Stryker Visum Operation Manual

Stryker Visum Operation Manual

Blade led surgical light system
Table of Contents

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Visum® Blade LED Surgical Light System
Operations Manual

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Table of Contents
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Summary of Contents for Stryker Visum

  • Page 1 Visum® Blade LED Surgical Light System Operations Manual...
  • Page 3: Table Of Contents

    Contents 1. Warnings and Cautions .............................5 2. About Your Product............................7 Product Description ............................7 Intended Use................................7 Indications for Use ............................... 7 Intended patient population ........................... 7 3. Symbol Definition ..............................8 4. Product Description ............................11 Optional Equipment ............................11 4.1.1 In-Light Camera ........................... 11 4.1.2 Wall Control Panel ..........................
  • Page 4 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...
  • Page 5: Warnings And Cautions

    7. To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. 8. Connection of the Visum® Blade Surgical Lighting System to devices not specified in this manual as part of the ME system could result in previously unidentified risks to patients, operators, or third parties.
  • Page 6 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.
  • Page 7: About Your Product

    • The Visum® Blade LED Surgical Light is intended to illuminate the operative site during surgical procedures with high intensity light. • The Visum® Blade LED Surgical Light system is not intended to interact or contact any part of the patient’s body or tissue.
  • Page 8: Symbol Definition

    3. Symbol Definition Warnings When this symbol appears on a device, it refers the user to the Operations and Maintenance manual for important safety information. When it appears in the manual, it is meant to alert the user to the presence of important safety, operating, and maintenance instructions. General warning.
  • Page 9 Electronic Equipment, this symbol indicates that the product must not be disposed of as unsorted municipal waste but should be collected separately. We request that you contact Stryker when you plan to withdraw this device from service. Denotes the device contains more than .002% cadmium.
  • Page 10 Do Not Touch Light Monitor Input Output Protective Earth (Ground) Fuse Neutral Line...
  • Page 11: Product Description

    Note: The medical grade flat panel monitor (pictured) is not included with the system. 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®...
  • Page 12 Stryker Wall-Mounted Control Panel 1. Light Controls 2. Camera Controls The system 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.
  • Page 13: Operation

    5. Operation Overview 1. Attach the sterilizable handle covers 2. Turn on and adjust the intensity of the lights 3. Position the lights 4. When finished, turn off lights and remove sterilizable handle covers 5. Clean and sterilize Attaching the Sterilizable Handle Covers Warning Before each and every use, check each sterilizable handle cover and sterilizable camera cover for damage.
  • Page 14: Sterilizable Camera Cover (Optional Component)

    5.2.2 Sterilizable Camera Cover (Optional Component) Attaching the Sterilizable Camera Handle to the SD Camera 1. Slide the Sterilizable Handle over the SD Release Camera. Button Camera 2. Twist and push the Sterilizable Handle Cover until you hear a click. The click indicates that the handle cover is securely fastened.
  • Page 15: Wall Control Panel (Optional Accessory)

    5.3.2 Wall Control Panel (Optional Accessory) Light Controls 1. Selects the light(s) being controlled 4. Adjusts the brightness of the selected light(s) 2. Powers the selected light(s) on and off 5. Indicates which light(s) is (are) selected 3. Indicates the current brightness of lights 6.
  • Page 16 • 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 Brightness Indicators Error...
  • Page 17 In-Light Camera Controls 1. Powers the camera on/off 4. Zooms out on the camera image 2. Corrects color differences caused by 5. Zooms in on the camera image varying light conditions 3. Turns auto focus on/off Press the Power button to power the camera on or off. The White Balance Button feature ensures the most accurate colors are captured by the camera and displayed on a monitor.
  • Page 18: Positioning The Lights

    The optimal distance is approximately 36 inches (915 mm). Note: The arms of the Visum® Blade LED Surgical Light system should move easily with minimal drifting, when properly adjusted. If the arms are too difficult to move or if they drift, refer to the Maintenance section of this manual to adjust them.
  • Page 19: Cleaning And Sterilization

    6. Cleaning and Sterilization Cleaning the Suspension Apparatus Caution • Power off the system during cleaning. Make sure that no cleaning fluid enters the system. • To avoid damage to plastic and painted surfaces, do not use any scouring, alkaline, acidic, or alcohol-based cleaning agents.
  • Page 20: Cleaning The Wall Control

    Cleaning the Wall Control The surface of the wall control can be cleaned using a damp, non-abrasive cloth. Using a mild soap and water solution, dampen the cloth and wipe the surface of the wall control until clean. Cleaning Compatibility of the HD Camera System Caution Professional Amphyl II Disinfectant Spray should not be used to disinfect or clean the HD Camera because it can cause fade the HD Camera logo.
  • Page 21 Preparation 1. Properly prepare an enzymatic detergent according to the detergent for Cleaning manufacturer’s recommendations. 2. Dip a clean cloth into the detergent and wipe the entire sterilizable handle cover. 3. Immerse the sterilizable handle cover in the detergent. 4. Soak the sterilizable handle cover in the detergent for at least 15 minutes. Cleaning: 1.
  • Page 22 Sterilization** Individually wrap in two layers of polypropylene wrap, (Kimguard KC600) or similar. Place in sterilizer with the following parameters: Full Sterilization Preconditioning Minimum Cycle Minimum Type Pulses Temperature Time Dry Time Gravity- 132°C displacement minutes minutes Steam Sterilization – US (wrapped) Gravity- 134°C displacement...
  • Page 23 Cleaning: 1. Remove debris from all surfaces of the articles using a soft bristled brush Manual Method that has been dipped in the enzymatic solution for a minimum of 2 minutes. 2. Use a pipe cleaner that has been dipped in the enzymatic solution to remove debris from hard to reach areas for a minimum of 2 minutes.
  • Page 24 Sterilization** Individually wrap in two layers of polypropylene wrap, (Kimguard KC600) or similar. Place in sterilizer with the following parameters: Full Sterilization Preconditioning Minimum Cycle Minimum Type Pulses Temperature Time Dry Time Gravity- 132°C † displacement minutes minutes Steam Sterilization –...
  • Page 25: Maintenance

