Stryker X8000 User manual

X8000 Light Source
220-200-000

1
X8000 Light Source
User Guide
Contents
Warnings and Cautions ......................................... 2
Symbol Definitions ............................................................................ 4
Product Description and Intended Use ................. 5
Setup and Assembly ............................................. 8
Connecting the AC Power Cable ...................................................... 8
Connecting the Light Cable .............................................................. 8
System Operation ............................................... 10
Powering the System On and Off ................................................... 10
Selecting the Operation Mode ........................................................ 11
Adjusting the Brightness ................................................................. 11
Visual Display .................................................................................. 12
Language Selection ........................................................................ 13
Safety Shutoff ................................................................................. 13
Checking the ESST Feature ............................................................ 14
Using the X8000 with a Voice-Controlled System Interface ........... 15
Using the SFB Serial Interface ........................................................ 15
Troubleshooting .............................................................................. 16
Cleaning and Maintenance ................................. 18
Cleaning the X8000 ......................................................................... 18
Caring for the Bulb Module ............................................................. 18
Replacing the Bulb Module ............................................................ 18
Replacing the Fuses ....................................................................... 20
Disposing of the X8000 ................................................................... 20
Technical Specifications ..................................... 21
Electromagnetic Compatibility ........................................................ 22
Warranty ............................................................. 26
Service and Claims ............................................. 27

2
Warnings and Cautions
Please read this manual and follow its instructions carefully. Certain symbols and
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
SERIOUS INJURY TO THE PATIENT OR USER.
Caution Special procedures or precautions must be followed to avoid
damaging the instrument.
Note Special information to make maintenance easier or important
information more clear.
An exclamation mark within a triangle is intended to alert the
user to the presence of important operating and maintenance
instructions in the manual.
A lightning bolt within a triangle is intended to warn of the
presence of hazardous voltage. Refer all service to authorized
personnel.
WARNING IMPORTANT SAFETY NOTICE: BEFORE OPERATING THIS
DEVICE, PLEASE READ THIS OPERATING MANUAL THOROUGHLY
AND CAREFULLY. WHEN USING THIS DEVICE WITH ALIGHT SOURCE,
FIRE AND/OR SEVERE INJURY MAY RESULT TO THE PATIENT, USER
OR INANIMATE OBJECTS, IF THE INSTRUCTIONS IN THIS MANUAL
ARE NOT FOLLOWED. ALL LIGHT SOURCES, INCLUDING THE X8000,
CAN GENERATE SIGNIFICANT AMOUNTS OF HEAT (EXCEEDING 41°C
/ 106°F) AT THE SCOPE TIP, THE SCOPE LIGHT POST, THE LIGHT
CABLE TIP, AND/OR NEAR THE LIGHT CABLE ADAPTER. HIGHER
LEVELS OF BRIGHTNESS FROM THE LIGHT SOURCE RESULT IN
HIGHER LEVELS OF HEAT. ALWAYS ADJUST THE BRIGHTNESS LEVEL
OF THE CAMERA AND THE MONITOR, BEFORE ADJUSTING THE
BRIGHTNESS LEVEL OF THE LIGHT SOURCE. ADJUST THE
BRIGHTNESS LEVEL OF THE LIGHT SOURCE TO THE MINIMUM
BRIGHTNESS NECESSARY TO ADEQUATELY ILLUMINATE THE
SURGICAL SITE. INADDITION, ADJUST THE INTERNAL SHUTTER OF
THE CAMERA HIGHER IN ORDER TO RUN THE LIGHT SOURCE AT A
LOWER INTENSITY. AVOID TOUCHING THE SCOPE TIP OR THE LIGHT
CABLE TIP TO THE PATIENT, AND NEVER PLACE THEM ON TOP OF
THE PATIENT, AS DOING SO MAY RESULT IN BURNS TO THE PATIENT
OR USER. INADDITION, NEVER PLACE THE SCOPE TIP, THE SCOPE
LIGHT POST, THE LIGHT CABLE ADAPTER, OR THE LIGHT CABLE TIP
ON THE SURGICAL DRAPES OR OTHER FLAMMABLE MATERIAL, AS

