Steris HarmonyAIR M Series Operator's Manual
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Steris HarmonyAIR M Series Operator's Manual

Steris HarmonyAIR M Series Operator's Manual

Surgical lighting system
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OPERATOR MANUAL
HarmonyAIR™ Surgical Lighting System M Series with
®
Harmony
LED Wall Control Unit
(Rev. C)
10083002

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  • Page 1 OPERATOR MANUAL HarmonyAIR™ Surgical Lighting System M Series with ® Harmony LED Wall Control Unit (Rev. C) 10083002...
  • Page 3 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.
  • Page 4 United Kingdom anesthetic mixture with air or oxygen or nitrous oxide. Suitable for continuous operation. Equipment provided and incorporated by STERIS Corporation into complete Optical Fiber Communication System (OFCS) satisfies applicable laser safety requirements of the IEC 60825-1 (Class 1 Laser Product) and IEC 60825-2 (Hazard Level 1M for OFCS).

  • Page 5: Table Of Contents

    TABLE OF CONTENTS Section Number Title Page Safety Precautions........................ 1-1 Symbol Definitions........................ 2-1 Product Performance......................3-1 Lighthead Optical Performance....................3-1 Environmental Conditions ......................3-2 Power Requirements........................3-2 Post Installation Verification....................4-1 Pre-operation Checklist........................ 4-2 Check Suspension Movement ..................... 4-3 Monitor Arms..........................4-4 Check System Operation ......................
  • Page 6 TABLE OF CONTENTS (CONT’D) Section Number Title Page 5.14.1 Ambient Light Operation Overview ................. 5-26 5.14.2 Configuring and Using the Ambient Light................ 5-27 5.15 ACT Enabled System......................... 5-29 5.16 Lighthead Runtime and Limit Values ..................5-30 Cleaning the Equipment ....................... 6-1 Cleaning Equipment........................
  • Page 7 LIST OF FIGURES Figure Title Page Figure 4-1. Tension Screw Location for Harmony Spring Arms................4-2 Figure 4-2. Check Suspension..........................4-3 Figure 4-3. Monitor Arms Positioning........................4-5 Figure 4-4. Use Control Center to Check System Operation ................. 4-6 Figure 4-5. Check Lighthead Intensity Operation Using Surgeon’s Control Buttons ..........4-7 Figure 4-6.
  • Page 8 10083002 Operator Manual Table of Contents...
  • Page 9 LIST OF TABLES Table Title Page Table 1-1. System Laser Components ......................1-2 Table 2-1. Symbol Definitions........................... 2-1 Table 3-1. M5 Lighthead and M7 Lighthead Optical Performance ..............3-1 Table 5-1. Harmony Lighthead Features ......................5-3 Table 5-2. Control Center Fault Indications ...................... 5-5 Table 5-3.
  • Page 10 viii 10083002 Operator Manual Table of Contents...

  • Page 11: Safety Precautions

    AINTENANCE ANUAL Harmony LA/LED and P764335-782 HarmonyAIR M Series.) Do not remove control center covers. Servicing must be performed by qualified service personnel. Avoid possibility of electric shock, and refer any servicing of the ambient light fixture to qualified service personnel.

  • Page 12: Table 1-1. System Laser Components

    (per wavelength) of corresponding STERIS transmitters listed in Table 1-1. It is the responsibility of the end user to ensure any device not supplied by STERIS corresponds to the values listed in Table 1-1.
  • Page 13 WARNING – PERSONAL INJURY HAZARD: (CONTINUED) Do not remove monitor-arm safety pin until monitor is installed. Monitor extension arm must have monitor (or equivalent counterweight) installed to keep arm in required positions while installing sliding guards. Do not modify this equipment without authorization of the manufacturer. WARNING –...
  • Page 14 CAUTION – POSSIBLE EQUIPMENT DAMAGE HAZARD: (CONTINUED) Appropriate components of this lighting system have been tested and found in compliance with IEC 60601-1-2:2007, Medical Electrical Equipment – Part 1: General Requirements for Safety; Electromagnetic Compatibility (EMC). There is, however, a potential for electromagnetic or other interference between this equipment and other devices.

