CUDA LED-3000 User manual

LIT195 CUDA®Surgical Rev. B
(English) Date of Revision: 08/05/15
Page 1 of 69
LED-3000
(US PATENT 8,911,130)
LED Light Source
Operator Manual
ST Technologies
6018 Bowdendale Avenue
Jacksonville, FL 32216 USA
Customer Service: 904 208 2291
Toll Free 877 814 2237
EC|REP RMS UK, Ltd.
28 Trinity Road
Nailsea, Somerset BS48 4NU
United Kingdom
TEL: [phone]

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TABLE OF CONTENTS
1.
INTRODUCTION
1.1 INDICATIONS FOR USE
2.
WARNINGS
3.
SPECIFICATIONS
4.
OPERATING ELEMENTS, SYMBOLS AND FUNCTIONS
4.1
FRONT PANEL
4.2
REAR PANEL
5.
INSTALLATION
5.1
SETTING UP LIGHT SOURCE
5.2
CONNECTING LIGHT CABLE
6.
OPERATION
6.1
POWERING UP LIGHT SOURCE
6.2
LIGHT BRIGHTNESS CONTROL
6.3
DATA PORTS
7.
CLEANING
CLEANING THE UNIT
8.
DISINFECTION
8.1
DISINFECTING UNIT
9.
SERVICING & REPAIR
FUSE REPLACEMENT
10.
11.
12.
13.
END OF PRODUCT LIFE
TROUBLESHOOTING
CHART OF MEDICAL DEVICE SYMBOLS
CHART OF ELECTRICAL SYMBOLS USED

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1. INTRODUCTION
Congratulations on the purchase of your new LED-3000 Light Source!
This user-friendly LED light source is a high efficiency light source utilizing state-of-the-
art superior illumination technology. It offers a variety of features such as:
7000º K daylight brightness for good color definition
Quiet operation
Long life, 30,000 hrs.
Compact and light weight
Turret which adapts to various types of light guides
Pulse-width Modulation (PWM) Electrical Dimming
In short, you have chosen the best and we would like to make sure you receive the optimal
results with your new LED light source by using it correctly.
This Operator Manual will help you to install the device and optimally integrate it with other
components of your system. It will also instruct you how to operate the LED light source
and how to keep it clean. It will give you maintenance and service guidelines as well as
recommendations for best performance results.
1.1 INDICATIONS FOR USE: The LED light source is used to illuminate the site of
surgery during minimally invasive surgical procedures in arthroscopy (orthopedic
surgery), laparoscopy (general and gynecological surgery) and in Endoscopy
(general, gastroenterological and ENT surgery) The light is transmitted from the light
source through a fiber optic cable and a scope.

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2. WARNINGS/ CAUTION
Caution Federal law restricts this device to sale by or on the order of a licensed practioner.
Caution To prevent fire or electric shock, do not open or expose the light source unit to rain or
moisture. Refer all servicing to qualified personnel only.
Caution Not suitable for use in presence of flammable anesthetic mixture with air or with oxygen
or nitrous oxide.
Caution To prevent any potential electro-magnetic interference, do not use any kind of cellular
phone near the light source.
Caution This product should be used only with type BF endoscopic instruments which have been
certified according to IEC 60601-1 for medical equipment and IEC 60101-2-18 for endoscopic
equipment.
This symbol indicates type BF equipment.
Caution
This product is not provided as sterile.
WARNING
Do not modify this equipment without authorization of the manufacturer.
Caution All devices connecting to the LED light source must be classified as medical
equipment. When additional information processing equipment is connected to the LED Light Source,
the operator must determine that all equipment complies with the appropriate end-product standards
(such as IEC 60950 or IEC 60065 and the Standard for Medical System, IEC 60601-1-1).
WARNING The LED 3000 is a highly concentrated light source (luminous power per area) and
this high energy density is retained through connected lightguides and instruments. The output of a
connected instrument left in close proximity to tissue or flammable materials presents a risk of patient
injury or fire. Qualified personnel must determine a safe working distance and intensity setting for each
application. The output should never be left on unattended. Turn the light source off or place it in
standby if it will not be required for a period of time.
Caution The LED light source can cause permanent eye damage if viewed directly with
unprotected eye. To reduce the chance of eye damage, place the light source in standby mode when
light is not required.
Caution The fiber optic cable must be a NON-CONDUCTIVE CABLE. It should not have
conductive shielding or any other conductive connection between the patient and equipment. Such
connection will impair safety of the equipment. It must be rinsed free of soaking/disinfectant solution
and dried before plugging into the LED light source receptacle. Ensure the optical surface is clean
before engaging into the light source.

