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2375 Camino Vida Roble, Suite B
Carlsbad CA 92011
U.S.A.
TEL. (760) 602-3300
FAX. (760) 602-3311
Excimer Laser
Phototherapy System
AL8000
SERVICE
MANUAL
12-95306-01 Rev F
AL8000 SERVICE MANUAL
Printed in USA.
The information contained in this document is subject to change without notice.
PhotoMedex shall not be liable for errors contained herein or for incidental or consequential damage in connection with furnishing, performance, or use of this material.
Use of this manual is not intended for individuals who have not received appropriate training.
Individuals who have not received formal training by an authorized PhotoMedex trainer cannot service the XTRAC Phototherapy System.
Attempts to service the XTRAC system without authorized training may cause serious injury to the service technician and/or operator and will also void the warranty.
This manual provides no information on the clinical use of the laser.
Page 2 of 37
AL8000 SERVICE MANUAL
REVISION HISTORY
ECO
2530
Pages/Sections
All
Revision
A
(Initial Release)
B Page 36
Pages 12-14,
29, 34, 35,
Appendix A, B,
C
Pages 1, 12, 36
Sections 3.3,
6.1, 15.2, 15.3,
17.3, 19.1, 19.2,
20.2, 21.2, 22.0
Sections 3.2,
3.3, 4.3, 19.0,
19.1, 19.2, 21.2,
Appendix A
Pages 30-32
C
D
E
F
G
2548
2575
2609
2669
2817
2896
Date
2/15/05
03/09/05
4/22/05
7/11/05
11/17/05
2/12/07
5/22/07
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AL8000 SERVICE MANUAL
Table of Contents
REVISION HISTORY ..............................................................................................................................................3
1.0
CAUTION ........................................................................................................................................................6
2.0
GENERAL SAFETY FOR OPERATING PERSONNEL AND PATIENTS.............................................6
2.1
U
SER
R
ESPONSIBILITIES FOR
A
PPROPRIATE
O
PERATION
................................................................................7
3.0
WARNINGS, LABELING AND SYMBOLS................................................................................................7
3.1
W
ARNINGS
.....................................................................................................................................................7
3.2
L
ABELING
.......................................................................................................................................................8
4.0
DEVICE DESCRIPTION .............................................................................................................................12
4.1
M
ANUFACTURER AND
EU R
EPRESENTATIVE
...............................................................................................12
4.2
S
TANDARDS
..................................................................................................................................................12
4.3
XTRAC X
E
C
L
E
XCIMER
L
ASER
P
HOTOTHERAPY
S
YSTEM
S
PECIFICATIONS
................................................12
4.4
XTRAC E
QUIPMENT
C
LASSIFICATION PER
UL 60601-1..............................................................................13
5.0
INDICATIONS ..............................................................................................................................................13
6.0
TRANSPORT AND STORAGE...................................................................................................................13
B
EFORE
S
HIPPING THE
XTRAC
SYSTEM
: .................................................................................................................14
6.2
T
RANSPORT AND STORAGE CONDITIONS ARE DEFINED AS FOLLOWS
:............................................................14
7.0
UNPACKING THE SYSTEM AND PERFORMING SYSTEM SET-UP ...............................................14
8.0
INSTALLING THE FOOTSWITCH ..........................................................................................................14
9.0
USING THE SYSTEM ROOM-DOOR INTERLOCK (OPTIONAL).....................................................15
10.0
ADJUSTING SYSTEM VOLTAGE AND FREQUENCY ........................................................................15
11.0
POWER-ON WARM-UP MODE ................................................................................................................15
12.0
EMERGENCY LASER STOP .....................................................................................................................16
13.0
OPERATING THE SYSTEM IN THE SERVICE MODE........................................................................16
13.1
A
CCESSING
S
ERVICE
M
ODE IN THE
XTRAC ................................................................................................16
14.0
GAS BOTTLE INSTALLATION ................................................................................................................17
14.1
N
EON
P
URGE
S
ET
-
UP
....................................................................................................................................17
14.2
C
ONNECTING
N
EON
P
URGE
& A
TTACHING OR
E
XCHANGING
X
E
C
L
C
YLINDER
...........................................17
14.3
R
EMOVING THE
N
EON
P
URGE
.......................................................................................................................19
15.0
ALIGNMENT AND LIQUID LIGHTGUIDE INSTALLATION.............................................................20
15.1
I
NTRODUCTION
.............................................................................................................................................20
15.2
A
LIGNMENT AND
A
LIGNMENT
C
HECK
P
ROCEDURES
....................................................................................22
15.3
PIN D
IODE
C
ALIBRATION
............................................................................................................................23
15.4
I
NSTALL THE
L
IGHTGUIDE
............................................................................................................................24
16.0
GAS BOTTLE CAPACITY MAINTENANCE ..........................................................................................25
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17.0
WINDOW CHANGE PROCEDURE ..........................................................................................................26
17.1
N
EON
P
URGE
S
ET
-U
P
...................................................................................................................................26
17.2
C
ONNECTING
N
EON
P
URGE
..........................................................................................................................26
17.3
R
EPLACING THE
C
HAMBER
W
INDOW
A
SSEMBLIES
......................................................................................26
17.4
R
EMOVING THE
N
EON
P
URGE
.......................................................................................................................28
17.5
R
E
-
GASSING AND RE
-
ALIGNMENT OF THE LASER CHAMBER
..........................................................................28
18.0
WINDOW ROTATION PROCEDURE ......................................................................................................28
18.1
R
OTATING THE
C
HAMBER
W
INDOW
A
SSEMBLIES
........................................................................................28
18.2
V
ERIFY LASER CHAMBER ALIGNMENT
..........................................................................................................29
19.0
XTRAC TROUBLESHOOTING AND EVENT CODE GUIDE .............................................................29
19.1
T
ROUBLESHOOTING
G
UIDE
...........................................................................................................................29
19.2
EVENT CODE AND GAS HISTORY G
UIDES
..........................................................................................30
20.0
MAINTENANCE...........................................................................................................................................33
20.1
S
CHEDULE OF
P
REVENTIVE
M
AINTENANCE
..................................................................................................33
20.2
E
NERGY
D
ETECTOR
C
ALIBRATION
V
ALIDATION
(
PER
15-90014-01) ...........................................................34
20.3
C
LEANING THE
XTRAC S
YSTEM
.................................................................................................................35
21.0
REFERENCES ..............................................................................................................................................35
21.1
I
NTELLECTUAL
P
ROPERTY
............................................................................................................................35
21.2
R
EFERENCE
D
OCUMENTATION
.....................................................................................................................35
21.3
D
ISPOSAL
.....................................................................................................................................................36
22.0
REPLACEMENT PARTS ............................................................................................................................36
APPENDIX A - DEFINITION OF TERMS............................................................................................................44
APPENDIX B - MSDS FOR XECL .........................................................................................................................45
APPENDIX C - ADDITIONAL DOCUMENTS.....................................................................................................46
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1.0 CAUTION
AL8000 SERVICE MANUAL
This Service Manual is intended to be used only by persons who have been trained to service this product. Procedures and instructions are to be followed as indicated. All cautions, precautions and warnings should be thoroughly understood prior to unpacking, assembling and operating the XTRAC system.
CAUTION: AVOID DIRECT OR SECONDARY LASER RADIATION. The
XTRAC phototherapy system is a laser-based device. When interlocks have been placed in the “service mode” there is the potential for laser energy to be present. Use precaution when operating the system in this mode. Always wear appropriate safety glasses, which are designed to block 308nm UVB wavelength energy.
CAUTION: Potentially lethal voltages are present within the XTRAC system. Always use caution when performing any service or maintenance to the system.
