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Technical Users Manual Fraxel Re Store DUAL Wavelength System
Technical Users Manual Fraxel Re Store DUAL Wavelength System
Manufactured by
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, Fraxel re:store, the Fraxel logo and Intelligent Optical Tracking are
trademarks or registered trademarks of Solta Medical, Inc. or its subsidiaries in the United
States and other countries. Other names and brands may be claimed as the property of
others.
Various aspects of the Fraxel re:store and Fraxel re:store DUAL 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.
®
Fraxel re:store and Fraxel
re:store DUAL Laser Systems
THE SOLTA MEDICAL FRAXEL RE:STORE AND FRAXEL RE:STORE DUAL LASER
SYSTEMS ARE 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 RE:STORE AND FRAXEL RE:STORE
DUAL LASER SYSTEMS OPERATORS MANUAL IN ITS ENTIRETY PRIOR TO USE OF
THE LASER SYSTEM.
TABLE OF CONTENTS
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
re:store Laser Systems and its accessories.
Note:
Warning:
PLEASE READ THE FRAXEL RE:STORE LASER SYSTEMS OPERATOR MANUAL IN ITS
ENTIRETY PRIOR TO USE OF THE SOLTA FRAXEL RE:STORE OR FRAXEL RE:STORE
DUAL 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.
This manual provides operating instructions for the Fraxel re:store and Fraxel re:store DUAL
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 re:store and Fraxel re:store DUAL 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.
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
Please note there are two differences between the International and Domestic systems:
1550 nm: The Fraxel re:store 1550 nm laser is indicated for use in dermatological
procedures requiring the coagulation of soft tissue, as well as for skin resurfacing
procedures. It 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 re:store DUAL 1927 nm laser is indicated for use in dermatological
procedures requiring the coagulation of soft tissue and the treatment of actinic keratosis.
The Fraxel re:store 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 re:store Laser System consists of a single infra-red fiber laser with wavelength of
1550 nm.
The Fraxel re:store DUAL Laser System has two infra-red fiber lasers with wavelengths of
1550 nm and 1927 nm. The two wavelength options 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 re:store and Fraxel re:store DUAL
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.
This manual is intended to help you get the most from your system as you make the Fraxel
re:store and Fraxel re:store DUAL 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 re:store and Fraxel re:store DUAL 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.
The Fraxel re:store Laser System has a single fiber laser source and the Fraxel re:store
DUAL 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 re:store and Fraxel re:store DUAL Laser Systems are shown
below:
Emergency switch
Calibration Port
Power Connection
Footswitch Connection
Remote Door Interlock
Product Labeling
and Identification
Locking Casters
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.
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.
When using the large Cool Roller Tip ensure that the cooling channel adaptor is
clipped onto that side of the handpiece as shown on page 10. 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.
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.
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.
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.
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..
The system has defined states of operation which include: utilities/home, system test,
simulate, and treat.
1.5.1 Utilities/Home
Allows the system and handpiece to be tested. After successful power-on, the
system will move to this 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.
2.1 Overview
This section provides a general guideline for the operation of the Fraxel re:store and Fraxel
re:store DUAL Laser Systems. These lasers 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.
2.2.2 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 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.
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.
NOTE: NEVER BLOCK THE COOLING SYSTEM VENTS. ENSURE ADEQUATE SPACE
AROUND THE UNIT AT ALL TIMES TO FACILITATE SYSTEM COOLING.
While powering up, the system will briefly display an introductory splash screen.
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.
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.
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 re:store
Home screen
From the Utilities/Home Mode, the user may access any of the other System modes,
including Simulate, Test System and Treat.
2.3.2 Simulate
Simulate Mode allows the user to simulate treatment but without discharging laser energy.
It is used during the training phase for new operators of the Fraxel re:store Laser Systems
and should be utilized fully before the first patient treatment is performed. The Operator can
also select Simulate Mode in order to familiarize a patient with the feel of the treatment tip
and the tones of the laser before initiating treatment of a new patient.
Once the footswitch is depressed, the system will indicate that the simulate mode is
activated.
2.3.3 Treat
Warning:
Do not lift the handpiece from treatment area with the footswitch depressed during treatment
as this may result in injury to the patient due to inadvertent laser exposure.
When the final selection of utilities has been performed and treatment simulations have
been completed, the Operator may select to transition into Treat Mode. If “Treat” is
selected, the system will begin initializing. Initialization is an idle mode for the system.
If the tip is not yet attached to the handpiece, the touch screen display will notify the
Operator that no tip is installed. Attach tip to the handpiece as directed in this manual.
Once the tip is detected by the system, the touch screen display will indicate that
initialization is occurring, but will remain in standby mode. After initialization, the Operator
may adjust the treatment settings as desired, and then must press “Ready” in order to exit
Standby and enter Treat mode.
In order to initiate treatment, the Operator must depress the footswitch and initiate
handpiece motion.
Active treatment and laser emission will only occur when the footswitch is depressed and
the IOTS senses motion across the skin’s surface. When the system is actively treating, the
screen will reflect that laser energy is emitted and treatment is occurring.
In order to change treatment parameters or interrupt treatment, the Operator must select
“Standby”. The touch screen display will then indicate that the system is in Standby mode.
When in Standby, treatment parameters may be selected. Energy, treatment level and
number of passes are described in the table below. After selections are made, the Operator
must press “Ready” in order to exit Standby and re-enter Treat mode.
Symbol Interpretation
It is important to perform a Pattern Preview Test with each tip prior to use on a patient, every
time the Fraxel re:store Laser Systems are used. Remember the following steps:
If lines are missing do not perform treatment and contact Solta Medical Customer Product
Support immediately.
To use the “Actual kJ” reading to determine whether the treatment was delivered as
intended, the Operator will need to measure the surface area of the treatment area. The
system handpiece will function as a measurement tool for assessment of surface area. After
surface area measurements are completed, the system will calculate the “Estimated kJ”
reading based on desired treatment level and measured surface area. This value should be
used as a point of reference in order to determine whether treatment dosimetry was
achieved as intended.
As described above, the handpiece may be used as a tool to measure the surface area of
the treatment region. Measurement selections may be performed while the system is in
Treat Standby mode or Simulate Standby mode. In order to begin, the Operator should
select the measurement icon.
