Users Manual
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COOLSTAR AIR INSUFLATOR User's manual* 1639 Version 1.8-E
COOLSTAR User's manual
14. Mar. 2014
NOTICE
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(*)Contents of this publication are subject to change without notice.
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For any informations, comments or suggestions about this manual or any other manual, please contact : Instrumentation DIFRA s.a. Industriestrasse 33 B-4700 Eupen BELGIUM Tel./fax +32 (0)87 89 80 80 / +32 (0)87 89 80 89 Email : [email protected]
Web site : http://www.difra.be •
Companies, names, and data used in examples herein are fictitious unless otherwise noted.
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All rights reserved.
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No part of this document may be reproduced or transmitted in any form or by any means, electronic or mechanical, for any purpose, unless its entire contents are included.
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Trademarks are the property of their respective owners.
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Copyright © 2013 Instrumentation DIFRA
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Printed in Belgium.
DI090320/UM/01.8E
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Instrumentation DIFRA
COOLSTAR User's manual
14. Mar. 2014
Contents Contents...3 Chapter I...5 General information...5 Introduction...5 Chapter II...6 Unpacking instructions...6 Examination of the packing...6 Standard contents of the packing...6 Examination of the device...6 Complain in case of damages...6 Chapter III...7 General description...7 Setting up temperatures...7 Setting up the insuflation time...7 Disoft software...8 Summary of the different versions...8 Accessible parts on the front panel...9 Accessible parts on the rear panel...10 Chapter IV...11 Installation procedure...11 Environment...11 Electric connection...11 Glass jar connection...12 Speculum...13 Ventilation of the device...14 Chapter V...15 Operation mode...15 Classic utilization description...15 Selection of the temperature...16 Adjustment of the light intensity of the display...16 Programming and reading set point temperatures...16 Programming timers...17 Selection of the insuflation time...17 Working of the stopwatch...18 Insuflation handle utilization...18 Sound and visual signals...19 Maintenance...19 Chapter VI...21 Guarantee and service...21 TERM and LIMIT of LIABILITY...21 CANCELLATION of WARRANTY...21 Support and service...21 TERM and CONDITIONS...21 RETURNS...22 RETURN SHIPPING POLICY...22 DI090320/UM/01.8E
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Instrumentation DIFRA
COOLSTAR User's manual
14. Mar. 2014
Repair/replacement policy...22 Chapter VII...23 Accessories...23 Chapter VIII...25 Appendix...25 Technical specifications...25 Registration...27 Return Report Form...28 Table of illustrations...29 List of symbol...29 Manufactured in Belgium by:...31
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Instrumentation DIFRA
COOLSTAR User's manual
14. Mar. 2014
Chapter I General information Introduction This manual is the operation mode of the COOLSTAR air insuflator manufactured by Instrumentation DIFRA in Belgium, allowing to carry out the caloric tests for the diagnosis of the vestibule. Important note: at every person who will use the COOLSTAR air insuflator, it is highly recommended to read this manual and to master this device, before using it. This manual is divided into 8 sections: I II III IV V VI VII VIII
General information Unpacking instructions General description of the device Installation procedure Operation mode Guarantee and service Accessories Appendix
As with any piece of sophisticated equipment, maximum benefit will be derived if special attention is paid to the care and maintenance of the device in order to master its capabilities and functions. If additional service is required, please contact your nearest Instrumentation DIFRA sales and service office or contact us directly: Instrumentation DIFRA Industriestrasse 33 B-4700 Eupen Tel. : 00-32-87/89.80.80 Fax. : 00-32-87/89.80.89 We will then communicate to you the address and phone numbers of your Instrumentation DIFRA representative.
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Instrumentation DIFRA
COOLSTAR User's manual
14. Mar. 2014
Chapter II Unpacking instructions Examination of the packing Before opening the package, please inspect the packing against all noticeable damage. In that case, immediately advise the carrier of the damages and keep the carton as proof. The COOLSTAR air insuflator is delivered in a package designed for transportation. Keep it in case of back shipment.
Standard contents of the packing Qty
Designation
Part number
1
COOLSTAR air insuflator
DI 0903X0-XXX-I
1
Glass jar
X038 COOLSTAR
1
Power cord IEC 10 Amperes
X200 ALIM10A
1
Operating manual
DI090320/UM
10
Speculum Ø 2.5 mm, green (Illustration 16)
-00013726
10
Speculum Ø 4 mm, blue (Illustration 17)
-00013727
Examination of the device Neither the device nor its accessories must present any default of appearance at its reception. Carefully inspect the box in case the carton has been damaged while transportation! In case of problems, contact the carrier and your nearest representative of Instrumentation DIFRA.