3
DOING SO MAY RESULT IN FIRE. ALWAYS PLACE THE LIGHT SOURCE
IN STANDBY MODE WHENEVER THE SCOPE IS REMOVED FROM THE
LIGHT CABLE OR THE DEVICE IS UNATTENDED. THE SCOPE TIP,
SCOPE LIGHT POST, LIGHT CABLE ADAPTER, AND LIGHT CABLE TIP
WILL TAKE SEVERAL MINUTES TO COOL OFF AFTER BEING PLACED
IN STANDBY MODE, AND THEREFORE MAY STILL RESULT IN FIRE OR
BURNS TO THE PATIENT, USER, OR INANIMATE OBJECTS.
WARNING TOHELP AVOID POTENTIAL SERIOUS INJURY TO THE USER AND
THE PATIENT AND/OR DAMAGE TO THIS DEVICE, THE USER MUST:
1. Read this operating manual thoroughly, especially the warnings, and be
familiar with its contents prior to using this equipment.
2. Carefully unpack the unit and check if any damage occurred during
shipment. If damage is detected, please refer to the “Service and Claims”
section in this manual.
3. Be a qualified physician, having complete knowledge of the use of this
equipment.
4. Test this equipment prior to a surgical procedure. This unit was fully
tested at the factory before shipment.
5. Attempt no internal repairs or adjustments that are not specifically
detailed in the Troubleshooting, Cleaning and Maintenance sections of
this operating manual.
6. Never sterilize any part of the X8000 console.
7. Disconnect the X8000 from the electrical outlet when inspecting the fuses.
8. No modification of this equipment is allowed.
9. To avoid risk of electric shock, this equipment must only be connected
to a supply mains with protective earth ground.
10. Do not position the console so that it is difficult to disconnect the power
cord from the supply mains.
11. Never use this equipment in the presence of flammable or explosive gases.
The warranty is void if any of these warnings or cautions contained in this manual
are disregarded. The user must also be ensure that:
• Readjustments, modifications, and/or repairs are carried out
exclusively by Stryker Endoscopy.
• The electrical installation of the relevant operating room complies
with the applicable IEC, CEC, and NEC requirements.
WARNING FEDERAL LAW (UNITED STATES OF AMERICA) RESTRICTS THIS
DEVICE TO USE BY, OR ON ORDER OF, APHYSICIAN.

4
Symbol Definitions
Type CF Applied Part
Protective Earth Ground
Equipotentiality
Denotes compliance to CSA 22.2 No.601.1-M90 and UL60601-1.
This symbol indicates that the waste of electrical and electronic
equipment must not be disposed as unsorted municipal waste
and must be collected separately. Please contact the
manufacturer or other authorized disposal company to
decommission your equipment.
Caution: Surface may be hot
The user must read the provided instructions to safely operate
the device. Disregarding the information could result in serious
injury to the patient or user.
Consult instructions for use
Caution (consult instructions for use)
Power on/off (alternates when button is pushed)
Alternating current
Device recycling code (applicable in China)
Relative humidity limitation

5
Product Description and Intended Use
The Stryker X8000 Light Source is a light-generating unit designed to illuminate
surgical sites during endoscopic applications. The X8000 uses a 300-watt xenon
bulb to generate bright, crisp light, which it delivers to the surgical site via a
fiberoptic light cable. The X8000 is compatible with all Stryker light cables, and,
with the proper light cable and adapters, can connect to any flexible or rigid
endoscope.
The X8000 is equipped with Electronic Scope Sensing Technology (ESST), a
special safety feature that helps prevent accidental burns caused by a light cable
that is not connected to the scope. For more information, refer to the section
“Checking the ESST Feature”. When operated with an ESST light cable, the X8000
senses when the scope and the light cable are separated and places the light source
in Standby mode. In Standby mode, the X8000 will reduce light output to a
minimum, preventing the light cable from generating excessive heat.
Temperature limitation
Pressure limitation
Federal law (USA) restricts this device to use by, or on order of, a
physician
Product catalog number
Product serial number
Date of manufacture
Legal manufacturer
Fuse rating

