LED-4000 LED Light Source Operator Manual Rev. B July 2018

TABLE OF CONTENTS 1.

INTRODUCTION 1.1 INDICATIONS FOR USE

2.

WARNINGS

3.

SPECIFICATIONS

4.

OPERATING ELEMENTS, SYMBOLS AND FUNCTIONS 4.1 FRONT PANEL 4.2 REAR PANEL BOTTOM PANEL 4.3

5.

INSTALLATION 5.1 SETTING UP LIGHT SOURCE 5.2 CONNECTING LIGHT CABLE

6.

OPERATION 6.1 POWERING UP LIGHT SOURCE 6.2 STANDBY BUTTON 6.3 LIGHT BRIGHTNESS CONTROL AND DISPLAY 6.4 DATA PORTS

7.

CLEANING AND DISINFECTION 7.1 CLEANING AND DISINFECTING THE UNIT 7.2 CLEANING THE OPTICS

8.

SERVICING & REPAIR 8.1 FUSE REPLACEMENT 8.2 LIMITED WARRANTY

9.

END OF PRODUCT LIFE

10.

TROUBLESHOOTING

11.

CHART OF MEDICAL DEVICE SYMBOLS

12.

CHART OF ELECTRICAL SYMBOLS USED

LIT-216 CUDA® SURGICAL (English)

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1. INTRODUCTION Congratulations on the purchase of your new LED-4000 Light Source! This user-friendly, high efficiency LED light source utilizes state-of-the-art illumination technology. It offers a variety of features such as: •

Quiet operation

•

Long life, >30,000 hrs.

•

Compact and light weight

•

Pulse-width Modulation (PWM) Electrical Dimming

•

Ergonomic turret whichacceptsvarious types of light guides, typically, ACMI, Wolf, Olympus and Storz

•

Sensor automatically shuts off LED when light guide is removed

•

LLS-4000T-SC provides 75 CRI and 6500K color temperature (nominal)

•

LLS-4000T-HC provides 92 CRI and 5600K color temperature (nominal)

In short, you have chosen the best and we would like to make sure you receive the optimal results with your new LED light source by using it correctly. This Operator Manual will help you to install the device and integrate it with other components of your system. It will also instruct you how to operate the LED light source and how to keep it clean. It will give you maintenance and service guidelines as well as recommendations for best performance results. 1.1 INDICATIONS FOR USE: The 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 typically transmitted from the light source through a fiber optic cable and a scope.

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2. WARNINGS/ CAUTION Caution Federal law restricts this device to sale by or on the order of a licensed practioner. Caution To prevent fire or electric shock, do not open or expose the light source unit to rain or moisture. Refer all servicing to qualified personnel only. Caution Not suitable for use in presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide. Caution This equipment is suitable for use in hospital and clinical settings. Avoid placement near other high RF equipment; user should determine proper placement and confirm normal operation of equipment when stacked or used near or with other RF equipment. Caution This product should be used only with type BF endoscopic instruments which have been certified according to IEC 60601-1 for medical equipment and IEC 60101-2-18 for endoscopic equipment. This symbol indicates type BF equipment. Caution This product is not provided as sterile. WARNING

Do not modify this equipment without authorization of the manufacturer. Caution All devices connecting to the LED light source must be classified as medical equipment. When additional information processing equipment is connected to the LED Light Source, the operator must determine that all equipment complies with the appropriate end-product standards (such as IEC 60950 or IEC 60065 and the Standard for Medical System, IEC 60601-1-1). WARNING The LED 4000 is a highly concentrated light source (luminous power per area) and this high energy density is retained through connected lightguides and instruments. The output of a connected instrument left in close proximity to tissue or flammable materials presents a risk of patient injury or fire. Qualified personnel must determine a safe working distance and intensity setting for each application. The output should never be left on unattended. Turn the light source off or place it in standby if it will not be required for a period of time.

