1. Warnings and Cautions .....................................................................................................................................5
2. About Your Product............................................................................................................................................7
2.3 Indications for Use ............................................................................................................................................... 7
2.4 Intended patient population ........................................................................................................................... 7
3. Symbol Denition ..............................................................................................................................................8
4.1.1 In-Light Camera ................................................................................................................................... 11
4.1.2 Wall Control Panel ............................................................................................................................... 11
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
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
10.7 HD Camera Specications ...............................................................................................................................35
10.7.1 HD Camera Components ...................................................................................................................35
10.8 EMC Information ................................................................................................................................................36
11. Disposal of the Product.................................................................................................................................40
14. Service and Claims .........................................................................................................................................42
15. Contact Information ......................................................................................................................................42
4
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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 specically 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 specied in this manual as part
of the ME system could result in previously unidentied 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, modications, 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
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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 aect 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
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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 eectors such as but not limited to monitor mounts. The mounting plates may be congured 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 congurations 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
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3. Symbol Denition
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.
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
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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 LightCharger
SuspensionCable Kit
Power SupplyRepair Kit
Drop TubeAccessories
CoverCamera
HandleInstructions for Use
Battery ModuleWall Control/Touch Panel
Power/StandbyAuto Focus
White BalanceLight Brightness/Intensity
Zoom In
+
9
Zoom In
Zoom Out
_
Zoom Out
S
LLine
Do Not TouchLight
MonitorInput
OutputProtective Earth (Ground)
FuseNNeutral
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 congured 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
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1
2
Stryker Wall-Mounted Control Panel
1. Light Controls2. Camera Controls
The system can be congured 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 congured lights. The camera controls
will not function if the system has not been congured 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
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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
5.3.2 Wall Control Panel (Optional Accessory)
Light Controls
3
2
1
S
4
6
1. Selects the light(s) being controlled
2. Powers the selected light(s) on and o
3. Indicates the current brightness of lights
4. Adjusts the brightness of the selected light(s)
5. Indicates which light(s) is (are) selected
6. Controls the Camera (if that optional equipment is
connected)
The Select button selects one light at a time or all lights together.
• Each time the Select button is pushed, one light will be selected in succession.
• After each light has been individually selected, pushing the button again selects all of the lights.
The Power button switches on or o the 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 o when one or more lights are on, select that light and press the Power button.
• To turn o all lights when all lights are on, select all lights and press Power.
n
5
Note: You may either select any light individually or all lights together. To turn on any
other combination of lights you may want, you must select each light individually and
turn on one at a time.
The Brightness buttons increase or decrease the intensity of the selected lights incrementally.
15
S
• Lights will automatically set to the lowest intensity when they are powered on.
• Each light will adjust one level in intensity when the brightness button is pushed.
Note: All selected lights will increase one level from their current setting when the
Brightness button 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 o, adjusting Brightness
down can not be used to turn o lights.
Visum Blade LED Wall Control Panel Error
1
Brightness IndicatorsErrorAction
All brightness indicators above one
light ash on and o
16
Communication Error with that lightCheck connections
In-Light Camera Controls
S
1
1. Powers the camera on/o
2. Corrects color dierences caused by
varying light conditions
3. Turns auto focus on/o
Press the Power button to power the camera on or o.
The White Balance Button feature ensures the most accurate colors are captured by the camera and
displayed on a monitor. To adjust the White Balance of the In-Light Camera:
• Set the lights to the intensity you will be using.
• Power on the In-Light Camera and point it at a white surface, 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
reection of the lights o the white surface can stimulate the retina and produce after-images.
Look only at the monitor image of the white surface.
243
4. Zooms out on the camera image
5. Zooms in on the camera image
5
• Look at the monitor that displays the camera image to make sure that the white surface lls the
entire monitor and that there is no visible glare from the white surface.
• Press the White Balance button. The LED above it turns on.
• Keep the camera pointed at the white surface until the LED turns o, which indicates that the
white balance adjustment is complete.
• You do not need to white balance again unless you want to use the camera in dierent light
settings.
17
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Press the Focus/Auto button to enable/disable the ability of the camera to focus automatically. The
LED above the button indicates whether or not the automatic setting is enabled.
Use the Zoom In and Zoom Out buttons to adjust the zoom level of the camera.
