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Stryker Visum, Руководство по эксплуатации

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1.2 Cautions

1.  Stryker trained personnel are the only personnel authorized to install the equipment described in this 

manual. 

2.  Follow the care and cleaning instructions in this manual. 
3.  The electrical installation of the operating room must comply with any applicable IEC, CEC, NEC 

requirements as well as the local codes and pre-installation manual. 

4.  Shielded video cables are required in order to assure proper function so that portable and mobile RF 

communications equipment do not affect this device’s performance. 

5.  Using accessories or cables other than those provided may result in increased emissions or decreased 

immunity of the system.

6.  For operating rooms only:    

• 

The Visum Blade LED Surgical Light must be equipped with emergency power back up systems. 

• 

The emergency power back up system must have the capability to restore power in 50 milliseconds 
or less.

1.3  EMC Precautions

This device is considered medical electrical equipment and requires special precautions regarding EMC and 
needs to be installed and put into service according to the information provided.

1.4  Electrical Safety Notes

1.  Class 1 Equipment: equipment in which the protection against electric shock does not rely on Basic 

Insulation only, but includes an additional safety precaution in such a way that means are provided for 
the connection of Accessible Conductive Parts to Protective (ground) Conductor in the fixed wiring of 
the installation in such a way that Accessible Conductive Parts cannot become Live in the event of a 
failure of the Basic Insulation.

2.  All electrical services for flat panel power connections must be routed in accordance with all applicable 

regulations including but not limited to local building and electrical codes. System circuits must be 
connected to correctly rated and protected branch circuits. 

3.  In the event that it becomes necessary to terminate power to the light head(s) and flat panel monitors, 

refer to hospital’s electrical diagrams to interrupt power at the mains breaker.

4.  Refer to IEC 60601-1 Ed. 3.0 and 3.1 for requirements of an ME system.

Содержание Visum

Страница 1: ...Visum Blade LED Surgical Light System Operations Manual ...

Страница 2: ......

Страница 3: ...ights 18 5 5 Turning off Lights and Removing the Sterilizable Handle Covers 18 6 Cleaning and Sterilization 19 6 1 Cleaning the Suspension Apparatus 19 6 2 Cleaning the Wall Control 20 6 3 Cleaning Compatibility of the HD Camera System 20 6 4 Cleaning and Sterilizing the Sterilizable Handle and Camera Covers 20 7 Maintenance 25 7 1 Maintenance Schedule 25 7 2 Quick Reference for Brake Screw Adjust...

Страница 4: ...Electrical Specifications 34 10 5 Mechanical Specifications 34 10 6 Illumination Specifications 34 10 7 HD Camera Specifications 35 10 7 1 HD Camera Components 35 10 8 EMC Information 36 10 9 Latex Policy 39 11 Disposal of the Product 40 12 Technical Specifications 40 13 Stryker Limited Warranty 42 14 Service and Claims 42 15 Contact Information 42 ...

Страница 5: ...cted to an emergency power backup system with the capability to restore power in 50 milliseconds or less 6 Disconnect the unit from the electric outlet before inspecting or servicing system components Note that more than one electrical supply may be used Disconnect all power sources before inspecting 7 To avoid the risk of electric shock this equipment must only be connected to a supply mains with...

Страница 6: ...l equipment and requires special precautions regarding EMC and needs to be installed and put into service according to the information provided 1 4 Electrical Safety Notes 1 Class 1 Equipment equipment in which the protection against electric shock does not rely on Basic Insulation only but includes an additional safety precaution in such a way that means are provided for the connection of Accessi...

Страница 7: ... is via the light handle An optional electronic wall control panel may be installed in the operating room for control by non sterile users The Visum Blade LED Surgical Light System allows for an in light camera option that may be added to a light head This option requires a wall control for camera operation 2 2 Intended Use The Visum Blade LED Surgical Light is intended to illuminate the operative...