After selection of the measurement icon, the touch screen display will prompt the Operator
to select a treatment area for measurement. The possible treatment areas include: the face,
neck, chest, forearm, hand and “other”. Vertical and horizontal measurements will be
required for measurement of each treatment region.
The Operator must establish contact between the handpiece and the surface of the
treatment region. Vertical and horizontal measurements must be completed as directed by
the measurement touch screen display.
After completion of the measurements for a particular treatment area, the Operator may
select an additional treatment region for measurement. In order to do so, the Operator must
select “Change Treatment Region” and must select a new treatment location. After
completion of vertical and horizontal measurements for the selected region(s), the Operator
must press “Done”. Upon completion of the requested measurements, the system will
provide the value for surface area (cm2).
The Operator shall measure the width of one half of the face. In order to begin, the
Operator must place the tip at the center of the philtrum (depression extending from the
base of the nose to the center of the lips) and complete a horizontal pass until the lateral
edge of the jawline (level with respect to the base of the earlobe). If the width measurement
was not completed properly, or needs to be repeated for any other reason, press “clear” and
perform the horizontal pass again. After the length and the width measurements are
obtained, the Operator must press “Done” in order to store the treatment area calculations.
After completion of all necessary measurements, the touch screen display will list the
“Estimated kJ” value and the treatment area measurement (cm2). If the surface area needs
to be recalculated, the Operator must select “reset all” and will need to perform the
measurements again.
The “Estimated kJ” value provided by the system is calculation-based. The calculated
energy estimate incorporates the surface area of the treatment region, as measured by the
Operator, and the intended treatment level. After treatment is completed, the system will
display the “Actual kJ” reading. If the “Estimated kJ” reading is more than the “Actual kJ” of
energy delivered to the patient, the Operator may not have administered the treatment as
intended. Several technique-dependent factors may reduce the amount of energy delivered
to the patient, including: rapid hand speed, inappropriate delivery of treatment passes,
omission of sections within a treatment region, etc.
2.5 Definitions
This section of the manual should familiarize the physician with the terminology used in the
Solta Training Program and describe other features of the Fractional Photothermolysis
process. It is the responsibility of the physician to fully understand the indications for use,
safety considerations and laser function associated with the Fraxel re:store and Fraxel
re:store DUAL Laser Systems, and to make medical decisions regarding the specific
application of the Laser Systems to the individual patient.
MTZ
An MTZ is a Microscopic Treatment Zone, the region of coagulated tissue resulting from one
pulse from the handpiece.
Pass
A “pass” is a single, unidirectional hand motion laying down one segment of MTZs.
Magnified it will be similar to the pattern shown below although the spot pitch and stride may
not be identical.
MEND
“The directions for use provided in this section are based on the results of a clinical trial
conducted by Solta Medical, Inc. A total of 27 subjects received a total of 4 non-ablative
fractional laser treatments at 4-7 day intervals. One treatment consisted of ten passes with
the device to create a final treatment density of 2500 spots per cm2. Five double passes
were made in one direction and five double passes were made in a perpendicular direction.
The average fluence per pass was 1.5 - 3 J/cm2, and (pulse energies) ranged from 6 to 12
mJ/pulse. Each pulse had a duration of 1.5 - 5 ms. The results of the clinical trial indicated
that the Fraxel Laser System safely and effectively provided treatment for the cleared
indications for use listed in Sections 1.1 and 4.1 of this manual. It is the responsibility of the
physician to fully understand the indications for use and safety considerations associated
with the Fraxel Laser System.”
The laser system console will generate audible tones during normal operation which vary as
a function of handpiece velocity. This indicates that the tracking system is functioning. The
frequency of the tone will increase as hand velocity increases, and decrease as hand
velocity decreases. Physicians should practice with the system in Simulate Mode to gain an
understanding of the relationship between hand velocity and audible tones.
If the handpiece is moved at an unsustainable velocity, i.e. above that where the system will
produce the correct pulse energy and repetition rate, the sound will change to a higher-
pitched tone designed to alert the operator. Slowing down will restore the audible tones to
normal.
There are two adjustments for volume control, “General” and “Alert” (see page 18). The
General volume control can be adjusted down, or turned off completely. If the General
volume is off, you will still hear a soft audible alarm if an alert presents itself.
The handpiece may get warm during treatment. This is normal and not typically a cause for
concern. If the handpiece gets abnormally hot, discontinue treatment and call Solta
Customer Service or your local authorized distributor of Solta Medical lasers.
Warning:
The tones generated by the machine indicate normal function. If the tone is unchanging but
hand velocity is changing, discontinue treatment and check the laser. If the fault persists,
call Solta Customer Service.
Warning:
Release the footswitch prior to lifting handpiece from the treatment area. Failure to do this
may result in burns or injury to the patient due to inadvertent laser exposure.
The IOTS senses velocity, i.e. not only the speed of the handpiece motion but also the
direction. This allows treatment to be bidirectional. The handpiece may be stopped after one
pass and the direction of motion reversed without loss of function. Simulate Mode allows the
operator to practice this hand motion and listen to the tones generated by the machine
without firing the laser.
NOTE: In order for the IOTS to stay locked during a treatment, it is important that the tip stay
in good physical contact and approximately perpendicular to the skin.
NOTE: There is a specific cadence preferred by physicians skilled in the use of the Fraxel®
re:store Laser system. After selection of the desired treatment wavelength, the sequence is:
1. Place the laser in Treat mode.
2. Place the handpiece on the area to be treated.
3. Press the footswitch down.
4. Move the handpiece, performing as many passes as are required to complete treatment
of the selected area.
5. Release the footswitch. Lift the handpiece and move it to the next area to be treated.
6. Restart the sequence at step 3.
7. When finished, release the footswitch, remove the handpiece from the skin, clean and
store carefully.
Warning:
Do not lift the handpiece from treatment area with the footswitch depressed during
treatment. Release footswitch prior to lifting handpiece from treatment area. Failure to follow
these guidelines may increase the risk of injury to the patient.
Warning:
The tones generated by the machine indicate normal function. If the tone is unchanging but
hand velocity is changing, stop treatment to reduce the risk of injury to the patient. Test the
system in Simulate mode. Restart the laser if necessary. If the fault persists, call Solta
Customer Service.
Warning:
Do not move the handpiece in a direction parallel to the long axis of the treatment tip. Do not
twist the handpiece in a circular motion while treating. Failure to observe these precautions
may result in increased risk of injury to the patient.
