L10 LED Light Source

with AIM Technology

0220-220-300
Contents

Warnings and Cautions........................................................ 1

Cautions.......................................................................................................................2
Warnings: General....................................................................................................2
Warnings: Laser.........................................................................................................3
Operating a Light Source.......................................................................................4

Product Description and Intended Use........................................5

Indications...................................................................................................................5
ENV Mode Requirements.......................................................................................6
IRIS Mode Requirements........................................................................................7
General Compatibility.............................................................................................8
Console Features.......................................................................................................9

Setup................................................................................... 11
Connecting the AC Power Cable ..................................................................... 12
Connecting to the Camera Control Unit....................................................... 12
Connecting a Light Cable................................................................................... 13
Connecting an IRIS Ureteral Kit........................................................................ 14

Operation............................................................................ 15
Powering the Console On and Off................................................................... 15
Activating White Light Mode............................................................................ 16
Placing the Light Source in Standby Mode.................................................. 16
Activating ENV Mode........................................................................................... 17
Activating IRIS Mode............................................................................................ 20

Using AIM IC-GREEN in ENV Mode.................................... 23

ICG Indications for Use......................................................................................... 24
ICG Contraindications.......................................................................................... 24
Pharmacology......................................................................................................... 24
Warning..................................................................................................................... 24
Adverse Reactions................................................................................................. 24
Precautions.............................................................................................................. 25
Required Supplies................................................................................................. 26
ICG Preparation...................................................................................................... 26
ICG Dosage............................................................................................................... 26
Administration........................................................................................................ 27
ICG Overview........................................................................................................... 27
ICG Storage.............................................................................................................. 27
Error Messages................................................................... 28

Troubleshooting................................................................. 29

Maintenance....................................................................... 31
Cleaning the Light Source.................................................................................. 31
Inspection................................................................................................................. 31
Checking the ESST Feature................................................................................ 32
Replacing the Fuses.............................................................................................. 33
Storage...................................................................................................................... 33
Expected Service Life........................................................................................... 33
Disposal..................................................................................................................... 33
Recycling Diagram................................................................................................ 34

Technical Specifications..................................................... 35
Electromagnetic Compatibility......................................................................... 36

Symbol Definitions............................................................. 40
Warnings and Cautions
Please read this manual and follow its instructions carefully. The words
warning, caution, and note carry special meaning and should be carefully
reviewed:

Warning Indicates risks to the safety of the patient or user. Failure to

follow warnings may result in injury to the patient or user.
Caution Indicates risks to the equipment. Failure to follow cautions
may result in product damage.
Note: Clarifies the instructions or presents additional useful information.

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.

1
Cautions
To avoid potential damage to this device, please note the following cautions.
1. Carefully unpack this device and check if any damage occurred during
shipment. If damage is detected, see the standard warranty.
2. Never sterilize the console. The delicate electronics cannot withstand a
sterilization procedure.
3. Ensure that the electrical installation of the relevant operating room
complies with the NEC and CEC guidelines.
4. Attempt no maintenance or adjustments that are not specifically detailed
in this user manual.
5. Ensure that any modifications or repairs are carried out by persons
authorized by Stryker. No modification of this equipment is allowed by
the user.

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. Must be a qualified physician to use this equipment.
2. Read this operating manual thoroughly, especially the warnings, and be
familiar with its contents before connecting and using this device.
3. Test this equipment prior to a surgical procedure. This unit was fully
tested at the factory before shipment.
4. Do not position the console so that it is difficult to disconnect the power
cord from the supply mains.
5. Never block the rear or side vents of the console. Failure to follow this
instruction can result in device damage or a possible fire.
6. To avoid the risk of electric shock, this equipment must only be
connected to a supply mains with protective earth ground.
7. Multiple portable socket-outlets shall not be placed on the floor.
8. Never use this equipment in the presence of flammable or explosive gas.
9. Disconnect the console from the electrical outlet when inspecting fuses
or making any repairs. Refer all repairs to authorized personnel.
10. Do not remove covers on the console, as doing so may cause damage to
electronics and/or electric shock.

2
Warnings: Laser
IMPORTANT SAFETY NOTICE - LASER RADIATION:
The L10 LED Light Source with Advanced Imaging Modality
Technology (or “L10 AIM Light Source”) is a laser product that
uses a Class 1 laser (IRIS mode) and a Class 1M laser (ENV 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. Observe the warning label shown below (located on the rear panel).

INVISIBLE LASER RADIATION

DO NOT VIEW DIRECTLY WITH
OPTICAL INSTRUMENTS
CLASS 1M LASER PRODUCT

2. Protect the L10 AIM Light Source against unqualified use.

3. Wear eye protection as appropriate. Refer to any applicable regional
regulations or standards for personal protective equipment.
4. Do not manipulate tissue while ENV mode is activated. The 1588 AIM
Video Camera is intended to visualize tissue manipulation only while ENV
mode is off.
5. Do not view the laser output in ENV mode with telescopic optical
instruments (for example, microscopes or magnifiers). Do not direct the
laser output in ENV mode into an area where such instruments are likely
to be used.
6. Do not activate ENV mode when the endoscope is outside of the patient’s
body.
7. When ENV mode is activated, never look into the following apertures or
direct the light emitted from the apertures toward another person:
• the light cable connection 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
8. When ENV 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.
9. Power off the light source (or place it in Standby mode and disable ENV
mode and IRIS mode) before connecting or removing the light cable,
endoscope, or disposable fibers.
3
Operating a Light Source
Please note the following special warnings to avoid user or patient injury or
product damage when using a light source.