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Caution The proximal end tip of installed lightguides and accessories can become hot. Allow
end tips to cool before removing.
Caution The end user is responsible to verify the cable and port are correctly matched before
light guide insertion, otherwise cable or light source damage may occur.
Caution The LED-3000 is designed to work safely and optimally with Sunoptic Technologies
fused light guides. The end user should determine the risk of using non- Sunoptic Technologies®light
guides.
Caution If while in use there is a momentary power interruption the LED-3000 will shut-down
and automatically restart itself if the power switch remains in the ON position; however there may be a
restart delay as internal components reset for normal operation.

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3. SPECIFICATIONS
Item
Specification
Light Source type
LED (Light Emitting Diode)
Color temperature
5900º K - 7300º K
LED life
30,000 hours (typical)
Light guide adapter
Turret type to fit your choice of four: Storz, ACMI, Wolf,
Olympus
Brightness control
PWM (Pulse-width Modulation) –0-100% Dimming
Input voltage
100-240V AC, 50/60 Hz
Fuses
5x20mm, 250V, 2A, Type F
Rated Power
90 watt
Regulatory Approvals
UL60601-1, 3rd Edition and CE marked
Equipment Class
BF-type
Mode of Operation
Continuous operation
Water Resistant
Not Protected Equipment, IPX0
Operating Environment
Temperature
Relative Humidity
Air Pressure
+0° to +40° C (32° to 104° F)
0 to 85%rh, non condensing
700 to 1060 hPa
Storage Environment
Temperature
Relative Humidity
Air Pressure
-20° to +60° C (-4° to 140° F)
30 to 95%rh, non condensing
700 to 1060 hPa
Dimensions
11.22” W x 4.49” H x 13.23” D
Weight
7.55 lbs / 3.42 kg

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4. OPERATING ELEMENTS, SYMBOLS AND FUNCTIONS
4.1 FRONT PANEL
Figure 1. LED light source Front Panel
No.
Name
Function
1
Main power switch
Turns the cabinet power on/off
2
Stand-by power on/off
switch with indicator
light
Independently turns the LED light on and off. In the off mode an
indicator lamp will be lit. The LCD intensity display will remain on
and adjustable while in stand by mode
3
Warning Indicator light
Indicates internal malfunction. Contact Technical Support.
4
Light guide adapter
Turret model includes: Storz, ACMI, Wolf, Olympus
5
LCD Intensity Display
10 bar LCD display. Each bar represents approximately 10%
change in light output
6
Brighter, Up Button
Increases the Light intensity
7
Dimmer, Down Button
Decreases the Light intensity
4
4
5
6
1
3
7
2

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4.2 REAR PANEL
Figure 2. LED Light Source Rear Panel
No.
Name
Function
1
AC main inlet
Accepts AC Power cord
2
Fuse
2A, 250V (1/4” x 1 ¼”) time delay
3
Equalization Connector
For potential equalization
4
Exhaust Vent
Allows exhaust ventilation and cooling of the light source
5
Serial Port
Data exchange port
6
USB-B
Data exchange port
7
USB-A
Firmware Update (Factory Use Only)
8
Product Label
Product Label containing: Model Number, Serial Number,
Electrical Ratings, Manufacturer Name, Regulatory Marks
and FDA “Rx Only” Symbol.

