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11-1

Appendix - EMC Compliance Technical Data

Operator Manual

10083002

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. The Customer or the user of the HarmonyAIR 
Surgical Lighting System M Series with Harmony LED Wall Control Unit should assure that it is 
used in such an environment.

Emissions test

Compliance

Electromagnetic environment – guidance

RF emissions

CISPR 11

Group 1

The HarmonyAIR Surgical Lighting System M Series with 
Harmony LED Wall Control Unit uses RF energy only for 
its internal function. Therefore, its RF emissions are very 
low and are not likely to cause any interference in nearby 
electronic equipment.

RF emissions

CISPR 11

Class A

The HarmonyAIR Surgical Lighting System M Series with 
Harmony LED Wall Control Unit 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.

Harmonic emissions

IEC 61000-3-2

Class A

Voltage fluctuations/

flicker emissions IEC 

61000-3-3

Complies

APPENDIX – EMC COMPLIANCE

TECHNICAL DATA

11

Содержание Harmony LED Wall Control Unit

Страница 1: ...OPERATOR MANUAL HarmonyAIR Surgical Lighting System M Series with Harmony LED Wall Control Unit Rev C 10083002 ...

Страница 2: ......

Страница 3: ... designed to provide visible illumination of the surgical field or the patient for the operating room staff Advisory The following is an important message from STERIS about the advantages and limitations associated with the use of high intensity surgical lighting systems Because of the variety of surgical procedures performed and the wide range of individual preferences of surgical staffs it is de...

Страница 4: ...ntrol throughout the entire range specified by the IEC At start up lighthead LED modules provide illumination levels higher than specifications To compensate output levels are electronically restricted during a 5 to 25 minute startup period to remain within specifications regardless of illumination level selected by the user This allows light output to be maximized at all times Manufactured by STE...

Страница 5: ...head Features 5 3 5 3 Lighthead Fault Indications 5 4 5 4 Control Center Fault Indication 5 4 5 4 1 Fault Display 5 4 5 4 2 Control Center Fault Log Indications 5 5 5 5 Lighthead Positioning 5 7 5 6 Harmony Lighthead Pattern Adjustment 5 8 5 7 Lighthandles 5 9 5 7 1 Plastic Lighthandle and Disposable Lighthandle Cover 5 9 5 7 2 Sterilizable Surgeon Control Handle 5 9 5 8 Monitor Arms 5 12 5 9 Inst...

Страница 6: ...ighthead Runtime and Limit Values 5 30 6 Cleaning the Equipment 6 1 6 1 Cleaning Equipment 6 1 6 2 General Cleaning Disinfecting Procedure 6 2 6 3 Areas to Be Cleaned Before Each Use 6 4 7 Operator Troubleshooting 7 1 8 1 Preventive Maintenance 8 1 8 2 Inspect Suspension 8 1 8 3 Inspect Control Center 8 1 8 Maintenance 8 1 9 Replacement Parts 9 1 10 Waste Management Guidelines 10 1 11 Appendix EMC...

Страница 7: ...ighthead Positioning 5 7 Figure 5 7 Light Pattern Size Adjustment 5 8 Figure 5 8 Standard Handle 5 11 Figure 5 9 Sterilizable Surgeon Control Handle 5 12 Figure 5 10 HarmonyAIR Surgical Lighting System M Series Monitor Arms Part 1 5 13 Figure 5 11 HarmonyAIR Surgical Lighting System M Series Monitor Arms Part 2 5 14 Figure 5 12 Installing Disposable Sterile Monitor Handle Covers Current Production...

Страница 8: ...vi 10083002 Operator Manual Table of Contents Healthcare Capital Equipment ...

Страница 9: ...creen 4 HD Video Signal Adjustment Operation 5 24 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 11 1 Table 11 2 Guidance and Manufacturer s Declaration Electromagnetic Immunity for all ME Equipment and ME Systems 11 2 Table 11 3 Guidance and Manufacturer s Declaration Electromagnetic Immun...

Страница 10: ...viii 10083002 Operator Manual Table of Contents Healthcare Capital Equipment ...