CAUTION: This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. If it causes unwanted interference the operator should consult the laser service representative. Changes or modification not expressly approved by
PhotoMedex could void the user’s authority to operate the equipment.
CAUTION: Do not operate the laser in the presence of flammable anesthetics or oxidizing gases such as nitrous oxide (N
2
O) and oxygen.
2.0 GENERAL SAFETY FOR OPERATING PERSONNEL AND
PATIENTS
• Laser equipment not in use should be protected against unqualified use, for example by removal of the key from the key switch.
• The invisible ultraviolet laser radiation emitted from the XTRAC system output laser aperture can cause eye and/or skin injury from either direct radiation. Only a trained user should operate the laser.
• The use of controls or adjustments, or performance of procedures, other than those specified in this labeling may result in hazardous radiation exposure.
• Users and support staff must wear eye protection during laser operation. The recommended safety eyewear should have an optical density (OD) of 2 at a wavelength of 308 nm.
• Do not look into the end of the handpiece when the laser is firing.
•
Do not point the handpiece at operating room personnel when the laser is firing.
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2.1 User Responsibilities for Appropriate Operation
It is the responsibility of the health care professional who is using the laser to be aware of requirements for safe use. It is strongly recommended that a hospital
Laser Safety Officer be responsible for the overall control of the laser and safety training. Note: Laser equipment not in use should be protected against unqualified use (e.g. by removal of the key from the key switch). The responsibilities of a Laser Safety Officer are described in American National
Standard for Safe Use of Lasers in Health Care Facilities ANSI Z136.3 2000.
The user is responsible for reading and following the XTRAC Operations Manual and for exercising all safety precautions recommended in the Operations Manual and product labeling including the use of eye protection at all times that the system is activated.
3.0 WARNINGS, LABELING and SYMBOLS
3.1 Warnings
WARNING: The invisible ultraviolet laser radiation emitted from the XTRAC system output port aperture can cause severe eye and/or skin injury from radiation. Only a trained user should operate the laser.
WARNING: The repair technician must exercise extreme care when operating the laser; safety glasses must be worn and skin exposure must be avoided.
WARNING: The use of controls or adjustments, or performance of procedures, other than those specified in this labeling may result in hazardous radiation exposure.
WARNING: At all times during the installation or operation of the laser, avoid possible exposure to laser radiation.
WARNING: Users and support staff must wear eye protection during laser operation. The recommended optical density for Safety eyewear is an optical density (OD) of 2 at a wavelength of 308 nm. The patient’s eyes should be protected with a covering of wet gauze.
WARNING: High voltage circuits are contained within the XTRAC system enclosure.
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AL8000 SERVICE MANUAL
3.2 Labeling
Throughout the system you will find labels applied to various areas, which are designed to warn or caution of certain hazards or other precautionary information.
This section will provide an outline of each symbol and it’s meaning. The current revisions of each label are filed with Document Control.
Description
Circuit Breaker
On
Off
Description
Foot-switch
Description
Remote Interlock
12-95306-01 Rev G
Description
Defeatable Interlock
CAUTION
-
VISIBLE AND INVISIBLE CLASS 4 LASER
RADIATION WHEN OPEN AND INTERLOCKS DEFEATED
AVOID EYE OR SKIN EXPOSURE TO
DIRECT OR SCATTERED RADIATION
Description
Label, Calibration Port
CALIBRATION
PORT
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AL8000 SERVICE MANUAL
Description
Optical Fiber
Description
Label, Nameplate, AL8000
REF
SN
Carlsbad, CA
100-230 V~ 50 / 60 Hz, 1kVA
0086
Complies with 21 CFR 1040.10 and 1040.11
except for deviations pursuant to
Laser Notice No. 50, dated July 26, 2001
EC REP
Scanlan Group B. V.
Postbus 75664
1118 ZS Schiphol Triport
The Netherlands
PhotoMedex, Inc.
U.S. Patent Numbers 4891818,
5044717 Other Patents Pending
Description
Laser Warning, Danger
Description
Laser Warning Explanation Class IV
Page 9 of 36
AL8000 SERVICE MANUAL
Description
Label, Physician Use Only (FDA Reqd.) sale by or on order of a physician.
Description
Attention – Yellow or White
Description
Caution, Invisible
CAUTION
-
CLASS 4 INVISIBLE AND VISIBLE LASER
RADIATION WHEN OPEN
AVOID EYE OR SKIN EXPOSURE TO
DIRECT OR SCATTERED RADIATION
12-95306-01 Rev G
Page 10 of 36
3.3 Symbols
Symbol
EC REP
AL8000 SERVICE MANUAL
Description
Batch Code
B Equipment
Date and location of Manufacture
Emergency Laser
Stop
European
Representative
Fiberoptic
Applicator
Footswitch
Fragile
Symbol Description
REF
Model Number
LASER APERTURE
Laser Aperture
Location
0086
On
Main
Off
Product complies with Directive
93/42/EEC for medical devices
Read Instructions
For Use
Ready Key
Remote Interlock
SN
Serial Number
Keep Dry
Temperature
Limitation
Laser Aperture
(Symbol)
Laser Emission
On
Part of System
Off
MED Ready
Mode
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AL8000 SERVICE MANUAL
4.0 DEVICE DESCRIPTION
4.1 Manufacturer and EU Representative
Manufacturer:
PhotoMedex, Inc.
2375 Camino Vida Roble, Suite B
Carlsbad, CA 92011
EU Representative:
Scanlan Group B.V.
Postbus 75664
1118 ZS Schiphol Triport
The Netherlands
4.2 Standards
The XTRAC (model AL8000) Excimer laser phototherapy system is a class IV Laser product, which complies with (US Code of Federal Regulations) 21 CFR 1040.10 and
1040.11 & IEC 60825-1.
The XTRAC system has tested in compliance with the safety laser requirements and electromagnetic compatibility per the following international standards:
EMC STANDARDS
EN 60601-1-2
EN 55011, Class A, Group 1
SAFETY STANDARDS
EN 60601-1
EN 60601-2-22
EN 60825
21 CFR 1002
UL 60601-1
IEC 60601-2-22
4.3 XTRAC XeCl Excimer Laser Phototherapy System Specifications
The XTRAC system is an Excimer laser designed for use in phototherapy treatment.
The XTRAC has been designed around a pulsed, 308 nanometer XeCl excimer laser which provides:
Wavelength
Pulse Repetition Rate
Pulse Width (FWHM)
Beam Diameter
Operating Energy
308 nanometers
Up to 250Hz
30-nanosecond nominal
0.75 in square (2cm X 2cm)
2-3.8 mJ/cm² (nominal per pulse)
Electrical
Weight
Gas System
100/230 VAC, 50/60 Hz, 1 kVA, universal
220 lb / 100 kg (approximate)
Self Contained Supply (approx 20 refills)
Dimensions 46 cm x 99 cm x 86 cm (W x L x H)
18 inches x 39 inches x 34 inches
Excimer Laser Product Classification Class IV per 21 CFR 1040.10 / IEC 60825-1
Diode Laser Product Classification
Nominal Ocular Hazard Distance
Maximum Laser Energy
Beam Divergence
Class IIIa/3R per 21 CFR 1040.1/ IEC 60825-1
20 cm from the handpiece tip
15mJ
750 mRad
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4.4 XTRAC Equipment Classification per UL 60601-1
Type of protection against electric shock- Class I equipment
Degree of protection against electric shock- Type B equipment
Degree of protection against harmful ingress of water-
Ordinary equipment without ingress protection
Degree of safety in the presence of flammable anesthetic mixture with air or oxygen or nitrous oxide-
Mode of Operation-
Equipment is not suitable to use in the presence of flammable anesthetic mixture with air or oxygen or nitrous oxide
Continuous operation
Liquid Lightguide and Handpiece: MODEL H7-4.0
LLG Material
Length
Diameter
Input
Output
HP Material
Projected Field
Proprietary liquid filled housing
2.0 meters
3.0 mm nominal
Custom connector (user replaceable)
Custom connector
Aluminum–housing
≈ 0.75 in square (4.0 cm
2
)
Handpiece Tip & Ink pad Kit : MODEL K7-4.0
Supplied non-sterile, with reusable Handpiece Marking Tip
5.0 INDICATIONS
Phototherapy with the XTRAC UVB Excimer Laser Phototherapy system is indicated for patients with Psoriasis, Vitiligo, Atopic Dermatitis or Leukoderma.