When selected, the tip should be attached to the distal portion of the handpiece. It
will latch magnetically when properly positioned, and will remain latched throughout
treatment with appropriate handling. The small and large tips attach in the same
manner and the dimensions of the tip bases are identical.
CAUTION: Make sure the tip is correctly latched prior to treatment. Check to make
sure that the surface of the handpiece where the tip attached is not contaminated.
Check in particular for obstructions or debris near the magnetic latch. The tip will not
seat properly if this surface is obstructed.
Warning:
The tips cannot be sterilized or disinfected by EtO, or products containing glutaraldehyde.
Using these disinfection/sterilization techniques will severely reduce the tip lifetime and
possibly lead to immediate damage, such as cracking, and possible injury to the patient.
After treatment AND WHILE STILL ATTACHED TO THE HANDPIECE, the tip should be
wiped with 70% alcohol (preps) and inspected for debris and other contamination. The tip
should then be removed from the handpiece and inspected again. Any remaining debris
should be removed. Care should be taken not to allow debris, cleaning materials, or other
contaminants to fall into the mouth of the tip. If the tip was used with off-white plastic rollers,
remove used rollers and replace with new set.
CAUTION: Tip cleaning and care protocols are critical to optimizing tip lifetime.
Treating through a contaminated tip may accelerate the degradation process and may
result in poor clinical outcomes, including possible injury to the patient, and sub-
optimal tip lifetimes.
Warning:
Do not allow the metal part of the handpiece to come into prolonged contact with corrosive
chemical solutions such as acetone, bleaches or disinfectants.
With the tip removed, wipe the handpiece window with 70% isopropyl alcohol and inspect for
debris and other contamination.
Solta Medical has tested and qualified a disinfection method using Cidex OPA, which
disinfects the tips to the reusable medical device classification of high level disinfection for
semicritical devices.
Warning:
Wear gloves and other appropriate body protection as directed by the materials
safety data sheets (MSDS) and instructions for use accompanying Cidex® OPA
solution.
Warning:
Do not allow the chip inside the tip to come into contact with any liquid such as the
Cidex® OPA solution, or water.
Do not allow the metal part of the handpiece to come into prolonged contact with any
liquid such as the Cidex® OPA solution.
Pre-cleaning Procedure
After tip use, remove and discard the tip rollers. Wipe off the outside of the tip with 70%
isopropyl alcohol (IPA) wipes until there is no visual sign of soil. Tips can then be placed, but
not submerged, in the Cidex solution (per the Cidex OPA solution instructions). DO NOT
submerge the tip completely. DO NOT allow the cleaning solution to come in contact with
the chip inside the tip.
If desired, precleaning can be done with a solution of an enzymatic detergent, e.g. Enzol®
enzymatic detergent, (per the manufacturer’s recommendations). Pre-clean devices by
immersing the soiled portion of the tips in the prepared detergent.
During cleaning or disinfection, DO NOT allow any liquid to come into contact with the chip
inside the tip.
Rinse the part of the tip exposed to either IPA or enzymatic detergent with water for a
minimum of 30 seconds, being careful not to expose the chip to any liquid.
Pour the Cidex® OPA solution into a container and immerse the base of the tip (where the
white rollers attach). Ensure that the Cidex® OPA solution completely covers the base of the
tip. Allow the tip to soak in the disinfectant for 12 minutes (or Cidex OPA instructions for
use).
Following disinfection with Cidex® OPA solution, rinse the tip with water. and then dry the tip
thoroughly and attach new unused rollers before use.
More details on the Enzol® and Cidex® OPA products can be found at:
http://www.aspjj.com/us/products/enzol/features-and-benefits
and
http://www.aspjj.com/us/products/cidex-opa/features-and-benefits
More details on preventing infection from reusable medical equipment can be found at:
http://www.biomedcentral.com/1471-2334/2/4
3.0 Safety
The Fraxel re:store Laser System and its 1550 nm laser as well as the Fraxel re:store DUAL
Laser System, its 1550 nm and its 1927 nm laser are each classified as Class 4 lasers
according to Center for Devices and Radiological Health (CDRH) and IEC / EN regulations.
This classification represents the highest power laser. Users and staff must take
precautions to prevent exposure of laser energy to the eye and/or skin from either direct or
diffusely reflected laser beams. In addition, precautions must be taken in the surgical
environment to prevent hazards of fire and electrical injury.
This section discusses the primary safety concerns when operating the both Fraxel re:store
and Fraxel re:store DUAL Laser Systems. The instructions are intended to raise awareness
of the safety issues and provide insight so that hazardous optical, mechanical, electrical,
and chemical risks may be minimized.
CAUTION: Prior to use of the Fraxel re:store Laser Systems, this manual must be
thoroughly read and understood by the personnel involved with operating the
System. Improper use may cause personal injury and damage to the System and may
invalidate any warranty agreement.
CAUTION: United States Federal law restricts this device to sale by or on the order of
a physician.
CAUTION: The availability of electronic alarms does not relieve operators of their
obligation to carefully monitor the entire system during operation.
Although the Solta system is a contact non-ablative system which normally cannot
produce any smoke or plume, any laser plume (debris) generated by the laser is
potentially hazardous. It may obscure the laser operating field and may contain viable
airborne pathogens. Any plume generated as part of a laser procedure must be
evacuated promptly and effectively. If such plumes are observed during normal
operation of the laser as instructed by this manual and as directed in the Solta
training, immediately stop treating, shut off the laser system and contact Solta
Customer Service
Warning:
Do not use this device in the presence of critical concentrations of flammables or explosives,
such as volatile anesthetics, alcohol, certain surgical preparation solutions, and other
substances known to have these fire hazards. An explosion and/or fire could occur and
severe injury could result.
Warning:
Take extra precautions when using this laser around an airway (endotracheal) oxygen tube.
Firing the laser into the airway oxygen tube could start a fire that will spread rapidly because
of the presence of oxygen which could in turn cause severe injury.
Warning:
The use of flammable anesthetics or oxidizing gases such as nitrous oxide (N2O) and
oxygen should be avoided. Some materials, for example cotton wool, when saturated with
oxygen, may be ignited by the high temperatures produced during NORMAL OPERATION
of the LASER EQUIPMENT.
Warning:
Flammable solutions used for cleaning / disinfecting and the solvents of adhesives should
be allowed to evaporate before the LASER EQUIPMENT is used. An explosion and/or fire
could occur and severe injury could result if these precautions are not observed.
