natus ICS Aircal User Manual Download Page 31

31 

ICS Aircal  

Notes on EMC (Electromagnetic Compatibility) 

 

 

10

 

Notes on EMC (Electromagnetic Compatibility) 

 

The ICS Aircal device is part of a medical electrical system and is thus subject to special safety precautions. For this 

reason, the installation and operating instructions provided in this document should be followed closely. 

 

Portable and mobile high-frequency communication devices, such as mobile phones, may interfere with the 

functioning of the ICS Aircal device. 

IEC 60601-1:2012 and IEC 60601-1-2:2014 

Guidance and manufacturer's declaration - electromagnetic emissions for all equipment and systems 

The ICS Aircal device is intended for use in the electromagnetic environment specified below. The user of the ICS Aircal device should ensure that it is 

used in such an environment. 

Emissions test 

Compliance 

Electromagnetic environment - guidance 

RF emissions CISPR11 

Group 1 

The ICS Aircal device uses RF energy only for its internal function. Therefore, its RF 

emissions are very low and are not likely to cause any interference in nearby electronic 

equipment. 

RF emissions CISPR11 

Class A 

The ICS Aircal device is suitable for use in hospital and clinic environments. 
The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas 

and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 

11 class B is normally required), this equipment might not offer adequate protection to 

radio-frequency communication services. The user might need to take mitigation 

measures, such as relocating or re-orienting the equipment. 

Harmonic emissions IEC 

61000-3-2 

Complies 

Voltage fluctuations/flicker 

emissions IEC 61000-3-3 

Complies 

 

Guidance and manufacturer's declaration - electromagnetic immunity for all equipment and systems 

The ICS Aircal device is intended for use in the electromagnetic environment specified below. The user of the ICS Aircal device should ensure that it is 

used in such an environment. 

Immunity test 

IEC 60601 test level 

Compliance level 

Electromagnetic environment - guidance 

Electrostatic discharge 

(ESD)  
IEC 61000-4-2 

+/- 8 kV contact 
+/- 2 kV, +/- 4 kV, 
+/- 8 kV, +/- 15 kV air 

+/- 8 kV contact 
+/- 2 kV, +/- 4 kV, 
+/- 8 kV, +/- 15 kV air 

Floors should be wood, concrete or ceramic tile. If 

floors are covered with synthetic material, the 

relative humidity should be at least 30%. 

Electrical fast 

transient/burst  
IEC 61000-4-4 

+/- 2 kV for power supply lines 
+/- 1 kV for input/output lines 

+/- 2 kV for power supply lines 
+/- 1 kV for input/output lines 

Mains power quality should be that of a typical 

commercial or hospital environment. 

Surge 
IEC 61000-4-5 

+/- 1 kV line(s) to line(s) 
+/- 2 kV line(s) to earth 
+/- 2 kV I/O line(s) to earth 

+/- 1 kV line(s) to line(s) 
+/- 2 kV line(s) to earth 
+/- 2 kV I/O line(s) to earth 

Mains power quality should be that of a typical 

commercial or hospital environment. 

Voltage dips, short 

interruptions and voltage 

variations on power supply 

input lines IEC 61000-4-11 

0% U

T

; 0.5 cycle 

At 0°, 45°, 90°, 135°, 180°, 225°, 

270° and 315° 
0% U

T

; 1 cycle  

and  
70% U

T

; 25/30 cycles 

Single phase: at 0° 

0% U

T

; 0.5 cycle 

At 0°, 45°, 90°, 135°, 180°, 225°, 

270° and 315° 
0% U

T

; 1 cycle 

and 
70% U

T

; 25/30 cycles 

Single phase: at 0° 

Mains power quality should be that of a typical 

commercial or hospital environment. If the user of 

the ICS Aircal device requires continued operation 

during power mains interruptions, it is 

recommended that the ICS Aircal device be powered 

from an uninterruptible power supply or a battery. 

