Solta Medical Fraxel 1550 User manual
Fraxel®1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System
Part Number 10-05170 Rev. O Page 1 of 92
Fraxel®1550, Fraxel 1927 and
Fraxel DUAL 1550/1927
Laser Systems Operator Manual
Fractional Resurfacing with IOTS
Intelligent Optical Tracking®System
Manufactured by
Solta Medical, Inc.
25881 Industrial Blvd
Hayward, CA 94545 U.S.A.
Phone: +1 510-782-2286
Customer Service +1 510-782-2286; or
Authorized Distributor
Fraxel®1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System
Part Number 10-05170 Rev. O Page 2 of 92
This manual may not be copied, translated, or reproduced in whole or in part without the
express written consent of Solta Medical, Inc. (henceforth “Solta”).
Solta Medical™, Fraxel, the Fraxel logo and Intelligent Optical Tracking are trademarks or
registered trademarks of Solta Medical, Inc. and its subsidiaries. Other names and brands
may be claimed as the property of others.
Various aspects of the Fraxel 1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser
Systems are covered by U.S. Patents 5,897,549 and 6,083,217, 7,282,060, 7,372,606;
7,646,522, D604,843, D601,697 and foreign equivalents and by patents pending.
Cidex®and Enzol®are registered trademarks of Johnson and Johnson, Inc.
© Solta Medical, Inc.
June 2013
Published in the USA
Fraxel®1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System
Part Number 10-05170 Rev. O Page 3 of 92
Solta Medical, Inc.
Fraxel 1550, Fraxel 1927 and
Fraxel DUAL 1550/1927 Laser
Systems
THE SOLTA MEDICAL FRAXEL 1550 (previously known as the Fraxel re:store,
FRAXEL 1927 AND FRAXEL DUAL 1550/1927 (previously known as the Fraxel re:store
DUAL ) LASER SYSTEMS ARE ALL NON-ABLATIVE LASERS AND INTENDED FOR
USE ONLY BY PROPERLY TRAINED PHYSICIANS AND PROPERLY TRAINED
PERSONS UNDER THE SUPERVISION OF SUCH A TRAINED PHYSICIAN
(HENCEFORTH “THE PHYSICIAN”).
PLEASE READ THE SOLTA MEDICAL FRAXEL 1550, FRAXEL 1927 AND FRAXEL
DUAL 1550/1927 LASER SYSTEMS OPERATORS MANUAL IN ITS ENTIRETY PRIOR
TO USE OF THE LASER SYSTEM.
Fraxel®1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System
Part Number 10-05170 Rev. O Page 4 of 92
TableofContents
1.0SYSTEMOVERVIEW.........................................................................................................................7
1.1INDICATIONSFORUSE.................................................................................................................................8
1.2DEVICEOVERVIEW.....................................................................................................................................9
1.3INTRODUCTIONTOTHESYSTEM....................................................................................................................9
1.4CONTROLFEATURES.................................................................................................................................13
1.5SYSTEMSTATES.......................................................................................................................................15
2.0SYSTEMOPERATION......................................................................................................................16
2.1OVERVIEW..............................................................................................................................................16
2.2ROUTINEPRECAUTIONSPRIORTOTREATMENT..............................................................................................16
2.3SYSTEMSTATEDESCRIPTIONS.....................................................................................................................18
2.4MEASUREMENT‐GUIDEDDOSIMETRY..........................................................................................................33
2.5DEFINITIONS...........................................................................................................................................39
2.6PARAMETERSELECTION.............................................................................................................................39
2.7TOTALTREATMENTDENSITY(TOTALMTZS/CM2)........................................................................................40
2.8SYSTEMAUDIBLEFEEDBACK.......................................................................................................................40
2.9HANDPIECETRACKING(IOTS–INTELLIGENTOPTICALTRACKING®SYSTEM)........................................................41
2.10TIPSELECTION,CLEANINGANDHIGHLEVELDISINFECTIONPROCEDURE..............................................................42
2.11NORMALSHUT‐DOWNPROCEDURE.............................................................................................................45
3.0SAFETY...........................................................................................................................................46
3.1GENERALCONSIDERATIONSANDHAZARDPOTENTIAL.....................................................................................47
3.2FIREPRECAUTIONS...................................................................................................................................47
3.3OPTICALSAFETY......................................................................................................................................49
3.4OPERATIONOFTHELASERSYSTEM..............................................................................................................53
3.5ELECTRICALSAFETY..................................................................................................................................55
3.6LASERTREATMENTCONTROLLEDAREA(LTCA)INFORMATION.........................................................................56
3.7LASERSUITEACCESSANDREMOTEDOORINTERLOCK.....................................................................................56
3.8PROPERLASERROUTINEMAINTENANCE,HANDLING,ANDSTORAGE..................................................................57
3.9REGULATORYCOMPLIANCEANDDEVICESAFETYINFORMATION........................................................................59
3.10LABELING...............................................................................................................................................61
4.0PHYSICIANINFORMATION..............................................................................................................67
4.1INDICATIONSFORUSE...............................................................................................................................67
4.2CONSIDERATIONS.....................................................................................................................................67
