L9000 LED Light Source User Guide Rev E Feb 2013

Contents Warnings and Cautions ... 2 Symbol Definitions ... 4

Product Description and Intended Use ... 6 Indications ... 7 Intended Use ... 7

Setup and Assembly ... 10 Connecting the AC Power Cable ... 10 Connecting the Light Cable ... 10

System Operation ... 12 Powering the System On and Off ... 12 Selecting the Operation Mode ... 13 Adjusting the Brightness ... 14 Visual Display ... 15 Language Selection ... 16 Safety Shutoff ... 17 Checking the ESST Feature ... 18 Using the L9000 with a Voice-Controlled System Interface ... 19 Using the SFB Serial Interface ... 19 Troubleshooting ... 20

Cleaning and Maintenance ... 22 Cleaning the L9000 ... 22 Replacing the Fuses ... 22 Disposing of the L9000 ... 22

Technical Specifications ... 23 Electromagnetic Compatibility ... 24

Warranty ... 28

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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: 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 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 (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 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

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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

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 “Warranty” 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. No modification of this equipment is allowed. 7. Never sterilize any part of the L9000 console. 8. Disconnect the L9000 from the electrical outlet when inspecting the fuses. 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.

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

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. 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 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. The user must read the provided instructions to safely operate the device. Disregarding this 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)

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Alternating current Device recycling code (applicable in China)

Humidity range

Temperature range

Pressure range Federal law (USA) restricts this device to use by, or on order of, a physician The device meets requirements for safety and effectiveness set forth in MDD 93/42/EEC Product catalog number Product serial number Stryker European representative

Date of manufacture

Legal manufacturer

Fuse rating Turn the light source cable connection in the indicated direction to detach the cable Stryker Firewire

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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. 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

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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.

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

1

2

3

4

Figure 1 Front panel of the L9000 console

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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.

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6

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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. The resulting medical electrical system shall follow all applicable IEC 60601-1 requirements.

8.

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

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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.

WARNING

BEFORE EACH USE, CHECK THE OUTER SURFACE OF THE ENDOSCOPE TO ENSURE THERE ARE NO ROUGH SURFACES, SHARP EDGES, OR PROTRUSIONS.

ONLY CONNECT ITEMS TO THE LIGHT SOURCE THAT HAVE BEEN SPECIFIED FOR USE WITH THE LIGHT SOURCE. CONNECTING INCOMPATIBLE EQUIPMENT MAY CAUSE UNEXPECTED RESULTS.

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.

WARNING

WHEN THE L9000 IS INTERCONNECTED WITH OTHER MEDICAL ELECTRICAL 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 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.

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1.

Lock open the cable clamp by turning the jaw handle clockwise until it stops (see Figure 3).

Figure 3 Locking open the cable clamp

WARNING

KEEP FINGERS AWAY FROM THE CABLE CLAMP AS THE CLAMP MAY INADVERTENTLY DEPLOY AND CAUSE INJURY.

WARNING

DO NOT LOOK DIRECTLY INTO THE CABLE PORT. THE HIGHINTENSITY LIGHT MAY CAUSE DAMAGE TO THE EYES.

2.

Insert a clean, dry fiberoptic cable into the cable port until the jaw latch releases and the jaw clamps the cable in place (see Figure 4). Pull gently on the fiberoptic cable to test that it is securely seated in the cable port.

Figure 4 Inserting the light cable into the cable port

3.

Connect an endoscope to the opposite end of the fiberoptic cable.

4.

To remove the light cable, press the mode button on the touch screen to put the unit into standby. Then, turn the jaw handle clockwise until the latch opens. 11

WARNING

IF THE LIGHT SOURCE IS NOT IN STANDBY MODE PRIOR TO REMOVING THE CABLE, THE HIGH INTENSITY LIGHT WILL SHINE DIRECTLY OUT OF THE LIGHT SOURCE BRIEFLY BEFORE TURNING OFF, POSSIBLY CAUSING INJURY TO THE USER’S EYES.

Note

The Light Source will default to Standby mode when a light cable is inserted.