5.4 Positioning the Lights
Warning
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.
Note: Sterile personnel should only use the sterilizable light handle in the center of the
light to move the light 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 eld. 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 dicult to move or if they drift,
refer to the Maintenance section of this manual to adjust them.
5.5 Turning o Lights and Removing the Sterilizable Handle Covers
After a Procedure
• Turn o the lights (see Section 5.3.1 and 5.3.2, if needed).
• Remove the sterilizable handle covers (see Sections 5.2.1 and 5.2.2, if needed).
18
6. Cleaning and Sterilization
6.1 Cleaning the Suspension Apparatus
Caution
• Power o the system during cleaning. Make sure that no cleaning uid enters the system.
• To avoid damage to plastic and painted surfaces, do not use any scouring, alkaline, acidic, or
alcohol-based cleaning agents.
Note:
• Cleaning and disinfecting must be performed by trained personnel. Follow the
requirements of the national committee responsible for hygiene and disinfection. It is
the user’s responsibility to qualify any deviations from the recommended method of
processing.
• Any modications to these parameters should be based on standard hospital cleaning
protocol, and are performed at the discretion of the user, who assumes the risk for
modifying these parameters.
S
Point of UseWipe excess soil from all suspension components using disposable paper
towels.
Preparation
for Cleaning
Cleaning:
Manual Method
DisinfectionNot applicable
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
1. Remove debris from all surfaces by applying the cleaning agent to a
clean, soft, lint-free cloth and wiping each component of the suspension,
including product labels.
2. Dry the suspension apparatus with a lint free cloth. For most eective
results, remove excess solution that may have collected in hard to reach
areas and equipment creases.
Maintenance,
Inspection, and
Testing
19
Inspect suspension apparatus before and after use. Do not continue using
equipment if it is damaged. Damage includes cracks, chips, holes, tears,
or anything else that might interfere with the integrity of the suspension
apparatus.
S
6.2 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.
6.3 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.
Note: Amphyl II Disinfectant Spray can be used on the decoder assembly.
The surface of the HD Camera System components can be cleaned using the following:
• Isopropyl alcohol
• Quaternary 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 sterilizable handle covers should be replaced after 260 sterilization cycles. The sterilizable aluminum
camera cover should be replaced after 390 sterilization cycles.
Instructions for Sterilizable Handle
Point of UseWipe excess soil from the sterilizable handle cover using disposable paper
towels.
Containment and
Transportation
Reprocess the sterilizable handle cover as soon as reasonably practical
following use.
20
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Preparation
for Cleaning
Cleaning:
Manual Method
Cleaning:
Automated Method
1. Properly prepare an enzymatic detergent according to the detergent
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.
1. Remove debris from all surfaces using a soft brush dipped in the
enzymatic solution.
2. Rinse the sterilizable handle cover thoroughly under running lukewarm
water; ush water through all passages.
3. Dry the sterilizable handle cover with a lint free cloth.
1. Rinse the sterilizable handle cover with treated water at ambient
temperature until there is no visible detergent residue. Continue to
rinse the sterilizable handle cover for a minimum of 30 seconds after all
detergent residue has been removed.
2. Place the sterilizable handle cover in the washer on an incline to facilitate
drainage.
3. Program the washer using the following parameters:
DryingIf necessary, use pressurized air to aid in drying.
Maintenance,
Inspection, and
Testing
PackagingWhen lling the autoclave, ensure that the open sides of the sterilizable
21
Inspect sterilizable handle cover before and after use. Discard the sterilizable
handle cover if it is damaged. Damage includes cracks, chips, holes, tears, or
anything else that might interfere with the integrity of the sterilizable handle cover.
handle covers are facing down for pre-vacuum sterilization cycles and are
placed on their side for gravity sterilization cycles (AAMI ST79). Make certain
the sterilizable handle covers are not touching any other items while being
sterilized.
* If necessary, use pressurized air to aid in drying. Visually inspect each
sterilizable handle cover for cleanliness.
S
Sterilization**Individually wrap in two layers of polypropylene wrap, (Kimguard KC600) or
similar.
