Viking Systems 8050-2-x 3DHD Light Source User Manual Rev A

©2010 by Viking Systems, Inc – All rights reserved. This publication is protected by copyright. Copying, disclosure to others, or other use of this publication is prohibited without express written consent of Viking Systems, Inc. Viking Systems, Inc. reserves the right to make changes shown herein without notice or obligation. Contact Viking Systems, Inc. or your representative for the latest information.

Important general instructions for use. Ensure that this product is only used as intended and described in the instruction manual by adequately trained and qualified personnel, and that maintenance and repair is only carried out by authorized technicians. Operate this product only in the combinations and with the accessories and spare parts listed in the instruction manual. Use other combinations, accessories and wearing parts only if they are expressly intended for this use and if the performance and safety requirements are met. Reprocess the products before every application and before returning them for repairs as required by the instruction manual in order to protect the patient, user or third parties.

CAUTION- USA only: Federal law restricts this unit to be used or sold, except under the supervision of a medical doctor.

Safety instructions and levels of danger WARNING

Failure to observe can result in death or severe injury. IMPORTANT Failure to observe can result in damage to the product or surroundings.

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CAUTION Failure to observe can result in slight injury or damage to the product.

NOTE Tips for optimum use and other useful information.

Table of Contents Product Overview ... 5

Product Description ... 5 Set Up & Inspection Prior to Use... 5 Notes on Safety... 5

Operation ... 7 Replacements ... 8

Xenon Lamp Module... 8 Fuse ... 9 Replacement Parts & Accessories... 9 Maintenance & Cleaning ...10 Troubleshooting ...10

Specifications...11 Electromagnetic Compatibility User Information ...12 Block Diagram...13 Repairs and Returns ...14

Warranty Service & Repair ...14 Limited express Warranty...14 Disposal of the Product, Packing, and Accessories...14

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Table of Symbols Symbol

Meaning

Meaning

On/Off (Power)

Stand-by

Consult instructions for use

Caution: High Voltage

Type CF Equipment

High Temperature

Date of Manufacture

Manufacturer

Decrease Intensity

Increase Intensity

System Status Display

Listed by CSA

Catalogue Number

Serial Number

Protective Ground

Keep Dry

Separate collection required. Do not dispose equipment in municipal waste

Identification in conformity with medical devices directive 93/42/EEC only valid if the product and/or packaging is marked with this symbol. Products of category IIa and above, as well as sterile products or products with measuring function pertaining to category I are additionally marked with code number of the notified body.

Fuse

Equipotentiality

Authorized Representative

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Symbol

~

Alternating Current

Hours

Intensity

Lamp

Over Temperature

Product Overview Product Description The Viking Systems 3DHD Light Source is designed to supply high-intensity white light through a fiber optic cable for illumination of a surgical field during a surgical and/or medical procedure. The Viking Systems light source delivers 300 watts of cool white infrared (IR) filtered light. The lamp is housed in a lamp module that can be easily serviced without special tools.

Set Up and Inspection Prior to Use •

The light source comes with the hospital grade power cord packaged separately. Verify that both components are in good condition.

•

Before turning power on to the light source, make sure the unit is plugged into any standard 100VAC to 240VAC 47-63Hz (as appropriate) outlet. Grounding reliability is guaranteed only when connected to a “hospital grade” receptacle.

•

Allow a minimum of 2 inches (5.08 cm) clearance at the rear and sides of the unit for cooling air flow. Ensure that the unit is not near air exhaust or against other equipment. WARNING

The light source monitors air intake temperature and will turn off if ambient temperature is > 40O C.

Notes on Safety General Warnings: • The user should carefully study the Operation and Service Manual before using the equipment in a clinical environment. Instructions should be followed, with special attention given to warnings, controls and specifications. The Manual should be available to the appropriate personnel. •This Manual contains information about the proper procedures for preparing this product for its use and care. • Before every procedure, carefully inspect the light source to ensure it has been properly maintained and cleaned, and that it is fully functional. DO NOT use if inspection reveals any damage such as case damage or loose connectors. • Follow the instructions of other manufacturer’s equipment when used in conjunction with this product.

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• To reduce the risk of fire and electric shock, do not expose electrical equipment to moisture. When cleaning, do not immerse any electrical device in liquid. •Do not use or store liquids on or above the light source. • SAFETY PRECAUTIONS MUST ALWAYS BE EXERCISED WHEN USING ELECTRICAL EQUIPMENT TO PREVENT OPERATOR/PATIENT SHOCK, FIRE HAZARD OR EQUIPMENT DAMAGE. • Electric shock hazard. If unit is not functioning properly, DO NOT OPEN. Please refer to the Repair and Return Section of this Manual. • All electrical equipment must be used with approved hospital grade power cords and power plugs inserted properly into grounded AC power outlets. • The light source should never be used in ocular surgery or in a surgical procedure requiring direct illumination of the eye. • Use care not to point any fiber optic cable directly at the eye while operating the light source. • The light source produces high intensity light. Thermal burns can result from improper use of the light source or from the light output of the fiber optic cable. • Explosion Hazard. Do not use in the presence of flammable anesthetics, liquids, vapors, gases or dusts. • Keep cooling vent and fans free of obstructions. • FIRE HAZARD: DO NOT DRAPE OR COVER THE LIGHT SOURCE WHILE IT IS OPERATING. • When light source is not in use, turn off the power or put the unit in stand-by mode. • Ensure that the fiber optic cable matches the port type to prevent damaging the optical components of the light source. For user convenience, the light source has a turret with labeled selectable ports.