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. An explosion
and/or fire could occur and severe injury could result.
3.2.1 A designated Facility Laser Safety Officer (F-LSO) and the physician shall
control and enforce the safety aspects of the laser in the health care facility.
3.2.3 Know the location of the nearest fire extinguisher in case of fire.
3.2.4 Never test-fire the laser over a patient who is receiving oxygen through an
endotracheal (airway) tube as inadvertent exposure may start an airway fire
which could result in serious injury.
3.2.5 Exercise great care with the use of oxygen, especially as an airway gas. In
the event of fire, oxygen will accelerate the progress of a fire which could
cause serious injury.
3.2.7 Always moisten gauze with water before treating to minimize the fire risk.
3.2.8 Hair in the treatment area should be shaved prior to the procedure to reduce
the potential for interference with the operation of the laser system, including
the IOTS, which may increase the risk of burns or other injury.
3.2.9 If alcohol is used for cleaning and disinfection of the skin, allow the area to
dry completely before using the laser in order to reduce the possibility of
alcohol fuelling a fire. Replace the cover on the alcohol container and
remove the alcohol from the immediate area prior to initiating treatment to
reduce the possibility of alcohol fuelling a fire which could cause serious
injury.
3.3.2 The F-LSO and physician are responsible for determining the appropriate
Nominal Ocular Hazard Distance (NOHD), Nominal Hazard Zone (NHZ) and
Maximum Permissible Exposure (MPE) per ANSI Standard Z136.1-2000,
Z136.3-2005 and/or IEC 60825-1.
3.3.3 The F-LSO and physician are responsible for providing appropriate laser
safety items including, but not limited to, the correct laser safety eyewear,
and enforcing the use of these items through laser safety protocols and
Standard Operating Procedures.
3.3.5 All operators shall attend the appropriate laser training course and shall
receive certification and/or credentialing prior to patient treatment.
3.3.6 Laser safety eyewear is routinely required with most lasers. Failure to use
appropriate eyewear with the Fraxel re:store Laser Systems increases the
risk of injury to the cornea, sclera and soft tissue of the eye.
3.3.7 The following formula, taken from ANSI Standard Z136.1, was used to
calculate the Worst Case NOHD for the Fraxel re:store Laser systems.
1 4
NOHD a
MPE
Where:
NOHD = the Nominal Ocular Hazard Distance, defined as the distance from the
source required to reduce the energy density incident on a 7 mm aperture
to less than the Maximum Permissible Exposure,
θ (theta) = the full angle beam divergence, is measured in mrad (milliradians),
Φ (phi), the energy or power of the laser is measured over one aversion response
time (Watts or Joules),
MPE, the Maximum Permissible Exposure, as defined per ANSI 136.1 and ANSI
136.3, is in Watts per unit area.
a = the beam waist diameter at the e-2 point in units of length, and the beam waist is
at the exit window.
3.3.8 Using this formula, and the values for the parameters above:
Worst Case NOHD for the Fraxel re:store Laser System when operating at
1550 nm is 45 feet / 13.8 meters. When operating at 1927 nm the worse case
NOHD is 145 feet / 44 meters.
All personnel within the NOHD are required to wear eye protection with a
minimum Optical Density of 4.58 at 1550 nm and 3.02 at 1927 nm. Appropriate
eye wear should be used that supports the minimum optical density for both
given wavelengths.
For operators complying with EN 207, all persons shall wear eyewear with
protection class of DL4.
3.3.9 Patients must have appropriate eye protection. The F-LSO and physician are
responsible for ensuring that the patient is adequately protected during
treatment. Failure to use appropriate eyewear with the Fraxel re:store Laser
Systems increases the risk of injury to the cornea, sclera and soft tissue of
the eye.
3.3.10 Extra precautions must be taken if treating inside the bony orbital rim of the
eye, including but not limited to treatment on the upper and lower eyelid.
Failure to use appropriate eyewear with the Fraxel re:store Laser Systems
increases the risk of injury to the cornea, sclera and soft tissue of the eye.
3.3.11 Protective eyewear of the correct optical density for the laser wavelength
must be worn at all times during the laser procedure and during laser
verification and calibration. Failure to use appropriate eyewear with the
Fraxel re:store Laser Systems increases the risk of injury to the cornea,
sclera and soft tissue of the eye.
3.3.12 All protective glasses or goggles must bear a label from the manufacturer
identifying the wavelengths for which their use is intended and the optical
density at those wavelengths.
3.3.13 All protective eyewear must have side shields for protection against
inadvertent exposure from the side. Failure to use appropriate eyewear with
the Fraxel re:store Laser Systems increases the risk of injury to the cornea,
sclera and soft tissue of the eye.
3.3.14 Laser safety eyewear shall be properly stored away from direct sunlight to
prevent degradation of the absorbing media, such as photobleaching.
3.3.15 When cleaning eyewear, do not use solvents or abrasives that might remove
protective coatings. Follow the manufacturers’ recommendations for
cleaning.
3.3.16 Two sets of appropriate protective eyewear are provided with each Fraxel
re:store Laser System. Additional sets may be purchased from Solta (See
Section 6 – Re-Order Information). One set of the eyewear is designed to be
used over optical spectacles.
3.3.17 Examples of patient-specific eye protection, not tested and not endorsed by
Solta, but used by practitioners skilled with the use of this and similar lasers,
are given in the “Re-Order Information – Section 6” of this manual. The
presence of these products in this manual does not constitute an all-inclusive
list of products, nor does it constitute an endorsement of any product or a
testimonial of safety or efficacy.
3.3.19 Contact lenses and regular glasses do not provide adequate protection.
Laser protective eyewear must be worn. Failure to use appropriate eyewear
with the Fraxel re:store Laser Systems increases the risk of injury to the
cornea, sclera and soft tissue of the eye.
3.3.20 The treatment room door shall be kept closed during operation of the laser.
Door interlocks can optionally be installed to automatically disable the laser
when the treatment room door is open.
3.3.21 Keep reflective objects out of the treatment field to avoid accidental
reflection. Remember that stainless steel eye shields may cause some
reflection of the laser beam.
Warning:
All persons within the NOHD shall wear appropriate eye protection with a minimum optical
density of 4.58. For operators complying with EN 207, all persons shall wear eyewear with a
protection class of DL4. Do not use eyewear that is visibly damaged in any way. Failure to
use appropriate eyewear with the Fraxel re:store Laser Systems increases the risk of injury
to the cornea, sclera and soft tissue of the eye.