4.3CONTRAINDICATIONS................................................................................................................................68
4.4TISSUEINTERACTION.................................................................................................................................68
4.5PRE‐TREATMENTPATIENTRECOMMENDATIONS............................................................................................69
4.6PRE‐OPERATIVEINSPECTION......................................................................................................................69
4.7ANESTHESIA............................................................................................................................................69
4.8PATIENTPREPARATION.............................................................................................................................71
4.9SPOTTREATMENTS...................................................................................................................................72
4.10IMMEDIATEPOST‐OPERATIVECARE.............................................................................................................72
4.11POST‐OPERATIVEINFORMATION.................................................................................................................72
4.12TREATMENTSREQUIREDANDTREATMENTINTERVALS.....................................................................................73
4.13COMPLAINTSANDADVERSEEFFECTS...........................................................................................................73
4.14COMPLICATIONS......................................................................................................................................74
5.0MAINTENANCEANDWARRANTY....................................................................................................75
5.1WARRANTYINFORMATION........................................................................................................................75
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Part Number 10-05170 Rev. O Page 5 of 92
5.2CLEANINGPROCEDURES............................................................................................................................75
5.3DISPOSALANDRECYCLING.........................................................................................................................76
6.0RE‐ORDERINFORMATION..............................................................................................................77
6.1ACCESSORIES...........................................................................................................................................77
6.2*EXTERNALSTEELEYEPROTECTION..............................................................................................................77
6.3*CORNEALSHIELDS..................................................................................................................................77
6.4*CORNEALSHIELDLUBRICATIONGEL...........................................................................................................77
6.5*TOPICALCORNEALANESTHETIC................................................................................................................77
7.0DECONTAMINATIONOFRETURNEDEQUIPMENT............................................................................78
8.0SAFETYSTANDARDSANDREGULATORYCLASSIFICATIONS..............................................................79
8.1GENERALSTANDARDS...............................................................................................................................79
9.0FRAXELLASERSYSTEMSSPECIFICATIONS........................................................................................80
9.1TREATMENTBEAM...................................................................................................................................80
9.2CONSOLE................................................................................................................................................80
9.3LASERSAFETYEYEWEAR............................................................................................................................81
9.4CART.....................................................................................................................................................81
9.5OPERATINGENVIRONMENT........................................................................................................................81
9.6SHIPPINGANDSTORAGE(NON‐OPERATIONAL)..............................................................................................81
9.7COMPATIBLEDELIVERYDEVICES.................................................................................................................81
9.8ELECTROMAGNETICCOMPATIBILITYANDIMMUNITY........................................................................................81
10.0EXTERNALFACTORYCALIBRATIONINSTRUCTIONS.........................................................................86
10.1TOOLSANDPARTSREQUIRED.....................................................................................................................86
10.2PROCEDURE............................................................................................................................................86
11.0SHIPPING,INSTALLATIONANDSET‐UPREQUIREMENTS..................................................................87
11.1SHIPPING................................................................................................................................................87
11.2INSTALLATION.........................................................................................................................................87
11.3SPACEREQUIREMENTS..............................................................................................................................87
11.4ENVIRONMENTAL.....................................................................................................................................88
11.5ELECTRICAL.............................................................................................................................................88
12.0LABELINGSYMBOLS.......................................................................................................................90
Fraxel®1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System
Part Number 10-05170 Rev. O Page 6 of 92
Warnings, Cautions, and Notes
Please note that the Fraxel 1550 was previously known as the Fraxel re:store and the
Fraxel DUAL 1550/1927 was previously known as the Fraxel re:store DUAL.