Place in sterilizer with the following parameters:
Full
Sterilization
Type
Gravitydisplacement
Steam Sterilization
– US (wrapped)
Gravitydisplacement
steam sterilization
– EU (wrapped)
Pre-vacuum steam
sterilization --US
(wrapped)
Pre-vacuum steam
sterilization --EU
(wrapped)
Preconditioning
Pulses
N/A132°C15
N/A134°C10
3132°C4
3134°C3
Minimum
Temperature
Cycle
Time
minutes
minutes
minutes
minutes
Minimum
Dry Time
minutes
minutes
minutes
minutes
20
20
20
20
StorageKeep in instrument tray until use.
** Sterilizable handle cover must be sterilized according to ISO17665-1.
Note: Any modications 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 UseWipe excess soil from the sterilizable camera cover using disposable paper
towels.
Containment and
Transportation
Preparation
for Cleaning
Reprocess the sterilizable camera cover as soon as reasonably practical
following use.
1. Properly prepare an enzymatic detergent according to the detergent
manufacturer’s recommendations.
2. Dip a clean soft cloth into the detergent and wipe the entire surface of the
sterilizable camera cover for a minimum of 2 minutes each.
3. Immerse the sterilizable camera cover in the detergent.
4. Soak the sterilizable camera cover in the detergent for at least 15 minutes.
22
S
Cleaning:
Manual Method
Cleaning:
Automated Method
1. Remove debris from all surfaces of the articles using a soft bristled brush
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.
3. Thoroughly rinse the articles under running lukewarm tap water for a
minimum of 2 minutes. During the minimum 2 minute rinse, use a syringe
to ush all hard to reach areas with a minimum of 50 mL of lukewarm tap
water.
4. Dry the sterilizable camera cover with a lint free cloth.
1. Rinse the sterilizable camera cover with treated water at ambient
temperature until there is no visible detergent residue. Continue to
rinse the sterilizable camera cover for a minimum of 30 seconds after all
detergent residue has been removed.
2. Place the sterilizable camera cover in the washer on an incline to facilitate
drainage.
3. Program the washer using the following parameters:
* If necessary, use pressurized air to aid in drying. Visually inspect each
sterilizable camera cover for cleanliness.
DisinfectionNot applicable
DryingIf necessary, use pressurized air to aid in drying.
Maintenance,
Inspection, and
Testing
PackagingWhen lling the autoclave, ensure that the open sides of the sterilizable
23
Inspect sterilizable camera cover before and after use. Discard the sterilizable
camera cover if it is damaged. Damage includes cracks, chips, holes, tears, or
anything else that might interfere with the integrity of the sterilizable camera cover.
camera covers are facing down for pre-vacuum sterilization cycles and are
placed on their side for gravity sterilization cycles (AAMI ST79). Make certain
the sterilizable camera covers are not touching any other items while being
sterilized.
S
Sterilization**Individually wrap in two layers of polypropylene wrap, (Kimguard KC600) or
similar.
Place in sterilizer with the following parameters:
Full
Sterilization
Type
Gravitydisplacement
Steam Sterilization
– US (wrapped)
Gravitydisplacement
steam sterilization
– EU (wrapped)
Pre-vacuum steam
sterilization --US
(wrapped)
Pre-vacuum steam
sterilization --EU
(wrapped)
Preconditioning
Pulses
N/A132°C15
N/A134°C10
3132°C4
3134°C3
Minimum
Temperature
Cycle
Time
minutes
minutes
minutes
minutes
Minimum
Dry Time
45†
minutes
45†
minutes
minutes
minutes
20
20
StorageKeep 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 modications 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.
24
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7. Maintenance
7.1 Maintenance Schedule
Hospital Personnel Responsibility
Every 6 Months
• Damage to paint
• Cracks on plastic parts
• Deformation of the system
• Loose parts
• M3 Safety Segment cover screw
• Properly tighten brake screws
• Tighten thumb screws on handle or in-light
camera
* Please contact Stryker Technical Support or your Stryker Representative to schedule your preven tative
maintenance service.