6.0 TRANSPORT AND STORAGE
Preparing the XTRAC system is to be performed only by PhotoMedex authorized service representatives.
If the system has been exposed to extreme temperatures, the unit must be returned to room temperature (15-25ºC) before operating. This is best accomplished by allowing the system to be left in a room temperature environment overnight before operation.
Caution: DO NOT attempt to lift the unit with the handles.
NEVER attempt to pull the unit by the power cord or the handpiece.
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Before Shipping the XTRAC system:
• Enter “CYLINDER” routine in service mode and vent the chamber to 17 psig.
• Remove the gas cylinder** by performing the following steps from section
14.2:
• Perform Steps 2 through 6, then 15 through 18
• Next, immediately install the aluminum shipping plug with KEL-F washer into the flex line to the XeCl gas bottle and tighten. Failure to do so will contaminate the laser and void the warranty.
• Finally, perform steps 20 and 23, and exit from the cylinder screen and shut the laser off.
• Remove the Neon purge per section 14.3, then remove gas cylinder.
• Remove the foot switch assembly.
• Remove the lightguide and handpiece assembly.
** It is illegal to transport a pressurized cylinder, which is not properly prepared with an appropriate safety cap!
6.2 Transport and storage conditions are defined as follows:
Temperature:
Humidity:
Atmospheric Pressure:
-40º C - +70º C
90% RH max. non-condensing
500 hPa – 1060 hPa
7.0 UNPACKING THE SYSTEM AND PERFORMING SYSTEM SET-UP
If the XTRAC system has been subjected to extreme temperatures, follow the directions in the section titled “Transport and Storage” prior to applying power to the system.
Remove the carton straps then open carton top and lift the ramp out at the front end of machine. Next remove the carton baseboards 4 sides by removing the screws then lift the carton over the top of the machine. Remove the accessory boxes under the machine and platform and unbolt the machine from the platform. Place ramp at the front of the crate and guide the machine down the ramp off the crate platform. Save the shipping container in the case that the system may be moved to another location.
Inspect the condition of the unit. If there is evidence of damage due to shipment, contact your PhotoMedex representative for instructions.
8.0 INSTALLING THE FOOTSWITCH
Locate the foot switch that was shipped with the unit (part number 01-08230-01).
NOTE: The XTRAC ULTRA footswitch is NOT compatible with any other XTRAC model (XTRAC, XTRAC XL, or XTRAC XL Plus).
(The foot-switch is located inside the XTRAC system restrained in the location where gas bottle is to be placed.)
• Insert the foot switch in the receptacle on the Rear Interface panel located on the rear of the unit. The footswitch label identifies the correct receptacle.
• Verify that the action of the foot switch is smooth and positive.
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AL8000 SERVICE MANUAL
9.0 USING THE SYSTEM ROOM-DOOR INTERLOCK (OPTIONAL)
The safety/remote interlock is a black-colored plug (P/N 03-08420-01) that is plugged into the main power panel. You may hardwire this interlock in series to a switch on the entry door of the room where you use the XTRAC using the Interlock wiring assembly
(P/N 01-08234-01). Authorized individuals, such as an electrician, can only perform this.
When anyone opens the room’s entry door the interlock is activated, preventing the laser from firing until the door is closed. Once the interlock circuit is normalized, and the
RESET key is pressed, the laser will function normally. The current/voltage running through the interlock is 0.005 amps and 0.7 volts.
Neither the plug nor the interlock wiring can be used with any other equipment other than the XTRAC ULTRA.
If you remove the safety interlock at any time after you turn on the laser, lasing will stop.
A matching plug with the pins internally connected is provided for service personnel to test the XTRAC system.
If the safety interlock has an open circuit (the room entry door is open), laser functions are inhibited. Once the interlock circuit is normalized (the room entry door closes), and you press the Reset Key, the laser will function normally.
10.0 ADJUSTING SYSTEM VOLTAGE AND FREQUENCY
The AL8000 power supply accepts supply voltage of 100 thru 230 Volts AC and frequencies of 50 or 60Hz. No manual adjustments are required for voltages and frequencies within these ranges.
The XTRAC system is supplied (normally) with a hospital grade AC male connector, within the United States. For International systems, the power cord has flying leads. You will need to install a plug that is appropriate for your installation.
CAUTION: Failure to install the proper AC connector for the XTRAC system may result in damage.
11.0 POWER-ON WARM-UP MODE
Power On Mode enables the XTRAC system to perform power-on self-tests prior to its clinical use. It also provides access to the system SET UP options and the treatment billing information screen. Power On is activated when you turn on the main power switch. The warm-up period enables the Thyratron tube within the XTRAC system to warm up to an adequate temperature prior to firing the laser. This period lasts five minutes.
1. The footswitch is inactive in this operating mode.
2. The software version is displayed on the top line of the display panel.
3. The setup mode and system information modes are available during system warm-up.
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12.0 EMERGENCY LASER STOP
On the top of the control panel is a red Emergency Laser Stop button. The button will remain down when pressed. When the laser is fired with the button depressed a system error will be displayed along with the message “RELEASE EMERGENCY STOP
BUTTON”. This is normal, and should not be interpreted as a system fault. If the button is pressed while the laser is firing, the laser will stop firing. While this button is down, the laser will not fire. Note that this button is easily accessed, as is necessary in case a quick stop is required. Note also that there are arrows on the button to indicate a rotation direction. To release the button, turn in the direction indicated by the arrows.
13.0 OPERATING THE SYSTEM IN THE SERVICE MODE
The XTRAC system can be operated in a “Service Mode” by using the service key switch located on the Rear Interface panel located on the rear of the unit. By using this feature, you can perform special functions that will allow you to isolate and verify specific functions of the system.
13.1 Accessing Service Mode in the XTRAC
1. Turn system power off.
2. Insert service key, part of the XTRAC ULTRA Specialty Tool Kit, into the switch, located on the rear of the unit, and turn on to set the laser to Service
Mode
3. Turn system on. The laser will now allow the technician to manually manipulate the high voltage, repetition rate and gas system settings.
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AL8000 SERVICE MANUAL
14.0 GAS BOTTLE INSTALLATION
PhotoMedex Gas System Connections
(Using Laser Gas Purge)
Laser window
Rupture Disc
(70 psig)
Laser Chamber
1/4” VCO
Neon Purge Regulator
AP2
AP1
AUX line
Inlet
Manual
Valve 2
Neon
Purge
Gas
1/2” VCO
Manual valve 3
Solenoid valve 1
2- Stage, SS,
Regulator
Bottle
Valve
XeCl
Laser
Gas
Mix
0 to 100 psia pressure transducer
Manual valve 5
(Closed for factory service only)
Solenoid Valve 4
~25 psia safety vent
HCl Scrubber
1 1/2 psi check valve
BS 02/11/05
Exhaust to atmosphere
14.1 Neon Purge Set-up
14.2
1. With both AP 1 & 2 valves closed, and the Neon purge line VCO cap in place, open the Neon cylinder main valve and set the pressure to ~5-10 psig.
