x8000_user_guide.pdf
Page 1
X8000 Light Source
REF 220-200-000
User Guide
English
Deutsch
Español
Français,
Italiano
Português
Nederlands
Dansk
Suomi
Svenska
Ελληνικά
Polski
日本語
中文
한국어
2006/09
www.stryker.com
1000-400-885 D
Page 3
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 ................................................................. 12
Visual Display .................................................................................. 12
Language Selection ........................................................................ 13
Safety Shutoff ................................................................................. 14
Checking the ESST Feature ............................................................ 15
Using the X8000 with a Voice-Controlled System Interface ........... 16
Using the SFB Serial Interface ........................................................ 16
Troubleshooting .............................................................................. 17
Cleaning and Maintenance ................................................... 19
Cleaning the X8000 ......................................................................... 19
Caring for the Bulb Module ............................................................. 19
Replacing the Bulb Module ............................................................ 20
Replacing the Fuses ....................................................................... 21
Disposing of the X8000 ................................................................... 21
Technical Specifications ....................................................... 22
Electromagnetic Compatibility ........................................................ 23
Warranty .......................................................................................... 27
Service and Claims .................................................................... 28
1
Page 4
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 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 A LIGHT
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 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. IN ADDITION, 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. IN ADDITION, 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 DOING SO MAY RESULT IN FIRE.
2
Page 5
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
TO HELP 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.
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, A PHYSICIAN.
3
Page 6
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
4
Page 7
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.
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. DO NOT 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
• power cord
• xenon bulb module (spare or replacement bulb modules can be
purchased separately as P/N 220-201-000)
5
Page 8
The features of the X8000 console are described below (see Figures 1 and 2).
5
6
7
4
3
2
1
9
8
Figure 1 Front panel of the X8000 console
6
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.
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.
Page 9
10
11
4USZLFS&OEPTDPQZ
0QUJDBM$PVSU
4BO+PTF $"64"
4*%/&
641BUFOUT
0UIFSQBUFOUTQFOEJOH
."%&*/64"
14
12, 13
Figure 2 Rear panel of the X8000 console
10. Voice-Control Port: 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 5A fuses.
14. Equipotentiality Plug: Provides a grounding post for common
grounding with other equipment.
7
Page 10
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.
TO MINIMIZE 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.
8
Page 11
1.
Lock open the cable clamp by turning the jaw handle clockwise until it
stops (see Figure 3).
Figure 3 Locking open the cable clamp
WARNING
KEEP FINGERS AWAY FROM THE CABLE CLAMP AS THE CLAMP MAY
INADVERTENTLY DEPLOY AND CAUSE INJURY.
WARNING
DO NOT LOOK DIRECTLY INTO THE CABLE PORT. THE HIGHINTENSITY LIGHT MAY CAUSE DAMAGE TO THE EYES.
2.
Insert a clean, dry fiberoptic cable into the cable port until the jaw latch
releases and the jaw clamps the cable in place (see Figure 4). Pull gently
on the fiberoptic cable to test that it is securely seated in the cable port.
Figure 4 Inserting the light cable into the cable port
3.
Connect an endoscope to the opposite end of the fiberoptic cable.
4.
To remove the light cable, press the mode button to put the unit into
standby. Then, turn the jaw handle clockwise until the latch opens.
9
Page 12
WARNING
IF THE LIGHT SOURCE IS NOT IN STANDBY MODE PRIOR TO
REMOVING THE CABLE, THE HIGH INTENSITY LIGHT WILL SHINE
DIRECTLY OUT OF THE LIGHT SOURCE BRIEFLY BEFORE TURNING
OFF, POSSIBLY CAUSING INJURY TO THE USER’S EYES.
Note
The Light Source will default to Standby mode when a light cable
is inserted.
System Operation
Note
Before operating the X8000, see the “Setup and Assembly” section
of this manual.
Powering the System On and Off
Caution
Do not power the system on and off in rapid succession. Allow
the bulb to run for at least five minutes once it has been
powered on, before turning the power off. Failure to do so can
cause the bulb to rapidly darken and fail.
To power on the X8000:
1.