Voltage interruptions on 

power supply input lines 
IEC 61000-4-11 

0 % U

T

; 250/300 cycles 

0 % U

T

; 250/300 cycles 

Power frequency  
(50/60 Hz) magnetic field 
IEC 61000-4-8 

30 A/m 

No relevant ports that could be 

affected 

Power frequency magnetic fields should be at levels 

characteristic of a typical location in a typical 

commercial or hospital environment. 

U

T

 is the AC mains voltage prior to application of the test level. 

 

Summary of Contents for ICS Aircal

Page 1: ...ICS Aircal Air Caloric Irrigator User Guide Doc No 7 50 1240 EN 07 Part No 7 50 12400 EN...

Page 2: ...ark ApS All rights reserved Natus the NatusIcon ICS Aircal ICS Chartr and HORTMANN areregistered trademarksof Natus Medical Denmark ApS in theU S A and or other countries Versionrelease date 2021 11 1...

Page 3: ...al device on off 13 3 2 Standby Operation mode 13 3 3 Temperature 14 3 3 1 Recommended and default temperature 14 3 3 2 Setting a new temperature 14 3 3 3 Switching between cool and warm temperature 1...

Page 4: ...4 6 2 2 Cautions 25 6 2 3 Notes 25 6 3 Manufacturer 25 6 3 1 Responsibility of the Manufacturer 26 6 3 2 Instructions to access the eIFU 26 7 Service cleaning andmaintenance 26 7 1 Service 26 7 2 Clea...

Page 5: ...th prior knowledge of the medical and scientific facts underlying theprocedure The ICS Aircal system is intended for patients of all ages who can tolerate testing 1 3 Clinical benefits The caloric tes...

Page 6: ...eused at anyconvenientlevel such as on a table orcart TheICS Aircal device can be stacked with the ICS Chartr 200 VNG ENG hardware Itis bestif the ICS Aircal device is on top so that water can be refi...

Page 7: ...ead determine how itshould be mounted The cradle can be mounted on the left or right side of the unit For units that are placed away from the edge of the table it is recommended that the cradle is mou...

Page 8: ...that holds the bottom of the delivery head facing the front of the unit Slide the cradle onto the bracket in the horizontal position For units placed at the edge of the table tilt the bracket forward...

Page 9: ...e Mains power cable The ICS Aircal device should beconnected to an electrical wall outlet by attaching the power cable to the ICS Aircal device and plugging the cable into the electrical wall outlet A...

Page 10: ...from the electrical wall outlet when filling or refilling the water reservoir Note Use this procedure 1 If the ICS Aircal device was just received from shipping and is dry It must be filled and primed...

Page 11: ...anyexcess water that mighthave spilled into thesmall indentions where the internal cover is placed Replacethe internal cover Priming Plug thepowercableofthe device into the electrical wall outlet and...

Page 12: ...e The tube will be facing toward the front of the irrigator Whilepressing the priming switch inject the water into theinlet Release the priming switch Press the priming switch to turn on and hold 5 se...

Page 13: ...rnal cover and remove Using the syringe kit provided remove the water from the reservoir Replace both covers after the water is removed 3 ICS Aircal Front Panel This section describes all operational...

Page 14: ...ture cool or warm can be stored The default is cool See Changing the Stored Default Values Temperature selection will beindicated on the display panel If theICS Aircal deviceis in operation mode only...

Page 15: ...a beep that you want as the default There are four levels for the beep volume To change the default value of the beep volume seeChanging the Stored Default Values 3 7 Changing the Stored Default Valu...

Page 16: ...held in any way that is comfortablefor the tester Flow timeactivation is accomplished by an activation trigger located on the delivery head The otoscopelight can be turned on and off using the button...

Page 17: ...n lens out and slide the new lens into place See Accessories 30 for an Accessories list 4 1 3 Light on off button The lightshould be turned on during irrigation to view the tympanic membrane the eardr...

Page 18: ...software Subsequent depressions will center the tracing ENG VNG or start the video recording VNG only If thecomputer is turned on butthe Natus VNG ENG software is notrunning flow time may beactivated...

Page 19: ...Aircal deviceis connected to an ICS VNG ENG system subsequent depressions of theflow time activation switch will center the tracing for VNG ENG or start the video recording for VNG If installed thefoo...

