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ICS Aircal

ICS Aircal system safety

Symbol

Standard

Reference

Standard Title of Symbol

Symbol Title

as per

Referenced

Standard

Explanation

ISO 15223-

1:2016

Reference no.

5.1.7. (ISO

7000-2498)

Medical devices — Symbols

to be used with medical

device labels, labeling, and

information to be supplied –

Part 1: General

requirements.

Serial number

Indicates the

manufacturer's serial

number so that a specific

medical device can be

identified.

UL Listing

N/A

Nationally Recognized

Testing Laboratories (NRTL)

certifications.

IEC 60601-1,

Reference no.

Table D.2,

Symbol 20 (ICE

60417-5333)

Medical electrical equipment

— Part 1: General

requirements for basic safety

and essential performance

Type BF applied

part

To identify a type BF

applied part complying

with, IEC 60601-1.

ISO 15223-

1:2016

Reference no.

5.4.3. (ISO

7000-1641)

Medical devices – Symbols to

be used with medical device

labels, labeling, and

information to be supplied.

Consult

Instructions for

Use

Indicates the need for the

user 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 performance.

Instructions for

Use

Refer to instruction

manual/Booklet.
NOTE on ME EQUIPMENT
“Follow Instructions for

use”.

ISO 15223-1,

Clause 5.4.4

ISO 60601-1

Table D.1

symbol 10

Medical devices — Symbols

to be used with medical

device labels, labeling and

information to be supplied.
Medical electrical equipment

— Part 1: General

requirements for basic safety

and essential performance.

Caution

Indicates the need for the

user to consult the

instructions for use for

important cautionary

information such as

warnings and precautions

that cannot, for a variety of

reasons, be presented on

the medical device itself.

IEC 60601-1,

Table D.2

symbol 2

Medical electrical equipment

— Part 1: General

requirements for basic safety

and Essential performance.

General

warning sign

Indicates the need for the

user to consult the

instructions for use for

important cautionary

information such as

warnings and precautions

that cannot, for a variety of

reasons, be presented on

the medical device itself.

Содержание ICS Aircal

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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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