Страница 11: ...NING POTENTIAL ENVIRONMENTAL HAZARD WARNING EXPLOSION HAZARD Do not use lighting fixture in the presence of flammable anesthetics This product contains materials which may require disposal through appropriately licensed and permitted hazardous waste management firms WARNING ELECTRIC SHOCK HAZARD Do not remove covers or perform service other than as described in SECTION 8 MAINTENANCE of this operat...

Страница 12: ... supplied by sources other than STERIS does not exceed the optical radiation power 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 Do not attempt to clean lighthead unless power is turned off and the lighthead has cooled sufficiently Do not atte...

Страница 13: ...use of alcohol or aerosol spray cleaner disinfectants containing a substantial amount of alcohol in the formula can damage the polycarbonate lens Use of any disinfectant solution OTHER than those listed here may cause discoloration or deformation on the lens surface Coverage Plus Germicidal Surface Wipes Disinfecting Deodorizing Cleaning Wipes Cleaning solutions other than those listed have NOT be...

Страница 14: ...than those specified with the exception of transducers and cables sold by the manufacturer of this device as replacement parts for internal components may result in increased EMISSIONS or decreased IMMUNITY of the HarmonyAIR Surgical Lighting System The HarmonyAIR Surgical Lighting System should not be used adjacent to or stacked with other equipment If adjacent or stacked use is necessary the equ...

Страница 15: ... 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 or Attention consult manual for further instructions SYMBOL DEFINITIONS 2 ...

Страница 16: ...ess optical fiber cables are fully connected Press key to access System Menu for system configuration or information Indicates control fault Refer situation to qualified trained service technician Serial Number of Unit V Voltage Rating of Unit Alternating Current A Amperage Rating of Unit Alternating Current Hz Frequency Rating of Unit Alternating Current Increase Intensity Surgeon s Control Butto...

Страница 17: ...Manual 10083002 Decrease Intensity Surgeon s Control Buttons a a Symbol is a fingertip contour molded into the lighthead surgeons s control bezel Table 2 1 Symbol Definitions Symbol Definition 123456 123456 123456 123456 123456 123456 ...

Страница 18: ...2 4 10083002 Operator Manual Symbol Definitions Healthcare Capital Equipment ...

Страница 19: ...eak Total Irradiance 500 W m2 540 W m2 Pattern Size Range 18 28 cm 7 11 22 30 cm 8 1 2 12 D50 Diameter 63 of small beam pattern see Pattern Size Range 50 of small beam pattern see Pattern Size Range Depth of Illumination to 20 100 cm 39 91 cm 36 Depth of Illumination to 60 52 cm 20 46 cm 18 Color Temperature CCT 4 400K 300K 4 400K 300K General Color Rendering Index CRI Up to 96 Up to 96 Deep Satur...

Страница 20: ...mended Transport Storage Temperature not exceeding 15 weeks 2 to 38 C 36 to 100 F Recommended Relative Humidity 30 to 75 Atmospheric Pressure 500 to 1060 hPascals Two Lighthead System no ambient light 100 240 Vac 50 60 Hz 6 3A 600 Watts at 100 Vac 720 Watts at 240 Vac Typical Lighthead Wattage M5 Lighthead 40 Watts M7 Lighthead 200 Watts Optional LED Ambient Light Kit 12 Vdc 26W ...

Страница 21: ...uipment complete the pre operation checklist It is essential to the safe operation and continuing maintenance of this equipment to verify that the installation is complete and correct Refer to Figure 4 1 through Figure 4 3 to locate parts WARNING ELECTRIC SHOCK HAZARD Do not remove covers or perform service other than as described in SECTION 8 MAINTENANCE of this operator manual Refer servicing to...

Страница 22: ...r down by pivoting at spring arm knuckle up to 40 up and 40 down Flat panel yoke also allows 6 tilt15 backward up and 90 forward down For additional information refer to separate operating instructions supplied with monitor s Monitor instructions not by STERIS Power supply and input signals to monitors can be routed through the suspension wiring from an external video source external video sources...

Страница 23: ...ication Operator Manual 10083002 Figure 4 3 Monitor Arms Positioning 320 10 UP 10 DN 320 15 UP 90 DN 15 UP 90 DN 10 UP 10 DN 10 UP 10 DN 5 3 1 4 2 5 Finished Floor 10 Clockwise 10 Counterclockwise 10 Clockwise 10 Counterclockwise ...