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5. INSTALLATION
5.1 SETTING UP THE LED LIGHT SOURCE
Place the LED light source on a stable surface (cart, counter, stand, etc.).
NOTE
Avoid places where the light source may be splashed with liquid.
Absolutely DO NOT use in any environment with explosive or flammable
gases.
DO NOT block the venting grids of the light source or impede exhaust
air flow. Users must ensure that ventilation air temperatures are
below the maximum rating for the light source and are not influenced
by warm exhaust from other sources.
Make sure the power switch is in OFF position.
Connect AC power cord to the power inlet located on the rear panel of the light
source.
CAUTION
Use only cords provided with the light source.
Plug the AC power cord into a wall outlet using the three-prong plug supplied
with the unit.
CAUTION
To prevent electric shock, connect power cords of peripheral
equipment through medical isolation transformers.
NOTE
When using medical isolation transformer, be sure to check the
transformer power ratings.Make sure that the power cord is connected to
the main power with three-prong plug (USA use UL2601-1 rated isolation
transformers and/or power strips only).
5.2 CONNECTING THE FIBER OPTIC CABLE
Connect the light cable to the instrument and then plug the light cable end fitting into
the turret port on the front panel.
NOTE
The turret has a cable in place sensing feature that will not allow the LED
light to turn on without a fiberoptic cable inserted into the turret port.

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6. OPERATION
6.1 POWERING UP THE LED LIGHT SOURCE
To operate the LED light source:
Turn on the power switch, the indicator light in the power switch will light.
6.2 STANDBY BUTTON
The standby button will allow the user to turn the light on or off when the main power switch
is on provided a light tip is inserted in the active port.
Press AND HOLD this button momentarily for operation.
6.3LIGHT INTENSITY CONTROL AND DISPLAY
The light intensity is adjustable enabling the user to obtain a brighter or dimmer output by
pressing and holding or repeatedly pressing the up or down arrow buttons until the desired
illumination is reached.
There is an illuminated vertical bar graph LCD display for visual reference to the amount of
light intensity. Each lit segment represents 10% of the available intensity.
6.4 DATA PORTS
There are three (3) DATA Transfer Ports; USB Type ‘A’, USB Type ‘B’ and a Serial Port
located on the rear of the cabinet to allow communications between the lightsource and
other monitoring or controlling equipment.
For technical information concerning the DATA Ports or assistance please contact
Customer Service for details.
7. CLEANING
NOTE
Always disconnect the power cord before cleaning the system.
7.1 CLEANING THE UNIT
The unit can be cleaned with any cleaning agent, which is used for external cleaning of
electric equipment and according to instructions given by the manufacturer of the cleaning
solution.
Do not allow excessive moisture or liquids to come in direct contact with the unit.
Do not use cleaning agents that are not permitted for use with plastics, i.e., ammonia,
acetone, salty acids (HCl), etc.
Do not allow cleaning agents or liquids to enter the unit outlets or openings.
7.2 CLEANING THE OPTICS
Exercising proper care for the glass optic in your LED 3000 lightsource can help maintain
light quality and extend usable lifetime. Using the proper cleaning products and methods
are as important as cleaning the component itself.

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Cleaning Solutions
There are a variety of cleaning solutions you can use such as Reagent-Grade Isopropyl
Alcohol, Reagent-Grade Acetone and De-Ionized Water to ensure a long product lifetime.
A good solvent mix to use is a mix of 60% acetone* and 40% methanol. (Acetone alone
dries too quickly to dissolve all of the debris. The methanol slows the evaporation time, and
also dissolves debris that acetone alone would not clean.)
*Acetone should never be used on plastic optics or components as it will damage them.
Cleaning Procedure
Step #1
First use compressed air (aerosol can) to remove surface dust without directly contacting
any coating the optic may have. Wiping a dusty optic with cotton swabs or lens paper is
like cleaning it with sandpaper.
Step #2
Soak with solvent a Cotton-Tipped Swabs or Lens Tissue then use a circular motion
starting from the edge of the optic moving towards the center to wipe away any dust or dirt.
Repeat as necessary, each time use a new cotton swab or lens tissue.
8. DISINFECTION
8.1 DISINFECTING THE UNIT
NOTE
Always disconnect the power cord before cleaning the system.
Use any disinfectant agents which are commonly applied while disinfecting surfaces of
electric medical equipment. Such disinfectant agents are usually in the form of sprays or
damp cloths.
Follow the instructions given by the manufacturer of the disinfectant solution.
9. SERVICING AND REPAIR
Defective items of equipment are to be serviced and repaired exclusively by persons
authorized by the manufacturer. All repair work shall employ original manufacturer’s parts
only.
9.1 FUSE REPLACEMENT
CAUTION
Always disconnect power cord and turn main switch off before fuse
replacement.
Turn light source off and unplug power cord. On back of unit remove the fuse holder located
in the power cord receptacle and pull out fuse holder. Replace fuses with 3 AMP Slow-Blow
250V rated fuse. Insert holder back into fuse housing.
Re-connect the power cord and turn the LED light source on according to section 6.1.