2. Crack open valve AP 1 & 2 and purge the line with Neon for ~5 seconds, then close AP1.
3. Remove the VCO cap on the Neon purge line, and continue to slowly vent
Neon gas through AP2 and the Neon purge line for ~5 seconds.
4. With AP2 still open, replace the VCO cap on the purge line until ready to use
Connecting Neon Purge & Attaching or Exchanging XeCl Cylinder
1. Enter “CYLINDER” routine in the laser Service Mode (solenoid valve 1
(FILL) should be closed).
2. If the laser system has a XeCl laser gas cylinder attached, close the XeCl main cylinder valve now.
3. Make sure the laser manual valve 2 is closed, then close manual valve 3.
4. Carefully remove the laser AUX line VCO cap and the VCO cap on the Neon purge line (Neon gas will begin to flow since AP2 is open). Clean the mating surfaces with an alcohol wipe, and connect the Neon purge line to the laser
AUX line inlet.
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5. Open AP1 and vent Neon gas for ~5 seconds, then close AP 1 & 2.
6. Open the laser manual valve 2.
IF NO XECL LASER GAS CYLINDER IS ATTACHED, CONTINUE WITH
STEP 7.
IF THE LASER SYSTEM HAS A XECL LASER GAS CYLINDER ATTACHED
THAT NEEDS TO BE EXCHANGED, PROCEED TO STEP 15.
Note: The laser should have 18 psia in the chamber prior to performing this procedure.
No XeCl Cylinder Attached
7. Open manual valve 3 and AP 1 for 3 seconds.
8. Close manual valve 3 and AP 1.
9. Open AP2 to provide a Neon gas purge flow.
10. Open solenoid valve 1 (FILL) from the control panel.
11. Remove the threaded metal cap-plug from the XeCl regulator pigtail. (Neon gas should be flowing from the disconnected tube! If this is not occurring, stop the procedure immediately and identify why Neon is not flowing. Neon purge gas must be flowing while the regulator pigtail is disconnected to prevent system contamination.)
Note: Cycle the XeCl regulator handle CW and CCW one turn to facilitate neon gas flow through it. This may need to be done more than one time.
12. With the Neon gas flowing, connect a full laser gas cylinder to the XeCl flex tube (wiping both mating surfaces with Alcohol wipes and using a new gasket).
NOTE: New gasket must be tightened to approximately 70 in-lbs. If nut holding gasket is loosened for any reason, the gasket must be replaced or the gas bottle WILL leak.
13. Close AP2.
14. Turn the XeCl regulator pressure adjustment knob fully CCW, slowly open the XeCl main cylinder valve, and then adjust the output pressure to 36-40 psig. However, under any circumstances, never exceed the red marking on the gauge (40psig). When this step is complete, go to Step 22.
XeCl Cylinder Attached
15. Open solenoid valve 1 (FILL) using the control panel.
16. Check to make sure the XeCl main cylinder valve is closed, and then slowly open AP1 to vent any residual laser gas in the XeCl gas regulator. Close
AP1.
17. Open AP2 to pressurize the XeCl regulator with Neon gas (pressure ~5-10 psig).
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14.3
AL8000 SERVICE MANUAL
18. Carefully disconnect the high-pressure regulator pigtail from the XeCl gas cylinder. (Neon gas should be flowing from the disconnected line! If this is not occurring, stop the procedure immediately and identify why Neon is not flowing. Neon purge gas must be flowing while the flex tube is disconnected to prevent system contamination.)
NOTE: Cycle the XeCl regulator handle CW and CCW one turn to facilitate neon gas flow through it. This may need to be done more than one time.
19. Exchange the used XeCl gas cylinder for a full one, and tighten the flex tube0 connection using a new gasket.
NOTE: New gasket must be tightened to approximately 70 in-lbs. If nut holding gasket is loosened for any reason, the gasket must be replaced or the gas bottle WILL leak
20. Close AP2.
21. Open the XeCl main cylinder valve and make sure the pressure is set to 36-40 psig. However, under any circumstances, never exceed the red marking on the gauge (40psig).
22. Carefully crack open AP1 and vent laser gas for ~5 seconds, then close AP 1
& manual valve 2.
23. Close solenoid valve 1 (FILL) from the laser control panel.
24. Open manual valve 3.
25. Enter the value of the XeCl cylinder pressure in the laser control panel screen.
This screen should automatically display the approximate number of laser fills available.
26. Exit Gas Service screen and press the Yes button to refill the laser chamber.
Return service key switch to the OFF position.
Removing the Neon Purge
1. Open AP2 and then AP1 to purge the line with Neon gas for ~5 seconds, then close AP1.
2. Disconnect the purge line from the AUX inlet connection and while continuing to purge the line, seal the purge line and the AUX inlet using the
VCO caps.
3. Close the Neon cylinder main valve and valve AP2.
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15.0 ALIGNMENT AND LIQUID LIGHTGUIDE INSTALLATION
15.1 Introduction
The alignment of the XTRAC ULTRA laser system presents two independent challenges to the technician. The alignment process therefore, must be viewed as, and performed in two separate steps.
1. The first challenge is achieving proper alignment of the laser cavity. Because the laser mirrors can be set parallel, but also at substantial angles that will all give nearly maximum energy, there needs to be a way to define the optimal alignment axis.
2. The second challenge in the alignment process is the coupling of laser light into the fiber delivery system. Proper alignment into the fiber is critically important to fiber lifetime. The beam should be input directly and precisely perpendicular into the face of the Liquid Light Guide. The beam should also be centered precisely into the 3mm light guide core and there should be no laser light hitting the outer portion of the core. The adjustment process should also be tolerant of minor misalignment of the optical hardware that is inherent in the XTRAC ULTRA laser system.
Proper Alignment
Rear
Mirror
Front
Mirror
XY-
Positioner
In the above example the laser mirrors are parallel with each other as well as being perpendicular to the laser discharge. This alignment will yield the optimal beam shape and energy.
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Improper Mirror Alignment
XY-
Positioner
Rear
Mirror
Front
Mirror
In the above example the laser mirrors are parallel but are NOT perpendicular to the laser discharge. This alignment will yield less than optimal energy and beam shape while aiming the beam away from the center of the fiber.
The second challenge in the alignment process is the coupling of laser light into the lightguide delivery system. The beam should be input directly and precisely perpendicular into the face of the lightguide. The beam should also be centered precisely into the lightguide face. The adjustment process should also be tolerant of minor misalignment of the optical hardware that is inherent in the XTRAC laser system. input dia.
Lightguide end view
Laser
Beam
Proper beam alignment Improper beam alignment
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AL8000 SERVICE MANUAL
Alignment and Alignment Check Procedures
1. Laser Mirror Alignment Check a. Open top skin and remove left skin as viewed from front of unit. b. Insert Alignment chuck into LLG port. c. Tape a piece of white paper to top skin interior directly in front of laser outlet. d. Install Laser Alignment Pin-Holes on front and rear laser mirrors. e. Operate laser at 50 Hz and 7 kV. f. Check alignment: i. Alignment is OK if a donut is centered in the larger, faint circle of light. ii. If the donut is visible but not centered then loosen clamps and iteratively adjust the laser mirrors until centered. Retighten clamps after centering and recheck alignment. iii. If the donut is not visible then proceed with full alignment.