Precautions: • Take precautions to verify that the fiber optic cable is appropriately suited for the light source. Xenon and other high illumination light sources require premium glass-fused fiber optic cables to achieve optimal performance and prevent damage to the fibers, thereby diminishing the quality of light output or the useful life of fiber optic cable. • Take precautions not to touch or disconnect the cable end fitting from the turret until the Light Source has been “shut down” for a period of time and allowed to cool. The cable end fitting will remain hot immediately following shut down, which can cause burns. • Take precautions to not place and rest a hot cable end fitting on a patient or allow the system to come in contact with un-protected hands or tissue. The entire system should be allowed to cool following use. Failure to do so can cause burns and/or tissue damage

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Operation 1. Insert a fiber optic cable in the proper port in the turret. The active port is indicated by a ◄ on the front panel (See Figure 1). Available ports are ACMI, Olympus, Storz and Wolf cable-compatible. All ports are identified appropriately. 2. Press the Power Switch in the upper left corner of the front panel (See Figure 2). 3. When the Power Switch is pressed the Stand-by Light (Figure 2) will blink and there will be a 3 – 4 second delay before the Xenon Lamp illuminates while the system does a self-diagnostic check.

Figure 1

Figure 2

5. The system will start up at the same light intensity as when last used. For new systems, the light intensity will start at the minimum 20% setting. 6. To adjust the light intensity, push the Membrane Switches (Figure 3): + to increase or - to decrease the light output or intensity. Range is 0%, 20 – 100% in 5% increments. Holding the + or – button will change the intensity more quickly. 7. The System Status Display button can be pressed to show both lamp age and system operation time. A second press of the button will show the software version of the system monitor. A third press returns to light output. (The system will automatically return to the light intensity reading after15 seconds). 8. The system can be placed in stand-by mode (no light emitted), allowing the surgeon to unplug a cable and move around the table or to change cables in a laparoscopic or endoscopic procedure.

CAUTION Cable end fitting can be HOT!!!

NOTE If unit is left in stand-by mode for 15 minutes, it will automatically shut off the lamp. Fans will keep running. To re-activate, push the Stand-by Button.

Figure 3

9. To shut the system off, simply press the main Power Switch as in Step 2.

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Replacements Xenon Lamp Module Replacement Note: Please adhere to appropriate safety precautions when performing lamp replacement. Only qualified personnel should service this device. Protective facemask and/or proper safety glasses should be worn when replacing the lamp module. Before changing the lamp module, turn power off and allow the light source to cool for at least fifteen (15) minutes. Please read and comply with all Precautions and General Warnings listed in this manual. To remove: 1. Make sure the power is off and the hospital grade power cord is disconnected. 2. Remove the retaining screws from the top plate (Figure 4) and retain screws. 3. Slide the top plate towards the back of the unit until it stops. 4. Lift the top cover up and off the unit. 5. Unscrew the lamp module door and remove (Figure 5) and retain screw. 6. Grasp the module by the tabs and pull directly up (Figure 6).

Figure 4

Figure 5

Figure 6 To Replace: 1. Orient the lamp module (8050-2-1) to face forward. 2. Place the module into the light source. 3. Seat module securely. 4. Replace the lamp module door and secure it with the screw. 5. Align top cover brackets into slots and slide forward. 6. Slide the top plate forward until it engages the front panel. 7. Replace the retaining screws in the rear panel. 8. Replace the hospital grade power cord and turn on power to verify operation. To Reset Lamp Age Meter: 1. Using the membrane switch, turn the display to the lamp age/system age screen.

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Figure 7

2. On the rear of the unit insert a pen/pencil or other suitable pointed object into the slot marked RESET (Figure 7). 3. Push until a click is felt. 4. Verify that the lamp age has been reset to 0.

NOTE The System Age reading CANNOT be reset.

Fuse Replacement To replace the fuse: • The fuse for the light source is located in the power entry module in the rear of the unit. • Remove the hospital grade power cord from the back of the light source. • Using a small flat screwdriver, pry open the retaining door (Figure 8) and pry out the red plastic block from the power entry module (Figure 9). • Check to see if the fuse is blown; if blown replace with a fuse of the same rating (T6.3AL250). • Replace the red block in the housing. • Snap the retaining door into place. • Plug cord back into light source and retest the unit.

Figure 8

Figure 9

Replacement Parts & Accessories To place an order, contact your local Viking Systems distributor or call Viking Customer Service at 1-888847-8268, ext 8224 (USA & Canada only) or +1-508-366-3662 to identify your local Viking representative.

