Model 9X3-C StarTrol Ceiling Mounted LED Medical Lighting System Installation & Operating Manual

Transcription

1 Model 9X3-C StarTrol Ceiling Mounted LED Medical Lighting System Installation & Operating Manual MADE IN USA April 21, 2010

2 Table of Contents page 1. Introduction 2 2. Safety Symbol definitions Safety agreement Transportation and Storage Conditions 3 3. Customer Responsibility agreement 4 4. Technical Description/ Specifications 4 5. Disposal 4 6. Contents and Assembly Pre-installation Contents and Packaging Installation and Assembly 8 7. Operating Instructions Activation Adjustments Troubleshooting Maintenance LED Replacement Preventative Maintenance Cleaning and Disinfecting Procedures Warranty Limited Warranty Disclaimers and Limitations Claims Procedure Customer Responsibilities Miscellaneous EMC Information 18 Pg. 1 Revision 0.1

3 1. Introduction Dear Customer, Thank you for your purchase of Huot Instruments StarTrol LED medical lighting system. We trust that our product will fulfill all of your illumination requirements and expectations. We are sure that you will find this StarTrol medical product easier, safer, and more maintenance-free than other lighting systems. Our led light uses 1/3 the electricity of traditional medical lights, yet provides superior lighting. At Huot Instruments, the needs and concerns of the customer are our primary concern. Our sales and service staff will be happy to assist you in any way possible. We are an American company and all of our products are made in the U.S.A. Again, we thank you for your purchase and look forward to providing to you a quality lighting experience. Sincerely, Rich Ward Huot Instruments, LLC Pg. 2 Revision 0.1

4 2. Safety/Warnings 2.1 Symbol definitions CAUTION Indicates a potentially hazardous situation which, if not avoided, may result in equipment damage, serious injury, or death. NOTE Y Indique une situation potentiellement dangereuse qui, si elle n'est pas évitée, peut entraîner des dommages matériels ou des blessures graves ou fatales. Is used to amplify an operating procedure, practice, or condition. Sert à amplifier une procédure, un protocole ou une condition. Indicates that the operator s High light intensity manual should be consulted. OFF Low light intensity ON Indicates a protective earth ground. Standby Type B applied part 2.2 Safety agreement The foremost concern of Huot Instruments is that this equipment be operated and maintained with the safety of users in mind. To assure safe and reliable operation, it is required you read this manual before installing or operating your StarTrol medical light. All appropriate personnel must be informed of the necessary components of this manual. It is strongly suggested that this manual be kept in close proximity to your StarTrol equipment. 2.3 Transportation and Storage Conditions Ambient Temperature Range: -30 C to +60 C (-22 F to 140 F) Relative Humidity: 10% to 95% (non-condensing) Atmospheric Pressure: 500 hpa to 1060 hpa (0.5 bar to 1.06 bar) Pg. 3 Revision 0.1

5 3. Customer Responsibility agreement Before using this product, the operator must be fully familiar with its proper care, function, and maintenance. The customer is responsible for compliance with applicable local and national codes and regulations. 4. Technical Descriptions/ Specifications Power Supply Light Source Light Field Diameter Color Temperature Color Rendering Index 94 Total Irradiance Internal sensing 115/230 V AC 1900mA 50-60Hz (9) LED light cluster assemblies housing 3 lights each 185 d 50 (mm) 4745 K 117 Watts/m² Medical Standard Class 2 Mode of Operation Continuous Shadow Dilution.01% - 99% Certifications IEC : 2000 CAN/CSA-C22.2 No M90 Central Illuminance 41,500 Lux Depth of Illumination 1702 mm The StarTrol LED minor surgical lighting system is a class 2 AC powered device that provides a field of illumination for general examination and surgery. This unit has ordinary protection against the ingress of water. Do not expose equipment to water. 5. Disposal It is the responsibility of the end user to dispose of equipment at a designated recycling collection point. Pg. 4 Revision 0.1