Page 20: ...be discarded together with unseparated waste but must be collected separately ISO 15223 1 2016 Reference no 5 1 1 ISO 7000 3082 Medical devices Symbols to be used with medical device labels labeling...

Page 21: ...r to consult the instructions for use IEC 60601 1 Reference no Table D 2 Safety sign 10 ISO 7010 M002 Medical electrical equipment Part 1 General requirements for basic safety and essential performanc...

Page 22: ...nce no 5 3 9 ISO 7000 2621 Medical devices Symbols to be used with medical device labels labeling and information to be supplied Atmospheric pressure limitation To indicate the acceptable upper and lo...

Page 23: ...r used for firmware upgrades and future development N A N A Priming switch Located on Back Panel Priming Switch for Water Reservoir 6 2 General warnings cautions and notes Natus Medical Denmark ApS IC...

Page 24: ...nce by maintaining a minimum distance between portable and mobile RF communications equipment The ICS Aircal device must be installed and put into service according to the EMC information provided in...

Page 25: ...ons Do not clean or reuse the speculum Do not stare into the light beam or point the light beam in the direction of other people s eyes It can damage them Note The following conditions or practices re...

Page 26: ...ions to use The files can be printed saved or searched using Adobe Reader A copy of Adobe Reader can be downloaded directly from Adobe Systems www adobe com 7 Service cleaning and maintenance 7 1 Serv...

Page 27: ...EEE is not handled correctly Therefore end users also have a role to play in ensuring that WEEE is reused and recycled safely Users of electrical and electronic equipment must not discard WEEE togethe...

Page 28: ...Complies with IEC 60601 1 2005 AMD1 2012 IEC 60601 1 6 2010 AMD1 2013 ANSI AAMI ES60601 1 2005 A1 2012 CAN CSA C22 2 No 60601 1 14 CAN CSA C22 2 No 60601 1 6 11 R16 EMC IEC 60601 1 2 2014 Performance...

Page 29: ...nches Weight With empty reservoir 7 9 kg 17 5 lbs With full reservoir 8 2 kg 18 lbs Power supply Input voltage 100 240 VAC 50 60 Hz Power consumption 192 VA Fuse T 1 6H 250V Applied part The applied p...

Page 30: ...66100 Cradle kit for delivery head 8 62 46200 7 pin mini DIN cable ICS Chartr 200 Hortmann Vestlab 8 71 90400 9 pin subminiature to 7 pin mini DIN ICS Chartr XP 8 71 90300 Foot switch 8 35 39700 Power...

Page 31: ...s intended for use in the electromagnetic environment specified below The user of the ICS Aircal device should ensure that it is used in such an environment Immunity test IEC 60601 test level Complian...

Page 32: ...V m 810 MHz 870 MHz 930 MHz 28 V m 1720 MHz 1845 MHz 1970 MHz 28 V m 1720 MHz 1845 MHz 1970 MHz 28 V m 2450 MHz 28 V m 2450 MHz 9 V m 5240 MHz 5500 MHz 5785 MHz 9 V m 5240 MHz 5500 MHz 5785 MHz Note...

Page 33: ...elines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people IEC 60601 1 2 2007 and EN 60601 1 2 2007 Guidance and man...

Page 34: ...ge IEC 61000 4 5 1 kV line s to line s 2 kV line s to earth 1 kV line s to line s 2 kV line s to earth Mains power quality should be that of a typical commercial or hospital environment Voltage dips s...

Page 35: ...tance for 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 pe...

Page 36: ...maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 2 80 MHz to 800 MHz d 1 2 800 MHz to 2 5 GHz d 2 3 0 01 0 12 0 12 0 23 0 1 0 38...

Page 37: ...port and report that the ICS AirCal is not performing as expected Water Removal Procedure 1 Turn the ICS AirCal off and unplug the ICS AirCal from the electrical wall outlet 2 Wipe off any dust on the...

Page 38: ...t pen press and hold thefirmware mode button while turning on the ICS Aircal Hold for 3 seconds the display will be blank Double click the AircalFirmwareUpdate exe file to run the update program Click...

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