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501-01-9035, Revision C Candela Corporation Proprietary,
GentleMAX PRO Service Manual
Service Manual
Model: Gentle MAX PRO
Candela Corporation
530 Boston Post Road
Wayland, MA 01776-1886
Telephone (508) 358-7400
Toll Free (800) 733-8550 ext. 734 (Technical Assistance)
Toll Free (800) 733-7400 ext. 740 (Customer Service)
PIN 8501-00-9035, Revision C
JULY 2012
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Table of Contents
SECTION ONE THEORY OF OPERATION
8501-00-4020 GentleMAX PRO Theory of Operation
SECTION TWO SERVICE PROCEDURES
8503-01-0930 GMAX PRO Installation Procedures
8503-01-0931 GMAX PRO System Software Initialization Procedure
8503-01-0932 GMAX PRO Preventative Maintenance Procedure
8503-01-0933 GMAX PRO Laser Head Replacement Procedure
8503-01-0934 GMAX PRO Flash Lamp Replacement Procedure
8503-01-0935 GMAX PRO Laser Rail Alignment Procedure
8503-01-0936 GMAX PRO Focus Lens Replacement Procedure
8503-01-0937 GMAX PRO Calport Verification Procedure
8503-01-0938 GMAX PRO Performance Test Procedure
8503-01-0939 GMAX PRO HVPS Verification Procedure
8503-01-0940 GMAX PRO Aiming Beam Test Procedure
8503-01-0941 GMAX PRO Inspect and Clean Optics
8503-01-0942 GMAX PRO Internal Circuit Calibration Procedure
8503-01-0943 GMAX PRO Efficiency and Ramp Test Procedure
8503-01-0944 GMAX PRO DCD Pressure Verification Procedure
8503-01-0945 GMAX PRO DI Water Temperature Calibration Procedure
10-400-00151 GMAX PRO Performance and Usage Data Sheet
8503-01-0946 GMAX PRO Troubleshooting Guide Faults List
SECTION THREE ENGINEERING SCHEMATICS
9914-80-9035 ‘System Schematic, GMAX PRO Dual Head
7111-80-2792 ‘Schematic Spectrum CPU 1/0
7111-80-2793 ‘Schematic AC Distribution PCB
7111-80-2798 ‘Schematic Spectrum HV Daughter Board
7111-80-2799 ‘Schematic Spectrum HV Split Cap PCB
7111-80-2804 Schematic HV Dump PCB GMAX PRO
SECTION FOUR — ENGINEERING DRAWINGS
9914-91-9035 GMAX PRO Family Tree
9914-84-9035 Block Diagram Control System 10f 10
9914-84-9035 Block Diagram HV Modulator Section 20f 10
9914-84-9035 Block Diagram Modulator Control 3 of 10
9914-84-9035 Block Diagram DCD Delivery System 4of 10
9914-84-9035 Block Diagram ACC Delivery System 5 of 10
9914-84-9035 Block Diagram Specialty Delivery System 6 of 10
9914-84-9035 Block Diagram CALPORT 7 of 10
9914-84-9035 Block Diagram DCD Section 8 of 10
9914-84-9035 Block Diagram Laser Rail Section 9 of 10
9914-84-9035, Block Diagram Fluid Section 10 of 10
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ASSEMBLY DRAWINGSIBOM
7111-99-2792
7111-99-2793
71411-99-2798
7111-99-2799
7411-99-2800
7111-99-2807
7122-99-9250
7122-00-3660,
7122-89-3660
7122-00-9216
7122-99-9216
7122-00-9228
7122-98-9228
7122-00-9234
7122-99-9234
7122-00-9235
7122-99-9235
7122-00-9236
7122-99-9236
7122-00-9250
7122-99-9250
7122-00-9400
7122-99-9400
7122-00-9401
7122-99-9401
7122-00-9403
7422-99-9403
7122-00-9404
7122-99-9404
7122-00-9416
7122-99-9416
7122-00-9417
7122-99-9417
7122-00-9419
8501-01-9035, Revision ©
CPU VO PCB Drawing
AC Distribution PCB Assembly Drawing
HY Daughter Board Assembly Drawing
HY Split Capacitor Board Assembly Drawing
LCD Display Interface PCB Drawing
DHP Dump PCB Drawing
AC Section Wire Kit Drawing
BOM, Assy Manifold DI Cartridge Heater
Assy Manifold Dl Cartridge Healer
BOM AC Section Assembly
AC Section Assembly
BOM Heat Exchanger Assembly
Heat Exchanger Assembly
BOM Tubing Kit Assembly
Tubing Kit Assembly
BOB DCD Assembiy
DCD Assembly
BOM DI Fiter/Cartridge Assembly
DI Filter/Cartridge Assembly
BOM AC Section Wiring Kit
AC Section Wiring Kit
BOM Assembly, DCD Electrical Cable
Assembly, DCD Electrical Cable
BOM DCD Hand Cable Assembly
DCD Hand Cable Assembly
BOM Assembly, ACC Electrical Cable
Assembly, ACC Electrical Cable
BOM ACC HP Cable Assembly
‘ACC HP Cable Assembly
BOM Slider Attachment 12/15/18
Slider Attachment 12/15/18
BOM Slider Attachment 6/8/10
Slider Attachment 6/8/10
BOM Fiber Assembly
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7122-00-9429
7122-99-9429
7122-00-9430
7122-99-9430
7122-00-9432
7122-99-9432
7122-00-9435
7122-99-9435
7122-00-9437
7122-99-9437
7122-00-9441
7122-99-9441
7122-00-9448,
7122-99-9448,
7122-00-9449
7122-99-9449
7122-00-9456
7122-99-9456
7122-00-9457
7122-99-9457
7122-00-9458
7122-99-9458
7122-00-9460
7122-99-9460
7122-00-9529
7122-99-9529
7122-00-9537
7122-99-9537
7122-00-9557
7122-99-9557
7122-00-9560
7122-99-9560
7122-00-9561
7122-99-9561
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GentleMAX PRO Service Manual
Fiber Assembly d
BOM Right Panel Assembly Spectrum
Right Panel Assembly Spectrum [
BOM Left Panel Assembly Spectrum.
Left Panel Assembly Spectrum.