  • Page 15: Symbol Definitions

    SYMBOL DEFINITIONS ® The following symbols appear on the HarmonyAIR™ Surgical Lighting System M Series with Harmony LED Wall Control Unit. Table 2-1. Symbol Definitions Symbol Definition Standby Turn System ON Turn System OFF Lighthead (designation and intensity) Symbol Definitions LED Module Failure Protective Earth (Ground) Pinch Point Label...
  • Page 16 Table 2-1. Symbol Definitions Symbol Definition Consult instructions before use Hot, Potential Burn Hazard Potential Impact Hazard Maximum Load Hazard (maximum load limit given on label) Ambient Light Control – ON/OFF (Control Center) Do not operate system unless optical fiber cables are fully connected Press key to access System Menu for system configuration or information Indicates control fault.
  • Page 17 Table 2-1. Symbol Definitions Symbol Definition 1 2 3 4 5 6 1 2 3 4 5 6 1 2 3 4 5 6 1 2 3 4 5 6 Decrease Intensity (Surgeon's Control Buttons) 1 2 3 4 5 6 1 2 3 4 5 6 a.
  • Page 18 10083002 Operator Manual Symbol Definitions...

  • Page 19: Product Performance

    PRODUCT PERFORMANCE 3.1 Lighthead Optical Important: Values are typical for the small pattern size at highest intensity setting (unless otherwise noted) at 100 cm (39-3/8") from the Performance lighthead. Definitions and measurements are in accordance with IEC 60601-2-41. Table 3-1. M5 Lighthead and M7 Lighthead Optical Performance Feature M5 Lighthead M7 Lighthead...

  • Page 20: Environmental Conditions

    3.2 Environmental Conditions Normal Operating Temperature 20 to 25°C (68 to 77°F), ambient Full System Recommended Transport/ 2 to 38°C (36 to 100°F) Storage Temperature (not exceeding 15 weeks) Recommended Relative 30% to 75% Humidity Atmospheric Pressure 500 to 1060 hPascals 3.3 Power Requirements Two-Lighthead System (no...

  • Page 21: Post Installation Verification

    Installation and Uncrating Instructions were furnished with the manual. Refer servicing to lighting fixture. qualified service personnel. If any of these documents are missing or misplaced, contact STERIS, AINTENANCE ANUAL giving the serial and model numbers of the equipment. Replacement...

  • Page 22: Check Suspension Movement

    Lightheads and monitors should move smoothly and easily. When positioned, the lighthead and monitor support arms should not drift. If binding or drifting is present in suspension movements, call your STERIS service representative to make adjustments. WARNING – PINCHING...

  • Page 23: Figure 4-3. Monitor Arms Positioning

    Finished Floor 15° UP 15° UP 90° DN 90° DN 320° 320° 10° Clockwise 10° Clockwise 10° Counterclockwise 10° Counterclockwise 10° UP 10° UP 10° DN 10° DN 10° UP 10° DN Figure 4-3. Monitor Arms Positioning Post Installation Verification Operator Manual 10083002...

  • Page 24: Check System Operation

    LED modules may have failed. Any service for LED module failure must be referred to a trained, qualified service technician (call STERIS for assistance with failed LED modules). Harmony LED System Module...

  • Page 25: Check Optional Video Camera Module Operation

    Check Intensity Controls at Each Surgeon's Control: Verify that the intensity level can be increased and decreased at each lighthead using the surgeon's control buttons (see Figure 4-5). Surgeon’s Control Buttons Figure 4-5. Check Lighthead Intensity Operation Using Surgeon’s Control Buttons Turn the control center ON.

  • Page 26: Figure 4-6. In Light Video Camera High-Definition Model Shown

    Important: HD camera modules do not support or provide settings for time or date. Figure 4-6. In Light Video Camera High-Definition Model Shown 10083002 Operator Manual Post Installation Verification...