Caution The LED light source can cause permanent eye damage if viewed directly with unprotected eye. To reduce the chance of eye damage, place the light source in standby mode when light is not required. Caution The fiber optic cable must be a NON-CONDUCTIVE CABLE. It should not have conductive shielding or any other conductive connection between the patient and equipment. Such connection will impair safety of the equipment. It must be rinsed free of soaking/disinfectant solution and dried before plugging into the LED light source receptacle. Ensure the optical surface is clean before engaging into the light source. Caution This equipment is intended to illuminate a surgical site; user is responsible for determining if interruption of light output, including due to effects from electromagnetic disturbances, will create an unacceptable risk. If such a determination is made, alternate arrangements (such as a standby illuminator) should be made by the user to reduce the risk.

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Caution The proximal end tip of installed lightguides and accessories can become hot. Allow end tips to cool before removing. Caution The end user is responsible to verify the cable and port are correctly matched before light guide insertion, otherwise cable or light source damage may occur. ®

Caution Only FUSED light guides manufactured by ST Technologies (CUDA Surgical) should be used with the LED-4000. Caution If while in use there is a momentary power interruption the LED-4000 will shut-down and automatically restart it self if the power switch remains in the ON position; however there may be a restart delay as internal components reset for normal operation. Caution Use only approved manufacturer accessories and power cables. For more information, contact your distributor. Caution For grounding reliability, use only hospital grade marked power cord and receptacle.

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3. SPECIFICATIONS Item

Specification

Light Source type Color temperature

Regulatory Approvals

LED (Light Emitting Diode) 5600K nominal for LLS-4000T-HC 6500K nominal for LLS-4000T-SC 30,000 hours (typical) Turret type to fit your choice of four: Storz, ACMI, Wolf, Olympus PWM (Pulse-width Modulation) – 0-100% Dimming 100-240V AC, 50/60 Hz 5x20mm, 250V, 2A, Type F 150 watt, max. 125 watt, typ. rd UL60601-1, 3 Edition and CE marked

Equipment Class

BF-type, Conforms to CISPR 11 Class A

Mode of Operation

Continuous operation

Water Resistant

Not Protected Equipment, IPX0

LED life Light guide adapter Brightness control Input voltage Fuses Rated Power

Operating Environment Temperature Relative Humidity Air Pressure Storage Environment Temperature Relative Humidity Air Pressure Dimensions Weight

+0° to +40° C (32° to 104° F) 0 to 85%RH, non-condensing 700 to 1060 hPa -20° to +60° C (-4° to 140° F) 30 to 95%RH, non-condensing 700 to 1060 hPa 11.2” W x 4.5” H x 13.2” D 28.5 cm x 11.4 cm x 33.6 cm 7.55 lbs / 3.42 kg

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4. OPERATING ELEMENTS, SYMBOLS AND FUNCTIONS 4.1 FRONT PANEL

4 4

5

6

3

1

7

2

Figure 1. LED light source Front Panel No.

Name

Function

1

Main power switch

Turns the cabinet power on/off

2 3

Stand-by mode switch Turns the LED on/off but keeps the lightsource energized and with indicator light adjustable. Warning Indicator light Indicates internal malfunction. Contact Technical Support.

4

Light guide adapter

Turret model includes: Storz, ACMI, Wolf & Olympus ports

5

LCD Intensity Display

6

Brighter, Up Button

10 bar LCD display. Each fully lit bar represents approximately 10% change in light output Increases the Light intensity

7

Dimmer, Down Button

Decreases the Light intensity

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4.2 REAR PANEL

Figure 2. LED Light Source Rear Panel No.

Name

Function

1

AC main inlet

Accepts AC Power cord

2

Fuse

2A, 250V (1/4” x 1 ¼”) time delay

3

Equalization Connector

For potential equalization

4

Exhaust Vent

Allows exhaust ventilation and cooling of the light source

5

Serial Port

Data exchange port

6

USB-B

Data exchange port

7

USB-A

Firmware Update (Factory Use Only)

LIT-216 CUDA® SURGICAL (English)

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4.3 BOTTOM PANEL

1

2

3

Figure 3. LED Light Source Bottom Panel No. 1

Name Product Label

2 3

Part Number Label Software Label

Function Product Label containing: Model Number, Serial Number, Part Number, Electrical Ratings, Manufacturer Name and Date, Regulatory Marks, UDI Information and FDA "Rx Only" Symbol. Label contains part number for unit Contains information denoting version of software installed on unit

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5. INSTALLATION 5.1 SETTING UP THE LED LIGHT SOURCE Place the LED light source on a stable surface (cart, counter, stand, etc.). NOTE

Avoid places where the light source may be splashed with liquid. Absolutely DO NOT use in any environment with explosive or flammable gases. DO NOT block the venting grids of the light source or impede exhaust air flow. Users must ensure that ventilation air temperatures are below the maximum rating for the light source and are not influenced by warm exhaust from other sources.