IMPORTANT SAFETY NOTICE - HIGH TEMPERATURES:

Before operating this device, please read this operating manual
thoroughly and carefully. 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 scope tip, the scope light post,
the light cable tip, and/or near the light cable adapter. Higher
levels of brightness result in higher levels of heat. Adjust the
brightness level of the camera and the monitor 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.
Always place the light source in Standby mode and disable ENV
mode before 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.

The warranty is void if any of the above warnings or cautions are disregarded.

4
Product Description and Intended Use
The Stryker L10 LED Light Source with Advanced Imaging Modality
Technology (or “L10 AIM Light Source”) is a light-generating unit designed
to illuminate surgical sites in the following applications: visible light (White
Light mode), near-infrared fluorescence (ENV 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.
• ENV 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.
• 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 light cable is not connected to the scope adapter, which
prevents exposure to laser radiation, high-intensity light, and accidental
burns. For more information, see the section Checking the ESST Feature.

Indications
The L10 AIM Light Source and SafeLight™ Cable are indicated for use to
provide real-time endoscopic visible and near-infrared fluorescence imaging.
The L10 AIM 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 L10 AIM 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 L10 AIM Light Source is also intended to transilluminate the ureter during
open or laparoscopic surgical procedures.

5
ENV Mode Requirements
The equipment listed below is required to achieve the intended results when
using the light source in Endoscopic Near-Infrared Visualization (ENV) mode.
Any model listed for the camera head and laparoscope may be used. Intended
results will not be achieved if any equipment is substituted.
ENV mode is intended to be used with a contrast agent drug called
indocyanine green (ICG). AIM IC-GREEN® (NDC # 69705-101-02) includes the
required ICG supplies. See the Using AIM IC-GREEN in ENV Mode section for
more detail.
Note: Regulation of ICG varies by country. In certain countries, ICG is not
registered for use as a pharmaceutical product. Contact your local Stryker
distributor for more information on the availability of ICG at your location.
Before using ENV mode, read and be familiar with the warnings and
instructions provided with each device in the system.

Light Source
0220-220-300 L10 LED Light Source with AIM Technology

Camera Control Unit

1588-010-000 1588 AIM Camera Control Unit1

Camera Head
1588-210-105 1588 AIM Camera Head, C-Mount1
1588-610-122 1588 AIM Camera Head with Integrated Coupler1
1588-710-105 1588 AIM Inline Camera Head, C-Mount1

Coupler
1588-020-122 AIM Coupler, 18 mm, C-Mount2

Laparoscope
0502-537-010 AIM, 5.4 mm, 0°, HD Laparoscope, 30 cm3
0502-537-030 AIM, 5.4 mm, 30°, HD Laparoscope, 30 cm3
0502-937-010 AIM, 10 mm, 0°, HD Laparoscope, 33 cm3
0502-937-030 AIM, 10 mm, 30°, HD Laparoscope, 33 cm3

AIM SafeLight Cable

0233-050-300 AIM SafeLight Fiber Optic Cable, 5.0 mm x 10 ft (3.05 m)4

Indocyanine Green
AIM IC-GREEN5
1
See Stryker user manual P29923 (English) or P29924 (multilingual). 2 See Stryker user manual
P30104 . 3 See Stryker user manual P27900. 4 See Stryker user manual P27701.
5
See AIM IC-GREEN instructions for use packaged with NDC # 69705-101-02.

6
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.

Light Source
0220-220-300 L10 LED Light Source with AIM Technology

Camera Control Unit

1588-010-000 1588 AIM Camera Control Unit1
1488-010-000 1488 HD 3-Chip Camera Control Unit2
1488-010-001 1488 HD 3-Chip Camera Control Unit with DVI Fiber Output2

Camera Head
1588-210-105 1588 AIM Camera Head, C-Mount1
1588-610-122 1588 AIM Camera Head with Integrated Coupler1
1588-710-105 1588 AIM Inline Camera Head, C-Mount1
1488-210-105 1488 HD 3-Chip Camera Head, C-Mount2
1488-610-122 1488 HD 3-Chip Camera Head with Integrated Coupler2
1488-710-105 1488 HD 3-Chip Inline Camera Head, C-Mount2

Coupler
1588-020-122 AIM Coupler, 18 mm, C-Mount3
1488-020-122 1488 HD 18 mm Coupler, C-Mount4

Laparoscope
0502-537-010 AIM, 5.4 mm, 0°, HD Laparoscope, 30 cm5
0502-537-030 AIM, 5.4 mm, 30°, HD Laparoscope, 30 cm5
0502-937-010 AIM, 10 mm, 0°, HD Laparoscope, 33 cm5
0502-937-030 AIM, 10 mm, 30°, HD Laparoscope, 33 cm5

Light Cable
Any Stryker light cable

Disposable Fiber
0220-180-518 IRIS Ureteral Kit6

7
1
See Stryker user manual P29923 (English) or P29924 (multilingual).
2
See Stryker user manual P18966 (English) or P18972 (multilingual).
3
See Stryker user manual P30104.
4
See Stryker user manual P18968.
5
See Stryker user manual P27900.
6
See Stryker user manual P26059.

Note: IRIS mode is also compatible with the following Intuitive Surgical®
robotic camera systems:

Intuitive Surgical® Robotic System

da Vinci® Xi System
da Vinci® Si System with Firefly™ mode

IRIS sensitivity is enhanced in the Intuitive Surgical® da Vinci® System by the

use of Firefly™ mode.
The Stryker light source and disposable fiber listed above are required to use
Intuitive Surgical® robotic camera systems with IRIS mode.