2. Laser Mirror Alignment: a. Place unit in Service Mode and set Rep-rate to 50Hz and Charge
Voltage to 7.0 kV unless otherwise noted. b. Rough alignment: i. Open top skin and remove left skin as viewed from front of unit. ii. Insert Alignment chuck into LLG port. iii. Tape a piece of white paper to top skin interior directly in front of laser outlet. iv. Run laser and adjust laser mirrors to maximize square-ness and brightness of beam. c. Moderate alignment: i. Install one (1) Laser Alignment Pin-Hole on rear of laser chamber. ii. Align vertical mirror axes iteratively until spots line up along horizontal axis. iii. Align horizontal mirror axes iteratively until spots overlap. d. Fine alignment: i. Install second Laser Alignment Pin-hole on front of laser chamber: output beam shape on white paper is a small bright donut within a larger faint circle. ii. Repeat iterative alignment on the horizontal and vertical axes until the donut is centered in the larger, faint circle of light. e. Re-tighten the clamps around each of the four alignment screws and ensure that the alignment did not change.
3. XY-Positioner Alignment Check a. Open top skin and remove left skin as viewed from front of unit. b. Tape a piece of white paper to top skin interior directly in front of laser outlet.
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15.3
AL8000 SERVICE MANUAL c. Place alignment chuck insert into alignment chuck. (NOTE: side with smaller hole is inserted first), then return chuck to XY-Positioner d. Operate laser at 50 Hz and 7 kV. e. Alignment is OK if the beam is rectangular with no clipping of the corners. If there is clipping then proceed with full alignment.
4. XY-Positioner Alignment: a. Remove strain relief mounting plate. b. Place alignment chuck insert into alignment chuck. (NOTE: side with smaller hole is inserted first), then return chuck to XY-Positioner c. Loosen (but do not remove) the four screws holding XY- Positioner to front optical mount plate. d. Run laser observing the beam on the white paper. Using a screwdriver, adjust the X and Y-axes on the stage until no circular aperturing of the rectangular beam exists. e. Tighten the four screws securing the XY-Positioner. Run laser to insure there is still no circular aperturing. f. Install external detector holder onto alignment chuck and attach energy detector. g. Run laser for about one minute and record “Apertured” pulse energy. h. Remove alignment chuck insert from alignment chuck and replace alignment chuck. i. Run laser for about one minute and record “Initial” laser energy. j. Calculate “minimum acceptable” energy by multiplying above
“Initial” energy by 0.97 and record “minimum acceptable” energy. k. If “Apertured” energy is less than minimum acceptable then repeat steps (b) through (k), otherwise procedure is complete. l. Remove alignment tools and re-bolt strain relief mounting plate such that strain relief and XY-Positioner are concentric: use alignment chuck as a guide.
5. Always perform PIN diode calibration after laser mirror or XYpositioner adjustments.
PIN Diode Calibration
1. Place unit in Service Mode.
2. Insert alignment chuck into XY-positioner and attach external energy detector holder and system energy detector.
3. Ensure that interlocks will not prevent shutter from opening.
4. Press the CALIB touch key then the DIODE key.
5. Press the footswitch then the START key. Keep footswitch depressed until machine stop firing. PIN Diode is now tuned.
6. Verify PIN Diode Calibration. a. Fire laser and adjust input kV to achieve 10, 15, and 20 mJ (±2mJ). b.
Verify efficiency (EFF) is 100 ± 3% and record value. If efficiency is out of spec, repeat PIN diode calibration. If it continues to be out of spec contact PhotoMedex to discuss possible resolution.
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15.4 Install the Lightguide
1. Remove the Laser Handpiece / Delivery Cable from its packaging. Inspect for any damage. If damage is noted, contact PhotoMedex Customer Service immediately. NEVER use a Handpiece /Delivery Cable you may suspect has been damaged.
2. If supplied, remove the protective caps from the Delivery Cable ends.
NOTE: NEVER hold the assembly by the fiber when removing the protective caps, always hold the handpiece or input end bezel while removing the caps.
3. Place the Laser Handpiece / Delivery Cable into the mating connection, carefully inserting the input end as far as it will go into its locating mount until it “clicks” into place. Do not use any tools to complete this step.
NOTE: The “click” noise made during insertion indicated that the fiber detection switch has been activated. There are two small switches used for this purpose. If you do not hear this noise, or suspect that the switches are not being activated, you must adjust the position of the switches in order to ensure activation. The
switches are active when the end portion of the barrel assembly on the fiber cable depresses the curved portion of the switch assembly. It is extremely important that this adjustment be made correctly, as improper adjustment will prevent the system from operating correctly.
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16.0 GAS BOTTLE CAPACITY MAINTENANCE
Note: The system must be in Service Mode for this procedure.
During routine maintenance of the XTRAC laser system it will be necessary to verify the accuracy of the “FILLS” remaining counter. Check the pressure of the gas cylinder as read on the high-pressure side of the gas regulator and compare it to the displayed pressure reading on the gas screen. Adjust the displayed pressure reading up or down as needed to achieve an accurate reading.
The laser will perform automatic gas exchanges every 5 million pulses or 4 weeks, whichever comes first. The laser operator cannot initiate gas exchanges at any time.
The system will count down as gas exchanges are performed giving a warning at < 600 psi remaining (“Refill supply low, X fills remaining, Contact Service Soon”) and an
Event Code 14 at 200 psi remaining, which will disable the laser. This gives the system approximately 4 fills between the first low gas warning and the critical Event Code 14.
1. Enter Service Mode.
2. Press the “CYLINDER” then “DONE” buttons to access the gas management screen.
3. Record the displayed and actual values.
4. Enter the value of the XeCl cylinder pressure in the laser control panel screen.
This screen should automatically display the approximate number of laser fills available.
5. Press the ENTER key to accept the new values and exit.
If the value between the pressure in the cylinder and the displayed pressure is more than
80 psi, then the “TOP OFFS” value should be checked in the gas management screen. To access the “TOP OFFS” value, perform the following.
1. Enter Service Mode.
2. Press the CYLINDER button to access the gas management screen.
3. The TOP OFF information will be visible in the middle of the screen.
If the laser shows more than 15 TOP OFFS per month on average then a gas leak from the chamber or plumbing may be suspected.
Most systems will exhibit some degree of thermal expansion and contraction of laser gas in the chamber. This expansion and contraction is the reason that most lasers will have some small value of TOP OFFS displayed on the screen. The TOP OFFS value should be reset after any work is performed to the pressure barriers on the chamber such as a window exchange or a pressure transducer replacement.
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17.0 WINDOW CHANGE PROCEDURE
This window change procedure uses the neon purge gas and regulator assembly. If you
DO NOT have a bottle of neon purge gas or the regulator assembly, then DO NOT attempt to change the windows! The laser will be contaminated and the warranty of the laser will be voided! See Section 14 for valve diagram.
17.1 Neon Purge Set-Up
17.2
17.3
1. With both AP 1&2 valves closed, and the Neon purge line VCO cap in place, open the Neon cylinder main valve and set the pressure to between 5 ±2 psig.
2. Crack open valve AP 1&2 and purge the line with Neon for 5 seconds, then close AP1.
3. Remove the VCO cap on the Neon purge line, and continue to slowly vent
Neon gas through AP2 and the Neon purge line for 5 seconds.
4. With AP2 still open, replace the VCO cap on the purge line until ready to use.
Connecting Neon Purge
1. Enter WINDOW routine in the laser Service Mode.
2. Make sure the laser manual valve 2 is closed, and then close manual valve 3.
3. Carefully remove the laser AUX line VCO cap and the VCO cap on the Neon purge line (Neon gas will begin to flow since AP2 is open from step I-3. above). Clean the mating surfaces with an alcohol wipe, and connect the
Neon purge line to the laser AUX line inlet.
4. Open AP1 and vent Neon gas for 5 seconds, then close AP 1&2.
5. Now, open the laser manual valve 2.
6. Using the laser control panel, open solenoid valve 1 (FILL) and carefully crack open AP1 and vent laser gas for 5 seconds, then close AP1.