Make sure the power switch is in OFF position. Connect AC power cord to the power inlet located on the rear panel of the light source. Use only cords provided with the light source. CAUTION

Plug the supplied AC power cord into a wall outlet.

CAUTION NOTE

To prevent electric shock, connect power cords of peripheral equipment through medical isolation transformers. When using medical isolation transformer, be sure to check the transformer power ratings. Make sure that the power cord is connected to the main power with a suitable plug (USA use UL2601-1 rated isolation transformers and/or power strips only).

5.2 CONNECTING THE FIBER OPTIC CABLE Connect the fiber optic cable to the instrument and then plug the lightguide endfitting into the appropriate turret port on the front panel. NOTE

The turret has a light guide sensing feature that will not allow the LED light to turn on until a fiberoptic cable is inserted into the active turret port.

6. OPERATION 6.1 POWERING UP THE LED LIGHT SOURCE To operate the LED light source: Turn on the power switch, the indicator light in the power switch will illuminate.

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6.2 STAND-BY BUTTON The STAND-BY button allows the user to turn the LED on or off when the main power switch is on, provided a light guide is inserted in the active port. Press AND HOLD this button momentarily for operation. An indicator lamp will be lit when stand-by mode is active (LED off) and the Light Intensity Control and Display will remain on and adjustable. 6.3 LIGHT INTENSITY CONTROL AND DISPLAY The light intensity is adjustable enabling the user to obtain a brighter or dimmer output by pressing and holding or repeatedly pressing the up or down arrow buttons until the desired illumination is reached. Each momentary press changes the intensity 5%. There is an illuminated vertical bar graph LCD display for visual reference to the amount of light intensity. Each fully lit segment represents 10% of the available intensity. 6.4 DATA PORTS There are three (3) DATA Transfer Ports; USB Type ‘A’, USB Type ‘B’ and a Serial Port located on the rear of the cabinet to allow communications between the lightsource and other monitoring or controlling equipment. For technical information concerning the DATA Ports or assistance please contact Customer Service.

7. CLEANING AND DISINFECTION 7.1 CLEANING AND DISINFECTING THE UNIT NOTE

Always disconnect the power cord before cleaning and while unit is drying if wet if wet-wiped.

Cleaning and disinfection agents should be commercially available cleansers commonly used for cleaning and/or disinfection of electronic equipment cabinents in hospitals, such as ethyl or isopropyl alcohols, disinfecting sprays containing quaternary ammonium compounds or hydrogen peroxide. 7.2 CLEANING THE OPTICS Exercising proper care for the glass optic in your LED 4000 lightsource can help maintain light quality and extend usable lifetime. Using the proper cleaning products and methods are as important as cleaning the component itself. Cleaning Solutions There are a variety of cleaning solutions you can use such as Reagent-Grade Isopropyl Alcohol, Reagent-Grade Acetone and De-Ionized Water to ensure a long product lifetime. A good solvent mix to use is a mix of 60% acetone* and 40% methanol. (Acetone alone dries too quickly to dissolve all of the debris. The methanol slows the evaporation time, and also dissolves debris that acetone alone would not clean.) *Acetone should never be used on plastic optics or components as it will damage them.

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Optic Cleaning Procedure Step #1 First use compressed air (aerosol can) to remove surface dust without directly contacting any coating the optic may have. (Wiping a dusty optic with cotton swabs or lens paper can abrade and damage the optic.) Step #2 Soak with solvent a Cotton-Tipped Swabs or Lens Tissue then use a circular motion starting from the edge of the optic moving towards the center to wipe away any dust or dirt. Repeat as necessary, each time use a new cotton swab or lens tissue.