Страница 24: ...aults indicated on the fault screen Immediately report all faults and LED Module out indications to a qualified service technician NOTE Turn power OFF to each lighthead using intensity controls when testing is complete Check LED Module Failure Indicators If any lamp fault graphic on the control center display is visible one or more LED modules may have failed Any service for LED module failure mus...

Страница 25: ...mera Check cable connection between control center and monitor if necessary Control Center Verify zoom rotation and focus functions with the control center switches Select camera menu 2 verify gain controls if necessary verify freeze frame function adjust camera zoom and focus speed as necessary from camera menu 4 Camera Faults Verify that camera powers on and that there are no camera communicatio...

Страница 26: ...4 6 10083002 Operator Manual Post Installation Verification 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 ...

Страница 27: ...4 7 Post Installation Verification Operator Manual 10083002 Figure 4 7 Camera Control Menus WIDE SHOT CAMERA CONTROL 1 2 3 4 MEDIUM SHOT CLOSE UP SD Camera HD Camera ...

Страница 28: ...8 The lighting system can include up to two monitor arms on a single central 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 Figure 4 8 Monitor Support Arm Typical Dual Flat Panel Monitor Arm Shown ...

Страница 29: ...s adjust the intensity level for that lighthead Important Avoid control center faults from excessive pressure on keys Do not continuously press and hold any control center button for more than 40 seconds Control Center see Figure 5 1 1 Use the Select Light touch pads to move the display indicator up or down until it aligns with the appropriate lighthead 2 Once the lighthead is selected press the r...

Страница 30: ... molded with the following symbols to increase the lighthead intensity Press any of the surgeon s control buttons molded with the following symbol to decrease lighthead intensity 4 To turn lighthead OFF a At the control center press the Select Light button until indicator points to the appropriate lighthead on the display Press the Decrease Intensity button until the light goes out b Press and hol...

Страница 31: ... high definition HD or standard definition SD See Section 5 10 Video Camera Module Installation or Removal page 5 17 for further information Yes Handle Position Central Backup Lamp Not Applicable 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 H...

Страница 32: ...dules 5 4 Control Center Fault Indication 5 4 1 Fault Display When one or more LED modules are missing or burned out the LED Fault Indicator appears on the display to the right of the corresponding lighthead s intensity control The indicator flashes once every two seconds Figure 5 4 Lighthead Exterior LED Indicator Lighthead Exterior LED Indicator Single LED Module Failure Figure 5 5 Harmony Contr...

Страница 33: ...e control center can no longer communicate with a lighthead yes BATTERY POWER SUPPLIED TO LIGHTHEAD Displayed when one or more lightheads are operating on battery backup power no CAMERA COMMUNICATION FAILURE ON LIGHTHEAD The lighthead cannot communicate with camera yes CAMERA MOTOR ROTATION OVER CURRENT ON LIGHTHEAD The motor that rotates the camera is drawing excessive current camera is not rotat...

Страница 34: ...ot maintained within current limits yes WALL CONTROL PARAMETERS DON T MATCH LIGHTHEAD A lighthead s runtime hours target drive current or duty cycle parameters do not match the same values in the wall controller Mismatch may be resolved using service menus Refer to MAINTENANCE MANUAL P764330 226 yes POWER SUPPLY REQUIRES ADJUSTMENT ON LIGHTHEAD Power supplies not adjusted optimally for the lighthe...

Страница 35: ...head Spring Arm Assemblies may See Figure 5 6 1 rotate continuously around central hub 2 rotate continuously at horizontal suspension arm spring arm connection 3 rotate continuously at spring arm yoke connection 4 tilt forward or backward in yoke approximately 310 and 5 move up or down by pivoting at suspension elbow 15 up and 85 down total range 100 CAUTION POSSIBLE EQUIPMENT DAMAGE HAZARD Do not...

Страница 36: ...he maximum diameter and minimum diameter Rotate the central lighthandle clockwise to decrease pattern size Rotate the central handle counterclockwise to increase pattern size NOTE Typical lighthead positioning is above and slightly behind the surgeon s right or left shoulder Figure 5 7 Light Pattern Size Adjustment Rotate to Decrease Pattern Size Rotate to Increase Pattern Size ...