This operator’s manual contains certain warnings, cautions and notes designed to alert the
operator to the proper care and use of the Fraxel 1550, Fraxel 1927 and Fraxel DUAL
1550/1927 Laser Systems, (hereinafter referred to as “Fraxel Laser Systems”) and
accessories. This manual refers to the Fraxel 1550, the Fraxel 1927 and the Fraxel DUAL
1550/1927 laser systems unless specifically stated. The cool roller tip / focal cooling feature
described in this manual is not available on all models. The following illustrates each of
these messages and how to recognize them.
Warning: Message
The “Warning: Message” alerts the operator about safety and non-compliance issues that
are of the highest importance. Failure to observe the instructions in these alerts could result
in serious injury, fire, or damage to the laser system or surrounding equipment.
CAUTION:
The “CAUTION: Box” alerts the operator to proper operation and proper use of the Fraxel
Laser Systems and their accessories.
Note:
The “Note: Box” designates information of special interest.
Warning:
PLEASE READ THE FRAXEL LASER SYSTEMS OPERATOR’S MANUAL IN ITS
ENTIRETY PRIOR TO USE OF THE SOLTA FRAXEL 1550, FRAXEL 1927, OR FRAXEL
DUAL 1550/1927 LASER SYSTEMS. PLEASE CONTACT SOLTA CUSTOMER SERVICE
AT +1 510-782-2286 OR YOUR LOCAL AUTHORIZED DISTRIBUTOR OF SOLTA
MEDICAL LASERS IF YOU HAVE ANY QUESTIONS.
ALL OPERATORS ARE REQUIRED TO PARTICIPATE IN FRAXEL LASER SYSTEMS
TRAINING PROGRAM PRIOR TO STARTING INDEPENDENT TREATMENTS.
Fraxel®1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System
Part Number 10-05170 Rev. O Page 7 of 92
1.0 System Overview
This manual provides operating instructions for the Fraxel 1550, Fraxel 1927 and
Fraxel DUAL 1550/1927 Laser Systems for physicians and qualified operators under
physician supervision. Section 1 of this manual will provide a brief description of the
laser systems and their major components. The Fraxel Laser Systems should only
be used by physicians and staff who have been appropriately trained and who are
thoroughly familiar with the instructions and safety precautions provided in this
manual.
This manual covers the following part numbers:
Part #
MC-SYS-SR1500-D-US
MC-SYS-SR1500-D-UPG-US
MC-SYS-SR1500-P-US
MC-SYS-SR1500-P-UPG-US
MC-SYS-SR1500-CPO-US
MC-SYS-SR1500-D-INTL
MC-SYS-SR1500-D-UPG-INTL
MC-SYS-SR1500-P-INTL
MC-SYS-SR1500-P-UPG-INTL
MC-SYS-SR1500-CPO-INTL
MC-SYS-SR1900-US
MC-SYS-SR1900-INTL
Please note there are two differences between the International and Domestic systems:
1) An additional laser “Door Warning Sign” is shipped with International systems
2) There are two different power cords:
a. Part # 08-01615 for International
b. Part # 08-00475 for Domestic
PLEASE CONTACT SOLTA MEDICAL CUSTOMER SERVICE AT +1 510-782-2286 OR
CONTACT YOUR LOCAL AUTHORIZED DISTRIBUTOR OF SOLTA MEDICAL LASERS IF
YOU HAVE QUESTIONS.