Confirm that the X8000 contains a properly installed bulb. The bulb
handle must be turned all the way to the left, to ensure proper latching. If
no bulb is installed, follow the instructions in the “Replacing the Bulb”
section of this manual before proceeding.
2.
Press the power switch on the front panel. The Standby LED will
illuminate, indicating the unit is in Standby mode.
Note
The bulb will not illuminate unless a light cable is installed in the
cable port.
To power off the X8000:
1.
Put the light source unit into Standby mode.
2.
Disconnect the light cable from the X8000 console.
3.
Run the fan for at least one minute to cool the unit.
4.
Press the power switch on the front panel of the X8000.
WARNING
10
TO ALLOW FOR ADEQUATE COOLING, NEVER BLOCK THE REAR OR
SIDE FAN VENTS. FAILURE TO FOLLOW THIS INSTRUCTION MAY
RESULT IN DAMAGE TO THE X8000 OR A POSSIBLE FIRE.
Page 13
Selecting the Operation Mode
The X8000 has two operation modes, Run and Standby.
• RUN mode: The Run mode is used during normal operation. It
enables light output to be controlled by the brightness controls on the
front console panel.
• STANDBY mode: The Standby mode is used when the X8000 is
powered on, but not in use. It reduces the light output to a minimum,
thereby reducing the heat generated at the tip of the light cable or
scope when the X8000 is not being used.
To select either the Run or Standby mode, press the Mode Button. The LED for
the selected mode will illuminate.
WARNING
TO HELP PREVENT BURNS TO THE PATIENT, USER OR INANIMATE
OBJECTS AND POSSIBLE FIRE, ALWAYS PUT THE X8000 IN
STANDBY MODE WHENEVER THE ENDOSCOPE IS REMOVED FROM
THE LIGHT CABLE. 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 INANIMATE OBJECTS IF NOT USED
PROPERLY. DO NOT PLACE THE SCOPE OR THE LIGHT CABLE ON
THE PATIENT, ON THE DRAPES, OR OTHER FLAMMABLE MATERIAL,
EVEN WHEN THE DEVICE IS IN STANDBY MODE.
11
Page 14
Adjusting the Brightness
The X8000 has up and down buttons for adjusting the bulb brightness.
Press the up arrow to increase brightness, and press the down arrow to decrease
brightness. The selection will appear on the LCD as a percentage between 0 and
100.
When in Standby mode, the previous Run mode brightness level appears in the
upper right-hand corner. The Run mode brightness level can be reset while still in
Standby mode, by pressing the up and down buttons.
WARNING
THE HIGHER THE BRIGHTNESS, THE MORE HEAT ENERGY THAT
WILL BE GENERATED IN THE SCOPE AND THE TIP OF THE CABLE.
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
ILLUMINATE THE SURGICAL SITE. FAILURE TO FOLLOW THIS
INSTRUCTION COULD RESULT IN FIRE OR BURNS TO THE PATIENT,
USER OR AN INANIMATE OBJECT. IN ADDITION, ADJUST THE
INTERNAL SHUTTER OF THE CAMERA HIGHER IN ORDER TO RUN
THE LIGHT SOURCE AT A LOWER INTENSITY.
WARNING
THE SURFACE TEMPERATURE NEAR THE SCOPE ADAPTER AND AT
THE TIP OF THE SCOPE MAY EXCEED 41ºC IF THE UNIT IS
OPERATED AT HIGH LEVELS OF BRIGHTNESS FOR EXTENDED
PERIODS OF TIME. THE HEATED SCOPE AND ADAPTER MAY CAUSE
BURNS TO THE PATIENT, USER OR AN INANIMATE OBJECT.
Visual Display
The X8000 provides feedback through the LCD.
• Brightness: The LCD display shows the intensity level of the light as a
percentage between 0 and 100. For example, if the LCD shows “70,”
the light output to the fiberoptic cable is running at 70 percent of
capacity.
• Bulb Hours: The LCD display shows how many total hours the bulb
has operated. For example, if the LCD shows “250,” the bulb has
operated 250 total hours. The bulb hours will flash after 500 hours,
and the LCD will display “Replace Bulb” after 1000 hours.
