Luxtec MLX 300
Luxtec MLX 300
EN
Integra® Luxtec® MLX 300 Watt
For use with ACMI, Wolf, Storz and Olympus Fiber Cables
Integra Luxtec
® ®
2
Integra Luxtec
® ®
CAUTION: FEDERAL (USA) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN
The Integra Luxtec MLX Light Source should never be used in ocular surgery or in a surgical procedure requiring
direct illumination of the eye.
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Symbols
Found on a medical grade light source, other illumination related equipment, fiber optic cables and corresponding packaging.
Alternating Current
High Temperature
Type CF Equipment
Refer to Instruction Manual
Type BF Equipment
Equipotentiality
Do Not Dispose
Protective Earth
Stand-by
Temperature Limitation
Keep dry
Push
Intensity
Serial Number
Motor
EC REP Authorized Representative in the European Community
Fan
Manufacturer
0123
This device meets CE requirements Lamp
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Integra Luxtec
® ®
General Warnings
The user should carefully study the Operation and Service Manual before using the equipment in a clinical environment. This
Manual contains information about the proper procedures for preparing this product for its use and care. Instructions should
be followed, with special attention given to warnings, controls and user specifications. The Manual should be available to the
appropriate personnel.
• SAFETY PRECAUTIONS MUST ALWAYS BE EXERCISED WHEN • Keep cooling vent and fans free of obstructions.
USING ELECTRICAL EQUIPMENT TO PREVENT OPERATOR/
PATIENT SHOCK, FIRE HAZARD OR EQUIPMENT DAMAGE. • When light source is not in use, turn off the power or put the
unit in stand-by mode.
• FIRE HAZARD: DO NOT DRAPE OR COVER THE LIGHT
SOURCE WHILE IT IS OPERATING. • Ensure that the fiber optic cable matches the port type
to prevent damaging the optical components of the light
• Before every procedure, carefully inspect the light source to source. For user convenience, the light source has a turret
ensure it has been properly maintained and cleaned, and that with labeled selectable ports.
it is fully functional. DO NOT use if inspection reveals any
damage such as case damage or loose connectors. • Do not use the headlight at distances of less than 10” (25cm).
• Follow the instructions of other manufacturer’s equipment • Warning: No modification of this equipment is allowed.
when used in conjunction with this product.
• Do not position the equipment so that it is difficult to
• To avoid risk of electric shock, this equipment must only be remove the power plug.
connected to a supply mains with protective earth.
• To reduce the risk of fire and electric shock, do not expose Precautions
electrical equipment to moisture. When cleaning, do not • Take precautions to verify that the fiber optic cable is
immerse any electrical device in liquid. appropriately suited for the light source. Xenon and other
high illumination light sources require premium fiber optic
• Do not use or store liquids on or above the light source. cables in order to achieve optimal performance and prevent
damage to the fibers, thereby diminishing the quality of the
• Electric shock hazard. If unit is not functioning properly, DO light output or the useful life of fiber optic cable. Use only
NOT OPEN. Please refer to the Repair and Return Section of fiber optic light guide cables with the correct proximal fitting
this Manual. for your turret and approved and tested for compatibility
with high intensity Xenon lamps of 300W or higher.
• All electrical equipment must be used with approved hospital
grade power cords and power plugs inserted properly into • Take precautions not to touch or disconnect the cable end
grounded AC power outlets. If replacement is necessary, fitting from the turret until the Light Source has been “shut
replace only with approved power cord. down” for a period of time and allowed to cool. The cable
end fitting will remain hot immediately following shut down,
• The light source should never be used in ocular surgery or in which can cause burns.
a surgical procedure requiring direct illumination of the eye.
• Take precautions to not place and rest a hot cable end fitting
• Use care not to point any fiber optic cable directly at the eye and/or head light on a patient or allow the system to come
while operating the light source. in contact with un-protected hands or tissue. The entire
system should be allowed to cool following use. Failure to do
• The light source produces high intensity light. Thermal burns so can cause burns and/or tissue damage.
can result from improper use of the light source or from the
light output of the fiber optic cable.
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Overview
The MLX 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.
This device should be used in environments that meet the operating environmental conditions in the specification section of
this manual.
Before turning power on to the light source, make sure the unit is plugged into any standard 100VAC to 240VAC 50-60Hz
(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 MLX light source monitors air intake temperature
and will turn off if ambient temperature is > 40o C
Operation
1. Insert a fiber optic cable in the proper port in the turret. The active port is indicated by a left facing arrow on the perimeter
of the turret (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 3) will blink and there will be a 3 – 4 second delay before the
Xenon Lamp illuminates while the system does a self-diagnostic check.
1 2 3
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Integra Luxtec
® ®
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 4): + 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 System Status Display 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).