8. SERVICING AND REPAIR Defective items are to be serviced and repaired exclusively by persons authorized by the manufacturer. All repair work shall employ original manufacturer’s parts only. 8.1 FUSE REPLACEMENT Always disconnect power cord and turn main switch off before fuse replacement.

CAUTION

Turn light source off and unplug power cord. On back of unit remove the fuse holder located in the power cord receptacle and pull out fuse holder. Users should use 2A Fast-acting 250VAC rated fuses. Insert holder back into fuse housing. Re-connect the power cord and turn the LED light source on according to section 6.1. 8.2 LIMITED WARRANTY Your LED-4000 light source carries a 3-year warranty from the date of shipment on workmanship and all defects of material. Should your product prove to have such defects within three years from the date of shipment from ST Technologies, we will repair or replace the product or component part without charge. Should your LED-4000 light source need servicing under this warranty, please contact ST Technologies for return authorization documentation. You should carefully pack the unit in a sturdy carton and ship it to the factory. Please include a note describing the defects, your name, telephone number and a return address. Warranty does not cover equipment subject to misuse, accidental damage, normal wear and tear or if transferred to a new owner without authorization from ST Technologies.This warranty gives you specific legal rights and you may also have other rights that vary from state to state. POST WARRANTY REPAIRS: You may return your product(s) for repair, shipping prepaid to the factory. Your product will be inspected and an estimate of repair charges will be submitted to you for approval. Payment must be received before repairs are completed. •

In the US:

877 814 2237 (toll free)

•

FAX number:

904 733-4832

•

Customer Service

904 208 2290

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9.

END OF PRODUCT LIFE

In accordance with the European Waste from Electrical and Electronic Equipment (WEEE) directive, we encourage our customers to recycle this product whenever possible. Disposal of this unit must be performed in accordance with the applicable local environmental regulations. In the US a list of recyclers in your area can be found at: http:/www.eiae.org/. Please contact our Repair Department to issue a return authorization to return product to manufacturer at the end of product life.

10.

TROUBLESHOOTING Problem

Solution

Check that the AC power cord is properly connected. Check the unit fuses. Replace if necessary; otherwise contact Customer Service. The power indicator is lit, but lamp is still off. Press Stand-by switch to turn on the LED. Insert light guide into the active turret port. Increase the LED intensity. Main switch power indicator (refer to 4.1) is not lit when switched on.

11.

CHART OF MEDICAL DEVICE SYMBOLS USED Manufacturer Date of manufacture (YYYY-MM-DD) “Authorized Representative” in the European Community Caution, consult accompanying documents Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner Consult Instructions for Use CE mark Not for disposal in general waste

Caution: Hot Surface Caution: Dangerous Voltage Product Safety Mark

Do not use if package is damaged.

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12.

CHART OF ELECTRICAL SYMBOLS USED AC Current Equipotentiality Power on Power off Type BF

Protective Earth (Ground)

LIT-216 CUDA® SURGICAL (English)

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LED-4000 (US PATENT 8,911,130)

LED Light Source Användarmanual ST Technologies 6018 Bowdendale Avenue Jacksonville, FL 32216 USA Kundtjänst: 904 208 2290 Avgiftsfritt: 877 814 2237 EC|REP

LIT-216 CUDA® SURGICAL (Svenska)

RMS UK, Ltd. 28 Trinity Road Nailsea, Somerset BS48 4NU United Kingdom TEL: 01275 858891

Version B Uppdateringsdatum : 07/12/18 Sida 85 av 112

LED-4000 (US PATENT 8,911,130)

LED 光源 操作マニュアル

ST Technologies 6018 Bowdendale Avenue Jacksonville, FL 32216 USA Customer Service: 904 208 2290 Toll Free 877 814 2237 EC|REP

LIT-216 CUDA® SURGICAL (日本語)

RMS UK, Ltd. 28 Trinity Road Nailsea, Somerset BS48 4NU United Kingdom TEL: 01275 858891

Rev. B 改訂日：07/12/18 7/14ページ Page 99 of 112