    • Measure light intensity according to specifications in user manual • Ensure wall control functions (if applicable) * Please contact Stryker Technical Support or your Stryker Representative to schedule your preven tative maintenance service. Contact Stryker Communications in case of: • Faults...
  • Page 26: Adjusting Brake Screws

    Adjusting Brake Screws Brake screws hold the suspension in place and reduces drifting. If the brake screws are too loose, the suspension may drift during use, but if they are too tight, the suspension may be difficult to move. 1. Central Axis 5.
  • Page 27: Adjusting Spring Arm Tension

    Note: If the brake screws require excessive tightening or frequent adjustment, follow the steps outlined in the section, Replacing Brake Screws. The frequency of adjustment will increase as the brake screws wear. While a week may be an appropriate span between adjustments, a day or less is too frequent.
  • Page 28 Increasing Tension (Light head drifts down when pushed up) 1. Insert a 5mm Allen wrench in the elbow joint of the Spring Arm. Turn the wrench counterclockwise to increase the tension. 3. Check tension by pushing light head towards ceiling and then toward the floor.
  • Page 29: Replacing Brake Screws

    To Loosen 1. Use a 4mm Allen wrench to loosen the brake screws, turning counterclockwise 30°. 2. Check for ease of movement. If it is still too difficult to move, loosen it up to 30° more. Note: If you have a torque wrench, the recommended brake screw adjustment for the Spring Arm (where it meets the Cardanic Suspension) is 5.3 lb-in Ncm).
  • Page 30: Optional Configurations

    8. Optional Configurations In-Light Camera (Camera-Ready Light 1 only) 8.1.1 Swapping Weighted Handle for the In-Light Camera Note: An HD Camera Decoder box is required for HD camera installation. If the light system is camera-ready, the light attached to the uppermost arm segment of the suspension (Light 1) is the one designed to hold the in-light camera.
  • Page 31: Replacing In-Light Camera With Weighted Light Handle

    8.1.2 Replacing In-Light Camera with Weighted Light Handle 1. Invert the light head so that the camera points straight up, perpendicular to the floor. 2. Loosen the three thumb screws securing the camera to the light. 3. Pull the camera free from the light head. Weighted Light Handle Caution When you remove the camera, the Spring Arm may drift up.
  • Page 32: Re-Orderable Parts

    S Video Cable From Light Head Power Cable HD Camera Decoder Box Installation Note: The yellow cable does not plug into anything. Re-Orderable Parts Description P24551 Handle Cover, 6-Pack 0682000811 Package of 3 Camera Handles with Ridge 0682000190 Package of 6 Camera Handles...
  • Page 33: Troubleshooting

    9. Troubleshooting Symptom Reference One of the arms of the Visum® Blade LED See Maintenance section of this manual to adjust brake Surgical Light system drifts too much. screws. One of the arms of the Visum® Blade LED See Maintenance section of this manual to adjust brake Surgical Light system is too difficult to move.
  • Page 34: Shipping Conditions

    10.3 Shipping Conditions Shipping Humidity Shipping Temperature Visum Blade LED Surgical Light* -40° – 131°F (-40 – 55°C) Visum Blade LED Suspension* 10 – 95% -40° – 158°F (-40 – 70°C) HD Camera StrykeCam 2 Camera -40–140°F (-40–60°C) * Individual system components may have less stringent shipping conditions. See shipping label for component-specific shipping conditions.
  • Page 35: Hd Camera Specifications

    Focus Automatic/Manual Automatic Electronic Shutter Iris Control Automatic/Manual Signal Output DVI 1080P60 Decoder Box Dimensions 8.66" W x 2.25" H x 6.88" D 10.7.1 HD Camera Components Stryker P/N Description P22338 Camera Assembly P22059 Decoder Assembly P22062 Decoder Wall Mount...
  • Page 36: Emc Information

    The Visum® Blade LED Surgical Light System is intended for use in the electromagnetic environment specified below. The customer or the user of the Visum® Blade LED Surgical Light System should assure that it is used in such an environment.
  • Page 37 The Visum® Blade LED Surgical Light System is intended for use in the electromagnetic environment specified below. The customer or the user of the Visum® Blade LED Surgical Light System should assure that it is used in such an environment.
  • Page 38 The Visum® Blade LED Surgical Light System is intended for use in the electromagnetic environment specified below. The customer or the user of the Visum® Blade LED Surgical Light System should assure that it is used in such an environment.
  • Page 39: Latex Policy

    The Visum® Blade LED Surgical Light System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Visum® Blade LED Surgical Light System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Visum®...
  • Page 40: Disposal Of The Product

    The device must be disposed of according to local laws and hospital practices. Local regulations 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...
  • Page 41 1196mm ° ° ° 260° ° 360° Standard Light Specifications Note: Do not adjust the light higher than 25°.
  • Page 42: Stryker Limited Warranty

    Stryker subsidiary. Stryker warrants that its products shall be free of defects of material and workmanship for a period of two years after date of installation. Stryker will provide all parts and service required to restore equipment under warranty to good working condition, which may include shipment of replacement parts and phone service consultation to conduct minor repairs.
  • Page 44 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 *P22364K* trademarks are trademarks of their respective owners or holders. *P22364K* 2016/04...

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