6
WARNING THE SCOPE TIP, SCOPE LIGHT POST, LIGHT CABLE ADAPTER, AND
LIGHT CABLE TIP WILL TAKE SEVERAL MINUTES TO COOL OFF
AFTER BEING PLACED IN STANDBY MODE AND THEREFORE MAY
STILL RESULT IN FIRE AND/OR BURNS TO THE PATIENT, USER, OR
AN INANIMATE OBJECT IF NOT USED PROPERLY. DONOT PLACE
THE SCOPE OR THE LIGHT CABLE ON THE PATIENT OR ON THE
DRAPES OR OTHER FLAMMABLE MATERIAL, EVEN WHEN THE
DEVICE IS IN STANDBY MODE.
The Stryker X8000 Light Source consists of one of each of the following:
• light source console
•powercord
• xenon bulb module (spare or replacement bulb modules can be
purchased separately as P/N 220-201-000)
The features of the X8000 console are described below (see Figures 1 and 2).
Figure 1 Front panel of the X8000 console
1. Power Button: Powers the unit on and off.
2. Standby LED: Illuminates when the unit is operating in the Standby
mode. In Standby mode, light output is reduced to a minimum level.
3. Mode Button: Selects either Standby or Run mode when pressed.
Standby is the default mode when the light source is powered on.
4. Run LED: Illuminates when the unit is operating in the Run mode. In
Run mode, light output is determined by the up and down switches.
5. LCD: Indicates the light intensity level (0-100%), bulb hours and
language.
1
57
98
6
3
2
4

7
6. Up Button: Increases light intensity in Run mode.
7. Cable Clamp: Grasps the light-source end of an inserted fiberoptic
cable. (When no cable is inserted, the bulb automatically turns off to
save bulb hours.)
8. Jaw Handle: Opens the fiberoptic-cable holder.
9. Down Button: Decreases light intensity in Run mode.
Figure 2 Rear panel of the X8000 console
10. Voice-C ontrol Por t: Connects to Stryker voice-control systems.
11. SFB Series Connectors : Enables FireWire connection with Stryker
FireWire devices. Provides connection for remote diagnoses and future
software upgrades.
12. AC Inlet: Connects to the provided power cord for AC power supply.
13. Fuse Holder: Contains two T 5.0 AH 250 V fuses.
14. Equipotentiality Plug: Provides a grounding post for common
grounding with other equipment. Connects to a potential equalization
conductor. The resulting medical electrical system shall follow all
applicable IEC 60601-1 requirements.
Stryker Endoscopy
5900 Optical Court
San Jose, CA 95138 USA
U.S. Patents:
5850496, 6110107, 6689050
Other patents pending
MADE IN USA
SIDNE
10
12, 13
11
14

8
Setup and Assembly
Note Your local Stryker Endoscopy sales representative will perform
inservice training at your convenience to instruct you and your
staff on the safe and effective operation and maintenance of the
X8000, and to help set up the equipment. Please contact your
local Stryker Endoscopy sales representative to schedule an
inservice after the equipment has arrived.
Note When selecting a setup location for the X8000, consult the
“Electromagnetic Compatibility” section included in this manual
to determine the best location.
To set up the X8000, make the following connections:
• Connect the AC power cable
• Connect the light cable
Connecting the AC Power Cable
1. Plug in the AC power cord to the AC Inlet on the rear console panel.
2. Plug in the other end of the AC cord to a hospital-grade outlet.
WARNING WHEN THE X8000 IS INTERCONNECTED WITH OTHER MEDICAL
ELECTRICAL EQUIPMENT, LEAKAGE CURRENTS MAY BE ADDITIVE.
TOMINIMIZE LEAKAGE CURRENT THAT MAY TRAVEL TO THE
PATIENT OR USER, ANY TYPE CF APPLIED PART SHOULD BE USED
ONLY WITH OTHER TYPE CF APPLIED PARTS. ENSURE ALL
SYSTEMS ARE INSTALLED ACCORDING TO THE REQUIREMENTS OF
IEC 60601-1-1.
Connecting the Light Cable
WARNING USE ONLY NONCONDUCTIVE FIBEROPTIC CABLES WITH THE
X8000 TO MAINTAIN ELECTRICAL ISOLATION.
Note The X8000 Light Source is compatible with all Stryker Light
Cables.