Warning:
Use extra caution when treating close to the eyes. The laser wavelengths used in the Fraxel
re:store Laser Systems are extremely hazardous to the cornea and soft tissue around the
eye. All operators must have a comprehensive understanding of the risks involved and
knowledge of the safety precautions required for these lasers to ensure the safety of the
patients and others within the NOHD.
Warning:
Never look directly into the path of the laser as this may cause permanent eye damage. In
addition, direct exposure to the laser beam can cause permanent damage to the safety
eyewear lens.
Warning:
A warning sign shall be placed on the outside of the treatment room door or controlled area.
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:
Never look into the handpiece exit window if the laser is turned on. Severe eye damage
could occur. Turn off the power to the laser before inspecting any of the optical components.
Warning:
Contact lenses and spectacles do not provide adequate ocular protection. Do not
substitute for the specified eye protection. Failure to use appropriate eyewear with
the Fraxel re:store Laser Systems increases the risk of injury to the cornea, sclera
and soft tissue of the eye.
Warning
This manual is not intended to be a complete guide to the use of the Fraxel re:store and
Fraxel re:store DUAL Laser Systems. Solta recommends that all qualified personnel who
operate the laser system first seek training that includes, but is not limited to, the following
aspects of laser operation:
Laser Safety
Laser/Tissue Interaction
Hands-On training by a qualified Solta representative
CAUTION: Solta does not and cannot recommend standard operating clinical
practice. The following guidelines are suggested as a starting point from which
operators may become familiar with good clinical laser technique through study of
the medical literature. The guidelines in ANSI Standards Z136.1, Z136.3, IEC60825-1
and EN207 are also recommended as reference material.
3.4.1 Check the laser prior to every procedure before admitting the patient into the
room.
3.4.2 Prepare the patient as directed with appropriate pain management, and
recommended contact lubricant.
3.4.4 The footswitch should be controlled only by the operator to prevent
accidental firing of the laser.
3.4.5 The laser is designed to fire only when:
(a) Either the 1550 nm or the 1927 nm laser is selected, and
(b) The system is in “Treat” mode, and
(c) The footswitch is depressed, and
(d) The Intelligent Optical Tracking System (IOTS) senses handpiece motion
when the tip is in contact with the skin. See Section 2.9 of this manual for a
more detailed explanation of the IOTS.
3.4.6 Press the footswitch only after positioning the laser handpiece over the
treatment area.
3.4.7 Do not allow the tip to lose contact with the skin during treatment.
3.4.8 The audible tones emitted by the unit during treatment are an indication of
hand velocity. If you are moving your hand at different velocities, but you
hear an unchanging monotonic sound, stop treatment immediately. This
indicates an IOTS fault. Stop treatment and go to Simulate mode to test the
IOTS. If the fault persists, restart the system. If this fault condition persists,
call Solta Customer Service or your local authorized distributor of Solta
Medical lasers.
3.4.9 Never place the system in Treat mode and depress the footswitch without
intending to initiate a treatment.
3.4.10 Refer to the list of “Indications for Use” and “Contraindications” before
treatment.
3.4.11 Do not use visibly damaged (cracked, crazed, cloudy) tips.
Warning:
Do not move the footswitch while the laser is in Treat mode other than to initiate a treatment.
Do not move the footswitch by placing a foot in the housing and lifting it up. Do not pull the
footswitch by its cord. Do not move the laser by the footswitch cord. Do not place the
footswitch or cord in an exposed area where it may be damaged by for example, being
tripped over, or where a sharp object such as a scalpel may fall on it.
Warning:
Laser equipment not in use should be protected against unauthorized operation by removing
the key from the key switch. Keep the laser key in a designated place and allow only trained
personnel access to the key.
Warning:
Do not allow the tip to lose physical contact with the skin during treatment. Serious injury or
undertreatment may result if the IOTS enters a cycle of rapid starts and stops due to loss of
signal.
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:
Laser treatment can only be initiated when the screen shows Treat mode, when the
footswitch is pressed down, and when the IOTS registers handpiece motion. Do not leave
the system in Treat mode and the footswitch pressed down when no treatment is desired,
otherwise inadvertent exposure could occur and serious injury could result.
CAUTION: Solta systems are intended for use solely by trained physicians and
authorized staff trained in the operation of these devices.
3.5.2 Place the power cord and footswitch cord where they cannot become
hazards.
CAUTION: Never operate the footswitch in water. Serious injury could result. The
footswitch must remain dry.
3.5.3 The high voltages of the Fraxel re:store and Fraxel re:store DUAL Laser
Systems are not accessible unless the protective housing is opened. Do not
open the protective panels unless trained and authorized to do so.
3.5.4 Do not attempt to coil the umbilical or power cable beyond the resistance
point of the armoring. Do not use if internal cables and wires are visible
through holes or gaps in the umbilical armoring as this may cause
inadvertent exposure of electrical energy to persons in the room.
3.5.5 Servicing high voltage and other components is to be done only by Solta
authorized personnel. If service is required call Solta Customer Service or
your local authorized distributor of Solta Medical lasers.
CAUTION: The Fraxel re:store Laser Systems are susceptible to Electrostatic Discharge
(ESD) and proper ESD procedures should be followed.
3.6.2 The signs must display "Danger" or "Warning", and the type and wavelength
of laser in use in accordance with ANSI Z35.1, the specification for accident
prevention signs, or per your local or regional regulations. Examples of
suitable signs are also shown in ANSI Z136.1, Z136.3 and IEC60825-1.
3.6.4 All LTCA windows should be covered with opaque non-flammable material or
a non-flammable window filter specific for the wavelength being used in
order to prevent inadvertent escape of laser light. Note that a material that
appears opaque to the eye may not be opaque at the treatment wavelength.
Most common ordinary window glass will allow the laser wavelength used in
the Solta Medical Fraxel re:store and Fraxel re:store DUAL Laser Systems to
escape.
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.
3.7.2 When connected, the interlock will automatically disable the laser if the door
is opened during the procedure. When the door is closed, the interlock is
reconnected and treatment can resume once the message is acknowledged.