• Inspect face glass for damage (cracks or chips)
• Inspect for haze inside the face glass
• Inspect all exposed screws and torque to
• Inspect for drifting. Adjust brake screws
• Measure light intensity according to
• Ensure wall control functions (if applicable)
Stryker Personnel Responsibility
Every Other Year*
specication (e.g. drop tube screws, sterile
handle assembly, etc.)
accordingly
specications in user manual
Contact Stryker Communications in case of:
• Faults
• Damage
• Service Needs
7.2 Quick Reference for Brake Screw Adjustment
BehaviorAdjustment
Extension Arm drifts
left or right
Extension Arm is
dicult to move
Spring Arm drifts left
or right
Spring Arm is dicult
to move left or right
Spring Arm drifts up or
down
Cardanic Suspension is
dicult to rotate
Tighten the two brake screws at the shoulder joint of the Extension Arm
Loosen the two brake screws at the shoulder joint of the Extension Arm
Tighten the two brake screws at the elbow joint of the Extension Arm
Loosen the two brake screws at the elbow joint of the Extension Arm
Adjust the Spring Arm tension near the elbow joint of the Spring Arm
Loosen the brake screw of the Spring Arm where it meets the Cardanic
Suspension (the cover for this brake screw will have to be removed before the
brake screw can be adjusted)
25
S
7.3 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 dicult to move.
1
23
7654
1. Central Axis
2. Spring Arm
3. Cardanic Suspension
4. Blade LED Surgical Light head
5. Elbow Joint Axes of Rotation (Vertical and
Horizontal)
6. Extension Arm
7. Shoulder Joint Axis of Rotation (Horizontal)
7.3.1 Adjusting Extension Arm Brake Screws
The Extension Arm rotates left and right (horizontally) from the shoulder joint. For each Extension Arm,
there are two brake screws at the shoulder joint and two at the elbow joint where the Extension Arm and
Spring Arm meet.
12
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 will move with relative ease and will stop moving once you let go of it. If the Extension
arm continues to drift left or right after you move it, you will need to tighten both brake screws at the
shoulder joint. If the Spring Arm drifts after you move it, you will need to tighten the brake screw at the
elbow joint. If either arm is dicult to move, you will need to loosen the appropriate brake screws.
26
S
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.
To Tighten
1. Use a 5mm Allen wrench to tighten both of the brake screws; with your ngertips, turn the wrench
clockwise until you feel the slightest of resistance.
2. Once you feel resistance, turn the brake screw 360° more at the shoulder joint and 270° more at the
elbow joint.
3. After tightening both brake screws, check for drifting by moving the arm and letting go. The arm should
stop when you stop moving it. If it continues to drift, tighten it in 90° adjustments and check again for
drifting.
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 screws, turning counterclockwise 90°.
2. Check for ease of movement. If it is still too dicult, loosen it 90° more and check again for ease of
movement.
7.3.2 Adjusting Spring Arm Tension
The Spring Arm tension controls the vertical (up and down) movement of the Spring Arm. It is located at the
elbow joint of the Spring Arm. To test the tension of the Spring Arm, push the light head toward the ceiling.
If it drifts down, increase the tension. Pull the light head toward the oor. If it rises, decrease the tension.
Note: The Spring Arm should always be parallel to the oor while adjusting the tension.
27
S
Increasing Tension
(Light head drifts down when pushed up)
1. Insert a 5mm Allen wrench in the elbow joint of the
Spring Arm.
2. Turn the wrench counterclockwise to increase the
tension.
3. Check tension by pushing light head towards ceiling
and then toward the oor.
Decreasing Tension
(Light head drifts up when pulled down)
1. Insert a 5mm Allen wrench in the elbow joint of the
Spring Arm
2. Turn the wrench clockwise to decrease the tension.
3. Check tension by pushing light head towards the
oor and then toward the ceiling.
Adjusting the Spring Arm Brake Screws
The Spring Arm brake screw controls the 360° rotation of the Cardanic Suspension. It is located where the
Spring Arm meets the Cardanic Suspension. This brake screw should be adjusted during initial installation
and when performing preventative 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 ts 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 indicated by the arrow in
the accompanying gure), insert a at head
screw driver between the two halves of the
cover and gently pry it apart.
3. Set the two halves aside in the same orientation
so you can easily put them back on (they can
only be properly joined in one way).
Adjusting Spring Arm Tension
Remove Spring Arm Front Cover
To Tighten
1. Use a 4mm Allen wrench to tighten the brake
screw; with your ngertips, turn the wrench
clockwise until you feel the slightest of
resistance.
