How it Works
Stryker
Loading...
Visum
Operation Manual
44 pgs3.19 Mb0

Stryker Visum Operation Manual

Download
Visum® Blade LED Surgical Light System
Operations Manual
S
Contents
1. Warnings and Cautions .....................................................................................................................................5
2. About Your Product............................................................................................................................................7
3. Symbol Denition ..............................................................................................................................................8
4. Product Description .........................................................................................................................................11
4.1 Optional Equipment .........................................................................................................................................11
4.1.1 In-Light Camera ................................................................................................................................... 11
4.1.2 Wall Control Panel ............................................................................................................................... 11
5. Operation ...........................................................................................................................................................13
5.1 Overview ............................................................................................................................................................... 13
5.2 Attaching the Sterilizable Handle Covers ..................................................................................................13
5.2.1 Sterilizable Handle Cover ................................................................................................................... 13
5.2.2 Sterilizable Camera Cover (Optional Component) ...................................................................... 14
5.3 Turning on and Adjusting the Intensity of the Lights ..........................................................................14
5.3.1 Light Head Handle...............................................................................................................................14
5.3.2 Wall Control Panel (Optional Accessory) ......................................................................................15
5.4 Positioning the Lights .......................................................................................................................................18
5.5 Turning o 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 Adjustment .........................................................................................25
7.3 Adjusting Brake Screws ....................................................................................................................................26
7.3.1 Adjusting Extension Arm Brake Screws .......................................................................................... 26
7.3.2 Adjusting Spring Arm Tension .......................................................................................................... 27
7.3.3 Replacing Brake Screws ......................................................................................................................29
8. Optional Congurations .................................................................................................................................30
8.1 In-Light Camera (Camera-Ready Light 1 only).........................................................................................30
8.1.1 Swapping Weighted Handle for the In-Light Camera.................................................................30
8.1.2 Replacing In-Light Camera with Weighted Light Handle ..........................................................31
8.2 HD Camera Decoder Box Installation .........................................................................................................31
8.3 Re-Orderable Parts ............................................................................................................................................32
3
S
9. Troubleshooting ...............................................................................................................................................33
10. Environmental Specications ......................................................................................................................33
10.1 Operating Conditions .......................................................................................................................................33
10.2 Storage Conditions ............................................................................................................................................33
10.3 Shipping Conditions .........................................................................................................................................33
10.4 Electrical Specications ...................................................................................................................................34
10.5 Mechanical Specications ...............................................................................................................................34
10.6 Illumination Specications .............................................................................................................................34
10.7 HD Camera Specications ...............................................................................................................................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 Specications ................................................................................................................................40
13. Stryker Limited Warranty .............................................................................................................................42
14. Service and Claims .........................................................................................................................................42
15. Contact Information ......................................................................................................................................42
4
S
1. Warnings and Cautions
Please read this manual and follow its instructions carefully. The words WARNING, CAUTION, and Note carry special meanings and should be carefully reviewed:
Warning: The personal safety of the patient or user may be involved. Disregarding this information could result in injury to the patient or user.
Warning: A lightening bolt is intended to warn of the presence of hazardous voltages. Refer all service to authorized personnel.
Caution: Special service procedures or precautions must be followed to avoid damaging the instrument.
Note: Special information to make maintenance easier or important information more clear.
To avoid potential serious injury to the user or the patient or both and to avoid damage to this device, the user must adhere to the following warnings and cautions.
1.1 Warnings
1. Caution: Federal law restricts this device to sale by or on the order of a physician.
2. Test this equipment prior to every procedure. This product was fully tested at the factory before shipment.
3. Do not remove or disable components. It may cause electric shock.
4. Attempt no repairs or adjustments, unless specically instructed to do so in this operating manual.
5. This equipment must be connected 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 protective earth.
8. Connection of the Visum® Blade Surgical Lighting System to devices not specied in this manual as part of the ME system could result in previously unidentied risks to patients, operators, or third parties.
9. Do not look directly into the surgical light while powered on.
10. Use caution when using multiple overlapping elds during surgical procedures to avoid wound drying. Do not overlap more than two light elds when lights are at maximum illumination setting.
11. Do not operate the surgical light if any component of the light (such as the face) is damaged.
12. Collision of equipment against other equipment or physical structures can cause components to fall. Pay special attention when maneuvering equipment.
13. Do not add additional weight to the surgical lights.
14. Do not place anything over the surgical lights.
15. Adjustments, modications, and/or repairs not described in this manual shall be performed by Stryker personnel only.
16. Do not service this equipment when a patient is present.
5
S
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 aect 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 xed 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 at 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 at 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.
6
S
2. About Your Product
2.1 Product Description
The Visum® Blade LED Surgical Light System is suitable for all major and minor surgical procedures in operating rooms and all other healthcare facilities where the need for illumination exists. The light intensity is variable up to 160,000 Lux. The light quality is based upon high quality LED’s to provide cool light with reduced shadow resolution.