General Compatibility
• All Stryker light cables are compatible with the L10 AIM Light Source
when used in White Light mode or IRIS mode. ENV mode requires the AIM
SafeLight cable (0233-050-300).
• Using the proper scope adapter, the Stryker light cable can connect the
light source system to any flexible or rigid endoscope. Before using another
manufacturer’s equipment, thoroughly read the accompanying documents
for all warnings and instructions.

8
Console Features
The features of the L10 AIM Light Source are described below.

Front Panel

1 2 3 4 5

1. Power Button Powers the unit on and off

2. IRIS Connectors For connecting the light source ends of the
IRIS Ureteral Kit (0220-180-518). 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 Connection For connecting the light-source end of
the light cable. Location of Class 1M laser
emissions when AIM SafeLight cable is
connected and ENV mode is activated.
5. Jaw Handle Opens and closes the clamp in the light
cable connection

9
Rear Panel
1 2 3

SDC CCU

4 5

1. SDC connection Connects to Stryker SDC for voice and device

control with a USB A-to-B cable
2. CCU connection Connects to Stryker 1588 AIM Camera Control
Unit with the provided USB A-to-A cable
3. Equipotential Connects to a potential equalization conductor.
Ground Plug 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

10
Setup
Stryker considers instructional training, or inservice, an integral part of the L10
AIM 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 L10 AIM Light Source involves four steps:
• Connecting the AC power cable
• Connecting a USB cable to the 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 camera 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.

11
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.

Connecting to the Camera Control Unit

To activate ENV mode, the L10 AIM Light Source must be connected to
the 1588 AIM Camera. White Light mode and IRIS mode do not require
connection to the camera.

Note: The 1588 AIM camera head can be programmed to control some

functions of the L10 AIM Light Source, such as toggling Active/Standby or
adjusting some settings in ENV mode. Contact a Stryker representative for
more information about enabling this advanced feature.

1. Using a USB A-to-A cable, connect the CCU port on the L10 AIM Light
Source to the Light Source port on the 1588 AIM Camera Control Unit.

1588 AIM Camera Control Unit

L10 AIM Light Source

SDC CCU

12
Connecting a Light Cable
To activate ENV 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 place it in Standby mode and
disable ENV mode and IRIS mode) before connecting or
removing the light cable or endoscope.

Keep fingers away from the light cable connection as the clamp
may inadvertently deploy and cause injury.
The light cable connection on the light source emits a Class 1M
laser when ENV 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 ENV mode.
Do not operate the light source in ENV mode with an AIM
SafeLight cable that is cut or damaged. If the AIM SafeLight
cable breaks during operation, place the light source in Standby
mode and disable ENV mode, then replace the cable.

1. Make sure the light source is powered off, or place it in Standby mode
and disable ENV mode.
2. Lock open the clamp in the light cable connection by turning the jaw
handle clockwise until it stops.

3. Insert a clean, dry light cable into the cable connection until the jaw
clamps the cable in place. Pull gently on the cable to test that it is securely
seated in the cable connection.

4. Connect an endoscope to the opposite end of the light cable.

Note: A scope adapter may be required to connect the cable to the
endoscope. See the light cable user manual for more detail.

Before each use, check the outer surface of the endoscope to

ensure there are no rough surfaces, sharp edges, or protrusions.

Note: To remove the light cable, place the light source in Standby mode and
disable ENV mode. Then, turn the jaw handle clockwise until the latch opens.

13
Connecting an IRIS Ureteral Kit
To activate IRIS mode, an IRIS Ureteral Kit (0220-180-518) must be connected
to the light source. White Light mode and ENV 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 guides 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. Make sure the light source is powered off, or place it in Standby mode
and disable IRIS mode.
2. Insert the light source ends of both fibers into the IRIS connectors on the
front panel of the light source.

14
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 L10 AIM Light Source, ensure all system components
have been set up according to the instructions in the Setup section.
ENV mode requires all of the equipment listed in the ENV 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.

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 default White Light screen and indicate that
the light source is in Standby mode.
Note: The light source will not illuminate unless a light cable is
connected to the cable port.

2. To power off the console, press the power button on the front panel.

15
Activating White Light Mode
White Light mode activates the LED diodes in the light source so it can
generate visible light.
Note: Activating White Light mode is also required as a preliminary step to
activate ENV mode or IRIS mode. While ENV mode is activated, it automatically
disables the white light output. While IRIS mode is activated, the user can
return to the White Light screen to toggle the white light output to Active or
Standby.
Follow the steps below to activate White Light mode.
1. Ensure a Stryker light cable is connected to the light source. See the
Connecting a Light Cable section for more information.
2. On the default White Light screen, press the touchscreen power button
so it appears green and the word “Active” appears above it.
3. Adjust the White Light brightness level by pressing the plus or minus
buttons.

Placing the Light Source in Standby Mode

Standby mode reduces white light output to a minimum, thereby reducing
the heat generated at the tip of the light cable or scope when the light source
is not being used.

To help prevent burns to the patient, user or inanimate objects

and possible fire, always put the light source 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.
16
To place the light source in Standby mode:
1. On the default White Light screen, press the touchscreen power button
so it appears gray and the word “Standby” appears above it.

Activating ENV Mode

Endoscopic Near-Infrared Visualization (ENV) mode activates the Class 1M
laser in the light source and enables fluorescence imaging.

