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Steris Harmony vLED Operator's Manual
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Steris Harmony vLED Operator's Manual

Steris Harmony vLED Operator's Manual

Surgical lighting system
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OPERATOR MANUAL
Harmony
vLED Surgical Lighting System
®
(10/15/14)
P136824-104

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Summary of Contents for Steris Harmony vLED

  • Page 1 OPERATOR MANUAL Harmony vLED Surgical Lighting System ® (10/15/14) P136824-104...

  • Page 3: Indications For Use

    STERIS maintains a nationwide staff of well-equipped, factory- trained technicians to provide this service, as well as expert repair services. Contact STERIS for details. STERIS is also able to provide Customer training; contact STERIS Customer Service for more information.
  • Page 4 The illumination level of Harmony vLED Surgical Lights can be adjusted through several intensity settings via conveniently located controls on either the wall-mounted control center or the lighthead handle.

  • Page 5: Table Of Contents

    3.1.1 Activate the Harmony vLED System .................... 3-1 3.1.2 Harmony vLED Wall Control Unit....................3-2 3.1.3 Surgeon's Intensity Control Buttons ..................... 3-3 Harmony vLED Lightheads vLED Module Status Indications ..............3-4 Lighthead Positioning ..........................3-5 Harmony vLED Lighthead Pattern Adjustment ..................3-6 Lighthandle and Lighthandle Cover .......................
  • Page 6 TABLE OF CONTENTS Section Number Description Page Maintenance ........................... 6-1 Preventive Maintenance ........................6-1 Inspect Suspension ..........................6-1 Inspect Wall Control..........................6-1 Optional Service Disconnect Switch ...................... 6-2 Replacement Parts ........................7-1 Waste Disposal Guidelines......................8-1 Appendi EMC Compliance Technical Data ................9-1 X –...

  • Page 7: List Of Figures

    LIST OF FIGURES Figure 3-1. Harmony vLED Wall Control (with Optional Camera Controls) ............3-1 Figure 3-2. Harmony vLED Lighthead........................3-3 Figure 3-3. Lighthead vLED Module Status Indicator .....................3-4 Figure 3-4. Lighthead Positioning ...........................3-5 Figure 3-5. Light Pattern Adjustment ........................3-6 Figure 3-6. Standard Lighthandle..........................3-9 Figure 3-7.
  • Page 8 P136824-104 Operator Instructions Table of Contents...

  • Page 9: List Of Tables

    Table Title Page Table 1-1. Definition of Symbols........................1-5 Table 2-1. Harmony vLED Lighthead Optical Performance ................2-3 Table 3-1. vLED Intensity Control........................3-2 Table 3-2. Harmony vLED Camera Features Summary................. 3-13 Table 3-3. Brightness and Focus Mode Summary ..................3-14 Table 5-1.
  • Page 10 viii Table of Contents Installation Instructions P136824-104...

  • Page 11: Safety Precautions

    WARNING – PERSONAL INJURY HAZARD AND/OR EQUIPMENT DAMAGE HAZARD: Safe and reliable operation of this equipment requires regularly scheduled preventive maintenance, in addition to the regular performance of routine maintenance. Contact STERIS Service Engineering to schedule preventive maintenance. Repairs and adjustments to this equipment should be made only by fully qualified service personnel.
  • Page 12 WARNING – STERILITY ASSURANCE HAZARD: Do not use the surgeon’s control buttons unless a disposable sterile cover is installed. If the sterilizable lighthandle (metal) is used without a disposable cover, the sterility of the surgical environment may be compromised. WARNING – BIOHAZARD: Sterile disposable covers for handles and camera are intended for single use only.
  • Page 13 WARNING – PINCHING HAZARD: Pinch points are created during extreme articulation of the suspension system. Do not place hands on or near the suspension knuckle during lighthead articulations. WARNING – LASER RADIATION: CAUTION: Class 3R invisible laser radiation when canopy opened. Avoid direct eye exposure. CAUTION: Use of controls or adjustments or performance of procedures other than those specified in the manual may result in hazardous radiation exposure.
  • Page 14 System. Accessories or replacement parts not listed in the Operator or Maintenance Manuals should not be used. Avoid potential EMISSIONS interference. The Harmony vLED system should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the equipment or system should be observed to verify normal operation in the configuration in which it will be used.

