User Guide
L9000 LED
Light Source
REF 0220210000
2009/02 www.stryker.com 1000401120 D
1
Contents
Warnings and Cautions ............................................................. 2
Symbol Definitions ............................................................................ 4
Product Description and Intended Use ........................... 5
Indications ......................................................................................... 6
Intended Use ..................................................................................... 6
Setup and Assembly ................................................................... 9
Connecting the AC Power Cable ...................................................... 9
Connecting the Light Cable .............................................................. 9
System Operation ....................................................................... 11
Powering the System On and Off ................................................... 11
Selecting the Operation Mode ........................................................ 12
Adjusting the Brightness ................................................................. 13
Visual Display .................................................................................. 13
Language Selection ........................................................................ 15
Safety Shutoff ................................................................................. 16
Checking the ESST Feature ............................................................ 17
Using the L9000 with a Voice-Controlled System Interface ........... 18
Using the SFB Serial Interface ........................................................ 18
Troubleshooting .............................................................................. 19
Cleaning and Maintenance ................................................... 21
Cleaning the L9000 ......................................................................... 21
Replacing the Fuses ....................................................................... 21
Disposing of the L9000 ................................................................... 21
Technical Specifications ....................................................... 22
Electromagnetic Compatibility ........................................................ 23
Warranty .......................................................................................... 27
2
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:
W
ARNING 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.
W
ARNING 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 L9000, 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.
3
A
LWAYS 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.
W
ARNING 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 L9000 console.
7. Disconnect the L9000 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.
W
ARNING FEDERAL LAW (UNITED STATES OF AMERICA) RESTRICTS THIS
DEVICE TO USE BY, OR ON ORDER OF, A PHYSICIAN.
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.
5
Product Description and Intended Use
The Stryker L9000 Light Source is a light-generating unit designed to illuminate
surgical sites during endoscopic applications. The L9000 uses light-emitting diode
(LED) technology to generate bright, crisp light, which it delivers to the surgical site
via a fiberoptic light cable. The L9000 is compatible with all Stryker light cables,
and, with the proper light cable and adapters, can connect to any flexible or rigid
endoscope.
The L9000 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 L9000
senses when the scope and the light cable are separated and places the light source
in Standby mode. In Standby mode, the L9000 will reduce light output to a
minimum, preventing the light cable from generating excessive heat.
W
ARNING 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 L9000 Light Source consists of one of each of the following:
• light source console
•power cord
6
Indications
The Stryker LED Light Source is used to illuminate the site of surgery during
minimally invasive surgical procedures in arthroscopy (orthopedic surgery),
laparoscopy (general and gynecological surgery) and in Endoscopy (general,
gastroenterological and ENT surgery). The light is transmitted from the source
through an optical cable and a scope.
The light source is an integral component of a visualization system which consists
of a video camera, video monitor, video recorder, video printer, light cable and
scope.
Intended Use
The Stryker LED Light Source is used to illuminate the site of surgery during
minimally invasive surgical procedures in Arthroscopy (orthopedic surgery),
Laparoscopy (general and gynecological surgery) and in Endoscopy (general,
gastroenterological and ENT surgery). The light is transmitted from the source
through an optical cable and a scope.
7
The features of the L9000 console are described below (see Figures 1 and 2).
Figure 1 Front panel of the L9000 console
1. Power Button: Powers the unit on and off.
2. Tou ch Scre en: Provides user controls and system feedback.
3. Cable Clamp: Grasps the light-source end of an inserted fiberoptic
cable.
4. Jaw Handle: Opens the fiberoptic cable holder.
12 34
8
Figure 2 Rear panel of the L9000 console
5.
SFB Series Connectors
: Enables FireWire connection with Stryker
FireWire devices. Provides connection for remote diagnoses and future
software upgrades.
6.
SIDNE Connector:
Enables connection to the SIDNE voice control
system
7. Equipotential ground plug: Connects to a potential equalization
conductor
8. AC Inlet: Connects to the provided power cord for AC power supply.
675
8
9
Setup and Assembly
Note When selecting a setup location for the L9000, consult the
“Electromagnetic Compatibility” section included in this manual
to determine the best location.
To set up the L9000, make the following connections:
• Connect the AC power cable
• Connect the light cable
Caution To ensure proper cooling, position the L9000 on its feet. Do
not operate the unit upside down or on its side.
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.