6 6. Contents and Assembly 6.1 Pre Installation CAUTION: ENSURE UNIT IS NOT UNDER POWER (PLUGGED IN) PRIOR TO ASSEMBLY. ASSUREZ-VOUS QUE L'APPAREIL NE SOIT PAS SOUS TENSION (BRANCHÉ) AVANT DE LE MONTER. UNIT IS HEAVY. TWO PEOPLE ARE REQUIRED FOR ASSEMBLY. L'APPAREIL EST LOURD. L'APPAREIL DOIT ÊTRE MONTÉ PAR DEUX PERSONNES. THIS UNIT HAS ORDIANRY PROTECTION AGAINST THE INGRESS OF WATER. DO NOT EXPOSE EQUIPMENT TO WATER. L'APPAREIL DISPOSE D'UNE PROTECTION ORDINAIRE CONTRE LA PÉNÉTRATION D'EAU. NE PAS EXPOSER L'APPAREIL À L'EAU. INTALATION MUST BE PERFORMED BY QUALIFIED INDIVIDUALS. NOTE: L'INSTALLATION DOIT ÊTRE EFFECTUÉE PAR DU PERSONNEL QUALIFIÉ. Tools required for assembly are included in accessory bag. Les outils requis pour monter l'appareil sont inclus dans le sac d'accessoires. The StarTrol LED minor surgical lighting system is a class 2 AC powered device that provides a field of illumination for general examination and surgery. Le système d'éclairage chirurgical à DÉL (diode électroluminescente) de StarTrol TM est un appareil à courant alternatif de catégorie 2 qui fournit un champ d'illumination pour l'oscultation et les interventions chirurgicales. If user experiences EM interference, remove light or source of interference from immediate area. Si l'utilisateur rencontre de l'interférence électromagnétique, retirer la lampe ou la source d'interférence de la zone concernée. This light is rated to withstand 35lbs (16kg) of force L'appareil peut résister à des chocs de 16 kg. Unit must be secured to permanent support structure L'appareil doit être fixé à un support permanent. Pg. 5 Revision 0.1

7 Figure Mounting Bracket Hole Alignment Figure Minimum Clearances To Achieve Floor to Light If Drop Ceiling is B Distance of A Mount bottom of Power Supply Housing From Floor At C 63 inches (1600 mm) 7.5 feet (2280 mm) 98 inches (2489 mm) 63 inches (1600 mm) 8.0 feet (2440 mm) 98 inches (2489 mm) 68 inches (1600 mm) 8.0 feet (2440 mm) 103 inches (2616 mm) 75 inches (1727 mm) 9.0 feet (2740 mm) 110 inches (2794 mm) Pg. 6 Revision 0.1

8 6.2 Contents and Packaging figure figure d. (a) (1) Balance arm assembly (b) (1) Counterweight (c) Z-arm assembly (d) (1) Accessory bag Instruction Manual Warranty Card (i) Sterilizable handle (ii) (1) 1/8 allen wrench (iii) (1) 5/16 allen wrench (iv) (3) x ½ flat-head screws (v) (1) 3/8 x 4 bolt (vi) (1) bezel (3) set screws included (e) (1) 10 foot External power cord ( part #: EI.0087) Pg. 7 Revision 0.1

9 6.3 Installation and Assembly 1. Locate the permanent support members to which the unit is to be affixed. 2. Consult figure to determine optimal mounting height for power supply. Mark position on wall using figure as a guide. Light should be placed in location with adequate clearances, as defined in figure Attach lag bolts (not included) to wall at marked points. NOTE: EACH LAG BOLT MUST BE CAPABLE OF RESISTING PULL OUT AND SHEAR FORCES OF 100 POUNDS (45kg). MINIMUM SCREW/BOLT USED FOR MOUNTING SHOULD BE 3/8 DIAMETER. 4. Mount Z-arm (c) to lag bolts using mounting bracket on power supply. 5. If installing with drop-ceiling, mark location of arm center pivot on ceiling tile. Cut out marked location leaving adequate clearance for Z-arm (c) to pivot freely. 6. Through removed area, slide ceiling tile over Z-arm (c) and return to original location in ceiling. 7. Slide bezel (vi) over Z-arm (c) adjacent with ceiling tile. Affix bezel to Z-arm using included set-screws. 8. Insert threaded rod on face of light head into corresponding recess of sterilizable handle (i). Rotate handle clockwise to fasten. Pg. 8 Revision 0.1