  • Page 15: Table 1-1. Definition Of Symbols

    The following symbols appear on the Harmony vLED Surgical Lighting System: Table 1-1. Definition of Symbols Symbol Definition ON-OFF Lighthead (designation and intensity) LED Module(s) Requires Service Protective Earth (Ground) Attention, consult manual for further instructions Consult instructions before use...
  • Page 16 Table 1-1. Definition of Symbols (Continued) Symbol Definition Zoom Rotate Manual Focus Auto Mode (Brightness or Focus) Potential Impact Hazard Potential Pinch-Point Hazard Brightness Battery Backup Fault Laser Radiation P136824-104 Operator Manual Safety Precautions...

  • Page 17: Installation Verification

    Installation and Uncrating Instructions were furnished with the Lighting Fixture. If any of these documents are missing or misplaced, contact STERIS, giving the serial and model numbers of the equipment. Replacement copies will be sent to you promptly. 2.1 Pre-operation Before operating the equipment, complete the pre-operation checklist.

  • Page 18: Check Optional Video Camera Operation

    ❑ Harmony vLED Wall Control: Verify zoom, rotation and focus functions with the control center switches. 2.2 Check Optional The Harmony vLED Surgical Lighting System can include up to three lightheads and up to two monitor arms (max.). Verify smooth and Monitor Support Arms easy movement (without binding) through the monitor arm(s) ranges of articulations.

  • Page 19: Harmony Vled Optical Performance

    Important: Values are typical for the small pattern size at highest intensity setting (unless otherwise noted) at 100 cm (39-3/8") from Optical Performance the lighthead. Definitions and measurements are in accordance with IEC 60601-2-41. Table 2-1. Harmony vLED Lighthead Optical Performance Feature Harmony vLED Maximum Central Illuminance 160,000 lux Peak Total Irradiance <...

  • Page 20: Environmental Conditions

    Requirements Two-Lighted System 100 – 240 Vac, 50/60 Hz 5-2A 500 Watts at 100 Vac 480 Watts at 240 Vac Typical Lighthead Wattage Harmony vLED: 40 Watts Recommended ac line fuse current rating 20 A P136824-104 Operator Manual Installation Verification...

  • Page 21: Operating Instructions

    System Backup Fault Indicator Indicator Figure 3-1. Harmony vLED Wall Control (with Optional Camera Controls) 3.1.1 Activate the Harmony vLED System Refer to Figure 3-1. Press ON/OFF touch pad. This turns the system WARNING – ELECTRIC on in active mode and restores system lightheads to same intensity SHOCK HAZARD: The OFF levels as before system was turned OFF.

  • Page 22: Harmony Vled Wall Control Unit

    Important: Avoid control faults. Do not continuously press and hold wall control buttons for more than 40 seconds. 3.1.2 Harmony vLED Wall Refer to Figure 3-1. Control Unit 1. Press the selected + touch pad to activate the corresponding WARNING –...

  • Page 23: Surgeon's Intensity Control Buttons

    3. At the wall control press and hold the - button until the light goes out. NOTE: For longer vLED module life, use lowest intensity level suitable for surgical procedure. Figure 3-2. Harmony vLED Lighthead 3.1.3 Surgeon's Intensity Refer to Figure 3-2. Control Buttons 1.

  • Page 24: Harmony Vled Lightheads Vled Module Status Indications

    A failed vLED module(s) should always be Module Status changed at the earliest opportunity. Indications Another vLED module status LED is located on each Harmony vLED lighthead (see Figure 3-3). When flashing, the lighthead LED indicates vLED module(s) should be replaced. •...

  • Page 25: Lighthead Positioning

    To optimize shadow control, position the lighthead as appropriate before starting the intended surgical procedure. 300° Figure 3-4. Lighthead Positioning Harmony vLED Lighthead/Spring Arm Assemblies may: See Figure 3-4. 1. Rotate continuously around central hub; 2. Rotate continuously at horizontal suspension arm/ spring arm connection;...

  • Page 26: Harmony Vled Lighthead Pattern Adjustment

    3.4 Harmony vLED The illumination pattern for Harmony vLED lightheads can be adjusted to any size between the maximum diameter and minimum Lighthead Pattern diameter. Refer to Figure 3-5. Adjustment • Adjust the light pattern by rotating the lighthandle clockwise to CAUTION –...