7. Close solenoid valve 1 (FILL) from the laser control panel.
8. Open solenoid valve 4 (VENT) from the laser control panel and vent the laser chamber to 17 psia, then close solenoid valve 4 (VENT).
9. Open manual valve 3 and AP2 to introduce neon into the chamber for positive pressure when the chamber windows are removed.
Replacing the Chamber Window Assemblies
1. Lock front wheels of laser.
2. Remove Rear Interface Panel (two bolts) and drape over the side.
3. Remove the rear optical plate to gain access to the windows.
4. Verify cleanliness of the replacement window assemblies and locate them where they can be easily accessed.
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5. Remove the rear window assembly by removing the six (6) outer most screws on the window flange. A small amount of laser gas will escape the chamber and the neon gas should begin to immediately flow. If this is not occurring, stop the procedure, immediately re-attach the window, and identify why Neon is not flowing. Neon purge gas must be flowing while the chamber is open to atmosphere to prevent system contamination.
6. If any white powder, dirt or other contamination is observed carefully clean the window flange area on the laser chamber with an alcohol wipe or a cotton swab with methanol.
7. Roll the O-ring to the outer edge of the window flange.
Roll O-ring outward
8. Place the replacement window assembly in front of the laser window flange, allowing neon purge gas to flush the air from the window assembly.
9. To prevent O-ring damage, tilt the window so that the bottom edge of the window is first inserted into the end flange. Press downward on the window assembly to compress the bottom edge of the O-ring and then press the window into place.
10. Be sure to leave the white registration line in the uppermost position. The window flange is a metal-to-metal fit; so don’t over tighten these screws.
11. Snug down all six hex-head screws used to attach the window assembly.
12. Rotate the window one full turn, this will help to identify if the O-ring was damaged when the chamber is pressurized.
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17.4
AL8000 SERVICE MANUAL
13. Align position #1 with the white registration line using a spanner wrench.
14. Replace the rear optical plate assembly using the spacing tool to maintain proper optical plate gapping. Then replace the Rear Interface Panel.
15. Repeat steps 4-13 for the front window assembly. (Note: To gain access to the front window remove the two screws holding the shutter assembly and move shutter assembly out of the way. Next loosen, but do not remove, the four middle optics plate clamps. Slide/walk the middle optics plate toward the front optics plate. Note: cover the laser mirror on the middle optics plate to prevent damage or being touched during the window change.
16. Slide/walk the middle optics plate back toward the laser. Use the two delrin spacers to precisely set the gap between the middle and front optics plates then tighten the clamps on the middle plate. Replace the shutter assembly.
17. Close manual valve 3.
Removing the Neon Purge
1. Close manual valve 2 and verify that AP2 is still open.
2. Disconnect the purge line from the AUX inlet connection and while continuing to purge the line, seal the purge line and the AUX inlet using the
VCO caps.
3. Close the Neon cylinder main valve and valve AP2.
Re-gassing and re-alignment of the laser chamber 17.5
1. Open manual valve 3.
2. From the laser control panel, press the DONE button and then the YES button to perform a gas exchange.
3. Verify that the XeCl regulator is set between 36-40 psig. (Do not exceed the red marking on the gauge (36 psig) under any circumstances.)
4. Re-align the laser per Section 15.
5. Return the laser to standard operating mode.
6. The procedure is now complete.
Carefully package and return the used window assemblies to PhotoMedex for re-work.
Ensure that the windows are returned under an RMA number.
18.0 WINDOW ROTATION PROCEDURE
Windows should only be rotated when the laser is no longer able to produce 20mJ at
8.0kV after alignment and gas exchange.
18.1 Rotating the Chamber Window Assemblies
1. Insert the spanner wrench into the window assembly.
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18.2
AL8000 SERVICE MANUAL
2. Rotate the assembly to line the next highest number on the window with the registration mark. Note: This type of rotating window has six positions. If the window is already on position number six (6) then the window assembly must be replaced. See Section 17 for replacement procedure.
Verify laser chamber alignment
Always check the alignment of the laser cavity and turning mirrors after rotation of the windows! Re-align the laser per Section 15.
19.0 XTRAC Troubleshooting and Event Code Guide
Use of the following tables will be useful in helping the technician isolate and resolve system malfunctions. If resolution cannot be obtained after exhausting these guides, please contact PhotoMedex to discuss possible resolution.
19.1 Troubleshooting Guide
Common system malfunctions with solutions.
SYMPTOM
Laser Will Not Start
POSSIBLE CAUSES
1. XTRAC ULTRA Circuit breaker not set to on position.
2. Power cable not plugged into system or wall outlet.
3. Supply (room) breaker is turned “off”
SUGGESTED ACTION
1. Turn XTRAC ULTRA breaker to on position.
2. Check power cable connections
3. Check room breaker.
Laser Will Not Fire
2. Footswitch not connected.
3. Internal system problems.
1. Interlock circuit was opened. minutes and try again.
2. Connect footswitch.
3. Contact PhotoMedex.
No Response to
Buttons or Foot switch
No Display, No Sound
From Unit
1. Key Switch was turned off.
2. XTRAC Ultra breaker switch is off.
3. Supply (room) breaker is turned “off”.
1. Close interlock circuit breaker located at the back of the laser, then press “Reset” button OR if the interlock circuit has been connected to a door in the room, close the door and press “Reset”.
1. Turn Key Switch to ON position.
2. Turn breaker switch on, then restart unit.
3. Check room breaker.
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19.2
AL8000 SERVICE MANUAL
EVENT CODE AND GAS HISTORY Guides
Event codes are displayed on the XTRAC front panel and are used to report functional abnormalities that are monitored by the MCU (Master Control Unit).
A comprehensive listing of all event codes is provided for reference
.
EVENT CODE GUIDE – Software Version 4.10.1
EVENT
NUMBER
0 – 9
SYSTEM EVENTS
UNDEFINED
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
37
38
39
CRITICAL_VALUE_ERROR
A2D_ERROR
MEMORY_INIT_FAILED
PRESSURE_TRANSDUCER_BAD
OUT_OF_GAS
RAM_ERROR_DETECTED
NOVRAM_RETENTION_FAILED
CHAMBER_PRESSURE_LOW
ROM_ERROR_DETECTED
UNINITIALIZED_CODE
TOO_LONG_TO_VENT
TOO_LONG_TO_PURGE
TOO_LONG_TO_FILL
**NOT USED**
PFN_FAILURE
HVPS_FAILURE
NB_SERVICE_MANDATORY
WDT_EXPIRED
WRONG_VERSION
BRIEF DESCRIPTION / ACTION undefined error - implies software problem
CALL CARLSBAD, REPLACE MCU / DETECTOR
NOV RAM value error during MemCheck
REPLACE MCU / DETECTOR
A/D wasn't ready when it should have been
REPLACE MCU / DETECTOR after making RAM copy of NOVRAM variables, MemCheck failed
REPLACE MCU / DETECTOR reading from pressure transducer is below possible reading
CHECK PRESSURE TRANSDUCER/CABLE, CHECK MCU / DETECTOR no more refills remaining as calculated from bottle pressure
REPLACE GAS BOTTLE failed RAM test at power on
REPLACE CPU CHIP OR MCU / DETECTOR failed NOVRAM test at power on
REPLACE MCU / DETECTOR failed minimum pressure test at power on, implies leak in chamber
SEARCH FOR LEAK failed ROM test at power on
REPLACE EPROMS OR MCU / DETECTOR software not initialized properly (billing-vs-non-billing)
REPLACE MCU / DETECTOR time exceeded during venting of chamber while exchanging gas
CHECK GAS SCRUBBER, VALVES/SOLENOIDS time exceeded during purging ...