W
ARNING WHEN THE L9000 IS INTERCONNECTED WITH OTHER MEDICAL
ELECTRICAL EQUIPMENT, LEAKAGE CURRENTS MAY BE ADDITIVE.
T
O 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
L9000
TO MAINTAIN ELECTRICAL ISOLATION.
Note The L9000 Light Source is compatible with all Stryker Light
Cables.
10
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.
W
ARNING DO NOT LOOK DIRECTLY INTO THE CABLE PORT. THE HIGH-
INTENSITY 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 on the touch screen to
put the unit into standby. Then, turn the jaw handle clockwise until the
latch opens.
11
W
ARNING 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 L9000, see the “Setup and Assembly” section
of this manual.
Powering the System On and Off
To power on the L9000:
Press the power switch on the front panel. The LCD will indicate that the unit is
in Standby mode.
Note The light will not illuminate unless a light cable is installed in the
cable port.
To power off the L9000:
1. Put the light source unit into Standby mode.
2. Disconnect the light cable from the L9000 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 L9000.
W
ARNING TO ALLOW FOR ADEQUATE COOLING, NEVER BLOCK THE REAR OR
SIDE FAN VENTS. FAILURE TO FOLLOW THIS INSTRUCTION MAY
RESULT IN DAMAGE TO THE L9000 OR A POSSIBLE FIRE.
12
Selecting the Operation Mode
The L9000 has two operation modes, Activate and Standby.
• ACTIVATE mode: The Activate 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 L9000 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 L9000 is not being used.
Press the Activate/Standby button on the LCD screen to toggle between the two
operational modes.
W
ARNING TO HELP PREVENT BURNS TO THE PATIENT, USER OR INANIMATE
OBJECTS AND POSSIBLE FIRE, ALWAYS PUT THE L9000 IN
S
TANDBY 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.
BRIGHTNESS
STANDBY
13
Adjusting the Brightness
The L9000 has up and down buttons for adjusting 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 Activate mode brightness level appears in
the lower right-hand corner.
W
ARNING THE HIGHER THE BRIGHTNESS, THE MORE HEAT ENERGY THAT
WILL BE GENERATED IN THE SCOPE AND THE TIP OF THE CABLE.
A
LWAYS 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.
W
ARNING 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 L9000 provides feedback through the touch-screen 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.
14
• 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 The LEDs have exceeded their
recommended operating temperature.
Return the L9000 for
repair.
E-2 All conditions are met for the LEDs to
illuminate, yet it remains off.
Return the L9000 for
repair.
E-3 The LEDs are kept off because the
electronics fan is not working properly.
Return the L9000 for
repair.
E-4 The LEDs are kept off because the heat
pipe fan is not working properly.
Return the L9000 for
repair.
E-5 All conditions are not met for the LEDs
to illuminate, yet it remains on.
Return the L9000 for
repair.
15
Language Selection
The L9000 LCD has the capability of displaying text in the following languages
To select a particular language, perform the following steps:
1. Go into Standby mode.
2. Press and hold the Activate/Standby toggle button until the language
identifier appears (approximately 5 seconds).
3. Use left and right arrows to scroll through the available languages.
4. Once the desired language is selected, press the Home button to return
to the previous menu.
Danish French Japanese Portuguese
Dutch German Korean Simplified Chinese
English Greek Norwegian Spanish
Finnish Italian Polish Swedish
16
Safety Shutoff
The L9000 Light Source is equipped with a Safety Shutoff feature which will
temporarily turn off the LEDs in the event of excessive heat in the LED assembly.
W
ARNING ONCE THE LIGHT SOURCE COOLS DOWN (AFTER 7-10 MINUTES),
POWER WILL RESUME TO THE LED MODULE 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 L9000 LIGHT SOURCE EXPERIENCES A
TEMPORARY SHUTDOWN, IT IS RECOMMENDED THAT THE DEVICE
BE RETURNED FOR SERVICE.
Caution Do not abruptly interrupt power to the unit. This will turn off
the fan and may cause severe damage to the internal cooling
system.
17
Checking the ESST Feature
The L9000 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 L9000 is used with an ESST light cable. When operated with an ESST light
cable, the L9000 senses when the scope and light cable are separated, and places
the light source in Standby mode. In Standby mode, the L9000 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 L9000 system with an ESST light cable and scope, and then
power on the system.