  • Page 27: Lighthandle And Lighthandle Cover

    3.5.1 Installing and Using The metal sterilizable handle is used to position the Harmony vLED Lighthandle and Lighthandle lighthead and to adjust the light pattern size. The sterilizable handle Cover may be used in place of a disposable sterile lighthandle cover.

  • Page 28: Install Monitor Yoke Handle Disposable Sterile Covers

    The metal sterilizable handle can be removed for sterilization by WARNING – STERILITY unscrewing it from the adaptor. ASSURANCE HAZARD: Do not use the surgeon’s control The metal sterilizable handle can be sterilized using standard hospital steam cycles intended for lumens. Always sterilize handle buttons unless a disposable sterile cover is installed.

  • Page 29: Figure 3-6. Standard Lighthandle

    Surgeon’s Intensity Control Buttons Lighthandle Lighthandle Adaptor Align Tab on Handle Lighthandle Adaptor Adaptor with Channel in Mounting Ring Push Cover Completely onto Disposable Lighthandle Lighthandle Align lighthead and spring arm as shown Cover when installing sterile covers. Figure 3-6. Standard Lighthandle Operating Instructions Operator Manual P136824-104...

  • Page 30: Harmony Vled Monitor Arms

    3.7 Harmony vLED The Harmony vLED lighting system can be equipped with one or two monitor support arms. Monitor Arms FPM Monitor Yoke Figure 3-7. Harmony vLED Monitor Arm Monitor arms can be included in the Harmony vLED lighting system WARNING –...

  • Page 31: Video Camera Installation Or Removal

    3.8 Video Camera • Installation Installation or Removal Important: If the lighting system is camera-ready, the bottom-most lighthead on the central spindle (lighthead 1), is the only lighthead in the system capable of accepting a camera module. Unless the system has been preconfigured for video (i.e., is camera-ready), it is not possible to install a camera module.

  • Page 32: Install Camera Disposable Sterile Cover

    3.9 Install Camera Important: Use new covers for each handle for each procedure where the monitor is used. Disposable Sterile Cover Covers are sterile and shipped in a protective wrapper. Wear sterile gloves when removing covers from packaging. When installing covers, follow sterility assurance procedures as outlined by facility protocols.

  • Page 33: Video Camera Operation

    3.10 Video Camera The optional video camera is integrated into a removable handle that can be fitted to specially ordered Harmony vLED lighthead. Operation Whenever the video option is used, a separate sterile disposable cover must be fitted over the camera before each procedure (see 3.9, I...

  • Page 34: Table 3-3. Brightness And Focus Mode Summary

    (Wide Angle). At extreme wide angle, the camera captures a large image with less detail than telephoto. NOTE: At extreme wide angle, the image field possesses a greater depth of focus and less sensitivity to light level changes. Rotat Use this function to change orientation of the video field. e –...

  • Page 35: Guidelines For Maximizing Video Image

    Table 3-3. Brightness and Focus Mode Summary (Continued) Brightness/ Brightness/ Switch Focus Focus LED Operation Pressed Mode Indicator • Mode switched to automatic. • Camera automatically adjusts brightness or Manual Brightness or focus. Focus • Mode LED indicator turned ON. Manual Focu Use this function to manually set the focus.

  • Page 36: Act Enabled System

    3.12 ACT Enabled The Harmony vLED Lighting System can be configured to operate using voice activated controls or touch-panel displays. The STERIS- System provided portion of this system is an interface point between Harmony system and the operating room control system.

  • Page 37: Cleaning The Equipment

    CAUTION – POSSIBLE EQUIPMENT • Germicidal Surface Wipes Disinfecting / Deodorizing / Cleaning DAMAGE HAZARD: Wipes (Available from STERIS. Do not use wipes from other • Cleaning and disinfecting manufacturers.) agents used on this lighting system must be certified by their •...

  • Page 38: General Cleaning/Disinfecting Procedure

    4.2 General Cleaning/ STERIS recommends the following procedures when cleaning the Harmony vLED Surgical Lighting System: Disinfecting Procedure 1. Ensure lighthead is turned off and has cooled sufficiently. WARNING – PERSONAL INJURY HAZARD and/or EQUIPMENT 2. Wear rubber gloves. DAMAGE HAZARD: Do not attempt 3.