2. Once you feel resistance, tighten the brake
screw an additional 180°.
3. Check for ease of movement. If it is still too
loose, tighten it up to 30° more.
28
Brake Adjustment Screw
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 dicult 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 (60 Ncm).
Put on Spring Arm Front Cover
1. Snap the two halves together. When properly
joined, both sides snap into place and t snugly
around the Spring Arm.
2. Use a P1 Phillips screwdriver to tighten the
screws at both sides of the cover.
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 ts snugly only when properly attached. The top has
slightly shorter curves and a slightly longer at surface. Use that orientation to secure it
properly.
S
7.3.3 Replacing Brake Screws
1. Remove the brake screw (using the Allen wrench recommended in the instructions to loosen the
appropriate brake screw).
2. Fill the hollow nose of the brass brake pads with Microgleit GP360 and lubricate the faces of the brake
pads with a thin layer of the grease.
3. Insert the brake screws and turn them with you ngertips until the threads engage.
4. Follow the instructions to tighten the appropriate brake screw.
29
S
8. Optional Congurations
8.1 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. The other lights
are not camera-ready, so these steps apply to Light 1 only.
1. Invert the light head so that the weighted light handle
points straight up, perpendicular to the oor.
2. Loosen the 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 the In-Light Camera rmly into place, and ensure that the base of the In-Light Camera sits ush
with the surface of the light.
6. Tighten the three thumb screws completely to secure camera.
Warning
If the base of the In-Light Camera is not ush with the surface of the light or if the thumb screws are
not completely tightened, the camera could fall o.
30
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 oor.
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. Be prepared to hold it down until the
weighted light handle is secure.
S
4. Align the connector of the weighted light handle with that of the light head and insert it into the light
head.
5. Press the weighted light handle rmly into place, and ensure that the base of the weighted light handle
sits ush 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 ush with the surface of the light or if the thumb
screws are not completely tightened, the weighted light handle could fall o.
8.2 HD Camera Decoder Box Installation
1. Connect the DVI cable from the decoder box to a 1080p monitor or video router (see the following
gure).
2. Connect the S-video from the light head to the decoder box using the S-Video to BNC split cable. The
BNC connection with the white cable should be connected to the decoder box. The connection with the
yellow cable is not used.
3. Connect the country-specic power cable from the decoder box to a power supply source.
31
S
S Video Cable
From Light Head
Power Cable
HD Camera Decoder Box Installation
Note: The yellow cable does not plug into anything.
8.3 Re-Orderable Parts
P/NDescription
P24551Handle Cover, 6-Pack
0682000811Package of 3 Camera Handles with Ridge
0682000190Package of 6 Camera Handles
32
S
9. Troubleshooting
SymptomReference
One of the arms of the Visum® Blade LED
Surgical Light system drifts too much.
One of the arms of the Visum® Blade LED
Surgical Light system is too dicult to move.
One of the light heads tilts when released.See Maintenance section of this manual to adjust brake
The camera image looks mostly green/blue/
red.
Camera control does not function but the
camera image is visible.
Camera does not transmit an image and
cannot be controlled through the Wall
Control.
Camera does not transmit an image but can
be controlled through the Wall Control Panel.
HD Video transmission is not clear.Make sure that the white cable is hooked into the decoder
See Maintenance section of this manual to adjust brake
screws.
See Maintenance section of this manual to adjust brake
screws.
screws.
• Adjust the White Balance in the camera.
• Check Monitor Settings.
Verify that Light 1 is connected to Control Port 1 and not
Port 2.
• 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
* Individual system components may have less stringent shipping conditions. See shipping label for
component-specic shipping conditions.
