9300XSP and 9300XDP Operation and Service Manual Feb 2002

TABLE OF CONTENTS

Table of Symbols

3

General Warnings

3

9300XSP/9300XDP Overview

4

Indication For Use

4

Inspection Before Use

4

Floor Stand Assembly

5

Installation to Floor Stand

5

Light Source Operation

6-7

Xenon Lamp Module Replacement

7–8

Turret Change

9

Troubleshooting

10

Maintenance and Cleaning

10

Light Source Specifications

11

Block Diagram

12

Ordering Equipment Parts List

13

Limited Warranty

14

Repair and Return

14

2

TABLE OF SYMBOLS Found on Light Source

Attention: Consult Accompanying Documents

Fuse

Caution: High Voltage

Equipotentiality

High Temperature

Brightness

Type CF Equipment

Intensity

GENERAL WARNINGS The user of this Luxtec product should be thoroughly familiar and trained in the assembly, use and care of this product. The user should carefully study the Operation and Service Manual before making any attempt to use the equipment in the clinical environment. Instructions should be followed specifically, with special attention given to warnings, controls and user specifications. The Manual should also be available to the appropriate personnel. This Manual contains information about the proper procedures for inspecting and preparing this product before its use, and care and storage after use. Follow the instructions and restrictions in the operating manuals of other manufacturer’s equipment when they are used in conjunction with this product. 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 cable cuts or loose connectors. 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. SAFETY PRECAUTIONS MUST ALWAYS BE EXERCISED WHEN USING ELECTRICAL EQUIPMENT TO PREVENT OPERATOR/PATIENT SHOCK, FIRE HAZARD OR EQUIPMENT DAMAGE. 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. The Light Source produces high intensity light. Thermal burns can be the result of improper use of the Light Source or the light output of the light guide cable. NOTE: It is strongly recommended that the light intensity be adjusted to the minimum level of brightness for the procedure. There is a risk that prolonged exposure on one spot during surgery, at close proximity may cause an increase in tissue temperature. Minimum intensity levels and exposure will mitigate this occurrence. Use only fiber optic light guide cables that are approved for high intensity light output.

3

OVERVIEW Indication for Use This device is designed to supply high-intensity white light to a fiber optic cable for illumination of a surgical field or other area of examination or operation. The 9300XDP and 9300XSP deliver 300-Watts of cool white IR filtered light. The lamp is housed in a lamp module that can be easily removed and replaced by the user without special tools.

Figure 1

Power Switch

Turret

An illuminated push-on and push-off power switch is located on the front panel. See Figures 1 and 2. The rotating turret wheel is designed to accommodate the user’s choice of 4 different light guide endfitting styles. The standard turret has ACMI, Olympus, Wolf and Storz adapter ports. The intensity of the light output is controlled manually by the light intensity knob located to the right of the turret wheel. The bulb life is indicated in hours of use on the front panel by a digital meter. NOTE: You must use ONLY a Luxtec supplied lamp module assembly for replacement in this Light Source. Use of other lamps or lamp assemblies will void all warranties for this product. Refer to Parts List later in this manual.

Digital Lamp Age Meter

Light Intensity Knob

9300XSP Front View

Figure 2

Digital Lamp Age Meter Secondary Turret Power Switch

Primary Turret

Beamsplitter Light Intensity Knobs

9300XDP Front View

Set Up and Inspection Before Use The 9300XDP and 9300XSP Light Sources come with the power cord attached. Please verify that both components have been received undamaged. All fiber optic light guides should be properly cleaned and sterilized prior to first time use. See light guide manufacturer’s manual for information.

Warnings: Do not use or store liquids on or above the Light Source. Electric shock hazard. If unit is not functioning properly, DO NOT OPEN. Please refer to the Repair and Return Section of this Manual. Explosion Hazard. Do not use in the presence of flammable anesthetics, liquids, vapors, gases or dusts. Use care not to point any light guide directly at the eye while operating the Light Source. 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 rotate the turret 1/8 turn to block light output. 4

OPTIONAL FLOOR STAND ASSEMBLY Figure 3

There are three (3) parts to the floor stand assembly: See Figure 3.

Swivel-top base Fiber optic headlight hanger Power cord hanger

Interlocking adapter plate lever Nylon bushing Top section Two-piece column Bottom section Casters base

Figure 4

Swivel-top base Interlocking adapter plate plunger

Interlocking adapter plate lever (“open”position)

To assemble the floor stand, remove the base from the box and stabilize it by placing a stop in front of one of the casters. Assemble the two column sections as shown in Figure 3. One section of the column has an arrow that should point up as the stand is assembled. Slide the lower end of the top section over the upper end of the bottom section. Position the tapered end of the two piece column in the base. Be sure the nylon bushing in the upper section of the column is at the top. Place the swivel top base through the nylon bushing. The base should rotate freely within this bushing. Open the interlocking adapter on the swivel top base by pulling down on the plunger and sliding the lever to the “open” position as labeled. See Figure 4. The swivel top base is now ready to receive the Light Source.