12
Page 15
• The LCD also displays warning and error codes. The table below lists
and defines the warning and error codes displayed.
Code
Definition
Recommended
Action
E-1
All conditions are met for the bulb to
illuminate, yet it remains off.
Return the X8000 for
repair.
E-2
All conditions are not met for the bulb
to illuminate, yet it remains on.
Return the X8000 for
repair.
E-3
The bulb has higher than expected
current or voltage applied to it.
Return the X8000 for
repair.
E-4
The bulb is kept off because the ballast
fan is not working properly.
Return the X8000 for
repair.
E-5
The bulb is kept off because the bulb fan
is not working properly.
Return the X8000 for
repair.
Blinking
500
The bulb has exceeded its
recommended lifetime of 500 hours.
Install a new Stryker
bulb.
Replace
Bulb
The bulb has reached 1000 hours and
has exceeded its recommended lifetime
of 500 hours.
Install a new Stryker
bulb.
Language Selection
The X8000 LCD has the capability of displaying text in the following languages:
Danish
Dutch
English
Finnish
French
German
Greek
Italian
Japanese
Korean
Polish
Portuguese
Simplified Chinese
Spanish
Swedish
To select a particular language, perform the following steps:
1.
Hold down the Up and Down buttons until the current language
identifier appears.
2.
Use Mode button to scroll through the available languages.
3.
Hold down the Up and Down buttons (until the light source resumes
normal operation) to lock in the selected language.
13
Page 16
Safety Shutoff
The X8000 Light Source is equipped with a Safety Shutoff feature which will
temporarily turn off the bulb in the event of excessive heat in the bulb assembly.
WARNING
ONCE THE LIGHT SOURCE COOLS DOWN (AFTER 7-10 MINUTES),
POWER WILL RESUME TO THE BULB AND THE UNIT WILL RESTART
IN STANDBY MODE. TO PREVENT FIRES AND ACCIDENTAL BURNS
TO THE PATIENT, USER OR INANIMATE OBJECTS, ALWAYS PLACE
THE SCOPES AND/OR FIBEROPTIC CABLES IN A SAFE PLACE, AND
NOT ON THE PATIENT, DRAPES, OR OTHER FLAMMABLE MATERIAL,
TO ENSURE SAFE RESUMPTION OF LIGHT OUTPUT. IF THE X8000
LIGHT SOURCE EXPERIENCES A TEMPORARY SHUTDOWN, IT IS
RECOMMENDED THAT THE DEVICE BE RETURNED FOR SERVICE.
Caution
14
Do not abruptly interrupt power to the unit. This will turn off
the fan and may cause severe damage to the internal cooling
system.
Page 17
Checking the ESST Feature
The X8000 is equipped with Electronic Scope Sensing Technology (ESST), a
special safety feature that helps prevent accidental fires or burns to the patient or
user caused by a light cable not connected to a scope. This feature will only work
if the X8000 is used with an ESST light cable. When operated with an ESST light
cable, the X8000 senses when the scope and 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.
To verify the ESST feature is active, perform the following test before every
surgical procedure:
1.
Set up the X8000 system with an ESST light cable and scope, and then
power on the system.
2.
Place the X8000 in Run mode.
3.
Remove the light cable from the ESST scope adapter.
The X8000 should return to Standby mode, indicating that the ESST feature is
functioning properly.
WARNING
ALWAYS CHECK TO ENSURE THAT THE UNIT HAS SWITCHED INTO
STANDBY MODE, BEFORE ASSUMING ESST SAFETY PROTECTION. IF
THE UNIT FAILS TO RETURN TO STANDBY MODE, THERE MAY BE A
FAULT WITH THE ESST FEATURE. IN THIS CASE, DO NOT ASSUME
ESST SAFETY PROTECTION, AND RETURN THE UNIT FOR SERVICE.
WARNING
EVEN WITH ESST PROTECTION, OR WHEN THE X8000 IS IN
STANDBY MODE, NEVER PLACE THE TIP OF THE LIGHT CABLE OR
LIGHT CABLE ADAPTER DIRECTLY ON THE PATIENT, DRAPES OR
OTHER FLAMMABLE MATERIAL, AS BURNS OR FIRE MAY RESULT.