Fraxel®1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System
Part Number 10-05170 Rev. O Page 8 of 92
1.1 Indications for use
The Fraxel 1550, Fraxel 1927, and Fraxel DUAL 1550/1927 Laser Systems are approved for
the following Indications for Use:
Geographic
Regions Indications for Use
For the
following
geographic
region:
U.S.A.
1550 nm: The Fraxel 1550 nm laser is indicated for use in dermatological
procedures requiring the coagulation of soft tissue, as well as for skin
resurfacing procedures. It is also indicated for treatment of dyschromia
and cutaneous lesions, such as, but not limited to lentigos (age spots),
solar lentigos (sun spots), actinic keratosis, and melasma, and for
treatment of periorbital wrinkles, acne scars and surgical scars.
1927 nm: The Fraxel 1927 nm laser is indicated for use in dermatological
procedures requiring the coagulation of soft tissue, treatment of actinic
keratosis, and treatment of pigmented lesions such as, but not limited to
lentigos (age spots), solar lentigos (sun spots) and ephelides (freckles).
For the
following
geographic
regions:
Australia
Brazil
Canada
EU
Hong Kong
India
Japan
Korea
Mexico
Russia
Philippines
Singapore
Taiwan
Thailand
UK
Vietnam
1550 nm: The Fraxel 1550 nm laser is indicated for use in dermatological
procedures requiring the coagulation of soft tissue, as well as for skin
resurfacing procedures. It is also indicated for treatment of dyschromia
and cutaneous lesions, such as, but not limited to lentigos (age spots),
solar lentigos (sun spots), actinic keratosis, and melasma, and for
treatment of periorbital wrinkles, acne scars and surgical scars.
1927 nm: The Fraxel 1927 laser is indicated for use in dermatological
procedures requiring the coagulation of soft tissue and the treatment of
actinic keratosis
Fraxel®1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System
Part Number 10-05170 Rev. O Page 9 of 92
1.2 Device Overview
The Fraxel Laser Systems are designed for cutaneous laser treatment. These devices are
part of the family of Solta Medical products utilizing the Fractional Photothermolysis
principle.
The Fraxel 1550 consists of a single infra-red fiber laser with wavelength of 1550 nm.
The Fraxel 1927 consists of a single infra-red Thulium fiber laser with wavelength of 1927
nm.
The Fraxel DUAL 1550/1927 Laser System has two infra-red fiber lasers with wavelengths
of 1550 nm and 1927 nm. The two wavelength option allows for targeted treatment of
different tissue depths. The 1550 nm laser coagulates the epidermis and dermis with up to
1.6 mm depth of penetration. The 1927 nm laser coagulates epidermis and superficial
dermis with up to 0.3 mm depth of penetration. The laser sources are controlled by an
embedded processor. The solid state design of the Fraxel 1550, Fraxel 1927 and Fraxel
DUAL 1550/1927 Laser Systems typically result in limited maintenance and minimal utilities
requirements. The output of the fiber laser is focused into the skin using lenses contained
within the handpiece. Computer controlled motors within the handpiece and the software
control architecture direct the laser system to deliver focused spots in an evenly spaced
treatment pattern. These advanced features allow for precisely controlled delivery of the
fractional laser treatment.
Interchangeable tips allow for treatment of both small and large areas. The small tip design
is intended to allow for treatment of smaller areas (not available with all systems).
This manual is intended to help you get the most from your system as you make the Fraxel
1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser Systems an integral part of your
practice. It is our intention that the information provided assists the operator in successful
use of this product. This manual is not intended to substitute for training by authorized Solta
Medical personnel prior to treatment of patients. If you have additional questions, please
contact your local Solta Customer Service representative directly.
Warning:
The Fraxel Laser Systems generate an intense beam of laser radiation which may cause
injury if not used properly. It is essential that this manual be read thoroughly and
understood in its entirety before operation.