Installation to Floor Stand 1. Place Light Source on the floor stand base so the front edge is up to the rim of the base. Verify that all rubber feet of the Light Source are positioned on the base. 2. Slide the interlocking adapter plate to the lock position. The plate plunger will snap into the locked position as shown in Figure 5. 3. Check the rear of the Light Source to be sure the floorstand plate captures the support plate underneath the Light Source and is secure.

Figure 5

Interlocking adapter plate (rear) Swivel-top base Rim

1. Casters base 2. Two-piece column 3. Swivel top base with interlocking adapter plate with cord hangers

Interlocking adapter plate lever (“locked”position)

Setting Up Before turning power on the Light Source, make sure the unit is plugged into any standard 100V to 240V 50/60Hz (as appropriate) three-conductor outlet. Grounding reliability is guaranteed only when connected to a “hospital grade” receptacle. 5

OPERATION Power on the Light Source The power switch is located on the front panel. See Figure 8. Ignition clicking sounds are normal. Some light will show through the turret wheel and the fan outlets. When the power switch is pressed, it will light up indicating power is on. The Light Source is now ready to use.

Figure 6

Rotate turret wheel 1⁄8 turn to block light output. See Figure 6. When finished using the Light Source, press the power switch again to turn off the unit.

Turret

Turret The 9300XDP and 9300XSP Light Sources are equipped with a rotary turret. See Figures 6 and 7. This turret is to attach light guide cables for instrument or headlight use to the Light Source. Luxtec offers three turret options:

Light intensity knob

9300XSP

Figure 7

Primary Turret

Secondary Turret

1. Kit “T”: ACMI, Wolf, Storz and Olympus (standard) 2. Kit “P”: ACMI, Wolf, Storz and Pilling 3. Kit “D”: Wolf, Storz, Designs for Vision and Olympus. To operate the turret, rotate the wheel until the desired connection lines up with the light channel. When the fiber optic cable is inserted, a click can be heard indicating the cable is properly seated.

Light intensity knobs

9300XDP

Light Attenuation The 9300XDP and 9300XSP have a manually operated light intensity knob to control the desired light output level. To increase the light output, rotate the knob clockwise until the desired level is reached. See Figures 6 and 7. NOTE: It is strongly recommended that the light intensity be adjusted to the minimum level of brightness for the procedure. There is a risk that prolonged exposure on one spot during surgery, at close proximity may cause an increase in tissue temperature. Minimum intensity levels and exposure will mitigate this occurrence.

Figure 8

Single or dual port indicator knob

9300XDP 6

Dual Port Mirror Mode (9300XDP only) The 9300XDP has a knob on the front panel which indicates single or dual port capability. See Figure 8. The knob rotates to allow the operator to use the Light Source in a single or dual port mode. NOTE: The second port is NOT a back-up port for the first port. From the front panel symbols: • Two yellow bulbs indicate two port operation. • One yellow bulb and one black bulb indicates single port operation.

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 gloves should be worn when replacing lamp module. Before changing the lamp module, turn power off and allow the Light Source to cool for at least fifteen (15) minutes.

Figure 9

Rear panel fasteners

Figure 10A

Please read and comply with all precautions listed in the General Warnings section of this manual. The Xenon Lamp Module should be replaced after 650 hours of use or if the lamp fails to start when the power is turned on. NOTE: You must use ONLY a Luxtec supplied lamp module assembly for replacement in this Light Source. Use of other lamps or lamp assemblies will void all warranties for this product. Refer to Parts List later in this manual.

To remove: 1. Make sure power switch is turned off. Disconnect the power cord from the hospital grade receptacle. Figure 10B

2. Allow the unit to cool down for a minimum of 15 minutes before replacing the lamp module. The lamp module may represent a burn hazard if not allowed to cool sufficiently prior to servicing the device. 3. Remove the two side screws and loosen the two quarter turn screws in the back of the unit. See Figure 9. Pull back on the top cover handle as indicated in Figure 10A and then pull up on the top cover to open as indicated in Figure 10B. 7

XENON LAMP MODULE REPLACEMENT 4. Firmly grasp the lamp module by the protective cover with one hand while pressing the release button with the other. Pull up to remove the assembly. See Figure 11. Do not use excessive force or prying tools.

