MLX 300 Watt Xenon Light Source Operation and Service Manual Rev A

TABLE OF CONTENTS Table of Symbols

3

General Warnings

4

Overview

5 Indication For Use

5

Set Up and Inspection Before Use

5

Operation

5-6

Xenon Lamp Module Replacement

6-7

Fuse Replacement

8

Optional Floor Stand Assembly

9

Replacement Parts and Accessories

10

Maintenance and Cleaning

10

Troubleshooting

11

Specifications

12

Electromagnetic Compatibility (EMC) User Information

13 - 15

Block Diagram

16

Limited Warranty

17

Repair and Return

17

TABLE OF SYMBOLS Found on the Light Source Attention: Consult Accompanying Documents

Type CF Equipment

Caution: High Voltage

System Status Display

High Temperature

System

Over Temperature

Hours

Fan

Motor

ON / OFF

Intensity

Stand-by

Alternating Current Fuse

Push

Lamp

Meets requirements of the Medical Device Directive Listed by CSA

Equipotentiality Protective Earth

3

GENERAL WARNINGS • The user of this product should be thoroughly familiar with the set-up, use and care of this product. • 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 user 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. • 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. • All electrical equipment must be used with approved hospital grade power cords and power plugs inserted properly into grounded AC power outlets. • Use only fiber-optic light guide cables that are approved for high intensity light output. • Electric shock hazard. If unit is not functioning properly, DO NOT OPEN. Please refer to the Repair and Return Section of this Manual. • 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 light guide 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 light guide 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. • Ensure that the fiber-optic light guide 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. • Do not use the headlight at distances of less than 10” (25cm) for periods exceeding 30 consecutive minutes.

4

OVERVIEW Indication for Use The Integra Luxtec MLX™ light source is designed to supply high-intensity white light to a fiber-optic cable for illumination of a surgical field during a surgical and/or medical procedure. The 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 Before Use The light source comes with the 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 of the unit for cooling air flow.

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 (Figure 1).

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.

4.

Press the Stand-by button.

Figure 1

Figure 2

5

OPERATION 5. The system will start up at the same light intensity as when last used (Figure 3). 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. NOTE: It is strongly recommended that the light be used at the minimum intensity for good visualization. 7. The membrane switch can be pressed to show both lamp time and system operation time. A second press of the switch 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 after 15 seconds).

Figure 3

8. The system can be placed in stand-by mode (no light emitted) allowing the surgeon to unplug a headlight and move around the table, or to change cables in a laparoscopic or endoscopic procedure. 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. 9. To shut the system off, simply press the main power switch as in Step 2.

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 listed in the General Warnings section of this manual.

6

XENON LAMP MODULE REPLACEMENT To remove: Make sure the power is off and the power cord is disconnected. 1. 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

Figure 7

To Replace: 1. Orient the lamp module (P/N 001320LX) 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 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. 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 tactile click is felt. 4. Verify that the lamp age has been reset to 0. NOTE: The System Age reading CANNOT be reset.

7

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 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 (Luxtec P/N 600987, or 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

8

OPTIONAL FLOOR STAND ASSEMBLY Figure 10

There are four (4) parts to the floor stand assembly: See Figure 10. 1. Base with five (5) casters (2 locking) 2. One column with light source base plate 3. Handle 4. MLX™ light source base Floor stand assembly instructions: 1. With the handle positioned so that the Luxtec® logo is properly aligned, slide the handle onto the column and center the handle about 5 inches (13cm) below the light source base plate. Tighten handle screw to hold in place. 2. Insert assembled column into the base. Seat firmly. 3. Attached the MLX™ light source base onto the base plate (Figure 10) with the four (4) screws provided. 4. Secure the MLX™ light source to base plate by aligning the feet to the holes on the surface of the plate. Tighten the two screws on the bottom of the plate to the MLX™ light source. See Figure 11.

