Stryker L11 LED Light Source REF 0220230300 Instructions for United States Users Rev F Dec 2019.pdf
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L11 LED Light Source with Advanced Imaging Modality
Instructions for United States Users
0220230300
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Contents
Warnings and Cautions........................................................ 1
Cautions.......................................................................................................................1
Warnings: General....................................................................................................2
Warnings: Laser.........................................................................................................3
Operating a Light Source.......................................................................................4
Product Description and Intended Use........................................5
Indications...................................................................................................................6
SPY Mode Requirements.......................................................................................6
Indocyanine Green (ICG) Information...............................................................8
IRIS Mode Requirements........................................................................................9
General Compatibility.......................................................................................... 10
Console Features.................................................................................................... 11
Setup................................................................................... 13
Connecting the AC Power Cable ..................................................................... 14
Connecting to the 1688 Camera Control Unit............................................ 14
Connecting a Light Cable................................................................................... 15
Connecting an IRIS Ureteral Kit........................................................................ 16
Operation............................................................................ 17
Powering the Console On and Off................................................................... 17
Using the Touchscreen Interface..................................................................... 18
Error Messages................................................................... 23
Troubleshooting................................................................. 25
Maintenance....................................................................... 28
Cleaning and Disinfecting the Console......................................................... 28
Inspection................................................................................................................. 29
Checking the ESST Feature................................................................................ 29
Replacing the Fuses.............................................................................................. 30
Storage...................................................................................................................... 30
Service Life............................................................................................................... 30
Disposal..................................................................................................................... 30
Recycling Diagram................................................................................................ 31
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Technical Specifications..................................................... 32
Electromagnetic Compatibility......................................................................... 33
Symbol Definitions............................................................. 37
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Warnings and Cautions
In this manual, the terms and definitions below apply.
Warning: Possible injury to the patient or user.
Caution: Possible damage to the equipment.
Note: More information to clarify the instructions.
Cautions
To avoid potential damage to this device, please note the following cautions.
1.
2.
3.
4.
5.
Carefully unpack this device and check if any damage occurred during
shipment. If damage is detected, see the standard warranty.
Never sterilize the console. The console is intended to be positioned
outside the sterile field. The delicate electronics cannot withstand a
sterilization procedure.
Ensure that the electrical installation of the relevant operating room
complies with the NEC and CEC guidelines.
Attempt no maintenance or adjustments that are not specifically detailed
in this user manual.
Repairs and equipment modifications shall be performed only by Strykerauthorized personnel. Stryker Endoscopy assumes no product liability or
warranty responsibility for devices repaired by or purchased from thirdparty service organizations.
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Warnings: General
To avoid potential serious injury to the user and the patient and/or damage to
this device, please note the following general warnings.
1.
2.
3.
4.
5.
6.
7.
8.
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10.
11.
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14.
2
Federal (USA) law restricts this device to sale by or on the order of a
physician.
Read this operating manual thoroughly, especially the warnings, and be
familiar with its contents before connecting and using this device.
Although the product was fully tested at the factory before shipment,
the user should always test it for proper function prior to a surgical
procedure.
To minimize electromagnetic interference that may impact functionality
of the L11 LED Light Source, position any active electrosurgical generator
and its cables at least 12 in (30 cm) away from the light source console.
When the electrosurgical generator is placed on a boom with the light
source console, it is advised to position the generator on the lowest shelf.
Do not position the console so that it is difficult to disconnect the power
cord from the supply mains.
Never block the rear or side vents of the console. Failure to follow this
instruction can result in device damage or a possible fire.
To avoid the risk of electric shock, this equipment must only be
connected to a supply mains with protective earth ground.
Portable multiple socket-outlets shall not be placed on the floor.
Additional portable multiple socket-outlets or extension cords shall not
be used with the equipment.
Never use this equipment in the presence of flammable or explosive
gases or in an oxygen-rich environment.
Avoid touching the endoscope 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 endoscope tip or
the area where the light cable connects to the endoscope on the surgical
drapes or other flammable material, as doing so may result in fire.
To prevent tampering, physically secure the device when not in use.
Disconnect the console from the electrical outlet when cleaning,
inspecting fuses or making any repairs. Refer all repairs to authorized
personnel.
Do not remove covers on the console, as doing so may cause damage to
electronics and/or electric shock.