  • Page 27: Figure 4-7. Camera Control Menus

    CAMERA CONTROL 1 2 3 4 WIDE SHOT MEDIUM SHOT CLOSE UP SD Camera HD Camera Figure 4-7. Camera Control Menus Post Installation Verification Operator Manual 10083002...

  • Page 28: Check Optional Monitor Support Arms

    4.6 Check Refer to Figure 4-8. Optional Monitor The lighting system can include up to two monitor arms on a single central Support Arms mount. Verify smooth and easy movement (without binding or drifting) through the monitor arm(s) ranges of articulations. Verify that monitor, or monitors, receive video signals.

  • Page 29: Operating Instructions

    OPERATING INSTRUCTIONS ® 5.1 Intensity Controls The Harmony LED Wall Control Unit allows the user to adjust the lighthead intensity level (brightness) by pressing a membrane switch (or “button”). An identifying number on the control display corresponds to the same number on the lighthead suspension arm. Additionally, each lighthead has its own “onboard”...

  • Page 30: Figure 5-2. Lighthead Surgeon's Control Buttons

    Surgeon’s Control Buttons Figure 5-2. Lighthead Surgeon’s Control Buttons Surgeon's Intensity Control Buttons (See Figure 5-2) 1. Grasp the handle of the appropriate lighthead. A ring of membrane buttons (six pairs) are located on the control bezel adjacent to the lighthead lens. ✙...

  • Page 31: Lighthead Features

    * Optional high-definition (HD) camera compatibility is available for one lighthead per suspension system. The system requires HD components for this option. Standard definition systems can be retrofitted for HD operation, contact STERIS for more information. † HarmonyAIR Surgical Lighting System (M5 and M7) lightheads are equipped with a full-circumference bezel, providing six sets of surgeon's intensity control buttons.

  • Page 32: Lighthead Fault Indications

    5.3 Lighthead Fault An exterior LED on the lighthead (see Figure 5-4) serves as an indicator for faults: Indications • If the LED flashes on for one second, off for one second then repeats, an LED module within the lighthead has failed. Contact a service technician to replace LED modules.

  • Page 33: Control Center Fault Log Indications

    Table 5-2. Important: Refer any problems with “yes” listed under the Service Required column to STERIS. Also, “#” indicates a numeric value on the display. Table 5-2. Control Center Fault Indications Service Fault Message...
  • Page 34 Table 5-2. Control Center Fault Indications (Continued) Service Fault Message Description Required DRIVE CONTROLLER N1, N2... Lighthead primary and LED drive controllers no longer COMMUNICATION FAILURE ON communicating with each other for more than two minutes. LIGHTHEAD: CURRENT REGULATION One or more lighthead drive currents not maintained within FAILURE ON LIGHTHEAD: current limits.

  • Page 35: Figure 5-6. M5 And M7 Lighthead Positioning

    5.5 Lighthead Lightheads can be positioned by using either the sterile handle, or by grasping the non-sterile handle around the lighthead housing. Positioning Each lighthead can be positioned as listed from outside or from within the sterile field. To optimize shadow control, position the lighthead as appropriate before starting the intended surgical procedure.

  • Page 36: Harmony Lighthead Pattern Adjustment

    5.6 Harmony The illumination pattern for Harmony lightheads can be adjusted to any size between the maximum diameter and minimum diameter. Lighthead Pattern Adjustment • Rotate the central lighthandle clockwise to decrease pattern size. • Rotate the central handle counterclockwise to increase pattern size.

  • Page 37: 5.7 Lighthandles

    5.7 Lighthandles Lighthandles are used to position the lightheads, allow access to intensity control on each lighthead and to adjust lighthead pattern size. If the lighthandle adaptor is not already in place, align the tab on the adaptor with the channel in the mounting ring and thread the adaptor in until fully engaged.
  • Page 38 Sterilization Recommendation 1. Metal handle and silicone ring must be sterilized before use in any surgical procedure. When placing handle and ring in the sterilizer for processing, the best practice is to orient all objects with openings downward, as if to allow water (or air) to flow out.