CHECK REGULATOR, VALVES/SOLENOIDS time exceeded during filling ...
CHECK REGULATOR, VALVES/SOLENOIDS
N/A pfn didn’t discharge
CHECK PFN / THYRATRON, CHECK MCU, OR CHECK WIRE W14 power supply didn’t charge
CHECK HVPS service mandatory due to pulse count since last service visit (NB only)
ENTER SERVICE MODE TO CLEAR watch dog timer timed out
REPLACE MCU / DETECTOR
Version verification failed...
REPLACE EPROMS WITH CORRECT VERSION
40 **NOT USED** N/A
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64
65
66
67
68
69
70
71
EVENT
NUMBER
41
AL8000 SERVICE MANUAL
SERVICE REQUIRED EVENTS
UNABLE_2_ACHIEVE_TWICE
BRIEF DESCRIPTION / ACTION even after a gas exchange, the system couldn't achieve min energy
CHECK ALIGNMENT, ROTATE / REPLACE WINDOWS, CHECK
POWER SUPPLY OR PFN/THYRATRON
N/A 42 – 50
WARNING
NUMBER
51
** NOT USED **
RECORDED WARNINGS
HANDPIECE_NOT_IN_CALPORT
BRIEF DESCRIPTION / ACTION
52
53
54
55
56
57
58
59
PIN_DIODE_EXCEEDED_MAX
SENSOR_RATIO_LESS_THAN_40_PC
NT
UNABLE_2_ACHIEVE_MIN_ENERGY
FOOTSWITCH_INACTIVE
KEYSWITCH_INACTIVE
** NOT USED **
SHUTTER_FAILURE
NB_SERVICE_NEEDED
60
WARNING
NUMBER
61
HVPS_DAC_MALFUNCTION
UNRECORDED WARNINGS
FIBER_NOT_CONNECTED system couldn't verify handpiece in cal port during calibration
CHECK CALPORT MICROSWITCHES energy at PFD exceeds maximum allowed to protect the fiber
CHECK SHUTTER, CHECK HVPS BIAS ratio of energy from end of fiber and PFD is lower than allowed
CHECK ALIGNMENT, CHECK LLG, CHECK OPTICS PANEL BOARD low energy from laser SEE EVENTS 80 TO 87
THIS EVENT CODE IS NEITHER SEEN NOR RECORDED can't verify footswitch active during cal
CHECK FOOTSWITCH AND WIRING keyswitch turned off (relay stuck?)
CHECK RELAY BOARD
N/A shutter wouldn’t open or close as required
CHECK ALL INTERLOCKS, CHECK SHUTTER/CABLES service needed due to pulse count since last service visit (NB only)
ENTER SERVICE MODE TO CLEAR
HV power supply DAC failed during SelfTest
REPLACE MCU / DETECTOR
BRIEF DESCRIPTION / ACTION
62 LID_OPENED system tried to move shutter, and found fiber not connected...
CHECK FIBER MICROSWITCHES service lid is opened
CHECK POSITION OF LID SWITCH AND CONNECTIONS
63 ESTOP_PRESSED the ESTOP button is pressed
PROCESS_ABORTED
ACCOUNT_DEPLETED
INVALID_CODE_ENTRY
**NOT USED**
REMOTE_INTERLOCK_BROKEN
**NOT USED**
SCREEN_CALIBRATION_FAILED
SYSTEM_NOT_WARMED_UP user cancelled an operation in progress no more codes in the treatment bank... invalid number entered in billing
N/A remote interlock was de-activated during calibration or treatment
N/A touch panel calibration routine failed
PUSH RECAL SCREEN BUTTON AND RETRY
PIN1_DIODE_VALUE_ZERO but system hasn't been active for at least 5 min. CHECK DIP SWITCHES: ALL MUST BE OFF
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103
104
105
106
107
108
WARNING
NUMBER
72
AL8000 SERVICE MANUAL
UNRECORDED WARNINGS BRIEF DESCRIPTION / ACTION
SYSTEM_NOT_TUNED_YET
73
74
75-79
WARNING
NUMBER
80
81
82
83
84
85
86
87
FOOTSWITCH_ACTIVE
CAL_PORT_ACTIVE
** NOT USED **
RECORDED WARNINGS
LOW_ENERGY_0
LOW_ENERGY_1
LOW_ENERGY_2
LOW_ENERGY_3
LOW_ENERGY_4
LOW_ENERGY_5
LOW_ENERGY_6
LOW_ENERGY_7
GAS
CODE
101
GAS HISTORY GUIDE
PROCESS
CHAMBER_TOP_OFF division by zero in cal routine - diode hasn't been tuned yet
TUNE PIN DIODE footswitch active when it shouldn’t be cal port active when it shouldn’t be
N/A
BRIEF DESCRIPTION / ACTION
Low energy – Auto Gas Pressure Adjustment to Follow: Gas Code 105
BRIEF DESCRIPTION topping off chamber pressure (too low)
102 CHAMBER_VENTING venting off chamber pressure (too high)
PULSE_COUNT_EXCEEDED
TIME_ELAPSED
CAL_FAILURE
EXCHANGE_RESTART
MANUAL
PRESSURE_BUMP too many pulses since last exchange too much time since last exchange gas exchange after event #80-87- calibration failed gas exchange restarting / never finished last time powered up gas exchange started from service mode manually gas pressure increased from 35 to 45psia
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20.0 MAINTENANCE
All service and preventive maintenance is to be performed by qualified PhotoMedex representatives. A schedule of required maintenance is provided in this section. It is required that the areas listed be serviced on the schedule as indicated in order to maintain proper system performance and operation. Failure to perform required maintenance will result in the inability of the XTRAC to perform as designed. A copy of all preventative maintenance as performed must be sent to PhotoMedex, Carlsbad CA as evidence of completion.
20.1 Schedule of Preventive Maintenance
See following table for list of required preventive maintenance.
Schedule of Required Preventative Maintenance:
FUNCTION: 1 year 2 years 3 years As Reqd.
Each Service
Visit
Scrubber
Gas Bottle
Regulator
R
R
I
I
I
I System Plumbing
Shutter Assembly
Panel Light Bulbs
I
R
I
I
System Fan Filters
System Hardware
R C
I
Handpiece & Light Guide
Energy Detector
R*
R I
I
R = Replace I = Inspect
Clean = Clean
* If the calibration date on the energy detector has expired, the energy detector must be replaced and/or re-verified against a traceable standard – see Section 20.2.
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20.2 Energy Detector Calibration Validation (per 15-90014-01)
1. Inspect Nova II Exposure Meter, adapter and Standard Energy Detector (standard) for physical damage. If damaged the complete unit must be re-calibrated at PhotoMedex,
Carlsbad before using.
2. Verify that the software version on the AL8000 is 3.00 or greater. If not, upgrade the unit to latest software revision.
3. Place the AL8000 laser system in service mode and warm up the machine for at least five minutes.
4. Place the liquid light guide into the machine, then, after pressing the CALIBRATE button and the STANDARD button, insert the LLG hand piece into the Cal Port and calibrate. After calibration, the system shows the calibration summary screen. Hit
EXIT once to continue.
5. Insert the hand piece into the Standard Energy Detector and press the footswitch to deliver a 1000 mJ dose. Observe the actual dose displayed on the exposure meter and record on Form AF-0205. Press the display screen once to reset.
6. Repeat Step 5 for three more doses and record on AF-0205.
7. Insert hand piece into the cal port and press the footswitch to deliver a 1000 mJ dose to the System Energy Detector. Observe the actual dose on the system display and record the value on Form AF-0205. Press the display screen once to reset.