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.
DO NOT PLACE
THE SCOPE OR THE LIGHT CABLE ON THE PATIENT, ON THE
DRAPES, OR OTHER FLAMMABLE MATERIAL, EVEN WHEN THE
DEVICE IS IN STANDBY MODE.
15
Page 18
Using the X8000 with a Voice-Controlled
System Interface
The X8000 can be used in conjunction with Stryker voice-control systems
(SIDNE®). For more information about using the X8000 with Stryker voicecontrol systems, refer to the SIDNE® Operating and Maintenance Manual
(P/N 1000-400-653).
Using the SFB Serial Interface
The SFB serial connection on the rear panel of the X8000 enables FireWire
connection to the Stryker Endoscopy Software Management site. Connecting to
this site enables remote diagnostics and software updates.
Note
This system feature is not necessary for regular light-source
operation.
Note
This system feature requires an additional device (i.e., a
computer) to connect to the Software Management site.
16
Page 19
Troubleshooting
Problem
Possible Solution
No light output
• Ensure the AC power cord is properly connected to a
hospital-grade power outlet and the inlet on the rear
console panel.
• Ensure the power switch on the front panel is
powered on. (It will illuminate when powered on.)
• Ensure all fuses are operating. See the “Replacing the
Fuses” section of this manual for further instructions.
• Ensure the bulb is properly seated in the bulb
housing. The bulb handle should be turned all the
way to the left within the light source.
• Ensure the bulb is in operating condition. Replace the
bulb if necessary.
• Ensure the light cable is correctly engaged with the
cable port. As a safety feature, the X8000 will provide
no light output unless a fiberoptic light cable is
properly seated in the cable port.
• Ensure the bulb access door is completely shut.
• Check for error codes E-1, E-2, E-3, E-4 or E-5. See
the “Visual Display” section of this manual for details.
• Check that vents are not obstructed.
• If the safety shutoff has been activated, please return
the X8000 for service. Please see the section entitled
“Safety Shutoff ” in this manual for additional
information.
17
Page 20
Too much or too
little light output
• Ensure the light cable is correctly engaged with the
cable port.
• Ensure the bulb has adequate bulb life remaining.
The bulb has a warranty of 500 hours.
• Ensure the X8000 is in Run mode. (The Run LED
should be illuminated.) If necessary, press the Mode
button to switch from Standby to Run. If the unit
remains in Standby:
1. Ensure the light cable is correctly engaged with
the cable port.
2.
If an ESST cable is connected to the X8000,
ensure the cable is attached to the scope using
an ESST scope adapter.
• Use the up/down buttons to adjust the brightness. For
details, see the “Adjusting the Brightness” section in
this manual.
• Ensure the fiberoptic cable is transmitting light
properly. Hold the light-source end of the cable up to
an overhead room light and look into the scope end
of the light cable. If the pattern contains any black
spots, the light cable may be worn out and may
require replacement.
• Ensure the light cable is of an adequate size for the
application. The cable diameter may be too small to
provide adequate light transmission for the medical
video camera in the endoscopic application.
Excessive glare in
the video
18
• Ensure the electronic shutter on the camera is
operating properly to control the video signal
brightness. If further light reduction is required,
decrease the light source brightness with the down
button.
Page 21
Cleaning and Maintenance
Cleaning the X8000
WARNING
UNPLUG THE X8000 BEFORE CLEANING THE UNIT.
1.
Clean the external surfaces of the X8000 using a cloth or sponge
dampened with a mild detergent or disinfectant.
2.
Clean and maintain the light cable according to the manufacturer’s
instructions.
Caution
Do not use any abrasive cleaners. Do not allow any liquid to
drip into the unit.
Caution
Do not sterilize or immerse the X8000.
Caring for the Bulb Module
The X8000 uses a Xenon bulb, which has a guaranteed life of 500 hours when
used properly. Always follow these guidelines to ensure maximum bulb life:
1.
Clean the bulb face with alcohol and a cotton swab if it is touched. Dirt
or oil on the bulb face will cause the bulb to heat unevenly and fail.
