ICS AirCal Reference Manual Rev 02 May 2012

Copyrightnotice No part of this documentation orprogram may be reproduced, stored in a retrieval system, ortransmitted, in any form orby any means, electronic, mechanical, photocopying, recording,or otherwise,without the prior written consent of GN Otometrics A/S. Copyright© 2012, GN Otometrics A/S Published in Denmark byGN Otometrics A/S, Denmark All information, illustrations, and specifications in this manual are based on the latest productinformation available at the time of publication. GN Otometrics A/Sreserves the right to make changes at any time without notice. Versionrelease date 5/31/2012 Technicalsupport Please contact your supplier.

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Table of Contents

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1

Introduction 1.1 Intended Use 1.2 Intended User 1.3 About this manual 1.4 Training 1.4.1 Safety 1.5 Typographical conventions

5 5 5 5 5 5 6

2

Comparing Air Irrigation to Water Irrigation

7

3

Getting started 3.1 Room Setup 3.2 Installation and setup 3.2.1 Removing the transportation screws 3.2.2 Installing the Delivery Head Cradle 3.2.3 Understanding the ICS AirCal Back Panel 3.2.3.1 Connecting the Foot Switch 3.2.3.2 Connecting to an ICS VNG/ENG system 3.2.3.3 Connecting the Mains power cable 3.2.3.4 Filling and priming procedure 3.2.4 Cleaning and maintenance 3.2.4.1 ICS AirCal device 3.2.4.2 Lens on the Delivery Head 3.2.4.3 Speculum (outer)

9 9 10 10 10 12 12 12 12 13 17 17 17 17

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ICS AirCal Front Panel 4.1 ICS AirCal device on/off 4.2 Standby/Operation Mode 4.3 Temperature 4.3.1 Recommended/Default Temperature 4.3.2 Setting a new temperature 4.3.2.1 Temporary Adjustment 4.3.3 Switching between cool and warm temperature 4.4 Duration Timer 4.4.1 Recommended/Default Duration Timer 4.4.2 Setting a new Duration Time 4.5 Airflow Rate 4.5.1 Recommended/Default Airflow Rate 4.5.2 Setting a new Airflow Rate 4.6 Beep Volume 4.6.1 Default Beep setting 4.6.2 Setting a new beep volume 4.7 Changing the Stored Default Values 4.8 Water level display 4.8.1 Refill Procedure:

19 19 19 19 19 20 20 20 20 20 20 21 21 21 21 21 21 21 21 22

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ICS AirCal Delivery Head & Foot Switch 5.1 Delivery Head 5.1.1 Speculum 5.1.2 Lens

23 23 24 24

3

5.2

4

5.1.3 Light on/off button 5.1.4 Activation Trigger Operation Foot Switch 5.2.1 Operation

24 24 24 24

6

Performing a Caloric Irrigation 6.1 Preparation for testing 6.2 Testing Procedure

27 27 27

7

ICS AirCal System Safety 7.1 Symbols used 7.2 Warning notes 7.3 Manufacturer 7.3.1 Responsibility of the Manufacturer

29 29 30 31 31

8

Technical Specifications 8.1 Accessories 8.2 Guidance and manufacturer’s declaration tables

33 34 34

9

Troubleshooting

39

10 Firmware procedures 10.1 Upgrading the firmware 10.2 Installing the device driver

41 41 42

Index

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1 Introduction 1.1 Intended Use

1

Introduction Congratulations! You are now the owner of a new ICS AirCal irrigator. The ICS AirCal was developed based on the 30 years of knowledge and being the market leader in caloric irrigators. We maintained all the accuracy and functionality of the ICS NCA-200 while adding functionality that will improve workflow. In addition, the ICS AirCal is designed to be much quieter, smaller, and lighter in weight. The ICS AirCal irrigator is a convenient and accurate air caloric stimulator to be used for evoking nystagmus during VNG/ENG examinations. The system 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. Precise temperature control is maintained through the use of a thermistor located close to the point of airflow delivery. The innovative design of the otoscopic delivery head allows observation of the point of stimulation, assuring valid and repeatable responses. To assist you in getting the most out of the ICS AirCal system, we have included this user manual. We hope you find it easy to use and that your use of the incorporated tips and information results in improved data collection accuracy as it relates to your assessment of vestibular-related disorders.