System Operation Note

Before operating the L9000, see the “Setup and Assembly” section of this manual.

Powering the System On and Off To power on the L9000: Press the power switch on the front panel. The LCD will indicate that the unit is in Standby mode. Note

The light will not illuminate unless a light cable is installed in the cable port.

To power off the L9000: 1.

Put the light source unit into Standby mode.

2.

Disconnect the light cable from the L9000 console.

3.

Run the fan for at least one minute to cool the unit.

4.

Press the power switch on the front panel of the L9000.

WARNING

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TO ALLOW FOR ADEQUATE COOLING, NEVER BLOCK THE REAR OR SIDE FAN VENTS. FAILURE TO FOLLOW THIS INSTRUCTION MAY RESULT IN DAMAGE TO THE L9000 OR A POSSIBLE FIRE.

Selecting the Operation Mode The L9000 has two operation modes, Activate and Standby. • ACTIVATE mode: The Activate mode is used during normal operation. It enables light output to be controlled by the brightness controls on the front console panel.

BRIGHTNESS

• STANDBY mode: The Standby mode is used when the L9000 is powered on, but not in use. It reduces the light output to a minimum, thereby reducing the heat generated at the tip of the light cable or scope when the L9000 is not being used.

STANDBY

Press the Activate/Standby button on the LCD screen to toggle between the two operational modes. WARNING

TO HELP PREVENT BURNS TO THE PATIENT, USER OR INANIMATE OBJECTS AND POSSIBLE FIRE, ALWAYS PUT THE L9000 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.

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Adjusting the Brightness The L9000 has up and down buttons for adjusting brightness. Press the up arrow to increase brightness, and press the down arrow to decrease brightness. The selection will appear on the LCD as a percentage between 0 and 100. When in Standby mode, the previous Activate mode brightness level appears in the lower right-hand corner. WARNING

THE HIGHER THE BRIGHTNESS, THE MORE HEAT ENERGY THAT WILL BE GENERATED IN THE SCOPE AND THE TIP OF THE CABLE.

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 ILLUMINATE THE SURGICAL SITE. FAILURE TO FOLLOW THIS INSTRUCTION COULD RESULT IN FIRE OR BURNS TO THE PATIENT, USER OR AN INANIMATE OBJECT. IN ADDITION, ADJUST THE INTERNAL SHUTTER OF THE CAMERA HIGHER IN ORDER TO RUN THE LIGHT SOURCE AT A LOWER INTENSITY.

WARNING

THE SURFACE TEMPERATURE NEAR THE SCOPE ADAPTER AND AT THE TIP OF THE SCOPE MAY EXCEED 41ºC IF THE UNIT IS OPERATED AT HIGH LEVELS OF BRIGHTNESS FOR EXTENDED PERIODS OF TIME. THE HEATED SCOPE AND ADAPTER MAY CAUSE BURNS TO THE PATIENT, USER OR AN INANIMATE OBJECT.

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Visual Display The L9000 provides feedback through the touch-screen LCD. • Brightness: The LCD display shows the intensity level of the light as a percentage between 0 and 100. For example, if the LCD shows “70,” the light output to the fiberoptic cable is running at 70 percent of capacity. • The LCD also displays warning and error codes. The table below lists and defines the warning and error codes displayed. Code

Definition

Recommended Action

E-1

The LEDs have exceeded their recommended operating temperature.

Return the L9000 for repair.

E-2

All conditions are met for the LEDs to illuminate, yet it remains off.

Return the L9000 for repair.

E-3

The LEDs are kept off because the electronics fan is not working properly.

Return the L9000 for repair.

E-4

The LEDs are kept off because the heat pipe fan is not working properly.

Return the L9000 for repair.

E-5

All conditions are not met for the LEDs to illuminate, yet it remains on.

Return the L9000 for repair.

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Language Selection The L9000 LCD has the capability of displaying text in the following languages Danish Dutch English Finnish

French German Greek Italian

Japanese Korean Norwegian Polish

Portuguese Simplified Chinese Spanish Swedish

To select a particular language, perform the following steps:

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1.

