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Steris HarmonyAIR G Series, Руководство оператора

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1-1

Safety Precautions

Operator Manual

10043124

1

The following 

Safety Precautions

 must be observed when operating or servicing this HarmonyAIR™ Surgical

Lighting System G Series. 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. It is important to review ALL 

Safety Precautions 

before operating or servicing the unit. 

Strictly following these 

Safety Precautions

 enhances your ability to safely and effectively utilize the unit and helps

the Customer avoid improper maintenance methods which may damage the unit or render it unsafe. It is
important to understand that these 

Safety Precautions 

are not exhaustive; Customers are encouraged to develop

their own safety policies and procedures to enhance and complement these 

Safety Precautions.

NOTICE: 

This product contains a Class 1 laser product: No known biological hazard. The light is shielded from

any possible viewing by a person and the laser system is enclosed and requires a tool to access.

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.
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 power is turned off and the lighthead has cooled sufficiently.

Do not attempt to adjust suspension system. Refer servicing to qualified service personnel.

Avoid looking directly at high-intensity light from the lighthead. Eye injury may result.

No part of this system shall be serviced while in use with a patient.

Flat Panel Monitor spring arm uses adjustable tension force to support monitor weight. Do not remove
monitor from the arm unless the arm has been locked in place by a trained and authorized technician. 

Lighthead arm uses adjustable tension force to support lighthead weight. Do not remove lighthead from
the arm unless the arm has been locked in place by a trained and authorized technician. 

Do not modify this equipment without authorization of the manufacturer.

If this equipment is modified, appropriate inspection and testing must be conducted to ensure continued
safe use of operation.

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SAFETY PRECAUTIONS

1

Содержание HarmonyAIR G Series

Страница 1: ...OPERATOR MANUAL HarmonyAIR Surgical Lighting System G Series Rev G 10043124 ...

Страница 2: ......

Страница 3: ... is to be used with this lighting system must comply with all applicable medical equipment standards Indications for Use The HarmonyAIR Surgical Lighting System G Series is a fixed or variable pattern variable intensity surgical lighting fixture designed to provide visible illumination of the surgical field or the patient for the operating room staff Advisory The following is an important message ...

Страница 4: ...ls on either the wall mounted control center or the lighthead handle The illumination level also decreases as the pattern size increases Maximum illuminance can reach 160 klx for the smallest pattern size of the lighthead and can be adjusted by intensity control or pattern size control throughout the entire range specified by the IEC Serious incidents that have occurred in relation to this medical...

Страница 5: ...urgical Lighting System G Series 3 1 3 1 2 Wall Control Unit 3 2 3 1 3 Surgeon s Intensity Control Buttons 3 3 3 2 G5 Lighthead Module Status Indications 3 4 3 3 G5 Lighthead Positioning 3 5 3 4 G5 Lighthead Pattern Adjustment 3 6 3 5 Lighthandles 3 7 3 5 1 Plastic Lighthandle and Disposable Lighthandle Cover 3 7 3 5 2 Sterilizable Surgeon Control Handle 3 7 3 6 Monitor Arms 3 11 3 7 Video Camera ...

Страница 6: ...n Page TABLE OF CONTENTS 6 Maintenance 6 1 6 1 Preventive Maintenance 6 1 6 2 Inspect Suspension 6 1 6 3 Inspect Wall Control 6 2 6 4 Optional Service Disconnect Switch 6 2 7 Replacement Parts 7 1 8 Waste Disposal Guidelines 8 1 9 Appendix EMC Compliance Technical Data 9 1 ...

Страница 7: ...head Positioning 3 5 Figure 3 5 G5 Lighthead Pattern Adjustment 3 6 Figure 3 6 Standard Lighthandle 3 9 Figure 3 7 Sterilizable Surgeon Control Handle 3 10 Figure 3 8 HarmonyAIR Surgical Lighting System G Series Monitor Arm 3 11 Figure 3 9 Optional Camera Installation 3 12 Figure 3 10 Install Disposable Sterile Camera Cover 3 13 Figure 5 1 Wall Control Fault Codes 5 4 Figure 6 1 Optional Service D...