1.1

Intended Use An air caloric stimulator is a device that delivers a stream of air to the ear canal at controlled rates of airflow and temperature and that is intended for vestibular function testing of a patient's body balance system. The vestibular stimulation of the semicircular canals produces involuntary eye movements that are measured and recorded by a nystagmograph.

Note • The ICS AirCal System is intended to be used only by qualified medical personnel.

1.2

Intended User This manual describes the use of the device. Readers are assumed to have prior knowledge of the medical and scientific facts underlying the procedure. For this reason, the examination methods are mentioned only to the degree that is necessary for a correct, safe application of the ICS AirCal system.

1.3

About this manual This is your guide to using the basic functions required for performing a caloric irrigation using the ICS AirCal. This includes key functionality such as temperature settings and selection, setting of duration timer and airflow rate, and use of irrigation delivery handle and foot switch.

1.4

Training It is recommended that you make yourself familiar with the features provided by the ICS AirCal device before testing a patient.

1.4.1

Safety This manual contains information, cautions, and warnings which must be followed to ensure the safe performance of the ICS AirCal system.

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1 Introduction 1.5 Typographical conventions

Caution • Local government rules and regulations, if applicable, should be followed at all times.

Safety information is stated where it is relevant, and general safety aspects are described inICS AirCal System Safety ► 29.

1.5

Typographical conventions The use of Warning, Caution and Note For safety reasons and appropriate use of the device and/or software, the manual contains Warnings, Precautions and Notes. These headings are used as follows:

Warning • Indicates that there is risk of death or serious injury to the user or patient.

Caution • Indicates that there is a risk of injury to the user or patient or risk of damage to data or the device.

Note • Indicates that you should take special notice.

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2 Comparing Air Irrigation to Water Irrigation 1.5 Typographical conventions

2

Comparing Air Irrigation to Water Irrigation Several studies have shown that both air and water irrigations can create comparable caloric responses. However, in order to obtain a comparable caloric response the air irrigator must be able to heat and cool the air, and the air stream must be able to be delivered directly to the tympanic membrane (i.e., the eardrum). The ICS AirCal meets both of these criteria. The following are the recommended settings for Air Irrigation: •

Air temperatures: 50°C warm, 24°C cool

•

Airflow rate: 8 liters per minute

•

Irrigation Duration Time: 60 seconds

Literature supporting the above statement is below:

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•

Barin, K. (2008). Background and Technique of Caloric Testing. In Balance Function Assessment and Management. 1st ed. San Diego: Plural Publishing: 197-228.

•

Barin, K. (2008). Interpretation and Usefulness of Caloric Testing. In Balance Function Assessment and Management. 1st ed. San Diego: Plural Publishing: 229-252.

•

British Society of Audiology (1999) Recommended Procedure: Caloric Testing. British Journal of Audiology 33: 179-184.

•

Ford, CR & Stockwell, CW (1978) Reliabilities of air and water caloric responses. Archives of Otolaryngology 104: 380382.

•

Zapala, D & Shaughnessy K Water vs. Air - Are they equivalent caloric stimuli? - Mayo Clinic Jacksonville, FL

•

Zapala, DA; Olsholt KF & Lundy LB (2008) The comparison of water and air caloric response sand their ability to distinguish between patients with normal and impaired ears. Ear & Hearing 29(4): 585-600.

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2 Comparing Air Irrigation to Water Irrigation 1.5 Typographical conventions

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3 Getting started 3.1 Room Setup

3

Getting started

3.1

Room Setup

A. B. C. D. E.

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Sink VNG/ENG Equipment Counter Cabinets over counter Examiner's stool

F. G. H. I.

Light bar Footstool Examining table Telephone

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3 Getting started 3.2 Installation and setup

The ICS AirCal is designed to be used at any convenient level such as on a table, or cart. The ICS AirCal can be stacked with the Chartr 200 VNG/ENG hardware. It is best if the ICS AirCal is on top in order to refill the water as needed. Make sure the delivery head can reach the patient's ear. Make sure the stool can be adjusted to a height that will allow you to view the tympanic membrane (i.e., the eardrum) while performing irrigation.