Before using ENV mode, read and follow all warnings in this
user manual. Use of controls or performance of procedures
other than those specified can result in hazardous radiation
exposure. Laser emissions from the light source in ENV mode
can cause injury to the user or patient’s eyes.
See the ENV Mode Requirements section for equipment
requirements. Use ENV mode only with the specified
equipment.

Note: See the 1588 AIM Video Camera user manual (P29923 English, P29924
multilingual) for additional controls over ENV fluorescence.
Follow the steps below to activate ENV mode.
1. Ensure an AIM SafeLight cable is connected to the light source. ENV mode
will not function unless an AIM SafeLight cable is properly connected. See
the Connecting a Light Cable section for more information.
Note: When an AIM SafeLight cable is properly connected to the light
source, an image of a light cable with a green connector will appear at
the top-right of the touchscreen in ENV mode.

17
2. On the default White Light screen, press the touchscreen power button
so it appears green and the word “Active” appears above it.
3. Press the AIM button.

4. On the Advanced Imaging Modality screen, press the ENV mode button.

Note: When the ENV mode button is green, the L10 AIM Light Source is
properly connected to the 1588 AIM Camera Control Unit and the AIM
SafeLight Cable, and ENV mode can be activated. If the ENV mode button
is gray, required equipment may not be properly connected and ENV
mode is not available. Refer to the Setup section.

18
5. On the ENV mode screen, press the touchscreen power button so it
appears green, which indicates the mode is activated.
Note: Press the touchscreen power button again to disable ENV
mode; the button will appear gray. (When ENV mode is disabled, White
Light mode will reactivate. To deactivate the White Light, press the
Home button to return to the White Light mode screen, and press the
touchscreen power button so it appears gray.)

6 7

6. Adjust the backlight level by pressing the plus or minus buttons.

Backlight increases or decreases the brightness of the surrounding
anatomy that is not displayed as glowing green on the display monitor.
7. Adjust the ENV laser level by pressing the plus or minus buttons. ENV
laser level affects the fluorescing green appearance of the camera image.

8. Press the Home button to return to the White Light screen.

9. If ENV mode is still activated when the user returns to the White Light
screen, an ENV indicator button appears to the right of the touchscreen
power button. Press the ENV indicator button to return to the ENV mode
screen.

19
Activating IRIS Mode
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 ENV mode is activated, it must be disabled before activating IRIS

mode.

Follow the steps below to activate IRIS mode.

1. Ensure an IRIS Ureteral Kit is connected to the light source. IRIS mode will
not function unless an IRIS Ureteral Kit is properly connected. See the
Connecting an IRIS Ureteral Kit section for more information.
Note: When an IRIS Ureteral Kit is properly connected to the light source,
an image of two red fibers will appear at the top-left of the touchscreen
in IRIS mode. (If only one fiber is connected, an image of one red fiber and
one gray fiber will appear on the touchscreen.)

2. On the default White Light screen, press the touchscreen power button
so it appears green and the word “Active” appears above it.
3. Press the AIM button.

20
4. On the Advanced Imaging Modality screen, press the IRIS mode button.

Note: When the IRIS mode button is red, the L10 AIM Light Source
is properly connected to the IRIS Ureteral Kit and IRIS mode can be
activated. If the IRIS mode button is gray, required equipment may not
be properly connected and IRIS mode is not available. Refer to the Setup
section.
5. On the IRIS mode screen, press the touchscreen power button so it
appears green, which indicates the mode is activated.
Note: Press the touchscreen power button again to disable IRIS mode;
the button will appear gray.

5
7
6

6. Adjust the IRIS brightness level by pressing the plus or minus buttons.
7. 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).

8. Press the Home button to return to the White Light screen.

21
9. If IRIS mode is still activated when the user returns to the White Light
screen, an IRIS indicator button appears to the left of the touchscreen
power button. Press the IRIS indicator button to return to the IRIS mode
screen.

22
Using AIM IC-GREEN in ENV Mode
Endoscopic Near-Infrared Visualization (ENV) mode is intended to be used
with a contrast agent drug called indocyanine green (ICG). AIM IC-GREEN®
(NDC # 69705-101-02) includes the required ICG supplies.
Note: Regulation of ICG varies by country. In certain countries, ICG is not
registered for use as a pharmaceutical product. Contact your local Stryker
distributor for more information on the availability of ICG at your location.
• Indocyanine green is a sterile, water soluble tricarbocyanine dye with a
peak spectral absorption at 800 nm in blood or blood plasma.
• ICG contains not more than 5.0% sodium iodide.
• ICG is administered intravenously. Under sterile conditions, the ICG
powder should be dissolved with the provided aqueous solvent. AIM
IC-GREEN has a pH of approximately 6.5 when reconstituted.
• Use of the ICG dye promotes the fluorescing appearance of the camera
image in ENV mode.

Each AIM IC-GREEN kit contains the following items:

• Six 25 mg vials of indocyanine green (ICG) imaging agent
• Six 10 mL ampules of aqueous solvent
• Instructions for use

See the ENV Mode Requirements section for complete hardware

requirements. The contents of AIM IC-GREEN must be used only with the
L10 AIM Light Source.
To use AIM IC-GREEN in conjuction with ENV mode, follow the instructions
and warnings below. The instructions for use are also packaged with AIM IC-
GREEN (NDC # 69705-101-02).

23
ICG Indications for Use
AIM IC-GREEN is indicated for use with the Stryker L10 LED Light Source with
AIM Technology and SafeLight™ Fiber Optic Cable.

ICG Contraindications
AIM IC-GREEN 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.