3.7.3 Access to the remote door interlock is through a plug and socket located on
the back panel of the laser. The appropriate pin-outs and wiring are shown in
the figure below. The laser system is delivered with this plug shorted
internally. Cut the internal wire and join to your external circuit when this is
required. The circuit used should be low impedance and use twisted-pair
wire connections. Consult an electrical professional if unsure about this.
3.7.4 Do not connect other power supplies to this interlock. Connecting devices to
the unit other than instructed may cause severe damage to the unit and will
result in voiding of the device warranty.
3.8.2 After each patient treatment, the portion of the handpiece tip that came in
contact with the patients’ skin should be wiped down with a 70% alcohol prep
pad and visually inspected for damage, debris, dirt, contamination, crazing or
cracks. Allow the alcohol to dry before initiating another treatment in order to
mitigate the risk of fire, or serious injury could result.
3.8.3 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.
3.8.4 Do not use acetone on the tip as this may cause damage preventing the tip
from functioning properly.
3.8.5 To clean the internal handpiece sealing window, carefully use an alcohol
prep pad or gauze moistened with 70% alcohol. Do not hold the prep pad or
gauze with bare hands while performing this operation. Allow the alcohol to
dry before initiating treatment in order to mitigate the risk of fire from which
serious injury could result.
3.8.6 Be careful not to contaminate the internal handpiece optics with any
substance used for cleaning and disinfecting the tip or with the topical
anesthesia gel.
3.8.7 Do not allow the inside of the tip window to become contaminated while
cleaning the handpiece sealing window.
3.8.9 The accessories should be stored in an area accessible only to qualified and
trained personnel.
3.8.10 Minimize the presence of dust particles and corrosive substances such as
salts and acids in the storage environment in order to extend the lifetime of
the laser system.
3.8.12 Examine the handpiece frequently to check for debris on the window.
3.8.13 Do not allow the plastic or metal parts of the handpiece to come into
prolonged contact with enzymatic detergents, Cidex® OPA or other
chemically aggressive cleaning solutions of chemicals.
3.8.14 Solta Medical suggests that the operators clean and disinfect the exterior
chassis of the laser system with a soft cloth dampened with mild soap and
water.
Warning:
Inspect the handpiece umbilical armoring for damage on a routine basis. Do not use the
device if the umbilical is damaged as inadvertent exposure to the laser may occur which
may result in serious injury.
Warning:
Never move the unit by pulling on the handpiece support arm.
Warning:
Never move the unit by pulling on the footswitch cable.
Warning:
Do not immerse or soak the handpiece or the umbilical cable containing the optical fiber.
Warning:
If the handpiece tip or internal sealing window is cleaned with alcohol prior to use, allow time
for the alcohol to evaporate before restarting the laser to mitigate the risk of fire and injury.
Warning:
Do not allow the metal part of the handpiece to come into prolonged contact with enzymatic
detergent, Cidex® OPA solution, or other chemically aggressive cleaning solutions.
3.9.6 The laser can only fire when the following conditions are met:
(a) The tip is installed correctly, and
(b) The footswitch is depressed, and
(c) The handpiece senses motion when the handpiece tip is placed in
contact with the skin.
The laser optical path is enclosed by four separate layers of protection, comprising
the fiber buffer, the fiber jacketing, the metal armoring on the fiber jacket and the
metal armoring on the handpiece umbilical cable. There is no exposed optical path
between the console (laser enclosure) and the delivery device. The only exposed
laser portal is the handpiece exit window.
3.10 Labeling
The Fraxel re:store Laser Systems contain the required manufacturing warning labels.
Warning:
The information which follows below is provided by Solta only as an information service to
physicians and is made available with the understanding that it does not constitute the
rendering of medical advice. Physicians should make their own assessment of and decision
on the use of any of the information.
1550 nm: The Fraxel re:store 1550 nm laser is indicated for use in dermatological
procedures requiring the coagulation of soft tissue, as well as for skin resurfacing
procedures. It 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 Fraxel re:store DUAL 1927 nm laser is indicated for use in
dermatological procedures requiring the coagulation of soft tissue and the treatment of
actinic keratosis.
4.2 Contraindications
4.2.1 Not all patients will necessarily react the same way to the laser treatment. The laser
system should not be used on any patient who is ineligible for general surgery. Appropriate
medical judgment should be exercised at all times.
4.2.2 The following contraindications are routine for many laser treatments and may also
be associated with non-ablative Fraxel re:store and Fraxel re:store DUAL Laser Systems
treatments. Pre-screening and informed consent should include, (but not be limited to):
4.2.3 Solta has no clinical information or experience concerning the use of the Fraxel
re:store and re:store DUAL Laser Systems on pregnant women or nursing mothers.
Tissue damage can occur with the application of incorrect laser energy settings, incorrect
use of the handpiece or inappropriate pretreatment regimens. Extreme caution should be
exercised until you are familiar with the system.
Warning:
The information which follows below is provided by Solta only as an information service to
physicians and is made available with the understanding that it does not constitute the
rendering of medical advice. It also does not constitute a statement that Solta has tested
these items for safety or efficacy, nor is it an endorsement or warranty of the safety or
efficacy of these products. Physicians should make their own assessment of and decision
on the use of any of the information.
4.5 Anesthesia
NOTE: The physician must be fully versed in the nature, presentation and treatment of
anesthesia toxicity. Physicians should inquire before starting this procedure as to whether
the patient has a history of potential sensitivity to amide-type anesthetics if, for example,
lidocaine is used. Do not use topical lidocaine or similar systems if contact allergies or
systemic allergic conditions have occurred in the past.
“After the anesthetic has been administered to the treatment area for an appropriate period
of time, perform a sensitivity test to gauge readiness for treatment. For example, perform an
“ice cube test”. This consists of placing a plastic-wrapped ice cube on the area coated with
topical ointment for 7 seconds and then placing a plastic-wrapped ice cube on the non-
treatment area for 7 seconds. The patient should score the sensation felt within the
treatment on a scale from 0 to 5, with “0” equal to no sensation of cold and “5” equaling the
sensation of cold felt on the non-treated region. If the patient scores the sensation within the
treatment region as being greater than 1, reapply the topical anesthetic and wait 15 more
minutes. Repeat until the patient has scored the cold sensation within the treatment region
as a “0” or a “1”. Another test may be used to gauge patient sensitivity and readiness for
treatment, however in the interest of maintaining an appropriate pain management protocol,
aim to begin treatment only when the anesthetic appears to have reached optimal
effectiveness.”