  • Page 39: Figure 5-8. Standard Handle

    Surgeon’s Intensity Control Buttons Install Standard Align Tab on Lighthandle Lighthandle Lighthandle Lighthandle Handle with Adapter Adapter Channel in Mounting Ring Disposable Push Cover Completely On To Lighthandle Lighthandle Align lighthead and spring arm as shown Cover when installing sterile covers. Figure 5-8.

  • Page 40: 5.8 Monitor Arms

    Power supply and input signals to monitors can be routed through the suspension wiring from an external video source (wiring services, when required, are provided by a third-party video integrator or through STERIS OR Integration. Contact STERIS for further information). 5-12...
  • Page 41 • Range of upward motion for spring arm can be adjusted to 20°, 30°, or 40° above horizontal, to expand storage/parking options when monitors are not in use. • If weight or range of motion for flat panel monitor mount system is changed in any way, refer to I NSTALLATION NSTRUCTIONS...
  • Page 42 Finished Ceiling Finished Floor 15° UP 15° UP 90° DN 90° DN 320° 320° 10° Clockwise 10° Clockwise 10° Counterclockwise 10° Counterclockwise 10° UP 10° UP 10° DN 10° DN 10° UP 10° DN Figure 5-11. HarmonyAIR Surgical Lighting System M Series Monitor Arms, Part 2 5-14 10083002 Operator Manual...

  • Page 43: Install Flat Panel Monitor Yoke Handle Disposable Sterile Covers

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

  • Page 44: Figure 5-13. Installing Disposable Sterile Monitor Handle Covers (Out-Of-Production Handles)

    Guide Disposable Cover Over Handle Until Handle is Monitor Yoke Closure Tie Disposable Sterile Cover Fully Covered Handle Cut Off and Discard Excess Closure Tie, if Desired Figure 5-13. Installing Disposable Sterile Monitor Handle Covers (Out-of-Production Handles) 5-16 10083002 Operator Manual Operating Instructions...

  • Page 45: Video Camera Module Installation Or Removal

    Installation CAUTION – POSSIBLE EQUIPMENT DAMAGE HAZARD: ® NOTE: The STERIS HD Camera Module alignment post is keyed to • The camera module tends to allow installation into HD-ready lightheads only. The SD camera roll if placed on a flat surface.

  • Page 46: Install Camera Disposable Sterile Cover

    Refer to Figure 5-15. (Disposable Disposable Sterile sterile covers are available from STERIS.) Do not use the lighthead Cover during a sterile procedure unless a sterile disposable cover has been placed on the camera.

  • Page 47: Table 5-3. Camera Functions

    NOTE: If two or more camera modules are installed on a system, none of the cameras will energize. Once the video camera module has been installed in the lighthead, the camera may be turned on at the control center by selecting the camera menu and then selecting camera on.

  • Page 48: 5.12.1 Camera Operation

    Figure 5-16. Camera Control Menus 1 and 2 (HD or SD Camera Modules) 5.12.1 Camera Operation The Harmony LED Wall Control Unit functions by transmitting signals via a control cable to the camera located in the lighthead. To initiate camera functions, press the appropriate touch pad on the control face panel.
  • Page 49 Rotate – Use this function to change orientation of the video field. Image field can be rotated in either clockwise or counterclockwise directions. Bright – Use this function to affect the overall brightness (or darkness) of the video image. The Bright control can be set to adjust itself automatically.

  • Page 50: Table 5-4. Camera Control Screen 4 - Speed Adjustment Operation

    Red Gain/Blue Gain – These controls are used to adjust image color settings, and are intended to allow the user to compensate for changes in color temperature provided by differing light sources. The gain control can be set to adjust automatically. Camera Presets –...