Figure 11

To replace: 1. Replace the lamp module assembly only with a Luxtec provided lamp module assembly. 2. Firmly grasp the lamp module by the protective cover with one hand while pressing the release button with the other. Do not touch the glass surface of the lamp itself. 3. Line up the base with its mating piece and firmly press the lamp module into place. See Figure 12. 4. Disengage the release button to secure lamp in its proper position. The lamp module should not tilt or jiggle while in place. 5. Pull the top cover down to close the Light Source (reverse movements shown in Figure 10) then push the cover toward the front of the unit to line up side screw holes. Replace side screws. Secure quarter turn screws in back of the unit by turning to the right. After closing the unit, push the front panel power button to turn the unit on. Record the number of hours indicated by the digital lamp age meter on the front panel. Note: the Light Source must be operating to reset the digital lamp age meter. See Figure 13. A maintenance log sticker is located on the rear panel of the unit for convenient recording and tracking of this information.

Lamp module

Figure 12

Lamp module

Figure 13

Reset switch

After recording the hours of operation, the digital lamp meter may be reset by momentarily depressing the rear panel reset switch as shown in Figure 13. Turn the Light Source off after completing this procedure. Do not leave the unit operating while unattended. Maintenance log sticker

8

TURRET CHANGE How to change the turret

Figure 14

To remove current turret assembly:

9300XSP

1. Turn off Light Source. Unplug unit. 2. Rotate turret until Wolf port is lined up at 12 o’clock. 3. Through the Wolf port hole, remove the screw with a Phillips screwdriver. 4. Rotate turret so the Wolf large hole is over the opposite screw, at 6 o’clock. 5. Through this large hole, remove the second screw. 6. While pulling forward, gently remove the turret assembly.

To install a new turret assembly:

Figure 15

9300XDP

1. Push desired turret into hole in bezel. A small pin in the plate behind the cup will line up with a small hole in the turret cup. It will allow the cup to seat only one way. 2. Rotate turret until Wolf port is lined up at 12 o’clock. 3. Through the Wolf port, install one of the flat head screws (supplied with turret). 4. Rotate turret so the Wolf large hole is over the opposite screw, at 6 o’clock. 5. Through the Wolf port, install the second screw. 6. When secured, turret should not rock but should rotate freely. Rotate turret to assure it is seated and secure. Light source is now ready to use.

9

TROUBLESHOOTING Problem

Cause

Action

No light output

Light source not turned on Bad/no lamp Attenuator closed Turret mispositioned Blown fuse

Reduced light output

Cable mismatched to turret Attenuator mispositioned Bad lamp

Turn power on Check lamp seating/replace lamp module Check position of knob on front panel Rotate turret to desired adapter fitting Replace fuse as indicated in maintenance section Rotate turret to matching adapter fitting Check position of knob on front panel Replace lamp module

No power

Light source not plugged in Top cover not closed

Plug in Light Source Close and secure top cover

MAINTENANCE AND CLEANING Maintenance:

To replace the fuse:

If the Light Source does not operate properly when connected to a grounded receptacle, check the fuse(s). Do not attempt to repair the unit if the lamp fails in use. Turn off the unit and allow it to cool for at least 15 minutes, then try to restart the unit. If the lamp still fails to illuminate, the lamp may be defective, the lamp has exceeded its useful life (see lamp replacement), or there is a power failure. Try replacing the lamp module. If you still experience difficulties, return the unit to Luxtec Corporation for evaluation.

The fuse(s) for the Light Source is (are) located in the power entry module in the rear of the unit. Remove the power cord by unscrewing the cord lock from the back of the Light Source with a small screwdriver, then unplug the cord from the unit. Using the small flat screwdriver, pry out the red plastic back from the power entry module. Check to see if the fuse(s) is (are) blown, then replace with fuse(s) of the same rating (T6.3A 250V). To replace the red block in the housing, snap the retaining ring in place. Plug cord back into Light Source and retest the unit. If unit now works, replace the cord lock with screws previously removed to secure cord to unit.

Cleaning: The Light Source can be cleaned and disinfected using 70% isopropyl alcohol. Unplug the power cord before cleaning. Allow 5 minutes for alcohol to evaporate before reconnecting to power.

10

SPECIFICATIONS Lamp Type

Xenon Short Arc Lamp

Wattage

300 Watts

Color Temperature

>6000 Kelvin, IR Filtered

Bulb Warranty

650 Hours, Prorated per Hour

Position

Horizontal ±15°

Light Source Dimensions

15"L x 12"W x 5"H (381mm L x 305mm W x 127mm H)

Weight

21 lbs. (9.5kg)

Power Input

100~240V AC 50 – 60 Hz

Circuit Protection

Fuse 6.3A 250V

Power Consumption

400 VA

AC Power Leakage

Leakage current to chassis (with ground wie intact), less than 100 microamps Leakage current to chassis (with ground wie interupted), less than 500 microamps

Classification

IEC 601-1, Type CF, Class 1

Electrical Safety

Meets or exceeds UL 2601-1, IEC 601-1, and CAN/CSA C22.2 NO. 601.1-M90, ETL Listed and CE marked

Electromagnetic Compatibility

Meets European EMC Directive

Environment: Operating/ Storage Temperature Range Humidity

10°C – 40°C 95% Relative Humidity Non-Condensing Maximum 11

BLOCK DIAGRAM

12

ORDERING EQUIPMENT

9300XSP/9300XDP Parts List To place an order, contact your local Luxtec distributor or call Luxtec Customer Service at 800-325-8966 to identify your local distributor.