Figure 11

9

REPLACEMENT PARTS AND ACCESSORIES To place an order, contact your local Luxtec distributor or call Luxtec Customer Service at 1-800-325-8966 (USA & Canada only) or +1-508-835-9700 to identify your local distributor. Light Sources 00MLX

300 Watt Xenon Light Source with Turret (ACMI, Wolf, Storz and Olympus)

Accessories 001320LX 600987 850469

Lamp Module Fuse 6.3 Amp, Slow Blow Operating and Service Manual MLX™ light source

Optional Accessories AX1375BIF Headband with bifurcated cable and UltraLite Mark II module AX1385BIF Sweatband with bifurcated cable and UltraLite Mark II module AX1375BIFSL Headband with bifurcated cable and UltraLite Mark II module with short linkage AX1385BIFSL Sweatband with bifurcated cable and UltraLite Mark II module with short linkage AX1375MAG MagniLux® Headlight System* AX1385MAG MagniLux® Sweatband Headlight System* 001337 MLX™ Floorstand

*Magnifiers sold separately, includes bifurcated cable and UltraLite Mark II module

MAINTENANCE AND CLEANING Maintenance: If the light source does not operate properly when connected to a grounded receptacle, check the fuse. 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 need to be replaced or there is a power failure. Try replacing the lamp module. If you still experience difficulties, return the unit to Luxtec or an authorized distributor for evaluation.

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.

10

TROUBLESHOOTING Problem

Cause

Action

No light output

Light source not turned on Cable not fully seated Defective/no lamp

Turn power on Fully insert cable Check lamp seating/replace lamp module Rotate turret to desired adapter fitting Check for air flow obstruction and proper vent clearance. Allow the unit to cool Push stand-by button Rotate turret to matching adapter fitting Replace lamp module Press “+” button

Turret mispositioned Thermal shutdown

Reduced light output

No power

Fault Symbol

In stand-by mode Cable mismatched to turret Aged lamp Attenuator closed Light source not plugged in Blown fuse Interlock switch not engaged

Plug in Light Source Replace fuse as indicated in maintenance section Check left top cover screw

Cause

Action

Lamp change (will blink after 1000 hours)

Change lamp. Module Part number 001320LX

Fan failure

Shut off unit to reset. If it does not reset contact Luxtec for service

Lamp overheat

Shut off system to reset. If it does not reset contact Luxtec for service

Attenuator motor failure

Shut off system to reset. If it does not reset contact Luxtec for service

NOTE: When the power is re-set for any of the above conditions, wait 15-30 seconds for the unit to fully shut down before re-starting the unit.

11

SPECIFICATIONS Lamp Type

Xenon Short Arc Lamp

Wattage

300 Watts

Lamp life

1000 Hours

Light Source Dimensions

15.4”L x 11.2”W x 5.9”H (390mm L x 285mm W x 150mm H)

Weight

12.5 lbs. (5.7 kg)

Power Input

100~240VAC 50 - 60Hz± 10%

Fuses (2)

6.3A, 250VAC, 5x20 mm, Slo-Blo, IEC Standard

Power Consumption

450 Watts (Maximum)

AC Power Leakage

Leakage current to chassis (with ground wire intact), less than 100 microamps Leakage current to chassis (with ground wire interrupted), less than 500 microamps

Classification

Type CF, Class 1 Device

Electrical Safety

CSA listed, Conforms to UL 60601-1 and CSA C22.2 NO. 601.1

Electromagnetic Compatibility

EN60601-1-2:2001, Class B

Environment: Storage Temperature

0°C to 50°C (32°F to 122°F)

Operating Temperature

10°C to 40°C(50°F to 104°F)

Humidity

10-85% non-condensing

Power Cord

Hospital grade

12

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. WARNING: Portable and Mobile RF Communications Equipment can affect Medical Electrical Equipment. WARNING: 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.

Table 201 Guidance and Manufacturer’s Declaration – Emissions All Equipment and Systems The MLX is intended for use in the electromagnetic environment specified below. The customer or user of the MLX should assure that it is used in such an environment. Emissions Test

Compliance

Electromagnetic Enforcement – guidance

RF Emissions CISPR 11

Group 1

The MLX uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF Emissions CISPR 11

Class B Radiated And Conducted Emissions

The MLX is suitable for use in all establishments including domestic, and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Conducted Emissions Tests Performed at both 240VAC, 50Hz And 120VAC, 60Hz

Harmonics IEC 61000-3-2

N/A

Equipment intended for Professional Use Only

Flicker IEC 61000-3-3

N/A

Equipment intended for Professional Use Only

13

Electromagnetic Compatibility (EMC) User Information Table 202 Guidance and Manufacturer’s Declaration-Immunity All Equipment and Systems The MLX is intended for use in the electromagnetic environment specified below. The customer or user of the MLX should assure that it is used in such an environment. Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic Environment - Guidance

Electrostatic Discharge (ESD) IEC 61000-4-2

±6kV contact ±8kV air

±6kV contact ±8kV air

Floors should be wood, concrete or ceramic tile. If floors are synthetic, the relative humidity should be at least 30%.