Complain in case of damages Any missing part or malfunction should be immediately reported to the supplier of the device. Attach to your complaint a copy of the invoice, serial number and a detailed report of the problem. The serial number is on the rear panel on the identification label. Instrumentation DIFRA takes no responsibility in case of misuse of the device.
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Instrumentation DIFRA
COOLSTAR User's manual
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Chapter III General description The air stimulator COOLSTAR uses micro-controller technology to bring a lot of possibilities, although it remains very simple to use and gives a high accuracy of temperature regulation for the vestibular stimulation during caloric tests. Its design allows the COOLSTAR to reach temperatures from 8°C to 48°C despite the ambient temperature. COOLSTAR has an otoscope handle with integrated light. The otoscope handle uses disposable specula for a better hygiene and has a led which lights the eardrum without obstructing the air flux and the visibility of the user. The visibility is improved thanks to a magnifying glass which is integrated in the otoscope handle. COOLSTAR is ideal when water cannot be used for the stimulation or for rooms not equipped by a water inlet and emptying. COOLSTAR is also ideal for countries with warmer ambient temperature.
Setting up temperatures Four temperatures are selected by means of a rotary switch. Each temperature may be set from 8°C to 48°C. By default, these are 20°C, 30°C, 44°C and 47°C for the caloric tests. The temperature of the air is stabilized within one minute from the powering of your COOLSTAR and is indicated on the numeric display.
Setting up the insuflation time By taking out the handle, the digital thermometer switches in chronometer and gives a delay of 9 seconds before to beep, which announces the beginning of insuflation. A second beep announces the end of insuflation after a time interval selected by means of a switch (40, 60, 80, 100 or 120 sec.). A third and a fourth beep announce the beginning and the end of ocular fixation. Hanging up the handle the chronometer is stopping automatically.
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Instrumentation DIFRA
COOLSTAR User's manual
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Disoft software COOLSTAR is provided with a connection to the NAC network which allows it to be connected directly to the DISOFT program for the caloric test.
Illustration 1: Disoft software
Summary of the different versions Ref. DI 090320-115-I DI 090320-230-I
DI090320/UM/01.8E
Description Air Insuflator 115V, with otoscope
COOLSTAR 2.0 handle COOLSTAR 2.0, Air Insuflator 230V, with otoscope handle
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Instrumentation DIFRA
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Accessible parts on the front panel B2 B1 P A M
Selection knob of insuflation time: OFF, 40, 60, 80, 100 or 120 seconds Selection knob of set point temperature: TA, TB, TC, TD Programming/reading button of the temperatures and adjustment of the light intensity of the display 4 digits screen Handle support for COOLSTAR
A
27.0
M
P
B2 TA
TB TC
TD
B1
Illustration 2: COOLSTAR front panel
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COOLSTAR User's manual
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Accessible parts on the rear panel I Main switch F Fuses P1 Power supply socket with earth C1&C2 NAC Bus connectors W Water mark SC Screw cap S Support for glass jar G Glass jar A Warning symbole to prevent you to connect other cable than NAC bus into RJ45 connectors 1 Aspiration water pipe 2 Output air pipe; in use air bubbles should come outside of this pipe (yellow pipe) 3 Output water pipe (blue pipe)
SC
2
1
3
G
W P1 1
I
F
S
3 2
C1 A
C2
Illustration 3: COOLSTAR rear panel
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Instrumentation DIFRA
COOLSTAR User's manual
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Chapter IV Installation procedure Environment The COOLSTAR may not be used in rooms where are explosive risks. The COOLSTAR respects the norm IEC60601-2 regarding EMC. This allows you to install and use the COOLSTAR in classic environments, but it does not allow you to use it in harsh environment like operating rooms or places polluted by devices generating a harsh electromagnetic environment.
COOLSTAR is designed to be used in rooms at ambient temperature and classic humidity. The device can perform from 10°C to 40°C and from 30 to 75% of relative humidity. For storage, keep the device between 5°C and 60°C at a relative humidity between 10% and 90%. Before first use, let the device off until its has taken the temperature of the room.
Electric connection The COOLSTAR hot air insuflator requires a P2 power source with ground, by means of the C1 power cord, which is delivered together with the device. Prior to connecting the COOLSTAR to the mains, the wall plug, fuse rating and the mains wall outlet should be checked. Check also the voltage of the wall plug, as COOLSTAR exists for 230VAC and for 115VAC supply, your device should match with your mains supply voltage. The 2 RJ45 connectors may only be connected to NAC network of your installation by means of cables provided by DIFRA.