Do not repair or adjust the device through a third-party service
organization; using such a device could expose patients to significant risk.
If repaired by or purchased from a third-party service organization, this
device is no longer validated by Stryker for safety and efficacy.
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Warnings: Laser
IMPORTANT SAFETY NOTICE - LASER RADIATION:
The L11 LED Light Source with Advanced Imaging Modality, or
“L11 LED Light Source,” is a laser product that uses a Class 1 laser
(IRIS mode) and a Class 1M laser (SPY mode).
Use of controls or performance of procedures other than those
specified herein can result in hazardous laser radiation exposure
and can cause severe eye injury to the patient or user.
To prevent exposure to laser radiation, follow all warnings and
guidelines presented below and throughout this user manual.
1.
2.
3.
4.
5.
6.
7.
8.
9.
Observe the warning label shown below (located on the rear panel).
• Invisible laser radiation
• Do not expose users of telescopic optics
• Class 1M laser product
Protect the L11 LED Light Source against unqualified use.
Wear eye protection as appropriate. Refer to any applicable regional
regulations or standards for personal protective equipment.
Do not manipulate tissue while Contrast mode (a SPY mode) is enabled.
Do not view the laser output in SPY mode with telescopic optical
instruments (for example, microscopes or magnifiers). Do not direct the
laser output in SPY mode into an area where such instruments are likely
to be used.
Do not activate SPY mode when the endoscope is outside of the patient’s
body.
When SPY mode is activated, never look into the following apertures or
direct the light emitted from the apertures toward another person:
• the light cable port on the light source (if the cable is not attached)
• the end of the light cable (if the SafeLight™ adapter is attached)
• the endoscope tip
When SPY mode is activated, never leave a SafeLight adapter attached
to the light cable without an endoscope attached. Laser radiation can
continue to emit from the adapter.
Power off the light source (or deactivate White Light, SPY, and IRIS modes)
before connecting or removing the light cable, endoscope, or disposable
fibers.
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Operating a Light Source
Please note the following special warnings to avoid user or patient injury
or product damage when using a light source. Note that the light source
adjustments described apply only to operating the light source manually (i.e.,
with Auto Light off ).
IMPORTANT SAFETY NOTICE - HIGH TEMPERATURES:
When using 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 can generate significant amounts of heat
(exceeding 41 °C/106 °F) at the endoscope tip and the area
where the light cable connects to the endoscope. Higher levels
of brightness from the light source result in higher levels of heat.
Always adjust the brightness level of the camera and the display
monitor before adjusting the brightness level of the light source.
If the brightness level of the light source can be adjusted, set it
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 endoscope 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 endoscope
tip or the area where the light cable connects to the endoscope
on the surgical drapes or other flammable material, as doing so
may result in fire.
Always deactivate the light output from the light source before
removing the endoscope from the light cable or leaving the
device unattended. The endoscope tip and the area where the
light cable connects to the endoscope will take several minutes
to cool off after deactivating the light output, and therefore
may still result in fire or burns to the patient, user, or inanimate
objects.
The warranty is void if any of the above warnings or cautions are disregarded.
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Product Description and Intended Use
The L11 LED Light Source with Advanced Imaging Modality, or “L11 LED
Light Source,” is a light-generating unit designed to illuminate surgical sites
in the following applications: visible light (White Light mode), near-infrared
fluorescence (SPY mode), and near-infrared transillumination (IRIS mode).
• White Light mode: The light source uses light-emitting diode (LED)
technology to generate bright, crisp light in the visible light spectrum that
is intended to illuminate surgical sites during endoscopic procedures. The
light is delivered to the surgical site through an endoscope via a fiber optic
light cable. White Light can be controlled with either of two methods:
»» Auto Light: automatic adjustment of light settings for optimal light
output
»» Manual Light: manual adjustment of light settings
• SPY mode: The light source uses laser technology to generate light in the
near-infrared light spectrum, which is intended to enable fluorescence
imaging of anatomy that has been targeted with the contrast agent
indocyanine green. The light is delivered to the surgical site through an
endoscope via a fiber optic light cable. Within SPY mode, three modes can
be selected:
»» ENV mode: greyscale white light image with ICG fluorescence
indicated by the color green
»» Overlay mode: white light image with ICG fluorescence indicated by
the color green
»» Contrast mode: ICG fluorescence indicated by the color white, and all
other areas of the image appear dark
• IRIS mode: The light source uses laser technology to generate light in the
near-infrared light spectrum that is intended to transilluminate the ureter
during open or laparoscopic surgical procedures. The light is delivered to
the surgical site via a disposable fiber.