Light Source: 8050-2

3DHD Light Source

Accessories: 8050-2-1

3DHD Light Source Replacement Bulb

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Maintenance & Cleaning •

Allow unit to cool for at least 15 minutes prior to cleaning.

•

Unplug the power cord before cleaning. The light source exterior can be cleaned and disinfected using 70% isopropyl alcohol.

•

Allow 5 minutes for alcohol to evaporate before reconnecting to power.

•

Use a vacuum cleaner and a soft brush to remove visible dust accumulation from fan and vent holes whenever necessary and always when replacing the lamp.

Troubleshooting

Problem

Cause

Action

No light output

Light source not turned on

Turn power on

Bad/no lamp

Bad lamp Light source not plugged in

Check lamp seating/replace lamp module Check light intensity setting on front panel Rotate turret to desired adapter fitting Replace fuse as indicated in maintenance section Rotate turret to matching adapter fitting Check light intensity setting on front panel Replace lamp module Plug in light source

Top cover not closed

Close and secure top cover

Attenuator closed Turret mispositioned Blown fuse Reduced light output

No power

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Cable mismatched to turret Attenuator mispositioned

Specifications Viking Systems Xenon Light Source Lamp Type Wattage Lamp Life

Xenon Short Arc Lamp 300 Watts 1000 Hours

Light Source Dimensions L x W x H Weight Power Input Fuses (2) Power Consumption AC Power Leakage Classification Electrical Safety Electromagnetic Compatibility Environment: Storage Temperature Operation Temperature Humidity Power Cord

15.4" x 11x2" x 5.9" (390mm x 285mm x 150mm) 15 lbs (6.8 grams) 100 - 240 VAC 50 - 60Hz ±10% 6.3A, 250VAC 5x20 mm, 450 Watts (maximum) Leakage current to chassis (with ground wire intact): less than 100 microamps; Leakage current to chassis (with ground wire interrupted): less than 500 microamps Type CF, class 1 Type A device CSA listed, Conforms to UL 60601-1 and CSA C22.2 No. 601.1 EN60601-1-2:2001 0°C to 50°C (32°F to 122°F) 10°C to 40°C (50° to 104°F) 10-85% non-condensing Hospital Grade

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Electromagnetic Compatibility (EMC) User Information WARNING Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the Electromagnetic Compatibility [EMC] information provided in the accompanying documents. Portable and Mobile RF Communications Equipment can affect Medical Electrical Equipment. The equipment or system should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the equipment or system should be observed to verify normal operation in the configuration in which it will be used.

NOTE The EMC tables and other guidelines that are included in the Instruction Manual provide information to the customer or user that is essential in determining the suitability of the Equipment or System for the Electromagnetic Environment of use, and in managing the Electromagnetic Environment of use to permit the Equipment or System to perform its intended use without disturbing other Equipment and Systems or non-medical electrical equipment.

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Block Diagram

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Repairs and Returns This device must be clean and decontaminated prior to return to Viking Systems. Viking Systems reserves the right to return unrepaired any equipment that is contaminated with blood or other organic material.

Warranty Service and Repair To obtain service under warranty or return product for repair, the customer should contact your local Viking representative or call Viking Customer Service at 1-888-847-8268, ext 8224 or +1-508-366-3662.

Limited Express Warranty Viking Systems warrants that the light source shall be free from defects in material and workmanship under normal use and service for a period of two (2) years from the date of shipment. Viking System's sole and exclusive liability under the warranty shall be, at Viking System's option, either to repair any component which fails during the warranty period due to any defect in workmanship or material F.O.B. factory if: 1. Customer promptly reports such defect to Viking in writing, 2. If requested by Viking, customer returns equipment to Viking with shipping charges and, 3. Upon inspection, Viking finds the equipment to be defective. This warranty is contingent upon normal and proper use of the equipment. It does not cover equipment that has been modified with non-Viking parts without the written approval of Viking, subjected to unusual physical or electrical stress, or damaged during shipment. This warranty is non-transferable unless authorized in writing by Viking. Viking reserves the right to make design changes on its products without liability to incorporate said change in Viking products previously designed or sold. Upon receipt of the product, it should be carefully inspected. If any defect is discovered, notification must be given immediately to the manufacturer or authorized distributor.

Disposal of the Product, Packing, and Accessories For disposal, observe the relevant regulations and laws in your country. For further information please contact your local Viking distributor.

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Manufactured For: Vision System Group, a Division of Viking Systems, Inc. 134 Flanders Road Westborough MA 01581 Tel: 1 800-200-9824 or 1 508-366-3668, ext. 8119 Fax: 1 508-366-1543 E-mail: [email protected]

Authorized Representative: Medical Device & QA Services 76 Stockport Road Timperley, Cheshire WA15 7SN United Kingdom TEL: 44 161 980 4310 Fax: 44 161 903 9787

15 P/N J02944-128 Rev. A