A system consists of 1-4 light heads supported by a pivoting suspension system that is attached to the health care facility’s super structure by a mounting plate. The system requires at least one of the following: a power supply box, ceiling cover, drop tube, central axis and spring arm. The system may include optional end eectors such as but not limited to monitor mounts. The mounting plates may be congured to accommodate a single or tandem mount suspension system.
Independent control of each light’s intensity 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 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.
• The primary users are hospital sta including doctors and nurses. Cleaning personnel also engage the equipment when performing routine cleaning.
2.3 Indications for Use
The Visum® Blade LED Surgical Light System is indicated to be used with various mounting congurations in operating rooms, examination rooms, emergency rooms, and all other health care facilities where the need for additional illumination exists.
2.4 Intended patient population
Any patient receiving a surgical procedure requiring illumination of the surgical site.
7
S
3. Symbol Denition
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.
A lightning bolt indicates the presence of hazardous voltage. Refer all service to authorized personnel.
Warning: Failure to properly install the screw(s) above can result in the attached component/equipment falling
Packaging/Labeling
Denotes the manufacturer of the device.
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.
Denotes relative pressure limits. Denotes humidity limits.
Denotes temperature limits. Denotes quantity.
Denotes the manufacturing date.
For U.S. audience only - Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.
Device
This symbol is intended to refer the user to important safety operating and maintenance (service) instructions in the literature accompanying the product.
Indicates hot surfaces.
8
S
Denotes compliance to CSA Standard C22.2, 60601.1, AAMI ES 60601-1.
In accordance with European Community Directive 2002/96/EC on Waste Electrical and 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.
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 Panel
Power/Standby Auto Focus
White Balance Light Brightness/Intensity
Zoom In
+
9
Zoom In
Zoom Out
_
Zoom Out
S
L Line
Do Not Touch Light
Monitor Input
Output Protective Earth (Ground)
Fuse N Neutral
10
4. Product Description
2
1
5
S
3
4
6
1. Drop Tube
2. Extension Arm
3. Flat Panel Yoke (Flat Panel Monitor not included)
4. Spring Arm
5. Cardanic Suspension
6. Light head ( Light 2)
Note: The medical grade at panel monitor (pictured) is not included with the system.
7
8
4.1 Optional Equipment
Suspension and Lights
7. In-Light Camera (optional)
8. Light 1
9. Light 4 (optional)
10. Weighted Light Handle
11. Light 3 (optional)
10
9
11
4.1.1 In-Light Camera
The Visum® Blade LED Surgical Light system can be congured to include an optional camera (item 7 in the Product Description gure). 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 Surgical Lights as well as the optional In-Light Camera.
Note: In-Light Camera is always associated with Light 1.
11
S
1
2
Stryker Wall-Mounted Control Panel
1. Light Controls 2. Camera Controls
The system can be congured 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 congured lights. The camera controls will not function if the system has not been congured with a camera-ready light and camera.
12
5. Operation
5.1 Overview
1. Attach the sterilizable handle covers
2. Turn on and adjust the intensity of the lights
3. Position the lights
4. When nished, turn o lights and remove sterilizable handle covers
5. Clean and sterilize
5.2 Attaching the Sterilizable Handle Covers
Warning
Before each and every use, check each sterilizable handle cover and sterilizable camera cover for damage. Damage includes cracks, chips, holes, tears, or anything else that might interfere with the integrity of the sterilizable handle cover or sterilizable camera cover. Replace the cover, if damage is detected.
S
Warning
Do not touch the weighted light handle or 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 the sterilizable handle cover to align its hole with the release button. Once the release button clicks into place, the sterilizable handle cover is secure.
Remove (when nished)
1. Press the release button at the base of the sterilizable handle cover.
2. Slide the sterilizable handle cover over the release button to remove it from the weighted light handle.
Release
Button
Sterilizable
Handle Cover
Sterilizable Handle Cover
Weighted Light
Handle
13
S
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 Camera.
2. Twist and push the Sterilizable Handle Cover until you hear a click. The click indicates that the handle cover is securely fastened.
Attaching the Sterilizable Camera Handle to the HD Camera
1. Slide the Sterilizable Handle over the HD Camera.
2. Align the hole in the handle cover with the release button on the HD camera.
3. Make sure the release button ts onto the hole on the sterilizable handle. This ensures that the handle is locked
Warning
Release
Button
Sterilizable
Handle Cover
Sterilizable Camera Cover
Camera
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 o.
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 control panel.
5.3.1 Light Head Handle
Power
• To power on the light, turn the light head handle clockwise and release.
• To power o the light, turn the light head handle counterclockwise until it stops, and then hold it
until the light shuts o (approximately 4 seconds).
Intensity
• Turn the handle on the light clockwise and release to increase the brightness.
• Turn the handle on the light counterclockwise and release to decrease the brightness.
14
Loading...
+ 30 hidden pages
Buy Points How it Works FAQ Contact Us Questions and Suggestions Privacy Policy Cookie Policy Terms of Use