10 9. With assistance, position balance arm assembly (a) below mounted Z-arm (c). 10. Join connector from balance arm assembly (a) to connector in Z-arm (c). Connectors will click when properly connected. 11. Align holes in exposed end of Z-arm (c) with holes in yolk of arm assembly (a) and raise into place. Protruding end of vertical pole should be inserted into flange of balance arm assembly. 12. Fasten three x ½ flat-head screws (iv) as hole aligns with corresponding recesses in Z-arm pole (c). Tighten with 1/8 allen wrench (ii). Pg. 9 Revision 0.1

11 13. With assistance, hold arm assembly (a) in the horizontal position and slide counterweight (b) onto end of arm assembly. Fasten counterweight to arm assembly using 3/8 x 4 bolt (v). Tighten with 5/16 allen wrench (iii). 7. Operating Instructions 7.1 Activation figure 7.1 CAUTION: DO NOT USE UN-GROUNDED OUTLETS. NE PAS UTILISER DE PRISES DE COURANT SANS TERRE. THIS UNIT HAS ORDINARY PROTECTION AGAINST THE INGRESS OF WATER. DO NOT EXPOSE EQUIPMENT TO WATER. L'APPAREIL DISPOSE D'UNE PROTECTION ORDINAIRE CONTRE LA PÉNÉTRATION D'EAU. NE PAS EXPOSER L'APPAREIL À L'EAU. Pg. 10 Revision 0.1

12 1. After successful assembly and installation of your StarTrol Lighting system, plug the hospital grade plug into an appropriate hospital grade outlet. 2. Set main power switch on power supply to the ON position. 3. Activate touch-sensitive stand-by switch on back side of lighthead by touching the area indicated in figure Adjustments 1. Light intensity can be adjusted utilizing the two touch-sensitive controls on back side of the lighthead. Adjust brightness by touching areas indicated in figure To adjust position of light, grasp sterile handle, then rotate arm assemblies and lighthead as necessary to obtain correct light position on target. 8. Troubleshooting Problem Probable Cause Solution No light from lighthead. Standby indicator light not illuminated. Power supply indicator light not illuminated. Power is turned off, or unit is not connected to a power source. Turn on main power switch on power supply. Make sure unit is plugged into proper outlet. If problem still cannot be resolved contact customer service. No light from lighthead. Standby indicator light not illuminated. Connection-point disruption Power supply malfunction (866) Check all wiring connections. If problem still cannot be resolved contact customer service. (866) Contact customer service. (866) Light from lighthead flickers or turns off when arm assembly is moved. Other problems Lighthead malfunction Circuit or wiring problem within arm assembly. Contact customer service. (866) Check wiring at armassembly connection point. If problem still cannot be resolved contact customer service. (866) Contact customer service (866) Pg. 11 Revision 0.1

13 9. Maintenance CAUTION: MAKE SURE PLUG IS REMOVED FROM OUTLET, AND POWER IS TURNED OFF BEFORE PERFORMING ANY INTERNAL MAINTENANCE. S'ASSURER QUE LA PRISE EST DÉBRANCHÉE DU COURANT ET QUE L'APPAREIL EST HORS TENSION AVANT D'EFFECTUER DE L'ENTRETIEN À L'INTÉRIEUR. IT IS IMPARATIVE THAT ONLY QUALIFIED INDIVIDUALS ARE ALLOWED ACCESS TO ELECTRICAL COMPONENTS OF LIGHT. IL EST IMPÉRATIF QUE SEUL DU PERSONNEL QUALIFIÉ AIT ACCÈS AUX COMPOSANTS ÉLÉCTRIQUES DE LA LAMPE. 9.1 LED Replacement The LED light source for the StarTrol medical light is designed never to need replacing. If for some reason LED failure is suspected, please see the Troubleshooting guide in section 8 of this manual or contact a customer service representative at (866) Preventative Maintenance Certain procedures should be performed on a semiannual schedule. Recommended semiannual preventative maintenance tasks include: Inspect rotation of lighthead. Make certain lighthead rotates freely, without noise, and has full rotation at lighthead joint. Make sure the lighthead is able to stay positioned at any point with respect to the balance arm assembly. Turn the light on. Rotate lighthead, and other moving components of the lamp while observing light output. Output should not stop, flicker, or vary while lamp is in motion. Inspect for excessive or restricted joint rotation. If movement is impaired, Physical hard stops for axis may be damaged. While light is turned off, inspect faceplate for indications of broken material or damage. Inspect lighthead for excessive dirt buildup. Pg. 12 Revision 0.1