Warning:
The information which follows below is provided by Solta only as an information service to
physicians and is made available with the understanding that it does not constitute the
rendering of medical advice. Physicians should make their own assessment of and decision
on the use of any of the information.
For both the Fraxel re:store and Fraxel re:store DUAL Laser System’s non-ablative
wavelengths, histology indicates that new epithelium (new skin) will start to form within about
24 hours, but that it will remain covered by the old stratum corneum and MENDS from 4 -14
days. Desquamation of MENDS may progress more slowly on non-facial skin and may vary
depending on individual patient response to the treatment. During that time normal /
accelerated exfoliation will reveal the repaired epidermal tissue and new stratum corneum.
Patients should avoid injury and sun exposure.
Skin Protection: Patients should plan to use a high SPF sunscreen on a regular basis for at
least 6 months whenever they are outside. Patients should apply a dual UVA/UVB
sunscreen containing both a physical sun block (either or both zinc oxide or titanium dioxide)
with a sun protection factor of at least 30 SPF. In addition, patients should be instructed to
avoid direct sunlight and wear sun-protective clothing (i.e. a wide-brimmed hat).
Most skin care products can be used 3 weeks after treatment. Avoid the use of retinoids and
topical corticosteroids for 1 – 2 weeks following treatment. Avoid systemic steroids e.g.
prednisone, dexamethasone throughout the course of the Fraxel treatment.
Edema: Mild to moderate edema (swelling) typically develops immediately after treatment
and diminishes, or resolves. within the first several days post-treatment. A small degree of
swelling may last longer in some cases.
Itching / Dryness of the Treated Area: These are common symptoms once the skin has
healed initially. Flakiness and dry crusting will gradually clear. Use of bland moisturizers
and/or moisturizing sunscreens that have previously been shown to not cause irritation
should help this condition.
Pain or Discomfort: Post-treatment ice packs may be applied to alleviate discomfort. Over-
the-counter itch and pain relievers may be used if necessary (e.g. Benadryl, Claritin, Tylenol
etc). Solta has no knowledge of the effects of NSAIDS on the outcome of treatment.
4.9 Complications
The following complications may be associated with the non-ablative Fraxel re:store and
Fraxel re:store DUAL Laser Systems. This is not intended to be an all-inclusive list, nor a
substitute for an informed consent form, which should be provided to every patient.
Eye injury: Protective eyewear or goggles are provided for the operator and
assistant. As discussed in the Safety Section (Section 3.0), it is important to keep the
eye protection on at all times during treatment in order to protect your eyes from
accidental laser exposure and serious injury.
Infection: A risk of infection exists whenever the skin is wounded. The possibility for
infection exists even with non-ablative fractional laser devices such the Fraxel
re:store Laser Systems. If observed, infection should be treated appropriately with
topical and/or systemic medications.
Keloid formation: A thickened scar can result from excessive growth of fibrous tissue.
Please refer to the contraindications section.
Scarring: The possibility for scarring exists even with non-ablative fractional laser
devices such the Fraxel re:store and Fraxel re:store DUAL Laser Systems. Local
scarring may occur directly from laser exposure if treatment procedures are not
followed properly, or from infection or physical irritation such as picking and rubbing.
Temporary bruising: Temporary bruising may develop over the treated areas.
The Fraxel re:store and Fraxel re:store DUAL Laser Systems should not require any specific
maintenance by the operator. Routine regular preventative maintenance should be
performed on the system as described in this manual. The device is covered by the warranty
described in the Solta Master Purchase Agreement and the included attachments thereto,
such as the Terms and Conditions of Sale.
The exterior surfaces of the laser console may be cleaned with a soft cloth damped
with a solution of soap and water. Do not use harsh detergents or acetone to clean
the exterior surfaces, including the console. A hospital grade disinfectant may be
used when the system is returned to Solta Medical. The display screen should be
cleaned with antistatic glass or plastic cleaner. Do not pour cleaning products
directly on the display screen, as this could potentially cause damage to the system.
5.2.2 Handpiece
WITH A TREATMENT TIP IN PLACE, wipe the exterior surface with a gauze pad
moistened with a small amount of 70% alcohol solution. The handpiece must be
thoroughly dried prior to initiation of laser treatment. Do not use harsh detergents or
acetone to clean the handpiece.
Solta Medical, Inc. offers full service warranty to cover all necessary modifications,
replacements, and repairs for the Fraxel re:store and Fraxel re:store DUAL Laser
Systems. Contact Solta Medical Customer Service to confirm return of the device for
these purposes.
Do not dispose of laser console as unsorted municipal waste. End of life electrical /
electronic equipment must be collected separately to prevent ill effects to the environment
and human health.
Contact your local recycling facility for separate collection or Solta Medical, Inc. for
appropriate disposal information.
To reorder accessory items contact Solta Customer Service or your local authorized
distributor of Solta Medical™ lasers.
6.1 Accessories
Accessory items include:
*Additional information on these items is available from their respective suppliers and/or
their regional distributors.
Goldman / Stefanovsky Laser Eye Shields are distributed by Rockwell Laser Industries, Inc.,
PO Box 43010, Cincinnati, OH 45243 USA, Phone (513) 271-1568, (800) 945-2737, Fax
(513) 271-1598
www.allergan.com/site/products/consumers/home.asp?id=celluvisc&largeText,
US Federal Postal and Transportation Law (Postal Law Title 18, US Code Section 1716,
Department of Transportation Rules CFR 49, Section 173.386 and 173.387) mandates that
equipment returned to Solta for repair or return must be properly decontaminated with a
chemical cleared for use as a “Hospital Disinfectant” and which is commercially available.
To ensure that transportation workers and Solta personnel are not exposed to pathogens, a
signed statement of decontamination must be enclosed with the return shipment.
If this is not done, Solta will not accept the shipment and the sender will be liable for all
costs and delays.
The text of the Decontamination Certificate must include the following statements or
information:
The undersigned individual, at the (institution) in
(City and State) certifies that the Solta equipment being
returned has undergone decontamination with a commercially available Hospital
Grade disinfectant / germicide, and is clear and free from biohazards including but
not limited to blood, dermal matter, other body tissues and fluids or components and
constituents thereof.
The undersigned also agrees to reimburse Solta for any costs incurred in shipping,
handling, cleaning of the enclosed equipment in the event that the items received by
Solta are found to be in a contaminated condition.