8. Repeat Step 7 for three more doses and record on AF-0205.
9. Touch the screen abort button to return to stand by mode.
10. Average the four doses into the Standard Energy Detector and the four doses into the
Cal Port (System Energy Detector) and determine the error of the AL8000 Energy
Detector relative to the Standard Energy Detector and record on Form AF-0205.
11. If the error is less than or equal to ± 6% the System detector has passed calibration validation. a. Fill out a Calibration Label (P/N 12-95272-01) completely. Enter date of calibration, calibration due date (18 months after Cal date), S/N of
Reference Energy Detector (attached to Nova II), and the Service
Engineers initials. b. Attach securely to the back of the AL8000 System Energy Detector Head. c. Return completed Form AF-0205 to PhotoMedex, Carlsbad, QA-
Department ASAP.
12. If the error is greater than ± 6% re-test per Steps 3 to 10 and record data on AF-0205.
13. If the error is greater than ± 6% for a second time the system detector has failed calibration validation. a. Remove the System Energy Detector and MCU and return, along with
Form AF-0205, to PhotoMedex, Carlsbad, QA-Department ASAP. b. Install a new MCU and System Energy Detector and repeat Steps 3 to 10. c. Complete paperwork and return to QA department at PhotoMedex in
Carlsbad, CA
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20.3
21.2
AL8000 SERVICE MANUAL
Cleaning the XTRAC System
The exterior of the laser unit may be cleaned using water with a mild detergent.
Never use solvents or other harsh chemicals to clean the exterior portion of the system. Never attempt to clean the output lens of the handpiece assembly.
21.0 REFERENCES
21.1 Intellectual Property
PhotoMedex, Inc. is the owner of United States patent number 4891818 and
5044717 that covers the XTRAC laser system. Additional patents pending.
Reference Documentation
• Operating instructions for the XTRAC system can be found in the Operations
Manuals # 12-95305-01 and 12-95350-01.
• Premarket Notification Approvals (510k) number that FDA has granted for the AL8000 is K0419343. Summaries of the application and approval order are available from FDA.
NOTE: SOP’s (or Standard Operating Procedures), which comprise the
PhotoMedex Quality System, are required to be followed by all PhotoMedex employees.
• SOP-026; Complaint Handling Procedure
• SOP-019; Servicing
• AF-0037; Complaint Form
• AF-0192; Field Service Report
• AF-0135; Return Material Authorization Tag
• 15-90014-01; Energy Detector Calibration Validation Procedure
• AF-0205; XTRAC ULTRA Energy Detector Calibration Validation Report
• 12-95272-01; Calibration Label
Page 35 of 36
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21.3 Disposal
AL8000 SERVICE MANUAL
The laser consists of the following items, which may be pertinent to disposal in accordance with the laws and ordinances governing the site of disposal:
1. The laser consists of an aluminum frame, steel panels, a nickel-plated aluminum chamber and miscellaneous plastic parts.
2. The laser system contains printed circuit boards with standard commercial components.
3. The halogen scrubber contains inert molecular sieve and indicating soda lime
(calcium oxide and sodium hydroxide). Soda lime reacts exothermally with water to form an alkaline solution so caution should be taken when mixing with water. A solution of the soda lime may be neutralized with common baking soda or a mild acid such as vinegar by appropriately trained personnel.
22.0 Replacement Parts
Listed below is a list of replacement parts for the XTRAC Excimer laser phototherapy system
.
Assy/Part #
01-05280-01 Gas Scrubber
Description
01-07795-02 Rotating Window Assembly, 6-position
01-08040-99 Control Panel Assembly
01-08097-01 Handpiece Tip and Ink Pad Assembly
01-08100-01 Cleaning Kit for LLG
01-08104-01 Liquid Light Guide Delivery System Kit
(includes tips and cleaning kit)
01-08208-99 PFN Top Assembly
Assy/Part #
05-70098-29
05-70204-24 Power Supply, High
Voltage, Output 120VAC-
10KVDC-24VDC
05-70204-24
05-70225-16
Description
FUSE 0.6A/500V Slo-Blo,
Inside PFN
Power Supply, High Voltage,
Output 120VAC-10KVDC-
24VDC
Switch, Modification,
Cal.Port
05-70225-18 Switch, Panel Mount, DPST
01-08222-xx Software PROMS A and B Assembly
Version of software needs to be provided for ordering
01-08225-xx Software PROMS A and B Assembly
Version of software needs to be provided
01-08223-99
05-70233-06 for ordering
MCU Assembly
Pyroelectric Energy Detector
01-08224-99 Optics Panel Board
01-08229-99 Relay Panel Board
01-08230-01 Footswitch Assembly
01-08231-99 Photodiode Assembly
03-08420-01 Remote Interlock, Plug
05-70236-07
05-70236-08
05-70399-04
06-80022-17
06-80023-12
06-80023-13
06-80023-14
06-80023-15
06-80064-23
Led, High Intensity, Yellow
Led, High Intensity, Green
Relay, Panel Mount Solid
State, Din Rail
Air Filter, 5.5x5.5
Fan Tangential
Fan, Galaxy, DC, Bottom of
System
Fan, Sprint, 24V, Front of
PFN
Fan, Muffin XL 24V, Rear of
PFN
Regulator, VCO Inlet, SS
04-07802-01 Micro Switch – X Y Positioner, Fiber
Switch
05-70098-26 FUSE 1.25A/250V 5X20MM FAST ACT,
Optics Board
05-70098-27 FUSE 6.3A/250V 5X20MM FAST ACT,
Relay Board
05-70098-28 FUSE 1.6A/500V Slo-Blo, Inside PFN
06-80071-14
06-80071-13
06-80275-12
06-80275-26
Washer, KEL-F
Gas Bottle
Key #311
Tubular Key, Top Panel Key
06-80280-09
06-80310-02
Polyethylene Dust Cover
Velcro Fastener
Page 36 of 36
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AL8000 SERVICE MANUAL
Appendix A - Definition of Terms
◊ Excimer Laser - A pulsed, 308-nanometer XeCl laser that, in the XTRAC system, provides the Phototherapy action spectrum required to provide dermatological treatment.
◊ Fiberoptic/ Liquid Light Guide - In the XTRAC system this term is used to describe the probe/cable that carries laser energy to the patient.
◊ HVPS - High Voltage Power Supply
◊ kV - Kilovolts
◊ mJ - Millijoules is used to express laser energy.
◊ PPS - Pulses Per Second. In the XTRAC system this refers to the number of LASER firing pulses per second.
◊ System Events - Events that necessitate a system power down or diagnostic procedure to allow continued operation assuming the condition has been corrected. Often, this is to assure starting the system from a known state.
◊ Thyratron Tube - A component within the XTRAC system that is used to switch on and off the current from the high voltage capacitor bank enabling the activation of the laser.
◊ VF - Vacuum fluorescent
Appendix A
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AL8000 SERVICE MANUAL
APPENDIX B - MSDS for XeCl
Appendix B
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AL8000 SERVICE MANUAL
APPENDIX B – (continued)
Appendix B
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AL8000 SERVICE MANUAL
APPENDIX C - ADDITIONAL DOCUMENTS
00-08000-01 AL8000 Domestic Assembly Tree
00-08030-01 Optics Wiring Schematic
00-08205-01 Power Supply Wiring Schematic
00-08218-01 Wiring Harness Assembly Schematic
15-08005-03 Wiring Inspection Guide
AF-0192
SP-006
AL8000 Field Service Report
AL8000 Installation Procedure
AF-0205 XTRAC ULTRA Energy Detector Calibration Validation Report
12-95272-01 Calibration Label
Appendix C
12-95306-01 Rev G Page 1 of 1
AL8000 SERVICE MANUAL
Replace this page with current revision of documents listed in Appendix C.
12-95306-01 Rev G
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