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Any alteration of this equipment not authorized or performed by a STERIS trained technician could affect the operation of the unit, will void the warranty and may result in the equipment being out of compliance with applicable laws and regulations.
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EC Authorized Representative: STERIS Ltd. Chancery House 190 Waterside Road Hamilton Industrial Park Leicester LE5 1QZ United Kingdom STERIS Corporation 5960 Heisley Road Mentor, OH 44060 • USA Made in Italy Class 1 Equipment Type B Equipment Ordinary Equipment (enclosed equipment without protection...
Control Keyboard ........................... 3-1 Ceiling Mounted Version........................3-2 Mobile Floor Stand Version ........................3-3 Lighthead Positioning ..........................3-4 Harmony LED385 Lighthead Optical Performance................3-5 Environmental Conditions ........................3-5 Cleaning the Equipment........................ 4-1 Cleaning Equipment ..........................4-1 General Cleaning/Disinfecting Procedure....................4-2 Sterilize the Handle..........................
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P093932-203 Equipment Manual Table of Contents...
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LIST OF FIGURES Figure Title Page Figure 2-1. Location of Labels ..........................2-2 Figure 3-1. Control Keyboard..........................3-1 Figure 3-2. Ceiling Mounted Version Overview...................... 3-2 Figure 3-3. Mobile Floor Stand Overview ......................3-3 Figure 3-4. Ceiling Mounted Version ........................3-4 Figure 3-5.
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P093932-203 Equipment Manual Table of Contents...
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LIST OF TABLES Table Title Page Table 2-1. Symbol Definitions........................... 2-1 Table 3-1. Harmony LED385 Lighthead Optical Performance ................. 3-5 Table 3-2. Transport/Storage ........................... 3-5 Table 3-3. Installation Site ..........................3-5 Table 5-1. Operator Troubleshooting ....................... 5-2 Table 6-1. Preventive Maintenance Schedule....................6-2 Table 7-1.
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viii P093932-203 Equipment Manual Table of Contents...
SAFETY PRECAUTIONS ® The following Safety Precautions must be observed when operating or servicing this Harmony LED385 Examination Lighting System. WARNING indicates the potential for personal injury and CAUTION indicates the potential for damage to equipment. For emphasis, certain Safety Precautions are repeated throughout the manual.
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This equipment/system is intended for use by healthcare professionals only. This equipment/system may cause radio interference or may disrupt the operation of nearby equipment. If interference becomes a concern, it may be necessary to reorient or relocate the Harmony LED385 Examination Lighting System or shielding the location.
SYMBOLS AND DEFINITIONS ® The following symbols appear on the Harmony LED385 Examination Lighting System and are provided here for reference. Table 2-1. Symbol Definitions Symbol Definition Type B Equipment. Indicates the level of protection against direct and indirect contact. Graphic symbol providing the EC marking of the product Symbol indicating the legal manufacturer name and address Fuses used by the device...
Location of Labels Serial Label (Typical) – Ceiling Version Serial Label (Typical) – Mobile Floor Stand Version Serial Label (Typical) – Lighthead Figure 2-1. Location of Labels P093932-203 Equipment Manual Symbols and Definitions...
OPERATING INSTRUCTIONS 3.1 Before Operating NOTE: Mobile floor stand may tip over if it is rolled over its connecting cable or any other object(s) on the floor. Mobile Floor Stand 1. Move mobile floor stand to the location of use and secure the two locking casters.
3.3 Ceiling Mounted Version Ceiling Cover Horizontal Arm Ceiling Anchoring Tube Side Handle Lighthead Spring Arm Side Handle Sterilizable Handle Control Keyboard Figure 3-2. Ceiling Mounted Version Overview P093932-203 Equipment Manual Operating Instructions...
3.4 Mobile Floor Stand Version Side Handle Spring Arm Side Handle Stand Extension Lighthead Stand Power Supply Plug Wheel Base Control Keyboard Sterilizable Handle Figure 3-3. Mobile Floor Stand Overview Operating Instructions Equipment Manual P093932-203...
3.5 Lighthead The lighthead can be positioned by using either the sterilizable handle or side handles. Positioning CAUTION – POSSIBLE EQUIPMENT DAMAGE: Do not bump lighthead into walls or other equipment. Always use handles when positioning lighthead during examination procedures, or when cleaning or servicing the examination lighting system.
