Stryker L9000 LED, L9000 User Manual

User Guide

L9000 LED

Light Source

REF 0220210000

2009/02 www.stryker.com 1000401120 D

1

Contents

Warnings and Cautions ............................................................. 2

Symbol Definitions ............................................................................ 4

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

Indications ......................................................................................... 6

Intended Use ..................................................................................... 6

Setup and Assembly ................................................................... 9

Connecting the AC Power Cable ...................................................... 9

Connecting the Light Cable .............................................................. 9

System Operation ....................................................................... 11

Powering the System On and Off ................................................... 11

Selecting the Operation Mode ........................................................ 12

Adjusting the Brightness ................................................................. 13

Visual Display .................................................................................. 13

Language Selection ........................................................................ 15

Safety Shutoff ................................................................................. 16

Checking the ESST Feature ............................................................ 17

Using the L9000 with a Voice-Controlled System Interface ........... 18

Using the SFB Serial Interface ........................................................ 18

Troubleshooting .............................................................................. 19

Cleaning and Maintenance ................................................... 21

Cleaning the L9000 ......................................................................... 21

Replacing the Fuses ....................................................................... 21

Disposing of the L9000 ................................................................... 21

Technical Specifications ....................................................... 22

Electromagnetic Compatibility ........................................................ 23

Warranty .......................................................................................... 27

2

Warnings and Cautions

Please read this manual and follow its instructions carefully. The words warning,
caution, and note carry special meanings and should be carefully reviewed:

W

ARNING THE PERSONAL SAFETY OF THE PATIENT OR USER MAY BE

INVOLVED. DISREGARDING THIS INFORMATION COULD RESULT
IN SERIOUS INJURY TO THE PATIENT OR USER.

Caution Special procedures or precautions must be followed to avoid

damaging the instrument.

Note Special information to make maintenance easier or important

information more clear.
An exclamation mark within a triangle is intended to alert the

user to the presence of important operating and maintenance
instructions in the manual.

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

W

ARNING IMPORTANT SAFETY NOTICE: BEFORE OPERATING THIS

DEVICE, PLEASE READ THIS OPERATING MANUAL THOROUGHLY
AND CAREFULLY. WHEN USING THIS DEVICE WITH A LIGHT
SOURCE, FIRE AND/OR SEVERE INJURY MAY RESULT TO THE
PATIENT, USER OR INANIMATE OBJECTS, IF THE INSTRUCTIONS IN
THIS MANUAL ARE NOT FOLLOWED. ALL LIGHT SOURCES,
INCLUDING THE L9000, CAN GENERATE SIGNIFICANT AMOUNTS
OF HEAT AT THE SCOPE TIP, THE SCOPE LIGHT POST, THE LIGHT
CABLE TIP, AND/OR NEAR THE LIGHT CABLE ADAPTER. HIGHER
LEVELS OF BRIGHTNESS FROM THE LIGHT SOURCE RESULT IN
HIGHER LEVELS OF HEAT. ALWAYS ADJUST THE BRIGHTNESS
LEVEL OF THE CAMERA AND THE MONITOR, BEFORE ADJUSTING
THE BRIGHTNESS LEVEL OF THE LIGHT SOURCE. ADJUST THE
BRIGHTNESS LEVEL OF THE LIGHT SOURCE TO THE MINIMUM
BRIGHTNESS NECESSARY TO ADEQUATELY ILLUMINATE THE
SURGICAL SITE. IN ADDITION, ADJUST THE INTERNAL SHUTTER OF
THE CAMERA HIGHER IN ORDER TO RUN THE LIGHT SOURCE AT A
LOWER INTENSITY. AVOID TOUCHING THE SCOPE TIP OR THE
LIGHT CABLE TIP TO THE PATIENT, AND NEVER PLACE THEM ON
TOP OF THE PATIENT, AS DOING SO MAY RESULT IN BURNS TO THE
PATIENT OR USER. IN ADDITION, NEVER PLACE THE SCOPE TIP,
THE SCOPE LIGHT POST, THE LIGHT CABLE ADAPTER, OR THE
LIGHT CABLE TIP ON THE SURGICAL DRAPES OR OTHER
FLAMMABLE MATERIAL, AS DOING SO MAY RESULT IN FIRE.

3

A

LWAYS PLACE THE LIGHT SOURCE IN STANDBY MODE
WHENEVER THE SCOPE IS REMOVED FROM THE LIGHT CABLE OR
THE DEVICE IS UNATTENDED. THE SCOPE TIP, SCOPE LIGHT POST,
LIGHT CABLE ADAPTER, AND LIGHT CABLE TIP WILL TAKE
SEVERAL MINUTES TO COOL OFF AFTER BEING PLACED IN
STANDBY MODE, AND THEREFORE MAY STILL RESULT IN FIRE OR
BURNS TO THE PATIENT, USER, OR INANIMATE OBJECTS.

W

ARNING TO HELP AVOID POTENTIAL SERIOUS INJURY TO THE USER AND

THE PATIENT AND/OR DAMAGE TO THIS DEVICE, THE USER MUST:

1. Read this operating manual thoroughly, especially the warnings, and be
familiar with its contents prior to using this equipment.

2. Carefully unpack the unit and check if any damage occurred during
shipment. If damage is detected, please refer to the “Service and Claims”
section in this manual.

3. Be a qualified physician, having complete knowledge of the use of this
equipment.

4. Test this equipment prior to a surgical procedure. This unit was fully
tested at the factory before shipment.

5. Attempt no internal repairs or adjustments that are not specifically
detailed in the Troubleshooting, Cleaning and Maintenance sections of
this operating manual.