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COOLSTAR User's manual
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0
P 2
Glass jar connection
1
C 1
Illustration 4: Electric connection
Fill in the glass jar up to the mark (W in Illustration 3) with demineralized water (+- 600ml) at ambient temperature. Using normal water will result in a sediment deposit in the device, that will end by blocking a pipe and cause irreparable failure. Change water in the glass jar every week.
Illustration 5: Fill the glass jar with demineralized water between top and minimum level
Illustration 6: Place the glass jar in its support
Put the glass jar in its support on the rear panel of the COOLSTAR. To install the cap on the jar, block the cap and turn the jar, so the cap will screw itself on the jar. Block the jar with the screw.
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COOLSTAR User's manual
14. Mar. 2014
Illustration 7: To screw the cap, block it and turn the glass jar
Illustration 8: Block the glass jar with the screw to avoid noise
At start up, the auto prime water pump will be noisy during 30-45 seconds due to air presence into water pipes (1&3 in Illustration 3). Air bubbles should always come out of the air pipe (2 in Illustration 3). If no air bubbles come out from the pipe, turn off the device and contact Instrumentation DIFRA.
Speculum Always dispose of the speculum after each patient to avoid contamination or infections. Speculum are single use products. Do not reuse them. To use the COOLSTAR, install a speculum on the tip of the otoscope head. With your device, you received 20 specula, ten with a diameter of 4mm and ten with a diameter of 2.5mm (See Illustration 16 and 17). These specula are single use only. They can not be cleaned or sterilized and they have to be exchanged for each patient. The air flowrate at the otoscope output will depend on the speculum size. Maximum air flowrate is 10L/min without speculum. To assemble a speculum on the ear tip of the handle, you have to insert it on the tip of the otoscope and turn it clockwise of about 45°. A small plastic tip will be crushed in the metal part of the head and will fix the speculum on the handle. See Illustration below.
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Instrumentation DIFRA
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Illustration 9: Mounting the speculum on the handle head, first step: presenting the speculum on the tip of the handle
Illustration 10: Turn the speculum clockwise on approximatively 45°
Illustration 11: Test if the speculum is fixed by pulling it smoothly
Specula are rubber and silicone free. Be aware not to put too much strength on the speculum or you will break the plastic tip and the speculum would not be fixed on the handle. Once this tip is broken, the speculum can not be fixed again on the handle. To disassemble the speculum from the handle turn it counterclockwise. Then you can take the speculum out of the head.
Ventilation of the device The COOLSTAR is provided with lateral ventilation openings. The ventilation of the device is performed by natural convection. Never put the COOLSTAR near a radiator or near any heating source. Let minimum 10 cm free space on each side of the device, to assure a good air circulation. DI090320/UM/01.8E
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Instrumentation DIFRA
COOLSTAR User's manual
14. Mar. 2014
Chapter V Operation mode
Glass jar has to be filled in with demineralized water up to the mark and air bubbles have to come out of the air pipe (See 2 in Illustration 18) during the use of the COOLSTAR. If not, turn off the device immediately. Change water in the glass jar every week.
Failure to comply with these instructions will void de warranty.
COOLSTAR is a thermal stimulation device exclusively designed to the diagnosis of the human vestibular organs (caloric tests).
Classic utilization description Five minutes prior to start your irrigation, turn on your COOLSTAR. Place a new speculum on the tip of the otoscope handle. See Speculum in the previous chapter to learn how to exchange it. This will let enough time to get your chosen temperature stable. Irrigate at correct temperature and during right time with the help of timer beep. After patient irrigations, turn off the COOLSTAR and throw away the used speculum. If you require to do several irrigations in series or if two irrigations are separated by less than 10 minutes, block the air flow coming outside of the tip with one finger for 20 to 30 seconds after each patient. This action will empty the tank from condensate water. During this operation, temperature will change and the COOLSTAR will probably beeps due to temperature gap between preset and actual temperature. Beeper will stop when COOLSTAR temperature will be again inside the ±1°C temperature security gap. Blocking the air flow will avoid to get condensate water coming outside of the tip when the tank is full. This can also be prevented by monitoring the amount of bubbles in the glass jar. When the level of condensate water is becoming too important, the bubbles number is decreasing. By blocking the air flow, you will get more bubbles in the jar and the tank will be freed of its water. DI090320/UM/01.8E
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14. Mar. 2014
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Instrumentation DIFRA
COOLSTAR User's manual
14. Mar. 2014
Selection of the temperature The B1 button below on the right of your display, on the front panel of your COOLSTAR (Illustration 12), enables to select one of the four set point temperatures, programmed beforehand in your device. Either TA, TB, TC or TD. In general, TA and TB are used for cold insuflation, TC and TD for hot insuflation. Default settings: TD=47°C, TC=44°C, TB=30°C and TA=20°C
A
27.0
M
P
B2 TA
TB TC
TD
B1
Illustration 12: Temperature selection
Adjustment of the light intensity of the display The P button allows to adjust the light intensity of the display.