Go into Standby mode.

2.

Press and hold the Activate/Standby toggle button until the language identifier appears (approximately 5 seconds).

3.

Use left and right arrows to scroll through the available languages.

4.

Once the desired language is selected, press the Home button to return to the previous menu.

Safety Shutoff The L9000 Light Source is equipped with a Safety Shutoff feature which will temporarily turn off the LEDs in the event of excessive heat in the LED assembly. WARNING

ONCE THE LIGHT SOURCE COOLS DOWN (AFTER 7-10 MINUTES), POWER WILL RESUME TO THE LED MODULE AND THE UNIT WILL RESTART IN STANDBY MODE. TO PREVENT FIRES AND ACCIDENTAL BURNS TO THE PATIENT, USER OR INANIMATE OBJECTS, ALWAYS PLACE THE SCOPES AND/OR FIBEROPTIC CABLES IN A SAFE PLACE, AND NOT ON THE PATIENT, DRAPES, OR OTHER FLAMMABLE MATERIAL, TO ENSURE SAFE RESUMPTION OF LIGHT OUTPUT. IF THE L9000 LIGHT SOURCE EXPERIENCES A TEMPORARY SHUTDOWN, IT IS RECOMMENDED THAT THE DEVICE BE RETURNED FOR SERVICE.

Caution

Do not abruptly interrupt power to the unit. This will turn off the fan and may cause severe damage to the internal cooling system.

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Checking the ESST Feature The L9000 is equipped with Electronic Scope Sensing Technology (ESST), a special safety feature that helps prevent accidental fires or burns to the patient or user caused by a light cable not connected to a scope. This feature will only work if the L9000 is used with an ESST light cable. When operated with an ESST light cable, the L9000 senses when the scope and 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. To verify the ESST feature is active, perform the following test before every surgical procedure: 1.

Set up the L9000 system with an ESST light cable and scope, and then power on the system.

2.

Place the L9000 in Activate mode.

3.

Remove the light cable from the ESST scope adapter.

The L9000 should return to Standby mode, indicating that the ESST feature is functioning properly. WARNING

ALWAYS CHECK TO ENSURE THAT THE UNIT HAS SWITCHED INTO STANDBY MODE, BEFORE ASSUMING ESST SAFETY PROTECTION. IF THE UNIT FAILS TO RETURN TO STANDBY MODE, THERE MAY BE A FAULT WITH THE ESST FEATURE. IN THIS CASE, DO NOT ASSUME ESST SAFETY PROTECTION, AND RETURN THE UNIT FOR SERVICE.

WARNING

EVEN WITH ESST PROTECTION, OR WHEN THE L9000 IS IN STANDBY MODE, NEVER PLACE THE TIP OF THE LIGHT CABLE OR LIGHT CABLE ADAPTER DIRECTLY ON THE PATIENT, DRAPES OR OTHER FLAMMABLE MATERIAL, AS BURNS OR FIRE MAY RESULT. 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, ON THE DRAPES, OR OTHER FLAMMABLE MATERIAL, EVEN WHEN THE DEVICE IS IN STANDBY MODE.

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Using the L9000 with a Voice-Controlled System Interface The L9000 can be used in conjunction with Stryker voice-control systems (SIDNE®). For more information about using the L9000 with Stryker voicecontrol systems, refer to the SIDNE® Operating and Maintenance Manual (P/N 1000-400-653).

Using the SFB Serial Interface The SFB serial connection on the rear panel of the L9000 enables Firewire connection to the Stryker Endoscopy Software Management site. Connecting to this site enables remote diagnostics and software updates. Note

This system feature is not necessary for regular light-source operation.

Note

This system feature requires an additional device (such as a computer) to connect to the Software Management site.

Note

The SFB serial connection can also be used to connect the L9000 to the 1288HD Camera Console. When connected, the user can control the L9000 from the 1288HD Camera Head. For more information about using the L9000 with the 1288HD Camera System, refer to the 1288HD Instructions For Use (P/N 1000-401-140).

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