Model
Serial Number
Date of Manufacture
Print Name
Signature
Date
Warning:
The Fraxel re:store and Fraxel re:store DUAL Laser Systems are classified to contain Class
4 lasers by the Center for Devices and Radiological Health and by IEC / EN. This
classification represents the highest power laser. The output power is in excess of 300 times
the maximum permissible exposure per ANSI Z136 and IEC60825-1. The physician and
associated staff must take precautions to prevent exposure of laser energy to the eye and
unintended skin exposure from either direct or diffusely reflected laser beams. In addition,
precautions must be taken in the surgical environment to prevent hazards of fire and
electrical injury.
Warning:
MDSS GmbH
Schiffgraben 41
D-30175 Hannover
Germany
9.2 Console
Dimensions / in 19.25w x 17.75h x 17.5d
(/cm) 48.9w x 45.1h x 44.45d
Weight ~ 55 lbs
Warning:
SEVERE DAMAGE TO THE UNIT MAY 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.
9.4 Cart
Dimensions / in 20w x 30h x 22d
(/cm) 50.8w x 76.2h x 55.9d
Weight <100 lbs
Regulations state that laser-based devices that are classified as CDRH Class 4 shall have
instructions for external Factory Calibration of the power output.
External Factory Calibration of the Fraxel re:store and Fraxel re:store DUAL Laser Systems
must be performed by a factory-qualified engineer or technician. Please contact Solta
Customer Service with questions relating to the external power calibration of the Fraxel®
laser.
10.2 Procedure
10.2.1 Connect the PC and the Fraxel re:store or Fraxel re:store DUAL Laser
System using the Serial Connector. Both systems must be “OFF” at time of
connection.
10.2.2 Turn on the computer. Once this has started, turn on the laser system. Wait
for Self-Test to complete.
10.2.5 When finished, power down the computer and the Laser System, and
disconnect the units by removing the serial connector.
11.1 Shipping
The Fraxel re:store and Fraxel re:store DUAL Laser Systems will be shipped in a specially
designed container. When the shipment is received, inspect the exterior container for
damage. Inspect the shock indicators for indications of shipping damage. If there is exterior
damage, DO NOT ACCEPT OR UNPACK THE SYSTEM. Contact Solta Customer Service
at +1 510-782-2286 or your local authorized distributor of Solta Medical lasers and the
shipping company immediately.
DO NOT ATTEMPT TO UNPACK THE SYSTEM even if the system is undamaged and the
shock indicators appear normal. Unpacking will be done as a part of installation by Solta
authorized representatives.
Store the system indoors and at a temperature similar to the temperature of the facility in
which it is to be installed. When the system has been successfully installed, return the
shipping containers to Solta with the enclosed shipping documents.
11.2 Installation
The Fraxel re:store Laser Systems will be installed by Solta Customer Service. At this time
the system, its use, indications and safety features will be explained to facility personnel as
part of the Solta Training Program. It is the customers’ responsibility to prepare the site. See
Site Preparation Guide for installation utilities, space, and other prerequisites.
The dimensions of the Fraxel re:store and Fraxel re:store DUAL Laser Systems are listed in
the specifications above. Allow adequate space for ventilation (at least a 12 inch perimeter
all around the laser system) to prevent overheating.
Allow extra space for placement of the footswitch. The footswitch must remain accessible
during all treatments. The unit must not be moved by pulling on the footswitch cable, the
handpiece support arm, or the handpiece umbilical.
11.4 Environmental
The temperature in the laser room should ideally remain between 65º to 80º F, (18 – 27°C)
both for patient comfort and for optimum operation of the laser. Patients may feel more
discomfort if the temperature of the room is excessively high. A maximum ambient operating
temperature of 104°F / 40ºC is allowed. The cooling system for the laser is forced air, and
no other external utilities are required.
The Fraxel re:store and Fraxel re:store DUAL Laser Systems will emit a maximum of 600W /
2050BTUh into the environment around the console.
11.5 Electrical
The Fraxel re:store and Fraxel re:store DUAL Laser Systems contain a universal, medical
grade, power-factor corrected power supply. The line voltage and power switch amperage
requirements are given in the specifications section of the manual. Solta recommends a
dedicated circuit for the laser system. Place the power cord where it cannot become a
hazard, for example by being tripped over or having sharp objects dropped on it.
Warning:
The operator is responsible for ensuring that the proper electrical specifications are met at
the installation site.
Warning:
Laser equipment not in use should be protected against unauthorized use by removing the
key from the key switch. Keep the key in a designated place accessible only to designated
and trained personnel. Moving the Laser
11.5.1 Shut down the laser and then remove the power cord from the wall and from
the power switch housing in the laser.
11.5.2 Remove the footswitch cable plug from the rear of the system and carefully
wrap the footswitch cable around the footswitch housing. Store the
footswitch in the basket in the rear of the cart. If the external interlock is
connected, remove this plug.
11.5.3 Lock the handpiece umbilical management arm prior to movement. Unlock
the cart wheels.
11.5.4 Using the console handle, move the system to the new location. Be careful
when pushing the unit over elevator thresholds, carpet-linoleum interfaces,
and other step-like features in the path of motion. Do not allow the unit to tip
over when in motion. The safest way to cross a high threshold is to back the
unit into the threshold and pull it across, so that the larger wheels cross the
threshold first.
11.5.5 When the Fraxel re:store and Fraxel re:store DUAL Laser Systems are
parked in their working location, the brakes located on the base of the
console must be locked thus avoiding accidental movement and reducing the
possibility of tilting the laser system.
11.5.6 The Fraxel re:store Dual has been fully tested and is compliant to the Class
A limits of the EN60601-1-2 medical device standards. The Class A limits in
the EN60601-1-2 standard are used to provide reasonable protection against
harmful electromagnetic interference caused by medical equipment. To
avoid interference with other devices, use the electrical cord provided with
the Fraxel re:store Dual system and always plug the cord into a grounded
outlet.
.
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:
Never move the unit by pulling on the handpiece support arm or by pulling on the footswitch
cable. Do not utilize an undersized substitute cart to move the system.
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.
Description Symbol
Caution / Warning: See Instructions for Use
Date of Manufacture
European Conformity
Footswitch
Fuse
Manufacturer
Handpiece Connector
MC-SYS-SR1500-D-US
MC-SYS-SR1500-D-UPG-US
MC-SYS-SR1500-P-US REF
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