24
Precautions
• Federal law (USA) restricts this device to use by, or on order of, a
physician.
• Observe sterile handling techniques when preparing and
administering the ICG solution. The inner contents of the ICG powder
vial and aqueous solvent capsule are sterile. Handle them aseptically
during the procedure to maintain the sterile field. Do not use any of
these packages if they appear to be damaged or improperly sealed.
• Due to freeze drying, the ICG powder may lump together or cling to
the vial. This is normal and the ICG should be suitable for use after
reconstitution with the aqueous solvent. If a precipitate is present after
preparation, however, discard the solution.
• Use only the aqueous solvent provided with the AIM IC-GREEN kit to
dissolve the ICG powder. Commercially available water for injection
may be incompatible and should not be used.
• Each preparation of the ICG solution should be used in only one
patient. Once the ICG solution is prepared, it must be used within
6 hours. ICG is not stable in aqueous solution.
• Heparin preparations that contain sodium bisulfite reduce the
absorption peak of ICG in blood. Do not use heparin preparations with
sodium bisulfite as an anticoagulant for the collection of samples for
analysis.
• Radioactive iodine uptake studies should not be performed for at least
one week after the use of ICG.
• The potential for ICG to impair fertility or have a carcinogenic or
mutagenic effect has not been studied. ICG should be administered
to a pregnant woman only when clearly indicated. Exercise caution
when administering ICG to a nursing woman. It is not known if ICG is
excreted in human milk.
• ICG is generally injected through a shared intravenous line with no
reported difficulties or unexpected results to date.
• Use ICG only at recommended doses and concentrations listed in this
user manual.

25
Required Supplies
AIM IC-GREEN® (NDC # 69705-101-02) includes the required ICG supplies.
Other items required to use AIM IC-GREEN shall be provided by the user.
Note: Regulation of ICG varies by country. In certain countries, ICG is not
registered for use as a pharmaceutical product. Contact your local Stryker
distributor for more information on the availability of ICG at your location.

Item Description
AIM IC-GREEN Includes six 25 mg vials of ICG powder and
six 10 mL ampules of aqueous solvent
Sterile normal saline Approximately 10 –12 mL following each ICG
injection
Syringe Minimum volume of syringe: 10 mL
(for ICG preparation)
Syringes Minimum volume of syringes: 3 or 5 mL
(for each ICG solution
injection)
Syringes Minimum volume of syringes: 12 mL
(for each saline flush
after ICG injection)

ICG Preparation
Prepare the ICG solution following the steps below. The instructions yield a
2.5 mg/mL solution.
1. Open the aqueous solvent ampule.
2. Draw 10 mL of the solvent into a syringe.
3. Remove the flip cap off the vial containing 25 mg of the ICG powder.
4. Inject the 10 mL of aqueous solvent into the ICG vial through the stopper
to dissolve the powder.
5. Gently shake the ICG vial to mix the solution. Ensure all ICG powder is
dissolved in the solution.
6. Inspect the reconstituted solution for precipitation. If a precipitate is
present, discard the solution and prepare a new vial as described above.

ICG Dosage
The typical dose administered is 2.5mg.
The total dose should be less than 2 mg/kg per patient.

26
Administration
1. Ensure there is a port available for the injection of the ICG solution
followed by the saline flush.
2. Draw the required dosage of ICG solution for each planned imaging
sequence into separate syringes.
3. Draw approximately 10 –12 mL of normal saline for each planned imaging
sequence into separate syringes.
Note: There should be the same number of saline syringes (or more) than
the prepared ICG solution syringes. If the saline syringes are prepared
prior to the procedure, place them in a convenient and sterile location for
use at the time of imaging.
4. Administer 2.5 mg of the prepared ICG solution intravenously.
• For visual assessment of the major extrahepatic bile ducts, administer
ICG at least 30 minutes prior to near-infrared imaging.
• For visual assessment of vessels, blood flow and related tissue
perfusion, administer ICG immediately before near-infrared imaging.
5. Immediately follow each ICG injection with a tight bolus injection of
approximately 10 –12 mL of normal saline.

After each injection of ICG solution, the ENV mode should be able to visualize
a fluorescence response in blood vessels and tissue within several seconds.
Note: Once the ICG solution is prepared, it must be used within 6 hours. If
additional ICG solution is required to administer, reconstitute a second vial of
ICG after the first reconstituted solution has been used completely.

ICG Overview
• Injection method: Intravascular
• Recommended dosage: Typically 2.5 mg

ICG Storage
• Discard any unused reconstituted ICG after the surgery is complete.
• Store AIM IC-GREEN at ambient room temperatures of 20 – 25 °C
(68 – 77 °F).
• Do not use AIM IC-GREEN if the expiration date on the packaging has
passed.

27
Error Messages
In the event of a light source error, an error message will display on the
touchscreen. See the table below for details.

If the light source displays any error message, reboot the console. If the
error recurs, it is recommended that the device be returned for service.

Code Definition Details

E-1 Over Output in White Light mode is disabled due to
temperature excessive heat in the console. All functionality is
(safety shutoff ) disabled.
E-2 Failure to color The light source will not actively balance the light
balance output color.
E-3 Power supply The light source continues operating but generates
fan failure excessive heat which may result in additional
damage and/or compromised functionality.
E-4 Heat sink fan The light source continues operating but generates
failure excessive heat which may result in additional
damage and/or compromised functionality.
E-5 Overcurrent The light output color may drastically change, and
LED failure the light source will not actively balance the light
output color.
E-6 Software All light source functionality is disabled. Return to
version Stryker for service.
mismatch
E-7 ENV power The light source will not actively balance the
balance failure backlight color until the console is rebooted.
E-8 IRIS power IRIS mode is disabled.
balance failure
E-9 ENV laser error ENV mode is disabled.
E-10 System All light source functionality is disabled. Return to
initiation error Stryker for service.

