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Summary of Contents for natus 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 Copyright notice © 2012, 2021 Natus Medical Denmark ApS. All rights reserved. ® Natus, the Natus Icon, ICS Aircal, ICS Chartr, and HORTMANN are registered trademarks of Natus Medical Denmark ApS in the U.S.A. and/or other countries. Version release date...
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Page 3: Table Of Contents
3.6.1 Default Beep setting ....................15 3.6.2 Setting a new Beep volume ..................15 3.7 Changing the Stored Default Values ................15 3.8 Water level display ......................15 3.8.1 Refill procedure ......................16 4 ICS Aircal Delivery Head and Foot Switch ................16 4.1 Delivery Head ........................16 ICS Aircal... - Page 4 4.2 Foot Switch ........................18 5 Performing a Caloric Irrigation ....................18 5.1 Preparation for testing ....................18 5.2 Testing procedure ......................19 6 ICS Aircal system safety ......................19 6.1 Glossary of symbol ......................20 6.2 General warnings, cautions and notes ................23 6.2.1 Warnings ........................24 6.2.2 Cautions .........................25...
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Page 5: Device Description
Device description Device description The ICS Aircal® Air Caloric Irrigator is a convenient and accurate air caloric stimulator to be used for evoking nystagmus during VNG/ENG examinations. The device provides thermal stimulation through the use of a carefully controlled flow of air. The air temperature is adjustable from 12°C to 50°C. The system provides for presetting two temperatures -- one for the warm and one for the cool caloric stimulation. -
Page 6: Getting Started
Telephone The ICS Aircal device is designed to be used at any convenient level such as on a table or cart. The ICS Aircal device can be stacked with the ICS Chartr® 200 VNG/ENG hardware. It is best if the ICS Aircal device is on top so that water can be refilled as needed. -
Page 7: Installation And Setup
Installing the Delivery Head Cradle Note Install the cradle prior to filling the water reservoir. Installation requires that the ICS Aircal device is tilted • more than 20°. If the water reservoir has water in it, tilting the device could introduce air into the system. The risk of damage to the system is small, but priming of the water reservoir would be required to make the system operate properly and not overheat. -
Page 8: Understanding The Ics Aircal Back Panel
Locate the bag that shipped with the cradle that contains three screws and an Allen key. With the side chosen to hold the cradle facing the ceiling and the bottom of the unit facing you, lay the ICS Aircal device on its side. - Page 9 2.2.3.4 Disconnecting the Mains power cable The ICS Aircal device and any device to be connected that has its own power supply must be turned off before any connections are established Warning • To disconnect the device from the mains supply, pull the mains plug out of the electrical wall outlet.
- Page 10 • 1. If the ICS Aircal device was just received from shipping and is dry. It must be filled and primed. 2. If the water level in the display has gone to zero because the user never refilled it when the orange bar was present.
- Page 11 Getting started Internal cover Expand the funnel supplied with the ICS Aircal device and place it in the refill hole of the reservoir. Funnel Pour water into the funnel to fill the reservoir. Monitor the water level closely. Fill to the bottom of the lip. Do NOT overfill the reservoir.
- Page 12 Repeat steps for a total of 10 times on and 10 times off. Press the cool button . Decrease the temperature to 12°C. If the temperature reaches the set temperature, then the irrigator is primed. Continue to step 11. ICS Aircal...
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Page 13: Ics Aircal Front Panel
This switch is a push on/push off switch on the bottom left of the front panel that turns the ICS Aircal device on and off. The device is on when the green LED and the digital display turn on. When the ICS Aircal device is turned on, it is in operation mode. -
Page 14: Temperature
ICS Aircal device should match the temperature of the first caloric protocol in your list (e.g. if you start with Left Cool, default the ICS Aircal device to start with Cool). The startup temperature (cool or warm) can be stored. -
Page 15: Airflow Rate
The airflow rate is set based on the knob position. The flow rate selection (actual only) will be indicated on the display panel. If the ICS Aircal device is in operation mode, the digital display shows the actual flow rate. If the ICS Aircal device is in standby mode, the display will be off. -
Page 16: Refill Procedure
Wipe off any dust on the top of the ICS Aircal device prior to opening the case to refill the reservoir. Face the ICS Aircal front panel. On the back right side is a small cover. Using the Allen key (supplied with the irrigator cradle), unscrew the external cover and remove. -
Page 17: Speculum
The light should be turned on during irrigation to view the tympanic membrane (the eardrum) to ensure that the air flow is being directed properly. By default, the light is turned on when the ICS Aircal device is in operation mode. The light will flash when the caloric test/irrigator is initiated by pressing the foot switch or the activation trigger on the delivery head to confirm initiation of the devices. -
Page 18: Activation Trigger Operation
Pressing the foot switch more than once will NOT stop or restart the countdown timer. If the ICS Aircal device is in standby mode, pressing the foot switch will NOT start the countdown timer. In standby mode, the foot switch can start any test in the ICS VNG/ENG software. -
Page 19: Testing Procedure
Start collecting response and start irrigation. Start tasking patient 20-30 seconds into irrigation. When duration time is reached and the ICS Aircal device beeps, remove the delivery head from the patient's ear and continue tasking. Right after the peak of the response, allow the patient to fixate. -
Page 20: Glossary Of Symbol
ICS Aircal system safety Glossary of symbol Symbol Title Standard as per Symbol Standard Title of Symbol Explanation Reference Referenced Standard An indication of This product is a medical Medical Device device. Directive Medical Device Directive CE marking Signifies European technical 93/42/EEC conformity. - Page 21 ICS Aircal system safety Symbol Title Standard as per Symbol Standard Title of Symbol Explanation Reference Referenced Standard ISO 15223- Medical devices — Symbols Serial number Indicates the 1:2016 to be used with medical manufacturer's serial Reference no. device labels, labeling, and number so that a specific 5.1.7.