39-3/8" (1 m) from the lighthead. Definitions and Lighthead Optical measurements are in accordance with International Electrotechnical Performance Commission (IEC) 60601-2-41. Table 3-1. Harmony LED385 Lighthead Optical Performance Central Illuminance 4,645 fc (50,000 lux) Pattern Size 6" (152 mm) Depth of Illumination 59"...
CLEANING THE EQUIPMENT 4.1 Cleaning Important: DO NOT use aggressive products such as floor cleaners, paint thinners, alkaline detergents or acids. Equipment The use of aggressive products such as floor cleaners can WARNING – ELECTRIC cause the plastic parts to crack and can damage the painted ®...
4.2 General 1. Ensure system power is turned off and lighthead has cooled sufficiently. Cleaning/Disinfecting Procedure 2. Wear rubber gloves. 3. Prepare an approved cleaning or disinfecting solution in WARNING – ELECTRIC accordance with the directions on the container’s label. SHOCK HAZARD: Verify that Important: DO NOT use aggressive products such as floor power to examination lighting...
4.3 Sterilize the Handle WARNING – PERSONAL INJURY HAZARD: Replace the handle as soon as it shows cracks or deformation in case the handle falls on the area of the wound. 4.3.1 Uninstall the Handle Press two lateral safety keys of the handle and extract the handle itself.
Clean/Disinfect These Areas Clean/Disinfect These Areas Clean/Disinfect These Areas Clean/Disinfect These Areas Figure 4-1. Areas to Be Cleaned (Ceiling Mounted Version) P093932-203 Equipment Manual Cleaning the Equipment...
Clean/Disinfect These Areas Clean/Disinfect These Areas Clean/Disinfect These Areas Clean/Disinfect These Areas Figure 4-2. Areas to be Cleaned (Mobile Floor Stand Version) Cleaning the Equipment Equipment Manual P093932-203...
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P093932-203 Equipment Manual Cleaning the Equipment...
STERIS. A representative will arrange to have your invalidate the warranty or equipment promptly put into working order by a factory-trained result in costly damage.
5. The light beam on the examination field is not in Contact STERIS. focus. 6. The lighthead does not turn on. 1. Check the power supply voltage and fuses. 2. Electronics are damaged: contact STERIS. P093932-203 Equipment Manual Operator Troubleshooting...
MAINTENANCE WARNING – PERSONAL INJURY HAZARD: Repairs and adjustments to the unit should be made only by trained, fully qualified personnel. Work by inexperienced or unqualified persons or the installation of unauthorized parts could cause personal injury, invalidate the warranty or result in costly damage.
Table 6-1. Preventive Maintenance Schedule Service Required Minimum Inspection Frequency 1.0 Administrative 2x per year 1.1 Discuss equipment operation with operator. 2.0 Restorative – Rebuilds and Replacements 2x per year 2.1 N/A 3.0 Calibration 2x per year 3.1 N/A 4.0 Routine Maintenance 2x per year 4.1 Check overall lighting system for appearance, visual damage, missing parts.
6.3 Adjustments 6.3.1 Adjust Spring Arm See Figure 6-2. The lighting system is supplied already balanced and needs no further adjustment. If, in time, the spring balancing swing arm stiffens or loosens, it is possible to adjust the compression of the internal spring.
6.3.2 Adjust Braking Force If the lighthead does not automatically keep the proper position, it is necessary to adjust the braking force. See Figure 6-3. Use a 2.5 mm hexagonal Allen wrench to increase the braking force, rotating arm brake screws clockwise. Arm Brake Screw Wrench Arm Brake Screw...
The parts listed in this section are those that would be necessary to do minor maintenance on the examination light. When ordering, please include the part number and description for each replacement part requested. To order directly, call STERIS. Table 7-1. Recommended Spare Parts Part Number...
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P093932-203 Equipment Manual Recommended Spare Parts List...
The Harmony LED385 Examination Lighting System is intended for use in the electromagnetic environment specified below. The Customer or the user of the Harmony LED385 Examination Lighting System should assure that it is used in such an environment. Emission Test Compliance Electromagnetic Environment –...
Electromagnetic Immunity The Harmony LED385 Examination Lighting System is intended for use in the electromagnetic environment specified below. The Customer or the user of the Harmony LED385 Examination Lighting System should assure that it is used in such an environment.
1 of this manual. Do not operate or service the equipment until ECTION you have been trained on this information. STERIS is committed to ensuring your continued satisfaction. This manual illustrates and identifies assemblies and components of the ® Harmony LED385 Examination Lighting System.