28
Troubleshooting
Problem Possible Solution
No output in • Ensure the AC power cord is properly connected to
White Light a hospital-grade power outlet and the inlet on the
mode 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 light source
will provide no light output unless the light cable is
properly seated in the cable port.
• Check that vents are not obstructed.
Too much • Ensure the light cable is correctly engaged with the
or too little cable port.
output in • Ensure that White Light mode is activated. (The
White Light brightness level should appear on the LCD.)
mode
• If necessary, press the White Light touchscreen
power button to switch from Standby to Active. If
the unit remains in Standby: (1) Ensure the light
cable is correctly engaged with the cable port.
(2) Ensure the light cable is attached to the scope
using the appropriate scope adapter.
• Ensure the light cable can transmit light properly.
While the cable is completely disconnected, hold
the light-source end of the cable up to an overhead
room light and look into the scope end of the
cable. If the pattern contains any black spots, the
light cable may be worn out and may require
replacement.
Excessive glare • Ensure the electronic shutter on the camera is
in the video operating properly to control the video signal
brightness.
• Decrease the White Light brightness level.

29
 Problem Possible Solution
Flickering light • Ensure a light cable is properly connected to the
in the video L10 AIM Light Source.
• Place the light source in Standby mode and disable
ENV mode, then remove the light cable from the
light source. Reattach the light cable.
Frozen • Turn off the console, wait 30 seconds, and then
Touchscreen turn it back on.
Cannot • Check connection of disposable fiber (to activate
advance past IRIS mode)
Advanced • Check connection of AIM SafeLight cable and
Imaging 1588 AIM Camera Control Unit (to activate ENV
Modality mode)
screen

Note: If this troubleshooting guide does not resolve the problem, call Stryker
Technical Support at 1-877-478-7953 (inside the U.S.) or see the standard
warranty.

30
Maintenance
Cleaning the Light Source
Should the light source console need cleaning, follow the warnings, cautions,
and instructions below. The user shall provide the mild detergent (or standard
disinfectant) and sterile cloth required for cleaning.

To avoid electric shock and potentially fatal injury, disconnect

the console from the AC power source before cleaning.

Observe the following cautions to avoid damaging the console:

• Do not sterilize the console.
• Do not immerse the console in any liquid.
• Do not allow liquid to drip onto the console or collect on any
of its surfaces.
• Do not spray cleaning liquid directly onto the console,
power buttons, or connectors. Spray the cleaning liquid onto
a cloth, and use the cloth to wipe the console.
• Do not clean the console with abrasive products or corrosive
cleaning solutions.

1. Spray a mild detergent or standard disinfectant onto a dry, sterile cloth.

Do not saturate the cloth.
2. Wipe the console. Do not allow liquid to drip from the cloth or collect on
the console.
3. When cleaning the front LCD screen, use extra care to prevent liquid from
dripping or pooling on the bottom of the screen. Excess liquid can enter
the console and cause product damage.
4. Visually inspect the external surface of the device for cleanliness, focusing
on hard-to-reach areas. If visible soil remains, repeat steps 1– 3.

Inspection
Inspect the device on a continual basis for unacceptable deterioration such
as (but not limited to) corrosion, discoloration, pitting, cracked seals, or
abnormal noises. If a problem is observed or suspected, the device should be
returned for service.

31
Checking the ESST Feature
The L10 AIM Light Source is equipped with a safety feature called Electronic
Scope Sensing Technology (ESST). The ESST feature prevents exposure to
laser radiation that can cause severe eye injury and high-intensity light that
can cause accidental fires or burns. The ESST feature will work only if the light
source is used with a Stryker SafeLight cable or AIM SafeLight cable.
The ESST feature senses when the cable and SafeLight scope adapter are
separated, and it places the light source in Standby mode and disables ENV
mode. In this state, the light source reduces light output to a minimum,
protecting the user and patient from laser radiation and high-intensity light.
To verify the ESST feature is functioning properly, perform the following
test before every surgical procedure:

During the test, do not point the scope or light cable at anyone.
Do not look directly into the scope tip or the end of the light
cable. The laser radiation or high-intensity light emitted from
the light source can cause severe eye injury.
Other than performing the ESST test while observing these
precautions, the user should never disconnect a light cable
when the light source is activated.

1. Set up the L10 AIM Light Source system with a SafeLight cable (or AIM
SafeLight cable) and scope, including a SafeLight scope adapter.
2. Power on the console.
3. Activate White Light mode.
4. Activate ENV mode (if testing with an AIM SafeLight cable).
5. Disconnect the cable from the SafeLight scope adapter.
The light source should return to Standby mode (and disable ENV mode
if testing with an AIM SafeLight cable). This indicates the ESST feature is
functioning properly.

Always check to ensure that the unit has switched into Standby
mode and ENV mode is disabled before assuming ESST safety
protection. If the unit fails to return to this state, there may be
a fault with the ESST feature. In this case, do not assume ESST
safety protection, and return the unit for service.

32
Replacing the Fuses
To avoid the risk of fire, use only fuses of the value specified on
the fuse label located on the rear panel of the console.

1. Unplug the power cord from the wall outlet and remove the cord from
the light source console.
2. Unlatch the fuse holder above the AC inlet and remove it. (You may need
to press the tab on the fuse holder with a slender screwdriver to release
the latch.)
3. Replace the fuse with the same value and rating.
4. Reinstall the fuse holder until the tab snaps in place.