BOM Aiming Beam Assembly
Aiming Beam Assembly
BOM Fiber Pole Assembly
Fiber Pole Assembly
BOM Fiber Cord and Hook Assembly
Fiber Cord and Hook Assembly
BOM GMAX DHP Display Bezel Assembly
GMAX DHP Display Bezel Assembly
BOM Top Panel GMAX PRO Assembly
Top Panel GMAX PRO Assembly
BOM Front Panel Assembly
Front Panel Assembly =
BOM Aiming Beam Mirror
Aiming Beam Mirror
BOM Head Detector Assembly
Head Detector Assembly
BOM Beam Splitter Assembly
Beam Splitter Assembly
BOM Display Bezel, Rear
Display Bezel, Rear
BOM Beam Blocker Assembly
Beam Blocker Assembly
BOM Fiber Pole Accessory Kit
Fiber Pole Accessory Kit
BOM GMAX DHP Head Rail Assembly
GMAX DHP Head Rail Assembly
BOM 1.5MM Slider Attachment Assembly
1.5MM Slider Attachment Assembly
BOM 3MM Slider Attachment Assembly
3MM Slider Attachment Assembly
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7122-00-9571
7122-99-9571
7122-00-9572
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7122-00-9574
7122-99-9574
7122-00-9575
7122-99-9575
7122-00-9576
7122-99-9576
7122-00-9577
7122-99-9577
7122-00-9578
7122-99-9578
7122-00-9579
7122-99-9579
7122-00-9580
7122-99-9580
7122-00-9581
7122-99-9581
7122-00-9587
7122-99-9587
7122-00-9588
7122-99-9588
7122-00-9592
7122-99-9592
7122-00-9596
7122-99-9596
7122-00-9598
7122-99-9598
7122-00-9601
7122-99-9601
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GentleMAX PRO Service Manual
BOM Upper Chassis Assembly
Upper Chassis Assembly
BOM GMAX DHP Tubing Kit
GMAX DHP Tubing Kit
BOM GMAX DHP Alex Head Assembly
GMAX DHP Alex Head Assembly
BOM Fiber Receptacle Assembly
Fiber Receptacle Assembly
BOM Focus Lens Housing Assembly
Focus Lens Housing Assembly
BOM GMAX DHP Beam Combiner Assembly
GMAX DHP Beam Combiner Assembly
BOM GMAX DHP Turning Mirror Assembly
GMAX DHP Turning Mirror Assembly
BOM GMAX DHP YAG Head Assembly
GMAX DHP YAG Head Assembly
BOM HV Section Assembly
HV Section Assembly
BOM HV Wire Harness Assembly
HV Wire Harness Assembly
BPM DHP AC Section Assembly
DHP AC Section Assembly
BOM DHP Fiber Bundle Assembly
DHP Fiber Bundle Assembly
BOM GMAX DHP Intermediate Lens Assembly
GMAX DHP Intermediate Lens Assembly
BOM Flow Switch 0.50GPM Assembly
Flow Switch 0.50GPM Assembly
BOM Spectrum Signal Hamess Assembly
Spectrum Signal Hamess Assembly
BOM Fluid Section Assembly
Fluid Section Assembly
BOM Frame Assembly
Frame Assembly
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7122-00-9602 BOM GMAX PRO Specialty DCD Handpiece Cable Assembly
7122-99-9602 GMAX PRO Specialty DCD Handpiece Cable Assembly
7122-00-9604 BOM Skins Kit GMAX PRO Assembly
7122-99-9604 Skins Kit GMAX PRO Assembly
7122-00-9608 BOM CALPORT Assembly
7122-99-9608 CALPORT Assembly
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GentleMax PRO Service Manual
INTRODUCTION
At the conclusion of each service call final closing-up steps should be performed
including exiting Maintenance Mode and replacing the system panels. The GMAX
PRO laser system must be turned off when replacing all panels/dust covers.
Whenever any service is performed on a GMAX PRO laser system, the Performance
and Usage Data Sheet should be filled out completely after the system is closed up.
The laser must be pulsed and tested in User Mode to make sure that nothing has
been disturbed during the installation of all dust covers and panels. You must verify
that the system is ready to be used by the customer and that all previous
parameters set by the customer are the same as when you arrived, including
the footswitch to handpiece setting, if customer was not using the footswitch.
ee
WARNING
FOLLOW THE INSTALLATION STEPS IN SEQUENCE TO ELIMINATE ANY
POSSIBLE DAMAGE TO THE SYSTEM.
Warnings, Cautions, and Precautions
‘Observe the following warnings and cautions when using the Candela Corporation
GMAX PRO Laser system.
Warning:
WARNING!
‘The electrical and laser radiation hazards present during servicing of the GMAX
PRO Laser can be extremely dangerous if proper safety precautions are not taken.
Consequently, the GMAX PRO Laser is to be serviced only by those qualified
technicians who have received appropriate training on the GMAX PRO Laser from
Candela, and who are familiar with the safety considerations discussed in this
manual.
WARNINGL
The GMAX PRO Laser system has been designed for the safest possible operation
and maintenance. However, any laser system can cause injury if itis not properly
installed, operated, moved or serviced, and the GMAX PRO Laser is no exception.
The potential hazards associated with the GMAX PRO Laser are: ocular (vision)
damage resulting from exposure to direct or reflected laser radiation, electrical shock
from contact with high voltage electrical components inside the system, and physical
injury incurred while moving the system.
WARNING!
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Invisible and visible laser radiation. Avoid eye or skin exposure to direct or scattered
radiation. Class 4 laser product (Per EN60825-1: 2002-07)
WARNING!
‘The Preset Treatment Parameters and Clinical Treatment Guidelines do not take the
place of the procedures and instructions found in the Operator's Manual. Failure 10
Use this laser in accordance with such procedures and instructions could result in
serious injury to the operator, the patient, and others, as well as damage to the laser
system
Follow OSHA and ANSI standards for laser safety. Protective eyewear must be worn
by all persons in the treatment room during laser operation.
Check the delivery system for any damage (i.e. dropped),
Discontinue use of your laser delivery system if you suspect a problem.
WARNING!
Always put the laser system into Standby or tur it off before attempting to check, clean,
and/or replace the Delivery System, Handpiece, Slider Attachments, or Distance Gauge.
WARNING!
