Stryker X8000 User Manual

X8000 Light Source

220-200-000

X8000 Light Source

User Guide

Contents

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

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

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

Setup and Assembly ............................................. 8

Connecting the AC Power Cable ...................................................... 8

Connecting the Light Cable .............................................................. 8

System Operation ............................................... 10

Powering the System On and Off ................................................... 10

Selecting the Operation Mode ........................................................ 11

Adjusting the Brightness ................................................................. 11

Visual Display .................................................................................. 12

Language Selection ........................................................................ 13

Safety Shutoff ................................................................................. 13

Checking the ESST Feature ............................................................ 14

Using the X8000 with a Voice-Controlled System Interface ........... 15

Using the SFB Serial Interface ........................................................ 15

Troubleshooting .............................................................................. 16

Cleaning and Maintenance ................................. 18

Cleaning the X8000 ......................................................................... 18

Caring for the Bulb Module ............................................................. 18

Replacing the Bulb Module ............................................................ 18

Replacing the Fuses ....................................................................... 20

Disposing of the X8000 ................................................................... 20

Technical Specifications ..................................... 21

Electromagnetic Compatibility ........................................................ 22

Warranty ............................................................. 26

Service and Claims ............................................. 27

Warnings and Cautions

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

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.

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 X8000, CAN GENERATE SIGNIFICANT AMOUNTS OF HEAT (EXCEEDING 41°C

/ 106°F)

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

AT THE SCOPE TIP, THE SCOPE LIGHT POST, THE LIGHT

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.

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 X8000 console.

7. Disconnect the X8000 from the electrical outlet when inspecting the fuses.

8. No modification of this equipment is allowed.

9. To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth ground.

10. Do not position the console so that it is difficult to disconnect the power cord from the supply mains.

11. Never use this equipment in the presence of flammable or explosive gases.

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.

ARNING FEDERAL LAW (UNITED STATES OF AMERICA) RESTRICTS THIS

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

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.

Caution: Surface may be hot

The user must read the provided instructions to safely operate the device. Disregarding the information could result in serious injury to the patient or user.

Consult instructions for use

Caution (consult instructions for use)

Power on/off (alternates when button is pushed)

Alternating current

Device recycling code (applicable in China)

Relative humidity limitation

Temperature limitation

Pressure limitation

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

Product catalog number

Product serial number

Date of manufacture

Legal manufacturer

Fuse rating

Product Description and Intended Use

The Stryker X8000 Light Source is a light-generating unit designed to illuminate surgical sites during endoscopic applications. The X8000 uses a 300-watt xenon bulb to generate bright, crisp light, which it delivers to the surgical site via a fiberoptic light cable. The X8000 is compatible with all Stryker light cables, and, with the proper light cable and adapters, can connect to any flexible or rigid endoscope.

The X8000 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 X8000 senses when the scope and the light cable are separated and places the light source in Standby mode. In Standby mode, the X8000 will reduce light output to a minimum, preventing the light cable from generating excessive heat.

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 X8000 Light Source consists of one of each of the following:

• light source console

•power cord

• xenon bulb module (spare or replacement bulb modules can be

purchased separately as P/N 220-201-000)

The features of the X8000 console are described below (see Figures 1 and 2).

Figure 1 Front panel of the X8000 console

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

2. Standby LED: Illuminates when the unit is operating in the Standby mode. In Standby mode, light output is reduced to a minimum level.

3. Mode Button: Selects either Standby or Run mode when pressed. Standby is the default mode when the light source is powered on.

4. Run LED: Illuminates when the unit is operating in the Run mode. In Run mode, light output is determined by the up and down switches.

5. LCD: Indicates the light intensity level (0-100%), bulb hours and language.

6. Up Button: Increases light intensity in Run mode.

Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 USA

U.S. Patents: 5850496, 6110107, 6689050 Other patents pending

MADE IN USA

SIDNE

12, 13

7. Cable Clamp: Grasps the light-source end of an inserted fiberoptic cable. (When no cable is inserted, the bulb automatically turns off to save bulb hours.)

8. Jaw Handle: Opens the fiberoptic-cable holder.

9. Down Button: Decreases light intensity in Run mode.

Figure 2 Rear panel of the X8000 console

10. Voi c e-C ontr o l Port : Connects to Stryker voice-control systems.

11.

SFB Series Connectors

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

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

13. Fuse Holder: Contains two T 5.0 AH 250 V fuses.

14. Equipotentiality Plug: Provides a grounding post for common grounding with other equipment. Connects to a potential equalization conductor. The resulting medical electrical system shall follow all applicable IEC 60601-1 requirements.

Setup and Assembly

Note Your local Stryker Endoscopy sales representative will perform

inservice training at your convenience to instruct you and your staff on the safe and effective operation and maintenance of the X8000, and to help set up the equipment. Please contact your local Stryker Endoscopy sales representative to schedule an inservice after the equipment has arrived.

Note When selecting a setup location for the X8000, consult the

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

To set up the X8000, make the following connections:

• Connect the AC power cable

• Connect the light cable

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.

ARNING WHEN THE X8000 IS INTERCONNECTED WITH OTHER MEDICAL

ELECTRICAL EQUIPMENT, LEAKAGE CURRENTS MAY BE ADDITIVE.

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

X8000

TO MAINTAIN ELECTRICAL ISOLATION.

Note The X8000 Light Source is compatible with all Stryker Light

Cables.

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