The light source is equipped with a safety feature that minimizes light output
if the fiber optic cable is not connected to the endoscope adapter, which
prevents exposure to laser radiation, high-intensity light, and accidental
burns. A SafeLight Cable is required to enable this safety feature. For more
information, see the section Checking the ESST Feature.
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Indications
The L11 LED Light Source and SafeLight Cable are indicated for use to provide
real-time endoscopic visible and near-infrared fluorescence imaging. The L11
LED Light Source and SafeLight Cable enable surgeons to perform minimally
invasive surgery using standard endoscope visible light as well as visual
assessment of vessels, blood flow and related tissue perfusion, and at least
one of the major extra-hepatic bile ducts (cystic duct, common bile duct and
common hepatic duct), using near-infrared imaging.
Fluorescence imaging of biliary ducts with the L11 LED Light Source and
SafeLight Cable is intended for use with standard-of-care white light and,
when indicated, intraoperative cholangiography. The devices are not
intended for standalone use for biliary duct visualization.
The L11 LED Light Source is also intended to transilluminate the ureter during
open or laparoscopic surgical procedures.
SPY Mode Requirements
The equipment listed below is required to achieve the intended results when
using the light source in SPY mode. Any option listed for the camera head,
laparoscope, and indocyanine green may be used. Intended results will not be
achieved if any equipment is substituted.
SPY mode is intended to be used with the imaging agent indocyanine green
(ICG). Use of ICG promotes the fluorescing appearance of the camera image in
SPY mode. To use ICG in SPY mode, refer to the following ICG section and the
user information provided in the ICG package for complete instructions.
Note: In the United States, the L11 LED Light Source and SafeLight Fiber
Optic Cable are indicated for use only with the ICG options below. For users
outside the U.S., refer to Stryker user manual P40559.
Before using SPY mode, read and be familiar with the warnings and
instructions provided with each device in the system.
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SPY Mode Requirements
Light Source
0220230300 L11 LED Light Source with Advanced Imaging Modality
Camera Control Unit
1688010000 1688 4K Camera Control Unit with Advanced Imaging
Modality1 (also referred to as “1688 Video Camera”)
Note: The L11 LED Light Source is not designed to be connected to a 1588 Video Camera
(1588010000), and therefore the L11 SPY modes (including ENV mode) are not operational
when the L11 is used with a 1588 Video Camera.
Camera Head
1688210105 1688 4K Camera Head, C-Mount, with Advanced Imaging
Modality1
1688610122 1688 4K Camera Head, Integrated Coupler, with Advanced
Imaging Modality1
Coupler
1688-020-122 4K Coupler, C-Mount, with Advanced Imaging Modality2
Laparoscope
0502-537-010
0502-537-030
0502-937-010
0502-937-030
AIM HD Laparoscope, 5.4 mm, 0°, 30 cm3
AIM HD Laparoscope, 5.4 mm, 30°, 30 cm3
AIM HD Laparoscope, 10 mm, 0°, 33 cm3
AIM HD Laparoscope, 10 mm, 30°, 33 cm3
Light Cable
0233-050-300 AIM SafeLight Fiber Optic Cable, 5.0 mm x 10 ft (3.05 m)4
Endoscope Adapter
0233-050-087 SafeLight Henke / Dyonics® / Storz® Endoscope Adapter5
Indocyanine Green (ICG)
PINPOINT PAQ® (PP9036)
AIM IC-GREEN®
1
See Stryker user manual P38139 (English) or P38888 (multilingual).
2
See Stryker user manual P40880.
3
See Stryker user manual P27900.
4
See Stryker user manual P27701.
5
See Stryker user manual P10238.
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Indocyanine Green (ICG) Information
ICG Indications for Use
PINPOINT PAQ and AIM IC-GREEN are indicated for use with the L11 LED Light
Source and SafeLight Fiber Optic Cable.
ICG Contraindications
The ICG contains sodium iodide. Use with caution in patients who have a
history of allergy to iodides or iodinated contrast agents.