10.4 Electrical Specications
Rated InputVoltage100 -240V ~50/60Hz
Current6A
Power per Light Head259 - 416 Btu/hr (76 - 122 W)
10.5 Mechanical Specications
Force Required to Move LightUp to 25 N
Load Capacity of Light Spring Arm95-176 Nm
Degrees of rotation at Spring Arm Light Head Joint
Degrees of rotation at shoulder and
elbow joints for light Spring Arm
Degrees of rotation at Cardanic Light
Head joint
Degrees of rotation at the shoulder
joint for at panel arms
Degrees of rotation at the elbow joint
at at panel arms
Unlimited (uninterrupted rotation)
Unlimited (uninterrupted rotation)
260° ± 10°
Up to 320°
Up to 310°
10.6 Illumination Specications
Central Illuminance (at 915mm from light)Up to 160,000 Lux
Light Field Diameter (d10 at 915mm)≥7.5 in (190mm)
Depth of Illumination (20%)36.8 in (935 mm)
Depth of Illumination (60%)17.9 in (454mm)
Light Field Diameter (d50 at 915mm)≥4.2in (107mm)
Color Temperature
Color Rendering Index
R9 Rendering Index
Total Irradiance at Maximum Intensity
Ratio of Irradiation to Illuminance
LED Lifetime** (L70)
* 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.
** LED light output: To remain at or above 70% initial output.
Estimate based on LED manufacturer data.
with 1 shadow caster 77% ±10%
with 2 shadow casters47% ±10%
S
Shadow Dilution
with 1 tube92% ±5%
with 1 tube and shadow caster69% ±10%
with 1 tube and 2 shadow casters43% ±10%
10.7 HD Camera Specications
Image Sensor1/2.8 Type EXMOR CMOS Sensor
Picture ResolutionFull HD 1080p (1920 x 1080) approx. 2,000,000 Active Pixels
Aspect Ratio16:9
Lens20x Optical Zoom, F=4.7mm (wide end) ~ 94.0mm (tele end F1.6 to F3.5) 4x
Digital Zoom
Horizontal Angle of ViewIncludes 55.4° (wide end) to 2.9° (tele end)
Minimum Object Distance10mm (wide end) ~ 1,000mm (tele end)
Minimum IlluminationLess than 1.7 LX (F1.6, 50 IRE)
Signal-to-Noise Ratio (S/N)More than 50 DB
White BalanceOne-Push
FocusAutomatic/Manual
Automatic Electronic ShutterYes
Iris ControlAutomatic/Manual
Signal OutputDVI 1080P60
Decoder Box Dimensions8.66" W x 2.25" H x 6.88" D
10.7.1 HD Camera Components
Stryker P/NDescription
P22338Camera Assembly
P22059Decoder Assembly
P22062Decoder Wall Mount
35
S
10.8 EMC Information
Guidance and Manufacturer's Declaration - Electromagnetic Emissions
The Visum® Blade LED Surgical Light System is intended for use in the electromagnetic environment
specied below. The customer or the user of the Visum® Blade LED Surgical Light System should assure that
it is used in such an environment.
The Visum® Blade LED Surgical Light System uses RF energy only
RF emissions
CISPR 11
Group 1
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
Harmonic emissions
IEC 61000-3-2
Voltage uctuations/
icker emissions
IEC 61000-3-3
Class A
Class A
Complies
The Visum® Blade LED Surgical Light System is suitable for use in all
establishments other than domestic and those directly connected
to the public low-voltage power supply network that supplies
buildings used for domestic purposes.
36
S
Guidance and Manufacturer's Declaration - Electromagnetic Immunity
The Visum® Blade LED Surgical Light System is intended for use in the electromagnetic environment
specied below. The customer or the user of the Visum® Blade LED Surgical Light System should assure that
it is used in such an environment.
Immunity TestIEC 60601 Test LevelCompliance Level
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
± 6 kV contact
± 8 kV air
± 2 kV for power
supply lines
± 1 kV for input/
output lines
± 1 kV line(s) to
line(s)
± 2 kV line(s) to
earth
<5 % UT
(>95 % dip in UT )
for 0,5 cycle
40 % UT
(60 % dip in UT) for
5 cycles
70 % U
T
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT )
for 5 s
± 6 kV contact
± 8 kV air
± 2 kV for power
supply lines
± 1 kV for input/
output lines
± 1 kV line(s) to
line(s)
± 2 kV line(s) to
earth
<5 % UT
(>95 % dip in UT )
for 0,5 cycle
40 % UT
(60 % dip in UT) for
5 cycles
70 % U
T
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT )
for 5 s
Electromagnetic Environment -
Guidance
Floors should be wood, concrete,
or ceramic tile. If oors are covered
with synthetic material, the relative
humidity should be at least 30%.
Mains power quality should be that
of a typical commercial or hospital
environment.
Mains power quality should be that
of a typical commercial or hospital
environment.