8. The system may be placed in and out of stand-by mode by using the stand-by switch. The system will emit no light in this
state and allow the surgeon to unplug a headlight, move around the table, or change cables in a laparoscopic or
endoscopic procedure.
Caution 4
Fiber Optic 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.
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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.
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To remove lamp:
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 5) 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 6) and retain screw.
6. Grasp the module by the tabs and pull directly up (Figure 7).
To replace lamp:
1. Orient the lamp module (P/N 001320LX) to face forward.
2. Place the module into the light source. 6
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.
Note
The System Age reading CANNOT be reset.
RESET
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Integra Luxtec
® ®
Fuse Replacement
The fuses for the light source are located in the power entry module in the rear 9
of the unit and may require replacement if the system does not respond to the
power switch.
To replace a fuse:
1. Remove the hospital grade power cord from the back of the light source.
2. Using a small flat screwdriver, pry open the retaining door (Figure 9) and
pry out the red plastic block from the power entry module (Figure 10).
3. Check to see if either fuse is blown; if blown, replace with a fuse of the
same rating (Integra P/N 600987).
4. Replace the red block in the housing.
5. Snap the retaining door into place.
6. Plug cord back into light source and retest the unit.
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9
Optional Floor Stand Assembly
The floor stand assembly includes the following components along with the necessary Phillips head screwdriver:
1. Base with five (5) casters (2 locking)
2. One column with light source base plate
Figure 10
3. Handle
4. MLX light source base
3. Attach the light source base onto the base plate (Figure 11) with the four (4) screws provided, using the Phillips
head screwdriver provided.
4. Secure the 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 light source (Figure 12).
11 10
Figure
12 11
Figure
Figure 11
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Integra Luxtec® ®
Light Source
Reference Description
00MLX 300 Watt Xenon Light Source with Turret (ACMI, Wolf, Storz and Olympus)
Accessories
Reference Description
Optional Accessories
Reference Description
AX2100BIF UltraLite® Pro headlight with 9ft (275cm) premium bifurcated cable, Mark II module and gown clips.
001337 MLX Floorstand
601949EUR6 European Power Cord 20’ (6m)
601949UK6 Hospital Grade UK Power Cord 20’ (6m)
601949US6P1 Hospital Grade USA Power Cord 20’ (6m)
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Troubleshooting
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Integra Luxtec® ®
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, 6.3A
Fuses (2) 6.3A, 250VAC, 5x20 mm, Slo-Blo, IEC Standard
Protection Class Class 1
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
Applied Part Classification Type CF
Electrical Safety Conforms to UL 60601-1, IEC 60601-1, and
CSA C22.2 NO. 601.1
Electromagnetic Compatibility IEC60601-1-2
Environment:
Storage Temperature 0 to 50°C (32 to 122°F)
Operating Temperature 10 to 40°C (41 to 104°F)
Storage Humidity 10 to 85% non-condensing
Operating Humidity 10 to 85% non-condensing
Atmosphere Pressure:
Storage 500 to 1060hPa
Operating 700 to 1060hPa
Power Cord Hospital grade
Mode of Operation Continuous
Ingress Protection IP20
Power Dissipation 450 Watts
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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.
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. 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 light source is intended for use in the electromagnetic environment specified below. The customer or user of the MLX
light source should assure that it is used in such an environment.
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Integra Luxtec
® ®
Table 202: Guidance and Manufacturer’s Declaration—Immunity All Equipment and Systems
The MLX light source is intended for use in the electromagnetic environment specified below. The customer or user of the MLX
light source should assure that it is used in such an environment.
Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment - Guidance
Electrostatic Discharge (ESD) ±6kV contact ±6kV contact Floors should be wood, concrete or ceramic
IEC 61000-4-2 tile. If floors are synthetic, the relative humid-
±8kV air ±8kV air ity should be at least 30%.
Electrical Fast Transient/ ±2kV on AC Mains ±2kV on AC Mains Mains power quality should be that of a typi-
burst cal commercial or hospital environment.
IEC 61000-4-4
Note - Tests Performed at both 240VAC,
50Hz and 120VAC, 60Hz
Surge ±1kV Differential ±1kV Differential Mains power quality should be that of a typi-
IEC 61000-4-5 ±2kV Common ±2kV Common cal commercial or hospital environment.
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Electromagnetic Compatibility (EMC) User Information
Table 204: Guidance and Manufacturer’s Declaration – Emissions Equipment and Systems
that are NOT Life-Supporting
The MLX light source is intended for use in the electromagnetic environment specified below. The customer or user of the MLX
light source should assure that it is used in such an environment.
Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment - Guidance
Conducted RF 3 Vrms from V1 = 3 Vrms Portable and mobile RF communications equipment should
IEC 61000-4-6 150 kHz to 80 MHz be separated from the MLX light source by no less than the
recommended separation distances calculated/listed below:
D = (3.5 / V 1) P
Radiated RF 3 V/m E1 = 3V/m
IEC 61000-4-3 80 MHz to 2.5 GHz D = (3.5 / E1) P 80 to 800 MHz
800 MHz to 2.5 GHz
D = (7 / E1) P
Table 206: Recommended Separation Distances Between Portable and Mobile RF Communi-
cations Equipment and the MLX Equipment and Systems that are NOT Life-Supporting
The MLX light source is intended for use in the electromagnetic environment in which radiated disturbances are controlled. The
customer or user of the MLX light source can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF Communications Equipment and the MLX light source as recommended below, according to
the maximum output power of the communications equipment.
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4 3 2 1
REVISIONS
REV DESCRIPTION INC BY APPROVED DATE
A ECN# 4980: ECN RELEASE
TKC
B ECO# 108904: REVISE FORMAT 08/30/11 GREG HARPER 08/30/11
CC
®
C ECO# 110774: ADDED NEW SWITCH/ THERMAL SWITCH/TOL BLOCK,.X .020 09/06/13 SEE AGILE SEE AGILE
Block Diagram
C
Integra Luxtec
®
P/S LAMP
FAN FAN
ATENUATOR
M MOTOR
J30 C
WHT/BRN
CONTROL LIMIT
BOARD BRN SWITCH
NC
MLX 300 Watt Xenon Light Source
DISPLAY J1
TP4
FERRITE
CORE
J20 J10 J9
t t t
FAN SIDE
B
N L
BLU
BRN
B4 A1
POWER WHITE
SWITCH
POWER ENTRY FERRITE LENS SIDE
MODULE CORE
FILTER
B5
A2
D BLUE BLUE BLU
BRN
N THERMAL SWITCH
BRN
GRN/YEL C N-C
GRN/YEL
A C
BRN
BRN BRN INTERLOCK
SAFETY
LINE LOAD LINE LOAD SWITCH
NO
PARTS LIST
UNLESS OTHERWISE SPECIFIED DRAWN DATE
DIMENSIONS ARE IN INCHES BJF 03/20/08 22 TERRY AVENUE
FRACTIONS DECIMALS ANGLES CHECKED BURLINGTON, MA 01803
.X±.020 TEL: (781)-272-1233 A
±1/32 .XX±.010 ±1/2 M.PUMA 08/30/11
.XXX±.005 32 APPROVED TITLE
INTEGRA PROPRIETARY INFORMATION MACHINED SURFACES:
BREAK SHARP EDGES .005 GREG HARPER 08/30/11
OCUMENT CONTAINS PROPRIETARY INFORMATION OF INTEGRA AND
NOT BE REPRODUCED. THE INFORMATION CONTAINED HEREIN SHALL MATERIAL MLX
E DISCLOSED TO PERSONS EXCEPT THOSE NECESSARY TO PRODUCE
RT OR PRODUCT OR USE THE PROCESS HEREIN SPECIFIED FOR NA SCHEMATIC
A. NOR SHALL THE VENDOR BY THIS DOCUMENT BE LICENSED TO
FACTURE SUCH PART OR PRODUCT OR USE SUCH PROCESS EXCEPT
QUANTITIES ORDERED ON INTEGRA PURCHASE ORDERS. ANY FINISH THIRD ANGLE PROJECTION SIZE PART NO. DRAWING NO. REV
TION TO THE FOREGOING CONDITIONS MUST BE APPROVED BY
NCE WRITTEN AGREEMENT SIGNED BY AN AUTHORIZED REPRESENTATIVE NA C 581519 581519 C
Repair And Return Information
This device must be clean and decontaminated prior to return to Integra. Integra reserves the right to return unrepaired any
equipment that is contaminated with blood or other organic material.
This warranty is contingent upon normal and proper use of the equipment. It does not cover equipment that has been
modified with non-Integra parts without the written approval of Integra, subjected to unusual physical or electrical stress, or
damaged during shipment. This warranty is non-transferable unless authorized in writing by Integra.
Integra reserves the right to make design changes on its products without liability to incorporate said changes in Integra
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.
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Integra Luxtec ® ®
Manufactured by:
Integra LifeSciences (Ireland) Limited
IDA Business and Technology Park
Sragh, Tullamore, County Offaly, Ireland
0123
www.integralife.com
Integra, the Integra logo, Luxtec and UltraLite are registered trademarks of Integra LifeSciences Corporation or its subsidiaries in
the United States and/or other countries. ACMI, Wolf, Storz, and Olympus are the trademarks or trade names of their respective owners.
©2019 Integra LifeSciences Corporation. All rights reserved. 60905988 Rev A 1430060-1