Note • The ICS AirCal can be ordered in 2 different cable lengths 3 meter/10 feet (standard) and 4 meter/13 feet (extended). The decision on which to order should occur prior to purchase.

3.2

Installation and setup

3.2.1

Removing the transportation screws To prevent possible damage during shipping, the air pump housing is secured with transportation screws. These screws must be removed to allow the housing to move and thereby reduce the amount of noise the air pump produces. It is important to keep the transportation screws to secure the housing in the event the device needs to be shipped. 1. Remove transportation screws (A) and (B). 2. Store them with your Syringe Kit, Funnel and Allen Key.

3.2.2

Installing the Delivery Head Cradle Caution • Install the cradle prior to filling the water reservoir. Installation requires that the ICS AirCal is tilted more than 20°. If the water reservoir has water in it, tilting the device could introduce air into the system. There is little chance of damage to the system but, priming of the water reservoir would be required to make the system operate properly and not overheat.

Before installing the cradle for the delivery head determine how it should be mounted:

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•

The cradle can be mounted on the left or right side of the unit.

•

For units placed away from the edge of the table, it is recommended that the cradle is mounted in the horizontal position (A). For units placed at the edge of the table, it is recommended that the cradle is mounted at an angle (B).

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3 Getting started 3.2 Installation and setup

1. Locate the bag shipped with the cradle that contains 3 screws and an Allen key. 2. With the side chosen to hold the cradle facing the ceiling and the bottom of the unit facing you, lay the ICS AirCal on its side. 3. Locate the bracket mounting holes.

4. Attach the bracket to the unit using the Allen key to tighten the screws. 5. Hold the cradle with the end that holds the bottom of the delivery head facing the front of the unit. Slide the cradle onto the bracket in the horizontal position.

6. For units placed at the edge of the table, tilt the bracket forward until it stops. 7. Ensure the mounting hole on the bracket aligns with the mounting hole of the cradle. Attach the cradle to the bracket using the Allen key to tighten the screw. 8. Store the Allen key with the syringe kit. You will need it when filling the water reservoir.

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3 Getting started 3.2 Installation and setup

3.2.3

Understanding the ICS AirCal Back Panel

Note • The USB port

3.2.3.1

allows for firmware upgrades. Refer to Firmware procedures ► 41

Connecting the Foot Switch The foot switch comes standard with the ICS AirCal. Connect the foot switch to the back of the irrigator . If the ICS AirCal is connected to an ICS VNG/ENG system and you want to use the foot switch to start tests other than the caloric test, you need to have the irrigator on in order to use the foot switch.

3.2.3.2

Connecting to an ICS VNG/ENG system The ICS AirCal can be connected to an ICS VNG/ENG system. Connect the irrigator cable to the back of the irrigator and to the ICS VNG/ENG system. Connecting the 2 devices together gives additional functionality. See Activation Trigger Operation ► 24 for more information.

3.2.3.3

Connecting the Mains power cable The ICS AirCal should be connected to an electrical wall outlet by attaching the power cable to the ICS AirCal irrigator and plugging the cable into the electrical wall outlet.

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3 Getting started 3.2 Installation and setup

A. Connector for power cable

3.2.3.4

Filling and priming procedure The ICS AirCal uses water to cool the air. It is required that the water reservoir be filled prior to use of the device.

Warning • To prevent electrical shock, the ICS AirCal irrigator must be turned off and disconnected from the electrical wall outlet when filling or refilling the water reservoir.