Страница 8: ...vi 10043124 Operator Manual Table of Contents Healthcare Capital Equipment ...

Страница 9: ...5 1 Table 7 1 HarmonyAIR Surgical Lighting System G Series Replacement Parts 7 1 Table 9 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 9 1 Table 9 2 Guidance and Manufacturer s Declaration Electromagnetic Immunity for all ME Equipment and ME Systems 9 2 Table 9 3 Guidance and Manufacturer s Declara...

Страница 10: ...ix Table of Contents Operator Manual 10043124 Healthcare Capital Equipment ...

Страница 11: ...tenance 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 Maintenance performed by inexperienced unqualified personnel or installation of unauthorized parts could cause personal injury invalidate the warranty or result ...

Страница 12: ...gical Lighting System G Series Accessories or replacement parts not listed in the Operator or Maintenance Manuals should not be used Avoid potential EMISSIONS interference The HarmonyAIR Surgical Lighting System G Series 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...

Страница 13: ...install the lighting fixture unless all utilities have been properly locked out Always follow OSHA Lockout Tagout and electrical safety related work practice standards Do not use this lighting system in the presence of flammable anesthetics Do not remove covers or perform service other than as described in this operator manual Refer servicing to qualified service personnel Do not remove wall contr...

Страница 14: ...ctant and Coverage Spray TB Plus Ready To Use Disinfectant Cleaner may cause discoloration of the lens surface Other cleaning solutions have NOT been tested for compatibility or effectiveness Always follow manufacturer instructions for concentrations and use of cleaning products Use only recommended cleaning disinfecting and or anti static agents on this light Staining pitting and or discoloration...

Страница 15: ...23 lb per monitor To avoid excessive radiated emissions on camera equipped systems utilize a maximum 3 1 m shielded HDMI cable with one Fair Rite shield bead 0446176451 and a single turn of cable at the HDMI output and a Fair Rite shield bead 0444164181 clamped to the distal end of the HDMI cable Shield bead characteristics for 0446176451 are 85 ohms at 10 MHz 137 ohms at 25 MHz 330 ohms at 100 MH...

Страница 16: ...uires Service Protective Earth Ground Attention consult manual for further instructions Consult instructions before use Maximum Load Hazard maximum load given on label Hot Potential Burn Hazard Serial Number of Unit V Voltage Rating of Unit Alternating Current A Amperage Rating of Unit Hz Frequency Rating of Unit Increase Intensity Surgeon s Control Buttons or Wall Control Decrease Intensity Surge...

Страница 17: ...ual 10043124 Camera ON OFF indicator Zoom Rotate Manual Focus Auto Mode Brightness or Focus Potential Impact Hazard Potential Pinch Point Hazard Brightness Battery Backup Fault Table 1 1 Definition of Symbols Continued Symbol Definition ...

Страница 18: ...1 8 10043124 Operator Manual Safety Precautions Laser Radiation Medical Device Unique Device Identifier Table 1 1 Definition of Symbols Continued Symbol Definition ...

Страница 19: ...ontrol ON OFF switch is OFF wall control ON OFF LED flashes Turn control ON by pressing wall control ON OFF touch pad Verify that wall control touch pads function Check intensity levels for each system lighthead If optional camera module is installed check camera controls NOTE Turn power OFF to each lighthead using intensity controls and to optional camera if installed when testing is complete Che...

Страница 20: ...ear signal is reaching the video display device monitor from the camera Check cable connection between video output connector at control center and monitor if necessary Wall Control Verify zoom rotation and focus functions with the control center switches 2 2 Check Optional Monitor Support Arms The HarmonyAIR Surgical Lighting System G Series can include up to three lightheads and up to two monito...