2.
Do not power on and off the bulb in rapid succession. Allow the bulb to
run for at least five minutes once it has been powered on. Failure to do so
can cause the bulb to rapidly darken and fail.
3.
The X8000 has been designed to start the bulb under most conditions,
even when it is hot. However, if the bulb does not start within 10 seconds
after the X8000 has powered on, turn the unit off and wait at least five
minutes for the bulb to cool before restarting. Further attempts to start
the bulb can damage the bulb and possibly the internal circuitry.
19
Page 22
Replacing the Bulb Module
Replace the bulb module when the LCD indicates 500 hours or when the bulb no
longer sufficiently illuminates the surgical site. If possible, replace the bulb
module between surgical procedures.
WARNING
DURING OPERATION, THE BULB AND THE HOUSING AROUND THE
BULB MAY BE HOT. WAIT AT LEAST THREE MINUTES FOR THE BULB
TO COOL BEFORE HANDLING IT.
To replace the bulb module,
1.
Power down the X8000.
2.
Open the bulb door (Figure 5).
Figure 5 Opening the bulb door
Note
3.
If the unit is on, opening the bulb door will turn off the bulb.
Rotate the handle to the right, grasp the bulb module by the handle, and
remove the bulb (Figure 6).
Figure 6 Removing the bulb module
20
Page 23
WARNING
DO NOT REACH INSIDE THE BULB DOOR FOR ANY REASON OTHER
THAN REPLACING THE BULB MODULE. TOUCHING PARTS OTHER
THAN THE BULB MODULE MAY CAUSE BURNS OR PRODUCT
DAMAGE.
WARNING
DO NOT TOUCH ANY PART OF THE BULB MODULE EXCEPT FOR
THE HANDLE. THE MODULE MAY BE VERY HOT AND CAUSE
BURNS.
4.
Insert the new bulb module (Stryker part number 220-201-000) along
the guide rails until it is fully seated on the mating connectors.
5.
Rotate the handle to the left to secure the bulb module within the light
source.
6.
Close and latch the bulb door.
7.
Power on the unit.
8.
Power on the bulb (if not already on) and verify that the LCD displays
the bulb hours as “0”.
Note
Using a non-Stryker replacement bulb module will result in no
light output.
Caution
Do not operate the X8000 with a burned-out bulb or with no
bulb installed.
Replacing the Fuses
1.
Unplug the light source from the AC outlet and remove the power cord
from the rear of the unit.
2.
Unlatch the fuse holder and remove the fuse(s).
3.
Replace the fuse(s) with fuses of the same value and rating.
WARNING
4.
TO HELP AVOID THE RISK OF FIRE, USE ONLY 5.0A 250V FUSES.
Reinstall the fuse holder.
Disposing of the X8000
The device must be disposed of according to local laws and hospital practices.
The device does not contain any hazardous materials.
This product is considered electronic equipment. It must not be disposed of as
unsorted municipal waste and must be collected separately. Please contact the
manufacturer or other authorized disposal company to decommission your
equipment.
21
Page 24
Technical Specifications
Electrical
Primary:
Fuses (2):
Dimensions
Height:
Width:
Depth:
Weight:
100 - 120 VAC, 50/60 Hz, 450 W
220 - 240VAC, 50/60 Hz, 450W
5.0A 250V
4.75"(12.1 cm)
12.5" (31.8 cm)
16.8" (42.7 cm)
16.0 lbs. (7.3 kg)
Fiberoptic Cable Range:
2 mm to 6.5 mm diameter
Bulb
Type:
Life:
300 Watt Xenon (Elliptical)
Approximately 500 hours
Operating Conditions
10 to 40°C
30 to 75% Relative Humidity
Transportation & Storage
-20 to 50°C
10% to 75% Relative Humidity
700hPa to 1060hPa
Classifications & Approvals
Complies with medical safety standards:
IEC 60601-1:2005
CAN/CSA C22.2 No.601.1-M90
UL 60601-1: 2003
Complies with medical EMC standard:
IEC 60601-1-2:2001
Class 1 Equipment
Type CF applied parts
Water Ingress Protection, IPX0 — Ordinary Equipment
Continuous Operation
Patent Protection
U.S. #5,850,496; 6,110,107; and 6,689,050. Other patents pending.