- Page 22 ICS Aircal system safety Symbol Title Standard as per Symbol Standard Title of Symbol Explanation Reference Referenced Standard ISO 15223- Medical devices – Symbols to Do not use if Indicates that the medical 1:2016 be used with medical device package device should not be used if Reference no.
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Page 23: General Warnings, Cautions And Notes
General warnings, cautions and notes Natus Medical Denmark ApS ICS products are not designed to be used in conjunction with any devices that are not approved by Natus Medical Denmark ApS. Using Natus ICS products with unapproved parts can impact patient risk. -
Page 24: Warnings
• The following conditions or practices might present possible risk of death or serious injury to the user or patient: For the sake of safety, and in order not to void the warranty, the ICS Aircal device should only be serviced •... -
Page 25: Cautions
ICS Aircal system safety 6.2.2 Cautions Caution • The following conditions or practices might present a risk of injury to the user or patient or risk of damage to data or the device. No parts may be eaten, burnt, or in any way used for purposes other than the applications defined in the •... -
Page 26: Responsibility Of The Manufacturer
Do not use a defective device. Cleaning Keep the ICS Aircal device clean and as free of dust as possible. To clean the outside case or delivery head, use a soft, slightly damp cloth with a small amount of mild detergent. -
Page 27: Speculum (Outer)
WEEE is reused or recycled safely. In line with that commitment Natus Medical Incorporated may pass along the obligation for take back and recycling to the end user, unless other arrangements have been made. Please contact us for details on the collection and recovery systems available to you in your region at natus.com. -
Page 28: Technical Specifications
<90%, 35°C non-condensing Air Pressure 500 hPa to 1060 hPa Reservoir Note If the ICS Aircal device will be stored for an extended time without • being used or shipped, the reservoir should be empty. Standards Safety Class I, Type BF, IPX0. - Page 29 Power supply Input voltage 100-240 VAC 50/60 Hz Power consumption <192 VA Fuse T 1.6H 250V Applied part The applied part of the ICS Aircal device is the irrigator head. Essential performance ICS Aircal device has no essential performance. ICS Aircal...
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Page 30: Accessories
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 cord, IEC power hospital grade, US 7630024 Power cord, standard, EU 8-71-240 Power cord, UK 8-71-80200 Power cord, AUS 8-71-82700 Power cord, BR 8-71-90600 ICS Aircal... -
Page 31: Notes On Emc (Electromagnetic Compatibility)
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. - Page 32 Guidance and manufacturer's declaration - electromagnetic immunity - for equipment and systems within Professional Healthcare use environment 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.
- Page 33 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.
- Page 34 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.
- Page 35 Guidance and manufacturer's declaration - electromagnetic immunity - for equipment and systems that are NOT life-supporting 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.
- Page 36 Recommended separation distances between portable and mobile RF communications equipment and the ICS Aircal device The ICS Aircal device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the ICS Aircal device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the ICS Aircal device as recommended below, according to the maximum output power of the communications equipment.
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Page 37: Troubleshooting
Firmware procedures To upgrade the ICS Aircal firmware, locate the ICS Aircal Firmware upgrade media and a computer on which the ICS Aircal device driver has been installed. To install the device driver, follow the instructions in Installing the device driver before continuing. -
Page 38: Upgrading The Firmware
Connect the USB cable to the ICS Aircal USB port and to the USB port on the computer. Turn on the computer and locate the ICS Aircal firmware upgrade. Using a ballpoint pen, press and hold the firmware mode button while turning on the ICS Aircal. Hold for 3 seconds (the display will be blank).
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