  • Page 51: Figure 5-17. Camera Control Menus 3 (Hd Or Sd Camera Modules)

    CAMERA CONTROL 1 2 3 4 WIDE SHOT MEDIUM SHOT CLOSE UP Figure 5-17. Camera Control Menus 3 (HD or SD Camera Modules) SD Camera HD Camera Figure 5-18. Camera Control Menu 4 (HD or SD Camera) 5-23 Operating Instructions Operator Manual 10083002...

  • Page 52: 5.12.2 Hd Settings

    5.12.2 HD Settings When a high definition (HD) camera is installed in the system, the video signal scan frequency and resolution can be adjusted (see Table 5-5). Table 5-5. Camera Control Screen 4 – HD Video Signal Adjustment Operation Row Selected Operation Press HD SETTING (with row identification text)

  • Page 53: Guidelines For Maximizing Video Image

    5.12.3 Guidelines for Observe the following guidelines to aid in maximizing video imaging Maximizing Video Image effectiveness: • Energize the light at medium setting on the control center and position the lighthead approximately 39" (1000 mm) from the surgical site. •...

  • Page 54: 5.13 System Standby

    5.13 System Standby The screen shown in Figure 5-19 is displayed when the control center has been placed in Standby mode. The screen displays “SYSTEM STANDBY” text and international symbol for a system in standby mode. Figure 5-19. System Standby Screen 5.14 Ambient Light The LED ambient light fixture accessory can be installed at the time the Harmony lighting system is installed, or can be added later to a...

  • Page 55: Configuring And Using The Ambient Light

    NOTE: LED ambient lights configured with LED light engines can be provided with either green or white lights depending on the option ordered. Figure 5-20. System Menu 5.14.2 Configuring and Using Once the ambient light fixture has been installed, it must be the Ambient Light configured for use with the lighting system.
  • Page 56 Avoid possibility of electric Important: If the ambient light fixture LED fails, refer light engine shock, and refer any servicing replacement to STERIS service, or to a STERIS-trained service of the ambient light fixture to technician. qualified service personnel. • Ambient light fixture operates...

  • Page 57: Act Enabled System

    5-22. 2. “STERIS ACT INTERFACE” selection should appear on the System Menu screen. • Check mark should appear in the check box next to “STERIS ACT INTERFACE,” under “Installed Components” (at the bottom of the System Menu). 5-29 Operating Instructions...

  • Page 58: Lighthead Runtime And Limit Values

    5.16 Lighthead Access system menu 2 by “System 2” button on the wall control. System menu 2 displays the runtime for each lighthead in hours. Runtime and Limit Values SYSTEM MENU 2 – LAMP RUNTIME HOURS RUNTIME LIGHTHEAD 1 28523 LIGHTHEAD 2 00000 LIGHTHEAD 3...

  • Page 59: Cleaning The Equipment

    Disinfectant cleaners such as: Coverage Plus Germicidal sufficiently. Surface Wipes Disinfecting/Deodorizing/Cleaning Wipes CAUTION – POSSIBLE (available from STERIS). EQUIPMENT DAMAGE HAZARD: • Use of any disinfectant solution OTHER than those listed here may cause discoloration or deformation on the lens surface: ®...

  • Page 60: General Cleaning/Disinfecting Procedure

    6.2 General Cleaning/ NOTE: The user must follow the requirements of the national committee responsible for hygiene and disinfection. Disinfecting Procedure 1. Ensure system is turned off and lightheads are cooled WARNING – PERSONAL sufficiently. INJURY HAZARD: Do not 2. Wear rubber gloves. attempt to clean lighthead unless power is turned off and 3.

  • Page 61: Figure 6-1. Areas To Be Cleaned

    Clean/Disinfect These Areas Clean/Disinfect These Areas HarmonyAIR Surgical Lighting System M Lighthead Single Flat Panel Monitor and Suspension Arm and Spring Arm Clean/Disinfect These Areas Dual Flat Panel Monitor and Suspension Arm Figure 6-1. Areas to Be Cleaned Cleaning the Equipment Operator Manual 10083002...

