Related Manuals for Stryker L9000 LED
Summary of Contents for Stryker L9000 LED
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Page 1: User Guide
L9000 LED Light Source 0220210000 User Guide 2009/02 www.stryker.com 1000401120 D... -
Page 3: Table Of Contents
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 ............... -
Page 4: Warnings And Cautions
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: ARNING HE PERSONAL SAFETY OF THE PATIENT OR USER MAY BE INVOLVED ISREGARDING THIS INFORMATION COULD RESULT IN SERIOUS INJURY TO THE PATIENT OR USER Caution Special procedures or precautions must be followed to avoid... - Page 5 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.
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Page 6: Symbol Definitions
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. -
Page 7: Product Description And Intended Use
(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. -
Page 8: Indications
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. - Page 9 The features of the L9000 console are described below (see Figures 1 and 2). Figure 1 Front panel of the L9000 console Power Button: Powers the unit on and off. Touch Screen: Provides user controls and system feedback. Cable Clamp: Grasps the light-source end of an inserted fiberoptic cable.
- Page 10 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 Equipotential ground plug: Connects to a potential equalization conductor AC Inlet: Connects to the provided power cord for AC power supply.
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Page 11: Setup And Assembly
NSURE ALL SYSTEMS ARE INSTALLED ACCORDING TO THE REQUIREMENTS OF IEC 60601-1-1. Connecting the Light Cable ARNING SE ONLY NONCONDUCTIVE FIBEROPTIC CABLES WITH THE L9000 TO MAINTAIN ELECTRICAL ISOLATION Note The L9000 Light Source is compatible with all Stryker Light Cables. - Page 12 Lock open the cable clamp by turning the jaw handle clockwise until it stops (see Figure 3). Figure 3 Locking open the cable clamp ARNING EEP FINGERS AWAY FROM THE CABLE CLAMP AS THE CLAMP MAY INADVERTENTLY DEPLOY AND CAUSE INJURY ARNING O NOT LOOK DIRECTLY INTO THE CABLE PORT HE HIGH...
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Page 13: System Operation
ARNING F THE LIGHT SOURCE IS NOT IN TANDBY MODE PRIOR TO REMOVING THE CABLE THE HIGH INTENSITY LIGHT WILL SHINE DIRECTLY OUT OF THE LIGHT SOURCE BRIEFLY BEFORE TURNING ’ POSSIBLY CAUSING INJURY TO THE USER S EYES Note The Light Source will default to Standby mode when a light cable is inserted. -
Page 14: Selecting The Operation Mode
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 •... -
Page 15: Adjusting The Brightness
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. - Page 16 • The LCD also displays warning and error codes. The table below lists and defines the warning and error codes displayed. Code Definition Recommended Action The LEDs have exceeded their Return the L9000 for recommended operating temperature. repair. All conditions are met for the LEDs to Return the L9000 for illuminate, yet it remains off.
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Page 17: Language Selection
Language Selection The L9000 LCD has the capability of displaying text in the following languages Danish French Japanese Portuguese Dutch German Korean Simplified Chinese English Greek Norwegian Spanish Finnish Italian Polish Swedish To select a particular language, perform the following steps: Go into Standby mode. -
Page 18: Safety Shutoff
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. 7-10 ARNING NCE THE LIGHT SOURCE COOLS DOWN AFTER MINUTES POWER WILL RESUME TO THE LED MODULE AND THE UNIT WILL RESTART IN TANDBY MODE... -
Page 19: Checking The Esst Feature
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. -
Page 20: Using The L9000 With A Voice-Controlled System Interface
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 voice- control systems, refer to the SIDNE® Operating and Maintenance Manual (P/N 1000-400-653). -
Page 21: Troubleshooting
Troubleshooting Problem Possible Solution • Ensure the AC power cord is properly connected to a No light output hospital-grade power outlet and the inlet on the rear console panel. • Ensure the power switch on the front panel is powered on. (It will illuminate when powered on.) •... - Page 22 Too much or too • Ensure the light cable is correctly engaged with the little light output cable port. • Ensure the L9000 is in Activate mode. (The brightness level should appear on the LCD.) If necessary, press the Activate/Standby toggle button to switch from Standby to Activate.
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Page 23: Cleaning And Maintenance
Cleaning and Maintenance Cleaning the L9000 L9000 ARNING NPLUG THE BEFORE CLEANING THE UNIT Clean the external surfaces of the L9000 using a cloth or sponge dampened with a mild detergent or disinfectant. Clean and maintain the light cable according to the manufacturer’s instructions. -
Page 24: Technical Specifications
Type CF applied parts Water Ingress Protection, IPX0 — Ordinary Equipment Continuous Operation Patent Protection U.S. #5,850,496; 6,110,107; and 6,689,050. Other patents pending. Stryker European Representative: Regulatory Manager, Stryker France ZAC Satolas Green Pusignan Av. De Satolas Green 69881 MEYZIEU Cedex, France... -
Page 25: Electromagnetic Compatibility
Electromagnetic Compatibility Like other electrical medical equipment, the L9000 requires special precautions to ensure electromagnetic compatibility with other electrical medical devices. To ensure electromagnetic compatibility (EMC), the L9000 must be installed and operated according to the EMC information provided in this manual. Note The L9000 has been designed and tested to comply with IEC 60601-1-2:2001 requirements for EMC with other devices. - Page 26 Guidance and Manufacturer's Declaration: Electromagnetic Immunity L9000 is intended for use in the electromagnetic environment specified below. The customer or the user of L9000 should ensure that it is used in such an environment. Electromagnetic IEC 60601 Test Immunity Test Compliance Level Environment: Level...
- Page 27 Guidance and Manufacturer's Declaration: Electromagnetic Immunity L9000 is intended for use in the electromagnetic environment specified below. The customer or the user of L9000 should ensure that it is used in such an environment. Immunity IEC 60601 Test Compliance Electromagnetic Environment: Test Level Level...
- Page 28 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the L9000 System The L9000 system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user of the L9000 system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the L9000 system as recommended below, according to the maximum output power of the communications equipment.
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Page 29: Warranty
Stryker Endoscopy. If a valid warranty claim is received within the Warranty Period, Stryker will, in its sole discretion: (1) repair the product at no charge, (2) replace the product at no charge with a product that is at least functionally equivalent to the original product, or (3) refund the purchase price of the product. - Page 30 When a product or component is replaced, the item provided in replacement will be the customer’s property and the replaced item will be Stryker’s property. If a refund is provided by Stryker, the product for which the refund is provided must be returned to Stryker and will become Stryker’s property.
- Page 31 Restocking Fees: Unless the product is defective or the return is the direct result of a Stryker Endoscopy error, a restocking fee of 10% may be charged on all returned products.
- Page 32 If a return does not comply with these terms, Stryker Endoscopy reserves the right to destroy the product at the customer’s expense. Any replacement would be at the customer’s expense.
- Page 34 European Representative: Regulatory Manager, Stryker France ZAC Satolas Green Pusignan Av. De Satolas Green 69881 MEYZIEU Cedex, France 1000401120 D 2009/2 Products referenced with ™ designation are trademarks of Stryker. Products referenced with ® designation are registered trademarks of Stryker.