Stryker European Representative:
Regulatory Manager, Stryker France
ZAC Satolas Green Pusignan
Av. De Satolas Green
69881 MEYZIEU Cedex, France
22
Page 25
Electromagnetic Compatibility
Like other electrical medical equipment, the X8000 requires special precautions
to ensure electromagnetic compatibility with other electrical medical devices. To
ensure electromagnetic compatibility (EMC), the X8000 must be installed and
operated according to the EMC information provided in this manual.
Note
The X8000 has been designed and tested to comply with IEC
60601-1-2:2001 requirements for EMC with other devices.
Caution
Equipment which employs radio frequency (RF)
communications may affect the normal function of the X8000.
WARNING
DO NOT USE CABLES OR ACCESSORIES OTHER THAN THOSE
PROVIDED WITH THE X8000, AS THIS MAY RESULT IN INCREASED
ELECTROMAGNETIC EMISSIONS OR DECREASED IMMUNITY TO
SUCH EMISSIONS.
WARNING
IF THE X8000 IS USED ADJACENT TO OR STACKED WITH OTHER
EQUIPMENT, OBSERVE AND VERIFY NORMAL OPERATION OF THE
X8000 IN THE CONFIGURATION IN WHICH IT WILL BE USED PRIOR
TO USING IT IN A SURGICAL PROCEDURE. CONSULT THE TABLES
BELOW FOR GUIDANCE IN PLACING THE X8000.
Guidance and Manufacturer's Declaration: Electromagnetic Emissions
X8000 is intended for use in the electromagnetic environment specified below. The customer or the
user of X8000 should ensure that it is used in such an environment.
Emissions test
Compliance
RF emissions CISPR
11
Class B
Harmonic emissions
IEC61000-3-2
Class A
Voltage Fluctuations/
flicker emissions
IEC61000-3-3
Complies
Electromagnetic Environment - guidance
X8000 is suitable for use in all establishments,
including domestic establishments and those
directly connected to the public low-voltage
power supply network that supplies buildings
used for domestic purposes.
23
Page 26
Guidance and Manufacturer's Declaration: Electromagnetic Immunity
X8000 is intended for use in the electromagnetic environment specified below. The customer or
the user of X8000 should ensure that it is used in such an environment.
Immunity Test
Electrostatic Discharge
(ESD)
IEC61000-4-2
Electrical fast transient/
burst
IEC61000-4-4
Surge
IEC61000-4-5
Voltage dips, short
interruptions and voltage
variations on power supply
input lines
IEC61000-4-11
Power frequency (50/60Hz)
magnetic field
IEC 60601 Test
Level
Compliance Level
±6kV contact
±2,4,6kV contact
±8kV air
±2,4,8kV air
±2kV for power
supply lines
±2kV line to ground
±1kV for input/
output lines
±1kV line to line
±1kV differential
mode
±0.5, 1kV
differential mode
±2kV common
mode
±0.5, 1, 2kV
common mode
<5% Ut (>95% dip
in Ut) for 0.5 cycle
<5% Ut (>95% dip
in Ut) for 0.5 cycle
40% Ut (60% dip in
Ut) for 5 cycles
40% Ut (60% dip in
Ut) for 5 cycles
70% Ut (30% dip in
Ut) for 25 cycles
70% Ut (30% dip in
Ut) for 25 cycles
<5% Ut (>95% dip
in Ut) for 5 sec.
<5% Ut (>95% dip
in Ut) for 5 sec.
3 A/m
N/A
IEC 61000-4-8
NOTE: Ut is the AC mains voltage prior to application of the test level.
24
Electromagnetic
Environment:
Guidance
Floors should be
wood, concrete, or
ceramic tile. If floors
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 X8000
requires continued
operation during
power mains
interruptions, it is
recommended that
X8000 be powered
from an
uninterruptible
power supply or a
battery.
Power-frequency
magnetic fields
should be at levels
characteristic of a
typical location in a
typical commercial
or hospital
environment.