Programming and reading set point temperatures Place the button B2 on OFF and the button B1 on the temperature to program. The button P above on the right of your display A, on the front plate of your COOLSTAR (Illustration 12), enables to program and/or read set points of your device. Press on the button P. Then, you hear a continuous sound beep during these 5 seconds. The set point associated with the position of the temperature selection knob is displayed. The letter P precedes this value, it means for example: P27.0. If you want to modify the set temperature, turn then the button P clockwise to increase or counterclockwise to decrease! Press a second time on the button, then release it. The device turns over in its normal mode and starts again to regulate.
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Instrumentation DIFRA
COOLSTAR User's manual
14. Mar. 2014
Programming timers The button B2 allows to select 5 fixed times, it means 40, 60, 80, 100 or 120 seconds, which correspond the irrigation times. The device emits a beep after this time (end of irrigation), then a second beep after a time t1 (beginning of ocular fixation) and a third beep after a time t2 (end of ocular fixation). The device will finally stop after a time t3 (end of caloric test). These three time, t1, t2 and t3 are programmable: t1 : max. 60 sec. t2 : max 40 sec. t3 : max 30 sec. To modify t1, place the button B2 on 40. Then follow the same steps as to modify the temperatures: push on button P during 5 seconds, turns then the button P left or right, push a second time on the button P to end the programming. To modify t2, place the button B2 on 60 and perform the same operation as for t1. To modify t3, place the button B2 on 80 and perform the same operation as for t1 and t2.
During programming temperatures or timers set points, it is imperative not to turn buttons B1 and B2.
Selection of the insuflation time On the left side of the front panel, you will find the insuflation time selector B2 (Illustration 13). This facility brings you the advantage to avoid the manipulation of a stopwatch during the insuflation.
A
M
27.0
B2 TA
TB TC
TD
Illustration 13: Insuflation time selection
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COOLSTAR User's manual
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Working of the stopwatch The stopwatch is driven by the insuflation time selector B2 (Illustration 13) and by the manipulation of the handle. With the selector in the "OFF" position, the stopwatch remains reset and hidden. Another position starts the counting at "t -9" seconds when you take up the handle. On passing at 0 second, a beep invites you to begin the insuflation. A second beep marks the end of the insuflation when the time is elapsed. After this second beep, the stopwatch turns 1 more minute after having hanged up the handle.
Insuflation handle utilization The insuflation handle of your COOLSTAR device is a precision mechanical piece. It is highly recommended to handle it carefully and to avoid any fall. The insuflation handle of your COOLSTAR contains water. This water comes from air condensate when the COOLSTAR cools the air. When you manipulate it take care not to lean it more than 30° degrees from vertical (see Illustration 14). If unfortunately the handle is being lean of more than 30°, some water drops may appears out of the tip. This will cause an error in the air temperature as water could be on the temperature probe. In this case, first block the air flow with a finger for 20 to 30 seconds. After this, set a high temperature on your COOLSTAR in order to dry the handle head.
Illustration 14: Maximum handle inclination
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Instrumentation DIFRA
COOLSTAR User's manual
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Sound and visual signals Your COOLSTAR air insuflator is equipped with protections, which offer a maximum security in case of handling errors: Taking up the handle M (Illustration 15) when the desired set point temperature is not reached, the COOLSTAR emits slow intermittent sound signals (bleep-bleep) If one of the maximal temperature limits is been passed (0°C and 50.0°C), the COOLSTAR emits rapid intermittent signals and the display A (Illustration 15) indicates an error by displaying a " E " on the first digit. Change then the set point to decrease the outlet temperature.
A
M
E
B2 TA
TB TC
TD
Illustration 15: Error message
Cleaning
Avoid any liquid to penetrate inside the device Avoid use of corrosive substances
Depending of the surrounding, a monthly cleaning can be sufficient for the device. But as soon as its utilization can be spoiled due to its state, a cleaning has to be done. To clean the COOLSTAR, make sure the caloric irrigator is switched OFF. Wipe the device with a soft cloth carfully using a mild cleaning agent or disinfectant. We recommend the utilisation of product such “Sani-cloth Active” from ECOLAB. They enable to clean and desinfect surfaces in one operation.
Maintenance No service operations of any kind except regular cleaning and desinfection processes may be conducted by the user. Every week Water in the glass jar has to be exchange every week. See glass jar connection for the manipulation description. Clean the glass jar when you have throw the water and replace water by new demineralized water. See glass jar connection in the previous chapter to find a description of how to do this. DI090320/UM/01.8E
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Instrumentation DIFRA