Страница 8: ...ached component equipment falling Packaging Labeling Denotes the manufacturer of the device Denotes the manufacturing date Denotes European Representative Denotes product part number Denotes product serial number Denotes lot or batch number Denotes compliance to European Community Directive 93 42 EEC For U S audience only Caution Federal Law USA restricts this device to sale by or on the order of ...

Страница 9: ...request that you contact Stryker when you plan to withdraw this device from service Denotes the device contains more than 002 cadmium Denotes the device contains more than 0005 mercury Denotes the device contains more than 004 lead Surgical Light Charger Suspension Cable Kit Power Supply Repair Kit Drop Tube Accessories Cover Camera Handle Instructions for Use Battery Module Wall Control Touch Pan...

Страница 10: ...10 S Do Not Touch Light Monitor Input Output Protective Earth Ground Fuse N Neutral L Line ...

Страница 11: ... Note The medical grade flat panel monitor pictured is not included with the system 4 1 Optional Equipment 4 1 1 In Light Camera The Visum Blade LED Surgical Light system can be configured to include an optional camera item 7 in the Product Description figure The camera would be attached to Light 1 4 1 2 Wall Control Panel The wall control panel controls the light intensity of the Visum Blade LED ...

Страница 12: ...stem can be configured for one to four LED lights and will have a control section for lights and the camera Note The system only functions for the number of configured lights The camera controls will not function if the system has not been configured with a camera ready light and camera ...

Страница 13: ...r the camera when attaching the sterilizable handle cover The weighted light handle and the camera are not sterile 5 2 1 Sterilizable Handle Cover Attach 1 Align the hole of the sterilizable handle cover with the release button on the weighted light handle 2 Slide the sterilizable handle cover to the base of the weighted light handle until the release button clicks into place If not aligned twist ...

Страница 14: ...ndle This ensures that the handle is locked Warning Do not touch the light handle camera or button when attaching the cover as they are not sterile Removing the Sterilizable Camera Handle 1 Press the release button on the camera 2 Slide the handle down and off 5 3 Turning on and Adjusting the Intensity of the Lights The lights can be controlled using the light head handle or the optional wall cont...

Страница 15: ...he selected lights To turn on all lights select all lights and press Power To turn on one light select that light and press Power When one or more lights are already on and you want to turn on the remaining lights select all lights and press Power When one or more lights are already on and you want to turn on just one more light select that light and press the Power button To turn one light off wh...

Страница 16: ...n is pushed regardless of whether or not they are all on the same level of brightness Adjust Brightness up can also be used to turn on selected lights Note In order to prevent lights from inadvertently being turned off adjusting Brightness down can not be used to turn off lights Visum Blade LED Wall Control Panel Error 1 Brightness Indicators Error Action All brightness indicators above one light ...

Страница 17: ...urface such as a piece of white paper Warning Do not look directly at the white surface or the lights Looking directly at the lights or at the reflection of the lights off the white surface can stimulate the retina and produce after images Look only at the monitor image of the white surface Look at the monitor that displays the camera image to make sure that the white surface fills the entire moni...

Страница 18: ...ht heads Before Starting a Procedure Position the surgical lights so that they can be easily maneuvered by the sterilizable handle during the procedure Keep the light surface between 24 46 inches 61 117cm away from the operative site for ideal shadow resolution and depth of field The optimal distance is approximately 36 inches 915 mm Note The arms of the Visum Blade LED Surgical Light system shoul...

Страница 19: ...all suspension components using disposable paper towels Preparation for Cleaning Properly prepare a cleaning agent according to the detergent manufacturer s recommendations Cleaning agents may include Enzol Enzymatic Detergent Quaternary Ammonium Isopropyl Alcohol Amphyl II Spray Soap and Water Solution Bleach and Water Solution Cleaning Manual Method 1 Remove debris from all surfaces by applying ...