Storage
Never store the light source in a non-ventilated, humid environment. This can
damage the delicate electronics in the device.

Expected Service Life

The L10 AIM Light Source has an expected service life of 2000 hours (2 years
based on 1000 cases per year).

Disposal
This product contains electrical waste or electronic equipment.
It must not be disposed of as unsorted municipal waste and
must be collected separately in accordance with applicable
national or institutional related policies relating to obsolete
electronic equipment.
Dispose of the light source according to local laws and hospital practices.
Refer to the diagram below to identify components that must be recycled.
(The console is shown with the chassis cover removed for clarity.)

33
Recycling Diagram

5
4 6
3

Item Material Qty. Comments

1 PC Board 1 —
2 Touchscreen LCD 1 —
3 PC Board 1 Not shown above; behind
touchscreen LCD
4 PC Board 1 —
5 PC Board 1 —
6 Power Supply 1 —
7 AC power cord 1 Not shown above
8 USB A-to-A cable 1 Not shown above

34
Technical Specifications
Electrical
Primary: 100 – 240 VAC, 50/60 Hz, 3.2 – 1.3 A
Fuses (2): T 5.0AH 250V

Dimensions and Weight

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)

Light Engine
Type: Red LED, Green LED, Blue LED, 808 nm Laser, 830 nm Laser

Operating Conditions
Temperature: 10 – 30 °C
Relative Humidity: 25 – 75%

Transportation and Storage Conditions

Temperature: -18 – 60 °C
Relative Humidity: 15 – 90%

Classifications and Approvals

Class I Equipment
Continuous Operation
Type CF Applied Part
Ingress Protection, IPX0—Ordinary Equipment
Class 1M Laser Product
Laser product classified per IEC 60825-1:2007, Safety of laser products – Part 1:
Equipment classification and requirements
This product complies with IEC 60825-1:2007
This product complies with 21 CFR, Subchapter J, Parts 1040.10 and 1040.11,
except for deviations pursuant to Laser Notice No. 50, dated July 26, 2001.

Laser Specifications
Emitted wavelength in ENV mode: 808 nm (Class 1M laser)
Emitted wavelength in IRIS mode: 830 nm (Class 1 laser)
Maximum output of laser radiation: Below Class 1M limit

35
Electromagnetic Compatibility
Like other electrical medical equipment, the L10 AIM Light Source requires
special precautions to ensure electromagnetic compatibility with other
electrical medical devices. To ensure electromagnetic compatibility (EMC), the
L10 AIM Light Source must be installed and operated according to the EMC
information provided in this manual.

Note: The L10 AIM Light Source has been designed and tested to comply
with IEC 60601-1-2 requirements for EMC with other devices.

Do not use cables or accessories other than those provided

with the L10 AIM Light Source, as this may result in increased
electromagnetic emissions or decreased immunity to such
emissions.
If the L10 AIM Light Source is used adjacent to or stacked with
other equipment, observe and verify normal operation of the
L10 AIM Light Source 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 L10 AIM Light Source.
Equipment which employs RF communications may affect the
normal function of the L10 AIM Light Source.

Guidance and Manufacturer’s Declaration: Electromagnetic Emissions

L10 AIM Light Source is intended for use in the electromagnetic environment specified below. The
customer or the user of L10 AIM Light Source should ensure that it is used in such an environment.
Emissions test Compliance Electromagnetic Environment -
guidance
RF emissions Class B The L10 AIM Light Source is suitable
for use in all establishments other
CISPR 11 than domestic establishments and
Harmonic emissions Class A those directly connected to the public
low-voltage power supply network that
IEC61000-3-2 supplies buildings used for domestic
purposes, provided the following warning
Voltage fluctuations/ Flicker Complies
is heeded:
emissions
Warning: This system is intended
IEC61000-3-3
for use by health care professionals
only. This system may cause radio
interference or may disrupt the operation
of nearby equipment. It may be
necessary to take mitigation measures,
such as reorienting or relocating the
system or shielding the location.

36
 Guidance and Manufacturer’s Declaration: Electromagnetic Immunity
L10 AIM Light Source is intended for use in the electromagnetic environment specified below.

The customer or the user of L10 AIM Light Source should ensure that it is used in such an
environment.
Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic
Environment:
Guidance
Electrostatic Discharge ±6kV contact ±6kV contact Floors should be
(ESD) wood, concrete, or
±8kV air ±8kV air ceramic tile. If floors
IEC61000-4-2 are covered with
synthetic material,
the relative humidity
should be at least
30%.
Electrical fast transient/ ±2kV for power supply ±2kV line to ground Mains power quality
burst lines should be that of a
±1kV for input/output typical commercial or
IEC61000-4-4 ±1kV for input/output lines hospital environment.
lines
Surge ±1kV differential mode ±1kV differential mode Mains power quality
should be that of a
IEC61000-4-5 ±2kV common mode ±2kV common mode typical commercial or
hospital environment.
Voltage dips, short <5% Ut (>95% dip in <5% Ut (>95% dip in Ut) Mains power quality
interruptions and Ut) for 0.5 cycle for 0.5 cycle should be that of a
voltage variations on typical commercial or
power supply input lines 40% Ut (60% dip in 40% Ut (60% dip in Ut) hospital environment.
Ut) for 5 cycles for 5 cycles If the user of L10 AIM
IEC61000-4-11 Light Source requires
70% Ut (30% dip in 70% Ut (30% dip in Ut)
continued operation
Ut) for 25 cycles for 25 cycles
during power mains
<5% Ut (>95% dip in <5% Ut (>95% dip in Ut) interruptions, it is
Ut) for 5 sec. for 5 sec. recommended that
L10 AIM Light Source
be powered from an
uninterruptible power
supply or a battery.
Power frequency 3 A/m 3 A/m Power-frequency
(50/60Hz) magnetic field magnetic fields
should be at levels
IEC 61000-4-8 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.