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9.2 LIMITED WARRANTY
Your LED-3000 light source carries a 3-year warranty from the date of shipment on
workmanship and all defects of material. Should your product prove to have such defects
within three years from the date of shipment from ST Technologies, we will repair or
replace the product or component part without charge. Should your LED-3000 light source
need servicing under this warranty, please contact ST Technologies for return
authorization documentation. You should carefully pack the unit in a sturdy carton and ship
it to the factory. Please include a note describing the defects, your name, telephone
number and a return address. Warranty does not cover equipment subject to misuse,
accidental damage, normal wear and tear or if transferred to a new owner without
authorization from ST Technologies.This warranty gives you specific legal rights and you
may also have other rights that vary from state to state.
POST WARRANTY REPAIRS: You may return your product(s) for repair, shipping prepaid to
the factory. Your product will be inspected and an estimate of repair charges will be submitted
to you for approval. Payment must be received before repairs are completed.
In the US: 877-814-2237 (toll free)
Customer Service 904-208-2291
10. END OF PRODUCT LIFE
In accordance with the European Waste from Electrical and Electronic Equipment (WEEE)
directive, we encourage our customers to recycle this product whenever possible. Disposal
of this unit must be performed in accordance with the applicable local environmental
regulations.
In the US a list of recyclers in your area can be found at: http:/www.eiae.org/.
Please contact our Repair Department to issue a return authorization to return product to
manufacturer at the end of product life.
11. TROUBLESHOOTING
Problem
Solution
Main switch power
indicator (refer to 4.1) is not
lit when switched on.
Check that the AC power cord is properly connected.
Check the unit fuses. If necessary, replace.
The power indicator is lit,
but lamp is still off.
Press Stand-by switch to turn on the LED.
Increase the LED intensity.

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12. CHART OF MEDICAL DEVICE SYMBOLS USED
Manufacturer
Date of manufacture
(YYYYMM or YYYY)
EC | REP
Symbol for “Authorized Representative in the
European Community.”
Caution, consult accompanying documents
Caution: Federal law restricts this device to
sale by or on the order of a (licensed
healthcare practitioner)
Consult Instructions for Use
CE mark
Not for disposal in general waste
Caution: Hot Surface
Caution: Dangerous Voltage
Product Safety Mark
Do not use if package is damaged.
13.CHART OF ELECTRICAL SYMBOLS USED
AC Current
Equipotentiality
Power on
Power off
Type BF
Protective Earth (Ground)
Product labeling Product label containing model number, serial number, electrical
ratings, manufacturer name, Regulatory marks, and FDA “Rx Only” symbol.

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LED-3000
(US PATENT 8,911,130)
Source de lumière à LED
Manuel d'utilisation
ST Technologies
6018 Bowdendale Avenue
Jacksonville, FL 32216 USA
Service à la clientèle : 904 208 2291
Appel sans frais 877 814 2237
EC|REP RMS UK, Ltd.
28 Trinity Road
Nailsea, Somerset BS48 4NU
Royaume-Uni
TEL: [phone]

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TABLE DES MATIÈRES
1.
INTRODUCTION
1.1NOTICE D’UTILISATION
2.
AVERTISSEMENTS
3.
SPÉCIFICATIONS
4.
ÉLÉMENTS DE COMMANDES, SYMBOLES ET FONCTIONS
4.1
PANNEAU AVANT
4.2
PANNEAU ARRIÈRE
5.
INSTALLATION
5.1
INSTALLATION DE LA SOURCE DE LUMIÈRE
5.2
CONNEXION DU CABLE OPTIQUE
6.
FONCTIONNEMENT
6.1
MISE SOUS TENSION DE LA SOURCE DE LUMIÈRE
6.2
CONTRÔLE DE LA LUMINOSITÉ
6.3
PORTS DE CONNEXION
7.
NETTOYAGE
NETTOYAGE DE L'APPAREIL
8.
DÉSINFECTION
8.1
DESINFECTION DE L'APPAREIL
9.
ENTRETIEN ET RÉPARATION
REMPLACEMENT DE FUSIBLES
10.
11.
12.
13.
FIN DE CYCLE DE VIE DU PRODUIT
DÉPANNAGE
TABLEAU DES SYMBOLES UTILISÉS POUR LES APPAREILS
MÉDICAUX
SYMBOLES ELECTRIQUES