Always recalibrate the laser after fixing, cleaning, or replacing the Delivery System,
Handpiece, or Slider Attachments and/or Windows. Failure to initiate a calibration after
cleaning/replacing the Handpiece, Slider Attachments, Windows, and/or Delivery System
may result in the delivery of excessive laser energy.
WARNING!
Ensure that the spot size on the Slider Aitachment and Distance Gauges match the spot
size displayed in the spot size field on the display panel. Failure to do so can result in the
delivery of improper energy to the patient.
WARNING:
Do not operate the laser if the aiming beam is on but not present when itis turned on! This
may be an indication of a broken fiber optic. If the aiming beam is on but is not present,
replace the Fiber Cable. If this does not correct the problem, call Technical Support.
Cautions:
Caution!
Use of controls or adjustments or performance of procedures other than those
specified herein may result in hazardous radiation exposure.
Caution!
Federal (USA) law restricts this device to sale by or on the order of a physician.
Caution!
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GentleMAX PRO Service Manual
Do not enter the Ready state without a Delivery Syst
i stall i
Do not aus te ety ie vi ry System installed and without having
Caution!
Before the laser system is tuned on, a Slider Attachment must be installed in the
Hand piece.
Caution!
Slider Attachment lenses and the tips of the fiber cable may be damaged from
exposure to dust particles or any other foreign particles that may deposit on their
surfaces. Particles on these surfaces will burn and leave a deposit when exposed to
laser energy. This may lead to lower fiber or Slider Attachment transmission and/or
failure of the assembly. In order to reduce the probability of mechanical damage,
please observe the following guidelines.
Cautioi
To reduce the risk of personal injury and damage to the Delivery System cables, use
the Fiber Pole to support the delivery system at all times. When not in use, insert the
Handpiece in the holder on the right side panel or in the Calibration Port. This
removes excess slack from the Delivery System cables and reduces the possibilty
‘of damage to property and/or personal injury from stepping on or tripping on the
cable or running the wheels over it.
Caution!
When using the Fiber Pole to support the Delivery System, make sure there are no
sharp bends in the Delivery System cables. The laser system can be damaged if the
cable is subjected to excessive bending. To prevent damage, never pulse the laser
system if the Delivery System cable bend radius is less than six inches.
Optical Hazards:
WARNING!
‘The laser operates at 755 nm and at 1064 nm, which lies in the invisible, near-
infrared region of the electromagnetic spectrum. The laser beam emitted by the
GMAX PRO is capable of causing loss of vision. Energy emitted by this Laser
System that enters the eye will likely be focused directly on the retina. Direct contact
of the laser beam on the retina can cause temporary clouded vision, retinal lesions,
ong-term scotoma (vision absence in an isolated area), long term photophobia
(sensitivity to light) and/or loss of vision.
WARNING!
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Use only safety eyewear that is known to have an optical density (0.D.) of > 5.8 for
745 - 765 nm and an optical density (0.D.) of > 6.3 for 1061 — 1065 nm. Safety
‘eyewear that is designed for use with other laser systems may not provide adequate
protection.
WARNING!
Nominal Ocular Hazard Distance (NOHD). The laser aperture of the GMAX PRO
Laser System is at the distal end of the Handpiece. The beam enlarges as the
distance from the Handpiece increases. The Nominal Ocular Hazard Distance
(NCHD) is the distance at which the beam is so big it is no longer dangerous to the
unprotected eye. The distance along with the full angle beam divergence for each
spot size is shown in the Table below.
Vision Hazards GentleMAX PRO Laser System NOHD Zone and MPE
sSnm 1064 nm
NA 2a
NA 55
156 252
170 282
164 7266]
TI 158
120 157
77 755]
WARNING!
To avoid vision hazards, everyone (including service personnel) within the NOHD
where the laser is operating must wear appropriate eye protection available from
Candela, Such eyewear provides adequate protection against reflected or scattered
laser radiation, or inadvertent brief exposure to the laser beam. Laser safety
eyewear should be stored away from direct sunlight at temperatures of 65°F - 75°F
or 18° - 24°C.
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WARNING!
During laser procedures, the patient's eyes must be protected. The opaque patient
goggles provided by Candela are appropriate for most patients. It is recommended
to place gauze sponges under the opaque patient goggles to ensure that the
patient's eyes remain closed. In addition, the opaque goggles do not fit well if used
on infants or small children. Gauze sponges can be used when moistened with
water and taped over the eyelids or a moistened facecloth can be held over the eyes
are recommended. If the patient is asleep, the eyes should be taped closed and
covered with moistened gauze sponges.
: WARNING!
Even when wearing protective eyewear, looking directly into the path of the laser
beam may cause permanent eye damage.
Caution!
The laser beam emitted by the GMAX PRO Laser System should never be directed
at any part of the body other than the intended site of treatment or testing.
Caution!
Removal of any of the exterior panels could allow access to hazardous levels of
laser radiation. For this reason, these panels are designed not to be easily
removable; they must not be removed except by authorized Candela trained service
personnel.
Electrical and Mechanical Hazards:
WARNING!
The GMAX PRO Laser converts and amplifies the AC line voltage to produce
extremely high voltages inside the laser system which are very dangerous, even
lethal. It is possible for high voltage components to retain a charge after the power
supply has been turned off, and even after the laser has been disconnected from the
line voltage or wall receptacle. Therefore, no part of the laser interior should be
opened or exposed, except by trained and authorized technicians,
WARNING!
The GMAX PRO laser delivery systems utilize fiber optics that can be damaged if
installed or subjected to excessive bending. To avoid damage to the optical fiber,
limit bends to a radius of 6 inches (15 cm) or greater. Failure to follow recommended
procedures may lead to damage to the fiber or delivery system and/or harm to the
patient or operator. When damaged, the fiber or delivery system becomes a
potential fire hazard.
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WARNING!
Although the GMAX PRO Laser system is well balanced, it weighs more than 250
pounds (almost 150 kg) and may cause injury if proper care is not used when
‘moving it. The system should always be moved carefully and slowly.
Caution!
To prevent the laser from moving, both front wheels must be locked. To lock the
wheels, step down on the tabs on the front of the wheels. To unlock, step down on
the top (smaller) tabs.