1.3 Introduction to the System
The Fraxel 1550 and Fraxel 1927 systems both have a single fiber laser source, and the
Fraxel DUAL 1550/1927 Laser System has two fiber laser sources. The fiber laser controls
are contained in a single console. The console is electrically connected to the facility power
source. Laser energy produced by the unit is delivered to the tissue through the handpiece.
Contact with the tissue is maintained by removable disposable contact tips which attach to
the handpiece.
The features of the Fraxel Laser Systems are shown below:
Fraxel®1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System
Part Number 10-05170 Rev. O Page 10 of 92
Front Console with Zimmer Cart
Umbilical
Cord and
Support Arm
Key Switch
Emergency
switch
Fraxel®1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System
Part Number 10-05170 Rev. O Page 11 of 92
Rear Console with Cart
Power Connection
Footswitch Connection
Remote Door Interlock
Locking Casters
Product Labeling
and Identification
Calibration Port
Fraxel®1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System
Part Number 10-05170 Rev. O Page 12 of 92
Treatment Handpiece with Cool Roller Tip installed
(Focal cooling not available on all models)
Fraxel®1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System
Part Number 10-05170 Rev. O Page 13 of 92
1.4 Control Features
1.4.1 On/Off Key Switch
The On/Off key switch turns the Laser System on and off. The key should always be
kept in a safe place (and not in the key switch), when not in use, to avoid
unauthorized use by untrained personnel and the possibility of injury or fire.
1.4.2 Touch Screen Display
The touch screen serves as the information center for the Fraxel Laser Systems.
The screen allows the operator to interact with the device. It displays the information
associated with the operating conditions, including: Laser ON / OFF, Machine Status,
Treatment Wavelength Selection (Fraxel 1550: 1550 nm; Fraxel 1927: 1927 nm and
DUAL 1550/1927: 1550 nm or 1927 nm), Laser Parameters for treatment,
Information Messages, Error Messages and System Prompts.
1.4.3 Emergency Stop Button
There is a red emergency stop button in the front center of the console. Press this
button during an emergency to stop the laser treatment beam. To restart, twist the
button and release it from the latched OFF position.
1.4.4 Calibration Port
The calibration procedure is enforced by the software.
CAUTION: The handpiece tip must be removed from the handpiece prior to
calibration. Take precautions to ensure that neither the handpiece internal sealing
window nor the tip window become contaminated before, during, or after the
calibration procedure as this may result in poor clinical outcome, damage to the
machine or injury to the physician or patient.
1.4.5 Umbilical Cord and Support Arm
The umbilical cord is managed by the adjustable support arm. When using focal
cooling with the Cool Roller Tip, the Zimmer cool air delivery hose may be clipped
onto the electrical umbilical cable and draped over the support arm as shown on
section 1.3 Ensure that there are no kinks in the hose.
CAUTION: Do not attempt to coil the umbilical beyond the resistance point of the
armoring. Do not use if the internal cables and wires are visible through holes or
gaps in the umbilical armoring as this may cause inadvertent exposure of laser
energy to persons in the room.
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1.4.6 Treatment Tip
Removable disposable tips attach to the distal portion of the handpiece and MUST
be in place prior to any treatment. The tips are interchangeable and are available in
small and large sizes of approximately 7 and 15 mm, respectively. The different
sizes allow for treatment of both small and large areas. The system detects contact
between the tip and skin and translates handpiece motion into velocity information.
The tips have a finite treatment lifetime.
When using the tips, ensure that the cooling channel adaptor is clipped onto that side
of the handpiece as shown on section 1.3. Connect the distal end of the Zimmer air
cooler delivery hose to the white cylinder at the end of the clear tubing. Cool air will
flow down the cooling channel into the Cool Roller Tip. The air will flow across the
skin between the rollers and exhaust from the opposite side.
Inspect tip window for contamination before the tip is installed onto the handpiece.
The rollers used in the Fraxel Cool Roller Tip, are for single patient use only. Do not
reuse. Multiple patient use may create the potential risk of cross contamination of
biological agents from one patient to another.
Note: Handpiece tracking could be adversely affected by tip window fogging or
condensation. Remove tip from handpiece to observe both sides of the tip window.