Electrical Fast Transient/burst IEC 61000-4-4

±2kV on AC Mains

±2kV on AC Mains

Mains power quality should be that of a typical commercial or hospital environment. Note - Tests Performed at both 240VAC, 50Hz and 120VAC, 60Hz

Surge IEC 61000-4-5

±1kV Differential ±2kV Common

±1kV Differential ±2kV Common

Mains power quality should be that of a typical commercial or hospital environment. Note - Tests Performed at both 240VAC, 50Hz and 120VAC, 60Hz

Voltage dips, Short interruptions and Voltage variations on power supply input lines IEC 61000-4-11

>95% Dip for 0.5 Cycle 60% Dip for 5 Cycles 30% Dip for 25 Cycles >95% Dip for 5 Seconds

>95% Dip for 0.5 Cycle 60% Dip for 5 Cycles 30% Dip for 25 Cycles >95% Dip for 5 Seconds

Mains power quality should be that of a typical commercial or hospital environment. If the user of the MLX requires continued operation during power mains interruptions, it is recommended that the MLX be powered from an uninterruptible power supply or battery. Note - Tests Performed at both 240VAC, 50Hz and 120VAC, 60Hz

Power Frequency 50/60Hz Magnetic Field IEC 61000-4-8

3A/m

3A/m

Power frequency magnetic fields should be that of a typical location in a typical commercial or hospital environment. Note - Tests Performed at both 50Hz and 60Hz

14

Electromagnetic Compatibility (EMC) User Information Table 204 Guidance and Manufacturer’s Declaration – Emissions Equipment and Systems that are NOT LifeSupporting The MLX is intended for use in the electromagnetic environment specified below. The customer or user of the MLX should ensure that it is used in such an environment. Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic Environment – Guidance

Conducted RF IEC 61000-4-6

3 Vrms from 150 kHz to 80 MHz

V1 = 3 Vrms

Portable and mobile RF communications equipment should be separated from the MLX by no less than the recommended separation distances calculated/listed below:

D = (3.5 / V 1) P Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2.5 GHz

E1 = 3V/m

D = (3.5 / E1) P

80 to 800 MHz

D = (7 / E1) P

800 MHz to 2.5 GHz

Where P is the maximum power rating in watts and D is the recommended separation distance in meters. Field strengths from fixed transmitters, as determined by an electromagnetic site survey, should be less that the compliance levels (V1 and E1). Interference may occur in the vicinity of equipment containing a transmitter.

Table 206 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the MLX Equipment and Systems that are NOT Life-Supporting The MLX is intended for use in the electromagnetic environment in which radiated disturbances are controlled. The customer or user of the MLX can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF Communications Equipment and the MLX as recommended below, according to the maximum output power of the communications equipment. Maximum Output Power (Watts)

Recommended Separation Distances for the MLX (meters) 150 kHz to 80 MHz

80 to 800MHz

800 MHz to 2.5 GHz

d = 1.1667 P

d = 1.1667 P

d = 2.3333 P

0.01

0.11667

0.11667

0.23333

0.1

0.36894

0.36894

0.73785

1

1.1667

1.1667

2.3333

10

3.6894

3.6894

7.3785

100

11.667

11.667

23.333

15

BLOCK DIAGRAM

16

LIMITED WARRANTY Luxtec warrants that the new MLX™ light source 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. Luxtec’s sole and exclusive liability under the warranty shall be, at Luxtec’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 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 that has been modified with non-Luxtec parts 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 be given immediately to the manufacturer or authorized distributor.

REPAIR AND RETURN This device must be clean and decontaminated prior to return 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 or +1-508-835-9700. Information contained in this manual is subject to change without notice.

99 Hartwell Street • West Boylston • MA, 01583 • USA Telephone: (800) 325-8966 (USA & Canada) or +1-508-835-9700 • Fax: +1-508-835-9976 • email: [email protected] www.integra-surgical.com Integra Surgical and the Integra wave logo are trademarks of Integra LifeSciences Corporation. Luxtec and MLX are registered trademarks of Integra LifeSciences Corporation or its subsidiaries.

P/N 850469 Rev.A