Chemical Hazards
There are no known chemical hazards associated with the GMAX PRO Laser
‘System.
Cryogen:
This laser system uses a Hydrofluorocarbon (HFC) or cryogen in the Dynamic
Cooling Device (DCD).
Inhalation: If high concentrations are inhaled, immediately move to fresh air. Keep
person calm. If not breathing, give artificial respiration. If breathing is difficult, give
‘oxygen. Call a physician,
‘Skin Contact: If large amounts of cryogen contact the skin due to a leak or rupture in
the cryogen system, flush skin immediately with water and call a Physician to check for
frostbite. Treat for frostbite if necessary by gently warming affected area.
Eye Contact: In case of eye contact, immediately flush eyes with plenty of water for at
least 15 minutes. Call a physician
Ingestion: Ingestion is not considered a potential route of exposure.
WARNING! IMPORTANT NOTE TO PHYSICIANS
Because of possible disturbance of cardiac rhythm, catecholamine drugs such
as epinephrine should only be used with special caution in situations, when
performing emergency life support. See MSDS sheet, Candela PIN 8501-00-1701.
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Labels and Symbols
The GentleMAX PRO laser system has been labeled in accordance with domestic and
‘international agency standards. All operators should be familiar with the location and meaning
of the labels.
Table 2-1 List of Labels and Symbols
| __Say
es:tor
CAUTION: Consult accompanying documents
Protected by one or more
US. Patent(s)
5,599,342, 6,514 244 US. patents that may cover the laser system
5.814.040; 6.171.301
aS EVE
WARNING: CONSULT SERVICE MANUAL FOR
FUSE REPLACEMENT. REPLACE ONLY WITH
ORIGINAL TYPE AND RATING.
WARNING consutr service
IANUAL FOR FUSE REPLACEMENT,
REPLACE ONLY WITH ORIGIAL TYPE
AND RATING.
ki CAUTION: Tip hazard when transporting the
i laser system.
Laser emission characteristics and classification
per the IECIEN standards
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SSC
Location of the footswitch control hose connection
on the rear of the laser system
WARNING: HIGH VOLTAGE
= Location of the remote interlock circuit that
a 7 i connects to the laser treatment room door switch
to shutdown the laser system should a person
i enter the laser treatment room during laser
Prcaurion
CAUTION: Class 4 visible and invisible
radiation when open. Avoid eye or skin
exposure to direct or scattered radiation.
Protective panel encloses a Class 4 laser light
Location of the USB software upgrade port
Complies wth FDA
parerance andarce , Selected requirements under CDRH 21 CFR
for Geviatons pursuant 1 1040.10 & 1040.11 were waived for comparable
eer tictee Ho. 60, IEC requirements as allowed by Laser Notice 50
sited June 24, 2007
peoer ent)
Ay
H,O
Reservoir is filled with distilled or deionized water
and should be kept full
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a EEE
Hand - the delivery system is “electrostatic
b R i sensitive”
Man - the delivery system is equipped with a
“Type B" applied part in accordance with IEC/EN
60601-1
The laser system emits laser energy
APERTURE
TOREDULE NO on GF CAUTION: To reduce the risk of shock, do not
SHOCK_DO NOT REMOVE. remove covers. Refer servicing to qualified
EOVERSLREFER SE RMICRIG TO servi L
GUALFED SERVICE PERSONS ice personnel.
CAUTION: Lethal voltages may be present on
the capacitor after system is off. Use a HV
meter to verify voltage has been discharged
before servicing.
Hot surface when laser system is on. Do not
touch,
Refer to the system Operator's Manual for
complete information on safe operation.
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Sa _____" 755
Waste Electrical and Electronic Equipment
(WEEE) Directive Label - the laser system and itS
components cannot be disposed of as regular
trash. Contact Candela for disposal information.
CE ores}
VA rating, model number, serial number, and date
and place of manufacture. The label also includes
the CE mark (in the lower left comer of the label)
with the registration number of Candela's ISO
Registrar. When present, this marking indicates
‘compliance with the European Medical Device
Directive
comouate
esp
puri
ase at
cenrompte
canent
‘The laser system is approved to ETL standards.
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Theory of Operation
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SYSTEM OVERVIEW
GentleMAX Pro
The GentleMAX Pro system is a solid state laser capable of delivering energy at wavelengths
of 755 nm or 1064nm. The laser system contains two separate laser heads, an Alexandrite
and a Nd:YAG (Neodymium-doped Yttrium Aluminum Garnet) which, when pulsed, produce
laser energy emitted at nominal wavelengths of 755 nm and 1064 nm, respectively. The
outputs of the two laser heads are optically combined on the laser rail so that their beam
paths are identical as they exit the laser system. This allows the use of a single delivery
system which can output either the 755 nm or 1064 nm wavelengths. The output energy is
delivered to the skin through an optical fiber delivery system.
The GentleMAX PRO is configurable for use with the DCD, which is internal to the system, or
Used in conjunction with an extemal air cooling compatible (ACC) system. There are three
diferent delivery system configurations
Standard DCD handpiece which consist of an optical fiber, handpiece and slider
attachements to support 6, 8, 10, 12, 15 and 18 mm spot sizes
+ Specialty DCD, which supports 1.5 mm and 3mm spot sizes
‘ACC delivery system with and air clip for connection to an external cooling device
and slider attachments to support 6, 8, 10, 12, 15 and 18 mm spot sizes
‘The GentleMAX Pro is capable of variable pulse durations ranging from 0.25ms to 100ms
using single and multiple sub-pulse outputs. Laser pulsing is activated by either a foot switch
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or a finger switch located on the delivery system handpiece. Only one method is active at @
time and is user selectable from the GUI.
Two pulsing modes are available:
* Single Pulse Mode: Each depression of the trigger switch generates a single
pulse.
+ Repeat Pulse Mode: Continuous pulses are delivered at the rate selected when
the trigger switch is continuously depressed.
Single pulse mode is enabled by selecting it from the rep rate settings on the GUI. Repeat
pulse mode is active whenever a pulse duration other than Single is selected and the
available selections range from 0.5Hz to 10Hz depending on the spot size, fluence and pulse
duration settings.