Страница 20: ... ammonium Soap and water solution Bleach water solution 6 4 Cleaning and Sterilizing the Sterilizable Handle and Camera Covers Warning Sterilizable handle covers and sterilizable camera covers are shipped non sterile For the safety of medical personnel and patients clean and sterilize sterilizable handle covers and sterilizable camera covers prior to use Limitations on Reprocessing The sterilizabl...

Страница 21: ...on an incline to facilitate drainage 3 Program the washer using the following parameters Phase Recirculation Time Water Temperature Detergent Type and Concentration if applicable Pre Wash 2 minutes Cold N A Enzyme Wash 2 minutes Hot Enzymatic Detergent Wash 1 2 minutes Set Point 66 C Regular Detergent Rinse 1 2 minutes Hot N A Dry Phase 7 minutes 115 C N A If necessary use pressurized air to aid i...

Страница 22: ...1 Note Any modifications to these parameters should be based on standard hospital cleaning sterilization protocol and are performed at the discretion of the user who assumes the risk for modifying these parameters Instructions for Sterilizable Camera Cover Point of Use Wipe excess soil from the sterilizable camera cover using disposable paper towels Containment and Transportation Reprocess the ste...

Страница 23: ...facilitate drainage 3 Program the washer using the following parameters Phase Recirculation Time Water Temperature Detergent Type and Concentration if applicable Pre Wash 2 minutes Cold N A Enzyme Wash 2 minutes Hot Enzymatic Detergent Wash 1 2 minutes Set Point 66 C Regular Detergent Rinse 1 2 minutes Hot N A Dry Phase 7 minutes 115 C N A If necessary use pressurized air to aid in drying Visually...

Страница 24: ...minutes 45 minutes Pre vacuum steam sterilization US wrapped 3 132 C 4 minutes 20 minutes Pre vacuum steam sterilization EU wrapped 3 134 C 3 minutes 20 minutes Storage Keep in instrument tray until use Sterilizable camera cover must be sterilized according to ISO17665 1 The validated gravity dry times exceed the AAMI ST79 standard dry time range for wrapped devices by 15 minutes Note Any modifica...

Страница 25: ...epresentative to schedule your preven tative maintenance service Contact Stryker Communications in case of Faults Damage Service Needs 7 2 Quick Reference for Brake Screw Adjustment Behavior Adjustment Extension Arm drifts left or right Tighten the two brake screws at the shoulder joint of the Extension Arm Extension Arm is difficult to move Loosen the two brake screws at the shoulder joint of the...

Страница 26: ...two brake screws at the shoulder joint and two at the elbow joint where the Extension Arm and Spring Arm meet 1 2 1 2 Extension Arm Brake Screws Shoulder joint and Elbow joint The brake screws at the shoulder joint adjust the right and left movement of the Extension Arm itself The brake screw at the elbow joint adjusts the right and left movement of the Spring Arm When properly adjusted each arm w...

Страница 27: ...rifting 4 Finally tighten the brake screw at the shoulder joint an additional 360 and the brake screw at the elbow joint an additional 90 to allow for brake wear Note If you have a torque wrench the recommended brake screw adjustment for the Extension Arm is 97 4 lb in 1100 Ncm at the shoulder joint and 53 lb in 600 Ncm at the Elbow joint To Loosen 1 Use a 5mm Allen wrench to loosen the brake scre...

Страница 28: ...entative maintenance At all other times the brake screw is covered Note Take care when setting aside the two halves of the Spring Arm front cover When properly joined the Spring Arm front cover fits snugly to the Spring Arm Removing the Spring Arm Front Cover 1 Use a P1 Phillips screwdriver to remove screws at both sides of the cover 2 At the bottom of the frontmost section of the Spring Arm where...

Страница 29: ...over Spring Arm Front Cover Properly Attached Note There should be no gaps at the back of the Spring Arm front cover While the front of the cover is circular the back fits snugly only when properly attached The top has slightly shorter curves and a slightly longer flat surface Use that orientation to secure it properly 7 3 3 Replacing Brake Screws 1 Remove the brake screw using the Allen wrench re...