2. Place the L9000 in Activate mode.
3. Remove the light cable from the ESST scope adapter.
The L9000 should return to Standby mode, indicating that the ESST feature is
functioning properly.
W
ARNING 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.
W
ARNING EVEN WITH ESST PROTECTION, OR WHEN THE L9000 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.
T
HE 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.
18
Using the L9000 with a Voice-Controlled
System Interface
The L9000 can be used in conjunction with Stryker voice-control systems
(SIDNE®). For more information about using the L9000 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 L9000 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 (such as a
computer) to connect to the Software Management site.
Note The SFB serial connection can also be used to connect the L9000
to the 1288HD Camera Console. When connected, the user
can control the L9000 from the 1288HD Camera Head.
For more information about using the L9000 with the 1288HD
Camera System, refer to the 1288HD Instructions For Use
(P/N 1000-401-140)
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 light cable is correctly engaged with the
cable port. As a safety feature, the L9000 will provide
no light output unless a fiberoptic light cable is
properly seated in the cable port.
• 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 L9000 for service. Please see the section entitled
“Safety Shutoff” in this manual for additional
information.
20
Too much or too
little light output
• Ensure the light cable is correctly engaged with the
cable port.
• Ensure the L9000 is in Activate mode. (The
brightness level should appear on the LCD.)
If necessary, press the Activate/Standby toggle
button to switch from Standby to Activate. 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 L9000,
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
• 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.
Frozen
To u ch s c re e n
• Turn off the console, wait 30 seconds, and then turn it
back on.
21
Cleaning and Maintenance
Cleaning the L9000
WARNING UNPLUG THE L9000 BEFORE CLEANING THE UNIT.
1. Clean the external surfaces of the L9000 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 L9000.
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.
W
ARNING TO HELP AVOID THE RISK OF FIRE, USE ONLY 5.0A 250V FUSES.
4. Reinstall the fuse holder.
Disposing of the L9000
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.
22
Technical Specifications
Electrical
Primary: 100 - 240 VAC, 50/60 Hz, 400 W
Fuses (2): 5.0A 250V
Dimensions
Height: 4.75"(12.1 cm)
Width: 12.5" (31.8 cm)
Depth: 16.8" (42.7 cm)
Weight: 16.0 lbs. (7.3 kg)
Fiberoptic Cable Range:
2 mm to 6.5 mm diameter
Light Engine
Type: Red, Green, Blue LEDs
Operating Conditions
5 to 40°C
30 to 95% Relative Humidity
Transportation & Storage
-20 to 60°C
10% to 75% Relative Humidity
700 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
23
Electromagnetic Compatibility
Like other electrical medical equipment, the L9000 requires special precautions to
ensure electromagnetic compatibility with other electrical medical devices. To
ensure electromagnetic compatibility (EMC), the L9000 must be installed and
operated according to the EMC information provided in this manual.
Note The L9000 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 L9000.
W
ARNING DO NOT USE CABLES OR ACCESSORIES OTHER THAN THOSE
PROVIDED WITH THE L9000, AS THIS MAY RESULT IN INCREASED
ELECTROMAGNETIC EMISSIONS OR DECREASED IMMUNITY TO
SUCH EMISSIONS.
W
ARNING IF THE L9000 IS USED ADJACENT TO OR STACKED WITH OTHER
EQUIPMENT, OBSERVE AND VERIFY NORMAL OPERATION OF THE
L9000
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 L9000.
Guidance and Manufacturer's Declaration: Electromagnetic Emissions
L9000 is intended for use in the electromagnetic environment specified below. The customer or the
user of L9000 should ensure that it is used in such an environment.
Emissions test Compliance Electromagnetic Environment - guidance
RF emissions CISPR
11
Class B
L9000 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.
Harmonic emissions
IEC61000-3-2
Class A
Voltage Fluctuations/
flicker emissions
IEC61000-3-3
Complies
24
Guidance and Manufacturer's Declaration: Electromagnetic Immunity
L9000 is intended for use in the electromagnetic environment specified below. The customer or
the user of L9000 should ensure that it is used in such an environment.
Immunity Test
IEC 60601 Test
Level
Compliance Level
Electromagnetic
Environment:
Guidance
Electrostatic Discharge
(ESD)
IEC61000-4-2
±6kV contact
±8kV air
±2,4,6kV contact
±2,4,8kV air
Floors should be
wood, concrete, or
ceramic tile. If floors
are covered with
synthetic material,
the relative humidity
should be at least
30%.