Pharmacology
Following intravenous injection, ICG is rapidly bound to plasma proteins,
of which albumin is the principal carrier (95%). Simultaneous arterial and
venous blood estimations have shown negligible renal, peripheral, lung or
cerebrospinal uptake of the dye. ICG is taken up from the plasma almost
exclusively by the hepatic parenchymal cells and is secreted entirely into
the bile. ICG does not undergo significant extrahepatic or enterohepatic
recirculation.
Warning
Anaphylactic deaths have been reported following ICG
administration during cardiac catheterization.
Adverse Reactions
Anaphylactic or urticarial reactions have been reported in patients with or
without history of iodide allergies. If an allergic reaction occurs, administer
treatment with the appropriate agents: for example, antihistamines,
corticosteroids, and epinephrine. Resuscitative measures may also be
required.
Administration
ICG is administered intravenously.
ICG Dosage
The typical dose administered is 2.5mg. The total dose should be less than 2
mg/kg per patient.
Please also reference the user information in the ICG package for further
instructions.
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IRIS Mode Requirements
The equipment listed below is required to achieve the intended results when
using the light source in Infrared Illumination System (IRIS) mode during
laparoscopic surgical procedures. Any model listed for the camera control
unit, camera head, coupler, and laparoscope may be used. Intended results
will not be achieved if any equipment is substituted.
Of the equipment listed below, only the light source and disposable fiber are
required to achieve the intended results when using IRIS mode during open
surgical procedures.
Before using IRIS mode, read and be familiar with the warnings and
instructions provided with each device in the system.
IRIS Mode Requirements
Light Source
0220230300
L11 LED Light Source with Advanced Imaging Modality
Camera Control Unit
1688010000
1588010000
1688 4K Camera Control Unit with Advanced Imaging
Modality1
1588 AIM Camera Control Unit2
Camera Head
1688210105
1688610122
1588210105
1588610122
1588710105
1688 4K Camera Head, C-Mount, with Advanced Imaging
Modality1
1688 4K Camera Head, Integrated Coupler, with Advanced
Imaging Modality1
1588 AIM Camera Head, C-Mount2
1588 AIM Camera Head with Integrated Coupler2
1588 AIM Inline Camera Head, C-Mount2
Coupler
1688-020-122 4K Coupler, C-Mount, with Advanced Imaging Modality3
1588-020-122 AIM Coupler, 18 mm, C-Mount4
Laparoscope
0502-537-010
0502-537-030
0502-937-010
0502-937-030
AIM HD Laparoscope, 5.4 mm, 0°, 30 cm5
AIM HD Laparoscope, 5.4 mm, 30°, 30 cm5
AIM HD Laparoscope, 10 mm, 0°, 33 cm5
AIM HD Laparoscope, 10 mm, 30°, 33 cm5
Light Cable
Any Stryker light cable
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IRIS Mode Requirements
Endoscope Adapter
See light cable user manual for appropriate endoscope adapter
Disposable Fiber
0220180518
IRIS Ureteral Kit6
1
See Stryker user manual P38139 (English) or P38888 (multilingual).
See Stryker user manual P29923 (English) or P29924 (multilingual).
3
See Stryker user manual P40880.
4
See Stryker user manual P30104.
5
See Stryker user manual P27900.
6
See Stryker user manual P26059.
2
General Compatibility
• All Stryker light cables are compatible with the L11 LED Light Source
when used in White Light mode or IRIS mode. SPY mode requires the AIM
SafeLight cable (0233-050-300).
• Using the proper endoscope adapter, the Stryker light cable can connect
the light source system to flexible or rigid endoscopes. Before using
another manufacturer’s equipment, thoroughly read the accompanying
documents for all warnings and instructions.
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Console Features
The features of the L11 LED Light Source are described below.
Front Panel
1
2
3
4
5
1. Power Button
Powers the unit on and off
2. IRIS Ports
For connecting the light source ends of the
IRIS Ureteral Kit (0220180518). Location of
Class 1 laser emissions when IRIS Ureteral
Kit is connected and IRIS mode is activated.
3. Touchscreen
Provides user controls and system
feedback
4. Light Cable Port
For connecting the light-source end of
the light cable. Location of Class 1M laser
emissions when an AIM SafeLight cable is
connected and SPY mode is activated.
5. Jaw Handle
Opens and closes the clamp in the light
cable port
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Rear Panel
1
2
3
4
5
1. SERVICE Port
Used for service only; no user function.