14 9.3 Cleaning and Disinfecting Procedures CAUTION: APPROPRIATE PROTECTIVE AND SAFETY GEAR SHOULD ALWAYS BE USED WHILE CLEANING. TOUJOURS PORTER L'ÉQUIPEMENT DE SÉCURITÉ ET DE PROTECTION APPROPRIÉ PENDANT LE NETTOYAGE. POWER TO UNIT SHOULD BE DISCONNECTED BEFORE ANY CLEANING PROCEDURES ARE PERFORMED. LA SOURCE D'ALIMENTATION DE L'APPAREIL DOIT ÊTRE DÉBRANCHÉE AVANT D'EFFECTUER UNE PROCÉDURE DE NETTOYAGE QUELCONQUE. MAKE CERTAIN UNIT IS COMPLETELY DRY BEFORE RESTORING POWER. S'ASSURER QUE L'APPAREIL EST COMPLÈTEMENT SEC AVANT DE LE REMETTRE SOUS TENSION. TO AVOID PRODUCT DAMAGE, NEVER APPLY CLEANING PRODUCT DIRECTLY ONTO UNIT. ADMINISTER A SMALL AMOUNT OF INDICATED CLEANER TO SOFT CLOTH AND APPLY TO DESIRED AREA. POUR ÉVITER D'ENDOMMAGER LE PRODUIT, NE JAMAIS APPLIQUER DE PRODUIT NETTOYANT DIRECTEMENT SUR L'APPAREIL. VERSER UNE PETITE QUANTITÉ DU NETTOYANT INDIQUÉ SUR UN CHIFFON DOUX ET APPLIQUER SUR LA ZONE VOULUE. USE OF CERTAIN CLEANSERS MAY CAUSE CLOUDING OF ACRYLIC LENSES. L'UTILISATION DE CERTAINS PRODUITS NETTOYANTS PEUT RENDRE TROUBLES LES LENTILLES EN ACRYLIQUE. PITTING, DISCOLORATION OR SOFTENING COULD OCCUR IF ALCOHOL, PHENOLIC, IODOPHOR, OR GLUTARALDEHYDE BASED CLEANERS OR DISINFECTANTS ARE USED ON PLASTIC COMPONENTS OF LIGHT. L'UTILISATION DE PRODUITS NETTOYANTS OU DÉSINFECTANTS À BASE D'ALCOOL, DE PHÉNOLS, D'IODOPHORES OU DE GLUTARALDÉHYDE SUR LES PARTIES EN PLASTIQUE DE LA LAMPE PEUT ENTRAÎNER CORROSION, DÉCOLORATION OU RAMOLLISSEMENT. Pg. 13 Revision 0.1

15 10. Warranty The covers and frame may easily be cleaned with a soft damp cloth and a mild soap water solution. Lenses should be cleaned with acrylic-safe glass cleaner and soft cloth. Metal components can be cleaned with a damp cloth and mild soap water solution. Periodically clean the light head vents to ensure uninterrupted convection of ambient air. Handles may be sterilized using autoclave: Refer to your individual autoclave operator s manual to determine the proper setting for sterilization. Replacement handles can be ordered through any authorized distributor. It is recommended cleaning procedures are performed on a weekly basis, and as needed depending on use Limited Warranty Huot Instruments, LLC warrants that the product, if properly used, will be free from defects in material and workmanship, for a period of ten (10) years from the date of shipment to the customer. This limited warranty extends only to the original buyer. If the product is determined to be defective within the warranty period, Huot Instruments, at its option, will repair or replace the product, at no charge or refund the then-current value of the product Disclaimers and Limitations This limited warranty shall be the sole remedy of the customer and the sole liability of Huot Instruments to the customer. This warranty is valid only under the condition that included warranty card is completed by the customer and received by the manufacturer within thirty (30) days of purchase. This limited warranty does not extend or apply to any defects, failure, or damage due to or resulting from: (a) acts of God, accident, misuse, use of the product other than its normal and customary manner, abuse or negligence; (b) everyday wear and tear; (c) alteration or modification of, or to any part of, the product; (d) improper operation and maintenance; or (e) any repairs or attempted repairs by anyone other than Huot Instruments, LLC. This warranty does not cover any products sold AS IS or WITH FAULTS. This limited warranty excludes the replacement of fuses for the product. TO THE FULL EXTENT PERMITTED BY APPLICABLE LAW, THIS LIMITED WARRANTY REPLACES ALL OTHER WARRANTIES OR CONDITIONS, EXPRESS OR IMPLIED INCLUDING, WITHOUT LIMITATION, ANY AND ALL IMPLIED WARRANTIES OF Pg. 14 Revision 0.1