Страница 37: ... install a clean sterilized handle by screwing it onto the threaded handle adaptor Ensure handle is firmly tightened prior to use The gap between the flange on the sterilizable handle and the surgeon s control buttons prevent accidental contact with the non sterile surface of the buttons Cleaning Recommendation 1 Remove visible debris by means of manual or automated cleaning using an enzymatic or ...

Страница 38: ... 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 3 Sterilize handle and silicone ring separately disassembled but in the same chamber using a cycle with either of the following parameters Prevacuum Temperature 270 F 132 C Exposure Time 4 minutes Gravity Temperature 270 F 132 C Exposure Time 10 minutes ...

Страница 39: ...dard Lighthandle Disposable Lighthandle Cover Push Cover Completely On To Lighthandle Align lighthead and spring arm as shown when installing sterile covers Lighthandle Align Tab on Handle with Channel in Mounting Ring Lighthandle Adapter Surgeon s Intensity Control Buttons Lighthandle Adapter ...

Страница 40: ...e up or down by pivoting at spring arm knuckle up to 40 up and 40 down Flat panel yoke also allows 6 tilt15 backward up and 90 forward down For additional information refer to separate operating instructions supplied with monitor s Monitor instructions for use are provided by monitor manufacturer Power supply and input signals to monitors can be routed through the suspension wiring from an externa...

Страница 41: ...arking 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 INSTALLATION INSTRUCTIONS 10043126 for procedures to help ensure proper balancing and motion Figure 5 10 HarmonyAIR Surgical Lighting System M Series Monitor Arms Part 1 Dual Flat Panel Monitor Single Flat Panel Monitor ...

Страница 42: ...gure 5 11 HarmonyAIR Surgical Lighting System M Series Monitor Arms Part 2 320 10 UP 10 DN 320 15 UP 90 DN 15 UP 90 DN 10 UP 10 DN 10 UP 10 DN Finished Ceiling 5 3 1 4 2 5 10 Clockwise 10 Counterclockwise 10 Clockwise 10 Counterclockwise 6 6 Finished Floor ...

Страница 43: ...over until it fully covers the handle NOTE Step 3 applies only to out of production handles 3 Refer to Figure 5 13 Pull closure tie until tight enough to prevent cover from slipping down the handle 4 Repeat procedure for second handle s WARNING BIOHAZARD Sterile disposable covers are intended for single use only WARNING STERILITY ASSURANCE HAZARD Do not use disposable handle covers if its packagin...

Страница 44: ...ure 5 13 Installing Disposable Sterile Monitor Handle Covers Out of Production Handles Disposable Sterile Cover Closure Tie Monitor Yoke Handle Guide Disposable Cover Over Handle Until Handle is Fully Covered Cut Off and Discard Excess Closure Tie if Desired ...

Страница 45: ...d align system connector properly and install camera module into lighthead b Select Camera Menu 1 on the control center c Verify all functions of the camera operate correctly using the control center 4 Once camera module functions are verified press the OFF touch pad on the face of the control center Removal 1 Rotate lighthead until perpendicular to floor 2 Unthread camera housing from mounting ri...

Страница 46: ...an function in any lighthead Whenever the video option is used a separate sterile disposable cover must be fitted over the camera before each procedure see Section 5 11 Install Camera Disposable Sterile Cover page 5 18 This cover allows the camera to be grasped and used in the same way as a standard handle including positioning the lighthead for optimal illumination adjusting lighthead intensity a...

Страница 47: ...s available through menus on the control center The list of camera features and how they may be controlled is summarized in the Table 5 3 The number shown is the number of the camera control menu on the wall mounted control center See Figure 5 16 for camera control screens 1 and 2 and Figure 5 17 for camera control screens 3 and 4 Table 5 3 Camera Functions Control Center Feature Camera Control Me...

Страница 48: ...e Zoom function adjusts the image field continuously between two extremes Telephoto At extreme telephoto the camera captures an image showing great detail in a small area NOTE At extreme telephoto any motion of the lighthead camera may be exaggerated jerky The field of focus has little depth at this extreme forcing the Auto Focus function if enabled to refocus the camera when any object such as a ...