(This port may be labeled differently in units
manufactured prior to 2019-10, but it is also
used for service only.)
2. CCU Port
Connects to the 1688 Camera Control Unit
with the provided USB 3.0 A-to-B cable. The
connection is required to enable SPY mode and
Auto Light. See the 1688 Video Camera user
manual for a complete list of device control
options it has over the L11 LED Light Source.
Note that previous-generation Stryker cameras,
such as the 1588 Video Camera, are not
designed to be connected to the L11 LED Light
Source. An error message will appear if one is
connected to the CCU port.
3. Equipotential
Ground Plug
Connects to a potential equalization conductor.
The resulting medical electrical system shall
follow all applicable IEC 60601-1 requirements.
4. Fuse Panel
Contains two T 5.0AH 250V (slow blow, high
breaking capacity 1500A) fuses
5. AC Inlet
Connects to AC mains with the provided,
separable power cord
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Setup
Stryker considers instructional training, or inservice, an integral part of the L11
LED Light Source. Your local Stryker sales representative will perform at least
one inservice at your convenience to help set up your equipment and instruct
you and your staff on its operation and maintenance. To schedule an inservice,
contact your local Stryker representative after your equipment has arrived.
Setting up the L11 LED Light Source involves four steps:
• Connecting the AC power cable
• Connecting the provided USB 3.0 A-to-B cable to the 1688 Camera Control
Unit
• Connecting a Light Cable
• Connecting an IRIS Ureteral Kit
Always connect the light source to an appropriate power
source, using a hospital-grade power cord. Loss of AC power
will cause the light source to shut down and the surgical image
to be lost.
Only connect items to the light source that have been specified
for use with the light source. Connecting incompatible
equipment may cause unexpected results.
When the light source is used with other 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
that all systems are installed according to the requirements of
IEC 60601‑1.
Equipment which employs RF communications may affect the
normal function of the light source. When choosing a location
for the console, consult the Electromagnetic Compatibility
section to ensure proper function.
Always set up the console in a location that allows adequate
ventilation (airflow) to the console. Insufficient ventilation may
cause the console to overheat and shut down. The console
must also be positioned on its feet; do not operate the unit
upside down or on its side.
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Connecting the AC Power Cable
1.
2.
Plug in the AC power cord to the AC Inlet on the rear console panel.
Plug in the other end of the AC cord to a hospital-grade outlet.
Connecting to the 1688 Camera Control Unit
To activate SPY mode and the Auto Light feature, the L11 LED Light Source
must be connected to the 1688 Video Camera. White Light mode and IRIS
mode do not require connection to the camera.
Note: The 1688 Camera Head can be programmed to control some functions
of the L11 LED Light Source, such as toggling light output on and off, or
adjusting some settings in SPY mode. Contact a Stryker representative for
more information about enabling this advanced feature.
1.
Using the provided USB 3.0 A-to-B cable, connect the CCU port on the
L11 LED Light Source to the Light Source port on the 1688 Camera
Control Unit.
1688010000
0220230300
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Connecting a Light Cable
To activate SPY mode, an AIM SafeLight cable (0233-050-300) must be
connected to the light source. White Light mode and IRIS mode will function
when other Stryker light cables are connected.
Power off the light source (or deactivate the light output)
before connecting or removing the light cable or endoscope.
Keep fingers away from the light cable port as the clamp may
inadvertently deploy and cause injury.
The light cable port on the light source emits a Class 1M laser
when SPY mode is activated. To assure proper and safe laser
application, connect only the AIM SafeLight cable to the light
source. Do not attempt to use any other fiber optic light cables
with SPY mode.
Do not operate the light source in SPY mode with a light cable
that is cut or damaged. If the cable breaks during operation,
deactivate the light output from the light source, then replace
the cable.
1.
2.
Make sure the light source is powered off, or deactivate the light output.
Lock open the clamp in the light cable port by turning the jaw handle
clockwise until it stops.
3.
Insert a clean, dry light cable into the light cable port until the jaw clamps
the light cable in place.
Note: The ring around the light cable port will appear white when
the light source is powered on and a valid light cable is successfully
connected.
4.
Connect an endoscope to the opposite end of the light cable.
Note: An endoscope adapter may be required to connect the light cable
to the endoscope. A SafeLight endoscope adapter is required to use SPY
mode. See the light cable user manual for more detail.