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1. INTRODUCTION
Félicitations pour l'achat de votre nouvelle source de lumière LED-3000 !
Cette source de lumière à LED à haute performance, facile à utiliser, bénéficie de la
technologie d'éclairage de pointe. Elle offre une variété de fonctions telles que :
7000º K de luminosité en lumière du jour pour une bonne définition de la couleur
Fonctionnement silencieux
Longue durée de vie, 30.000 heures.
Compacte et légère
Tourelle qui s'adapte aux différents types de guides de lumière
Gradation électrique par modulation de largeur d'impulsion (PWM)
En résumé, vous avez choisi l’excellence et nous tenons à nous assurer que vous obtenez
les meilleurs résultats avec votre nouvelle source de lumière à LED en l'utilisant
correctement.
Ce Manuel d'utilisation vous aidera à installer l'appareil et à l'intégrer de façon optimale
avec les autres composants de votre système. Il vous indiquera également comment faire
fonctionner la source de lumière à LED et comment la garder propre. Il vous donnera des
instructions d'entretien et de réparation ainsi que des recommandations pour obtenir les
meilleurs résultats et performances.
1.1 MODE D'EMPLOI : La source de lumière à LED est utilisée pour l'éclairage du
champ opératoire pendant les interventions mini invasives pour les spécialités telles
que l'arthroscopie (chirurgie orthopédique), la laparoscopie (chirurgie générale et
gynécologique) et l'endoscopie (chirurgie générale, gastro-entérologie et ORL). La
lumière est transmise à partir de la source de lumière grâce à un câble à fibres
optiques et un oscilloscope.

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2. AVERTISSEMENTS / MISE EN GARDE
Mise en garde La loi fédérale impose que ce dispositif soit limité à la vente par ou sur l'ordre d'un
praticien agréé.
Mise en garde Afin d’éviter tout risque d’incendie ou de décharge électrique, ne pas ouvrir ou
exposer la source de lumière à la pluie ou à l'humidité. Confier toute réparation à un personnel qualifié.
Mise en garde Ne convient pas à une utilisation en présence de produit anesthésique
inflammable avec l'air, l'oxygène ou l'oxyde nitreux.
Mise en garde Pour éviter toute interférence électromagnétique éventuelle, ne pas utiliser de
téléphone portable à proximité de la source de lumière.
Mise en garde Ce produit doit être utilisé uniquement avec des instruments endoscopiques de
type BF qui sont certifiés selon la norme IEC 60601-1 pour les équipements médicaux et IEC 60101-2-
18 pour les équipements endoscopiques.
Ce symbole indique un équipement de type BF.
Mise en garde
Ce produit n'est pas stérile à la livraison.
AVERTISSEMENT
Ne pas modifier cet appareil sans l'autorisation du constructeur.
Mise en garde Tous les appareils branchés à la source de lumière à LED doivent être classés
comme équipement médical. Lorsque du matériel supplémentaire de traitement de l'information est
relié à la source de lumière à LED, l'opérateur doit s'assurer que le matériel est conforme aux normes
de produits finis appropriées (telles que IEC 60950 ou IEC 60065 et la norme pour système médical,
IEC 60601-1-1).
AVERTISSEMENT La LED-3000 est une source lumineuse à lumière très concentrée
(puissance lumineuse par unité de surface) et cette densité d'énergie élevée est conservée grâce aux
guides de lumière et appareils auxquels il est raccordé. Tout flux lumineux sortant d’appareils
raccordés au dispositif qui se trouve à proximité de tissus ou matériaux inflammables présente un
risque de blessure ou d'incendie. Le personnel qualifié doit déterminer une distance de travail de
sécurité et le réglage de l'intensité appropriés pour chaque application. La sortie ne doit jamais être
laissée sans surveillance. Éteindre la source de lumière ou la placer en mode veille si elle ne doit pas
être utilisée pendant un certain temps.
Mise en garde La source de lumière à LED peut causer des dommages oculaires permanents, si
les yeux sont dirigés directement vers la lumière sans protection . Pour réduire le risque de lésions
oculaires, il est recommandé de laisser la source de lumière en mode veille lorsque la lumière n'est pas
nécessaire.