Страница 49: ...have been labeled near and far The focus indicator slides only as far as required to establish a sharp focus When sharp focus cannot be achieved the focus indicator cannot slide all the way to the near setting Example When the indicator cannot be moved left toward near the camera has been forced beyond its optical focusing limit In this case adjust to a shorter zoom length and try focusing the ima...

Страница 50: ...focus 1 Up down arrows are used to select either zoom speed adjustment or focus speed adjustment 2 Left right arrows are used to adjust the speed of zoom and focus Pressing the LEFT ARROW causes zoom and focus functions to occur more slowly SLOW Pressing the RIGHT ARROW causes zoom and focus functions to occur more quickly FAST 3 Press center dot key below Menu 1 icon to advance display to camera ...

Страница 51: ...structions Operator Manual 10083002 Figure 5 17 Camera Control Menus 3 HD or SD Camera Modules WIDE SHOT CAMERA CONTROL 1 2 3 4 MEDIUM SHOT CLOSE UP Figure 5 18 Camera Control Menu 4 HD or SD Camera SD Camera HD Camera ...

Страница 52: ...ew setting takes effect NOTE Exiting Camera Control Screen 4 using the Camera Menu button causes wall control to display Camera Control Screen 1 INITIALIZING CAMERA message replaces IDENTIFYING CAMERA message on Camera Control Screen 1 Table 5 5 Camera Control Screen 4 HD Video Signal Adjustment Operation Row Selected Key Press Operation HD SETTING with row identification text LEFT HD camera scan ...

Страница 53: ...us beyond the nearest object i e the surface area surrounding the incision so that the desired image can be viewed clearly Position Light Pattern in Center of Video Image to Avoid Distortion 1234567890123456789012345678901212345678 1234567890123456789012345678901212345678 1234567890123456789012345678901212345678 1234567890123456789012345678901212345678 1234567890123456789012345678901212345678 1234...

Страница 54: ... added later to a previously installed system 5 14 1 Ambient Light Operation Overview The ambient light provides low level general illumination in the surgical suite Illumination from the ambient light fixture can be configured to operate manually turned on or off at the Harmony Control Center or the ambient light can be configured to operate automatically turns off when any system lighthead is tu...

Страница 55: ...een installed it must be configured for use with the lighting system Refer to Figure 5 20 1 Access the system menu by pressing the system menu button on the control center 2 Select Ambient Light Installed and change to Yes Ambient Light Mode selection should appear on the system menu screen Check mark should appear in the check box next to Ambient Light under Installed Components near the bottom o...

Страница 56: ...bient light remains on until the control center is placed in Standby When using the Auto configuration but the ambient light was turned on or off manually the automatic feature resets once the light fixture undergoes one full on off cycle Important If the ambient light fixture LED fails refer light engine replacement to STERIS service or to a STERIS trained service technician WARNING ELECTRIC SHOC...

Страница 57: ...provided with the Operating Room Control System ORCS for specific details NOTE The lighting system must be ON when operating with Operating Room Control System ORCS Verify system with STERIS ACT Interface configuration as follows 1 Access the System Menu by pressing the System Menu button on the control center Refer to Figure 5 22 2 STERIS ACT INTERFACE selection should appear on the System Menu s...

Страница 58: ...s the wall control units s stored value for the corresponding lighthead s runtime in hours Lighthead runtime hours are accumulated by the lighthead PC board whenever lightheads are turned on Accumulated lighthead runtime hours are periodically transmitted to the wall control Figure 5 23 System Menu 2 Runtime and Limit Values LIGHTHEAD 2 LIGHTHEAD 3 LIGHTHEAD 4 LIGHTHEAD 1 SYSTEM MENU 2 LAMP RUNTIM...

Страница 59: ...dorizing Cleaning Wipes Cleaning solutions other than those listed have NOT been tested for compatibility or effectiveness Always follow manufacturer instructions for concentrations and use of cleaning products Avoid discoloration of control center keypad and display Do not clean control center with povidone iodine solutions or allow such solutions to contact keypad and display surfaces Prevent le...