Electrical fast transient/
burst
IEC61000-4-4
±2kV for power
supply lines
±1kV for input/
output lines
±2kV line to ground
±1kV line to line
Mains power quality
should be that of a
typical commercial
or hospital
environment.
Surge
IEC61000-4-5
±1kV differential
mode
±2kV common
mode
±0.5, 1kV
differential mode
±0.5, 1, 2kV
common mode
Mains power quality
should be that of a
typical commercial
or hospital
environment.
Voltage dips, short
interruptions and voltage
variations on power supply
input lines
IEC61000-4-11
<5% Ut (>95% dip
in Ut) for 0.5 cycle
40% Ut (60% dip in
Ut) for 5 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 0.5 cycle
40% Ut (60% dip in
Ut) for 5 cycles
70% Ut (30% dip in
Ut) for 25 cycles
<5% Ut (>95% dip
in Ut) for 5 sec.
Mains power quality
should be that of a
typical commercial
or hospital
environment. If the
user of L9000
requires continued
operation during
power mains
interruptions, it is
recommended that
L9000 be powered
from an
uninterruptible
power supply or a
battery.
Power frequency (50/60Hz)
magnetic field
IEC 61000-4-8
3 A/m N/A
Power-frequency
magnetic fields
should be at levels
characteristic of a
typical location in a
typical commercial
or hospital
environment.
NOTE: Ut is the AC mains voltage prior to application of the test level.
25
Guidance and Manufacturer's Declaration: Electromagnetic Immunity
L9000 is intended for use in the electromagnetic environment specified below. The customer or
the user of L9000 should ensure that it is used in such an environment.
Immunity
Test
IEC 60601 Test
Level
Compliance
Level
Electromagnetic Environment:
Guidance
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
3 V
Equipment which employs RF
communications equipment should be
used no closer to any part of the L9000
system, including its cables, than the
recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.
Recommended Separation Distance
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects, and people.
(a) Field strengths from fixed 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
fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field
strength in the location in which the L9000 system is used exceeds the applicable RF compliance level
above, the L9000 system should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or relocating the L9000 unit.
(b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
d1.17P=
26
Recommended Separation Distances Between Portable and Mobile RF Communications
Equipment and the L9000 System
The L9000 system is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The user of the L9000 system can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile RF communications
equipment (transmitters) and the L9000 system as recommended below, according to the maximum
output power of the communications equipment.
Rated maximum output
power (W) of transmitter
Separation distance (m) according to frequency of transmitter
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
0.01 0.12 0.12 0.23
0.1 0.37 0.37 0.74
11.171.172.33
10 3.70 3.70 7.37
100 11.70 11.70 23.30
For transmitters rated at a maximum output power not listed above, the recommended separation
distance (d) in meters (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 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects, and people.
d1.17P=
d1.17P=
d2.33P=
27
Warranty
Stryker Endoscopy warrants all products, subject to the exceptions provided
herein, to be free from defects in design, materials, and workmanship and to
substantially conform to the product specifications contained in the
documentation provided by Stryker Endoscopy with the products for a period of
one year from the date of purchase (the “Warranty Period”). This warranty shall
apply only to the original end-user purchaser of products directly from Stryker
Endoscopy or a Stryker Endoscopy authorized distributor. This warranty may
not be transferred or assigned without the express written consent of Stryker
Endoscopy.
If a valid warranty claim is received within the Warranty Period, Stryker will, in
its sole discretion: (1) repair the product at no charge, (2) replace the product at
no charge with a product that is at least functionally equivalent to the original
product, or (3) refund the purchase price of the product. In any event, Stryker’s
liability for breach of warranty shall be limited to the replacement value of the
defective or non-conforming part or component.
This warranty does not apply to: (1) products that have been misused, neglected,
modified, altered, adjusted, tampered with, improperly installed or refurbished;
(2) products that have been repaired by any person other than Stryker Endoscopy
personnel without the prior written consent of Stryker Endoscopy; (3) products
that have been subjected to unusual stress or have not been maintained in
accordance with the instructions in the user manual or as demonstrated by a
Stryker Endoscopy representative; (4) products on which any original serial
numbers or other identification marks have been removed or destroyed; or
(5) products that have been repaired with any unauthorized or non-Stryker
components, including replacement lamps.
