Stryker Visum User manual

Visum® Blade LED Surgical Light System
Operations Manual

3
S
Contents
1. Warnings and Cautions .....................................................................................................................................5
2. About Your Product............................................................................................................................................7
2.1 Product Description ............................................................................................................................................ 7
2.2 Intended Use.......................................................................................................................................................... 7
2.3 Indications for Use............................................................................................................................................... 7
2.4 Intended patient population........................................................................................................................... 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

4
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

5
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.

6
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.

7
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.

8
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 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 a
physician.
Denotes relative pressure limits. Denotes humidity limits.
Denotes temperature limits. Denotes quantity.
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.

9
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
Zoom In
_
Zoom Out
Zoom Out

10
S
Do Not Touch Light
Monitor Input
Output Protective Earth (Ground)
Fuse N Neutral
L Line