16 MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. HUOT INSTRUMENTS, LLC DISCLAIMS ALL OTHER WARRANTIES AND CONDITIONS, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITAION, IMPLIED WARRANTIES OF TITLE, NONINFRINGEMENT, ABSENCE OF LIENS OR INCUMBRANCES, MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, REGARDLESS OF WHETHER HUOT INSTRUMENTS KNOWS OR HAS REASON TO KNOW IF THE CUSTOMER S PARTICULAR NEEDS. IF IMPLIED WARRANTIES MAY NOT BE DISCLAIMED UNDER APPLICABLE LAW, THEN ANY IMPLIED WARRANTIES THAT MAY BE IMPOSED BY LAW ARE LIMITED IN DURRATION TO THE LIMITED WARRANTY PERIOD SET FORTH HEREIN, AND THEREAFTER ANY IMPLIED WARRANTIES ARE EXPRESSLY DISCLAIMED. No agent, dealer, reseller, or distributor of Huot Instruments, LLC is authorized to modify this limited warranty, or to make any additional warranties. REPAIR, REPLACEMENT, OR REFUND, AS APPROVED UNDER THIS LIMITED WARRANTY, ARE CUSTOMER S SOLE AND EXCLUSIVE REMEDIES. IN NO EVENT SHALL HUOT INSTRUMENTS, LLC BE LIABLE FOR ANY DIRECT, INDIRECT, SPECIAL, INCIDENTAL CONSEQUENTIAL OR TORT DAMAGES OR LOSSES, WHETHER TO PERSON OR PROPERTY, INCLUDING DEATH, ARISING OUT OF OR RESULTING FROM ANY BREACH OF WARRANTY OR ANY OTHER LEGAL THEORY, OR ARISING OUT OF OR IN CONNECTION WITH THE PRODUCT OR THE CUSTOMER S USE OF THE PRODUCT, EVEN IF HUOT INSTRUMENTS IS ADVISED OF THE POSSIBILITIES OF SUCH DAMAGES. IN ANY EVENT, THE TOTAL LIABILITY OF HUOT INSTRUMENTS, LLC TO THE CUSTOMER FOR ANY CAUSE WHATSOEVER SHALL BE LIMITED TO THE PURCHASE PRICE PAID FOR THE PRODUCT. THIS LIMITIATION SHALL APPLY REGARDLESS OF THE FORM OF ACTION, WHETHER IN CONTRACT OR IN TORT (INCLUDING, WITHOUT LIMITIATION, NEGLIGENCE). SOME STATES DO NOT ALLOW THE EXCLUSION OR LIMITATIONS OF INCIDENTAL OR CONSEQUENTIAL DAMAGES, OR ALLOW LIMITATIONS ON HOW LONG AN IMPLIED WARRANTY LASTS, SO THE ABOVE LIMITATIONS OR EXCLUSIONS MAY NOT APPLY. THIS LIMITED WARRANTY GIVES SPECIFIC LEGAL RIGHTS, AS WELL AS RIGHTS WHICH VARY FROM STATE TO STATE. Pg. 15 Revision 0.1