The GentleMAX Pro operates from an input line voltage of 180 to 264 VAC at 50/60 Hz and
there are no adjustments required on the laser to operate over this voltage range. The system
does not contain an isolation transformer. All of the components that are directly connected
to the AC input were chosen for low line leakage current to ensure the systems meets the
leakage current requirements of IEC-60601. Maximum power drawn by the laser system is
4600VA at 230 VAC input. The thermal load for the laser system is 2200W (7508 BTU/hr)
when in STANDBY and 4000W (13,649 Btu/hr) when in READY.
All fans used are operated from 24 VDC so their performance is constant for low or high AC
input line voltage and for 50 or 60 Hz power sources. There are a total of 7 fans in the
system:
1. One is built into the high voltage power supply (HVPS).
2. One fan is mounted to the rear of the frame to cool the AC module area.
3. One is mounted in the HP Assembly.
4. Two are mounted to the heat exchanger (Firmware controlled based on fluid
temperature); other fans turn on as soon as the system is powered on).
One in the Upper Chassis Section.
One in the DCD Section.
The GentleMAX Pro contains a closed loop fluid system that maintains the laser heads at a
constant temperature. The fluid is deionized (or distilled) water and is maintained at 65°C.
(149°F) to obtain optimum performance from the ALEX laser head and allow efficient system
cooling. A 2000 Watt heater is used to heat the water to operating temperature. A liquid to air
heat exchanger with two fans removes heat when the laser is being operated to maintain the
water at its proper temperature.
ee
An initial warm-up time of approximately 12 minutes (from a cold start) is required for the
deionized water to reach operating temperature. This time can vary depending on the ambient
temperature in the room and the line voltage (the heater wattage varies with line voltage). The
warm-up time of the cryogen canister is about 10 minutes thus the system warm-up time is
usually less than 12 minutes,
The CPU 1/0 PCB uses a PIC DSP33 microprocessor to monitor and control all of the system
hardware I/O functions. A serial interface provides communications between the PIC DSP33
and an Atom based ETX board running windows CE. The ETX board configured with RAM
and a solid state IDE flash drive provides the Graphical User Interface (GUI) on a 10.4" SVGA,
LCD Display with a resistive touch screen and a USB data port.
A built in Maintenance Mode accessed through the GUI gives the service technician access to
system status and control functions for debug, repair and maintenance. The USB Port located
n the rear of the Display bezel provides a means to download a log file containing laser
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—____ Gentieax Pro Theory of Operation
parornance data and also a means upgrade GUI and 1/0 firmware revisions from a memory
slic
For purposes of technical review, the laser can be divided into four major subsections:
+ Optical System
© RAILICAPLORT MODULE
© DELIVERY SYSTEM MODULE
© DCD Module
© Fluid Module
+ Electronics
© AC Module
o HV Module
© CPUI/O Module
+ Performance
© Rep Rate & fluence ranges
Pulse Durations
Each section will be addressed in this theory of operation. The system fiemware will not be
discussed unless it is required to explain the functioning of the laser. Detailed information on
the system firmware is covered in the GenlleMAX Pro Software Development Plan 1010-18-
3268
SERVICE NOTE
‘Whenever maintenance or repair of the laser system is required be sure to adhere to the
following safety statements:
WARNING
The electrical hazards present during servicing of the GentleMAX Pro can be extremely
dangerous and lethal if proper precautions are not taken. The GentleMAX Pro should
be serviced only by qualified technicians who have received appropriate training on
the GentleMAX Pro.
WARNING
During servicing of the laser system use only safety eyewear known to have an optical
density of 5.8 or more at 755 nm + 10 nm and eyewear with an optical density of 6.3 or
more for 1064 nm. Safety eyewear designed for use with other laser systems may not
provide adequate protection.
OPTICAL SYSTEM
‘A drawing of the optical system is shown in Figure 1. The optical assemblies located inside
the laser system are the laser rail and the calibration port. The Laser Rail contains the
following:
|. ALEX and YAG Laser Heads
I. Beam Shutter Assembly
Ill. Turning Mirror
IV. Beam Combiner
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V. Intermediate Lens
VI. Aiming Beam Assembly
Vil. Head Detector Assembly
Vill. Fiber Receptacle Assembly
Alll of the above components are precisely located on the laser rail with pins, Laser Rail
alignment is required for the laser head beam to aim into the fiber receptacle. The fiber
receptacle is pre-aligned and normally does not require alignment unless the lenses are
replaced in the field (However, it should be, at a minimum, verified at each service call)
The other two optical assemblies are:
IX. Optical Fiber Delivery System (includes-optical fiber, Slider and Slider Attachments),
which connects to front of laser
X. Calport Detector Assembly (Not on laser rail)
|. Alexandrite and ND:YAG Laser Heads
The Alexandrite laser head contains two identical flashlamps (8 mm bore, 4 inch arc length,
700 torr) connected in series and the Alexandrite rod. The Alexandrite rod ends are coated to
form the laser resonator. The partial reflector is 81.5% reflective and the high reflector is
99.9% reflective. The rod is orientated in the laser head in such a way to prevent “hot spots”
in the laser beam, which could damage the proximal end of the fiber.
The ND:YAG laser head contains the Nd:YAG rod and also has two identical flashlamps of
the same type as the Alexandrite head. The Nd:YAG rod ends are coated to form the laser
resonator. The partial reflector is 42.5.5% +/-2.5% reflective and the high reflector is 99.9%
reflective.
Operation of the Nd:YAG laser head at more than 99 Joules of laser output energy could
greatly reduce the lifetime of the head. Operation of the Alexandrite laser head at more than
66.3 Joules of laser output energy could greatly reduce the lifetime of the head. Therefore,
maximum delivered energy and fiuencies are determined by this maximum head energy and
realistic delivery system transmission.
Since the laser rods have the optical reflectors coated on the ends, there is no laser head
alignment required; but alignment into the Fiber Receptacle is required. Caution should be
used when servicing the laser heads since a damaged high reflector coatings can allow
significant laser energy to exit the rear end of the laser rod
A metal cover is mounted over the laser rail to protect the optics from dust contamination. It
also protects the service technician from the high voltages present in the vicinity of the laser
head and from optical hazards. Unless required for trouble-shooting and alignment, the laser
should not be pulsed with the laser cover removed. If the cover is removed, it should be
replaced as soon as possible and the laser should never be left with the laser cover off.