6. Never sterilize any part of the L9000 console.

7. Disconnect the L9000 from the electrical outlet when inspecting the
fuses.

The warranty is void if any of these warnings or cautions contained in this manual
are disregarded. The user must also be ensure that:

• Readjustments, modifications, and/or repairs are carried out

exclusively by Stryker Endoscopy.

• The electrical installation of the relevant operating room complies

with the applicable IEC, CEC, and NEC requirements.

W

ARNING FEDERAL LAW (UNITED STATES OF AMERICA) RESTRICTS THIS

DEVICE TO USE BY, OR ON ORDER OF, A PHYSICIAN.

4

Symbol Definitions

Type CF Applied Part

Protective Earth Ground

Equipotentiality

Denotes compliance to CSA 22.2 No.601.1-M90 and UL60601-1.

This symbol indicates that the waste of electrical and electronic
equipment must not be disposed as unsorted municipal waste
and must be collected separately. Please contact the
manufacturer or other authorized disposal company to
decommission your equipment.

5

Product Description and Intended Use

The Stryker L9000 Light Source is a light-generating unit designed to illuminate
surgical sites during endoscopic applications. The L9000 uses light-emitting diode
(LED) technology to generate bright, crisp light, which it delivers to the surgical site
via a fiberoptic light cable. The L9000 is compatible with all Stryker light cables,
and, with the proper light cable and adapters, can connect to any flexible or rigid
endoscope.

The L9000 is equipped with Electronic Scope Sensing Technology (ESST), a
special safety feature that helps prevent accidental burns caused by a light cable
that is not connected to the scope. For more information, refer to the section
“Checking the ESST Feature”. When operated with an ESST light cable, the L9000
senses when the scope and the light cable are separated and places the light source
in Standby mode. In Standby mode, the L9000 will reduce light output to a
minimum, preventing the light cable from generating excessive heat.

W

ARNING THE SCOPE TIP, SCOPE LIGHT POST, LIGHT CABLE ADAPTER, AND

LIGHT CABLE TIP WILL TAKE SEVERAL MINUTES TO COOL OFF
AFTER BEING PLACED IN STANDBY MODE AND THEREFORE MAY
STILL RESULT IN FIRE AND/OR BURNS TO THE PATIENT, USER, OR
AN INANIMATE OBJECT IF NOT USED PROPERLY. DO NOT PLACE
THE SCOPE OR THE LIGHT CABLE ON THE PATIENT OR ON THE
DRAPES OR OTHER FLAMMABLE MATERIAL, EVEN WHEN THE
DEVICE IS IN STANDBY MODE.

The Stryker L9000 Light Source consists of one of each of the following:

• light source console

•power cord

6

Indications

The Stryker LED Light Source is used to illuminate the site of surgery during
minimally invasive surgical procedures in arthroscopy (orthopedic surgery),
laparoscopy (general and gynecological surgery) and in Endoscopy (general,
gastroenterological and ENT surgery). The light is transmitted from the source
through an optical cable and a scope.

The light source is an integral component of a visualization system which consists
of a video camera, video monitor, video recorder, video printer, light cable and
scope.

Intended Use

The Stryker LED Light Source is used to illuminate the site of surgery during
minimally invasive surgical procedures in Arthroscopy (orthopedic surgery),
Laparoscopy (general and gynecological surgery) and in Endoscopy (general,
gastroenterological and ENT surgery). The light is transmitted from the source
through an optical cable and a scope.

7

The features of the L9000 console are described below (see Figures 1 and 2).

Figure 1 Front panel of the L9000 console

1. Power Button: Powers the unit on and off.

2. Tou ch Scre en: Provides user controls and system feedback.

3. Cable Clamp: Grasps the light-source end of an inserted fiberoptic
cable.

4. Jaw Handle: Opens the fiberoptic cable holder.

12 34

8

Figure 2 Rear panel of the L9000 console

5.

SFB Series Connectors

: Enables FireWire connection with Stryker
FireWire devices. Provides connection for remote diagnoses and future
software upgrades.

6.

SIDNE Connector:

Enables connection to the SIDNE voice control

system

7. Equipotential ground plug: Connects to a potential equalization

conductor

8. AC Inlet: Connects to the provided power cord for AC power supply.

675

8

9

Setup and Assembly

Note When selecting a setup location for the L9000, consult the

“Electromagnetic Compatibility” section included in this manual
to determine the best location.

To set up the L9000, make the following connections:

• Connect the AC power cable

• Connect the light cable

Caution To ensure proper cooling, position the L9000 on its feet. Do

not operate the unit upside down or on its side.

Connecting the AC Power Cable

1. Plug in the AC power cord to the AC Inlet on the rear console panel.

2. Plug in the other end of the AC cord to a hospital-grade outlet.

W

ARNING WHEN THE L9000 IS INTERCONNECTED WITH OTHER MEDICAL

ELECTRICAL EQUIPMENT, LEAKAGE CURRENTS MAY BE ADDITIVE.

T

O MINIMIZE LEAKAGE CURRENT THAT MAY TRAVEL TO THE
PATIENT OR USER, ANY TYPE CF APPLIED PART SHOULD BE USED
ONLY WITH OTHER TYPE CF APPLIED PARTS. ENSURE ALL
SYSTEMS ARE INSTALLED ACCORDING TO THE REQUIREMENTS OF

IEC 60601-1-1.

Connecting the Light Cable

WARNING USE ONLY NONCONDUCTIVE FIBEROPTIC CABLES WITH THE

L9000

TO MAINTAIN ELECTRICAL ISOLATION.

Note The L9000 Light Source is compatible with all Stryker Light

Cables.