Light Sources 00-9300XDPCF-DD 00-9300XDPCF-DP 00-9300XDPCF-DT 00-9300XDPCF-PD 00-9300XDPCF-PP 00-9300XDPCF-PT 00-9300XDPCF-TD 00-9300XDPCF-TP 00-9300XDPCF-TT

Note: Dual Turrets are identified as a two letter suffix. The first letter indicates the primary turret option and the second letter indicates the secondary turret option. 300 Watt Xenon Dual Turret Light Source with 2 D Turrets 300 Watt Xenon Dual Turret Light Source with 1 D and 1 P Turret 300 Watt Xenon Dual Turret Light Source with 1 D and 1 T Turret 300 Watt Xenon Dual Turret Light Source with 1 P and 1 D Turret 300 Watt Xenon Dual Turret Light Source with 2 P Turrets 300 Watt Xenon Dual Turret Light Source with 1 P and 1 T Turret 300 Watt Xenon Dual Turret Light Source with 1 T and 1 D Turret 300 Watt Xenon Dual Turret Light Source with 1 T and 1 P Turret 300 Watt Xenon Dual Turret Light Source with 2 T Turrets

00-9300XSP-T 300 Watt Xenon Single Turret Light Source with A–W–O–S Turret 00-9300XSP-P 300 Watt Xenon Single Turret Light Source with A–W–P–S Turret 00-9300XSP-D 300 Watt Xenon Single Turret Light Source with W–D–O–S Turret For any 9300XDP purchased prior to November 2000, call Luxtec Customer Service for parts.

T, D, and P Turret Kits 00-0662 00-0663 00-0664

Kit, “T” CF Turret, ACMI, Wolf, Storz and Olympus Kit, “P” CF Turret, ACMI, Wolf, Storz and Pilling Kit, “D” CF Turret, Wolf, Storz, Designs for Vision and Olympus

Lamp Assembly (same for both XSP and XDP product lines) 00-0090 00-2500-1

Lamp Assembly* Lamp only* * For warranty compliance, a Luxtec lamp assembly or lamp must be used in these Luxtec products. The use of non-Luxtec bulb or lamp assembly will void the warranty for that product.

Power Cords 00-1390 00-1830 00-1388 850159 410116 600972 604035 600987 601058 601059 400456 400681 601318 601981 601178

Hospital Grade USA Power Cord 10' Hospital Grade USA Power Cord 20' European Power Cord 9' Operating and Service Manual 9300XSP/XDP Fan Assembly Power Supply, 300 Watt Xenon Interlock Switch Fuse 6.3 Amp, Slow Blow Intensity Knob Actuator Knob Power Switch Assembly Digital Age Meter Assembly Rubber Bumper Feet Handle Attenuator O-Ring

13

LIMITED WARRANTY Luxtec warrants that the equipment manufactured by Luxtec shall be free from defects in material and workmanship under normal use and service for a period of three (3) years from the date of shipment from Luxtec. Luxtec’s sole and exclusive liability under the warranty shall be, at Luxtec’s option, either to repair or to replace 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 Luxtec in writing, 2. If requested by Luxtec, customer returns equipment to Luxtec with shipping charges and, 3. Upon inspection, Luxtec finds the equipment to be defective. This warranty is contingent upon normal and proper use of the equipment. It does not cover equipment modified without the written approval of Luxtec, subjected to unusual physical or electrical stress, or damaged during shipment. This warranty is non-transferable unless authorized in writing by Luxtec. Luxtec reserves the right to make design changes on its products without liability to incorporate said change in Luxtec products previously designed or sold. Upon receipt of the product, it should be carefully inspected. If any defect is discovered, notification must immediately given to the manufacturer.

REPAIR AND RETURN This device must be clean when returned to Luxtec. Luxtec 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 Luxtec distributor or call Luxtec Customer Service at 1-800-325-8966 (US only) or +1-508-835-9700.

Information contained in this manual is subject to change without notice. 14

Luxtec Corporation declares that this product meets the Essential Requirements specified in Annex 1 of the Medical Device Directive (MDD).

99 Hartwell Street • West Boylston, MA 01583• USA Telephone: 1-800-325-8966 (US only) or +1-508-835-9700 Facsimile: +1-508-835-9976 E-mail address: [email protected] P/N 850159G