17 10.3 Claims Procedure (a) Customer must contact Huot Instruments, LLC at (866) with a request for warranty service or to report a technical issue. Huot Instruments technical support will attempt to identify, diagnose, and resolve the reported problem via telephone. (b) If attempts by Huot Instruments to resolve a reported problem are unsuccessful, the customer will then be provided with a customer-specific Return Merchandise Authorization number ( RMA ). The RMA must be noted on any correspondence to Huot Instruments, LLC and displayed prominently on the outside packaging of any product shipped to Huot Instruments. (c) Within ten (10) days of receipt of the RMA number, the customer must ship the product to Huot Instruments at their expense (insuring the product is recommended) in either its original packaging or packaging affording an equal degree of protection, to Huot Instruments, LLC N50 W13740 Overview Drive, Suite A Menomonee Falls, WI 53051, along with a statement describing the problem in reasonable specificity. Huot Instruments will not be held responsible for shipping damages that occur in transit. Any damage to the product during shipping will not be covered under this limited warranty and shall be subject to a service charge. (d) Subject to the limitations herein, upon receipt, Huot Instruments will inspect the shipped product with the same or a like product to the extent it does not conform to this limited warranty. In the event Huot Instruments, at its sole discretion, opts to replace the product, should said product be discontinued or no longer offered for sale by Huot Instruments, a like product in design and functionality will be provided to the customer. (e) Huot Instruments will ship the repaired product or a replacement to the customer within ten (10) business days after receipt from the date that Huot Instruments receives the product. Standard shipments to the customer will be paid by Huot Instruments, LLC. Huot Instruments assumes no responsibility for shipment delays by the carrier Customer Responsibilities (a) The customer is required to follow the user manual associated with the product for proper operation (b) The customer is required to perform periodic preventative maintenance as called for in the user manual associated with the product. (c) Any modifications or repairs made to the product without prior written authorization from Huot Instruments will render this limited warranty void Miscellaneous In the event that any provision of this limited warranty should be or becomes invalid and/or unenforceable during the warranty period, the remaining provisions shall continue in full force and effect. Pg. 16 Revision 0.1

18 The provisions of this limited warranty shall be governed by the laws of the state of Wisconsin without regard to its conflict of laws principles. This limited warranty shall not be modified except by an agreement signed by both parties specifically referencing this limited warranty. This limited warranty represents the entire agreement between Huot instruments, LLC and the customer with respect to the subject matter herein and supersedes all prior or contemporaneous written or oral communications, representations, understandings, or agreements relating to this subject. For service assistance or resolution of a service problem, or for product or warranty information, write to: Huot Instruments, LLC N50 W13740 Overview Drive Suite A, Menomonee Falls, WI or visit Pg. 17 Revision 0.1

19 11. Electromagnetic Interference Information NOTE: Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this manual. Les appareils électriques médicaux font l'objet de précautions spéciales concernant la CEM et doivent être installés et mis sous tension en suivant les directives sur la CEM contenues dans ce manuel. Portable and mobile RF communications equipment can affect medical electrical equipment Les appareils de communication portables à fréquence radio peuvent affecter les appareils électriques médicaux. The use of accessories, transducers, and cables other than those specified by the manufacturer may result in increased emissions or decreased immunity of this product. L'utilisation d'accessoires, de transducteurs et de câbles autres que ceux spécifiés par le fabricant peut entraîner des émissions plus fortes ou rendre moins efficaces les protections de ce produit. The 9x3 LED light should not be used adjacent to or stacked with other equipment if adjacent or stacked use is necessary, the product should be observed to verify normal operation in the configuration in which it will be used. La DÉL (diode électroluminescente) 9x3 ne doit pas être utilisée près d'autres appareils ou être posée sur ceux-ci. Si l'utilisation proche ou sur d'autres appareils est nécessaire, le produit doit être observé afin de vérifier qu'il fonctionnera correctement dans la configuration prévue. Cables in this medical light are certified by the manufacturer to be compatible with equipment and systems that are compliant with cruus, VDE: 0245, RoHS: 2002/95/EC regulations. WARNING: Les câbles de cette lampe médicale sont certifiés par le fabricant comme étant compatibles avec les appareils et systèmes conformes aux normes cruus, VDE : 0245, RoHS : 2002/95/EC. THE USE OF UNAPPROVED ACCESSORIES MAY RESULT IN DEGRADATION L'UTILISATION D'ACCESSOIRES NON AUTORISÉS PEUT ABÎMER L'APPAREIL. THE 9x3 LED LIGHT SHOULD NOT BE USED ADJACENT TO OTHER EQUIPMENT LA DÉL (DIODE ÉLECTROLUMINESCENTE) 9x3 NE DOIT PAS ÊTRE UTILISÉE PROCHE D'AUTRES APPAREILS. Pg. 18 Revision 0.1