Caution • Use this procedure if: 1) the ICS AirCal was just received from shipping dry. It needs to be filled and primed, 2) If the water level in the display has gone to zero because user never refilled it when orange bar was present. 3) If the ICS AirCal was tilted at more than 20° with the water pump running.If none of these criteria were met and the water level display is showing an orange bar and needing refill, please follow the instructions in Refill Procedure: ► 22 .

Caution • Only use distilled water. Using common water from the tap will result in mineral deposits and will harm the ICS AirCal.

Filling 1. Turn off the ICS AirCal irrigator and unplug from the electrical wall outlet. 2. Wipe off any dust on the top of the case. 3. Facing the front panel, locate the small cover at the back right side. Using the Allen key (supplied with the cradle) unscrew the reservoir cover and remove.

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3 Getting started 3.2 Installation and setup

A. Reservoir cover

4. Using the Allen key unscrew the internal cover and remove.

A. Internal cover

5. Expand the funnel supplied with the ICS AirCal irrigator and place in the refill hole of the reservoir.

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3 Getting started 3.2 Installation and setup

A. Funnel

6. Pour water into the funnel to fill the reservoir. 7. Monitor the water level closely. Fill to the bottom of the lip. Do NOT overfill the reservoir. 8. Remove the funnel. 9. Wipe up any excess water that might have spilled into the small indentions where the internal cover is placed. 10. Replace the internal cover.

Priming 1. Plug in the irrigator into the electrical wall outlet and turn on. 2. Turn off the airflow. 3. Locate the priming switch on the back panel

.

4. Press the priming switch to turn on and hold 5 seconds. 5. Release the priming switch to turn off and wait 5 seconds. 6. Repeat steps 4 and 5 for a total of 10 times on and 10 times off. 7. Press the cool button

. Decrease the temperature to 12°C.

8. If the temperature reaches the set temperature, then the irrigator is primed. Continue to step 10. 9. If the temperature does not reach 12°C in approximately 3 minutes or, if the over temperature alarm sounds, skip to the procedure Priming with bent tube ► 16. 10. Turn off the irrigator and unplug from the electrical wall outlet. 11. Remove the internal cover. 12. Check if the water reservoir is full. If not, place the funnel in the refill hole of the reservoir and add additional water. 13. Remove the funnel and replace the internal cover. Tighten the screws to secure.

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3 Getting started 3.2 Installation and setup

14. Replace the external cover and tighten screws to secure. 15. Plug in the irrigator into the electrical wall outlet and turn on.

Note • The default airflow rate for caloric irrigation is 8 liters per minute. Shipping may cause the airflow knob to move. You may have to reset the airflow.

Priming with bent tube 1. Take the syringe with bent tube and remove enough water from the reservoir to fill the syringe. 2. Put the end of the bent tube into the pump inlet hole. The tube will be facing toward the front of the irrigator.

3. While pressing the priming switch

, inject the water into the inlet.

4. Release the priming switch. 5. Press the priming switch to turn on and hold 5 seconds. 6. Release the priming switch to turn off and wait 5 seconds. 7. Repeat steps 5 and 6 for a total of 10 times on and 10 times off. 8. Press the cool button

. Decrease the temperature to 12°C.

9. If the temperature reaches the set temperature, then the irrigator is primed. Continue to step 11. 10. If the temperature does not reach 12°C in approximately 3 minutes or,repeat steps 1 through 9. 11. Turn off the irrigator and unplug from the electrical wall outlet. 12. Check if the water reservoir is full. If not, place the funnel in the refill hole of the reservoir and add additional water. 13. Remove the funnel and replace the internal cover. Tighten the screws to secure. 14. Replace the external cover and tighten screws to secure. 15. Plug in the irrigator into the electrical wall outlet and turn on.

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3 Getting started 3.2 Installation and setup

Caution • Due to the possibility of freezing during shipment, water must be drained from the reservoir before shipping the ICS AirCal. See Troubleshooting ► 39 for draining instructions.

3.2.4

Cleaning and maintenance

3.2.4.1

ICS AirCal device Keep the instrument 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.

3.2.4.2

Lens on the Delivery Head The Lens can be cleaned with a cleaning cloth like the Otometrics optical cleaning cloth (part # 7590527).