CAUTION: The handpiece tip must be attached to the distal portion of the handpiece
prior to any treatment. If this is not done, the laser system will not function properly
which may result in injury to the physician or patient.
1.4.7 Power Cord
A hospital grade power cord connects the laser to the electrical outlet. The power
cord entry on the back of the console is a standard IEC60320 type C14 male
connector. The power cord needs to have a standard IEC60320 type C13 female
connector.
CAUTION: Do not substitute another power cord for the one supplied with the unit or
provided by your local representative. Do not use the power cord if it becomes frayed
or damaged in any way. Contact Solta Medical or your local authorized distributor of
Solta Medical lasers for a replacement, if necessary. Do not pull on the cord to pull
the plug out of the socket.
Fraxel®1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System
Part Number 10-05170 Rev. O Page 15 of 92
1.4.8 Cart
The cart serves as a platform for the console when counter space is limited. The
cart has wheels which allows for better mobility when moving the laser system, and
drawers available for storage of accessories.
CAUTION: Always lock the wheels prior to operation of the laser.
Warning:
If it is necessary to manually lift the Laser System Console and Cart, or to separate the
console from the cart, two people must perform the lifting operation. Failure to follow this
directive may result in serious injury or damage to the unit.
1.5 System States
The system has defined states of operation which include: utilities/home, system
test, simulate, and treat.
1.5.1 Utilities/Home
Allows access to various functional parameters of the system.
1.5.2 System Test Mode
Allows the system and handpiece to be tested. After successful power-on,
the system will move to this mode.
1.5.3 Simulate Mode
Allows the user to simulate treatment but without discharging laser energy.
1.5.4 Treat Mode
The system is ready and/or receiving input from the footswitch and
handpiece. This mode presents the highest potential risk of injury to the
physician and patient.
These functions are described in Section 2.0 in the context in which they
appear on the screen.
Fraxel®1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System
Part Number 10-05170 Rev. O Page 16 of 92
2.0 System Operation
2.1 Overview
This section provides a general guideline for the operation of the Fraxel 1550, Fraxel
1927 and Fraxel DUAL 1550/1927 Laser Systems. These laser systems have
specific operating requirements. It is the physician’s responsibility to fulfill these
requirements. Failure to do so can result in incorrect and/or intermittent operation or
damage to the laser.
2.2 Routine Precautions Prior to Treatment
2.2.1 Affix the laser warning sign, supplied with the system, to the door of
the room or the point denoting the perimeter of the Nominal Hazard
Zone (NHZ) (see Safety section of this manual).
2.2.2 Ensure that all persons in the NHZ are provided with the appropriate
eyewear (see Safety section of this manual).
2.2.3 Take precautions to mitigate the fire hazards associated with the
laser system, including the use of fire-retardant curtains, water-
soaked towels, or gauze where necessary. See Section 3.0 for
more details.
2.2.4 Check the power cord for damage. Ensure that the appropriate
electrical utilities are available in the treatment room. Connect the
power cord to the laser and to the wall socket.
2.2.5 Make sure that the handpiece umbilical cable is not excessively
twisted from the unit. Do not tape the umbilical to any structure. Do
not attempt to coil the umbilical beyond the resistance point of the
armoring. Do not use if the internal cables and wires are visible
through holes or gaps in the umbilical armoring as this may cause
inadvertent exposure of laser energy to persons in the room. Do not
move the unit using the arm.
2.2.6 Check handpiece and tip cleanliness per sections. Do not use tips
with damaged windows.
2.2.7 Ensure that the red emergency switch is in disengaged position (not
pushed in) to enable the system for start up.
2.2.8 Insert the key into the key switch. Turn the unit on and verify that
the unit powers up normally with no error messages. Instructions
will appear on the screen to guide the operation of the system.
Fraxel®1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System
Part Number 10-05170 Rev. O Page 17 of 92
Warning:
All personnel within the Nominal Ocular Hazard Distance (NOHD) must be wearing
approved eye protection at this point. Failure to wear appropriate eyewear increases the
risk of serious eye injury.