Страница 21: ...ng System G Series Lighthead Optical Performance Feature G5 Lighthead Maximum Central Illuminance 160 000 lux Peak Total Irradiance 500 W m2 Pattern Size Fixed 18 cm 7 Adjustable 18 cm 7 28 cm 11 D50 Diameter 62 of small beam pattern see Pattern Size Depth of Illumination to 20 to 60 97 cm 38 53 cm 21 Color Temperature CCT 4 400K 300K General Color Rendering Index CRI Up to 96 Deep Saturated Red C...

Страница 22: ...stance along the beam axis less than 1000 W m2 3 Provide white light to illuminate the operating field The apparent whiteness of the light can be verified by visual observation 4 Loss of illumination could result in delay of surgical procedure 5 In extreme cases of electromagnetic interference the operator may experience temporary loss of light function or camera operation This can be corrected by...

Страница 23: ...e Control Center Ambient 60 C 140 F Maximum Room Ambient 20 to 25 C 68 to 77 F To avoid adverse thermal effects on canopy control electronics thermal contributions from interstitial space and room ambient temperatures must NOT result in canopy ambient temperatures exceeding 60 C 140 F Recommended Transport Storage Temperature not exceeding 15 weeks 2 to 38 C 36 to 100 F Recommended Relative Humidi...

Страница 24: ...2 6 10043124 Operator Manual Installation Verification Healthcare Capital Equipment ...

Страница 25: ... and restores system lightheads to same intensity levels as before system was turned OFF When the system is ON ON OFF LED glows green and it does not blink i e is steady This state is referred to as ACTIVE mode When the system ON OFF switch is pressed while system is ACTIVE system switches to STANDBY mode In STANDBY mode all lights turn off the optional camera module if present turns off and ON OF...

Страница 26: ... in the presence of flammable anesthetics Table 3 1 HarmonyAIR Surgical Lighting System G Series Intensity Control Module State Module Intensity Button Pressed Duration of Switch Press Operation OFF N A Any Module turns ON at stored intensity setting ON Any except highest Any Module increases to next higher intensity setting ON Highest Any Module remains at highest intensity setting OFF N A Any Mo...

Страница 27: ... 3 2 1 Grasp the handle of the appropriate lighthead A ring of membrane buttons bumps are located on the control bezel adjacent to the lighthead lens 2 Press any of the surgeon s intensity control buttons molded with symbols to increase the lighthead intensity Press any of the surgeon s control buttons molded with symbols to decrease lighthead intensity 3 To turn lighthead OFF press and hold any o...

Страница 28: ... status LED is lit it indicates the module s has failed A failed module s should always be changed at the earliest opportunity Another module status LED is located on each lighthead see Figure 3 3 When flashing the lighthead LED indicates the module s should be replaced Check the module status LED each time the surgical light is used If the module status LED is blinking call your STERIS service re...

Страница 29: ...appropriate before starting the intended surgical procedure HarmonyAIR Surgical Lighting System G Series 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 3 Rotate continuously at spring arm yoke connection 4 Rotate at the dual cardanic yoke hub 270 5 Tilt forward or backward in yoke ...

Страница 30: ...between the maximum diameter and minimum diameter Refer to Figure 3 5 Adjust the light pattern by rotating the lighthandle clockwise to decrease pattern size Rotate the handle counterclockwise to increase pattern size CAUTION POSSIBLE EQUIPMENT DAMAGE HAZARD Do not bump lightheads into walls or other equipment Figure 3 5 G5 Lighthead Pattern Adjustment Rotate Handle to Decrease Pattern Size Rotate...

Страница 31: ... See Figure 3 7 Prior to starting a procedure 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 Recommendations 1 Remove visible debris by means of manua...

Страница 32: ...ing 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 NOTE Before using silicone ring note the following 1 Reuse limit is 1 000 cycles 2 Replace ring if yellowing deformation cracking or other signs of deterioration are present ...

Страница 33: ... Surgeon s Intensity Control Buttons Lighthandle Adaptor Lighthandle Align Tab on Handle Adaptor with Channel in Mounting Ring Align lighthead and Spring Arm as Shown When Installing Sterile Covers Disposable Lighthandle Cover Push Cover Completely onto Lighthandle Lighthandle Adaptor ...

