Stryker L9000 LED Bedienungsanleitung

User Guide

L9000 LED

Light Source

REF 0220210000

2009/02 www.stryker.com 1000401120 D

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

Warnings and Cautions

Please read this manual and follow its instructions carefully. The words warning,

caution, and note carry special meanings and should be carefully reviewed:

WARNING THE PERSONAL SAFETY OF THE PATIENT OR USER MAY BE

INVOLVED. DISREGARDING THIS INFORMATION COULD RESULT

IN SERIOUS INJURY TO THE PATIENT OR USER.

Caution Special procedures or precautions must be followed to avoid

damaging the instrument.

Note Special information to make maintenance easier or important

information more clear.

An exclamation mark within a triangle is intended to alert the

user to the presence of important operating and maintenance

instructions in the manual.

A lightning bolt within a triangle is intended to warn of the

presence of hazardous voltage. Refer all service to authorized

personnel.

WARNING IMPORTANT SAFETY NOTICE: BEFORE OPERATING THIS

DEVICE, PLEASE READ THIS OPERATING MANUAL THOROUGHLY

AND CAREFULLY. WHEN USING THIS DEVICE WITH ALIGHT

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. INADDITION, 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. INADDITION, 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

WHENEVER THE SCOPE IS REMOVED FROM THE LIGHT CABLE OR

THE DEVICE IS UNATTENDED. THE SCOPE TIP, SCOPE LIGHT POST,

LIGHT CABLE ADAPTER, AND LIGHT CABLE TIP WILL TAKE

SEVERAL MINUTES TO COOL OFF AFTER BEING PLACED IN

STANDBY MODE, AND THEREFORE MAY STILL RESULT IN FIRE OR

BURNS TO THE PATIENT, USER, OR INANIMATE OBJECTS.

WARNING TOHELP 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.

WARNING FEDERAL LAW (UNITED STATES OF AMERICA) RESTRICTS THIS

DEVICE TO USE BY, OR ON ORDER OF, APHYSICIAN.

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.

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.

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

LIGHT CABLE TIP WILL TAKE SEVERAL MINUTES TO COOL OFF

AFTER BEING PLACED IN STANDBY MODE AND THEREFORE MAY

STILL RESULT IN FIRE AND/OR BURNS TO THE PATIENT, USER, OR

AN INANIMATE OBJECT IF NOT USED PROPERLY. DONOT 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

•powercord

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.

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. Touch Screen: 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

Figure 2 Rear panel of the L9000 console

SFB Series Connectors

: Enables FireWire connection with Stryker

FireWire devices. Provides connection for remote diagnoses and future

software upgrades.

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

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