Warning:
Laser equipment not in use should be protected against unauthorized operation by removing
the key from the key switch. Keep the key in a designated place accessible only to
authorized and trained personnel to avoid unauthorized use by untrained personnel and the
possibility of injury or fire.
Warning:
Do not attempt to coil the umbilical beyond the resistance point of the armoring. Do not use
if the internal cables and wires are visible through holes or gaps in the umbilical armoring as
this may cause inadvertent exposure of laser energy to persons in the room.
Warning:
If it is necessary to manually lift the Laser System console and cart, or to separate the
console from the cart, two people must perform the lifting operation. Failure to follow this
directive may result in serious injury or damage to the unit.
Warning:
SEVERE DAMAGE TO THE UNIT WILL RESULT FROM IMMEDIATE POWER UP
FOLLOWING MOVEMENT OF THE UNIT FROM A COLD ENVIRONMENT INTO A WARM
ENVIRONMENT. THIS CONDITION WILL OCCUR IF FOR EXAMPLE THE UNIT IS
MOVED FROM LOCATION TO LOCATION ON A DAILY BASIS AND IS STORED IN A
SHIPPING CONTAINER, AUTOMOBILE, OR TRUCK OVERNIGHT.
THE UNIT MUST BE ALLOWED TO EQUILIBRATE WITH ITS SURROUNDINGS FOR A
MINIMUM OF 90 MINUTES FOLLOWING A CHANGE OF ENVIRONMENT. FAILURE TO
OBSERVE THESE PRECAUTIONS WILL RESULT IN THE WARRANTY OF THE UNIT
BEING VOIDED.
NOTE: NEVER BLOCK THE COOLING SYSTEM VENTS. ENSURE ADEQUATE SPACE
AROUND THE UNIT AT ALL TIMES TO FACILITATE SYSTEM COOLING.
CAUTION: USE OF CONTROLS, ADJUSTMENTS, OR PROCEDURES OTHER THAN
THOSE SPECIFIED MAY RESULT IN HAZARDOUS ELECTROMAGNETIC RADIATION
EXPOSURE WHICH MAY RESULT IN INJURY, OR DAMAGE TO OTHER EQUIPMENT.
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Part Number 10-05170 Rev. O Page 18 of 92
2.3 System State Descriptions
This section provides a general overview of the Fraxel Laser Systems operation.
These laser systems have specific operating requirements. It is the responsibility of
the physician to fulfill these requirements. Failure to do so can result in incorrect
and/or intermittent operation or damage to the laser.
While powering up, the system will briefly display an introductory splash screen.
2.3.1 System Test Mode
Upon completion of the system power-up, the system will enter the System Test mode.
Please follow the instructions as they appear on the touch screen display. The initial system
test screen will direct the placement of the handpiece into the calibration port.
In order to perform system testing, remove the tip from the handpiece. Place the tip in a
clean, dust-free container while the testing is in progress. Then, proceed by placing the
handpiece in the calibration port located on the top right hand side of the laser console. The
touch screen will indicate when testing has initiated.
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If the testing is not successful, check the internal window and calibration port window for
damage, check the handpiece seating in the port to make sure it is correctly placed, and try
again, to a maximum of 3 times. After three attempts, contact Solta Medical Customer
Service.
If the system fails to calibrate to within 80% of the requested energy (more than 20% below
specification), it will not allow further treatment. Solta Medical then requires that the system
be serviced. Repeated power cycling will not clear this fault. Contact Solta Medical
Customer Service to schedule service.
Fraxel®1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System
Part Number 10-05170 Rev. O Page 20 of 92
2.3.2 Utilities/Home
Upon successful completion of the System Test, the touch screen display will immediately
transition to the Utilities/Home Mode. The Utilities/Home Mode allows various system
parameters to be selected, including Treatment Wavelength.
Fraxel DUAL 1550/1927
Home screen
This manual suits for next models
15
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GE
GE marquette MAC 1100 Servicing instructions