9.2 How To Use The 1. Determine the function and application of the part required. Examine the list of illustrations and select the most appropriate Illustrated Parts title. Note the illustration page number. Breakdown 2. Turn to the page indicated and locate the desired part on the illustration (see Figure 9-1).
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List of Illustrations Figure Page Figure 1. Ceiling Mount Examination Light..........9-4 Figure 2.
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Figure 1. Ceiling Mount Examination Light P093932-203 Equipment Manual Illustrated Parts Breakdown...
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UNITS PER FIG. & PART DESCRIPTION ASSEMBLY ITEM NUMBER Ceiling Mount Examination Light............ P 755718 301 CEILING PLATE, Medium ..............P 755718 304 TUBE, Suspension................P 755718 302 SCREW, Tip Conical, M8 x 12............. P 755718 306 ASSEMBLY, Horizontal Tube, Complete..........P 755718 307 HOOD, Ceiling ..................
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Figure 2. Ceiling Mount Examination Light P093932-203 Equipment Manual Illustrated Parts Breakdown...
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UNITS PER FIG. & PART DESCRIPTION ASSEMBLY ITEM NUMBER Ceiling Mount Examination Light............ P 755718 315 PLATE....................P 755718 317 CLIP, Mounting ..................P 755718 316 POWER BOARD.................. P 764335 300 TERMINAL 2 POLE ................P 764335 301 TERMINAL 2 POLE w/FUSE ............... P 755718 320 FUSE, 5 x 20..................
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Figure 3. Ceiling Mount Examination Light P093932-203 Equipment Manual Illustrated Parts Breakdown...
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UNITS PER FIG. & PART DESCRIPTION ASSEMBLY ITEM NUMBER Ceiling Mount Examination Light............ P 755718 325 TUBE, Horizontal ................. P 755718 224 SCREW, Stainless Steel, M5 x 8 ............P 755718 326 INTERNAL HUB................... P 755718 327 WASHER ..................... P 755718 226 BUSHING, Teflon.................
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Figure 4. Ceiling Mount Examination Light 9-10 P093932-203 Equipment Manual Illustrated Parts Breakdown...
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UNITS PER FIG. & PART DESCRIPTION ASSEMBLY ITEM NUMBER Ceiling Mount Examination Light............ P 755718 335 FRAME ....................P 755718 333 COVER, Tube Round ................P 755718 254 FITTING, Washer................. P 755718 255 ROD, Internal, Complete..............P 755718 256 TIE ....................... P 755718 257 COVER, Joint, Top ................
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Figure 5. Ceiling Mount Examination Light 9-12 P093932-203 Equipment Manual Illustrated Parts Breakdown...
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HANDLE, Sterilizable................P 755718 278 SPRING ....................P 755718 279 PIN, Latch .................... P 755718 280 LIGHT, STERIS LED ................P 755718 282 PC BOARD ..................P 755718 283 KEYPAD MEMBRANE, Three Keys ............ P 755718 284 SCREW, 30 x 10..................
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Figure 6. Mobile Floor Stand Examination Light (1 of 4) 9-14 P093932-203 Equipment Manual Illustrated Parts Breakdown...
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Figure 6. Mobile Floor Stand Examination Light (2 of 4) 9-15 Illustrated Parts Breakdown Equipment Manual P093932-203...
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Figure 6. Mobile Floor Stand Examination Light (3 of 4) 9-16 P093932-203 Equipment Manual Illustrated Parts Breakdown...
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Figure 6. Mobile Floor Stand Examination Light (4 of 4) 9-17 Illustrated Parts Breakdown Equipment Manual P093932-203...
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UNITS PER FIG. & PART DESCRIPTION ASSEMBLY ITEM NUMBER Mobile Floor Stand Examination Light ........... P 755718 218 BASE, Floor Stand................P 755718 219 ARM ..................... P 755718 220 SCREW, M4 x 10................. P 755718 221 O-RING ....................P 755718 222 YOKE, Arm ..................
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HANDLE, Sterilizable................P 755718 278 SPRING ....................P 755718 279 PIN, Latch LED ..................P 755718 280 LIGHT, STERIS LED ................P 755718 281 SHELL, Cover, Lighthead Top ............. P 755718 282 PC BOARD ..................P 755718 283 KEYPAD MEMBRANE, 3 Keys............
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9-20 P093932-203 Equipment Manual Illustrated Parts Breakdown...
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