When the laser is in Ready state, never touch the laser head or rest test equipment on it as it
is only a trigger switch away from being pulsed. Therefore, use extreme caution when
servicing the laser head.
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Figure 1 LASER RAIL BLOCK DIAGRAM.
il, Beam Shutter Assembly
The beam shutter allows laser light to pass on to the fiber coupling lenses when itis
energized. Normally it is not energized so it blocks any laser light exiting the partial reflector
end of the laser head. A ceramic block is mounted to the surface of the beam shutter blade so
that its in line with the laser beam when the shutter is in the blocking position. The ceramic
block reflects most of the laser energy that hits it and absorbs the rest. The reflected laser
light is dispersed in a divergent pattern. The beam shutter does get hit with laser eneray
during a bleeder pulse when entering Ready State to discharge the capacitor voltage to
support the calibration routine, The beam shutter is also used as a safety device to prevent
laser energy from exiting the laser system under fault conditions.
The beam shutter is controlled by firmware on the CPU /O PCB. It can not be opened unless
the Firmware command is present. A slotted optical switch on the shutter assembly is used to
sense the position of the shutter. The sensor is positioned so that it detects infrared light from
the LED side of the optical switch when the shutter is in the laser beam path. When the
shutter is energized and moves out of the beam path, the infrared light is blocked by the back
end of the shutter blade. The firmware will only allow the laser system to enter the Ready
state if the beam shutter is blocking the laser beam path in Standby state.
I, Turning Mirror
The turning mirror is a fused silica mirror that is reflects more than 99% of the Alexandrite
beam 90 degrees onto the beam combiner.
\V. Beam Combiner
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The beam combiner assembly contains a dichroic beamsplitter and has two purposes. First
it combines both laser beams by transmitting the ND:YAG beam and reflecting the
Alexandrite beam. Second it aligns the Alexandrite laser beam onto the fiber receptacle
lens.
V. Intermediate Lens
The intermediate lens is adjustable and used to center the YAG beam onto the fiber
receptacle, It also reduces the beam size onto the fiber receptacle lens allowing the use of
smaller diameter lenses.
Vi. Aimit m Assembl
The Aiming Beam Assembly consists of a Green LED which works in the 525-550 nm range.
In User mode the operator can choose from different settings of brightness. In MM mode the
service technician can control the LED brightness via % duly cycle. The aiming beam reflects
off a mirror and onto the beam splitter. The beam splitter has a special coating on one side
that reflects the aiming beam and transmits the Alexandrite and YAG beam. The ail
beam reflects off the beam splitter into the fiber receptacle focusing lenses where it is focused
into the fiber. There is an optical filter immediately after the LED to block 755nm and 1064nm
back reflections.
Vil. Head Detector Assembly
The head detector assembly is between the fiber recepticle assembly and beam shutter
assembly. The head detector assembly consists of a beam splitter, ceramic disc, and fiber
port. The beam splitter is at 15° to the input beam. This allows the input side of the beam
splitter to be uncoated and reflect 3.5%. The other side of the beam splitter is coated to
reflect at least 50% of the aiming beam and transmit the Alexandrite and YAG beams. In this
way, the majority of the reflected beam into the head detector is from an uncoated surface, so
there are no signal strength variations due to an optical coating. The reflected beam transmits
thru a ceramic diffuser which homogenizes the transmitted beam. The transmitted beam.
floods the end of a fiber optic cable so a small portion of the beam is transmitted down the
fiber to a photodiode on the CPU /0 PCB. The photodiode detector on the laser CPU 0
PCB converts the optical signal to a current pulse. This current pulse is processed and
calibrated before being sent on to the firmware to measure the actual energy out of the laser
head. The head detector is used to control the energy in the beam by using the
measurements to adjust the pulse duration and voltage within allowed limits.
Vill. Fiber Receptacle
The fiber receptacle assembly contains two lenses which are used to couple the laser beam
onto the end of the fiber. The lenses are designed and located so that the proximal tip of the
fiber is at the focal point of the lenses. This causes the laser beam diameter to be 1.2 mm on
the 1.5 mm diameter fiber resulting in maximum coupling efficiency, good beam profile, and
lifetime. They are designed to be field replaceable. If lens replacement is performed, itis
important to note the orientation of the existing lenses so that the new lenses are installed
properly. The proximal end of the fiber is inserted into the fiber receptacle and locked into
Position with ball plungers on the fiber assembly. A microswitch mounted inside the fiber
receptacle is used to allow the firmware on the CPU /O PCB to detect the presence of a fiber.
This same signal is used by firmware to prevent operation of the high voltage power supply
without a fiber installed. If the laser is turned on and the fiber is removed, the firmware will
assume that a new fiber has been installed and it will clear out the existing calibration table
stored by the firmware. This will cause the laser system to perform a full calibration the next
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time the laser is put into Ready state. The laser can be pulsed in Maintenance Mode without
the fiber.
IX. Delivery System
There are three different delivery systems configurations:
* DCD Delivery System, which consists of:
°
0000
DCD cabled handpiece
Fiber Assembly
618/10 mm Slider Attachment
12/15/18 mm Slider Attachment
6/8, 10, 12, 15, and 18 mm distance gauges (the 6 mm and 8 mm spot sizes,
share the same distance gauge).
* Specialty DCD Delivery System, which consists of:
°
°
DCD cabled handpiece
Fiber Assembly (same as on DCD Delivery system)
1.5 mm Slider Attachment
3mm Slider Attachment
1.5, 3mm distance gauges
* ACC Delivery System, which consists of:
°
°
°
°
°
Dep D
ACC cabled handpiece
Fiber Assembly (same as on DCD Delivery system)
6/8/10 mm Slider Attachment
12/15/18 mm Slider Attachment
6/8, 10, 12, 15, and 18 mm distance gauges (the 6 mm and 8 mm spot sizes
share the same distance gauge).
Air Clip
ry System
This delivery system has the DCD cabled handpiece which is used to deliver the DCD
cryogen spray just prior to the lasing energy. See Figure DS-1. The DCD Delivery System
has the DCD components incorporated in it. The DCD components in the lower section of the
handpiece (HP) assembly consist of the cryogen valve, cryogen nozzle (0.020" ID), and HP
Bubble PCB. There is also a fan in this section for keeping it cool to reduce bubble faults.