  • Page 62: Areas To Be Cleaned Before Each Use

    6.3 Areas to Be NOTE: Refer to the user manual supplied with the monitor for the manufacturer's recommended procedures for cleaning the monitor Cleaned Before Each and the monitor control surface. The following areas of the lighting system must be cleaned and WARNING –...

  • Page 63: Operator Troubleshooting

    Chart, or if a problem occurs that is not described on the chart, cooled sufficiently. please call STERIS. A representative will arrange to have your • Do not attempt to adjust equipment promptly put into working order by a STERIS-trained suspension system.
  • Page 64 One or more LED Modules fail to turn on, power supply is not calibrated or power supply is not optimally adjusted. Check control center Fault Log and report failure code to STERIS Service. 8. Poor light pattern. 1. Dirt/debris inside of lighthead, refer problem to qualified STERIS or STERIS-trained service technician.

  • Page 65: Preventive Maintenance

    MAINTENANCE 8.1 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 66 10083002 Operator Manual Maintenance...

  • Page 67: Replacement Parts

    STERIS service representative. Quantities listed are the minimum number of spares that STERIS recommends to be kept on hand. When ordering, please include the part number, description, and quantity for each replacement part requested.
  • Page 68 10083002 Operator Manual Replacement Parts...

  • Page 69: Waste Management Guidelines

    WASTE MANAGEMENT GUIDELINES The following materials are contained within the HarmonyAIR™ ® Surgical Lighting System M Series with Harmony LED Wall Control Unit. 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.
  • Page 70 10-2 10083002 Operator Manual Waste Management Guidelines...

  • Page 71: Appendix - Emc Compliance Technical Data

     APPENDIX – EMC COMPLIANCE TECHNICAL DATA Guidance and Manufacturer’s Declaration – Electromagnetic Emissions for all ME Equipment and ME Systems Table 11-1. Guidance and Manufacturer’s Declaration – Electromagnetic Emissions – for all ME Equipment and ME Systems (per IEC 60601-1-2 clause 5.2.2.1 c) Table 1) The HarmonyAIR Surgical Lighting System M Series with Harmony LED Wall Control Unit with or without video monitor and video-monitor related components is intended for use in the electromagnetic environment specified below.

  • Page 72: Table 11-2. Guidance And Manufacturer's Declaration - Electromagnetic Immunity For All Me Equipment And  Me Systems

    Guidance and Manufacturer’s Declaration – Electromagnetic Immunity – for all ME Equipment and ME Systems (per IEC 60601-1-2 clause 5.2.2.1 f) Table 2) Table 11-2. Guidance and Manufacturer’s Declaration – Electromagnetic Immunity for all ME Equipment and ME Systems The HarmonyAIR Surgical Lighting System M Series with Harmony LED Wall Control Unit is intended for use in the electromagnetic environment specified below.

  • Page 73: Table 11-3. Guidance And Manufacturer's Declaration - Electromagnetic Immunity For Me Equipment And  Me Systems That Are Not Life-Supporting

    Guidance and Manufacturer’s Declaration – Electromagnetic Immunity – for ME Equipment and ME Systems that are not Life-Supporting (per IEC 60601-1-2 clause 5.2.2.2 Table 4) Table 11-3. Guidance and Manufacturer’s Declaration – Electromagnetic Immunity for ME Equipment and ME Systems that are not Life-Supporting The HarmonyAIR Surgical Lighting System M Series with Harmony LED Wall Control Unit is intended for use in the electromagnetic environment specified below.

  • Page 74: Table 11-4. Recommended Separation Distances Between Portable And Mobile Rf Communications

    Table 11-3. Guidance and Manufacturer’s Declaration – Electromagnetic Immunity for ME Equipment and ME Systems that are not Life-Supporting (Continued) a: 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.

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