If Stryker determines in its reasonable discretion that the claimed defect or nonconformance in the product is excluded from warranty coverage as described
hereunder, it will notify the customer of such determination and will provide an
estimate of the cost of repair of the product. In such an event, any repair would be
performed at Stryker’s standard rates.
28
Products and product components repaired or replaced under this warranty
continue to be warranted as described herein during the initial Warranty Period
or, if the initial Warranty Period has expired by the time the product is repaired
or replaced, for thirty (30) days after delivery of the repaired or replaced product.
When a product or component is replaced, the item provided in replacement will
be the customer’s property and the replaced item will be Stryker’s property. If a
refund is provided by Stryker, the product for which the refund is provided must
be returned to Stryker and will become Stryker’s property.
The inspection, testing, acceptance, or use of the products and services furnished
hereunder shall not affect Stryker’s obligation under this warranty, and such
warranty shall survive inspection, test, acceptance, and use.
Notwithstanding the above, the following products are warranted for a period of
ninety (90) days from the date of purchase: Scopes, Associated Scope Hardware,
Fiber Optic Cables, Laparoscopic Instruments, VCRs, Monitors, and Printers;
replacement light bulbs are warranted for a period of sixty (60) days from the
date of purchase.
TO THE FULLEST EXTENT PERMITTED BY LAW, THE EXPRESS
WARRANTY SET FORTH HEREIN IS THE ONLY WARRANTY
APPLICABLE TO THE PRODUCTS AND IS EXPRESSLY IN LIEU OF ANY
OTHER WARRANTY BY STRYKER, EXPRESSED OR IMPLIED,
INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
EXCEPT AS SPECIFICALLY PROVIDED IN THIS WARRANTY AND TO
THE EXTENT PERMITTED BY LAW, STRYKER IS NOT RESPONSIBLE FOR
INDIRECT, SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES
RESULTING FROM ANY BREACH OF WARRANTY OR UNDER ANY
OTHER LEGAL THEORY.
29
Return Policy
Stryker Endoscopy values customer relationships and strives for satisfaction in
purchases made by our customers. Therefore, we offer a return policy for most
products. Under this policy, customers may return purchased products to Stryker
Endoscopy, within 90 days of customer’s receipt of the product, for a credit or a
refund of the purchase price paid, less shipping and handling and applicable
restocking fees. Products that fail after the first 90 days may be covered by and are
subject to the terms of applicable product warranty. Sterile products may not be
returned for credit or refund unless they are in their original, unopened
packaging or if they are in breach of the applicable warranty.
Restocking Fees: Unless the product is defective or the return is the direct result
of a Stryker Endoscopy error, a restocking fee of 10% may be charged on all
returned products.
A Returned Merchandise Authorization (RMA) number must be obtained from
Stryker Endoscopy before returning product. To obtain an RMA number, please
contact Stryker Endoscopy Customer Service at 1.800.624.4422.
Please send any returned products to:
Stryker Endoscopy
Attn: Returns
5900 Optical Court
San Jose, CA 95138
With the return, please include the following:
1. RMA number
2. Purchase order number
3. Original invoice number
4. Name, address, and account number (of the organization returning the product)
5. Itemized list of the items being returned
6. Reason for the return
7. Product Experience Report/Complaint number, if applicable
30
Please carefully package the product being returned. Credit will not be given for
items that are damaged in return shipment due to inadequate packaging.
Stryker Endoscopy does not accept any COD returns. Return shipping costs are
borne by the customer unless Stryker Endoscopy specifically agrees otherwise.
Please clean and sterilize all potentially contaminated products prior to returning
them to Stryker Endoscopy. It is unlawful to transport bio-contaminated
products through interstate commerce, unless they are properly packaged and
labeled as such. Stryker Endoscopy reserves the right to destroy contaminated
product at the customer’s expense and charge the customer for
a replacement unit.
If a return does not comply with these terms, Stryker Endoscopy reserves the
right to destroy the product at the customer’s expense. Any replacement would
be at the customer’s expense.
Stryker Endoscopy
5900 Optical Court
San Jose, CA 95138 USA
1-408-754-2000, 1-800-624-4422
www.stryker.com
European Representative:
Regulatory Manager, Stryker France
ZAC Satolas Green Pusignan
Av. De Satolas Green
69881 MEYZIEU Cedex, France
1000401120 D
2009/2
Products referenced with ™ designation are trademarks of Stryker.
Products referenced with ® designation are registered trademarks of Stryker.
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