Страница 60: ...andle covers are used verify a new one is used for each procedure WARNING PERSONAL INJURY HAZARD Do not attempt to clean lighthead unless power is turned off and the lighthead has cooled sufficiently CAUTION POSSIBLE EQUIPMENT DAMAGE HAZARD Use of any disinfectant solution OTHER than those listed here may cause discoloration or deformation on the lens surface Coverage Plus Germicidal Surface Wipes...

Страница 61: ... 6 1 Areas to Be Cleaned HarmonyAIR Surgical Lighting System M Lighthead and Spring Arm Clean Disinfect These Areas Clean Disinfect These Areas Single Flat Panel Monitor and Suspension Arm Clean Disinfect These Areas Dual Flat Panel Monitor and Suspension Arm ...

Страница 62: ...osable sterile lighthandle covers verify a new one is used for each procedure NOTE Always sterilize metal sterilizable handle between procedures Sterilize lighthandle using conventional hospital sterilization procedures and a standard sterilization prevacuum or gravity cycle Control Center Wipe housing and control center with an anti static cleaner and soft cloth WARNING PERSONAL INJURY HAZARD Do ...

Страница 63: ...nstructions for modem housing and contents WARNING PERSONAL INJURY HAZARD Do not attempt to clean lighthead unless power is turned off and lighthead has cooled sufficiently Do not attempt to adjust suspension system Refer servicing to qualified service personnel WARNING IMPACT HAZARD Do not remove tension screw from the lighthead spring arm joint until the lighthead has been securely installed ont...

Страница 64: ...vice 8 Poor light pattern 1 Dirt debris inside of lighthead refer problem to qualified STERIS or STERIS trained service technician 2 LED mis alignment on lighthead cover 9 Light pattern will not change Refer problem to qualified STERIS or STERIS trained service technician 10 Monitor does not operate as expected 1 Make sure all connections are complete and secure Make sure power is supplied to moni...

Страница 65: ...mmends establishing an annual maintenance agreement with STERIS service 8 2 Inspect Suspension Start at the highest point on the suspension and work out toward the lightheads on each suspension arm Verify proper operation of each braking point If necessary adjust each of the brakes in turn with the goal of eliminating both binding and drift in the system Refer to MAINTENANCE MANUAL P764335 782 if ...

Страница 66: ...8 2 10083002 Operator Manual Maintenance Healthcare Capital Equipment ...

Страница 67: ...cal Lighting System M Series Maintenance Manual P764335 782 Harmony LA LED Surgical Lighting and Visualization System Maintenance Manual P764330 226 Plastic Lighthandle LB20 Camera Handle Sterile Cover LB54 Sterile Cover for Lighthandle LB53 Sterilizable Surgeon Control Handle LB23 Silicone Replacement LB24 Monitor Sterile Cover Single LB45 Monitor Sterile Cover Dual LB46 Brake Screw Spindle 10050...

Страница 68: ...9 2 10083002 Operator Manual Replacement Parts Healthcare Capital Equipment ...

Страница 69: ...l WEEE RoHS regulations Electronic and Electrical Parts not known to require special disposal methods at date of this manual Metal Parts made from aluminum Al steel Fe cast iron Fe copper Cu and copper alloys Cu x plastic synthetic rubber plating Cr Ni Zn Au and adhesives not known to require special disposal methods at date of this manual Polyvinylchloride PVC The approximate weight of PVC within...

Страница 70: ...10 2 10083002 Operator Manual Waste Management Guidelines Healthcare Capital Equipment ...

Страница 71: ...ontrol Unit should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The HarmonyAIR Surgical Lighting System M Series with Harmony LED Wall Control Unit uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipm...

Страница 72: ... that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV line s to line s 2 kV line s to earth 1 kV line s to line s 2 kV line s to earth Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 c...

Страница 73: ...5 GHz 3 Vrms 3 V m Portable and mobile RF communications equipment should be used no closer to any part of the HarmonyAIR Surgical Lighting System M Series with Harmony LED Wall Control Unit including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance 80 MHz to 800 MHz 800 MHz to 2 5 GHz where ...

Страница 74: ...l Control Unit The HarmonyAIR Surgical Lighting System M Series with Harmony LED Wall Control Unit is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The Customer or the user of the HarmonyAIR Surgical Lighting System M Series with Harmony LED Wall Control Unit can help prevent electromagnetic interference by maintaining a minimum distance betwee...

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