Страница 30: ...three thumb screws securing the weighted light handle to the light 3 Pull the weighted light handle free from the light head In Light Camera Caution When you remove the weighted light handle the Spring Arm may drift up Be prepared to hold it down until the camera is secure 4 Align the serial port connector of the In Light Camera with that of the light head and insert it into the light head 5 Press...

Страница 31: ... the base of the weighted light handle sits flush with the surface of the light 6 Tighten the three thumb screws completely to secure weighted light handle Warning If the base of the weighted light handle is not flush with the surface of the light or if the thumb screws are not completely tightened the weighted light handle could fall off 8 2 HD Camera Decoder Box Installation 1 Connect the DVI ca...

Страница 32: ...ble HD Camera Decoder Box Installation Note The yellow cable does not plug into anything 8 3 Re Orderable Parts P N Description P24551 Handle Cover 6 Pack 0682000811 Package of 3 Camera Handles with Ridge 0682000190 Package of 6 Camera Handles ...

Страница 33: ...t be controlled through the Wall Control Make sure that the camera is installed correctly and then wait 90 seconds before you turn on the camera at the wall control Check the power and communication connections For an HD camera make sure the decoder assembly is connected to the video output Camera does not transmit an image but can be controlled through the Wall Control Panel Inspect the video con...

Страница 34: ... rotation Degrees of rotation at shoulder and elbow joints for light Spring Arm Unlimited uninterrupted rotation Degrees of rotation at Cardanic Light Head joint 260 10 Degrees of rotation at the shoulder joint for flat panel arms Up to 320 Degrees of rotation at the elbow joint at flat panel arms Up to 310 10 6 Illumination Specifications Central Illuminance at 915mm from light Up to 160 000 Lux ...

Страница 35: ...1080p 1920 x 1080 approx 2 000 000 Active Pixels Aspect Ratio 16 9 Lens 20x Optical Zoom F 4 7mm wide end 94 0mm tele end F1 6 to F3 5 4x Digital Zoom Horizontal Angle of View Includes 55 4 wide end to 2 9 tele end Minimum Object Distance 10mm wide end 1 000mm tele end Minimum Illumination Less than 1 7 LX F1 6 50 IRE Signal to Noise Ratio S N More than 50 DB White Balance One Push Focus Automatic...

Страница 36: ... emissions CISPR 11 Group 1 The Visum Blade LED Surgical Light System 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 Visum Blade LED Surgical Light System is suitable for use in all establishments other than domestic and those directly connected to th...

Страница 37: ...ine 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 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 s 5 UT 95 dip in UT for 0 5...

Страница 38: ...rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol Note At 80 MHz and ...

Страница 39: ...System as recommended below according to the maximum output power of the communications equipment Rated Maximum Output Power of Transmitter W Separation Distance According to Frequency of Transmitter m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum ou...

Страница 40: ...ions may include specifications regarding the disposal of this product We request that you contact Stryker when you plan to withdraw this device from service with the intention of discarding it 12 Technical Specifications 90 30 330 50 45 360 330 850mm 1000mm 760mm 1150mm 360 360 330 260 310 320 Standard Light Specifications ...

Страница 41: ... 41 S 220 220 25 42 260 360 1196mm Standard Light Specifications Note Do not adjust the light higher than 25 ...

Страница 42: ...products and only such products that were installed or if necessary reinstalled by Stryker personnel This warranty is valid only to the original purchaser of Stryker products directly from a Stryker authorized agent The warranty cannot be transferred or assigned by the original purchaser 14 Service and Claims Shipping is FOB Origin Title transfers to customer upon shipment Stryker assumes responsi...

Страница 43: ......

Страница 44: ... 75028 1 866 841 5663 www stryker com Stryker Corporation or its divisions or other corporate affiliated entities own use or have applied for the following trademarks or service marks the Stryker logo All other trademarks are trademarks of their respective owners or holders 2016 04 ...

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