Страница 34: ...ating Instructions Figure 3 7 Sterilizable Surgeon Control Handle Surgeon s Intensity Control Buttons Lighthandle Adaptor Align Tab on Handle Adaptor with Channel in Mounting Ring Lighthandle Adaptor Sterilizable Surgeon Control Handle ...

Страница 35: ...ve up by pivoting at spring arm knuckle 45 up move down by pivoting at spring arm knuckle 50 down Flat panel monitor FPM yoke tilts 5 forward 15 or backward 90 in yoke 6 FPM yoke tilts 10 up or down See Figure 3 8 Refer to separate operating instructions supplied with the monitor Input signals to monitors can be routed through the suspension wiring from an external video source not provided by STE...

Страница 36: ...e same support used by the standard handle a Align the post with recess this should align system connector properly and install camera assembly to lighthead Refer to Figure 3 9 b Turn ON camera at the wall control c Verify all functions of the camera operate correctly using the wall control 4 Once camera functions are verified press the OFF touch pad on the face of the wall control Removal 1 Rotat...

Страница 37: ...tted to specially ordered HarmonyAIR Surgical Lighting System G Series lighthead Whenever the video option is used a separate sterile disposable cover must be fitted over the camera before each procedure see SECTION 3 8 INSTALL DISPOSABLE STERILE CAMERA COVER PAGE 3 13 This cover allows the camera to be grasped and used in the same way as a standard handle including positioning the lighthead for o...

Страница 38: ...rated 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 hand enters the image field or if camera position is adjusted The camera is also sensitive to light level changes at extreme telephoto Minimum distance for HD camera is 800 mm 31 when using extreme telephoto zoom Wide Angle At extreme wide angle...

Страница 39: ...era brightness decreases as long as the brightness switch is pressed Brightness or focus decreases stop when the camera reaches its internal lower limit Auto ON Brightness or Focus Mode switched to Manual Mode LED indicator turned OFF The camera brightness or focus increases as long as the brightness switch is pressed Brightness or focus increases stop when the camera reaches its internal upper li...

Страница 40: ... prevent the camera from refocusing on hands and other objects introduced into the image field while video imaging procedures 3 10 Guidelines for Maximizing Video Image Observe the following guidelines to aid in maximizing video imaging effectiveness Energize the light at medium setting and position the front face of the camera module approximately 39 1 m from the surgical site Using the zoom swit...

Страница 41: ...perate using voice activated controls or touch panel displays The STERIS provided portion of this system is an interface point between HarmonyAIR system and the operating room control system integration Refer to the operator manual and technical specifications provided with the integration system for specific details NOTE The lighting system must be ON when operating with the integration system To...

Страница 42: ...3 18 10043124 Operator Manual Operating Instructions Healthcare Capital Equipment ...

Страница 43: ...infecting agents used on this lighting system must be certified by their manufacturer to be compatible with the following materials polycarbonate polyetherimide santoprene DO NOT SPRAY any cleaning product directly onto the lighthead modem chassis or any system components Use only recommended cleaning disinfecting and or anti static agents on this light Staining pitting and or discoloration could ...

Страница 44: ...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 Disinfecting Deodorizing Cleaning Wipes Coverage Spray HB Plus Ready To Use One Step Disinfectant and Coverage Spray TB Plus Ready To Use Disinfectant Cleaner Cleaning solutions other than those list...

Страница 45: ...andle covers verify a new one is used for each procedure NOTE Always sterilize handle using conventional hospital sterilization procedures and a standard sterilization prevacuum or gravity cycle Wall Control Wipe panel with an anti static cleaner and soft cloth WARNING PERSONAL INJURY and or POSSIBLE EQUIPMENT DAMAGE HAZARD Do not attempt to clean lighthead unless power is turned off and the light...

Страница 46: ...4 4 10043124 Operator Manual Cleaning The Equipment Healthcare Capital Equipment ...