37
 Guidance and Manufacturer’s Declaration: Electromagnetic Immunity
L10 AIM Light Source is intended for use in the electromagnetic environment specified below.

The customer or the user of L10 AIM Light Source should ensure that it is used in such an
environment.
Immunity Test IEC 60601 Test Level Compliance Electromagnetic Environment:
Level
Guidance
Conducted RF 3 Vrms 3V Portable and mobile RF
communications equipment
IEC 61000-4-6 150 kHz to 80 MHz should be used no closer to any
part of the L10 AIM Light Source
system, including its cables, than
the recommended separation
distance calculated from the
equation applicable to the
frequency of the transmitter.

Recommended Separation
Distance

d = 1.17 √P

Radiated RF 3 V/m 3 V/m d = 1.17 √P 80 MHz to 800 MHz

IEC 61000-4-3 80MHz to 2.5 GHz
d = 2.33 √P 800 MHz to 2.5
GHz

where P is the maximum output

power rating of the transmitter
in watts (W) according to the
transmitter manufacturer and d
is the recommended separation
distance in meters (m).

Field strengths from fixed RF

transmitters, as determined
by an electromagnetic site
survey (a), should be less than
the compliance level in each
frequency range(b). Interference
may occur in the vicinity of
equipment marked with the
following:

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.

38
 Guidance and Manufacturer’s Declaration: Electromagnetic Immunity

L10 AIM Light Source is intended for use in the electromagnetic environment specified below.

The customer or the user of L10 AIM Light Source should ensure that it is used in such an
environment.
(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 L10 AIM Light Source system is used exceeds the applicable
RF compliance level above, the L10 AIM Light Source system should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as
reorienting or relocating the L10 AIM Light Source unit.

(b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Recommended Separation Distances Between Portable and Mobile RF Communications

Equipment and the L10 AIM Light Source System

The L10 AIM Light Source system is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The user of the L10 AIM Light Source system can help
prevent electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the L10 AIM Light Source system as
recommended below, according to the maximum output power of the communications equipment.

Rated maximum output Separation distance (m) according to frequency of transmitter

power (W) of transmitter
150 kHz to 80 MHz 80MHZ to 800 MHz 800 MHz to
2.5 GHz
d = 1.17 √P d = 1.17 √P
d = 2.33 √P
0.01 0.12 0.12 0.23
0.1 0.37 0.37 0.74
1 1.17 1.17 2.33
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.

39
Symbol Definitions
This device and its labeling contain symbols that provide important
information for the safe and proper use of the device. These symbols are
defined below.

Touchscreen Interface

Green=selected mode is activated

Gray=Selected mode is disabled (or light source is in Standby

mode)

White Light brightness level (white icon)

AIM button (navigate to Advanced Imaging Modality screen)

Home button (navigate to White Light screen)

Green=ENV mode is available

Gray=ENV mode is not available (connect required equipment

to make the mode available)

Red=IRIS mode is available

Gray=IRIS mode is not available (connect required equipment to

make the mode available)

AIM SafeLight cable is properly connected

Backlight level

ENV laser level (green icon)

ENV indicator button (mode is activated; press to return to ENV

mode screen)

40
 IRIS Ureteral Kit is properly connected (image of one red fiber
appears for each fiber connected)

IRIS brightness level (red icon)

Continuous IRIS light output

Pulsating IRIS light output

IRIS indicator button (mode is activated; press to return to IRIS

mode screen)

Device/Package Labeling

Consult instruction manual

Caution (consult instructions for use)

Federal law (USA) restricts this device to use by, or on order of, a
physician

Date of manufacture

Legal manufacturer

Product catalog number

Product serial number

The device meets requirements for safety and effectiveness set

forth in MDD 93/42/EEC.

Stryker European representative

41
 Denotes compliance to CAN/CSA C22.2 No 60601-1 and
ANSI/AAMI 60601-1

IRIS connector icon (on front panel)

Turn jaw handle in indicated direction to lock open the cable

clamp

Type CF applied part

Power on/off (power state alternates when button is pushed)

Class 1M laser product

INVISIBLE LASER RADIATION
DO NOT VIEW DIRECTLY WITH
OPTICAL INSTRUMENTS
CLASS 1M LASER PRODUCT

Equipotentiality

Alternating current

Fuse rating

Device recycling code (applicable in China)

This product contains electrical waste or electronic equipment.

It must not be disposed of as unsorted municipal waste and
must be collected separately.

User Manual
A lightning bolt within a triangle is intended to warn of the
presence of hazardous voltage. Refer all service to authorized
personnel.

Radiation emitting

42
Stryker Endoscopy
5900 Optical Court
San Jose, CA 95138 USA
1-800-624-4422
U.S. Patents: www.stryker.com/patents

Stryker or its divisions or other corporate affiliated

entities own, use or have applied for the following
trademarks or service marks: SafeLight™ and the
Stryker logo. IC-GREEN® is a registered trademark
of Akorn, Inc. All other trademarks are trademarks of
their respective owners or holders.
2015/10