to using the Air Fx with a patient A...

Страница 5: ...C 10 Amperes Speculum 2 75 mm Speculum 4 25 mm 60cc syringe and tube USB Cable 3m 9 8ft User s Manual Drain Fill Kit Hose Management Tape 1 4 Warnings and precautions Throughout this manual the follow...

Страница 6: ...he 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 pl...

Страница 7: ...sed 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...

Страница 8: ...ons 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 compo...

Страница 9: ...ol Irrigation to be performed returns to standby state C Adjust temperature set point up 1 C D Adjust temperature set point down 1 C E Hose connection F Handle support G LCD output screen Figure 2 Rea...

Страница 10: ...e tube to the Fill Drain Water Outlet Fully push the tube into the Fill Drain Water push in connector about 1 2cm of tubing Gently pull on the tubing to confirm the tube is secure 5 Switch the Fill Dr...

Страница 11: ...urn 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 Select Cool Warm Air Fx v1 4 3 4 Attaching the s...

Страница 12: ...mperature e g 23 4 C Cool 24 C 23 4 C Irrigation will be available after the desired temperature has been reached and stabilized Once this occurs the Air Fx will emit an indicator tone and will displa...

Страница 13: ...n the irrigator and isolate the problem ambient temperature too low bubbles in the water line distilled or demineralized water level too low etc Contact Interacoustics Service Department or the local...

Страница 14: ...ube Squirt any distilled or demineralized water into a waste container Reconnect the syringe to the tube Repeat this process until all of the distilled or demineralized water is removed from the inter...

Страница 15: ...ion control The WHO s recommended level of decontamination for non critical devices is cleaning Disinfection and sterilization are not recommended However in case of an epidemic outbreak disinfection...

Страница 16: ...r Then fill the irrigator with distilled or demineralized water and run couple of cool irrigation cycles Drain the irrigator to ensure that the disinfectant is washed out Then refill the reservoir wit...

Страница 17: ...ed 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 se...

Страница 18: ...ctric and electronic waste as unsorted municipal waste Electric and electronic waste may contain hazardous substances and therefore has to be collected separately Such products will be marked with the...

Страница 19: ...D 0128226 A 2020 12 Air Fx Caloric Irrigator Instructions for Use US Page 16...

Страница 20: ...faster 3 m 9 8 ft cable Case dimensions 35W x 32D x 22H cm 13 8 x 12 6 x 8 7 in Air hose length 3 m 9 8 ft Weight 8 kg 18 lb Voltage 110 130 VAC 50 60 Hz 220 240 VAC 50 60 Hz Fuses 2 each 110VAC unit...

Страница 21: ...ons 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 includ...

Страница 22: ...omagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Air Fx can help prevent electromagnetic interferences by maintaining a minimum distance between p...

Страница 23: ...nvironment 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 Vol...

Страница 24: ...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...

Страница 25: ...s 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 treatm...

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