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the Visum®
Blade LED Surgical Light System
requires continued operation during
power mains interruptions, it is
recommended that the Visum® Blade
LED Surgical Light System be powered
from an uniterruptible power supply or
battery.
Power frequency
(50/60 Hz) magnetic
eld
3 A/m3 A/m
IEC 61000-4-8
Note: UT is the a.c. mains voltage prior to application of the test level.
37
Power frequency magnetic elds
should be at levels characteristic of a
typical location in a typical commercial
or hospital environment.
S
Guidance and Manufacturer's Declaration - Electromagnetic Immunity
The Visum® Blade LED Surgical Light System is intended for use in the electromagnetic environment
specied below. The customer or the user of the Visum® Blade LED Surgical Light System should assure that
it is used in such an environment.
Immunity TestIEC 60601 Test LevelCompliance Level
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
3 V/m
Radiated RF
80 MHz to 2,5 GHz
IEC 61000-4-3
3 Vrms
3 V/m
Electromagnetic Environment -
Guidance
Portable and mobile RF
communications equipment should
be used no closer to any part of the
Visum® Blade LED Surgical Light
System, including cables, than the
recommended separation distance
calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation distance
d = 1,2√P
d = 1,2√P 80 MHz to 800 MHz
d = 2,3√P 800 MHz to 2,5 GHz
where P is the maximum output
power 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 xed 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 800 MHz, the higher frequency range applies.
• These guidelines may not apply in all situations. Electromagnetic propagation is aected
by absorption and reection from structures, objects and people.
a
Field strengths from xed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to xed RF transmitters, an
electromagnetic site survey should be considered. If the measured eld strength in the location in which
the Visum® Blade LED Surgical Light System is used exceeds the applicable RF compliance level above,
38
S
the Visum® Blade LED Surgical Light System should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as re-orienting or relocating the
Visum® Blade LED Surgical Light System.
b
Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.
Recommended separation distances between portable and mobile RF communications
equipment and the Visum® Blade LED Surgical Light System
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® Blade LED Surgical
Light 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
100121223
For transmitters rated at a maximum output power not listed above, the recommended separation distance
d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter,
where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter
manufacturer.
Note:
• At 80 MHz and 800 MHz, the higher frequency range applies.
• These guidelines may not apply in all situations. Electromagnetic propagation is aected
by absorption and reection from structures, objects and people.
10.9 Latex Policy
Stryker Communications guarantees that all Visum LED equipment including accessories, packaging
material, labels, pouches, or other similar items do not contain latex.
39
S
90
°
30
°
330
°
50
°
45
°
360
°
330
°
850mm
1000mm
760mm1150mm
360
°
360
°
330
°
11. Disposal of the Product
The device must be disposed of according to local laws and hospital practices.
Local regulations may include specications 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 Specications
320°
310°
260°
Standard Light Specications
40
220
°
220
°
25
°
42
°
360°
S
1196mm
260°
Standard Light Specications
Note: Do not adjust the light higher than 25°.
41
S
13. Stryker Limited Warranty
This warranty applies to customers in the United States only. Outside of the USA, contact your Stryker sales
representative or your local 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.
Any modications to this warranty policy are not valid unless made with explicit written approval of Stryker.
This warranty covers all Stryker products with the exception of bulbs, sterilizable handles, lters, and any
other disposable parts.
This warranty does not cover any cosmetic or supercial damage to product. Any modication to product
by Customer without the approval of Stryker will immediately void this warranty in its entirety.
This warranty covers only Stryker 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 responsibility for loss or
damage during shipping. Please contact Technical Support (866) 841-5663 for inside the U.S., (972) 4107100 for international, or your Stryker representative if your shipment is lost or damaged.
If you need to return any item, contact Customer Service for an RMA number. After receiving an RMA
number, package the item as described by Customer Service. Ship the item to the following address:
Contact Stryker Customer Service with questions or concerns.
Stryker Communications
571 Silveron Blvd.
Flower, Mound, TX 75028
Toll Free: (866) 841-5663
1-972-410-7100
For international service locations, refer to the Stryker website at the following URL:
www.stryker.com.
Stryker Corporation or its divisions
or other corporate aliated 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
*P22364K*
*P22364K*
WCR: NONE
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