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Mise en garde Le câble à fibres optiques doit être un CABLE NON CONDUCTEUR. Il ne doit
pas y avoir de blindage conducteur ou toute autre raccordement conducteur entre le patient et
l'équipement. Un tel raccordement nuirait à la sécurité de l'équipement. L’équipement doit être rincé de
toute solution de nettoyage/ désinfectant et séché avant d'être branché au réceptacle de la source de
lumière à LED. S'assurer que la surface optique est propre avant le branchement à la source de
lumière.
Mise en garde L'extrémité proximale des guides de lumière et accessoires installés peuvent
devenir très chauds. Laisser les extrémités refroidir avant de les retirer.
Mise en garde L'utilisateur final est responsable de vérifier que le câble et le port sont
correctement adaptés avant l'insertion du guide de lumière, afin d’éviter d'endommager le câble ou la
source lumineuse.
Mise en garde Le LED-3000 est conçu pour fonctionner en toute sécurité et de façon optimale
avec les guides de lumière Sunoptic Technologies® intégrés. L'utilisateur final doit déterminer le risque
d'utiliser des guides de lumière qui ne sont pas de la marque Sunoptic Technologies®.
Mise en garde Si en cours d'utilisation, une interruption momentanée de l'alimentation électrique
se produit, le LED-3000 s'éteindra et redémarrera automatiquement si l'interrupteur reste en position
ON (allumé), il peut, cependant y avoir un délai de redémarrage, tandis que les composants internes se
réinitialisent pour reprendre un fonctionnement normal.

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3. SPÉCIFICATIONS
Point
Spécifications
Type de source lumineuse
LED (diode électroluminescente)
Température de couleur
5900º K - 7300º K
Durée de vie de la LED
30.000 heures (typique)
Adaptateur de guide de
lumière
Type tourelle pour s'adapter à votre choix de quatre : Storz,
ACMI, Wolf, Olympus
Contrôle de la luminosité
Modulation de largeur d'impulsion (PWM) - gradation 0-
100%
Tension d'entrée
100-240V CA, 50 / 60 Hz
Fusibles
5 x 20 mm, 250 V, 2 A, Type F
Puissance nominale
90 watt
Autorisations
réglementaires
UL60601-1, 3ème Édition et marquage CE
Catégorie d'équipement
Type BF
Mode de fonctionnement
Fonctionnement continu
Résistance à l'eau
Matériel non protégé, IPX0
Environnement de
fonctionnement
Température
Humidité relative
Pression d'air
+0° à +40° C (32° à 104° F)
0 à 85 % d'humidité relative, sans condensation
700 à 1060 hPa
Environnement de
stockage
Température
Humidité relative
Pression d'air
-20° à +60° C (-4° à 140° F)
30 à 95 % d'humidité relative, sans condensation
700 à 1060 hPa
Dimensions
Largeur 11,22 po x Hauteur 4,49 po x Profondeur 13,23 po
Poids
7,55 livres / 3,42 kg

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4. ÉLÉMENTS DE COMMANDES, SYMBOLES ET FONCTIONS
4.1 PANNEAU AVANT
Figure 1. Panneau avant de la source de lumière à LED
No.
Nom
Fonction
1
Interrupteur principal
d’alimentation
Permet la mise sous / hors tension de l’appareil
2
Interrupteur marche /
arrêt de la mise en veille
avec témoin lumineux
Allume et éteint de manière indépendante la lumière LED. En
mode éteint, un voyant lumineux s'allume. L'écran LCD de
l'intensité reste allumé et réglable en mode veille
3
Voyant lumineux
d'avertissement
Indique un dysfonctionnement interne. Contactez le soutien
technique.
4
Adaptateur de guide
lumière
Le modèle tourelle comprend : Storz, ACMI, Wolf, Olympus
5
Écran LCD de l'intensité
Écran LCD à 10 bars. Chaque barre représente environ 10 %
de variation du flux lumineux
6
Bouton du haut,
augmente la luminosité
Augmente l'intensité lumineuse
7
Bouton Bas, atténue la
luminosité
Diminue l'intensité lumineuse
4
4
5
6
1
3
7
2