  • Page 39: Areas To Be Cleaned Before Each Use

    4.3 Areas To Be Cleaned Before Each Use NOTE: Refer to the user manual supplied with the monitor for the WARNING–PERSONAL INJURY manufacturer's recommended procedures for cleaning the monitor and/or POSSIBLE EQUIPMENT and the monitor control surface. DAMAGE HAZARD: Do not attempt to clean lighthead unless power is The following areas of the system must be cleaned and disinfected turned off and the lighthead has...
  • Page 40 P136824-104 Operator Manual Cleaning The Equipment...

  • Page 41: Operator Troubleshooting

    If you are unable to correct the problem with this operator troubleshooting table, or if a problem occurs not described on the chart, please call STERIS. A representative will arrange to have your equipment promptly put into working order by a factory-trained representative.
  • Page 42 8. Poor video image quality. Restore camera default settings by turning camera OFF and then back ON at wall control. 9. Poor light color or intensity. Refer problem to qualified STERIS or STERIS- trained service technician. P136824-104 Operator Manual Operator Troubleshooting...

  • Page 43: 5.2 Wall Control Faults

    5.2 Wall Control Faults If the Harmony vLED Lighting System experiences a control fault, the fault LED on the wall control blinks; even if the system is OFF (see Standby mode as described under S 3.1.1, A ECTION CTIVATE THE LED S 3-1).
  • Page 44 End of fault sequence ❑ ■ KEY: LED ON LED OFF Important: Only STERIS-trained service technicians are familiar with methods for resolving any of these control faults; the summary is given here for informational purposes only. P136824-104 Operator Manual Operator Troubleshooting...

  • Page 45: Maintenance

    ON/OFF LED flashes once per second while system is in this mode. 6.1 Preventive 1. Regular service and maintenance MUST be performed only by STERIS or a STERIS-trained technician. Any work performed by Maintenance inexperienced or unqualified persons or the installation of unauthorized parts could cause personal injury, invalidate the warranty or result in costly damage.

  • Page 46: Optional Service Disconnect Switch

    This switch is referred to as a service disconnect switch and its purpose is to provide a method of temporarily removing power from the STERIS Lighting System without having to access the ON/OFF switch inside the canopy. It is important that you refer to...

  • Page 47: Replacement Parts

    Maintenance performed by inexperienced, unqualified personnel or installation of unauthorized parts could cause personal injury, invalidate the warranty or result in costly equipment damage. Contact STERIS Service regarding service options. • Do not attempt to clean lighthead unless lighthead is turned off and has cooled sufficiently.
  • Page 48 ® Table 7-1. Harmony vLED Lighting System Replacement Parts Part Number or Description (Equipment Number) Harmony vLED Lighthead Call STERIS Harmony vLED Maintenance Manual P764332-337 Brake Screw, Lighthead Spring Arm P000661-69D Brake Screw, Light, Main Suspension System P000358-99D ®1 P129377-290...

  • Page 49: Waste Disposal Guidelines

    WASTE DISPOSAL GUIDELINES ® The following materials are contained within the Harmony vLED Surgical Lighting System. When disposing of the EMS or its parts, ensure proper disposal of hazardous and other regulated waste in compliance with national, state and local WEEE/RoHS regulations. Electronic and Electrical Parts –...
  • Page 50 P136824-104 Operator Manual Waste Disposal Guidelines...

  • Page 51: Appendix - Emc Compliance Technical Data

    ® The Harmony vLED Surgical Lighting System is intended for use in the electromagnetic environment specified below. The Customer or the user of the Harmony vLED System should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment –...

  • Page 52: Electromagnetic Immunity For All Me Equipment And Me Systems

    Electromagnetic Immunity for all ME Equipment and ME Systems The Harmony vLED Surgical Lighting System is intended for use in the electromagnetic environment specified below. The Customer or the user of the Harmony vLED System should assure that it is used in such an environment.

  • Page 53: Table 9-3. Guidance And Manufacturer's Declaration - Electromagnetic Immunity For Me Equipment And Me Systems That Are Not Life-Supporting

    ME Systems that are not Life-Supporting The Harmony vLED Surgical Lighting System is intended for use in the electromagnetic environment specified below. The Customer or the user of the Harmony vLED System should assure that it is used in such an environment.

  • Page 54: Table 9-4. Recommended Separation Distances Between Portable And Mobile Rf Communications Equipment And The Harmony Vled System

    The Harmony vLED Surgical Lighting System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The Customer or the user of the Harmony vLED System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Harmony vLED System as recommended below, according to the maximum output power of the communications equipment.
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