To remove the light cable, deactivate the light output on the light source.
Then, turn the jaw handle clockwise until the latch opens.
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Connecting an IRIS Ureteral Kit
To activate IRIS mode, an IRIS Ureteral Kit (0220180518) must be connected to
the light source. White Light mode and SPY mode do not require connection
to an IRIS Ureteral Kit.
The IRIS connectors on the light source emit a Class 1 laser
when IRIS mode is activated. To assure proper and safe laser
application in IRIS mode, connect only the Stryker IRIS Ureteral
Kit to the IRIS connectors. Do not attempt to use any other fiber
optic light cables or emitting fibers.
Do not attempt to operate the light source with an IRIS Ureteral
Kit that is cut or damaged. If the IRIS Ureteral Kit breaks during
operation, disable IRIS mode, then replace the Kit.
Before connecting or using an IRIS Ureteral Kit, read and
be familiar with all warnings in this user manual and the
IRIS Ureteral Kit user manual (P26059). Use of controls or
performance of procedures other than those specified can
result in hazardous laser radiation exposure.
To connect an IRIS Ureteral Kit:
1.
2.
16
Make sure the light source is powered off, or deactivate the light output.
Insert the light source ends of both fibers into the IRIS connectors on the
front panel of the light source.
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Operation
Before operating the light source, read and be familiar with all
warnings in this user manual. Failure to follow these warnings
can result user or patient injury.
Before operating the L11 LED Light Source, ensure all system components
have been set up according to the instructions in the Setup section.
• SPY mode requires all of the equipment listed in the SPY Mode
Requirements section in order to achieve the intended results.
• IRIS mode requires all of the equipment listed in the IRIS Mode
Requirements section in order to achieve the intended results.
Note: The Class 1M laser in the L11 LED Light Source that is used for SPY
mode is controlled by the 1688 Video Camera. The light source indicates the
status of SPY mode, but SPY mode selections and image adjustments are
made from the 1688 Camera Control Unit or a 1688 Camera Head. See the
1688 Video Camera user manual (P38139 English, P38888 multilingual) for
more information about controlling SPY mode.
Powering the Console On and Off
1.
To power on the console, press the power button on the front panel. The
touchscreen will display the Home screen.
Note: The light source will not illuminate unless a light cable is
connected to the light cable port.
2.
To power off the console, press the power button on the front panel.
Note: When restarting the console, wait 30 seconds after powering
the console off before pressing the power button again to power the
console on. Rapidly pressing the power button can cause the console to
improperly function or the touchscreen to freeze.
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Using the Touchscreen Interface
The touchscreen interface on the console provides access to menus and
controls for adjusting the light output. The features are described below.
Navigation Bar
The Navigation Bar appears on the left side of each screen described in this
Operation section. The currently selected screen is highlighted with a blue
line in the Navigation Bar.
Home: Press the Home button to navigate to the Home
screen.
IRIS: Press the IRIS button to navigate to the IRIS screen.
Settings: Press the Settings button to navigate to the
Settings screen.
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Home Screen
The Home Screen is the default screen. It displays if White Light mode is
activated, the White Light intensity level, the current SPY mode, and if the
Auto Light feature is on.
5
2
1. Activate White Light Mode: Press and briefly hold the touchscreen
power button to toggle White Light mode on or off. Blue = on. Gray = off.
• Activating White Light mode is required as a preliminary step to
activate SPY mode.
• While SPY mode is activated and ENV mode or Contrast mode are
selected, white light output is automatically disabled.
• While IRIS mode is activated, the user can return to the White Light
screen to toggle the white light output on or off.
2. Intensity Level: Press the plus or minus button to increase or decrease
the intensity level of White Light mode. Range: 10%-100%.
3. SPY Mode Indicator: The current SPY mode selected from the 1688
Video Camera is displayed. The three SPY modes are described below:
• ENV Mode: greyscale white light image with ICG fluorescence
indicated by the color green.
• Overlay Mode: white light image with ICG fluorescence indicated by
the color green.
• Contrast Mode: ICG fluorescence indicated by the color white, and all
other areas of the image appear dark.
Note: SPY modes are selected from the 1688 Video Camera and cannot
be selected from the light source. See the 1688 Video Camera user
manual (P38139 English, P38888 multilingual) for more information
about controlling SPY mode.