There is a serviceable filter in front of this fan that can be cleaned or replaced by removing
the cover.
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Standby/Ready
Fiter cover
Finger Switch
Figure Ds
Window Holder
Air vent
Slider Lock
1 of 4nozzle
DCD Deliver adjusters
The upper section of the handpiece contains the HP Sensor PCB, the DCD Electrical cable,
the finger switch, the Standby/Ready button the slider lock button, and the slider tube. The
HP Sensor PCB has optical sensors to determine spot size and a memory IC to determine HP
Type. Both of these PCBs allow the firmware to determine the Delivery System configuration.
The handpiece also contains a user serviceable window. This window is removed by
removing the window holder at the top of the handpiece. This operation must be done with
the handpiece pointing up otherwise the window will fall out. The holder is held into the
handpiece with a magnet. See Figure DS-1.
If necessary, the cryogen nozzle can be aligned by adjusting the 4 set screws at the front of
the handpiece. These screws are locked with a special adhesive that does not attach the
handpiece shell plastic. The distance gauge must be removed to access the top screw.
The handpiece should never be opened. There are no serviceable parts in the handpiece.
The lower DCD section is sealed to prevent the air from the fan escaping except through the
vent holes at the front of the handpiece.
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specialty DCD Delivery System
The specialty DCD delivery system provides 1.5mm and 3mm spot sizes and is very similar to
the standard DCD delivery system with a few exceptions. The cryogen nozzle is reduced from
0.020" ID to 0.016"ID and an in-line particle fiter is installed in the DCD tubing to prevent
clogging of the small diameter nozzle. The window holder is removed to accommodate the
increased length of the 1.5 and 3mm slider attachments. The 85% nominal fiber transmission
is reduced to approximately 80% for the 3mm and 40% for the 1.5mm.
Figure DS-2. Specialty DCD Delivery System.
‘ACC Delivery System
The ACC Delivery System is identical in components and operation to the upper section of
the DCD Delivery System. This handpiece does not have the lower section DCD
components. Instead, there is an air clip that attaches to the bottom of the ACC to deliver
refrigerated air to the treatment area. The air clip is designed to interface with at Zimmer type
cooling device. The air clip attaches by inserting the nose of the handpiece into the latch at
the front of the air clip, and then pressing the back down until it clicks into place. The air clip
is removed by pressing the two back buttons to release the back of the handpiece. See
Figure DS-3
Finger Switch
Figure DS-3. ACC Handpiece.
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Fiber Assembly
‘The fiber assembly (Figure DS-4) consists of a 1.5 mm diameter core optical fiber, a proximal
connector, one scrambler located about 1" from the connector and a slider and receptacle for
the slider attachments. At each end of the fiber there is a 1’ section of steel bend limiting
tubing that prevents the fiber from bending by more than 6" radius. The middle section has a
nylon tube over the fiber to protect it from crushing. The EPROM for serial number and pulse
data storage is located in the proximal connector. Nominal fiber transmission is ~B5% for the
6 — 18 mm spot sizes.
Figure DS-4, Fiber Assemb)
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Slider Attachments
All Slider Attachments contain 2 or more lenses and 1 protective window. The output window
is held in with a retainer. This retainer is unscrewed (no tools) to remove the window for
cleaning or replacement by the user. See Figure DS-5.
12/18/18 Slider
‘Attachment
618/10 Slider
Attachment
4
ae
Baal A Window retainers
are at the tip of,
sliderireceptacte aha
attachment
— 3mm Slider
Tea)
~—— ] 1.5mm siider
Attachment
Figure DS-5. Slider Attachments.
Spot Size Detection
To select a spot size, the appropriate slider attachment is inserted into the slider on the distal
end of the fiber and then this slider with the attachment is inserted into the slider tube at the
back end of the handpiece (the slider lock button must be depressed to insert the slider). The
slider has distinct grooves for each spot size that lock into place when property positioned and
the slider lock button is released.
A reflective optical sensor is used to monitor the position of the slider lock button. A spot size
will not be decoded or valid until the slider lock is latched into one of the distinct grooves.
Once the sensor indicates the slider lock is in the “locked” position, a series of 6 reflective
‘sensors are used to determine the position of the slider and thus the spot size setting. The
teflective sensors are positioned in a linear row along the handpiece. In the absence of a
slider, the six sensors are looking at an empty space and get no reflected signal. As the slider
is inserted into the optical path of the sensors, it causes a signal to reflect as it passes in front
of each sensor. The pattern of the reflected signals from the 6 sensors indicate the slider
Position and thus the selected the spot size.
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The 1.5mm and 3mm are sensed in a similar manner except the slider attachments have an
additional deep groove. When the groove is aligned in front of a reflective sensor, the sensor
gets no reflection creating a unique combination of signals from the 6 sensors. The block
diagrams in Figures DS-6, DS-7 and DS-8 depict how the combination signals from the
sensors are used to determine the spot size.
8507-00.
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Calport Assembly
The GentleMAX Pro calport (Figure#3A) collects the laser light out of the handpiece and
transmits an optical signal via fiber optic cable to the optical sensor on the CPU VO PCB in
order to measure delivered energy. The Calport contains four micro switches for sensing
when the handpiece is fully inserted. The front two sense the DCD handpiece and the back
two sense the ACC handpiece. All 4 are depressed when the ACC handpiece is installed, D
because the system knows what type of handpiece is being used it ignores the two front
switches for the DCD handpeice. The calportis positioned at an angle and contains an
adjustable spring loaded ball plunger for each handpiece to prevent the handpiece from falling
out.
Laser energy from the handpiece projects through a serviceable protective window and
ceramic plate which scatters the beam into a white integrating chamber. This chamber
creates a high level of scattering which nearly eliminates calport sensitivity to misalignment of
the handpiece and changes in spot size at the ceramic. Some of this scattered energy
passes through an optical fiber cable to a photodiode detector on the CPU 1/0 PCB. The
photodiode detector on the laser CPU I/O PCB converts the optical signal to a current pulse.
‘This current pulse is processed and calibrated before being sent on to the firmware to
measure the actual energy into the Calport.