Страница 47: ...ot remove covers or perform service other than as described in this operator manual Refer servicing to qualified service personnel The OFF position on the system ON OFF touch pad of the wall control turns off control to camera and lightheads but system is still energized This mode is referred to as STANDBY and the ON OFF LED flashes once per second while system is in this mode WARNING PERSONAL INJ...

Страница 48: ...ead is an adjustable pattern model If an adjustable pattern model refer problem to qualified STERIS or STERIS trained service technician 6 Monitor does not operate as expected Refer to user manual supplied with monitor 7 Poor video image quality Restore camera default settings by turning camera OFF and then back ON at wall control 8 Poor light color or intensity Refer problem to qualified STERIS o...

Страница 49: ...f fault code The cycle is repeated five times before returning to normal light intensity display When the fault codes are being displayed on the last four LEDs of Lighthead 3 all other LEDs on the wall control are turned off To manually exit the fault display before completing five cycles press and hold either the or button on Lighthead 3 for one second at any time during the fault display cycle C...

Страница 50: ... 6 LED module failure 7 Unknown Lighthead assembly ID 8 Drive controller communication fault 9 Current regulation fault 10 Power supply requires adjustment 11 Wall control parameter mismatch 12 LED illuminance check recommended NOTE 1 13 LH MCU Firmware mismatch 14 Master control cannot communicate with autocal board 15 Drive output digital POT range too wide 16 Autocal board power supply adjustme...

Страница 51: ...ation Instructions 10043123 and HarmonyAIR Surgical Lighting System G Series Maintenance Manual P764335 779 to safely replace components 6 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 an...

Страница 52: ...ac voltage to the lighting system and also dc battery backup voltage if the latter is available 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 INSTALLATION INSTRUCTIONS P129388 228 included in ...

Страница 53: ...armonyAIR Surgical Lighting System G Series Replacement Parts Description Part Number or Equipment Number HarmonyAIR G Series Maintenance Manual P764335 779 Brake Screw Lighthead 00035899D Brake Screw Light Spindle 00016717D Single Use LOCTITE 1 242 P129377 290 Plastic Lighthandle LB20 Sterilizable Surgeon Control Handle LB23 Silicone Replacement LB24 Sterile Cover for Lighthandle LB53 Sterile Cov...

Страница 54: ...7 2 10043124 Operator Manual Replacement Parts Healthcare Capital Equipment ...

Страница 55: ...imate weight of PVC within a HarmonyAIR Surgical Lighting System G Series varies with configuration and options ranging between 0 2 lb 0 1 kg and 1 9 lb 0 9 kg WARNING DISPOSAL HAZARD This product contains materials which may require disposal through appropriately licensed and permitted hazardous waste management firms The materials listed in SECTION 8 are contained within the HarmonyAIR G Series ...

Страница 56: ...8 2 10043124 Operator Manual Waste Disposal Guidelines Healthcare Capital Equipment ...

Страница 57: ...ighting System G Series is intended for use in the electromagnetic environment specified below The Customer or the user of the HarmonyAIR Surgical Lighting System G Series 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 G Series uses RF energy only for its inter...

Страница 58: ...t output lines Mains power quality should be 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 Dropout IEC 61000 4 11 0 UT for 0 5 cycle 0 45 90 135 180 225 270 and 315 degrees 0 UT for 1 cycle 9...

Страница 59: ...mmunity test IEC 60601 4th Edition Test Level Compliance Level Electromagnetic Environment Guidance Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 3 Vrms Outside ISM 6 Vrms In ISM Bands 150 kHz to 80 MHz 3 V m 80 MHz to 2 7 GHz V1 3 Vrms V2 6 Vrms V3 10 Vrms E1 3 V m Portable and mobile communications equipment should be separated from the HarmonyAIR Mobile Stand by no less than the distance...

Страница 60: ...and WLAN 802 11 a n Table 9 4 Recommended Separation Distances Between Portable and Mobile RF communications Equipment and the HarmonyAIR Surgical Lighting System G Series The HarmonyAIR Surgical Lighting System G Series 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 G Series...

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