4. Laser Indicator: When SPY mode is on, a Laser indicator will appear blue.
When SPY mode is off, the indicator is not visible.
5. Auto Light Indicator: When the 1688 Video Camera activates the Auto
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Light feature, the Auto Light indicator appears blue. When Auto Light
is off, the indicator appears gray. The Auto Light feature automatically
adjusts light source settings for optimal light output.
Note: Auto Light is selected from the 1688 Video Camera and cannot
be selected from the light source. When the Auto Light feature is on, the
Intensity Level settings are not available for user adjustment.
Deactivating the Light Output
Deactivating the light output reduces the heat generated at the tip of the
light cable or endoscope when the light source is not being used.
To help prevent burns to the patient, user or inanimate objects
and possible fire, always deactivate the light output whenever
the endoscope is removed from the light cable.
The endoscope tip and the area where the light cable connects
to the endoscope will take several minutes to cool off after
deactivating the light output, 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 endoscope or the light cable on
the patient, on the drapes, or other flammable material, even
when the light output is deactivated.
To deactivate the light output on the light source:
1.
On the Home screen, press and briefly hold the touchscreen power
button so it appears gray.
1
Note: As a safety feature, the light source will automatically deactivate the
light output when the SafeLight endoscope adapter is detached from the
SafeLight cable.
• If the SafeLight endoscope adapter is reattached to the SafeLight cable
within approximately one minute, the light output will automatically
reactivate.
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• If the SafeLight endoscope adapter is reattached to the SafeLight
cable after approximately one minute, the user must reactivate light
output from the touchscreen (or a camera head button if it has been
programmed to activate the light source).
IRIS Screen
Infrared Illumination System (IRIS) mode activates the Class 1 laser in the light
source and enables use of the IRIS Ureteral Kit.
Before using IRIS mode, read and follow all warnings in this
user manual and the IRIS Ureteral Kit user manual (P26059).
Use of controls or performance of procedures other than those
specified can result in hazardous radiation exposure.
See the IRIS Mode Requirements section for equipment
requirements. Use IRIS mode only with the specified
equipment.
Note: If SPY mode is on, it must be disabled from the 1688 Video Camera
controls before activating IRIS mode on the light source.
6
5
4
2
3
1. Activate/Deactivate IRIS mode: Press and briefly hold the touchscreen
power button to toggle IRIS mode on or off.
2. Fiber Connection Indicators: The Fiber Connection Indicators will
appear blue when an IRIS Ureteral Kit is properly connected to the light
source (one indicator for each fiber).
3. Continuous/Pulsating Setting: Press the solid line or the dotted line to
toggle the IRIS light output between the continuous or pulsating setting,
respectively.
• In the continuous setting, the laser energy is continuous.
• In the pulsating setting, the laser energy pulses in a repeating pattern
of 0.5 second on/0.5 second off (1 pulse cycle per second).
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4. IRIS Level: Press the plus or minus button to increase or decrease the IRIS
laser intensity. Range: 1-5.
5. Laser Indicator: When SPY mode is on, a Laser indicator will appear blue
in this space (as shown on the Home screen). When SPY mode is off, the
indicator is not visible. Note that IRIS mode cannot be activated when SPY
mode is on.
6. Auto Light Indicator: When the 1688 Video Camera enables the Auto
Light feature, the Auto Light indicator appears blue. When Auto Light
is off, the indicator appears gray. The Auto Light feature automatically
adjusts light source settings for optimal light output.
Note: Auto Light is selected from the 1688 Video Camera and cannot
be selected from the light source. When the Auto Light feature is on, the
Intensity Level settings on the Home screen are not available for user
adjustment.
Settings Screen
The Setting screen allows the user to toggle sound on and off (from pressing
the touchscreen), and it shows the software version.
5
4
2
3
1. Software Version: The software version is displayed.
2. Sound Setting: Press the Sound button to toggle sound on and off when
the Touchscreen is pressed.
3. Language Setting: Press the left or right arrows to select the language
that will be used for text on the touchscreen interface.
4. Cable Type / Adapter Indicator: For software version v0.1.40 and higher,
a Cable Type field identifies if a light cable is properly connected to the
light source and the type of cable (SafeLight, Standard, or --- [none]). A
blue adapter icon appears if a SafeLight adapter is properly connected to
the SafeLight cable.
5. Serial Number: The serial number of the device is displayed.
22