The GentleMAX Pro operating fluence range is currently 6 - 300 Jicm2, depending on the
spot size. There are 8 different spot sizes, which correspond to specific fluence levels. The
conversion factors used to convert energy to fluence are shown in Table 1. These factors are
equal to 1/spot area.
Spot Size | Fluence Conversion Factor
1.5mm | 59.59x External Meter Energy
3mm 44.15 x External Meter Energy
6mm 3.54 x External Meter Energy
8mm 1.99 x External Meter Energy
40mm 1.27 x External Meter Energy
12mm 0.88 x External Meter Energy
15mm 0.566 x External Meter Energy
18mm 0.393 x External Meter Energy
Table 1 Energy to Fluence Conversion Factors
The available energy density settings for each spot size and the external energy meter value
associated with that spot size are shown in Appendix A at the end of the Theory of Operation.
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i
Le
—
‘CALPORI DIAGRAM
Figure 3A Calport Assembly
FLUID SYSTEM
The GENTLEMAX PRO contains a de-ionized water system that regulates the temperature of
the Alexandrite rods at 65°C (149°F). The total water capacity of this system is approximately
1 Gallon (4 Liters). A centrifugal pump is used to circulate the de-ionized water in the system.
The pump is mounted directly under the water reservoir. Typical pump output pressure
generated is 12 PSI (measured at the pump outlet) with a nominal flow rate of 1.7 GPM. The
water flow and pressure are not adjustable. A block diagram detailing the fluid system is
shown in Figure 4.
The pump output is connected to the DI heat exchanger. The heat exchanger is cooled with
two 24 VDC fans which are controlled by the firmware on the CPU I/O PCB. The fans are
mounted on the heat exchanger and pull air up from the side of the laser fluid compartment.
Exhaust air exits the fluid compartment out the rear of the laser chassis. A foam filter in the
side of the fluid compartment minimizes the amount of dust picked up by the incoming air.
The foam filter must be changed at regular intervals to prevent restriction of the cooling air.
Scanned with CamScannerFigure 4, FLUID SECTION BLOCK DIAGRAM
The output of the heat exchanger is connected to the heater manifold. The heater manifold
contains a single 2000 Watt heater, the DI temperature sensor and a thermal over
temperature switch. If an over temperature problem occurs that cannot be corrected by the
firmware or hardware, then the thermal over temperature (OT) switch will open which
removes 24 VDC power from the key switch circuit thus turning off the entire laser system.
The OT switch is self resetting. After it opens, it typically takes from 10 to 20 minutes for it to
reset. The heater is disabled by the firmware when the trigger switch is depressed. This is
done to limit the AC input current drawn by the system during pulsing of the laser. The heater
is not required when pulsing since the majority of the pulsed energy goes into the D! water in
the laser head. The temperature sensor is based on a thermistor that has a resistance that
varies with temperature. This signal is used in conjunction with circuits on the CPU 1/0 PCB to
allow the firmware to monitor the temperature of the water. The drain valve is located after the
pump and is manually operated to remove water from the system. It is located at the lowest
point in the DI fluid system.
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Water exits the heater manifold and flows up to the laser head on the upper chassis. The
tubing connection between the heater manifold and the laser head has several components in
it. The first is a parallel path, this parallel path consists on one side a flowswitch and the other
side a DI cartridge/particulate filter assembly which then recombines to the inlet of the laser
head. Most of the water travels through the flowswitch side. Approximately 5% of the flow is
through the DI cartridge/particulate filter side. The DI cartridge contains a de-ionizing section
to maintain the purity of the water (high resistivity) and the particulate filter keeps the water
free of 1.2um or larger particles. The DI cartridge/particulate filter must be changed at least
once per year if the pellets in the DI cartridge change color from a dark purple to light brown.
In most cases the color change will occur internal to the cartridge and not be noticed by the
Service Technician. This is because the DI cartridge is operated with a very low flow rate so
the majority of the water travels through small channels inside the cartridge. These channels
tend to form closer to the center of the cartridge (since the inlet and outlet are in the center),
so the color change will usually occur in the center.
The DI cartridge/particulate filter and flowswitch sides join up just before passing through to
the upper chassis where they connect into the Alexandrite laser head. Water exiting the laser
head is connected through tubing directly into the reservoir. This minimizes any back
pressure generated by the water when the laser heads are pulsed.
Removal of the laser heads does not require draining any water from the reservoir. When the
water fittings on the head are loosened, most of the water in the head drains back into the
reservoir which has enough capacity for it. After installing a new head, the water level in the
reservoir must be checked and “topped off" after the pump has been run for several minutes.
The combination of the 2000 watt heater in the heater manifold and the heat exchanger fans
work together to maintain the water in the laser system at 65°C (149°F). The temperature is
regulated to + 5°C to ensure efficiency and stability and to minimize variations from different
laser heads. For best accuracy, the temperature sense circuit should only be calibrated when
the temperature has stabilized and both the heater and heat exchanger fans are off. This
ensures that the water temperature in the reservoir is at the same temperature as the sensor
in the heater manifold.
The firmware uses two set points to control the heater and fans. The heater is turned on
whenever the water temperature is at 64°C or less. The heat exchanger fans are turned on to
maintain the water temperature at 65°C. There is some undershoot and overshoot in the
water temperature at each of these set points. The firmware over temperature fault is set for
70°C. The laser will not go into the Ready state if this fault is present. Normally, the firmware
should declare an over temperature fault before the over-temperature thermostat turns off the
laser. If this does not happen, then most likely the temperature sensor is bad or mis-
calibrated. The firmware will also declare an over-temperature fault if the temperature is less
than 9°C or greater than 90°C. If the temperature is outside this range the firmware assumes
the temperature sensor has failed or become open or short circuited. Also, if the temperature
drops below 53.5°C while in the Ready state, a fault will be displayed.
DCD (Dynamic Cooling Device)
The DCD system is located on the upper chassis of the frame. Access to the DCD canister is
located under the DCD cover. The cryogen connector and electrical interface are located on
the front bezel of the laser system. A block diagram of the system is shown in Figure 5
Operation of some of the DCD functions such as bubble detect, and DCD pressure circuits
are covered in detail in the CPU /O PCB section
The DCD canister is warmed by two 100 Watt heater resistors in series at a mains voltage ~
220VAC. The feedback in the control loop is the cryogen pressure. The firmware on the CPU
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