20 Guidance and manufacturer s declaration electromagnetic emissions The 9x3 LED Light is intended for use in the electromagnetic environment specified below. The customer or the user of the 9x3 LED Light should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance RF emissions CISPR 11 RF emissions CISPR 11 Harmonic Emissions IEC Voltage fluctuations/ Flicker emissions IEC Group 1 Class A Class A Complies The 9x3 LED Light uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause interference in nearby electronic equipment. The 9x3 LED Light is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Guidance and manufacturer s declaration electromagnetic immunity The 9x3 LED Light is intended for use in the electromagnetic environment specified below. The customer or the user of the 9x3 LED Light should assure that it is used in such an environment Immunity test IEC Test level Compliance level Electromagnetic environment - guidance Electrostatic discharge (ESD) IEC Electrical inst transient/burst IEC Surge IEC Voltage dips, short interruptions and voltage variations on power supply input lines. IEC ±6 kv contact ±8 kv air ±2 kv for power supply lines ±1 kv for input/output lines ±1 kv differential mode ±2 kv common code <5% U t (>95% dip in U t) for 0.5 cycle 40% U t (60% dip in U t ) for 5 cycles 70% U t (30% dip in U t) for 25 cycles ±6 kv contact ±8 kv air ±2 kv for power supply lines Not applicable ±1 kv differential mode ±2 kv common code <5% U t (>95% dip in U t) for 0.5 cycle 40% U t (60% dip in U t ) for 5 cycles 70% U t (30% dip in U t) for 25 cycles Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30% Mains power quality should that of a typical commercial or hospital environment. Mains power quality should that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of the 9x3 LED Light requires continued operation during power mains interruptions, it is recommended that the 9x3 LED Light be powered from an uninterruptible power supply or a battery. <5% U t (>95% dip in U t) for 5 sec <5% U t (>95% dip in U t) for 5 sec Power frequency (50/60 Hz) magnetic field IEC NOTE U t is the mains voltage prior to application of the test level. 3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. Pg. 19 Revision 0.1

21 Guidance and manufacturer s declaration- electromagnetic immunity The 9x3 LED Light is intended for use in the electromagnetic environment specified below. The customer or the user of the 9x3 LED Examination Light should assure that it is used in such an environment. Immunity test IEC test level Compliance level Electromagnetic environment- guidance Portable and mobile RF communications equipment should be used no closer to any part of the 9x3 LED Light, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance Conducted RF IEC Vrms 150 khz to 80 MHz 3 Vrms d= 1.2 P Radiated RF IEC V/m 80MHz to 2,5 GHz 3 V/m d= 1.2 P 80 MHz to 800 MHz d= 2.3 P 800 MHz to 2.5 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined b an electromagnetic site survey a should be less than the compliance level in each frequency range b. Interference may occur in the vicinity of equipment marked with the following symbol: NOTE 1 at 80 MHz and 800 MHz, 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 people. a b Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the 9x3 LED Examination Light is used exceeds the applicable RF compliance level above, the 9x3 LED Light should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the 9x3 LED Light Over the frequency range 150 khz to 80 MHz, field strengths should be less than 3 V/m. Pg. 20 Revision 0.1

22 Recommended separation distances between portable and mobile RF communications equipment and the 9x3 LED Light The 9x3 LED Light is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the 9x3 LED Light can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the 9x3 LED Light as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 800 MHz to 2,5 150 khz to 80 MHz 80 MHz to 800 MHz GHz d=1.2 P d=1.2 P d=2.3 P 0, , For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance 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 people. Manufactured by: Huot Instruments, LLC N50 W13740 Overview Drive Suite A, Menomonee Falls, WI Call 1(866) or visit Pg. 21 Revision 0.1