3.2.4.3

Speculum (outer) The speculum is disposable and single-use only. It is not recommended that they be cleaned. Additional specula (part # 8-6244100 - Qty 25) can be obtained from Otometrics or your local representative.

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3 Getting started 3.2 Installation and setup

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4 ICS AirCal Front Panel 4.1 ICS AirCal device on/off

4

ICS AirCal Front Panel This section describes all operational controls located on the front panel of the ICS AirCal.

4.1

ICS AirCal device on/off This is a push on/push off switch located on the bottom left of the front panel that applies power to the ICS AirCal. On is indicated by the illumination of a green LED and the digital display. When the ICS AirCal is first turned on it is in operation mode.

4.2

Standby/Operation Mode When the ICS AirCal is turned on the default is airflow on. Pressing the airflow button will switch the ICS AirCal between standby mode and operation mode. In standby mode (airflow off), the irrigator is on but the airflow, water and air pump, fan, warming and cooling mechanisms are off. Standby mode is recommended when the ICS AirCal is connected to an ICS VNG/ENG and the foot switch is used for starting other tests (e.g., Dix Hallpike) in the Chartr software. Turn off the airflow when the device is not in use.

4.3

Temperature

4.3.1

Recommended/Default Temperature The default temperatures are 24°C for cool and 50°C for warm. These temperatures are recommended based on literature that states using these temperatures will create a comparable caloric response as water irrigation. See Chapter Comparing Air Irrigation to Water Irrigation ► 7 for more information.

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4 ICS AirCal Front Panel 4.4 Duration Timer

4.3.2

Setting a new temperature

4.3.2.1

Temporary Adjustment To adjust the temperature for a single patient use, press the buttons. The - decreases the temperature, the + increases the temperature. Press button quickly if small increments are needed or press and hold to change more rapidly. The range for the cool temperature is 12°C to 37°C. The range for the warm temperature is 37°C to 50°C. The temperatures are adjustable in 1/10 of a degree increments. To change the warm or cool temperature stored default value, see Changing the Stored Default Values ► 21.

4.3.3

Switching between cool and warm temperature The warm or cool temperature buttons allow the operator to select the stimulus desired. If the ICS AirCal is connected to an ICS VNG/ENG system, selecting the caloric protocol (e.g., Left Warm) will automatically select the temperature on the irrigator. Therefore, no manual selection is needed. However, the default startup temperature of the ICS AirCal should match the temperature of the first caloric protocol in your list (e.g. if you start with Left Cool - default the ICS AirCal to start with Cool). The startup temperature (cool or warm) can be stored. The default is cool. See Section Changing the Stored Default Values ► 21. Temperature selection will be indicated on the display panel. If the ICS AirCal is in operation mode only the temperature currently selected will display. The digital display shows the actual and set temperatures. Once a temperature has been selected, the display will flash until it reaches +/- 0.4 degrees from the set or default temperature. Time to reach the temperature is < 60 seconds. If the ICS AirCal is in standby mode both the warm and cool set temperatures will display, the actual temperature will not display.

4.4

Duration Timer

4.4.1

Recommended/Default Duration Timer The default duration for caloric irrigation is 60 seconds. This duration is recommended based on literature that states this duration will create a comparable caloric response as water irrigation. See Chapter Comparing Air Irrigation to Water Irrigation ► 7 for more information.

4.4.2

Setting a new Duration Time To adjust the duration time, press the buttons. The - decreases the time, the + increases the time. Press button quickly if small increments are needed or press and hold to change more rapidly. The range for the time is 1 to 99 seconds. To change the duration time stored default value, see Section Changing the Stored Default Values ► 21. Duration Time selection will be indicated on the display panel. If the ICS AirCal is in operation mode, the digital display shows the set time. Once an irrigation is started by using the foot switch or activation trigger on the delivery head, the actual timer will count down to 0. A beep will sound when the timer reaches 0 to alert the tester to stop irrigation. If the ICS AirCal is in standby mode only the set time will display.

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